trips agreement article 73

(a) to require a Member to furnish any information the disclosure of which it considers contrary to its essential security interests; or (b) to prevent a Member from taking any action which it considers necessary for the protection of its essential security interests; (i) relating to fissionable materials or the materials from which they are derived; (ii) relating to the traffic in arms, ammunition and implements of war and to such traffic in other goods and materials as is carried on directly or indirectly for the purpose of supplying a military establishment; (iii) taken in time of war or other emergency in international relations; or

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The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic

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Preprint from SSRN , 28 Aug 2020 https://doi.org/10.2139/ssrn.3682260   PPR: PPR241791 

Abstract 

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PPRID: PPR241791 EMSID: EMS105308 SSRN preprint, version 4, posted 2020 August 28 https://doi.org/10.2139/ssrn.3682260

• 1. Edward Ball Eminent Scholar Prof. of International Law, Florida State University College of Law, Tallahassee, United States of America

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This preprint is made available via the Europe PMC open access subset , for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original preprint source.

The COVID-19 pandemic has caused Governments to contemplate measures to override patents and other intellectual property rights (IPRs) in order to facilitate production and distribution of vaccines, treatments, diagnostics and medical devices. This paper discusses whether the COVID-19 pandemic may be considered an “emergency in international relations” and how WTO Member States may invoke Article 73 (“Security Exceptions”) of the TRIPS Agreement as the legal basis for overriding IPRs otherwise required to be made available or enforced. It concludes that the pandemic constitutes an emergency in international relations within the meaning of Article 73(b)(iii) and that this provision allows Governments to take actions necessary to protect their essential security interests.

I. Introduction

The COVID-19 pandemic has caused governments to contemplate measures to override patents and other intellectual property rights (IPRs) in order to facilitate production and distribution of vaccines, treatments, diagnostics and medical devices (hereinafter generally “pharmaceuticals”). Regulatory-based marketing exclusivity rights are included for this purpose within IPRs.

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) that entered into force on 1 January 1995 establishes certain minimum standards of IPRs protections that WTO members are expected to maintain, including minimum standards of enforcement procedures available to private IPR owners. 1

This paper addresses whether, and under what circumstances, WTO Member States may invoke Article 73 (“Security Exceptions”) of the TRIPS Agreement as the legal basis for overriding IPRs otherwise required to be made available. In particular, the paper addresses whether the COVID-19 pandemic may be considered an “emergency in international relations”, and whether measures taken to override IPRs may be actions “a member … considers necessary for the protection of its essential security interests” within the meaning of Article 73(b).

In undertaking this analysis, the paper also addresses an argument that may foreseeably be raised against such invocation, namely that because the TRIPS Agreement provides certain specific rules with respect to emergency situations, the invocation of the security provision may not be justified.

The paper concludes that the COVID-19 pandemic (1) constitutes an emergency in international relations, (2) that measures taken by WTO members to override IPRs may be considered necessary to protect their essential security interests, and (3) specific provisions in the TRIPS Agreement addressing emergencies do not preclude members from invoking Article 73.

II. Article 73 and its Interpretation

A. the legal text.

Article 73 of the TRIPS Agreement provides as follows:

“Article 73

Security Exceptions

Nothing in this Agreement shall be construed:

• (a) to require a member to furnish any information the disclosure of which it considers contrary to its essential security interests; or

to prevent a member from taking any action which it considers necessary for the protection of its essential security interests ;

• (i) relating to fissionable materials or the materials from which they are derived;
• (ii) relating to the traffic in arms, ammunition and implements of war and to such traffic in other goods and materials as is carried on directly or indirectly for the purpose of supplying a military establishment;
• (iii) taken in time of war or other emergency in international relations ;
• (c) to prevent a member from taking any action in pursuance of its obligations under the United Nations Charter for the maintenance of international peace and security.” [emphasis added]

The Article 73, Security Exceptions, provision in the TRIPS Agreement is identical to the Article XXI, Security Exceptions provision in the General Agreement on Tariffs and Trade (GATT), the latter dating back to the inception of GATT in 1947. 2

B. Precedent

Throughout GATT and WTO history there were situations in which governments invoked “national security” as grounds for non-compliance with otherwise applicable norms. For example, when the US State of Massachusetts adopted a law prohibiting State agencies from procuring products from companies doing business with Burma (now Myanmar), and the United States of America (“United States”) was challenged at WTO by the European Union, the US Federal Government (on behalf of Massachusetts) invoked national security. 3 That case did not result in a WTO Dispute Settlement Body (“DSB”) decision because the US Supreme Court overturned the relevant Massachusetts legislation based on conflict with Federal statute. 4

In recent years, however, the invocation of national security grounds as the basis for WTO inconsistent measures has become commonplace, in particular as the United States has invoked national security as the basis for various WTO-inconsistent measures, including measures imposed on steel imports from China and the European Union, 5 on imports from Canada and Mexico during negotiation of USMCA, 6 and on a wide range of imports from China as part of President Trump’s agenda to restrain China’s economic ascendance. 7 This relatively recent step up in invocation of national security as grounds for imposing WTO-inconsistent measures has not yet resulted in review of these measures by the DSB. 8

There are, however, two recent WTO dispute settlement panel decisions that address challenges to WTO-inconsistent measures on national security grounds, one involving a complaint by the Ukraine against Russia with respect to transit of goods, 9 and the other involving a complaint by Qatar against Saudi Arabia for non-application of intellectual property protections otherwise required under the TRIPS Agreement. 10 Recognizing the importance of the first detailed consideration by a WTO panel of the GATT Article XXI exception, the Panel in the Russia-Transit case provided an extensive historical review of previous incidents, and a detailed treatment of the issues raised under Article XXI. 11 The Panel in the Saudi Arabia-IPRs case substantially relied on the jurisprudence of the Panel in the Russia-Transit case, with the important distinction for present purposes that the Saudi Arabia-IPRs Panel analyzed the situation under Article 73 of the TRIPS Agreement.

C. Justiciability

A key threshold issue in both WTO proceedings was whether the DSB has authority to make a decision regarding the legality of actions taken by a member based on national security grounds. In the Russia-Transit case, some members, including Russia, 12 and the United States as a third-party, argued that assertions of national security are effectively nonjusticiable. The Panel summarized the United States’ third-party position:

• 7.51. The United States, in a letter to the Chair of the Panel submitted on the due date for third-party submissions, argues that the Panel "lacks the authority to review the invocation of Article XXI and to make findings on the claims raised in this dispute". The reason advanced is that every WTO member retains the authority to determine for itself those matters that it considers necessary for the protection of its essential security interests, as "reflected" in the text of Article XXI of the GATT 1994. The United States describes this as an "inherent right" that has been repeatedly recognized by GATT contracting parties and WTO members.
• 7.52. In its subsequent submissions, the United States clarifies that it considers the Panel to have jurisdiction in the context of this dispute "in the sense that the DSB established it, and placed the matter raised in Ukraine's complaint within the Panel's terms of reference under Article 7.1 of the DSU". However, it considers that the dispute is "non-justiciable" because there are no legal criteria by which the issue of a member's consideration of its essential security interests can be judged. The United States bases its position on its interpretation of the text of Article XXI, specifically, the "self-judging" language of the chapeau in Article XXI(b) "which it considers necessary for the protection of its essential security interests". For the United States, the "self-judging" nature of Article XXI(b)(iii) establishes that its invocation by a member is "non-justiciable", and "is therefore not capable of findings by a panel", obviating the possibility of making recommendations under Article 19.1 of the DSU in this dispute.

That is, once national security grounds are asserted, a panel may not further assess the situation. If panels accepted that rationale, the assertion of national security would automatically act as a shield against a finding of WTO-inconsistency, and against any corollary demand that the claimed-against member withdraw its measures or suffer suspension of concessions.

The Panel in Saudi Arabia-IPRs summarized a challenge by Saudi Arabia, and by the United States as third-party, to the scope of authority of the Panel as follows:

• 7.9. While Saudi Arabia did not present the Panel with any arguments formulated in terms of the Panel's "jurisdiction" or the "justiciability" of the dispute, several third parties, including Australia and the European Union, construed Saudi Arabia's arguments as implying that Saudi Arabia regarded the matter as "non-justiciable". Furthermore, the United States argued that Saudi Arabia's invocation of the security exception in Article 73(b)(iii) of the TRIPS Agreement is not reviewable, and therefore, the matter is not "justiciable". There is a degree of overlap between the third parties' arguments presented in terms of "justiciability", on the one hand, and the arguments presented by the parties and third parties in relation to Saudi Arabia's argument that the Panel should decline to make any findings or recommendation based on Articles 3.4, 3.7 and 11 of the DSU, on the other hand.

Neither the Panel in the Russia-Transit or Saudi Arabia-IPRs cases accepted the argument that national security claims are effectively non-justiciable. After extensive review of the text and the negotiating history of GATT Article XXI, the Russia-Transit Panel concluded:

7.102. It follows from the Panel's interpretation of Article XXI(b), as vesting in panels the power to review whether the requirements of the enumerated subparagraphs are met, rather than leaving it to the unfettered discretion of the invoking member, that Article XXI(b)(iii) of the GATT 1994 is not totally "self-judging" in the manner asserted by Russia.

7.103. Consequently, Russia's argument that the Panel lacks jurisdiction to review Russia's invocation of Article XXI(b)(iii) must fail. The Panel's interpretation of Article XXI(b)(iii) also means that it rejects the United States' argument that Russia's invocation of Article XXI(b)(iii) is "non-justiciable", to the extent that this argument also relies on the alleged totally "self-judging" nature of the provision.

The Saudi Arabia-IPRs panel, in rejecting the non-justiciability argument and a “political question” variant proffered by Saudi Arabia, said:

• 7.13. With these general considerations in mind, the Panel will now turn to the specific arguments presented by Saudi Arabia, beginning with its argument that the current dispute is "not a trade dispute at all", but a "political, geopolitical, and essential security dispute".
• 7.16. The Panel is not persuaded that it can decline to make any findings or a recommendation, i.e. "decline to exercise its jurisdiction" on the basis of Saudi Arabia's argument that the "real dispute" between the parties is not a "trade dispute". The Panel considers that it is evident from its terms of reference that it has not been asked by Qatar or the DSB to make any findings or recommendation on any wider dispute between the parties. The matter raised by Qatar in its panel request, which now forms the Panel's terms of reference, concerns alleged violations of the TRIPS Agreement. Accordingly, the matter before the Panel falls within the legal subject-matter jurisdiction of a WTO dispute settlement panel.
• 7.17. For similar reasons, the Panel is not persuaded that it can decline to exercise jurisdiction on the basis of Saudi Arabia's argument that it is impossible for any findings or recommendation to secure a positive solution to "the matter" and/or achieve a satisfactory settlement of "the dispute" under the DSU. The Panel considers that this argument, like Saudi Arabia's argument concerning the "real dispute" not being a "trade dispute", is directed at the wider political dispute between the parties that is not at issue before the Panel. …

The dispute concerning whether invocations of GATT Article XXI and/or TRIPS Agreement Article 73 are “justiciable” is important for two reasons, at least. First, the decisions of the Panels make it clear that WTO members are under an obligation to invoke the Security Exceptions provisions with good faith justification, even if the members may have substantial discretion with respect to that justification. Second, the United States was the motivating force behind negotiation of the TRIPS Agreement and has pursued other members for alleged violations of the TRIPS Agreement with vigor. But the United States has argued that invocation of Article 73 (and GATT Article XXI) is entirely at the discretion of the member taking that action, and that there are no grounds for challenging such invocation under WTO law. The United States therefore should be seen to be “equitably estopped” from challenging a measure taken by another member under Article 73 because it is bound to respect its own reiterated position that such action is “non-justiciable”. 13 It would indeed be strange for the United States to argue that security-based actions taken against the Ukraine and Qatar are non-justiciable, but that emergency measures affecting US-owned patents are justiciable.

D. Elements of Article 73(b), TRIPS Agreement

1. analytic framework.

With the issue of justiciability resolved, the Panels in each the Russia-Transit dispute and the Saudi Arabia-IPRs dispute went on to review the measures taken by the complained-against parties and the justifications under Article XXI (GATT) and Article 73 (TRIPS Agreement), respectively. Because this paper is assessing potential invocation of Article 73, it focuses here on the jurisprudence of the Panel in the Saudi Arabia-IPRs dispute, noting that the Saudi Arabia-IPRs Panel relied on the jurisprudence of the Panel in Russia-Transit . In doing so, the Panel in Saudi Arabia-IPRs presented a consolidated overview of the analytical method followed by the Russia-Transit Panel. The Saudi Arabia-IPRs Panel said:

• 7.230. Article XXI(b)(iii) of the GATT 1994, which is identical to Article 73(b)(iii) of the TRIPS Agreement, was recently addressed by the panel in Russia – Traffic in Transit . It held that a panel must determine for itself whether the invoking member's actions were "taken in time of war or other emergency in international relations" in subparagraph (iii) of Article XXI(b) of the GATT 1994. It further found that a panel's review of whether the invoking member's actions are ones "which it considers necessary for the protection of its essential security interests" under the chapeau of Article XXI(b) of the GATT 1994 requires an assessment of whether the invoking member has articulated the "essential security interests" that it considers the measures at issue are necessary to protect, along with a further assessment of whether the measures are so remote from, or unrelated to, the "emergency in international relations" as to make it implausible that the invoking member implemented the measures for the protection of its "essential security interests" arising out of the emergency. According to the panel in Russia – Traffic in Transit , the obligation of a member to interpret and apply Article XXI(b)(iii) of the GATT 1994 in "good faith" requires "that the measures at issue meet a minimum requirement of plausibility in relation to the proffered essential security interests, i.e. that they are not implausible as measures protective of these interests".
• “7.241. As previously stated, the wording of Article 73(b)(iii) of the TRIPS Agreement is identical to that of Article XXI(b)(iii) of the GATT 1994, which was first interpreted by the panel in Russia – Traffic in Transit . The panel's interpretation of Article XXI(b)(iii) in that dispute gave rise to an analytical framework that can guide the assessment of whether a respondent has properly invoked Article XXI(b)(iii) of the GATT 1994, or, for the purposes of this dispute, Article 73(b)(iii) of the TRIPS Agreement.
• whether the existence of a "war or other emergency in international relations" has been established in the sense of subparagraph (iii) to Article 73(b);
• whether the relevant actions were "taken in time of" that war or other emergency in international relations;
• whether the invoking member has articulated its relevant "essential security interests" sufficiently to enable an assessment of whether there is any link between those actions and the protection of its essential security interests; and
• whether the relevant actions are so remote from, or unrelated to, the "emergency in international relations" as to make it implausible that the invoking member considers those actions to be necessary for the protection of its essential security interests arising out of the emergency.
• 7.243. The parties in this dispute and multiple third parties each express agreement with the general interpretation and analytical framework enunciated by the panel in Russia – Traffic in Transit . These parties and third parties therefore considered that both can be transposed to Article 73(b)(iii) of the TRIPS Agreement.” [footnotes omitted]

2. Emergency in international relations

The first question that a WTO panel would need to assess is whether an “emergency in international relations” exists within the meaning of Article 73(b)(iii). On 30 January 2020, the WHO Director-General declared a Public Health Emergency of International Concern (PHEIC) over the COVID-19 outbreak, 14 stating, inter alia , “Our greatest concern is the potential for the virus to spread to countries [outside China] with weaker health systems, and which are ill-prepared to deal with it.” The declaration by WHO provides objective evidence of an emergency in international relations.

PHEIC involves interaction between States in the sense that a virus or other pathogen is transmitted across national borders, and it affects individuals across diverse geographies. One of the major issues in addressing the pandemic concerns the allocation of medicines (including vaccines) and medical devices among States. Already as of July 2020 the constrained production capacity of the drug and vaccine suppliers is being allocated to high income countries (HICs) based on their financial capacity to subsidize and/or to pay for these products. 15 Low- and middle-income countries (LMICs) face serious risk that their needs for medicines and medical devices will not be met in a timely way. The issue of allocation of scarce resources is decidedly an issue of “international relations”. The international community has yet to establish a viable mechanism to assure equitable access.

Beyond the issue of allocation of scarce resources, there are other aspects relating to the pandemic that create an emergency in international relations, including those created by a sharp slowdown in international trade and travel, which is having a major impact on economies around the world, particularly affecting the most economically vulnerable. Moreover, as the UN Secretary-General has observed to the Security Council, the fact of the pandemic is leading to escalations of hostility and threats of terrorist activities. These circumstances also cross the legal threshold of an emergency in international relations. 16 On 1 July 2020, the UN Security Council adopted a resolution directed to the COVID-19 pandemic:

Resolution 2532 (2020)

Adopted by the Security Council on 1 July 2020

The Security Council,

Recalling its primary responsibility for the maintenance of international peace and security,

Reaffirming the principles and purposes of the Charter of the United Nations,

Expressing grave concern about the devastating impact of the COVID-19 pandemic across the world, especially in countries ravaged by armed conflicts, or in post-conflict situations, or affected by humanitarian crises,

Recognizing that conditions of violence and instability in conflict situations can exacerbate the pandemic, and that inversely the pandemic can exacerbate the adverse humanitarian impact of conflict situations,

Recognizing that the peacebuilding and development gains made by countries in transition and post-conflict countries could be reversed in light of the COVID-19 pandemic outbreak,

Underscoring that combating this pandemic requires greater national, regional and international cooperation and solidarity, and a coordinated, inclusive, comprehensive and global international response with the United Nations playing a key coordinating role,

Commending the continued contribution and commitment of national and international health and humanitarian relief personnel to respond urgently to the COVID-19 pandemic,

Recognizing efforts and measures proposed by the Secretary-General concerning the response to the potential impact of the COVID-19 pandemic to conflict-affected countries, in particular his appeal for an immediate global ceasefire,

Having considered the resolution 74/270 “Global solidarity to fight the coronavirus disease 2019 (COVID-19)” adopted by the UN General Assembly on 2 April 2020,

Acknowledging the launch of the Global Humanitarian Response Plan for COVID-19 by the United Nations, which puts the people at the center of the response,

Considering that the unprecedented extent of the COVID-19 pandemic is likely to endanger the maintenance of international peace and security,

• Demands a general and immediate cessation of hostilities in all situations on its agenda and supports the efforts undertaken by the Secretary-General and his Special Representatives and Special Envoys in that respect;
• Calls upon all parties to armed conflicts to engage immediately in a durable humanitarian pause for at least 90 consecutive days, in order to enable the safe, unhindered and sustained delivery of humanitarian assistance, provisions of related services by impartial humanitarian actors, in accordance with the humanitarian principles of humanity, neutrality, impartiality and independence, and medical evacuations, in accordance with international law, including international humanitarian law and refugee law as applicable;
• Affirms that this general and immediate cessation of hostilities and this humanitarian pause do not apply to military operations against the Islamic State in Iraq and the Levant (ISIL, also known as Da’esh), Al Qaeda and Al Nusra Front (ANF), and all other individuals, groups, undertakings and entities associated with Al Qaeda or ISIL, and other terrorist groups, which have been designated by the Security Council;
• Requests the Secretary-General to help ensure that all relevant parts of the United Nations system, including UN Country Teams, in accordance with their respective mandates, accelerate their response to the COVID-19 pandemic with a particular emphasis on countries in need, including those in situations of armed conflict or affected by humanitarian crises;
• Requests the Secretary-General to provide updates to the Security Council on the UN efforts to address the COVID-19 pandemic in countries in situations of armed conflict or affected by humanitarian crises, as well as on the impact of COVID-19 on the ability of peace-keeping operations and Special Political Missions to deliver their mandated priority tasks;
• Requests the Secretary-General to instruct peace-keeping operations to provide support, within their mandates and capacities, to host country authorities in their efforts to contain the pandemic, in particular to facilitate humanitarian access, including to internally displaced persons and refugee camps and allow for medical evacuations, and further requests the Secretary-General and Member States to take all appropriate steps to protect the safety, security and health of all UN personnel in UN peace operations, while maintaining the continuity of operations, and to take further steps towards the provision of training for peacekeeping personnel on issues related to preventing the spread of COVID-19;
• Acknowledges the critical role that women are playing in COVID-19 response efforts, as well as the disproportionate negative impact of the pandemic, notably the socio-economic impact, on women and girls, children, refugees, internally displaced persons, older persons and persons with disabilities, and calls for concrete actions to minimize this impact and ensure the full, equal and meaningful participation of women and youth in the development and implementation of an adequate and sustainable response to the pandemic;
• Decides to remain seized of the matter.

The Panels in both the Russia-Transit and Saudi Arabia-IPRs disputes recognized that a presumption of deference should be accorded to members that determine an emergency in international relations exists. There should be objective facts supporting the determination. The COVID-19 pandemic appears to satisfy the requirement of objectively verifiable circumstances of emergency in international relations. 17

The first element necessary to justify invocation of Article 73 – the existence of an emergency in international relations – is satisfied by the COVID-19 pandemic.

The second element is that the relevant measures be “taken in time of” war or international emergency. Not much discussion is required here. Whatever measures a WTO Member Government takes to address the pandemic are almost certainly to be taken during the course of the pandemic, including what could be an extended period of continuing requirement for medicines and vaccines to prevent re-emergence once the virus has been brought under control. At some point in the future COVID-19 will no longer represent a threat to public health, and at some point further action by members might not be justified as “taken in time of” international emergency, but when that end-point might arise does not need to be addressed at this stage.

The third element is that the country taking the measures articulated its “essential security interests”. This element, as with the second, should not require detailed elaboration in the context of the COVID-19 pandemic. The Russia-Transit Panel referred to this element in the context, inter alia , of the “maintenance of law and public order internally”, as well as in the context of external threats. 18 While the Panel went on to say that members have an obligation to make a determination regarding essential security interests “in good faith”, and may not simply relabel trade interests as essential security interests, the obligation on the invoking member is to “articulate the essential security interests said to arise from the emergency in international relations sufficiently enough to demonstrate their veracity”. 19 The protection of the public health of the nation is one of the core obligations of a government, and the threat of a pandemic to public health directly affects the internal order of the state. Even if member interests are looked at from the narrow perspective of military/defense vulnerability, the health of the national population is manifestly related to “essential security interests”. It is difficult to foresee the WTO Dispute Settlement Body deciding that protecting the national population from a pandemic is not within the essential security interests of the state.

The fourth and final element is whether “the relevant actions are so remote from, or unrelated to, the ‘emergency in international relations’ as to make it implausible that the invoking member considers those actions to be necessary.” 20 This fourth element derives from the language of Article 73(b) referring to actions that the member “considers necessary”, and the limits on what a member might consider necessary within the parameters of a good faith determination.

It is important to distinguish the concept of “considers necessary” in the context of Article 73(b) as compared with the concept of “necessary” in the context of Article XX of GATT, such as in Article XX(b) with respect to measures “necessary to protect human, animal or plant life or health” and XX(d) with respect to measures “necessary to secure compliance with laws or regulations which are not inconsistent …”. There is a rich WTO jurisprudence concerning the circumstances in which members may invoke Article XX(b) and (d), and other subparagraphs of GATT Article XX, to justify measures otherwise inconsistent with GATT. 21 These decisions include as part of the analysis of whether a measure is “necessary” the consideration of potential reasonably available alternative measures that might be less trade restrictive. Under Article XX(b) and (d) jurisprudence, a measure inconsistent with GATT should not be “more trade restrictive than necessary”. (There is consistent jurisprudence that each member may determine the level of protection it considers appropriate. 22 ) Whatever the precise boundaries of the “necessity test” under GATT Article XX, the Panel in the Russia-Transit case made clear that a different approach is proper under GATT Article XXI, and by extension TRIPS Agreement Article 73.

The Panel in the Russia-Transit dispute, reflecting also the views of all third-party participants, said that members have substantial discretion to decide what measures they “consider necessary” to protect their essential security interests, and that a WTO Panel would not analyze whether the same objectives could be accomplished using alternative measures. 23 This flows from the underlying concept underlying Article XXI that recognizes the inherent sovereign right of Governments to protect essential security interests, and that GATT (and WTO) will not try to dictate the measures that governments may take to do that.

The Panel in the Russia-Transit readily found that Russia’s action in blocking the transit of Ukrainian goods across its territory was within Russia’s necessity discretion once it had established that it acted in times of emergency in international relations. 24 Russia was not required to demonstrate that it could accomplish its objectives with alternative or less trade restrictive measures.

And yet, while members have wide discretion to decide on measures necessary to protect their essential security interests, the discretion is not “unlimited”. A measure does not need to be “reasonable”, nor does it need to be the “least trade restrictive”, but it does need to be “plausibly related” to the emergency that the member is addressing. 25

The requirement of a plausible relationship was important in the outcome of the Saudi Arabia-IPRs dispute. There was in Saudi Arabia a “pirate” satellite broadcast network (“beoutQ”) that was showing content produced by nationals of various countries and regions, including by nationals of Qatar, but also prominently including by producers in the European Union, Brazil and elsewhere. This included popular European football matches. When Saudi Arabia announced a series of measures against Qatar based on protecting its essential security interests, it included non-application of criminal proceedings against the Saudi pirate network. The availability of such criminal procedures is a requirement of Article 61 of the TRIPS Agreement. 26

Qatar and its nationals owned and operated a satellite TV broadcast station (“beIN”) that broadcast works own by foreign copyright owners under license, such as broadcasts of European football league games. Saudi Arabia was claiming that by failing to protect content broadcast by Qatar, it was pursuing a broad regime of sanctions against Qatar and its nationals. But third-party members whose nationals owned copyrights in the work broadcast by the pirate station in Saudi Arabia demanded an explanation regarding how failure by Saudi Arabia to enforce third-country member copyrights could plausibly protect Saudi Arabia’s essential security interests.

The Panel found that there was no plausible relationship between Saudi Arabia’s non-application of criminal enforcement actions against pirate broadcasts of works of non-Qatari nationals and whatever essential security interest Saudi Arabia might have vis-à-vis Qatar, saying:

• 7.289. In the Panel's view, however, the same conclusion cannot be reached regarding the connection between Saudi Arabia's stated essential security interests and its authorities' non-application of criminal procedures and penalties to beoutQ. In contrast to the anti-sympathy measures, which might be viewed as an aspect of Saudi Arabia's umbrella policy of ending or preventing any form of interaction with Qatari nationals, the Panel is unable to discern any basis for concluding that the application of criminal procedures or penalties to beoutQ would require any entity in Saudi Arabia to engage in any form of interaction with beIN or any other Qatari national.
• 7.290. Multiple third-party right holders submitted evidence directly to the Saudi authorities and have made such evidence available to these authorities in the course of this dispute…. 27
• 7.291. The Panel recalls that the non-application of criminal procedures and penalties to beoutQ, a commercial-scale broadcast pirate, affects not only Qatar or Qatari nationals, but also a range of third-party right holders. The Panel recalls that several third parties commented on the question of whether—and, if so, how—the non-application of criminal procedures and penalties to beoutQ could plausibly be connected to Saudi Arabia's essential security interests. Brazil stated that it "fails to see how the respondent's proffered essential security interests, or any country's essential security interests for that matter, could be protected by allowing the operation of a copyright pirate whose broadcasts have spread beyond the respondent's borders and encompass not only the copyrights held by the claimant's nationals but by other countries' nationals as well, including Brazil's". Similarly, the European Union stated that, without taking a position on the facts of this case, it would "welcome a detailed explanation clarifying why, in order to protect its essential security interests, Saudi Arabia considers it necessary to breach the rights of third party right-holders". In its third-party oral statement, the European Union reiterated that it "would appreciate it if Saudi Arabia could provide a plausible explanation of the reasons why 'it considers necessary' to allow the systematic infringement of the intellectual property rights of EU right holders in order to protect its essential security interests" .
• 7.292. The Panel observes that, in further contrast to the anti-sympathy measures, neither party has suggested that there is any direct link between the non-application of criminal procedures and penalties, on the one hand, and any action taken on, or consequential to, the 5 June 2017 "comprehensive measures" severing relations with Qatar, on the other hand . Whereas the anti-sympathy measures were announced on 6 June 2017, there is no such temporal connection between the non-application of criminal procedures and penalties and the 5 June 2017 "comprehensive measures". For the reasons given above, there is also no rational or logical connection between the comprehensive measures aimed at ending interaction with Qatar and Qatari nationals, and the non-application of Saudi criminal procedures and penalties to beoutQ.
• 7.293. The Panel concludes that the non-application of criminal procedures and penalties to beoutQ does not have any relationship to Saudi Arabia's policy of ending or preventing any form of interaction with Qatari nationals. Therefore, the Saudi authorities' non-application of criminal procedures and penalties to beoutQ is so remote from, or unrelated to, the "emergency in international relations" as to make it implausible that Saudi Arabia implemented these measures for the protection of its "essential security interests". As a consequence, the Panel concludes that the non-application of criminal procedures and penalties to beoutQ does not "meet a minimum requirement of plausibility in relation to the proffered essential security interests, i.e. that they are not implausible as measures protective of these interests". [emphasis added]

This is the first time that a WTO panel has disallowed a national security exception claim, whether under GATT XXI, Article 73 of the TRIPS Agreement, or Article XIV bis of the General Agreement on Trade in Services (GATS).

The Panel in Saudi Arabia-IPRs , and the third-party submissions, framed the issue of the necessary-ness of the Saudi measures that affected foreign (non-Qatari) IP owners as one of “plausible relationship” to protecting Saudi Arabia’s essential security interests. It might equally well have framed the issue as one of acceptable levels of “collateral damage” to third-party member interests. Saudi Arabia’s decision to allow the operation of the pirate broadcast network that affected the commercial interests of Qatar and its nationals presumably had an adverse financial impact on Qatar. It might affect Qatari policy in a way deemed desirable by Saudi Arabia. Saudi Arabia’s “bad act” was not that it put a Saudi pirate broadcast station into competition with a Qatar broadcast station, but that it failed or refused to license its content from European and/or other content originators. This created unacceptable damage to third-member content owners – an injury “collateral” to the intended target of its action – which could have been avoided, and presumably without undermining its objective of adversely affecting Qatari commercial interests.

Whether the issue is framed in terms of “plausible relationship” or “acceptable collateral damage”, it is difficult to foresee a situation where this issue could prove problematic in relation to use of Article 73 to override patent or market exclusivity interests in medicines or medical devices used to address COVID-19. If a WTO member seeking to produce or supply medicines overrides patents held by foreign nationals, that is directly related to addressing the problem it is seeking to address. These measures would be “plausibly related” to protecting essential security interests. If to secure a vaccine a WTO member suspended patent rights in vaccine technology to allow its domestic industry, or importers, to use a foreign-IP owner’s technology, that would manifestly be reasonably related to addressing the national security interest.

For present purposes it does not appear important to speculate as to what the “outer boundaries” of a security exception claim might be with respect to a WTO member that chooses to suspend patent, regulatory marketing exclusivity or other IP addressed by the TRIPS Agreement in order to address the COVID-19 pandemic. 28

The fourth element of a “not implausible” relationship between suspending IPRs and the objective of protecting essential security interests is met in the context of invoking TRIPS Agreement Article 73 to address the COVID-19 pandemic.

III. TRIPS Agreement Obligations and Flexibilities

A. flexibilities.

As is well-known, the TRIPS Agreement embodies various “flexibilities” that authorize governments to take measures allowing use by third parties of otherwise protected rights. Though often framed as “exceptions”, the flexibilities are a customary part of the international IP framework that seeks a balance between exclusive private interests, on one side, and broader public interests, on the other. In this regard, rather than “exceptions”, the flexibilities might better be thought of as the flip side of the exclusive characteristic of various IP subject matters covered by the TRIPS Agreement.

The main flexibilities relevant to addressing the COVID-19 pandemic are the compulsory patent licensing (Articles 31 and 31 bis , TRIPS Agreement) provisions, and the patent-related limited exception (Article 30) provision. The compulsory licensing provisions authorize governments to permit parties other than the owners/grantees (i.e. third parties) to make use of patents without the consent of the patent owners. (The third-party user may be the government itself under a “government use” license.) With respect to Articles 31 and 31 bis certain procedural steps are laid out. National law generally should incorporate these procedural steps in accordance with the relevant member’s customary practices.

Copyright, design right, trademark and trade secret (as well as regulatory data protection), each incorporate TRIPS Agreement flexibilities, some more relevant than others to addressing the pandemic.

In reaction to political and legal hostility faced by developing countries attempting to make use of TRIPS Agreement flexibilities, WTO members in November 2001 adopted the Doha Declaration on the TRIPS Agreement and Public Health that affirmed the right of WTO members to use the flexibilities, and to promote access to medicines “for all”. 29

As discussed earlier, the COVID-19 pandemic is a public health emergency affecting all WTO members, even those without significant numbers of infected individuals. 30 The fact of an emergency triggers certain specific accommodations under Article 31 of the TRIPS Agreement, in particular that a compulsory license may be issued without prior negotiation with the patent owner for a license on reasonable terms and conditions. 31

Other procedural rules under Article 31 include that a license be considered on its individual merits, and that a mechanism for contesting the grant of a license before an administrative or judicial body is available.

Article 31 also requires that the patent owner receive adequate remuneration in the circumstances of the case, and that a compulsory licensee should not export a predominant part of its production (Article 31(f)). The latter limitation of Article 31 is modified by Article 31 bis that establishes procedures pursuant to which compulsory licenses may be issued predominantly for export, and that establishes criteria for “eligible importing countries”. Eligibility is automatically open to least developed countries (LDCs), and to other countries that do not have adequate capacity to manufacture the pharmaceutical products they are seeking.

A number of high income countries (HICs) have “opted out” of eligibility as importing countries, and in principle may not import the products exported under Article 31 bis , although there is possibility that at least some of the opted out WTO members may choose to opt back in as eligible importing members. Rather than opting back in, HICs that have opted out may invoke Article 73.

B. TRIPS and Emergencies

Existing jurisprudence regarding the TRIPS Agreement might affect analysis under the Security Exceptions. The most relevant jurisprudence is in the decision by the Panel in the Canada-Patent Protection of Pharmaceutical Products case that addressed the EU claim that Canadian legislation embodying a regulatory review exception (and stockpiling exception) was inconsistent with Article 30 of the TRIPS Agreement. 32 In assessing Canada’s argument in favor of a broad exception reflecting public health interests, the Panel (chaired by Prof. Robert Hudec) observed that the countries negotiating the TRIPS Agreement deliberately designed mechanisms to take account of public health interests, including certain limitations, and that this balancing during the negotiating process should not be reassessed by a Panel:

• 7.25 The EC did not dispute the stated goal of achieving a balance within the intellectual property rights system between important national policies. But, in the view of the EC, Articles 7 and 8 are statements that describe the balancing of goals that had already taken place in negotiating the final texts of the TRIPS Agreement. According to the EC, to view Article 30 as an authorization for governments to "renegotiate" the overall balance of the Agreement would involve a double counting of such socio-economic policies. In particular, the EC pointed to the last phrase of Article 8.1 requiring that government measures to protect important socio-economic policies be consistent with the obligations of the TRIPS Agreement. The EC also referred to the provisions of first consideration of the Preamble and Article 1.1 as demonstrating that the basic purpose of the TRIPS Agreement was to lay down minimum requirements for the protection and enforcement of intellectual property rights.
• 7.26 In the Panel's view, Article 30's very existence amounts to a recognition that the definition of patent rights contained in Article 28 would need certain adjustments. On the other hand, the three limiting conditions attached to Article 30 testify strongly that the negotiators of the Agreement did not intend Article 30 to bring about what would be equivalent to a renegotiation of the basic balance of the Agreement . Obviously, the exact scope of Article 30's authority will depend on the specific meaning given to its limiting conditions. The words of those conditions must be examined with particular care on this point. Both the goals and the limitations stated in Articles 7 and 8.1 must obviously be borne in mind when doing so as well as those of other provisions of the TRIPS Agreement which indicate its object and purposes.

Assume for the sake of argument that a national government invokes Article 73, TRIPS Agreement, to justify a failure to follow certain steps or substantive requirements with respect to the grant of a compulsory license under Article 31, or to act inconsistently with the Article 31 bis provisions applicable to compulsory licensing predominantly for export. Article 31 makes express provision regarding the compulsory patent licensing rules that may be avoided in a situation of national emergency or other circumstances of extreme urgency. 33 It can be argued that Article 31 expressly contemplates the situation of a pandemic outbreak (i.e. a national emergency) and prescribes the rules to be followed in such event. If the negotiating members expressly addressed that situation – and confirmed that in the Doha Declaration on the TRIPS Agreement and Public Health 34 – might this affect a determination that an emergency measure under Article 73 is “necessary”?

Simply put, the argument against invocation of Article 73 as grounds for avoiding otherwise applicable obligations under Article 31 or 31 bis would be that these provisions were negotiated with the possibility of an international emergency and/or pandemic in mind, and that the rules for addressing those situations were spelled out in advance. Therefore, WTO members have no basis to assert that the COVID-19 pandemic represents some new or un-contemplated circumstance justifying extraordinary measures.

There are several potential responses to this line of argument.

First, the Russia-Transit Panel and the Saudi Arabia-IPRs Panel have recognized that a member taking measures to protect its essential security interests can take those measures which it “considers necessary” and does not need to analyze whether there are alternative or less trade-restrictive measures available. The measures need only be plausibly related to the objectives of the measures. This alone is enough to rebut the suggestion that the existence of alternative mechanisms in the TRIPS Agreement precludes invocation of Article 73.

Second, notwithstanding that Article 31 and 31 bis contemplate the possibility of a national emergency involving public health, the negotiators may not have foreseen the extent to which a particular event would impact national and global public health, and so did not have all the information relevant to negotiating the proper framework. Even six months into the COVID-19 outbreak there remain major gaps in scientific understanding of the nature of the disease and the means to bring the pandemic under control. Therefore, to say that the negotiators of the TRIPS Agreement in 1986-1993, or of the 2017 amendment, contemplated the COVID-19 pandemic is not correct.

Third, Article 31 and Article 31 bis are only part of the TRIPS Agreement rule set that are applicable to members with respect to intellectual property in relation to the pandemic. There are various other provisions that affect matters such as the ability of pharmaceutical manufacturers to place vaccines, treatments, diagnostics and medical devices on the market. 35 For example, Article 39.3 governs the treatment of regulatory data submitted to drug regulatory authorities, providing protection in specific circumstances against “unfair commercial use” of that data. Article 39.3 is the basis for the adoption by various members of regulatory marketing exclusivity rules (although Article 39.3 does not require such rules). If members choose to authorize manufacturing and distribution, and/or importation, of pharmaceutical products to address COVID-19, they may need to suspend prior grants of marketing exclusivity rights. Article 73 would provide the flexibility to overcome exclusive marketing rights, regardless of proffered interpretation of Article 39.3. Articles 31 and 31 bis of the TRIPS Agreement operate in tandem with provisions addressing other IPRs, and invocation of Article 73 would facilitate an efficient approach to overcoming IP-related obstacles.

Beyond rules regarding patents and regulatory market exclusivity, trademark claimants may attempt to block distribution of pharmaceutical products that have the same color and shape of products they have previously marketed; copyright claimants may seek to block reproduction of information pamphlets, online materials, etc., used by physicians and patients; design right claimants might assert exclusive rights with respect to delivery devices (e.g., syringes, vials, etc.); 36 trade secret holders may attempt to prevent use of production processes or other commercially valuable information used to make relevant products. These additional forms of IP and related subject matter are covered by a significant group of TRIPS Agreement rules.

In addition to the substantive obligations established by the TRIPS Agreement, there are the enforcement-related obligations, which in certain cases prescribe procedural steps that should be followed by judicial and administrative authorities, as well as conferring procedural rights on holders of IP.

Article 73 addresses a broader set of TRIPS Agreement rules than those applicable to compulsory patent licensing (including the Article 61 criminal enforcement provision addressed by Saudi Arabia-IPRs Panel). Article 73 may be invoked to address the panoply of rules provided that the measures taken by the invoking government plausibly related to the objective of addressing its essential security interests.

IV. Articles 73 and Other Obligations

A. national laws and measures.

A government suspending IP rights may face challenges under its national Constitution, or under a domestic legislative enactment protecting the interest of IP owners. This paper does not address the potential domestic legal complexities that may be involved in suspending IPRs. It is important not to confuse the national and international legal issues. The reason for invoking Article 73 is that one WTO member may claim against another member in WTO for having violated an international obligation (i.e., the TRIPS Agreement), which raises a different set of issues than whether the claimed-against WTO member acted improperly under its domestic Constitution and/or legislation. Solving a TRIPS Agreement problem by invoking Article 73 does not “cure” a potential domestic law problem. At the same time, the fact that a government has acted improperly (or properly) under its domestic law does not in itself create a TRIPS Agreement violation or problem. The international and legal issues are generally distinct. 37

This point is worth emphasizing. The questions that may be raised by invocation of Article 73 of the TRIPS Agreement (or Article XXI of GATT) are questions of international law and principally affect inter-governmental relations.

B. Trade and Investment Agreements

It is also important to recognize that the TRIPS Agreement is not the only set of international rules that may affect government decisions to suspend IPRs. Many WTO members are also parties to preferential trade and investment agreements (TIAs) that incorporate obligations similar to those arising under the TRIPS Agreement and may include more restrictive rules (such as in the area of investment and related disputes). These TIAs also include security exceptions that may be equivalent to those found in the WTO agreements, though there might be differences. A WTO member should be careful to study the range of its international commitments before it acts.

With that said, with the life and health of the national population under threat by COVID-19, the grounds for invoking protection of essential security interests appears to be compelling. Article 73 is a flexibility provided by the TRIPS Agreement, and the Doha Declaration “affirm[s] that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all”. 38

V. The Context of Invocation

A. article 73 as the basis for domestic action.

As discussed in the previous section, the obligations established by the TRIPS Agreement are generally among WTO Member Governments at the international level. For some countries, the TRIPS Agreement nevertheless is directly effective as a part of national law as a consequence of the constitutionally defined relationship between treaties and domestic law. In countries where treaties are directly effective an individual may rely on the treaty as a source of rights, and the Government may act based on the treaty rules, provided that the treaty rules have not otherwise been modified for domestic purposes. In other countries, the rules of treaties they have joined must be “transformed” into domestic law by an act of the parliament or legislature. 39

With respect to the TRIPS Agreement it would be unusual – even in cases where the agreement is directly effective – for IP rules such as those defining the terms and conditions under which patents are granted to be implemented solely based on the TRIPS Agreement patent provisions. Most likely there will be a patent act prescribing terms and conditions, as well as patent office regulations further refining those rules. A government act to override patent rights must not only address TRIPS Agreement obligations, but also rights provided for under national patent rules.

Article 73 says that the TRIPS Agreement does not prevent a member from taking action to protect its essential security interests. From an internal domestic legislative standpoint, Article 73 standing alone might not sufficiently empower the Government to override the various rights that patent owners may have under national law.

In most cases it is likely preferable that existing national legislation relating to emergencies, and/or newly adopted legislation (or executive action), is used to implement emergency measures relating to IP.

B. Article 73 as a WTO Defense

On the other hand, while Article 73 may not be designed to serve as the basis for domestic action to override patents and other IP, it is precisely designed to serve as the basis for a defense against an action brought by a WTO member challenging that domestic action.

To solidify a defense in WTO, it may be useful for a WTO member overriding IP to expressly take cognizance of an international emergency, such as by referring to the WHO declaration of a Public Health Emergency of International Concern, and stating that its actions are taken to address essential interests. Although it may be preferable to frame the national declaration of emergency in a way that tracks the language of Article 73 (e.g., referring to an “emergency in international relations” and “essential security interests”) this is not required as a condition of defending the action under WTO law.

A national declaration might take form along the following lines:

• Taking cognizance of an emergency in international relations as evidenced by the declaration of a Public Health Emergency of International Concern in relation to the COVID-19 Pandemic by the WHO Director-General;
• Recognizing the necessity and urgency of taking appropriate measures to protect the essential security interests of the nation, and especially to protect public health and social order;
• The State hereby suspends any and all intellectual property rights, including rights in and deriving from patents, trademarks, copyrights, design rights, trade secrets and regulatory data (including regulatory market exclusivity), that pertain to health products used to address COVID-19, including vaccines, pharmaceuticals (including biologics), diagnostics and medical equipment (including personal protective equipment (PPE)). The aforesaid suspension is effective immediately and remains in effect until terminated by a subsequent act of the State.

The suspension of intellectual property rights by a national Government does not presuppose that the Government will not establish some mechanism for compensating owners for the IP that may be used during the period of suspension. Whether and how much compensation might be paid will likely be a function of the capacity to pay of the country suspending the rights. By way of illustration, least developed countries would not be expected to pay compensation. Article 73 of the TRIPS Agreement makes no provision for compensating those economically affected by emergency measures. Compensation is not a legal requirement under Article 73.

VI. Conclusion

This paper has reviewed the legal rules and jurisprudence applicable to the potential use of Article 73 of the TRIPS Agreement by WTO members in addressing the COVID-19 pandemic. It concludes that Article 73 may justifiably be invoked to override protections of intellectual property otherwise mandated by the TRIPS Agreement because the pandemic constitutes an emergency in international relations within the meaning of Article 73(b)(iii), and because a WTO member acting to override IP rights will be taking action necessary to protect its essential security interests within the meaning of the introductory clause of Article 73(b). The presence in the TRIPS Agreement of some provisions that address public health emergencies does not constitute an obstacle to the justifiable invocation of Article 73.

It is a fundamental responsibility of sovereign governments to protect the health and safety of their citizens. Article 73 acknowledges that reality and concedes that the TRIPS Agreement cannot stand in the way.

1 WTO Agreement on Trade-Related Intellectual Property Rights Agreement on Trade-Related Aspects of Intellectual Property Rights, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Apr. 15, 1994, in WORLD TRADE ORGANIZATION, THE LEGAL TEXTS: THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS 321 (1999), as amended on 23 January 2017 [hereinafter “TRIPS Agreement”]. Available from https://www.wto.org/english/docs_e/legal_e/31bis_trips_01_e.htm .

2 The General Agreement on Tariffs and Trade (GATT 1947)[hereinafter “GATT”], https://www.wto.org/english/docs_e/legal_e/gatt47_01_e.htm , provides:

Article XXI: Security Exceptions

Nothing in this Agreement shall be construed

• (a) to require any contracting party to furnish any information the disclosure of which it considers contrary to its essential security interests; or
• (iii) taken in time of war or other emergency in international relations; or
• (c) to prevent any contracting party from taking any action in pursuance of its obligations under the United Nations Charter for the maintenance of international peace and security.

3 United States — Measure Affecting Government Procurement , consultations requested by the European Communities, mutually agreed solution notified (Feb. 11, 2000), WT/DS88/6, WT/DS95/6, Note by Secretariat, 14 February 2000, see, e.g., Ryan Goodman, “Norms and National Security: The WTO as a catalyst for inquiry”, Chicago Journal of International Law vol. 2, No. 1, (2002). Available from: https://chicagounbound.uchicago.edu/cjil/vol2/iss1/7 .

4 Crosby v. National Foreign Trade Council , 530 U.S. 363 (2000).

5 See American Institute for Int’l Steel v. United States , US Ct of Appeals for the Fed. Cir., Feb. 28, 2020, cert. denied June 22, 2020.

6 Ana Swanson and Jim Tankersley, “Mexico, hitting back, imposes tariffs on $3 billion worth of U.S. goods”, New York Times , 5 June 2018. Available from https://www.nytimes.com/2018/06/05/us/politics/trump-trade-canada-mexico-nafta.html .

7 See USTR Section 301 Fact Sheet, Press Release, June 2018, https://ustr.gov/about-us/policy-offices/press-office/fact-sheets/2018/june/section-301-investigation-fact-sheet .

8 But see initiation of dispute settlement consultations by China, United States – Tariff Measures on Certain Goods from China III , Request for Consultations by China, WT/DS587/1, G/L/1322, 4 Sept. 2019, “concerning the tariffs measures that the United States accords to certain goods with the estimated trade value of approximately $300 billion originating from China.”

9 Russia - Measures Concerning Traffic in Transit , Report of the Panel, WT/DS512/R, 5 April 2019 [hereinafter “ Russia-Transit ”].

10 Saudi Arabia – Measures Concerning the Protection of Intellectual Property Rights , Report of The Panel, WT/DS567/R, 16 June 2020 [hereinafter " Saudi Arabia-IPRs ”].

11 The terms of the Security Exceptions of GATT Article XXI and TRIPS Agreement Article 73 are identical.

12 Russia-Transit , at para. 7.27.

13 Estoppel may be defined as “a legal bar to alleging or denying a fact because of one’s own previous actions or words to the contrary”, https://www.merriam-webster.com/dictionary/estoppel .

14 WHO Director-General's statement on IHR Emergency Committee on Novel Coronavirus (2019-nCoV), 30 Jan. 2020, https://www.who.int/dg/speeches/detail/who-director-general-s-statement-on-ihr-emergency-committee-on-novel-coronavirus-(2019-ncov) .

15 See, e.g., Helen Branswell, As coronavirus pandemic worsens, health officials fear nationalization of drugs and supplies, STAT HEALTH , 15 March 2020, https://www.statnews.com/2020/03/15/as-coronavirus-pandemic-worsens-health-officials-fear-nationalization-of-drugs-and-supplies/ ; Leila Abboud, Michael Peel and Hannah Kuchler, “Macron summons Sanofi chief for claim US has “right to” first Covid-19 jab”, Financial Times, 14 May 2020. Available from https://www.ft.com/content/60434224-a70d-4a8d-821f-6ac239b4a349 .

16 “The UN Secretary General, on April 9, 2020, addressed the Security Council, saying:

While the COVID-19 pandemic is first and foremost a health crisis, its implications are much more far-reaching. We are already seeing its ruinous social and economic impacts, as governments around the world struggle to find the most effective responses to rising unemployment and the economic downturn.

But the pandemic also poses a significant threat to the maintenance of international peace and security – potentially leading to an increase in social unrest and violence that would greatly undermine our ability to fight the disease.

My concerns are many and widespread, but let me identify eight risks that are particularly pressing: …

17 In the Russia-Transit and the Saudi Arabia-IPRs cases, the conflicts related to disputes over threats to territorial boundaries and political independence to which the complained-against parties had reacted with transit restrictions and non-enforcement of intellectual property rights, respectively. But "international relations" is capable of broader definition than political or territorial conflict. International relations also involve movement of persons, trade, finance and other aspects of human interaction.

18 See Russia-Transit , paras. 7.130-7.131.

19 See Russia-Transit , paras. 7.132-7.133

20 See Saudi Arabia-IPRs , para. 7.242.

21 See, e.g., discussion in European Communities – Measures Affecting Asbestos and Asbestos-Containing Products , AB-2000-11, Report of the Appellate Body, WT/DS135/AB/R, 12 March 2001, at paras. 169-72.

22 EC-Asbestos, Ibid ., at para. 168.

23 See Russia-Transit , paras. 7.146-7.147:

• 7.146. … [I]t is for Russia to determine the "necessity" of the measures for the protection of its essential security interests. This conclusion follows by logical necessity if the adjectival clause "which it considers" is to be given legal effect.222
• 7.147. The Panel has been referred to EC – Bananas III (Ecuador) (Article 22.6 – EC) in which the arbitrators interpreted the phrase "if that party considers" in Articles 22.3(b) and 22.3(c) of the DSU as providing a margin of appreciation to the party which was nevertheless subject to review by the arbitrators. The arbitrator's decision regarding the scope of review under Article 22.3 of the DSU was based on the fact that the discretion accorded to the complaining party under the relevant subparagraphs of that provision was subject to the obligation in the introductory words to Article 22.3 of the DSU, which provides that "[i]n considering what concessions or other obligations to suspend, the complaining party shall apply the following principles and procedures". There is no equivalent obligation anywhere in the text of Article XXI that expressly conditions the discretion accorded to an invoking Member under the chapeau of Article XXI(b).

24 See Russia-Transit , para. 7.144.

25 See Russia-Transit , para 7.138:

• The obligation of good faith, referred to in paragraphs 7.132 and 7.133 above, applies not only to the Member's definition of the essential security interests said to arise from the particular emergency in international relations, but also, and most importantly, to their connection with the measures at issue. Thus, as concerns the application of Article XXI(b)(iii), this obligation is crystallized in demanding that the measures at issue meet a minimum requirement of plausibility in relation to the proffered essential security interests, i.e. that they are not implausible as measures protective of these interests.

26 TRIPS Agreement, Article 61, provides: "Members shall provide for criminal procedures and penalties to be applied at least in cases of wilful trademark counterfeiting or copyright piracy on a commercial scale…."

27 Excerpted evidence materials quoted in decision, para. 7.290:

• letters issued by UEFA and BBC Studios to the Ministry and GCAM containing evidence concerning beoutQ's operations and efforts to target the Saudi market, its use of Arabsat satellites and its sale of STBs and subscriptions in Saudi Arabia and elsewhere in the MENA region;
• letters from UEFA, La Liga and the Premier League to Arabsat reporting beoutQ's use of particular Arabsat satellite frequencies to transmit its pirated content, which Arabsat's legal representative stated in letters to third-party right holders that Arabsat would take into account in its ongoing investigation;
• FIFA's letter to Arabsat concerning the scope of its satellite coverage and its transmission of beoutQ's pirated content;
• submissions made to the USTR concerning beoutQ's piracy, which were summarized in the USTR's 2019 Special 301 Report and have been submitted to the Panel and Saudi Arabia in this dispute;
• a public joint statement made by seven major football right holders condemning beoutQ and requesting enforcement action by Saudi Arabia against beoutQ; and
• a technical report produced by the anti-piracy and cybersecurity firm MarkMonitor, at the request of the seven football right holders, making specific findings concerning beoutQ's unauthorized re-streaming of copyrighted content, the transmission of beoutQ's pirated content on specific Arabsat satellites and frequencies, the design and operation of the hardware and software of beoutQ STBs to target Saudi Arabia, and the technically sophisticated and organized nature of beoutQ's operation.

28 As example of a nuanced case, a Member might suspend broadcast copyright on the theory that individuals in self-quarantine need access to video content and might not be able to afford it. Is Netflix streaming plausibly related to addressing the COVID-19 pandemic? Some would think so.

29 Declaration on the TRIPS Agreement and Public Health (14 November 2001), Doc. WT/MIN(O1)/DEC/2 (20 November 2001) [hereinafter “Doha Declaration”].

30 There is ample evidence that a small outbreak may rapidly evolve into a wide-scale outbreak.

31 This same flexibility to avoid prior negotiation applies with respect to “government use” licenses in the absence of an emergency.

32 Canada – Patent Protection of Pharmaceutical Products , Report of the Panel, WT/DS114/R, 17 March 2000.

33 TRIPS Agreement, Article 31(b):

• “such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable . In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;” [emphasis added].

34 Doha Declaration, Para. 5(c):

• “Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.”

35 Under ordinary circumstances, a significant part of the world’s legal profession is devoted to asserting protections on behalf of the pharmaceutical industry enterprises and associations, and a more modest part of the world’s legal profession is devoted to challenging those assertions of protection. What this means is that “everything is complicated”. Virtually every effort by a generic producer to bring a product to market confronts IP-owner legal representatives seeking to block that effort through threats of legal action, and/or legal action before courts or administrative bodies. Governments “as such” ordinarily do not step in to mediate these activities, except to provide the courts, administrative bodies, and police enforcement agents required to carry out orders.

36 The term "claimants" is used in this paragraph because certain of the potentially asserted "rights" may not be within the legitimate scope of the relevant IP.

37 In countries that follow a monist approach to the incorporation of treaty rules in domestic law, violation of a national rule may be the equivalent of a violation of the TRIPS Agreement.

38 Doha Declaration, at para. 4.

39 There is no uniform rule that prescribes the way that national or regional governments incorporate treaties into their domestic legislative systems, and there is considerable nuance in the way this relationship is addressed. See, e.g., S. Riesenfeld and F. Abbott, eds., Parliamentary Participation in the Making and Operation of Treaties: A Comparative Study , (Dordrecht, Martinus Nijhoff, 1994).

• Posted August 28, 2020.

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Andrew Mitchell, PhD (Cantab), LLM (Harv), Grad Dip Intl L (Melb), LLB (Hons) (Melb), BCom (Hons) (Melb) is Associate Professor, Faculty of Law, University of Melbourne; Member, WTO indicative list of governmental and non-govern-mental panelists; Fellow, Tim Fischer Centre for Global Trade & Finance, Bond University; Barrister and Solicitor, Supreme Court of Victoria and High Court of Australia; and Advisory Board Member, Melbourne Journal of International Law; Author of Legal Principles in WTO Disputes (Cambridge: Cambridge University Press, 2008).

Tania Voon University of Melbourne. Email: [email protected]

• Published: 18 September 2012
• Cite Icon Cite
• Permissions Icon Permissions

.   The Nature of the TRIPS Agreement   187

.   Developments to Date   189

Dispute Settlement   189

Access to Medicines and Public Health   192

.   Outstanding Issues   195

Exhaustion and Parallel Imports   195

Anti-competitive Practices   197

Geographical Indications   198

.   Beyond the WTO   200

TRIPS-plus in FTAs   201

A Human Rights Approach to TRIPS   203

.   Conclusion   205

I. The Nature of the TRIPS Agreement

During the Uruguay Round of negotiations that finally created the WTO in 1995, the TRIPS Agreement was one of the most controversial new agreements added by the GATT 1947 Contracting Parties. 1 The TRIPS Agreement defines ‘intellectual property’ (IP) as copyright and related rights, trademarks, geographical indications, industrial designs, patents, layout-designs (topographies) of integrated circuits, and undisclosed information (Article 1.2). Thus, this agreement on ‘trade-related aspects’ of IP bears on subjects as wide-ranging as books, computer programs, inventions, and trade secrets. Not surprisingly, given this subject matter, its ‘strongest proponents’ have been the US, the EC, and Japan, along with their IP industries. 2

The TRIPS Agreement establishes minimum standards for the protection of IP rights in each of the seven defined areas of IP, meaning that WTO Members are generally entitled to provide higher but not lower levels of IP protection. The most important way in which the TRIPS Agreement establishes these standards is by incorporating several existing multilateral treaties on IP. In particular, Members must comply with Articles 1 to 12 and 19 of the Paris Convention 1967 (Article 2.1) and with Articles 1 to 21 of the Berne Convention 1971 (excluding Article 6 bis ) (Article 9.1). The TRIPS Agreement builds on these existing treaties by imposing additional substantive obligations while recognizing certain exceptions, such as those regarding security and anti-competitive practices (Articles 73, 40.2).

Like several other WTO agreements, the TRIPS Agreement also creates general obligations of ‘national treatment’ and ‘MFN treatment’. With regard to IP protection, subject to permitted exceptions (again defined in part by reference to existing IP treaties), Members agree to accord to the nationals of other Members ‘treatment no less favourable’ than they accord to their own nationals (Article 3) and to accord immediately and unconditionally to the nationals of all Members ‘any advantage, favour, privilege or immunity’ granted to the nationals of any other country (Article 4).

The TRIPS Agreement also incorporates rigorous requirements concerning the enforcement of IP rights through judicial and administrative proceedings and appropriate remedies (Part IV) and a sophisticated system for resolving disputes between Members pursuant to the DSU (Part V). The TRIPS Council monitors the operation of the TRIPS Agreement and Members’ compliance with it (Article 68).

A frequent criticism of the TRIPS Agreement is that it has no place in the WTO because it entails harmonizing laws (positive integration) rather than removing or prohibiting barriers to international trade (negative integration). Moreover, the grant of exclusive or monopoly rights pursuant to the TRIPS Agreement may itself constitute a trade barrier. 3 Cottier responds that other aspects of the WTO agreements are ‘equally harmonizing’ and that the recognition of IP rights does not of itself conflict with the goals of trade liberalization; rather, the impact on trade and global welfare depends on the balance struck between providing incentives to innovate and protecting investment, on the one hand, and safeguarding competitive opportunities, on the other. 4 The TRIPS Agreement does recognize (under the explicit heading ‘Objectives’) the relevance of IP rights to ‘social and economic welfare’ and the need to achieve ‘a balance of rights and obligations’ (Article 7). 5

Another, perhaps more serious, challenge to the TRIPS Agreement arises from ‘the strong and widespread perception that [it] is against the interests of developing countries’. 6 Notwithstanding the variation in interests among developing country Members, their eventual acceptance during the Uruguay Round of WTO obligations concerning IP is generally regarded as having been a necessary sacrifice in order to achieve broader liberalization objectives, 7 though they arguably received a poor bargain given the relatively limited disciplines agreed in sectors such as agriculture and textiles. 8 The TRIPS Agreement does allow developing country and LDC Members longer transition periods to implement their obligations and also provides for developed country Members to assist them with technical and financial cooperation in this regard (Articles 65–67). However, like many special and differential treatment provisions, these were insufficient to address the difficulties faced by many developing countries in implementing the TRIPS Agreement, 9 and they did little to change the fact that the main beneficiaries of stronger IP rights were (at least initially) industrialized countries. 10

In the second part of this chapter, we outline certain significant developments under the TRIPS Agreement since its entry into force in 1995, namely in the course of dispute settlement and in relation to public health. The third part explores some of the issues under the TRIPS Agreement that are yet to be resolved: exhaustion, anticompetitive practices, and geographical indications. In the final part, we address a number of areas in which TRIPS-related issues expand beyond the boundaries of the WTO. In particular, we consider the role of the World Intellectual Property Organization (WIPO), the increasing frequency of ‘TRIPS-plus’ provisions in preferential trade agreements, and the call for greater acknowledgement of human rights concerns in interpreting and applying the TRIPS Agreement. Due to space constraints, we do not address the many other important subjects arising under the TRIPS Agreement, such as traditional knowledge and biodiversity. The following overview nevertheless exemplifies the wide range of dilemmas arising under the TRIPS Agreement, which is sure to continue as one of the chief battlegrounds in the development of WTO law, even as bilateral trade agreements and other areas of public international law, such as human rights, intervene.

II. Developments to Date

In this section, we examine two areas in which the TRIPS Agreement has undergone major developments: disputes arising under the TRIPS Agreement that have proceeded to formal adjudication in the WTO, and negotiation among WTO Members regarding access to medicines and public health under the TRIPS Agreement.

A. Dispute Settlement

As at the end of 2006, 25 formal complaints had been brought in connection with the TRIPS Agreement: a reasonable number, though not as many as under several other WTO agreements 11 such as the GATT 1994, the SCM Agreement, or the Agreement on Agriculture. In addition, on 10 April 2007, the US requested consultations with China alleging violations of the TRIPS Agreement in relation to the availability of criminal procedures and penalties for IP infringement, the disposal of goods that infringe IP rights, and the denial of copyright protection for works that have not been authorized for publication or distribution within China. 12 To date, nine Panel reports (some related) and three Appellate Body reports in relation to the TRIPS Agreement have been circulated and adopted.

The most recent TRIPS dispute to reach the stage of a final Panel report concerned geographical indications (GIs), which are also the subject of continued negotiations in the Doha Round as discussed below. Indeed, Australia and the US may have decided to challenge the EC’s GIs scheme in part to buttress their position in negotiations on this issue. 13 In this case, which was not appealed, the Panel found that several aspects of the EC’s scheme violated the national treatment (NT) obligations in the TRIPS Agreement and the GATT 1994. For example, the Panel found that such violations stemmed from the prima facie case made by Australia and the US (not successfully rebutted by the EC) that a GI located in another WTO Member could be registered under the relevant EC regulation only if the Member had adopted an equivalent system for GIs protection and provided reciprocal protection to EC products. 14

The US and EC have also played prominent roles in several other TRIPS disputes. In two cases, the EC challenged the US, once regarding its protection of trademarks used in connection with a business or assets that were confiscated by the Cuban government, 15 and once regarding its limitations on performers’ copyright for certain broadcasts. 16 The US has not yet implemented the adverse rulings in either of these cases, 17 much to the annoyance of other Members, particularly given the US role in championing the TRIPS Agreement. 18 Other TRIPS disputes have explored matters such as the term of patent protection required under Article 33, 19 the limited exceptions to patent protection allowed under Article 30, 20 the transition period for developing country Members, 21 and the provision of a ‘mailbox’ filing system for patent applications pending the availability of a patent protection system. 22

The TRIPS Agreement has given rise to two other developments in WTO dispute settlement. First, developing countries have often considered the TRIPS Agreement a useful instrument in responding to another Member’s failure to implement an adverse ruling by the DSB, even when the original violation was in respect of goods or services rather than IP rights. This generally requires the retaliating developing country Member to establish that ‘it is not practicable or effective to suspend concessions or other obligations with respect to the same’ sector or agreement and that ‘the circumstances are serious enough’ to warrant suspension under the TRIPS Agreement instead. 23 For example, Brazil proposed suspending concessions under the TRIPS Agreement rather than increasing tariffs on imports in response to US violations of the SCM Agreement because, ‘[g]iven the asymmetries between the two economies, additional import duties would have a much greater negative impact on Brazil than on the [US]’. 24

Whether ‘cross-retaliation’ of this kind is allowed in the WTO depends on the circumstances of the case. If the implementing Member does not object to the proposed suspension, the DSB authorizes it by reverse consensus. If the implementing Member does object, arbitrators (usually the original panel) determine whether it accords with the relevant dispute settlement provisions. 25 One such arbitration approved Ecuador’s request to suspend concessions to the EC under the TRIPS Agreement following EC violations regarding banana imports, noting that ‘the considerable economic differences between a developing WTO Member and the world’s largest trader … confirm … that it may not be practicable or effective for Ecuador to suspend concessions or other obligations under the [GATS] or with respect to all product categories under the GATT’. 26 The utility of this approach for a developing country Member may nevertheless be limited by constraints under its domestic law or other IP conventions to which the Member is a party, as well as economic considerations. 27

A second noteworthy feature of the TRIPS Agreement in connection with WTO dispute settlement is that ‘non-violation’ and ‘situation’ complaints as described respectively in Article XXIII:1(b) and (c) of the GATT 1994 were precluded under Article 64.2 TRIPS Agreement until 1 January 2000 and since that date have remained inapplicable by agreement between the Members. 28 In the GATT 1994 context, violation complaints are much more common (under Article XXIII:1(a)), but a Member may also bring a WTO dispute where it considers that, as a result of a Member’s measure that does not necessarily violate WTO law or some other situation, its WTO benefits are being nullified or impaired, or the attainment of any objective of the agreement is being impeded. Special dispute settlement provisions apply to these complaints under Article 26 DSU. The Council for TRIPS continues to work on the scope and modalities for complaints of this type under the TRIPS Agreement, 29 which could cover, for example, a patent regime imposing ‘an excessively high level of inventive step’ for pharmaceutical products that effectively preclude patent protection for these products without banning it outright. 30 Some regard non-violation complaints as unnecessary in the TRIPS context, given that the agreement is less concerned with market access and tariff concessions than the GATT 1994; others regard it as crucial in preventing Members from circumventing their TRIPS obligations. The impact of such complaints on security and predictability of trade is debated. 31

B. Access to Medicines and Public Health

The TRIPS Agreement recognizes the relationship between IP rights and public health, 32 allowing Members to ‘adopt measures necessary to protect public health and nutrition … provided that such measures are consistent with the provisions of this Agreement’ (Article 8.1). Patent protection for pharmaceutical products as mandated in the TRIPS Agreement represents one possible obstacle to public health measures and provides the setting for some of the most crucial advances made under the TRIPS Agreement and, indeed, the WTO agreements as a whole, since their enactment.

Subject to certain limited exceptions, 33 Members must make patents available for pharmaceuticals, and owners of these patents have exclusive rights to prevent others from making, selling, or importing the relevant products (Articles 27–28). These rights tend to elevate the prices of patented medicines (as compared to ‘generic’ or ‘off-patent’ medicines), 34 creating a potential difficulty particularly for developing countries seeking to manufacture or import them to deal with serious public health concerns, such as HIV/AIDS crises. Without further discussion, this difficulty would have crystallized when the transition period for pharmaceutical patents ended on 1 January 2005 for many developing countries such as India, and on 1 January 2006 for LDCs (Articles 65.1, 65.2, 65.4, 66.1).

Exceptions in Articles 30 and 31 might have assisted, in particular, by allowing the grant of compulsory licences to manufacture patented pharmaceuticals subject to conditions such as the payment of adequate remuneration and prior attempts to negotiate a voluntary licence on reasonable commercial terms and conditions (which condition could be waived ‘in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use’) (Article 31(b)). However, under Article 31(f), this kind of ‘use of the subject matter of a patent without the authorization of the right holder’ is to be ‘authorized predominantly for the supply of the domestic market of the Member authorizing such use’, meaning that a Member without sufficient capacity to manufacture the requisite pharmaceuticals could not take advantage of a compulsory licence to import these products from another Member. These Members might have been able to rely on the principle of international exhaustion (as discussed further below) to import products made under compulsory licence, but on one view parallel imports invariably violate the patent owner’s rights unless they are imports of products made under voluntary licence. 35

In recognition of this predicament, the WTO Members at the Fourth Ministerial Conference (MC) in Doha in 2001 issued a declaration ‘affirm[ing] that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all’. 36 Among other things, this Ministerial Declaration on the TRIPS Agreement and Public Health noted Members’ freedom to determine the grounds for granting compulsory licences and acknowledged that ‘public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency’. 37 It also provided the setting for several more substantive changes. First, LDC Members were granted an additional transition period until 1 January 2016 in relation to certain obligations regarding pharmaceutical patents. 38 Second, Members agreed on a waiver of Article 31(f) so that LDC Members and other Members lacking sufficient manufacturing capacity may import pharmaceutical products created under compulsory licence, subject to certain conditions. 39 This waiver will become permanent through an amendment to the TRIPS Agreement after two-thirds of the Members accept it; this would be the first ever formal amendment to the WTO agreements, introducing a new Article 31 bis into the TRIPS Agreement. 40

Although these steps are very welcome, their practical implications have been limited to date. At the time of writing, only 18 of the 153 WTO Members 41 have accepted the amendment, 42 and a handful of Members have implemented legislation to enable them to issue compulsory licences in accordance with the waiver. 43 At the end of 2007, the GC noted that acceptance of the amending protocol by two-thirds of the Members was ‘taking longer than initially foreseen’ and therefore decided, on the recommendation of the TRIPS Council, to extend the deadline for acceptance from 1 December 2007 to 31 December 2009 ‘or such later date as may be decided by the Ministerial Conference’. 44

One positive development stands out. On 17 July 2007, Rwanda (an LDC) became the first Member to notify the TRIPS Council of its intention to use the waiver of Article 31(f) as an importing Member. The notification concerned the HIV/AIDS drug TriAvir, manufactured in Canada by generic pharmaceutical company Apotex, Inc. 45 In turn, Canada notified the TRIPS Council in early October 2007 of its grant of a compulsory licence as an eligible exporting Member to enable the manufacture and export of TriAvir to Rwanda. 46 The successful outcome of this arrangement may encourage further use of the flexibilities on which the Members have agreed.

III. Outstanding Issues

We now consider three areas under the TRIPS Agreement raising questions that the Members are yet to resolve: the exhaustion of IP rights associated with a product through the sale of that product with the right holder’s authority, the relationship between IP rights and anti-competitive conduct, and the category of GIs. Of these, only GIs are currently subject to negotiation under the Doha Round.

A. Exhaustion and Parallel Imports

In his seminal work, Warwick Rothnie describes parallel imports as follows:

They are lawfully put on the market in the place of export , the foreign country. But, an owner of the [IP] rights in the place of importation , the domestic country, opposes their importation … [S]ome enterprising middleman buys stock in the cheaper, foreign country and imports them into the dearer, domestic country. Hence, the imports may be described as being imported in ‘parallel’ to the authorised distribution network. 47

Under a rule or system of ‘national exhaustion’, by authorizing the first sale of a product in a given country, the owner of IP rights in that product exhausts those rights in that country only, such that a parallel import of the product into another country may infringe the IP owner’s rights in the second country. Under a system of ‘international exhaustion’, the first sale exhausts the IP rights associated with the product worldwide, allowing parallel imports of the product after that sale. A country’s choice of which system to adopt in relation to any given category of IP (as the considerations may differ for each) 48 raises the same balancing questions as determining the extent of protection of IP rights more generally. International exhaustion may encourage lower-priced parallel imports and promote competition, benefiting consumers and industrial users of the relevant products, while national exhaustion may advance the interests of IP owners and creators. 49 Jayashree Watal cautions against assuming that developing countries would necessarily benefit from international exhaustion. 50

Article 6 TRIPS Agreement provides that, ‘[f]or the purposes of dispute settlement under this Agreement, subject to the provisions of Articles 3 and 4 nothing in this Agreement shall be used to address the issue of exhaustion of [IP] rights’. This provision reflects a failure to agree on the treatment of exhaustion and parallel imports and, consequently, a degree of discretion for WTO Members. Nevertheless, whatever approach a Member chooses, it must apply this on a non-discriminatory basis, that is, in accordance with the principles of NT and MFN treatment as set out in Articles 3 and 4. The choice for patents may affect the Member’s ability to respond to public health crises as discussed above. 51 Accordingly, the ‘Doha Declaration on TRIPS and Public Health’ confirms that ‘[t]he effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of [IP] rights is to leave each member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions’. 52 This makes clear that Article 6 is not to be interpreted as being limited to dispute settlement such that, for example, the substantive TRIPS Agreement provisions on patents could be read as mandating international exhaustion. 53

Although Members are not examining exhaustion in the Doha Round, given the absence of agreement to date as to a uniform approach on this issue, it may resurface to be resolved in future.

B. Anti-competitive Practices

Article 8.2 TRIPS Agreement allows Members to take ‘[a]ppropriate measures, provided that they are consistent with the provisions of this Agreement, … to prevent the abuse of [IP] rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology’. The scope of this allowance therefore depends on how other TRIPS Agreement provisions are interpreted in relation to anti-competitive practices. In addition, Article 40.1 TRIPS Agreement recognizes that ‘some licensing practices or conditions pertaining to [IP] rights which restrain competition may have adverse effects on trade and may impede the transfer and dissemination of technology’. Accordingly, Members are entitled to ‘specif[y] in their legislation licensing practices or conditions that may in particular cases constitute an abuse of [IP] rights having an adverse effect on competition in the relevant market’ (Article 40.2). 54 Article 40.2 provides examples of the kinds of practices that may be anti-competitive (‘exclusive grantback conditions, conditions preventing challenges to validity and coercive package licensing’) but not an exhaustive or binding list. Indeed, apart from an obligation to enter consultations on request in relation to these matters (Article 40.3), the provisions regarding anticompetitive conduct are ‘permissive rather than mandatory’. 55

The question whether WTO Members should adopt additional, mandatory rules aimed at harmonizing competition laws or producing an overarching international competition law goes beyond the TRIPS Agreement, 56 and, potentially, the WTO itself. 57 It concerns numerous aspects of the WTO agreements, including goods, services, and dispute settlement. The WTO’s Working Group on the Interaction between Trade and Competition Policy was previously discussing the ‘interaction between trade and competition policy, including anti-competitive practices, in order to identify any areas that may merit further consideration in the WTO framework’. 58 However, this so-called ‘Singapore issue’ has now been excised from the Doha Work Programme and is no longer under negotiation. 59 Nevertheless, the absence of a multilateral competition framework is problematic and will need to be addressed at some point. ‘Although competition law has traditionally dealt with private action within the border, while trade law has traditionally dealt with public action at the border’, 60 this dichotomy is weakening. In relation to IP rights as in other areas, the effects of domestic competition laws and anti-competitive practices frequently extend across national borders, increasing the risk of conflict and unnecessary costs on consumers and firms. 61

C. Geographical Indications

The TRIPS Agreement defines GIs as indications that ‘identify a good as originating in the territory of a Member, or a region or locality in that territory, where a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin’ (Article 22.1). The WTO website offers the examples of Champagne, Tequila, and Roquefort. 62 Members have a general obligation to provide the legal means for interested parties to prevent the use of GIs for goods (for example in a trademark) in such a way as to mislead the public about the origin of the good or to constitute unfair competition (Articles 22.2–22.4). Members must provide greater protection in relation to GIs for wines and spirits—that is, preventing their use in relation to wines or spirits not originating in the relevant place ‘even where the true origin is indicated or the [GI] is used in translation or accompanied by expressions such as “kind”, “type”, “style”, “imitation” or the like’ (Article 23.1). Some exceptions apply, such as for GIs that are generic terms, or where a GI was used continuously in good faith before 15 April 1994 (when the WTO agreements were signed) or was included in a trademark registered in good faith (Articles 24.4–24.6).

GIs provide one issue that remains under negotiation in the Doha Round. At Doha in 2001, Members agreed, in accordance with Article 23.4 TRIPS Agreement, ‘to negotiate the establishment of a multilateral system of notification and registration of [GIs] for wines and spirits’. 63 Members have since ‘agree[d] to intensify these negotiations’. 64 Members are currently negotiating on the basis of three main proposals in this regard. 65 In addition, although Members disagree as to the link with the wines and spirits negotiations and the Doha Round more generally, they are discussing the extension of the higher level of GI protection to products other than wines and spirits, as arguably envisaged in Article 24.1 TRIPS Agreement. 66

The alignment of Members on both sides of the GI debate is illustrated by existing proposals regarding the register for wines and spirits. The EC, long an advocate for GIs, calls for the higher levels of protection for wines and spirits to be simply extended to all products, along with a multilateral register for all products whereby registration of a particular GI would create, for participating Members not having lodged a reservation in respect of that GI, ‘a rebuttable presumption of the eligibility for protection of that [GI]’. 67 Hong Kong, China has submitted a proposal under which registration of an indication would provide prima facie evidence of ownership and that the indication is a GI protected in the country of origin. 68 In contrast, under a third proposal, participating Members would have much greater flexibility: they would merely have to ensure that they provide for consultation of the register when making domestic decisions regarding trademarks and GIs for wines and spirits. This proposal is endorsed by Argentina, Australia, Canada, Chile, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Japan, Mexico, New Zealand, Nicaragua, Paraguay, Chinese Taipei, and the US. 69 In many of these ‘New World’ countries, terms that the EC regards as GIs are already considered generic. 70

This is an extremely sensitive area of negotiations, made more complex by the uncertain effects that GI protection may have on different Members. For instance, Evans and Blakeney suggest that, whereas ‘large, commodity-dependent developing countries, such as India, Egypt, or Kenya, are well placed to take advantage of an extension of additional protection for agricultural products, foodstuffs, and traditional handicrafts’, other developing countries may lack ‘the financial resources, the technical expertise and the institutional capacity’ necessary to commercialize goods that could benefit from GI protection and to provide that protection. 71 Ultimately, a link exists between negotiations on the extension of GIs beyond wines and spirits, the multilateral register, and agriculture more generally. Failure in any one of these areas may necessitate failure in the other two. 72

IV. Beyond the WTO

In this final section, we identify three ways in which the TRIPS Agreement is influenced by outside forces and consider how these forces are changing international IP law. We first consider WIPO before turning to IP provisions in preferential, regional, or free trade agreements (FTAs) 73 and then the growing drive for a human rights approach to the TRIPS Agreement.

WIPO is a specialized agency of the United Nations (UN) established by a treaty signed in 1967 ‘to promote the protection of [IP] throughout the world through cooperation among States and, where appropriate, in collaboration with any other international organization’. 74 It has 184 contracting parties, 75 as compared with the WTO’s 153 Members. 76 The preamble to the TRIPS Agreement records the Members’ desire ‘to establish a mutually supportive relationship between the WTO and [WIPO] as well as other relevant international organizations’. Certain other TRIPS Agreement provisions also refer to WIPO, including Article 68, which directs the TRIPS Council to ‘seek to establish … appropriate arrangements for cooperation with bodies of that Organization’. The two organizations entered a cooperation agreement in 1995, pursuant to which, among other things, they provide access to each other’s collection of countries’ IP laws and regulations and cooperate in technical assistance activities. 77 WIPO has observer status in meetings of the GC, 78 the TRIPS Council and certain other WTO bodies. 79

The locus for multilateral IP negotiations shifted from WIPO to the GATT 1947 with the Uruguay Round of negotiations leading to the WTO, largely on the initiative of the US and the EC, though WIPO ‘continues to function as a critically important venue for [IP] lawmaking by all of its member states in a post-TRIPs environment’. 80 Since the WTO was established, WIPO has concluded several treaties expanding international IP coordination. 81 These newer treaties are not incorporated into the TRIPS Agreement leading some WTO Members to suggest their inclusion either in the TRIPS Agreement 82 or through the alternative route of FTAs, as discussed in the following section.

B. TRIPS-plus in FTAs

A common feature in the proliferation of FTAs 83 in recent years 84 (and particularly those of the US) has been the insertion of so-called ‘TRIPS-plus’ provisions, requiring FTA partners to impose higher standards of IP protection than those set in the TRIPS Agreement. 85 This tends to increase IP protection not only between the FTA partners but more broadly across the WTO Membership, because the TRIPS Agreement does not include a general exemption from the MFN rule for FTAs. Because of the US push to align others’ IP laws with its own, it also continues the process of international harmonization of IP laws supported by the TRIPS Agreement. 86 Here, too, the TRIPS Agreement may be seen as having failed developing countries in particular, who remain prey to bilateral pressures to accept and impose higher standards because the TRIPS Agreement imposes minimum but not maximum thresholds of protection. 87

As foreshadowed above, in some instances, TRIPS-plus is achieved by requiring FTA partners to become party to certain WIPO treaties not incorporated in the TRIPS Agreement. For example, Article 17.1.4 Australia — United States Free Trade Agreement 88 provides that ‘[e]ach Party shall ratify or accede to the WIPO Copyright Treaty (1996) and the WIPO Performances and Phonograms Treaty (1996) by the date of entry into force of this Agreement, subject to the fulfilment of their necessary internal requirements’.

Other FTA provisions remove the flexibility maintained under the TRIPS Agreement. Thus, the Agreement between the United States of America and the Hashemite Kingdom of Jordan on the Establishment of a Free Trade Area 89 restricts the circumstances in which a party may permit the use of the subject matter of a patent without the patent owner’s authority. Whereas the TRIPS Agreement does not prescribe the circumstances in which a WTO Member may grant a compulsory licence, for example to address a public health concern (provided that certain conditions are met such as payment of adequate remuneration) (Article 31(h)), the FTA between the US and Jordan precludes such licences except to remedy anti-competitive practices, where the patent owner has not sufficiently worked the patent, or ‘in cases of public non-commercial use or in the case of a national emergency or other circumstances of extreme urgency, provided that such use is limited to use by government entities or legal entities acting under the authority of a government’. 90 Several commentators regard these and other common TRIPS-plus provisions put forward by the US as reducing access to medicines in developing countries and ‘negat[ing] the letter and spirit of the Doha Declaration’. 91 Some even query whether they may violate WTO law. 92

TRIPS-plus approaches in FTAs, as highlighted above, are closely linked to US trade policies and negotiating strategies and are therefore subject to change. For instance, in May 2007, the Bush Administration reached a conceptual agreement with Congress regarding IP protections in pending FTAs that would (particularly for developing countries) increase flexibility in relation to pharmaceuticals and public health. 93 Nevertheless, the general trend towards strengthening TRIPS through FTAs remains apparent. 94

C. A Human Rights Approach to TRIPS

Since the creation of the WTO, various UN bodies have commented on the relationship between human rights and WTO law. 95 The resulting work includes several statements regarding the relationship between human rights and the TRIPS Agreement in particular. The UN Sub-Commission on the Promotion and Protection of Human Rights has warned that an ‘actual or potential conflict exists between the implementation of the TRIPS Agreement and the realization of economic, social and cultural rights, in particular the rights to self-determination, food, housing, work, health and education, and in relation to transfers of technology to developing countries’. 96

In 2001, the UN High Commissioner for Human Rights expressed support for the notion of a ‘human rights approach’ to the TRIPS Agreement, which ‘would explicitly place the promotion and protection of human rights … at the heart of the objectives of intellectual property protection, rather than only as permitted exceptions that are subordinated to the other provisions of the Agreement’. 97 The High Commissioner referred specifically to Article 15 International Covenant on Economic, Social and Cultural Rights (ICESCR) 98 as requiring States, in protecting IP rights, to balance the public interest in accessing new knowledge with the interests of knowledge creators. 99 On one view, Members already have suffi cient discretion to take a human rights approach to the TRIPS Agreement, for example, by using domestic competition rules to avert practices that infringe the right to health. 100

More recently, the Committee on Economic, Social and Cultural Rights, which monitors the implementation of the ICESCR, issued a general comment on Article 15(1)(c), distinguishing IP rights from the right recognized under that provision (‘to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he or she is the author’). 101 Among other things, the Committee called on States parties to the ICESCR to ‘exclud[e] inventions from patentability whenever their commercialization would jeopardize the full realization of … human rights and dignity, including the rights to life, health and privacy’, in some contrast to the TRIPS Agreement’s exception for excluding inventions from patentability. 102

Concerns relating to the impact of the TRIPS Agreement on the right to health have been partially addressed by the WTO’s work in relation to compulsory licensing as discussed above. 103 One might even argue that paragraph 4 of the Declaration on the TRIPS Agreement and Public Health embodies a limited human rights approach to the TRIPS Agreement in affirming that ‘the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health’. However, as already mentioned, 104 some FTAs threaten to undermine this progress. 105

V. Conclusion

The TRIPS Agreement raises an array of complex questions and its implications for development, trade, and competition are difficult to identify in the abstract. On the one hand, it risks favouring IP owners, traditionally residing in developed countries, at the expense of vigorous competition and open trade. On the other hand, as the scope of IP expands (for example in the context of GIs), it offers potential benefits to at least some developing countries. In addition, it provides developing country Members with the possibility of cross-retaliation as an effective means of inducing compliance of other Members with their WTO obligations following adverse rulings in WTO dispute settlement. The Members’ ultimate response to the public health problems of developing countries (especially those with limited pharmaceutical manufacturing capacity) is also a significant achievement, although this would be best consolidated through the passing of a formal amendment to the TRIPS Agreement and the use of the available flexibilities in practice.

Moving beyond the first decade of the TRIPS Agreement, and even beyond Doha, WTO Members may need to reinvigorate discussions on areas of disagreement such as non-violation complaints, exhaustion, and anti-competitive practices. At the same time, they must recognize that the TRIPS Agreement is not operating in a vacuum. Especially in the absence of progress under the TRIPS Agreement from the perspective of all Members, IP laws including those relevant to international trade will continue to advance outside of the WTO. This is already evident in the work of WIPO and several FTAs, most often in the direction of strengthening IP rights, which may upset the balance achieved in the TRIPS Agreement (if indeed it is regarded as having struck an appropriate balance to begin with). On the opposite side, UN calls for greater appreciation of human rights in the TRIPS Agreement and its application should remind Members of the need to consider the wider ramifications of stronger IP protection in the longer term. While many debated the propriety of including the TRIPS Agreement in the WTO to begin with, it need not be a one-sided document in future.

Selected Bibliography

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S Picciotto , ‘ Is the International Trade Regime Fair to Developing States?: Private Rights v Public Interests in the TRIPS Agreement ’ 2003   American Society of International Law Proceedings (97) 167

D Rangnekar , ‘Geographical Indications: A Review of Proposals at the TRIPs Council’ UNCTAD/ICTSD Capacity Building Project on Intellectual Property Rights and Sustainable Development Paper (2002)

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W Rothnie , Parallel Imports (London: Sweet & Maxwell, 1993 )

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H Sun , ‘ The Road to Doha and Beyond: Some Reflections on the TRIPS Agreement and Public Health ’ 2004   European Journal of International Law 15(1) 123

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M Vincent , ‘ Extending Protection at the WTO to Products Other Than Wines and Spirits: Who Will Benefit? ’ 2007   Estey Centre Journal of International Trade Law and Policy 8(1) 57

E Vranes , ‘Cross Retaliation under GATS and TRIPS — An Optimal Enforcement Device for Developing Countries?’ in F Breuss , S Griller , and E Vranes (eds), The Banana Dispute: An Economic and Legal Analysis (Vienna: Springer, 2003 ) 113

J Watal , Intellectual Property Rights in the WTO and Developing Countries (Boston: Kluwer Academic Publishers, 2001 )

World Bank, Global Economic Prospects: Trade, Regionalism, and Development (Washington DC: World Bank, 2005 )

See, generally, chapters 2 and 3 of this Handbook.

L Helfer , ‘Regime Shifting: The TRIPs Agreement and New Dynamics of International Intellectual Property Lawmaking’ 2004 Yale Journal of International Law 29(1) 1, at 2 .

See, eg, A Deardorff , ‘What Might Globalization’s Critics Believe?’ 2003 World Economy 26(5) 639, at 653–54 ; E-U Petersmann , ‘From Negative to Positive Integration in the WTO: The TRIPs Agreement and the WTO Constitution’ in T Cottier and P Mavroidis (eds), Intellectual Property: Trade, Competition, and Sustainable Development (Ann Arbor: University of Michigan Press, 2003) 21, at 22–23 ; cf W Davey and W Zdouc , ‘The Triangle of TRIPS, GATT and GATS’ in Cottier and Mavroidis , ibid , 53, at 54 . See also Preamble and Arts 7 and 8.2 TRIPS Agreement.

T Cottier , ‘The Agreement on Trade-Related Aspects of Intellectual Property Rights’ in P Macrory , A Appleton , and M Plummer (eds), The World Trade Organization: Legal, Economic and Political Analysis , Vol I (New York: Springer, 2005) 1041, at 1054 . Cottier refers to ‘safeguards, dumping, subsidies, and agriculture’. Consider also, eg, the SPS Agreement.

See also Art 8 TRIPS Agreement; C Correa , Trade-Related Aspects of Intellectual Property Rights: A Commentary on the TRIPS Agreement (Oxford: Oxford University Press, 2006), at 91–114 .

J Watal , Intellectual Property Rights in the WTO and Developing Countries (Boston: Kluwer, 2001) 363 ; cf F Abbott , ‘Intellectual property rights in world trade’ in A Guzman and A Sykes (eds), Research Handbook in International Economic Law (London: Edward Elgar, 2007) 444, at 453 .

A Pacón , ‘What Will TRIPs Do For Developing Countries’ in FK Beier and G Schricker (eds), From GATT to TRIPs: The Agreement on Trade-Related Aspects of Intellectual Property Rights (Munich: Max Planck Institute, 1996) 329, at 332–33 ; F Abbott , ‘Commentary: The International Intellectual Property Order Enters the 21st Century’ 1996 Vanderbilt Journal of Transnational Law 29(3) 471, at 472–73, 476 ; Petersmann , above fn 3, at 32–33 .

AD Mitchell , ‘A legal principle of special and differential treatment for WTO disputes’ 2006 World Trade Review 5(3) 445, at 449–50 .

See, eg, TRIPS Council, Special and Differential Treatment Proposals Referred to the TRIPs Council: Report to the General Council by the Chair , IP/C/36 (20 July 2005) ; TRIPS Council, Annual Report (2006) , IP/C/44 (4 December 2006), at para 9 .

F Abbott , ‘Toward a New Era of Objective Assessment in the Field of TRIPS and Variable Geometry for the Preservation of Multilateralism’ 2005 Journal of International Economic Law 8(1) 77, at 80–83 .

K Leitner and S Lester , ‘WTO Dispute Settlement 1995–2006—A Statistical Analysis’ 2007 Journal of International Economic Law 10(1) 165, at 171 .

WTO, China — Intellectual Property Rights: Request for Consultations by the United States , WT/DS362/1, IP/D/26, G/L/819 (16 April 2007) .

M Handler , ‘The WTO Geographical Indications Dispute’ 2006 Modern Law Review 69(1) 70, at 79 .

Panel Report, EC — Trademarks and Geographical Indications (Australia) , at paras 7.89, 7.152, 7.249, 7.272, 8.1(e), 8.1(f)(i), 8.1(i)(i) ; Panel Report, EC — Trademarks and Geographical Indications (US) , at paras 7.38, 7.102, 7.213, 7.238, 8.1(c), 8.1(d)(i), 8.1(h)(i) .

US — Section 211 Appropriations Act .

US — Section 110(5) Copyright Act .

WTO, United States — Section 211 Omnibus Appropriations Act of 1998: Status Report by the United States — Addendum , WT/DS176/11/Add.53 (13 April 2007) ; WTO, United States — Section 110(5) of the US Copyright Act: Status Report by the United States — Addendum , WT/DS160/24/Add.28 (13 April 2007) .

DSB, Minutes of Meeting Held on 20 February 2007 , WT/DSB/M/226 (26 March 2007), at paras 4–13, 22 .

Canada — Patent Term .

Canada — Pharmaceutical Patents .

Indonesia — Autos .

India — Patents (EC); India — Patents (US) .

Art 22.3 DSU.

WTO, United States — Subsidies on Upland Cotton: Recourse to Article 7.9 of the SCM Agreement and Article 22.2 of the DSU by Brazil , WT/DS267/26 (7 October 2005), at 2 .

Art 22.6 DSU.

Decision by the Arbitrators, EC — Bananas III (Ecuador) (Article 22.6 — EC) , at paras 126, 138, 173(d).

E Vranes , ‘Cross Retaliation under GATS and TRIPS — An Optimal Enforcement Device for Developing Countries?’ in F Breuss , S Griller , and E Vranes (eds), The Banana Dispute: An Economic and Legal Analysis (Vienna: Springer, 2003) 113, at 124–28 .

MC, Doha Work Programme: Ministerial Declaration Adopted on 18 December 2005 , WT/MIN(05)/DEC (22 December 2005) (Hong Kong Declaration), at para 45 .

TRIPS Council, Minutes of Meeting Held on 13 February 2007 , IP/C/M/53 (22 March 2007), at paras 62–64 .

K Lee and S von Lewinski , ‘The Settlement of International Disputes in the Field of Intellectual Property’ in Beier and Schricker , above fn 7, 278, at 313 .

TRIPS Council, Non-Violation and Situation Complaints: Summary Note by the Secretariat — Revision , IP/C/W/349/Rev.1 (24 November 2004), at paras 10–12 .

See also chapter 21 of this Handbook.

These include excluding inventions from patentability where ‘necessary to protect ordre public or morality, including to protect human, animal or plant life or health’, but ‘provided that such exclusion is not made merely because the [commercial exploitation of the invention] is prohibited by their law’: Art 27.2 TRIPS Agreement.

F Abbott , ‘The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO’ 2002 Journal of International Economic Law 5(2) 469, at 472 .

Ibid at 495–97 .

MC, Declaration on the TRIPS Agreement and Public Health Adopted on 14 November 2001 , WT/MIN(01)/DEC/2 (20 November 2001), at para 4 .

Ibid at para 5 .

TRIPS Council, Extension of the Transition Period under Article 66.1 of the TRIPS Agreement for Least-Developed Country Members for Certain Obligations with Respect to Pharmaceutical Products: Decision of 27 June 2002 , IP/C/25 (1 July 2002), at para 1 ; GC, Least-Developed Country Members — Obligations Under Article 70.9 of the TRIPS Agreement with Respect to Pharmaceutical Products: Decision of 8 July 2002 , WT/L/478 (12 July 2002), at para 1 .

GC, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Decision of 30 August 2003 , WT/L/540 (1 September 2003) . A waiver of Article 31(h) is also included so that an importing Member need not pay adequate remuneration where it has already been paid in the exporting Member.

GC, Amendment of the TRIPS Agreement: Decision of 6 December 2005 , WT/L/641 (8 December 2005), at para 4 .

< http://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm > (last visited 24 August 2008).

< http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm > (last visited 24 August 2008). See also latest revisions of TRIPS Council, Protocol Amending the TRIPS Agreement — Status of acceptances: Note from the Secretariat (Revision) , IP/C/W/490/Rev.1 (19 October 2007) .

Council for TRIPS, Annual Review of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Report to the General Council , IP/C/46 (1 November 2007), at para 19 (Switzerland) ; TRIPS Council, Annual Review of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Report to the General Council , IP/C/42 (2 November 2006), at para 5 (European Communities) ; TRIPS Council, Annual Review of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Report to the General Council , IP/C/37 (3 November 2005), at para 5 (Canada) , at para 6 (India), at para 7 (Korea); TRIPS Council, Annual Review of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Report to the General Council , IP/C/33 (8 December 2004), at para 4 (Norway) .

GC, Amendment of the TRIPS Agreement — Extension of the Period for the Acceptance by Members of the Protocol Amending the TRIPS Agreement: Decision of 18 December 2007 , WT/L/711 (21 December 2007) . See also TRIPS Council, Amendment of the TRIPS Agreement: Proposal for a Decision on an Extension of the Period for the Acceptance By Members of the Protocol Amending the TRIPS Agreement , IP/C/45 (29 October 2007) .

TRIPS Council, Rwanda — Notification under Paragraph 2(A) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health , IP/N/9/RWA/1 (19 July 2007) .

TRIPS Council, Canada — Notification under Paragraph 2(C) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health , IP/N/10/CAN/1 (8 October 2007) .

W Rothnie , Parallel Imports (London: Sweet & Maxwell, 1993), at 1 (original emphasis) .

F Abbott , ‘First Report (Final) to the Committee on International Trade Law of the International Law Association on the Subject of Parallel Importation’ 1998 Journal of International Economic Law 1(4) 607, at 614 .

V Chiappetta , ‘The Desirability of Agreeing to Disagree: The WTO, TRIPS, International Exhaustion and a Few Other Things’ 2000 Michigan Journal of International Law 21(3) 333, at 336, 341, 350–53 ; Rothnie , above fn 47, at 3 . See also above section I .

Watal , above fn 6, at 303 .

See above section II.B .

MC , Declaration on the TRIPS Agreement and Public Health Adopted on 14 November 2001 , WT/MIN(01)/DEC/2 (20 November 2001), at para 5(d) .

Watal , above fn 6, at 296–97 .

See also Arts 17, 22–4, 30, 39 TRIPS Agreement; A Heinemann , ‘Antitrust Law of Intellectual Property in the TRIPs Agreement of the World Trade Organization’ in Beier and Schricker , above fn 7, 239, at 240, 244 .

R Anderson , ‘Intellectual Property Rights, Competition Policy and International Trade: Reflections on the Work of the WTO Working Group on the Interaction between Trade and Competition Policy (1996–1999)’ in Cottier and Mavroidis , above fn 3, 235, at 240 .

See generally M Taylor , International Competition Law: A New Dimension for the WTO? (Cambridge: Cambridge University Press, 2006) . See also chapter 23 of this Handbook.

W Fikentscher , ‘Historical Origins and Opportunities for Development of an International Competition Law in the TRIPs Agreement of the World Trade Organization (WTO) and Beyond’ in Beier and Schricker , above fn 7, 226 ; ‘OECD Committee Lacks Enthusiasm for Draft International Antitrust Code’ (1993) 65 ATRR 771; M Desta and N Barnes , ‘Competition Law and Regional Trade Agreements: An Overview’ in L Bartels and F Ortino (eds), Regional Trade Agreements and the WTO Legal System (Oxford: Oxford University Press, 2006) 239, at 243 .

MC, Ministerial Declaration adopted on 13 December 1996 , WT/MIN(96)/DEC (18 December 1996), at para 20 . See also MC, Ministerial Declaration adopted on 14 November 2001 , WT/MIN(01)/DEC/1 (20 November 2001) (Doha Declaration), at paras 23–25 .

GC, Decision Adopted by the General Council on 1 August 2004 , WT/L/579 (2 August 2004), at para 3 .

AD Mitchell , ‘Broadening the Vision of Trade Liberalisation: International Competition Law and the WTO’ 2001 World Competition 24(3) 343, at 346 .

Ibid at 347–51 ; A Guzman , ‘International competition law’ in Guzman and Sykes , above fn 6, 418, at 428–32 .

< http://www.wto.org/english/tratop_e/trips_e/gi_e.htm > (last visited 14 January 2008).

Doha Declaration, at para 18.

Hong Kong Declaration, at para 29.

See TRIPS Council, Side-by-Side Presentation of Proposals: Prepared by the Secretariat , TN/IP/W/12 (14 September 2005), TN/IP/W/12/Add.1 (4 May 2007), TN/IP/W/12/Add.1/Corr.1 (10 May 2007) .

See TNC, Issues Related to the Extension of the Protection of Geographical Indications Provided for in Article 23 of the TRIPS Agreement to Products Other Than Wines and Spirits: Compilation of Issues Raised and Views Expressed — Note by the Secretariat , WT/GC/W/546, TN/C/W/25 (18 May 2005) . See also Doha Declaration, at paras 12, 18; Hong Kong Declaration, at para 39.

TRIPS Council, Special Session, Geographical Indications: Communication from the European Communities , WT/GC/W/547, TN/C/W/26, TN/IP/W/11 (14 June 2005), at paras 2–3, 16 .

TRIPS Council, Special Session, Multilateral System of Notification and Registration of Geographical Indications under Article 23.4 of the TRIPS Agreement: Communication from Hong Kong, China , TN/IP/W/8 (23 April 2003), at para 4(iv) .

TRIPS Council, Special Session, Proposed Draft TRIPS Council Decision on the Establishment of a Multilateral System of Notification and Registration of Geographical Indications for Wines and Spirits , TN/IP/W/10 (1 April 2005), at para 4, TN/IP/W/10/Add.1 (18 November 2005), TN/IP/W/10/Add.2 (7 April 2006), TN/IP/W/10/Add.3 (20 April 2006) .

J Martín , ‘The WTO TRIPS Agreement: The Battle between the Old and the New World over the Protection of Geographical Indications’ 2004 Journal of World Intellectual Property 7(3) 287, at 288 .

G Evans and M Blakeney , ‘The Protection of Geographical Indications After Doha: Quo Vadis?’ 2006 Journal of International Economic Law 9(3) 575, at 607–08 .

Ibid at 575, 606–07 .

We use the term ‘free trade agreements’ to refer to bilateral and regional agreements between States or customs territories that focus at least in part on liberalizing trade between the parties, as distinct from the multilateral system established under the WTO. ‘FTAs’ therefore include free-trade areas and customs unions within the meaning of Art XXIV GATT 1994.

Convention Establishing the World Intellectual Property Organization , done at Stockholm, 14 July 1967, 828 UNTS 3, Art 3(i).

See < http://www.wipo.int/treaties/en/ShowResults.jsp?lang=en&treaty_id=1 > (last visited 14 January 2008).

See above fn 41.

Agreement Between the World Intellectual Property Organization and the World Trade Organization , signed 22 December 1995, entered into force 1 January 1996, Arts 2, 4.

See Art V:1 WTO Agreement.

See < http://www.wto.org/english/thewto_e/igo_obs_e.htm#trips > (last visited 18 May 2007); WTO, Rules of Procedure for Sessions of the Ministerial Conference and Meetings of the General Council , WT/L/161 (25 July 1996) Annex 3 .

Helfer , above fn 2, at 20–23, 26 ; see also Watal , above fn 6, at 400–02 .

See, eg, WIPO Copyright Treaty , done at Geneva, 20 December 1996, 36 ILM 65; WIPO Performances and Phonograms Treaty , done at Geneva, 20 December 1996, 36 ILM 76; Patent Law Treaty , done at Geneva, 1 June 2000, 39 ILM 1047; Singapore Treaty on the Law of Trademarks , done at Singapore, 27 March 2006 (not yet in force at time of writing).

See, eg, TRIPS Council, Work Programme on Electronic Commerce: Communication from Australia , IP/C/W/144 (6 July 1999), at para 21 ; TRIPS Council, Work Programme on Electronic Commerce: Communication by the European Communities and their Member States , IP/C/W/140 (7 May 1999), at para 12 .

See, generally, chapter 10 of this Handbook.

See, eg, Consultative Board, The Future of the WTO: Addressing Institutional Challenges in the New Millennium (Geneva: WTO, 2004), at para 76 ; World Bank, Global Economic Prospects: Trade, Regionalism, and Development (Washin gton DC: World Bank, 2005), at 28–30 .

See, generally, C Fink and P Reichenmiller , ‘Tightening TRIPS: The Intellectual Property Provisions of Recent US Free Trade Agreements’, World Bank Trade Note 20 (7 February 2005), at < http://www.siteresources.worldbank.org/INTRANETTRADE/Resources/Pubs/TradeNote20.pdf > (last visited 27 March 2008) .

B Mercurio , ‘TRIPS-Plus Provisions in FTAs: Recent Trends’ in Bartels and Ortino , above fn 57, 215, at 220–23 .

S Picciotto , ‘Is the International Trade Regime Fair to Developing States?: Private Rights v Public Interests in the TRIPS Agreement’ 2003 American Society of International Law Proceedings (97) 167, at 168 ; see also A Endeshaw , ‘Free Trade Agreements as Surrogates for TRIPs-Plus’ 2006 European Intellectual Property Review (28) 374, at 379–80 ; Art 1.1 TRIPS Agreement.

Signed 18 May 2004, entered into force 1 January 2005.

Signed 24 October 2000, entered into force 17 December 2001.

Art 4.19. In contrast, Article 31(b) TRIPS Agreement provides that in cases of public noncommercial use, national emergency, or other circumstances of extreme urgency, the Member may waive the requirement to ‘ma[k]e efforts to obtain authorization from the right holder on reasonable commercial terms and conditions’. These circumstances are not a prerequisite to compulsory licensing per se .

C Correa , ‘Implications of Bilateral Free Trade Agreements on Access to Medicines’ 2006 Bulletin of the World Health Organization 84(5) 399, at 402 ; see also J Kuanpoth , ‘TRIPS-Plus Intellectual Property Rules: Impact on Thailand’s Public Health’ 2006 Journal of World Intellectual Property 9(5) 573, at 584–89 ; above section II.B.

F Abbott , ‘Intellectual Property Provisions of Bilateral and Regional Trade Agreements in Light of U.S. Federal Law’, UNCTAD-ICTSD Capacity Building Project on Intellectual Property Rights and Sustainable Development, Issue Paper No 12 (2006) 18–19 .

See, eg, Office of the United States Trade Representative, Bipartisan Agreement on Trade Policy: Intellectual Property Provisions (May 2007) ; ‘Peru IPR Text Reflects FTA Template, Shows Reduced PhRMA Sway’ Inside US Trade (6 July 2007) 27 .

See, eg, ‘U.S. Seeks New Anti-Counterfeiting Treaty With Key Trading Partners’ Inside US Trade (26 October 2007) 42 ; ‘Baucus Calls for Stronger TRIPS Deal As Part of New Trade Policy’ Inside US Trade (12 October 2007) 40 .

See also chapter 20 of this Handbook.

United Nations High Commissioner for Human Rights, Sub-Commission on the Promotion and Protection of Human Rights, Intellectual Property and Human Rights: Sub-Commission on Human Rights Resolution 2001/21 , Preamble.

ECOSOC, Commission on Human Rights, Sub-Commission on the Promotion and Protection of Human Rights, The impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights on human rights: Report of the High Commissioner , E/CN.4/Sub.2/2001/13 (27 June 2001), at para 22.

Done at New York, 16 December 1966, 993 UNTS 3.

ECOSOC, above fn 97, at para 10.

F Abbott , ‘The “Rule of Reason” and the Right to Health: Integrating Human Rights and Competition Principles in the Context of TRIPS’ in T Cottier , J Pauwelyn , and E Bürgi (eds), Human Rights and International Trade (Oxford: Oxford University Press, 2005) 279, at 291, 297, 300 .

ECOSOC, Committee on Economic, Social and Cultural Rights, General Comment No 17 (2005): The right of everyone to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he or she is the author (article 15, paragraph 1(c), of the Covenant) , E/C.12/GC/17 (12 January 2006), at paras 2–3.

See above fn 33 and corresponding text.

See above fn 87 and corresponding text.

ECOSOC, Commission on Human Rights, Sub-Commission on the Promotion and Protection of Human Rights, Economic, Social and Cultural Rights: Globalization and its impact on the full enjoyment of human rights , E/CN.4/Sub.2/2001/10 (2 August 2001), at paras 21, 25.

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Is the National Security Exception in the TRIPS Agreement a Realistic Option in Confronting COVID-19?

It has been suggested by some scholars and commentators that states can invoke the national security exception in the TRIPS Agreement as part of measures to tackle COVID-19 (see here , here , and here ). This would entail invoking the security exception to suspend the enforcement of patent rights in order to facilitate either the importation or local production of needed medicines and/or vaccines. But is this a realistic option for states in the fight against COVID-19? That is the key question that will be addressed in this post.

Article 73 of the TRIPS Agreement provides for the security exceptions that states can invoke to defend their non-compliance with the TRIPS Agreement. This is a unique provision in the context of international intellectual property law. Crucially, the major intellectual property treaties that were in existence before the TRIPS Agreement i.e. the Berne Convention for the Protection of Literary and Artistic Works and the Paris Convention for the Protection of Industrial Property do not contain any security exceptions. Article 73 mirrors similar provisions in Article XXI of the WTO’s General Agreement on Tariffs and Trade (GATT) and Article XIV bis of the General Agreement on Trade in Services (GATS). 

The most pertinent provision with regard to COVID-19 is Article 73(b)(iii) of the TRIPS Agreement which mirrors Article XXI(b)(iii) of GATT. Article 73(b)(iii) permits a state to take ‘any action which it considers necessary for the protection of its essential security interests’ during the ‘time of war or other emergency in international relations’. Until very recently, the precise scope of this security exception was unclear and a number of states took the view that these exceptions were ‘self-judging’ and non-justiciable. Fortunately, Article XXI(b)(iii) of GATT and Article 73(b)(iii) of the TRIPS Agreement have now been recently considered and interpreted by two WTO dispute settlement panels. Article XXI(b)(iii) of GATT was interpreted in Russia -Traffic in Transit (2019) while Article 73(b)(iii) of the TRIPS Agreement was interpreted in  Saudi Arabia – Intellectual Property Rights (2020). These two decisions have been discussed here and here .

For the purposes of this post, I will proceed with the assumption that COVID-19 can be regarded as an ‘emergency in international relations’ as interpreted in these two cases. Let us therefore assume that states, if they wish to do so, can invoke Article 73(b)(iii) to suspend the enforcement of patent rights to facilitate the production or importation of patented medicines or vaccines in response to COVID-19. I would however suggest here that invoking Article 73(b)(iii) is not a realistic option for a number of states for the following three reasons.

One, with regard to the production of patented medicines or vaccines, only states that possess the capability to manufacture pharmaceutical products domestically can arguably invoke Article 73(b)(iii) to justify the suspension of the enforcement of patent rights in order to protect their essential security interests during a pandemic such as COVID-19. While the so called BRICS countries (i.e. Brazil, Russia, India, China, and South Africa) do possess the capacity to produce generic versions of a number of pharmaceutical products, this is not the case in a number of other developing and least-developed countries . In addition, the production of vaccines occurs in only a few developed countries .

Two, in relation to the importation of patented medicines or vaccines, the security exception in Article 73(b)(iii) cannot be used to circumvent the problems associated with the waiver system contained in Article 31 bis of the TRIPS Agreement. Article 31 bis waives the obligation contained in Article 31(f) of the TRIPS Agreement where a state grants a compulsory licence for the production of a pharmaceutical product and its export to an eligible importing country. The genesis of Article 31 bis is traceable to paragraph 6 of the Doha Declaration on TRIPS and Public Health which recognised that ‘WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement.’ Paragraph 6 further instructed the Council for TRIPS to ‘find an expeditious solution to this problem and to report to the General Council before the end of 2002.’ Eventually, in 2003, the General Council of the WTO adopted a decision on the ‘ Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health ’. This decision established a mechanism for the waiver of Article 31(f) of the TRIPS Agreement with respect to a WTO Member that grants a compulsory licence for the purposes of producing pharmaceutical products and exporting it to an eligible importing WTO Member. In 2005, this waiver mechanism was transformed into a permanent amendment to the TRIPS Agreement as Article 31 bis which entered into force in January 2017 . The usefulness of this waiver mechanism however remains doubtful as it contains a number of complex and cumbersome requirements and this has meant that it has been used only once to export anti-retroviral drugs from Canada to Rwanda.

To illustrate the uselessness of Article 73(b)(iii) in terms of circumventing the problems associated with Article 31 bis , State A cannot invoke the security exception in Article 73(b)(iii) to justify a decision to suspend the enforcement of patent rights in its territory in order to produce and export patented medicines or vaccines into the territory of State B. As interpreted by the panel in Russia – Traffic in Transit and in Saudi Arabia – Intellectual Property Rights , the measures implemented by State A pursuant to Article 73(b)(iii) must not be remote from or unrelated to the emergency that it is implausible that State A implemented the measures for the protection of its own essential security interests arising out of the emergency. In other words, it is doubtful whether State A can invoke Article 73(b)(iii) to justify the suspension of the enforcement of patent rights in its own territory in order to protect the essential security interests of State B by exporting patented medicines or vaccines from State A into State B.

Three, least-developed countries are currently exempted from providing patent protection for pharmaceutical products until 2033 . In fact, in June 2013, least-developed countries were granted a further extension till July 2021 with regard to the implementation of the TRIPS Agreement . Thus, it is unnecessary for least-developed countries (or at least those currently using these extensions) to implement measures to suspend the enforcement of patent protection for pharmaceutical products.

In conclusion, the above analysis shows that, in the absence of domestic manufacturing capacity, most of the flexibilities in the TRIPS Agreement (including the most extreme one i.e. the national security exception) may not be useful to some countries during a pandemic such as COVID-19. Importantly, it also demonstrates the point that facilitating access to medicines and vaccines in some situations may require measures that (include but also) transcend intellectual property rights. Going forward, a more useful strategy might be to focus on steps that countries (especially developing countries) can take to boost their domestic manufacturing capacity .

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Aditya Roy says

August 6, 2020

Dear Emmanuel Thanks for the intervention. Does this means that the Art 31bis obligations prevail over Art 73. Best Wishes Aditya Roy

Ruth Lopert says

Using TRIPS flexibilities to transcend IP rights in order to facilitate the procurement of medicines and vaccines at affordable prices is to be encouraged, but patent rights are not the only IP barriers that may need to be circumvented.

In most countries medicines and vaccines must have regulatory approval and in order to obtain this, the manufacturer must submit a dossier to the national medicines regulatory agency presenting clinical trial data demonstrating the efficacy and safety of the product. These data are frequently subject to long periods of protection or 'exclusivity' – particularly in countries with trade agreements with the US or EU – up to 11 years in the EU for example, from the date of marketing approval.

When a generic version of that medicine subsequently seeks marketing approval, it is not required to repeat the clinical trials conducted by the manufacturer of the originator product. Instead it may submit an abbreviated dossier, and may ‘rely’ on the originator’s safety and efficacy data in order to support its approval. But that reliance may only occur after the period of data and/or market exclusivity has expired.

Some countries – Malaysia, Chile and Colombia, for example – have recognised the importance of ensuring that data exclusivity provisions do not hinder the appropriate use of compulsory licensing, and have incorporated explicit waivers in their medicines’ regulations or patent laws, to facilitate registration of generic medicines where needed to protect public health. Boosting manufacturing capacity and utilising TRIPS flexibilities to circumvent patent barriers are important, but may not be sufficient.

Emmanuel says

Dear Aditya,

Thank you for your question. I don't think it is really about one set of obligations being superior to another. It really boils down to the circumstances in which Article 73(b)(iii) can be invoked by a state. Based on my reading of the panel reports in both Russia-Traffic in Transit and Saudi Arabia - Intellectual Property Rights, a state can only invoke this exception to address its own 'essential security interests' and not those of another state.

Jakob Cornides says

August 7, 2020

This learned inquiry into how the security exception of TRIPs might be used to confront COVID19 suffers from one very fundamental flaw: it is hypothetical to such a point that one can only describe it as grotesque.

Yes, there is a national security exception in TRIPs. And yes, there is a possibility to grant compulsory licenses on drugs, including for export to other countries. We all know that. But what this contribution completely fails to explain is how a patent for a drug (which drug???) is currently blocking countries from addressing the COVID crisis.

In the initial phase, the main concern for governments was how to procure a sufficient number of face masks. There was initially a scarcity of masks, or at least there was perceived to be. But those face masks are not patented, so TRIPs has nothing to do with them.

Much the same can be said regarding ventilation systems.

Then there was (and very probably continues to be) a scarcity of hospital beds and intensive care units - but scarce as they may be, they are not scarce because of any patent. Again, what does this have to do with TRIPs?

Finally, there is the problem of vaccines and drugs. COVID can be (and is) treated with existing drugs, and in most cases the treatment is successful. Maybe I have missed something, but is anyone actually saying that any of these drugs are unaffordable as a result of being patented? Which drug would that be? The contribution fails to mention it?

With regard to a vaccine, the problem is that it still needs to be developed. If TRIPs has any relevance in the COVID19 context, it is that pharmaceutical patents create the economic incentive for commercial enterprises to invest billions into research and development in order to develop such a vaccine.

But for the time being the problem is not that IPR stands in the way of people getting access to treatment.

August 8, 2020

Dear Jakob,

Thank you for your comment. I think your conclusion that 'for the time being the problem is not that IPR stands in the way of people getting access to treatment' is a fair and reasonable opinion. And yes, the analysis in my post is hypothetical, but I am not sure why it should be described as grotesque. My post is in response to calls by others (not me) for the invocation of the security exception in the TRIPS Agreement. Even if, for now, IP is not seen as a barrier to treatment for COVID-19, the pandemic is far from over and IP could still be an issue somewhere along the line. Given that, I think one can understand why some would suggest the invocation of the security exception. In this post, I am not arguing for or against the invocation of the security exception. I merely examine whether it is a realistic option in the current circumstances. Moreover, while the analysis in my post is about COVID-19, the arguments therein transcend the current pandemic.

Daniel Nicholas Pakpahan says

September 13, 2020

Dear Emmanuel,

Thank you for your post. However, I failed to understand how the first reason you stated is relevant for the invocation of Art 73 TRIPS, i.e. why would State invoke Art. 73 instead of just rely on Art 31bis, since it was created to overcome the lack of domestic capacity? On the second reason, does your concern relate to the feasibility of States' effort in getting around the cumbersome process of Art 31bis by invoking Art 73 TRIPS? I think the concern raised by the previous posts is whether (developed) States who opted out as eligible importers under Art 31bis can still access such mechanism in case their domestic capacity is overwhelmed; this emphasis on importers' opt out commitment is different from what your post is suggesting, i.e. that exporting States cannot use Art 73 for the security interest of other States, which I could agree on.

Dear Daniel,

Thank you for your questions. With regard to your first question, a state that possesses domestic manufacturing capacity can successfully invoke Article 73 to produce patented medicines or vaccines. However, while a state that lacks domestic manufacturing capacity can in theory invoke Article 73, I am not sure what the effect would be if it cannot actually produce the necessary drugs or vaccines locally. Of course, Article 31bis was introduced to address the problems faced by states that lack domestic manufacturing capacity. But, as you may already know, the procedure for making use of this exception is quite complex and cumbersome such that it has only been used once i.e. by Rwanda & Canada. So, I think the key point here is that, both Article 31bis and Article 73 may (realistically, not in theory) be unhelpful to states that do not possess domestic manufacturing capacity.

In relation to your second question, yes, my concern in this regard relates to the feasibility of States' effort in getting around the cumbersome process of Art 31bis by invoking Art 73. In this post, I do not address the question of 'whether (developed) States who opted out as eligible importers under Art 31bis can still access such mechanism in case their domestic capacity is overwhelmed'. That is a separate question that, I think, is distinguishable from whether those developed states can also invoke Article 73 (if they want to). I am glad we both agree that 'exporting States cannot use Art 73 for the security interest of other States'. That is actually the point I am trying to make here i.e. Article 73(b)(iii) cannot be used to circumvent the strictures of Article 31bis. Importantly, my goal is simply to ensure that people are realistic about the scope of Article 73 in the context of COVID-19. Once again, thanks for your questions.

Interpreting the Flexibilities Under the TRIPS Agreement

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While the TRIPS Agreement provides for minimum standards of protection of intellectual property, it leaves certain degree of policy space for WTO members, whether developed or developing countries, to implement the Agreement’s provisions in different manners, to legislate in areas not subject to the minimum standards under the Agreement, and to develop legal interpretations of such provisions to determine the scope and content of the applicable obligations. This paper focuses on some aspects of how panels and the Appellate Body of the WTO have interpreted said provisions. The paper also draws general conclusions for the implementation of TRIPS flexibilities, which are of crucial importance for the design of a pro-competitive intellectual property system and, in particular, for achieving public health objectives, as specifically recognized by the Doha Declaration on TRIPS and Public Health.

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Establishing Conformity Between TRIPS and Human Rights: Hierarchy in International Law, Human Rights Obligations of the WTO and Extraterritorial State Obligations Under the International Covenant on Economic, Social and Cultural Rights

1 introduction.

While the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘the TRIPS Agreement’) has had a major impact in framing national laws on intellectual property rights (IPRs)—notably in developing countries—and has led to some degree of harmonization of such laws, it is not a uniform law on IPRs.

One the one hand, the TRIPS Agreement provides for minimum standards, thereby allowing the members of the World Trade Organization (WTO) to adopt broader protections. Footnote 1 Many such ‘TRIPS-plus’ protections have been established through free trade agreements signed by the US and the European Union with developing country partners. Footnote 2 Examples of such TRIPS-plus protections include (in the area of patents) the extension of the patent term in order to compensate for delays in the grant of a patent or the marketing approval of a pharmaceutical product, Footnote 3 data exclusivity, Footnote 4 and what is known as ‘patent linkage’, Footnote 5 among others.

On the other hand, the TRIPS Agreement leaves some room for WTO members, whether developed or developing countries, to implement the Agreement’s provisions in different manners, to legislate in areas not subject to the minimum standards under the Agreement, and to develop legal interpretations of such provisions to determine the scope and content of the applicable obligations.

The possibility, and admissibility, of differences in the implementation of the provisions of the TRIPS Agreement are expressly recognized in Article 1.1 of the Agreement: “Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.” Competition law, which may be applied to control the acquisition or exercise of IPRs, is an example of the second situation in which the Agreement does not provide a binding standard. Footnote 6 The room for different interpretations may result from the absence of definitions. One example is the lack of a definition of the concept of ‘invention,’ which differs among countries and allows WTO members not to grant patents, for instance, on developments without a technical effect (such as under European law), or to grant or not grant patents on genetic materials. Footnote 7 In many cases, the space for different interpretations derives from general expressions or ambiguities in the text resulting from compromises reached in the negotiation of the Agreement. An outstanding example is the WTO members’ right to grant compulsory licenses due to lack of working of a patent, an issue indirectly referred to in Article 27.1 of said Agreement. Footnote 8 The task of the interpreter is particularly daunting when the text includes general terms such as “reasonably,” “unreasonably,” Footnote 9 “unjustifiable,” Footnote 10 or “unjustifiably.” Footnote 11

The actual policy space available under the TRIPS Agreement—beyond those areas not covered under the Agreement—depends, in the last instance, on the interpretation of the Agreement’s provisions. This paper focuses on some aspects of how panels and the Appellate Body of the WTO have interpreted said provisions. It discusses, first, the concept of ‘TRIPS flexibilities’ and the possible types of such flexibilities as found in the legislation of developing and developed countries. Second, the paper discusses the references to such flexibilities in WTO jurisprudence. Third, it briefly refers to some of the principles of interpretation that are relevant for the use of TRIPS flexibilities, including the value of dispute settlement rulings, the search for the ordinary meaning of the terms used, the context, and the object and purpose of the treaty. Fourth, it discusses the legal status of the Doha Declaration on the TRIPS Agreement and Public Health adopted at the 4th WTO Ministerial Conference in November 2001. Footnote 12 There is no attempt in this paper to analyze the specific content of the rulings in TRIPS-related disputes; however, the paper does draw some general conclusions for the implementation of such flexibilities, which are of crucial importance for the design of a pro-competitive intellectual property system and, in particular, for achieving public health objectives (as specifically recognized by the Doha Declaration). Footnote 13

2 Defining the TRIPS Flexibilities

The terminology used to refer to the policy space available for the implementation of the TRIPS Agreement has evolved. Expressions such as “room to maneuver,” “margins of freedom,” “safeguards,” and “margin of discretion” were used in the early studies and reports that identified various aspects of such space. Footnote 14 Currently, the diversity of legislative options available under said Agreement is generally known as ‘TRIPS flexibilities.’

The term ‘flexibility’ appears in the Preamble (sixth paragraph) and in Article 66.1 of the TRIPS Agreement but it is used there with a broader meaning. It indicates that least-developed countries (LDCs) are not bound to comply with the TRIPS Agreement obligations (except Articles 3 through 5) during the transition period:

In view of the special needs and requirements of least-developed country Members, their economic, financial and administrative constraints, and their need for flexibility to create a viable technological base, such Members shall not be required to apply the provisions of this Agreement, other than Articles 3, 4 and 5, for a period of ... Footnote 15

The terminology ‘TRIPS flexibilities’ does include the exemption for LDCs, but it also encompasses possible variations in the manner in which the TRIPS Agreement’s provisions are interpreted and implemented as they are applied to countries actually subject to them. Such terminology was used for the first time with this latter meaning in the context of the WTO in paragraph 4 of the Doha Declaration. Footnote 16 Said paragraph states:

4. We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose. Footnote 17

The Declaration confirmed the availability of a number of flexibilities. Its adoption was a response to the concerns of developing countries about the obstacles they faced when seeking to implement measures to promote access to affordable medicines, without limitation to certain diseases, in the interest of public health. Footnote 18

Since the adoption of the Doha Declaration, the concept of ‘TRIPS flexibilities’ has been referenced in a vast body of literature, especially (but not only) in relation to access to medicines, Footnote 19 and in numerous resolutions of UN agencies Footnote 20 and bodies, including the World Health Organization (WHO), the Human Right Council (HRC), Footnote 21 and the UN Assembly, as well as in reports of the UN Special Rapporteur on the Right to Health. Footnote 22 For instance, the World Health Assembly (WHA) urged member states “to consider, whenever necessary, adapting national legislation in order to use to the full the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)”. Footnote 23 The Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property Footnote 24 explicitly referred to the flexibilities reaffirmed by the Doha Declaration, including the research exception (Element 2.4e), the transitional period for least-developed countries (LDCs) (Element 6.1b), and the regulatory exception or “Bolar exception” (Element 6.3a). A 2011 resolution adopted by the HRC, and subsequent resolutions on the matter, also noted the governments’ right to use, to the fullest extent, the provisions of the TRIPS Agreement, the Doha Declaration, and the WTO General Council Decision of 30 August 2003 in the context of the HIV/AIDS epidemic. Footnote 25 Importantly, Goal 3. Target 3.b of the Sustainable Development Goals (SDGs), as adopted by the UN General Assembly, also refers to the TRIPS flexibilities:

Goal 3. Target 3.b: Support the research and development of vaccines and medicines for the communicable and noncommunicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all. Footnote 26

There is no agreed-upon definition of ‘TRIPS flexibilities.’ In accordance with a WIPO document, the term “flexibilities” means that there are “different options through which TRIPS obligations can be transposed into national law so that national interests are accommodated and yet TRIPS provisions and principles are complied with.” Footnote 27 That concept implies that the legislative options made are compatible with the TRIPS Agreement and, hence, fully legitimate . Although this remark may be deemed trite , it is important to make it in view of the reluctance of some developed countries to accept the use of such flexibilities, and even to exert pressures on or apply retaliatory trade sanctions against countries that do comply with the Agreement’s obligations. This position is well reflected in the continuous use by the US of the Special Section 301 of the US Trade Act 1974, Footnote 28 and in the European Commission Staff Working Document on the protection and enforcement of intellectual property rights in third countries. Footnote 29

There are different types of TRIPS flexibilities. Some refer to the scope and extent of the substantive rights to be recognized under the Agreement, Footnote 30 and others to the ways in which such rights can be enforced. One way of grouping flexibilities is also to take into account “the point in time at which Members may resort to them: (i) in the process of the acquisition of the right; (ii) defining the scope of the right; and (iii) when enforcing the right.” Footnote 31 As noted in one report, those flexibilities

…sometimes are made very explicit (as in the right of each WTO Member to choose its national regime of exhaustion of IP rights, hence allowing parallel imports), and in other instances follow from the use of general and open terms in TRIPS provisions (such as legitimate interests, justifiability, ordre public and morality) that WTO Member can – within the limits of accepted principles of treaty interpretation in public international law – interpret and implement in accordance with their public policy preferences. Footnote 32

Given the possible variations in national regimes in interpreting and implementing the TRIPS Agreement, it would be an impossible task to identify all flexibilities. They can be found in all the areas covered by the Agreement, and they can be identified as new circumstances arise. Thus, the exception to copyright protection, which is of particular importance to ensure access to knowledge and preserve a robust public domain, Footnote 33 needs to be considered in light of technological developments. Footnote 34 WIPO’s Database on Flexibilities in the Intellectual Property System Footnote 35 provides information on just fourteen TRIPS flexibilities as provided for in the national laws of some countries, but the list is certainly much longer and their use in national laws and regulations more extensive. As noted, the type and use of such flexibilities have been widely explored, most particularly in relation to public health policies and access to medicines, Footnote 36 in academic literature, numerous reports, and other sources of information. Footnote 37 Box 1 includes references to some of the flexibilities available in the field of public health.

Box 1 Public health-related TRIPS flexibilities

Flexibility in the choice of patentability criteria, including for chemical entities and biologics —WTO members have considerable policy space to define what an ‘invention’ is and to apply rigorous standards of patentability to avoid the grant of patents that, without making a genuine technical contribution, may distort market competition.

Compulsory license —Widely recognized in the legislation of developed and developing countries—and granted since the adoption of the TRIPS Agreement by administrations or courts in countries such as Thailand, Ecuador, Indonesia, India, USA, Italy, and Germany—compulsory licenses may be necessary to correct market distortions (abuses of market power, unfair pricing, refusal to license, etc.).

Government use —In many cases governments may decide, consistently with the TRIPS Agreement, to use patented inventions for non-commercial purposes, such as for ensuring the supply of essential medicines.

Compulsory licenses for the supply of medicines to countries with a lack of or insufficient manufacturing capacity —Compulsory licenses exclusively for the export of medicines can be granted under the amendment introduced to the TRIPS Agreement in 2017 and the waiver adopted by WTO in 2003.

Test data protection —The TRIPS Agreement (Article 39.3) requires WTO members to protect test data against unfair competition, which does not create exclusive rights. The Agreement is complied with if legislation on unfair competition is implemented to protect such data.

Exemptions) for LDCs —LDCs need not grant patents for pharmaceuticals and test data protection at least until 2033 under the extended transition period provided for under Article 66.1 of the TRIPS Agreement.

Parallel importation —Importing protected medicines from any country where they can be purchased cheaper than locally is consistent with the TRIPS Agreement.

Pre and post patent grant opposition —Procedures before patent offices provide for the possibility for third parties to contribute to the examination process through ‘observations’ or ‘oppositions,’ whether before or after the grant of a patent, or both.

Use of competition law to address the misuse of IPRs —Competition law may be applied to correct market distortions created through the abuse of IPRs.

Bolar exception —‘Bolar exceptions’ are important to accelerate the entry of generic products and promote a dynamic market for medicines.

Research or experimentation exception —This exception allows research to be conducted by third parties on patented inventions, for instance, to improve on them or derive new inventions.

Disclosure requirement, particularly for biologics —The full and precise disclosure of an invention is crucial for the patent system to perform its informational function. This is particularly relevant for biologicals, which cannot be described in the same way as medicines produced by chemical synthesis

Flexibilities in enforcement of IP —Measures to enforce IPRs—such as reversal of the burden of proof, determination of infringement by equivalence and damages, and border measures—if overly broad, may distort competition by discouraging or preventing market entry and the availability of generic medicines. Provisional injunctions need to be cautiously granted so as not to distort the market dynamics, generally after giving the alleged infringer an opportunity to articulate his defense. Permanent injunctions may be denied for public health reasons under certain circumstances.

Security exception —Compliance with obligations under the TRIPS Agreement can be suspended, inter alia, in cases of emergency in international relations, such as in the case of a pandemic (Article 73 (b) of the Agreement).

Source: adapted from South Centre, “A Public Health Approach to Intellectual Property Rights: Public Health Related Flexibilities in the TRIPS Agreement,” available from: https://ipaccessmeds.southcentre.int/wp-content/uploads/2018/12/Public-Health-Related-Flexibilities-in-the-TRIPS-Agreement.pdf .

Any WTO member can make use of the TRIPS flexibilities, as applicable, in order to attain public health or other public objectives and, in fact, both developed and developing countries have done so. Thus, the flexibility in the TRIPS Agreement permitted the US to maintain a double-novelty standard depending on whether the disclosure of the invention had taken place within or outside the territory of the US (35 USC section 102 (a)). Footnote 38 In defending this flexibility, which has allowed for the misappropriation of genetic resources and traditional knowledge, Footnote 39 the US held that in the TRIPS Agreement there was “no prescription as to how WTO Members define what inventions are to be considered ‘new’ within their domestic systems” and, hence, that its legislation was “perfectly consistent with the provisions of the TRIPS Agreement.” Footnote 40 Another example in the US is the doctrine that allows US courts not to grant a permanent injunction despite the proven existence of an infringement of IPRs, in accordance with the precedent set by the US Supreme Court in the eBay vs. MercExchange case. Footnote 41 There are also many examples in Europe Footnote 42 where, for instance, the European Parliament’s Resolution of 2 March 2017 on EU options for improving access to medicines (2016/2057(INI)) emphasized “that the European Patent Office (EPO) and the Member States should only grant patents on medicinal products that strictly fulfil the patentability requirements of novelty, inventive step and industrial applicability, as enshrined in the European Patent Convention” (paragraph 48). Footnote 43 More recent examples are the amendments to the patent laws in Canada and Germany to address the COVID-19 emergency. Bill C 13 2020 of Canada, Footnote 44 for instance, added a new section to the Patent Act implementing a new type of compulsory license for patents:

19.4  (1)  The Commissioner shall, on the application of the Minister of Health, authorize the Government of Canada and any person specified in the application to make, construct, use and sell a patented invention to the extent necessary to respond to the public health emergency described in the application.

In Germany, an amendment to the Patent Act provided that an invention relating to medicinal products, including narcotics; the active ingredients, starting materials, and auxiliary materials for these products; medical devices; laboratory diagnostics; aids; personal protective equipment; and products for disinfection of the products shall be used in the interest of public welfare (“öffentliche Wohlfahrt”) or in the interest of the security of the Federation. Footnote 45

3 TRIPS Flexibilities in WTO Jurisprudence

Despite the TRIPS Agreement being one of the most controversial components of the WTO system, and that it has given rise to a large number of proceedings under the Dispute Settlement Understanding, a relatively small number of cases has reached the phase of a panel or Appellate Body intervention.

Paradoxically, although the adoption of the TRIPS Agreement essentially was aimed at disciplining developing countries, who have been forced to make massive legislative changes to adapt to the Agreement’s high minimum standards, Footnote 46 most disputes leading to the establishment of a panel have been against developed countries (two against the US, Footnote 47 two against the European Communities and their Member States, Footnote 48 two against Canada, Footnote 49 and one against Australia Footnote 50 ). Only two developing countries were subject to such procedures: Footnote 51 India (two complaints concerning the implementation of Article 70.8, the so called “mailbox” provision) Footnote 52 and China (criminal sanctions for copyright infringement and other issues). Footnote 53 Only four developing countries (Indonesia, Cuba, Honduras, and the Dominican Republic) have been complaining parties (against Australia in the tobacco plain packaging case) in WTO disputes under the TRIPS Agreement that have reached such stage. Footnote 54

In other cases of disputes initiated against developing countries, no panel was established. One example was a complaint by the US against Argentina on patents and test data protection. Footnote 55 A mutually agreed-upon solution was communicated to the Dispute Settlement Body (DSB) on 20 June 2002. However, the parties did not reach a common understanding on the interpretation of Article 39.3 of the TRIPS Agreement, nor on the application of Article 70.7. Footnote 56 Argentina has not to date introduced the data exclusivity regime that the US claimed would remedy the (unproven) violation of Article 39.3. Another example, further discussed below, was the US challenge in January 2001 against Brazilian legislation that authorizes the granting of compulsory licenses and parallel imports in instances when patents are not worked. Footnote 57 The dispute ended several months later when the US complaint was withdrawn. Footnote 58

The panel and Appellate Body reports produced in relation to the disputes mentioned above have, in practice, addressed the policy space available under the TRIPS Agreement, but they have only occasionally referred to the concept of ‘flexibilities.’ In China—Intellectual Property Rights , for instance, third parties alluded to the ‘flexibility’ allowed by the TRIPS Agreement in relation to the definition of ‘commercial scale.’ Footnote 59 The US noted, with respect to Article 1.1 of the Agreement, that the provision “only offers flexibility in how a Member implements TRIPS obligations and does not exempt a Member from full compliance with TRIPS obligations.” Footnote 60 In this case the panel confirmed that the TRIPS Agreement does not mandate specific forms of legislation. Footnote 61 In relation to the US claim that China did not comply with Article 61 of the TRIPS Agreement, it stated:

The Panel may not simply assume that a Member must give its authorities wide discretion to determine what is on a commercial scale in any given case, and may not simply assume that thresholds, including numerical tests, are inconsistent with the relative benchmark in the first sentence of Article 61 of the TRIPS Agreement. As long as a Member in fact provides for criminal procedures and penalties to be applied in cases of wilful trademark counterfeiting or copyright piracy on a commercial scale, it will comply with this obligation. If it is alleged that a Member's method of implementation does not so provide in such cases, that allegation must be proven with evidence…(para. 7.602).

A few references to the ‘flexibilities’ allowed by the prohibition contained in Article 20 of the TRIPS Agreement can be found in the panel report in Australia—Tobacco Plain Packaging . For instance, the panel stated:

On their face, the explicit prohibitions contained in Article 20 of the TRIPS Agreement and Article 2.2 of the TBT Agreement respectively must be read and, absent a conflict, applied together. The principle of harmonious reading dictates that the flexibilities implicitly left by those prohibitions also need to be viewed together, without a priori giving precedence to one over, and to the exclusion of, the other. Footnote 62

The panel in the same case also referred, as discussed below, to the Doha Declaration as a “re-affirmation by Members of the flexibilities provided in the TRIPS Agreement in relation to measures taken for the protection of public health”; Footnote 63 the concept of TRIPS flexibilities was also alluded to, for example, by Brazil and Thailand as third parties Footnote 64 and by the panel itself (para. 7.2407 and 7.2408). Interestingly, the Appellate Body in Australia—Tobacco Plain Packaging referred to the concept of Members’ ‘regulatory autonomy’ in encumbering the use of trademarks by special requirements under Article 20. Footnote 65

4 Interpretation of the TRIPS Agreement

This section is partially based on Carlos Correa, op. cit., 2005, which examines other aspects, such as the role of the negotiating history and the application of prior intellectual property conventions incorporated into the TRIPS Agreement;—,; see also Kennedy ( 2016 ).

This section considers some principles for and aspects of the interpretation of the TRIPS Agreement particularly relevant for the application of the TRIPS flexibilities.

4.1 Precedential Value of GATT/WTO Jurisprudence

Neither the GATT nor the WTO jurisprudence have precedential value; however, even if unrelated to intellectual property, such jurisprudence may influence and provide guidance for future rulings on the TRIPS Agreement. Footnote 66 One issue of particular relevance is whether jurisprudence on subjects other than those covered by this Agreement should be used to interpret it. The panel in India—Patent Protection for Pharmaceutical and Agricultural Chemical Products, for instance, held that although the TRIPS Agreement has a “relatively self-contained, sui generis status within the WTO,” it also was “an integral part of the WTO system, which itself builds upon the experience of over nearly half a century under the GATT 1947.” Footnote 67 In United States—Section 110(5) of the U.S. Copyright Act , while the panel noted that caution was required when interpreting the TRIPS Agreement provisions in the light of precedents developed in GATT dispute settlement practice, it stated that

given that the agreements covered by the WTO form a single, integrated legal system, we deem it appropriate to develop interpretations of the legal protection conferred on intellectual property right holders under the TRIPS Agreement which are not incompatible with the treatment conferred to products under the GATT, or in respect of services and service suppliers under the GATS, in the light of pertinent dispute settlement practice. Footnote 68

The application of general GATT and WTO jurisprudence to cases involving the TRIPS Agreement would ignore the specificity of intellectual property issues and one major difference between the TRIPS Agreement and other WTO covered agreements: the former provides for disciplines on intellectual property rights, which are private rights , Footnote 69 the exercise of which may restrain rather than facilitate international trade (as in the case of other WTO agreements). The private rights nature of intellectual property rights was highlighted in the panel report in China—Intellectual Property Rights :

Viewed in context, the phrase “shall have the authority” does not require Members to take any action in the absence of an application or request. Therefore, a condition that authority shall only be available upon application or request seems to be assumed in much of Sections 2, 3 and 4 of Part III. This is consistent with the nature of intellectual property rights as private rights, as recognized in the fourth recital of the preamble of the TRIPS Agreement. Acquisition procedures for substantive rights and civil enforcement procedures generally have to be initiated by the right holder and not ex officio . Footnote 70

One corollary of this, for instance, is that in contrast to the general GATT/WTO jurisprudence, the exceptions in the TRIPS Agreement need not to be read narrowly, but instead with the aim of achieving the objectives as defined in Article 7 (see below). Notably, intellectual property rights constitute exceptions in terms of Article XX(d) of GATT and, hence, their restrictive effects should not be augmented but mitigated through the interpretation of the scope and extent of the conferred exclusive rights. Footnote 71 The exceptions to exclusive rights are crucial to preserve market dynamics and achieve a diversity of public interests; they are a key component of the TRIPS flexibilities. Footnote 72

4.2 Ordinary Meaning

The GATT and WTO panels, as well as the WTO Appellate Body, have relied on the interpretive method codified by the Vienna Convention on the Law of the Treaties (VCLT). One of the basic steps for interpretation under Article 31 of the VCLT is the determination of the ‘ordinary meaning’ of the terms employed in the treaty, provided that “a special meaning shall be given to a term if it is established that the parties so intended” (Article 31.4). Many WTO panel and Appellate Body reports clearly indicate that such ordinary meaning is searched in the dictionary in order to clarify the scope and content of the relevant texts. Footnote 73 Thus, the Appellate Body in EC – Chicken Cuts states: "The Appellate Body observed that dictionaries

are a useful starting point” for the analysis of 'ordinary meaning' of a treaty term, but they are not necessarily dispositive. The ordinary meaning of a treaty term must be ascertained according to the particular circumstances of each case. Importantly, the ordinary meaning of a treaty term must be seen in the light of the intention of the parties “as expressed in the words used by them against the light of the surrounding circumstances.” Footnote 74

In China—Intellectual Property Rights , the panel observed that

the general rule of treaty interpretation in Article 31 of the Vienna Convention refers in paragraph 1 to the ordinary meaning of the terms of the treaty, read in context. Where the terms are a single term, or ordinarily used together, then the treaty interpreter should refer to the ordinary meaning of that single term, or of each term in the particular context of each other. This is a distinct exercise from that in paragraph 4 of Article 31 of the Vienna Convention which requires a “special meaning” to be given to a term if it is established that the parties so intended. No party to this dispute considers that a “special meaning” should be given to the phrase "on a commercial scale," and nor does the Panel. Footnote 75

While the rule regarding the ordinary meaning seems clear, an important question relates to the temporal aspect of the interpretation, that is, whether panels and Appellate Body should rely on the meaning of a term at the time of negotiation or adoption of an agreement, or whether they would be authorized to apply an evolutionary approach, that is, to rely on the meaning of a term at the time of its interpretation. Two approaches exist on this issue:

…the principle of contemporaneity , according to which the terms of a treaty are to be interpreted according to the meaning which they possessed, or which would have been attributed to them, and in the light of current linguistic usage, at the time when the treaty was originally concluded. Opposed to that is the dynamic approach , very often also labelled ‘evolutionary’ interpretation, which seeks to establish the meaning of a treaty at the time of its interpretation. Footnote 76

In Canada—Patent Protection for Pharmaceutical Products, the panel examined the status of the legislation at the time of the negotiation of the Agreement to determine the concept of “legitimate interest” as contained in Article 30:

Moreover, the Panel believed that it was significant that concerns about regulatory review exceptions in general, although well known at the time of the TRIPS negotiations, were apparently not clear enough, or compelling enough, to make their way explicitly into the recorded agenda of the TRIPS negotiation. The Panel believed that Article 30’s “legitimate interests” concept should not be used to decide, through adjudication, a normative policy issue that is still obviously a matter of unresolved political debate. Footnote 77

The WTO jurisprudence has adopted in some cases the evolutionary method of interpretation. Footnote 78 In United States—Section 110(5) of the US Copyright Act , reference was made to the WIPO Copyright Treaty (WCT) adopted in 1996, 2 years after the TRIPS Agreement. The panel stated that the WCT should be viewed as “relevant to seek contextual guidance ... when developing interpretations that avoid conflicts within the overall multilateral copyright framework …” Footnote 79 Although it noted that the statement concerning WCT’s Article 10 adopted by the signatory parties did not fall under the Vienna Convention rules on a subsequent agreement on the same matter or subsequent practice, the recourse to a post-TRIPS treaty to interpret a provision of the TRIPS Agreement constitutes a troubling precedent as long as it may lead to interpretations unduly expanding the Agreement’s obligations. This is particularly the case in the light of technological developments and the increase of the level of protection beyond the standards of the TRIPS Agreement resulting from free trade agreements. Footnote 80

It is also worth noting that article 71 of the TRIPS Agreement specifically provides for the TRIPS Council to review the Agreement “in the light of any relevant new developments, which might warrant modification or amendment of this Agreement,” thereby suggesting that any further ‘developments’ in intellectual property law need to be incorporated on the basis of WTO members’ consensus, rather than via interpretation.

4.3 Context

In accordance with Article 31 of the VCLT, the terms in a treaty need to be considered taking their context into account. The preambles of WTO agreements have often been considered as the relevant context for the interpretation of particular provisions. Footnote 81 In India–Patents (US) , the Appellate Body referred to the Preamble of the TRIPS Agreement for the interpretation of Article 70.8(a): “The Panel’s interpretation here is consistent with the object and purpose of the TRIPS Agreement.” According to the Appellate Body, the object and purpose of the Agreement is, inter alia , “the need to promote effective and adequate protection of intellectual property rights.” Footnote 82 References to the preamble were also made in China—Intellectual Property Rights . Footnote 83 The Preamble of the Agreement on Technical Barriers to Trade was largely invoked as well by the panel in Australia—Tobacco Plain Packaging . Footnote 84

The appropriate choice of treaty provisions that provide the context for interpreting other provisions is crucial. One example is the interpretation of Article 27.1 in fine . As noted above, the US initiated a case against Brazil arguing that Article 68 of the Brazilian patent law, which authorizes the government to grant a compulsory license if the patent owner fails to work the patent, was inconsistent with Article 27.1 in fine of the TRIPS Agreement. In accordance to this provisions, “patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.” Key to addressing the US argument is identifying the context for the interpretation of this phrase in Article 27.1. In fact, this text incorporated a compromise reached, at the final stages of the negotiation of the Agreement, between developed and developing countries since the latter wanted to preserve the possibility of granting compulsory licenses for the lack or insufficient working of a patent. Footnote 85

Developing countries expressed the concern that Article 27.1 could be read in a way that restricts the use of compulsory licenses, for instance, on the grounds of lack of working, as specifically provided for under Article 5A of the Paris Convention for the Protection of Industrial Property. In fact, the “patent rights” referred to in Article 27.1 are defined in Article 28.1, which only requires the granting of negative rights with regard to the exploitation of the invention, that is, the right to prevent third parties from using (without authorization) the patented invention. Hence, a proper interpretation of Article 27.1 read in conjunction with Article 28.1, based on the rules of the Vienna Convention, indicates that the products mentioned in Article 27.1 are infringing products, not the products of the patent owner itself, since patents only confer exclusionary and not positive rights. In other words, Article 27.1—if read in the context of Article 28 of the Agreement—forbids discrimination between infringing imported and infringing locally-made products, but it does not prevent the establishment of differential obligations with regard to non-infringing imported and locally-made products (i.e., products made or imported by the patent owner or with his/her consent). Hence, it does not outlaw compulsory licenses for lack of working.

The principle of “effective interpretation” (or “l’effet utile”) requires that a treaty must be interpreted in such a way as to give meaning and effect to all the terms of the treaty. This is certainly possible with respect to Article 27.1 in fine . This non-discrimination clause may apply, for instance, to a case in which the rights enjoyed by patent owners differ depending on whether the alleged infringing goods have been locally produced or imported. For instance, Section 337 of the U.S. Tariff Act was found inconsistent with the GATT in United States—Section 337 of the Tariff Act of 1930 , since it accorded less favorable treatment to imported products challenged as infringing on US patents than the treatment accorded to similarly challenged products of United States origin. Footnote 86

Another example in which the correct identification of the context for a provision may have decisive effects relates to Article 39.3, which has been interpreted by the US and the European Commission as requiring the grant of exclusive rights (‘data exclusivity’) with respect to test data for pharmaceuticals and agrochemical products. This interpretation is clearly inviable in light of Article 39.1 which provides an essential contextual element and only requires protection against unfair commercial practices, which does not entail such exclusive rights. Footnote 87

In engaging in the difficult task of clarifying the meaning of ‘unjustifiably’ in Article 20 of the TRIPS Agreement, the panel in Australia—Tobacco Plain Packaging elaborated on the context of that provision. It specifically alluded to the Preamble and Articles 7 and 8 of the Agreement:

We first note that the first recital of the preamble to the TRIPS Agreement expresses a key objective of the TRIPS Agreement, namely to “reduce distortions and impediments to international trade” and takes into account the need, on one hand, “to promote effective and adequate protection of intellectual property rights” and, on the other, “to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade” (para. 7.2398).

We also consider that Article 7 entitled “Objectives” and Article 8 entitled “Principles” provide relevant context (para 7.2399).

Articles 7 and 8, together with the preamble of the TRIPS Agreement, set out general goals and principles underlying the TRIPS Agreement, which are to be borne in mind when specific provisions of the Agreement are being interpreted in their context and in light of the object and purpose of the Agreement. As the panel in Canada – Pharmaceutical Patents observed in interpreting the terms of Article 30 of the TRIPS Agreement, “[b]oth the goals and the limitations stated in Articles 7 and 8.1 must obviously be borne in mind when doing so as well as those of other provisions of the TRIPS Agreement which indicate its object and purposes” (para. 7.2402).

The panel further elaborated on the ‘balance’ suggested by Articles 7 and 8.1 of the TRIPS Agreement and, in particular, on the fact that the Agreement did not intend to prevent WTO members from adopting measures to protect public interests, such as public health. It stated:

Article 7 reflects the intention of establishing and maintaining a balance between the societal objectives mentioned therein. Article 8.1, for its part, makes clear that the provisions of the TRIPS Agreement are not intended to prevent the adoption, by Members, of laws and regulations pursuing certain legitimate objectives, specifically, measures “necessary to protect public health and nutrition” and “promote the public interest in sectors of vital importance to their socio-economic and technological development,” provided that such measures are consistent with the provisions of the Agreement (para. 7.2403).

Article 8 offers, in our view, useful contextual guidance for the interpretation of the term “unjustifiably” in Article 20. Specifically, the principles reflected in Article 8.1 express the intention of drafters of the TRIPS Agreement to preserve the ability for WTO Members to pursue certain legitimate societal interests, at the same time as it confirms their recognition that certain measures adopted by WTO Members for such purposes may have an impact on IP rights, and requires that such measures be “consistent with the provisions of the [TRIPS] Agreement” (para. 7.2404).

The specific objectives expressly identified in Article 8.1 do not, in our view, necessarily exhaust the scope of what may constitute a valid basis for the “justifiability” of encumbrances on the use of trademarks under Article 20. However, their identification in Article 8.1 may shed light on the types of recognized “societal interests” that may provide a basis for the justification of measures under the specific terms of Article 20, and unquestionably identify public health as such a recognized societal interest (para. 7.2406).

In summary, while the Preamble and Articles 7 and 8 of the TRIPS Agreement provide the context for the interpretation of all its provisions, as suggested by the examples above, the careful choice of other specific provisions to examine the scope and extent of particular obligations is key to preserving the flexibilities under that agreement.

4.4 Object and Purpose

As noted, the interpretative method codified by the VCLT—as spelled out in Articles 31 and 32 of the VCLT—relies on the textual interpretation of treaty provisions. The reference, however, to the ‘object and purpose’ of the treaty as one of the elements for interpretation has been understood by some courts as leaving room to consider the ‘intention’ of the negotiating parties or to apply a teleological approach. Footnote 88 It has been noted, for instance, that the European Court of Human Rights, “has developed its own version of these rules of interpretation—a version that tracks the three traditional approaches to treaty interpretation: the textual approach, the subjective approach, and the teleological approach. Footnote 89 However, as noted by two commentators,

The consideration of object and purpose finds its limits in the ordinary meaning of the text of the treaty. It may only be used to bring one of the possible ordinary meanings of the terms to prevail and cannot establish a reading that clearly cannot be expressed with the words used in the text. Footnote 90

The quoted authors note in this regard the opinion in the Iran-US Claims Tribunal which pointed out:

Even when one is dealing with the object and purpose of a treaty, which is the most important part of the treaty’s context, the object and purpose does not constitute an element independent of that context. The object and purpose is not to be considered in isolation from the terms of the treaty; it is intrinsic to its text. It follows that, under Article 31 of the Vienna Convention, a treaty’s object and purpose is to be used only to clarify the text, not to provide independent sources of meaning that contradict the clear text. Footnote 91

In the case of the WTO agreements, adherence to the treaty text and avoiding ‘activism’ in the interpretation of their provisions is of utmost importance—as shown by recent debates on the functioning of the Appellate Body Footnote 92 —so as not to expand the Members’ obligations or create new ones, and to provide certainty to their trade relations.

Notably, under Article 4.2 of the Dispute Settlement Understanding (“DSU”), panels and the Appellate Body are mandated to ‘clarify’ the various WTO agreements, and in doing so they cannot add to or diminish the rights and obligations provided in such agreements. Moreover, Article 4.9 provides that the DSU does not prejudice a government's right to seek an ‘authoritative interpretation’ of any of those agreements from the Ministerial Conference or General Council of the WTO. Hence, the WTO attempts to introduce a difficult distinction between ‘clarification’ and ‘interpretation.’ The panels and Appellate Body reports regularly note, however, that they ‘interpret’ the provisions invoked by the members in accordance to the VLCT rules. This has indeed been the case in those disputes referring to the TRIPS Agreement. Footnote 93

However, although the literal interpretation is the basic rule of interpretation under Article 31 (1) of the VCLT as recognized in the Convention itself, in some cases the textual reading of a provision or a term thereof in its context may still leave ambiguity as to the legal meaning of a text. At this point, the identification of the ‘object and purpose’ of the treaty, conceived as part of the literal interpretation and not as a separate step, acquires particular importance. It is difficult to think of judgments that are absolutely neutral in terms of the policy objectives enshrined in the treaty.

Identifying the object and purpose of the TRIPS Agreement is different from characterizing the purpose of intellectual property rights, as the objectives pursued by governments with these rights, as well as the way of implementing them, may differ significantly, even while they comply with the standards of the Agreement and other applicable international treaties). There is no global, uniform system of intellectual property protection.

In Canada—Patent Protection for Pharmaceutical Products , the panel elaborated on the policy objective of patent laws. It stated:

The normal practice of exploitation by patent owners, as with owners of any other intellectual property right, is to exclude all forms of competition that could detract significantly from the economic returns anticipated from a patent’s grant of market exclusivity … Patent laws establish a carefully defined period of market exclusivity as an inducement to innovation, and the policy of those laws cannot be achieved unless patent owners are permitted to take effective advantage of that inducement once it has been defined. Footnote 94

This view seems to suggest that obtaining ‘economic returns’ as an ‘inducement to innovation’ is what underpins patent policies. It is not consistent with the purpose of the TRIPS Agreement as reflected in Articles 7 and 8. This approach overlooks that patents, as well as other intellectual property rights, can and should be designed and implemented to achieve public rather than private interests, including the diffusion of technical knowledge, technological progress, and access to the outcomes of innovation. Footnote 95 Thus, in 1917, the US Supreme Court noted that “the primary purpose of that [patent] law is not to create private fortunes, but is to promote the progress of science and the useful arts.” Footnote 96

Articles 7 (‘Objectives’) and 8 (‘Principles’) of the TRIPS Agreement are key for the determination of the object and purpose of the Agreement, in conjunction, as discussed below, with the Doha Declaration as a subsequent agreement among the parties. Importantly, those provisions are not just hortatory provisions Footnote 97 but have been incorporated—upon the demand of developing countries during the negotiations Footnote 98 —among the prescriptive provisions of the Agreement.

In Canada–Patent Term , the Appellate Body referred to the need to interpret Article 70.1 of the Agreement as having particular regard to the object and purpose of the treaty, but it eluded an interpretation and application of Articles 7 and 8:

[W]e note that our findings in this appeal do not in any way prejudge the applicability of Article 7 or Article 8 of the TRIPS Agreement in possible future cases with respect to measures to promote the policy objectives of the WTO Members that are set out in those Articles. Those Articles still await appropriate interpretation. Footnote 99

The Panel Report in Canada—Pharmaceutical Patents dealt more specifically with the question of the ‘object and purpose’ of the TRIPS Agreement. It relied to this end on Articles 7 and 8 for that determination, but in conjunction with other provisions of the Agreement. It stated:

Article 30’s very existence amounts to a recognition that the definition of patent rights contained in Article 28 would need certain adjustments. On the other hand, the three limiting conditions attached to Article 30 testify strongly that the negotiators of the Agreement did not intend Article 30 to bring about what would be equivalent to a renegotiation of the basic balance of the Agreement. Obviously, the exact scope of Article 30’s authority will depend on the specific meaning given to its limiting conditions. The words of those conditions must be examined with particular care on this point. Both the goals and the limitations stated in Articles 7 and 8.1 must obviously be borne in mind when doing so as well as those of other provisions of the TRIPS Agreement which indicate its object and purposes. Footnote 100

It is unclear what “other provisions of the TRIPS Agreement which indicate its object and purposes” are suggested by the panel. While there might be different perceptions about the object and purpose of the TRIPS Agreement—as the debates between developed and developing countries have shown during the negotiation and after the adoption of the TRIPS Agreement Footnote 101 —the panels and Appellate Body need to be guided by the text of the Agreement and not by the individual views of the members of those bodies.

Paragraph 5(a) of the Doha Declaration confirmed the importance of Articles 7 and 8 for the interpretation of the TRIPS Agreement:

Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPS Agreement, we recognize that these flexibilities include: a. In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles.

The wording of this paragraph (“in particular”) suggests that while Articles 7 and 8 are determinant in defining the object and purpose of the Agreement, other provisions of the Agreement, as well as the preambular provisions, can also contribute to the determination of its object and purpose. Such may be the case, for instance, of Article 41.2 which states: “Procedures concerning the enforcement of intellectual property rights shall be fair and equitable …” This provision makes it clear that one purpose of the Agreement is to ensure that the enforcement of intellectual property rights (as mandated in Part III of the Agreement) is ‘fair and equitable’ to all the parties concerned, and that it does not provide undue advantages to the right holders over third parties in judicial or administrative procedures, or vice versa.

An interesting elaboration on the object and purpose of the TRIPS Agreement based on Articles 7 and 8 was undertaken by the panel in Australia—Tobacco Plain Packaging . Footnote 102 The panel largely relied on the Doha Declaration to address this issue. It noted:

We note in this respect that the Doha Declaration, adopted by Ministers on 14 November 2001, provides that, “[i]n applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles” (para. 7.2407).

While this statement was made in the specific context of a re-affirmation by Members of the flexibilities provided in the TRIPS Agreement in relation to measures taken for the protection of public health, we note that paragraph 5 of the Doha Declaration is formulated in general terms, inviting the interpreter of the TRIPS Agreement to read “each provision of the TRIPS Agreement” in the light of the object and purpose of the Agreement, as expressed in particular in its objectives and principles. As described above, Articles 7 and 8 have central relevance in establishing the objectives and principles that, according to the Doha Declaration, express the object and purpose of the TRIPS Agreement relevant to its interpretation (7.2408).

The Appellate Body essentially followed the panel’s views on this matter. It clarified, however, that the conclusions reached regarding the purpose of the TRIPS Agreement are supported by Articles 7 and 8, and that the analysis of the Doha Declaration reconfirmed the panel’s findings. It held:

The Panel also remarked that the societal interests referred to in Article 8 may provide a basis of the justification of measures under Article 20. Thus, we agree with Australia that, in any event, the reliance on the Doha Declaration was not of decisive importance for the Panel's reasoning since the Panel had reached its conclusions about the contextual relevance of Articles 7 and 8 of the TRIPS Agreement to the interpretation of Article 20 before it turned to the Doha Declaration. The Panel relied on the Doha Declaration simply to reconfirm its previous conclusions regarding the contextual relevance of Articles 7 and 8 of the TRIPS Agreement (6.658).

This analysis and the observations above show that the WTO case law has considered Articles 7 and 8, both as part of the context for interpretation and as defining elements of the object and purpose of the TRIPS Agreement. It confirms the relevance of said provisions for the interpretation of other provisions in the Agreement.

4.4.1 Legal Weight of the Doha Declaration

In order to give authority to its argument regarding the relevance of Articles 7 and 8 for the interpretation of the TRIPS Agreement’s provisions, the panel in Australia—Tobacco Plain Packaging specifically elaborated on the legal weight of the Doha Declaration. This is one of the most distinct (and welcome) contributions of this panel’s report, as it is the first time in which the normative effects of that Declaration have been considered in WTO jurisprudence.

In some WTO disputes prior to the Australia tobacco case, the issue of subsequent practices as an element for interpretation of the TRIPS provisions was very cautiously considered. Thus, in Canada—Patent Protection for Pharmaceutical Products, the panel considered comparative law in order to determine whether the interest claimed as “legitimate” by the EC was a “widely recognized policy norm.” Footnote 103 In United States—Section 110(5) of the US Copyright Act , the panel confirmed its conclusion with reference to examples of “state practice” of members of the Berne Union and WTO, but it warned that it “did not wish to express a view on whether these are sufficient to constitute ‘subsequent practice’ within the meaning of Article 31(3)(b) of the Vienna Convention.” Footnote 104 In China—Intellectual Property Rights , the panel rejected certain material submitted by China to prove a “subsequent practice” in the application of the TRIPS Agreement within the meaning of Article 31(3) of the Vienna Convention. The panel considered that it lacked “the breadth to constitute a common, consistent, discernible pattern of acts or pronouncements” and that “the content of the material does not imply agreement on the interpretation of Article 61 of the TRIPS Agreement.” Footnote 105

A key panel assertion in the referenced case against Australia is that the Doha Declaration must be considered a ‘subsequent agreement’ as defined in the VCLT. Footnote 106 In accordance with Article 31.3(a) of the VCLT, “any subsequent agreement between the parties regarding the interpretation of the treaty or the application of its provisions” shall be taken into account, together with the context. Footnote 107 It is worth noting that the International Law Commission adopted in its 2018 report “Draft Conclusions on Subsequent Agreements and Subsequent Practice in Relation to the Interpretation of Treaties” Footnote 108 which, in accordance with one commentator, suggests a “subtle elevation of subsequent agreement and subsequent practice,” which would thereby become an integral part of the main rule of interpretation. Footnote 109

In making reference to the Appellate Body ruling in US – Clove Cigarettes (para. 262), the panel stated:

This paragraph of the Doha Declaration may, in our view, be considered to constitute a “subsequent agreement” of WTO Members within the meaning of Article 31(3)(a) of the Vienna Convention. As the Appellate Body has clarified: Based on the text of Article 31(3)(a) of the Vienna Convention, we consider that a decision adopted by Members may qualify as a “subsequent agreement between the parties” regarding the interpretation of a covered agreement or the application of its provisions if: (i) the decision is, in a temporal sense, adopted subsequent to the relevant covered agreement; and (ii) the terms and content of the decision express an agreement between Members on the interpretation or application of a provision of WTO law (para. 7.2409).

The panel’s view rebuts the United States Trade Representative' (USTR) opinion expressed upon the conclusion of the Doha Conference that the Doha Declaration merely was a “political declaration.” Footnote 110 As noted by a commentator, “[d]istinguishing legal claims from non-legal or political claims, such as access to essential medicines, can deprive them of their status as rights and thereby serve to legitimize an unjust status quo.” Footnote 111

The panel further explored the legal status of the Doha Declaration under WTO law, noting that although being a ‘declaration,’ it was adopted by a consensus decision at the WTO Conference. The panel argued as follows:

In this instance, the instrument at issue is a “declaration,” rather than a “decision.” However, the Doha Declaration was adopted by a consensus decision of WTO Members, at the highest level, on 14 November 2001 on the occasion of the Fourth Ministerial Conference of the WTO, subsequent to the adoption of the WTO Agreement, Annex 1C of which comprises the TRIPS Agreement. The terms and contents of the decision adopting the Doha Declaration express, in our view, an agreement between Members on the approach to be followed in interpreting the provisions of the TRIPS Agreement. This agreement, rather than reflecting a particular interpretation of a specific provision of the TRIPS Agreement, confirms the manner in which “each provision” of the Agreement must be interpreted, and thus “bears specifically” on the interpretation of each provision of the TRIPS Agreement (7.2410).

This paragraph reiterates the characterization of the Doha Declaration as a ‘subsequent agreement’ under the VCLT and adds two important elements: its adoption ‘at the highest level’ and an agreement ‘on the approach’ to be followed in interpreting each provision of the Agreement. This ‘approach’ is reflected in paragraph 5(a) of the Declaration quoted above but also in the rest of the Declaration, particularly as it makes a clear case for protecting public health, a key public interest and a matter of respect and realization of human rights, in implementing the TRIPS Agreement. Footnote 112

The panel’s analysis on the Doha Declaration does not aim, however, at asserting its legal value per se but its role as a confirmation that Articles 7 and 8 of the TRIPS Agreement provide both the context and define the object and purpose of the Agreement. The panel stated in this regard:

The guidance provided by the Doha Declaration is consistent, as the Declaration itself suggests, with the applicable rules of interpretation, which require a treaty interpreter to take account of the context and object and purpose of the treaty being interpreted, and confirms in our view that Articles 7 and 8 of the TRIPS Agreement provide important context for the interpretation of Article 20 (7.2411).

The analysis of the legal status of the Doha Declaration is one of the most significant contributions by the panel in Australia—Tobacco Plain Packaging . It supported the panel’s conclusion with respect to the justifiability of the plain packaging measures adopted by that country and, hence, their consistency with Article 20 of the TRIPS Agreement. Footnote 113

5 Conclusions

The notion that the TRIPS Agreement is not a uniform law and that it allows WTO members some room to maneuver in interpreting and implementing the Agreement’s obligations is well established in the literature and numerous resolutions by UN agencies and bodies. The adoption of the Doha Declaration, and several rulings by panels and the Appellate Body, point in the same direction. An evolution is perceptible in the WTO jurisprudence on the matter. In particular, the most recent panel report in Australia—Tobacco Plain Packaging shows the explicit acceptance of the concept of TRIPS flexibilities in WTO case law and their role in preserving the required policy space to pursue public policies such as public health. This is an important development that could provide the basis for a further step in that jurisprudence: the integration of human rights law, as a component of international law, in the analysis of the obligations imposed by that Agreement and of the leeway that states should preserve for the realization of such rights. Footnote 114

The extent to which the TRIPS flexibilities can be implemented at the national level without the risk of trade retaliations depends on the way the Agreement’s provisions are interpreted by panels and the Appellate Body. Several issues need to be addressed in considering how such provisions should be interpreted, consistently with the interpretive method codified by the VCLT. While the search for the ordinary meaning of the terms used is a well-established methodology, divergences may exist with regard to whether they should be deemed as ‘static’ or ‘evolutionary.’ An evolutionary approach creates the risk of unduly expanding the obligations under the Agreement, as actively promoted by some developed countries through free trade agreements. The adequate determination of the context—beyond the Preamble and Articles 7 and 8—for interpretation of a particular provision is also important, as it may decisively influence the determination of the scope and extent of the obligation under the Agreement. Similarly, the understanding on the object and purpose of the Agreement plays an important role. The WTO jurisprudence seems to have firmly admitted that such a determination is to be based on said Articles 7 and 8.

The impact of the TRIPS Agreement on public health and, particularly, access to medicines has been one of the most sensitive issues since its adoption. This issue has been key in promoting debates and analyses on the TRIPS flexibilities (although they are also important in relation to other public interests, such as access to knowledge or food security). In this regard, the panel ruling in the case against Australia on plain packaging has confirmed the legal status of the Doha Declaration—seen by some as a merely political instrument—as a ‘decision’ taken by consensus that constitutes a ‘subsequent agreement’ among the WTO members. This is also an important development as it suggests that a pro-public health interpretation is not only tenable but also mandated, and confirms the room that governments have to confidently adopt pro-public health measures without fearing the risk of costly and burdensome litigation under the DSU.

Article 1.1 of the TRIPS Agreement makes it clear, however, that no WTO member is obliged to grant such a broader protection. See, e.g., Correa ( 2020b ), p. 21.

See, e.g., Morin and Surbeck ( 2020 ).

See, e.g., The Law Library of Congress, Global Legal Research Center ( 2016 ). Available from: https://www.loc.gov/law/help/patent-terms/patent-term-extensions-adjustments.pdf .

Shaikh ( 2016 ).

Son et al. ( 2018 ). Available from: https://doi.org/10.1186/s12992-018-0423-0 .

UNDP ( 2015b ). Available from: https://www.undp.org/content/undp/en/home/librarypage/hiv-aids/using-competition-law-to-promote-access-to-medicine.html .

Minn ( 2016 ).

Article 27.1 in fine: “…patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.” See, e.g., Correa ( 2005 ). See also below.

A large number of provisions in the TRIPS Agreement uses these terms, e.g., Articles 8.2, 13, 15.5, 25.5, 26.2, 30. 31(b), 31(l), 34.2, 37, 1, 39.2(c), 41, 43.

Article 4(d) of the TRIPS Agreement.

Article 20 of the TRIPS Agreement.

Available from: https://www.who.int/medicines/areas/policy/tripshealth.pdf?ua=1 . Hereinafter, “the Doha Declaration.”

See, e.g., Velásquez et al. ( 2020 ). https://www.southcentre.int/book-by-the-south-centre-2020/#more-14014 .

Germán Velásquez ( 2013 ), p. 5. https://www.southcentre.int/wp-content/uploads/2013/05/RP47_WTO-role-in-IP-and-access-to-medicines_EN.pdf .

Emphasis added.

Paragraph 17 of the general Doha Ministerial Declaration states: “We stress the importance we attach to implementation and interpretation of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) in a manner supportive of public health, by promoting both access to existing medicines and research and development into new medicines and, in this connection, are adopting a separate Declaration.” https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_e.htm .

The Council for TRIPS convened special sessions (which were held in June, August, and September of 2001) to deal with the relationship between health and TRIPS. See, e.g., the submissions made by the European Communities and their Members States on the relationship between the provisions of the TRIPS Agreement and access to medicines, IP/C/W/280 (12 June 2001); and submissions by the African Group, Barbados, Bolivia, Brazil, Cuba, Dominican Republic, Ecuador, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka, Thailand, and Venezuela on TRIPS and public health, IP/C/W/296 (29 June 2001). See also Council for TRIPS Special Discussion on Intellectual Property and Access to Medicines, IP/C/M/31 (10 July 2001).

One of the first studies on TRIPS flexibilities was published by the UNCTAD ( 1996 ). https://unctad.org/en/docs/ite1_en.pdf .

On the relationship between the TRIPS Agreement and the human right to health, see, e.g., Sellin ( 2015 ). https://link.springer.com/article/10.1007/s40802-015-0047-5#Abs1 .

See, e.g., WHO, WIPO, and WTO ( 2012 ). https://www.wipo.int/edocs/pubdocs/en/global_challenges/628/wipo_pub_628.pdf .

WHA 56.27, “Intellectual property rights, innovation and public health” (28 May 2003). Available from: https://apps.who.int/gb/archive/pdf_files/WHA56/ea56r27.pdf?ua=1 . For a list of WHO resolutions referring to intellectual property, see Germán Velásquez, Carlos M. Correa, and Vitor Ido, op. cit., pp. 73–75.

Available from: https://www.who.int/phi/implementation/phi_globstat_action/en/ . See, Germán Velásquez ( 2019 ).

See, https://www.ohchr.org/EN/Issues/HIV/Pages/Documents.aspx .

Resolution adopted by the General Assembly on 25 September United Nations General Assembly ( 2015 ), A/RES/70/1. https://www.un.org/ga/search/view_doc.asp?symbol=A/RES/70/1&Lang=E .

WIPO ( 2010 ), p. 11. https://www.wipo.int/meetings/en/doc_details.jsp?doc_id=142068 .

See, e.g., Correa ( 2020a ).

European Commission ( 2020 ). https://trade.ec.europa.eu/doclib/docs/2020/january/tradoc_158561.pdf .

The ‘scope’ of a right delimits the boundaries and defines its content; the ‘extent’ refers to the legal limitations on the exercise of the right.

WIPO ( 2010 ), op. cit., p. 12.

Ruse-Khan and Puutio ( 2017 ), p. 10. Available from: https://www.unescap.org/sites/default/files/IPR%20Handbook.pdf .

See, e.g., Geiger et al. ( 2013 ). https://digitalcommons.wcl.american.edu/cgi/viewcontent.cgi?article=1041&context=research .

Eger and Scheufen ( 2012 ). https://www.researchgate.net/publication/280043122_The_past_and_the_future_of_copyright_law_technological_change_and_beyond .

Available from: https://www.wipo.int/ip-development/en/agenda/flexibilities/database.html .

See, e.g., Germán Velásquez, Carlos M. Correa, and Vitor Ido, op. cit.

See, e.g. , Medicines Law & Policy, The TRIPS Flexibilities Database. Available from: http://tripsflexibilities.medicineslawandpolicy.org/ . See also, The Graduate Institute Geneva, Knowledge Portal on Innovation and Access to Medicines. https://www.knowledgeportalia.org/ .

According to this section, “[a] person shall be entitled to a patent unless the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States.” This rule was amended by the Leahy-Smith America Invents Act (2011). http://www.wipo.int/edocs/lexdocs/laws/en/us/us219en.pdf .

Reid ( 2019 ). https://digitalcommons.law.ou.edu/cgi/viewcontent.cgi?article=1121&context=ailr .

See, Document IP/Q3/USA/1 (1 May 1998). As a result of the relative novelty requirement of the US, several patents were granted to researchers or firms relating to or consisting of genetic materials or traditional knowledge acquired in developing countries. See, e.g., Mgbeoji ( 2006 ). https://books.google.fr/books?id=q4MIoBKy88MC&pg=PA121&lpg=PA121&dq=biopiracy+us+patents&source=bl&ots=-ZBMOhXLLn&sig=ACfU3U0DslCI-lxiwQuSmN-jeuuC-fafLQ&hl=en&sa=X&ved=2ahUKEwitsrmu8N_pAhUSx4UKHe1_DHYQ6AEwEnoECAkQAQ#v=onepage&q=biopiracy%20us%20patents&f=false .

eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006), https://www.supremecourt.gov/opinions/05pdf/05-130.pdf .

For the use of TRIPS flexibilities in relation to plant patents, see, e.g., Correa ( 2014 ). https://www.southcentre.int/wp-content/uploads/2014/11/RP55_Patent-Protection-for-Plants_EN.pdf . See also, Prifti ( 2015 ).

Available from: https://www.europarl.europa.eu/doceo/document/TA-8-2017-0061_EN.html .

Available from: https://www.parl.ca/DocumentViewer/en/43-1/bill/C-13/royal-assent .

Fuchs ( 2020 ). https://www.twobirds.com/en/news/articles/2020/germany/covid-19-new-german-legislation-to-fight-pandemic-may-affect-granted-patents .

See, e.g., Correa ( 2011a ).

See, DS 160 Panel Report United States — Section 110(5) of US Copyright Act (2010); Appellate Body report DS 176 United States — Section 211 Omnibus Appropriations Act of 1998 (2002).

See, DS 174 Panel Report European Communities — Protection of Trademarks and Geographical Indications for Agricultural Products and Foodstuffs (2005); DS 290 Panel Report , European Communities — Protection of Trademarks and Geographical Indications for Agricultural Products and Foodstuffs (2005).

See, Report of the WTO Panel, Canada—Patent Protection for Pharmaceutical Products , WT/DS114/R; Report of the Appellate Body, Canada—Term of Patent Protection , WT/DS170/AB/R (2000).

See Panel Report in DS435, 441, 458, 467, Australia — Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging (2018) (hereinafter, “ Australia—Tobacco Plain Packaging ”). The panel report was appealed by Honduras and the Dominican Republic (see, https://www.wto.org/english/tratop_e/dispu_e/cases_e/ds441_e.htm ). The report of the Appellate Body was issued on June 9, 2020 (WT/DS435/AB/R WT/DS441/AB/R). On the situation of the Appellate Body as a result of the US blockade to the appointment of new members, see, e.g., Danish and Aileen Kwa ( 2019 ). Available from: https://www.southcentre.int/wp-content/uploads/2019/12/PB69_Crisis-at-the-WTO%E2%80%99s-Appellate-Body-AB-Why-the-AB-is-Important-for-Developing-Members_EN-1.pdf .

A violation to the TRIPS Agreement was incidentally invoked in the Indonesia-Autos case in relation to the protection of trademarks. The panel, however, found that the United States had not demonstrated that Indonesia was in breach of its TRIPS obligations (Report of the WTO Panel, Indonesia—Certain Measures Affecting The Automobile Industry, WT/DS 54/R, WT/DS 55/R, WT/DS 59/R, WT/DS 64/R (1998), para. 11.1–11.43).

See Report of the Appellate Body, India-Patent Protection for Pharmaceutical and Agricultural Chemical Products, WT/DS50/AB/R (1998) and Report of the WTO Panel, India—Patent Protection for Pharmaceutical and Agricultural Chemical Products , WT/DS79/R (1998) (hereinafter, “ India—Patents (US) ”).

See Panel Report in lDS362, China—Measures Affecting the Protection and Enforcement of Intellectual Property Rights (2009) (hereinafter, “ China—Intellectual Property Rights ”).

Brazil requested the US consultations with regard to provisions of US legislation that limits the right to use or sell any federally-owned invention only to a licensee that agrees that any products embodying the invention or produced through the use of the invention will be manufactured substantially in the United States. See, United States—US Patents Code , WT/DS224/1 (7 February 2001). In DS 408, India complained about border measures imposed on the transit of medicines. See, European Union and a Member State—Seizure of Generic Drugs in Transit ( 2010 ) . These cases were not ultimately pursued.

Argentina—Patent Protection for Pharmaceuticals and Test Data Protection for Agricultural Chemicals , WT/DS171 (6 May 1999) and Argentina-Certain Measures on the Protection of Patents and Test Data , WT/DS196 (30 May 2000).

See, Notification of Mutually Agreed Solution According to the Conditions Set Forth in the Agreement (IP/D/18/Add.1, IP/D/22/Add.1).

See, Brazil—Measures Affecting Patent Protection , Request for the Establishment of a Panel by the United States , WT/DS199/3 (9 January 2001).

Brazil—Measures Affecting Patent Protection, Notification of Mutually Agreed Solution , WT/DS199/4, G/L/454, IP/D/23/Add.1 (19 July 2001).

See, China—Intellectual Property Rights , para. 7.484, 7.493, 7.597, and 7.678.

Idem, para. 7.199.

Para 7.602.

Australia—Tobacco Plain Packaging , para. 7.100.

Idem, para. 7.2408.

Idem, para. 7.2391 and 2387.

Appellate Body Report, op. cit., para. 6.697.

See, e.g., Flowers ( 2019 ), pp. 90–104. See also, Howse ( 2000 ). Available from: https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1747-1796.2000.tb00139.x .

Para. 7.19.

Para. 6.185.

See , the Preamble to the TRIPS Agreement, fourth paragraph.

Panel Report, lDS362, China—Measures Affecting the Protection and Enforcement of Intellectual Property Rights , op. cit., para 7.247. See also, para. 7.135. See also, para. 7.247, 7.135, 7.241, and 7.530; and Australia—Tobacco Plain Packaging , footnote 4472.

See, e.g., Okediji ( 2017 ).

Rodrigues Jr. ( 2012 ). https://www.researchgate.net/publication/288719106_The_general_exception_clauses_of_the_TRIPS_agreement_Promoting_sustainable_development .

See, e.g., the elaboration DS 160 Panel Report, United States — Section 110(5) of US Copyright Act (2010); Appellate Body report DS 176, United States — Section 211 Omnibus Appropriations Act of 1998 (2002).

Appellate Body Report in EC – Chicken Cuts , para. 175, quoting Appellate Body Report in US – Softwood Lumber IV , para. 59, and referring to Appellate Body Reports in US – Offset Act (Byrd Amendment) , para. 248, and US – Gambling , para. 166, and quoting McNair ( 1961 ), p. 365.

Para 7.558.

Dörr and Schmalenbach ( 2012 ). Available from: https://link.springer.com/chapter/10.1007%2F978-3-642-19291-3_34 , para. 58 (emphasis in the original), para. 23 (emphasis in the original). On the importance of the principle of “contemporaneity” in treaty interpretation, see also, Brownlie ( 1998 ), p. 627.

Canada—Patent Protection for Pharmaceutical Products , para. 7.82.

In United States – Import Prohibition of Certain Shrimp and Shrimp Products , WT/DS58/AB/R, para. 130 (1998), the Appellate Body held that certain terms in the WTO Agreements are not “static” but evolutionary, in relation to the term “exhaustible natural resources” as it appears in GATT Article XX(g) (para. 127, 130).

United States—Section 110(5) of the U.S. Copyright Act , para. 6.70.

See, e.g., Ruse-Khan ( 2017 ) (forthcoming, Netherlands Yearbook of International Law); Max Planck Institute for Innovation & Competition Research Paper, No. 18-02; University of Cambridge Faculty of Law Research Paper, No. 3/2018. https://ssrn.com/abstract=3082718 .

See, e.g. Carlos Correa, op. cit., 2020, Chapter 1.

See, https://www.wto.org/english/docs_e/legal_e/27-trips_02_e.htm .

See, para. 7.135.

See, e.g., para. 7.2398.

UNCTAD and ICTSD ( 2005 ), p. 467. https://unctad.org/en/PublicationsLibrary/ictsd2005d1_en.pdf .

See, e.g., Haedicke ( 2000 ), p. 1774.

See, e.g., Correa ( 2011b ).

Linderfalk ( 2007 ), p. 205. https://www.corteidh.or.cr/tablas/r32592.pdf .

See, e.g., Dothan ( 2019 ), p. 765; iCourts Working Paper Series, No. 141. https://ssrn.com/abstract=3241331 .

Oliver Dörr and Kirsten Schmalenbach, op. cit., para 58.

Iran-United States Claims Tribunal, Federal Reserve Bank of New York v. Bank Markazi (n 19) para 58.

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See, e.g., M. Kennedy, op. cit., 2016.

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Motion Picture Patents Co. v. Universal Film Co. [1917] 243 U. S. 502 .

See, e.g., “TRIPS provisions as interpreted by the WTO dispute settlement organs”, Law Explorer . https://lawexplores.com/trips-provisions-as-interpreted-by-the-wto-dispute-settlement-organs/ .

See, Carlos Correa, op. cit., 2020, pp. 83–95.

Appellate Body Report, Canada – Term of Patent Protection , WT/DS170/AB/R (18 September 2000), para. 101. https://www.wto.org/english/tratop_e/dispu_e/170abr_e.pdf .

See, Canada—Patent Protection for Pharmaceutical Products , supra note 23, para. 7.26.

Shadlen ( 2004 ). Available from: https://link.springer.com/article/10.1007%2FBF02686283 .

Romero ( 2020b ). Available from: https://www.southcentre.int/policy-brief-79-june-2020/ .

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Para. 7.581.

For an early analysis on this subject, see, Correa ( 2002 ), p. 45. https://apps.who.int/iris/handle/10665/67345 .

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Tladi ( 2018 ). https://www.ejiltalk.org/is-the-international-law-commission-elevating-subsequent-agreements-and-subsequent-practice/ .

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Romero ( 2020a ). https://www.southcentre.int/research-paper-108-april-2020/ .

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Correa, C.M. (2022). Interpreting the Flexibilities Under the TRIPS Agreement. In: Correa, C.M., Hilty, R.M. (eds) Access to Medicines and Vaccines. Springer, Cham. https://doi.org/10.1007/978-3-030-83114-1_1

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Training and other tools offered by the south centre on ip and health, south centre tax initiative, article 73 trips, southviews no. 235, 10 march 2022.

The WTO TRIPS Waiver and Essential Security Rights in 2022

By Dr. Alexander Beyleveld

Almost two years have passed since the start of the COVID-19 pandemic, and we are still far from bringing the pandemic to an end. One of the main reasons for this is the fact that large vaccine inequities remain worldwide. In order to address this problem, a large subset of World Trade Organization (WTO) members are in favour of waiving certain obligations contained in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement). Against this backdrop, this article contemplates the legal necessity of such a waiver given that Article 73 of the TRIPS Agreement contains essential security exceptions which may render the obligations in question inapplicable under the interpretation that the pandemic affects law and public order interests.

(more…)

Policy Brief 92, April 2021

Expanding the production of COVID-19 vaccines to reach developing countries

Lift the barriers to fight the pandemic in the Global South

By Carlos M. Correa

The unfolding of COVID-19 has shown that the international system has been unable to ensure equal access to the vaccines and other products necessary to fight the pandemic. While the need for a strong response remains obvious, proposals for scaling up the production of COVID-19 vaccines across the globe are still blocked in the World Trade Organization.

Statement, November 2020

South Centre Statement to the WHA 73 Session

The COVID-19 pandemic has revealed that, despite the magnitude of the global health challenges it has to face, the WHO is currently unable to fully enforce its directives, norms and standards. It also shows that its funding is neither sustainable nor adequate to respond effectively to current and future global health crises. Overreliance on voluntary targeted funding puts at risk its capacity to operate as the global agency responsible for public health. These are some of the main challenges facing the WHO today.

Statement, October 2020

PROPOSAL BY I NDIA AND S OUTH A FRICA TO WAIVE CERTAIN PROVISIONS OF THE WTO TRIPS A GREEMENT TO SUPPORT THE GLOBAL C OVID -19 PANDEMIC RESPONSE

The prolongation of the coronavirus COVID-19 pandemic threatens developing countries disproportionately, deepening the catastrophic social and economic crisis and reversing the gains made to date to eradicate extreme poverty and meet the Sustainable Development Goals (SDGs). In this situation, ensuring timely access to essential commodities by overcoming acute shortages faced by countries due to high demand and disruptions in the supply chain is critical. There is also an urgent need to speed up development of new vaccines, treatments and diagnostics, at scale, and make these widely available.

As reaffirmed by many delegations in the special session of the WHO Executive Board, transfer of technology and know-how is fundamental for scaling up manufacturing of medical products and equipment. In this regard, India and South Africa have made a joint proposal to the World Trade Organization (WTO) to temporarily waive certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to support the global Covid-19 pandemic response.

Research Paper 116, August 2020

The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic

By Frederick Abbott

The COVID-19 pandemic has caused Governments to contemplate measures to override patents and other intellectual property rights (IPRs) in order to facilitate production and distribution of vaccines, treatments, diagnostics and medical devices. This paper discusses whether the COVID-19 pandemic may be considered an “emergency in international relations” and how WTO Member States may invoke Article 73 (“Security Exceptions”) of the TRIPS Agreement as the legal basis for overriding IPRs otherwise required to be made available or enforced. It concludes that the pandemic constitutes an emergency in international relations within the meaning of Article 73(b)(iii) and that this provision allows Governments to take actions necessary to protect their essential security interests.

VIEWPOINT Protecting Public Health through Technology Transfer: The Unfulfilled Promise of the TRIPS Agreement

Volume 24/2, December 2022, pp. 211-214 |  PDF

Ellen ‘t Hoen

The scrambling for access to COVID-19 vaccines by developing countries has reignited the debate on the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and its effects on public health and health-related rights.

In such debates, the TRIPS Agreement is often cast as “the big evil.” There is no denying that when the TRIPS Agreement was adopted in 1995, it ushered in intellectual property (IP) norms and standards derived from wealthy nations with robust industries. These norms and standards were suitable to expand the global protection of the IP assets of these industries. However, TRIPS was ill-suited to the needs of developing and least-developed nations, representing the majority of the WTO’s membership. In 2002, the World Bank estimated that the implementation of the TRIPS Agreement by developing countries would amount to more than US$20 billion in income transfers from developing countries to technology-creating nations—particularly the United States, Germany, and France. [1] The promised trade-off from the TRIPS Agreement was that the higher levels of IP protection would lead to technology transfers from high-income to lower-income countries and that the benefits of this technology transfer, creating research and industrial activities in lower-income countries, would outweigh the cost of expanded levels of IP protection. Article 66.2 of the TRIPS Agreement stipulates that high-income countries “shall provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to least-developed country Members in order to enable them to create a sound and viable technological base.”

Disputes around access to HIV medicines in the late nineties and early 2000 first called the TRIPS promise into question: medicines were accessible in wealthy countries, but IP protection meant that treatment prices were often several times the per capita income if they were available at all in the lower-income countries hardest hit by the disease. It was not until patent barriers were cleared away that low-cost generic medicines became widely available where they were needed most. More recently, the unsuccessful attempts by vaccine producers—most of them in developing countries—to access the intellectual property, manufacturing know-how, and technology needed to produce COVID-19 vaccines may have confirmed the view that the TRIPS Agreement primarily serves the rich to the detriment of the poor. [2]

The right to health, including access to medicines and vaccines, is firmly rooted in international human rights law and some domestic constitutional law. [3] However, this right is hard to realize and enforce when medicines and vaccines are predominantly available from private corporations that hold monopoly rights to those products. As a result, those companies determine when, where, and at what price the products are made available.

While this is the reality of today, the stated objective of the TRIPS Agreement in fact focuses on creating societal benefits for all and supporting the transfer of technologies. In particular, articles 7 and 8, which lay out the objectives and principles of the TRIPS Agreement, deserve more attention.

Article 7 acknowledges that the protection and enforcement of IP should benefit society as a whole, not only rights holders. It describes the IP system as a social policy tool rather than a means to gather and hold on to assets. It refers explicitly to technology transfer and dissemination of technology. Article 8 acknowledges countries’ rights to take measures to protect the public interest and specifically public health. It further states that measures may be needed to prevent abuse by IP holders and to prevent practices that restrain trade or adversely affect technology transfer.

The Doha Declaration on the TRIPS Agreement and Public Health, adopted by the WTO Ministerial Conference in 2001, confirmed this right and spotlighted compulsory licensing (the authorization to use patents without the consent of the patent holder against an adequate remuneration) to ensure access to medicines for all, further strengthening the hand of governments to intervene when patents are a barrier to accessing medical products. [4]

While TRIPS articles 7 and 8 and the Doha Declaration do not explicitly refer to human rights, they are crucial provisions for the realization of the right to health. [5] For example, the Doha Declaration states that the TRIPS Agreement “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.” This paragraph echoes article 12 of the International Covenant on Economic, Social and Cultural Rights, which requires that states take steps necessary for the full realization of the right to health. The importance of taking the Doha Declaration into account when interpreting the TRIPS Agreement was confirmed by a WTO panel in the Australia – Tobacco Plain Packaging case. [6] This ruling offered important encouragement for pro-public health interpretation and implementation of the TRIPS Agreement.

The TRIPS Agreement provides ample scope for WTO members to intervene in private IP rights on public interest grounds, to protect public health, or to respond to an emergency in international relations such as a pandemic. [7]

In the past, countries have resorted to compulsory licensing, including government use of patents, to allow the supply of generic antiretroviral medicines for the treatment of HIV. Since 2001, the TRIPS Flexibilities Database—a resource that tracks when TRIPS flexibilities are proposed or executed—has documented 80 instances of compulsory licensing for public health in 43 countries. [8] Thirty-four least-developed country (LDC) members of the WTO have used the special provision for LDCs that allows them not to grant or enforce pharmaceutical product patents. [9] The WTO has 35 LDC members.

In 2021, all of the 10 new instances of compulsory licenses concerned products to prevent or treat COVID-19. This underlines the value of being able to get around IP protection when public health is at risk. Of course, compulsory measures come into play only when voluntary measures are not sufficient, which was the case for COVID-19 vaccines. Collaboration with the World Health Organization’s COVID-19 Technology Access Pool, a voluntary mechanism for sharing IP related to pandemic countermeasures established in May 2020, was rejected by COVID-19 vaccine companies.

Compulsory licensing is also at the core of the WTO Ministerial Decision of June 17, 2022, on the TRIPS Agreement in the context of the COVID-19 pandemic, often referred to as “the TRIPS waiver.” [10] The decision reiterates members’ rights to authorize the use of the subject matter of patents needed for the production and supply of COVID-19 vaccines, without the consent of the patent holder. The decision further waives the TRIPS requirement that a compulsory license of vaccine technology be predominantly for the supply of the domestic market, so that equitable access can be achieved across countries. But since compulsory licensing extends only to patents and not to other forms of IP that are essential in vaccine production, such as manufacturing know-how, the utility of the decision for vaccines will likely be limited. Discussions are now ongoing at the WTO to extend the decision to COVID-19 therapeutics and diagnostics, which are more suitable technologies for compulsory licensing.

Tension between protecting IP and protecting the human right to health remains. The COVID-19 pandemic and the inability of developing-country manufacturers to obtain IP, know-how, and technology needed to produce COVID-19 vaccines through voluntary measures illustrates the need for a more forceful implementation of the measures the TRIPS Agreement offers to rebalance IP and human rights. If vaccine companies had agreed to collaborate with the COVID-19 Technology Access Pool to share IP, provide manufacturing know-how, regulatory information needed to obtain marketing authorization, and technical assistance, eligible producers in various countries would have been able to start producing and supplying COVID-19 vaccines. Instead, vaccines were first supplied within the wealthy nations that held the technology to produce them. The subsequent hoarding of vaccines by those nations might have cost a million lives. [11]

In 2015, the then United Nations Secretary-General Ban Ki-moon established the High-Level Panel on Innovation and Access to Health Technologies to “review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.” [12] The eight recommendations of the panel regarding the protection of intellectual property center around the use of TRIPS flexibilities, which can be implemented within the current TRIPS framework. However, the panel also warned against the pursuit of stricter levels of IP protection in bilateral and regional trade talks. Specifically, the panel recommended that countries refrain from demanding that their trading partners implement IP obligations that go beyond TRIPS. The recently leaked draft IP chapter of the UK-India free trade agreement is evidence that high-income countries continue to seek to erode TRIPS flexibilities implemented in national law. [13] The lack of transparency around such trade negotiations means that democratically crafted national legislation is changed in closed-door trade negotiations. Considering the important role of the Indian pharmaceutical industry in the supply of low-cost medicines, applying stricter IP rules that are not required under WTO law will have consequences far beyond India alone.

The panel further recommended that public financing for research should require that the research results be shared and that IP be licensed, including through patent pools, to promote technology transfer and enable broad access to innovations.

The pandemic treaty that is currently being negotiated at the World Health Organization is an opportunity to remind the international community about the objectives and principles underlying the TRIPS Agreement and to see them put into practice for more equitable management and sharing of IP, know-how, and knowledge needed for pandemic preparedness and response. In October 2021, Medicines Law & Policy held an expert working group meeting that formulated seven recommendations for the pandemic treaty that are consistent with international human rights law. [14] One of the recommendations is to mandate technology transfer for government-funded research and to incentivize or mandate it for privately funded research on pandemic countermeasures.

The lack of equity in access to COVID-19 vaccines makes us wonder what would have happened if governments had taken measures to ensure the sharing of health innovations and the knowledge needed to make them. The World Health Organization’s pandemic treaty negotiations offer a new opportunity to put technology transfer and sharing of IP at the heart of global pandemic preparedness and response for more equitable and rights-based access to medicines for all.

Ellen ‘t Hoen, PhD, is a lawyer and public health advocate with a focus on pharmaceutical and intellectual property policies, and director of Medicines Law & Policy, Amsterdam, the Netherlands.

Please address correspondence to the author. Email: [email protected].

Competing interests: None declared.

Copyright © 2022 ‘t Hoen. This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original authors and source are credited.

[1] World Bank, Global Economic Prospects and the Developing Countries (Washington, DC: World Bank, 2001) .

[2] G. Krikorian and E. Torreele, “We Cannot Win the Access to Medicines Struggle Using the Same Thinking That Causes the Chronic Access Crisis,” Health and Human Rights Journal 23/1 (2021).

[3] L. Forman, “‘Rights’ and Wrongs: What Utility for the Right to Health in Reforming Trade Rules on Medicines?,” Health and Human Rights Journal 10 (2008); K. Perehudoff, B. Toebes, and H. Hogerzeil, “Essential Medicines in National Constitutions: Progress since 2008,” Health and Human Rights Journal 18/1 (2016).

[4] Fourth WTO Ministerial Conference, Doha Declaration on the TRIPS Agreement and Public Health, WT/MIN(01)/DEC/2 (2001); E. ‘t Hoen, “TRIPS, Pharmaceutical Patents, and Access to Essential Medicines: A Long Way from Seattle to Doha,” Chicago Journal of International Law 3 (2002).

[5] C. Correa, “Interpreting the Flexibilities under the TRIPS Agreement,” South Centre Research Paper 132 (2021).

[6] T. Romero, “Public Health and Plain Packaging of Tobacco: An Intellectual Property Perspective,” South Centre Research Paper 108 (2020).

[7] Agreement on Trade-Related Aspects of Intellectual Property Rights, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1896 U.N.T.S. 299 (1994), arts. 27, 30, 31, 31bis, 44.2, 66, 73(b)iii; South Centre, “A Public Health Approach to Intellectual Property Rights: Public Health Related Flexibilities in the TRIPS Agreement,” https://ipaccessmeds.southcentre.int/wp-content/uploads/2018/12/Public-Health-Related-Flexibilities-in-the-TRIPS-Agreement.pdf; F. Abbott, “The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic,” South Centre Research Paper 116 (2020).

[8] Medicines Law & Policy, “The TRIPS Flexibilities Database, http://tripsflexibilities.medicineslawandpolicy.org; E. ‘t Hoen, J. Veraldi, B. Toebes, and H. Hogerzeil, “Medicine Procurement and the Use of Flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001–2016,” Bulletin of the World Health Organization 96/3 (2018).

[9] Fourth WTO Ministerial Conference (see note 4), para. 7.

[10] World Trade Organization, Ministerial Decision on the TRIPS Agreement (June 17, 2022).

[11] H. Ledford, “Covid Vaccine Hoarding Might Have Cost More Than a Million Lives,” Nature (November 2, 2022).

[12] United Nations, Report of the United Nations Secretary-General’s High-Level Panel on Access to Medicines: Promoting Innovation and Access to Health Technologies (New York: United Nations, 2016).

[13] Bilaterals.org, “UK-India FTA: Draft Intellectual Property Chapter” (April 2022), https://www.bilaterals.org/IMG/pdf/uk-india_fta_ip_chapter_dated_april_2022_68_.pdf.

[14] K. Perehudoff, E. ‘t Hoen, K. Mara, et al., “A Pandemic Treaty for Equitable Global Access to Medical Countermeasures: Seven Recommendations for Sharing Intellectual Property, Know-How and Technology,” BMJ Global Health 7/7 (2022).

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URUGUAY ROUND AGREEMENT: TRIPS

Part II — Standards concerning the availability, scope and use of Intellectual Property Rights

Sections 5 and 6

• PART I General Provisions and Basic Principles
• PART II Standards Concerning the Availability, Scope and Use of Intellectual Property Rights
• 1. Copyright and Related Rights
• 2. Trademarks
• 3. Geographical Indications
• 4. Industrial Designs
• 6. Layout-Designs (Topographies) of Integrated Circuits
• 7. Protection of Undisclosed Information
• 8. Control of Anti-Competitive Practices in Contractual Licences
• PART III Enforcement of Intellectual Property Rights
• 1. General Obligations
• 2. Civil and Administrative Procedures and Remedies
• 3. Provisional Measures
• 4. Special Requirements Related to Border Measures
• 5. Criminal Procedures
• PART IV Acquisition and Maintenance of Intellectual Property Rights and Related Inter-Partes Procedures
• PART V Dispute Prevention and Settlement
• PART VI Transitional Arrangements
• PART VII Institutional Arrangements; Final Provisions

Section 5: patents

Article 27 patentable subject matter.

1.  Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.  (5) Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

2.  Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.

3.  Members may also exclude from patentability:

(a)  diagnostic, therapeutic and surgical methods for the treatment of humans or animals;  

(b)  plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.

Article 28 Rights Conferred

1.  A patent shall confer on its owner the following exclusive rights:

(a)  where the subject matter of a patent is a product, to prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling, or importing  (6) for these purposes that product;  

(b)  where the subject matter of a patent is a process, to prevent third parties not having the owner’s consent from the act of using the process, and from the acts of: using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process.

2.  Patent owners shall also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts.

Article 29 Conditions on Patent Applicants

1.  Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application.

2.  Members may require an applicant for a patent to provide information concerning the applicant’s corresponding foreign applications and grants.

Article 30 Exceptions to Rights Conferred

  Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.

Article 31 Other Use Without Authorization of the Right Holder

  Where the law of a Member allows for other use  (7) of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

(a)  authorization of such use shall be considered on its individual merits;  

(b)  such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;  

(c)  the scope and duration of such use shall be limited to the purpose for which it was authorized, and in the case of semi-conductor technology shall only be for public non-commercial use or to remedy a practice determined after judicial or administrative process to be anti-competitive;  

(d)  such use shall be non-exclusive;  

(e)  such use shall be non-assignable, except with that part of the enterprise or goodwill which enjoys such use;  

(f)  any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;  

  (g)  authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances;  

(h)  the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;  

(i)  the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;  

(j)  any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;  

(k)  Members are not obliged to apply the conditions set forth in subparagraphs (b) and (f) where such use is permitted to remedy a practice determined after judicial or administrative process to be anti-competitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases. Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur;  

(l)  where such use is authorized to permit the exploitation of a patent (“the second patent”) which cannot be exploited without infringing another patent (“the first patent”), the following additional conditions shall apply:  

(i)  the invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent;  

(ii) the owner of the first patent shall be entitled to a cross-licence on reasonable terms to use the invention claimed in the second patent; and  

(iii)  the use authorized in respect of the first patent shall be non-assignable except with the assignment of the second patent.

Article 32 Revocation/Forfeiture

  An opportunity for judicial review of any decision to revoke or forfeit a patent shall be available.

Article 33 Term of Protection

  The term of protection available shall not end before the expiration of a period of twenty years counted from the filing date  (8)

Article 34 Process Patents: Burden of Proof

1.  For the purposes of civil proceedings in respect of the infringement of the rights of the owner referred to in paragraph 1(b) of Article 28, if the subject matter of a patent is a process for obtaining a product, the judicial authorities shall have the authority to order the defendant to prove that the process to obtain an identical product is different from the patented process. Therefore, Members shall provide, in at least one of the following circumstances, that any identical product when produced without the consent of the patent owner shall, in the absence of proof to the contrary, be deemed to have been obtained by the patented process:

(a)  if the product obtained by the patented process is new;  

(b)  if there is a substantial likelihood that the identical product was made by the process and the owner of the patent has been unable through reasonable efforts to determine the process actually used.

2.  Any Member shall be free to provide that the burden of proof indicated in paragraph 1 shall be on the alleged infringer only if the condition referred to in subparagraph (a) is fulfilled or only if the condition referred to in subparagraph (b) is fulfilled.

3.  In the adduction of proof to the contrary, the legitimate interests of defendants in protecting their manufacturing and business secrets shall be taken into account.

Section 6: layout-designs (topographies) of integrated circuits

Article 35 relation to the ipic treaty.

Members agree to provide protection to the layout-designs (topographies) of integrated circuits (referred to in this Agreement as “layout-designs”) in accordance with Articles 2 through 7 (other than paragraph 3 of Article 6), Article 12 and paragraph 3 of Article 16 of the Treaty on Intellectual Property in Respect of Integrated Circuits and, in addition, to comply with the following provisions.

Article 36 Scope of the Protection

Subject to the provisions of paragraph 1 of Article 37, Members shall consider unlawful the following acts if performed without the authorization of the right holder:  (9) importing, selling, or otherwise distributing for commercial purposes a protected layout-design, an integrated circuit in which a protected layout-design is incorporated, or an article incorporating such an integrated circuit only in so far as it continues to contain an unlawfully reproduced layout-design.

Article 37 Acts Not Requiring the Authorization of the Right Holder

1.  Notwithstanding Article 36, no Member shall consider unlawful the performance of any of the acts referred to in that Article in respect of an integrated circuit incorporating an unlawfully reproduced layout-design or any article incorporating such an integrated circuit where the person performing or ordering such acts did not know and had no reasonable ground to know, when acquiring the integrated circuit or article incorporating such an integrated circuit, that it incorporated an unlawfully reproduced layout-design. Members shall provide that, after the time that such person has received sufficient notice that the layout-design was unlawfully reproduced, that person may perform any of the acts with respect to the stock on hand or ordered before such time, but shall be liable to pay to the right holder a sum equivalent to a reasonable royalty such as would be payable under a freely negotiated licence in respect of such a layout-design.

2.  The conditions set out in subparagraphs (a) through (k) of Article 31 shall apply mutatis mutandis in the event of any non-voluntary licensing of a layout-design or of its use by or for the government without the authorization of the right holder.

Article 38 Term of Protection

1.  In Members requiring registration as a condition of protection, the term of protection of layout-designs shall not end before the expiration of a period of 10 years counted from the date of filing an application for registration or from the first commercial exploitation wherever in the world it occurs.

2.  In Members not requiring registration as a condition for protection, layout-designs shall be protected for a term of no less than 10 years from the date of the first commercial exploitation wherever in the world it occurs.

3.  Notwithstanding paragraphs 1 and 2, a Member may provide that protection shall lapse 15 years after the creation of the layout-design.

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• 5. For the purposes of this Article, the terms “inventive step” and “capable of industrial application” may be deemed by a Member to be synonymous with the terms “non-obvious” and “useful” respectively. Back to text
• 6. This right, like all other rights conferred under this Agreement in respect of the use, sale, importation or other distribution of goods, is subject to the provisions of Article 6. Back to text
• 7. “Other use” refers to use other than that allowed under Article 30. Back to text
• 8. It is understood that those Members which do not have a system of original grant may provide that the term of protection shall be computed from the filing date in the system of original grant. Back to text
• 9. The term “right holder” in this Section shall be understood as having the same meaning as the term “holder of the right” in the IPIC Treaty. Back to text

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