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Patent Term Guarantee Overview

Karin L. Tyson and Robert W. Bahr

Before June of 1995, 35 U.S.C. § 154 provided that the term of a utility or plant patent ended seventeen years from the date of patent grant. To comply with Article 33 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement resulting from the Uruguay Round Agreements of the General Agreement on Tariffs and Trade (GATT), the United States was required to establish a minimum term for patent protection ending no earlier than twenty years from the date the application was filed. Thus, the Uruguay Round Agreements Act amended 35 U.S.C. § 154 in June of 1995 to change the term of utility and plant patents from ending seventeen years from the date of patent grant to ending twenty years from the filing date of the application (or twenty years from the earliest filing date claimed under 35 U.S.C. §§ 120, 121, or 365(c)). With this change, 35 U.S.C. § 154 was also amended to provide for patent term extension in the event that issuance of the application as a patent was delayed due to secrecy order, interference or successful appellate review, subject to a five-year cap on any patent term extension under 35 U.S.C. § 154(b).

The American Inventors Protection Act of 1999 amended 35 U.S.C. § 154(b) to expand the list of administrative delays which may give rise to patent term adjustment. Original utility and plant patents issuing from applications filed on or after May 29, 2000 will be eligible for patent term adjustment if issuance of the patent is delayed due to one or more of the listed administrative delays. The USPTO implemented the patent term adjustment provisions of the American Inventors Protection Act of 1999 in a notice of proposed rulemaking published in March of 2000, and a final rule published in September of 2000.

The patent term adjustment provisions of the American Inventors Protection Act of 1999 apply to original ( i.e. , non-reissue) utility and plant applications filed on or after May 29, 2000, which include continuation ( e.g. , a continued prosecution application (CPA)), divisional, or continuation-in-part applications. A request for continued examination (RCE) under 35 U.S.C. § 132(b) and 37 CFR § 1.114 is not a new application and filing an RCE in an application filed before May 29, 2000 will not cause the application to be eligible for patent term adjustment under the American Inventors Protection Act of 1999. The patent term extension provisions of the Uruguay Round Agreements Act (for delays due to secrecy order, interference or successful appellate review) continue to apply to utility and plant applications filed on or after June 7, 1995 and before May 29, 2000.

The "patent term guarantee" set forth in the American Inventors Protection Act of 1999 establishes three main bases for adjusting the term of a utility or plant patent: (1) if the USPTO fails to take certain actions within specified time frames; (2) if the USPTO fails to issue a patent within three years of the actual filing date of the application; or (3) for delays due to interference, secrecy order, or successful appellate review.

The first main basis for patent term adjustment establishes four "time clocks" for certain actions by the USPTO. If the USPTO fails to meet any of the enumerated "time clocks," the term of the patent is (subject to certain conditions discussed below) adjusted one day for each day by which the USPTO misses the time frame.

The first time clock is for the USPTO to initially act on the application within fourteen months of its filing date for application filed under 35 U.S.C. § 111(a), or the date on which an international application fulfilled the requirements of 35 U.S.C. § 371 (the date of entry into the national stage). An "initial action" that meets the fourteen-month time clock would be a notification under 35 U.S.C. § 132 or a notice of allowance under 35 U.S.C. § 151. Each of a written restriction (or election of species) requirement, a first Office action on the merits of an application, an action under Ex parte Quayle , or a notice of allowability (PTOL-37) is a notification under 35 U.S.C. § 132. A notice under 37 CFR § 1.53(f) requiring a missing oath or declaration under 37 CFR § 1.63 or the filing fee, however, is not a notification under 35 U.S.C. § 132 and mailing such a notice would not meet the fourteen-month time clock.

The second time clock is for the USPTO to respond to a reply under 35 U.S.C. § 132 or to an appeal taken under 35 U.S.C. § 134 within four months of the date on which the reply was filed or the appeal was taken. In the final rule, the USPTO indicated that it considers an appeal to have been taken on the date an appeal brief in compliance with 37 CFR § 1.192 is filed.

The third time clock is for the USPTO to act on an application within four months of the date of a decision by the Board of Patent Appeals and Interferences under 35 U.S.C. § 134 or 135, or a decision by a Federal court under 35 U.S.C. §§ 141, 145 or 146, in an application in which allowable claims remain. Allowable claims are considered to remain in an application when there are claims indicated as allowable or there are claims with no outstanding objection or rejection ( e.g. , all of the rejections of at least one claim were reversed as a result of the appeal). A dependent claim which has been indicated prior to an appeal as objected to but allowable if rewritten into independent form is not an allowable claim.

A fourth time clock is that the USPTO must issue a patent within four months after the date on which the issue fee was paid and all outstanding formal requirements are met. Thus, if the notice of allowability requires submission of formal drawings, this fourth time clock does not begin until the date the issue fee is paid or the date the formal drawings are filed, whichever date is later.

The second main basis provides for term adjustment if the USPTO does not issue a patent within three years of the "actual filing date" of the application. The USPTO indicated in the final rule that (for purposes of 35 U.S.C. § 154(b)(1)(B)) it considers the "actual filing date" of an international application to be the date of commencement of the national stage as to the United States under 35 U.S.C. 371(b) or (f). In addition, the three-year period begins with the "actual filing date" of the application, not any earlier-filed application for which a benefit is claimed under 35 U.S.C. §§ 120, 121, or 365(c). Thus, if an application is filed on May 29, 2000, and a continuation of that application is filed on June 5, 2002, the three-year period is measured from June 5, 2002, and not May 29, 2000.

Certain periods of time during processing or examination of an application do not count against this three-year period. For example, any time consumed by continued examination under 35 U.S.C. § 132(b) (37 CFR § 1.114), imposition of a secrecy order, declaration of an interference, appellate review, or applicant-requested delays does not count against the three-year period. Although filing a request for continued examination (RCE) under 35 U.S.C. § 132(b) and 37 CFR § 1.114 cuts off any additional patent term adjustment due to failure of the USPTO to issue a patent within three years, an applicant may continue to accrue patent term adjustment for events after the filing of the RCE. For example, if an application was filed on June 1, 2000, an RCE is filed on August 1, 2003, during the processing of the RCE the USPTO fails to meet one of the "time clock" periods by one month ( e.g. , acting on a reply within four months of the filing date of the reply), and the application issues as a patent on August 1, 2004, the applicant (assuming there are no other events relevant to patent term adjustment) will be entitled to patent term adjustment of three months (two months for the time from the three-year anniversary date to the filing date of the RCE plus one month for missing the four-month reply period).

The third main basis for patent term adjustment is similar to the patent term extension provisions which apply to applications filed on or after June 8, 1995 and before May 29, 2000, in that is provides for patent term adjustment due to for delays caused by an interference proceeding (35 U.S.C. § 135(a)), imposition of a secrecy order (35 U.S.C. § 181), or a successful appellate review. Unlike the provisions applying to applications filed before May 29, 2000, however, there is no five-year cap, no preclusion from patent term adjustment for a successful appellate review if the patent is subject to an obviousness-type double patenting terminal disclaimer, or provision for a minimum pendency of three years before patent term adjustment may accrue for a successful appellate review.

In calculating patent term adjustment, any overlapping delays are counted only once. Accordingly, if the USPTO misses a "time clock" event by one month ( e.g. , the patent is not issued until five months after payment of the issue fee and compliance with all formal requirements) and the patent is issued thirty-seven months after the actual filing date of the application, these two one-month periods are overlapping and (assuming there are no other events relevant to patent term adjustment) the applicant is entitled to patent term adjustment of only one month. In addition, if there is a terminal disclaimer in the application, the term of the patent may not be extended beyond the terminal disclaimer date.

The patent term adjustment provisions of the American Inventors Protection Act of 1999 also provide that patent term adjustment is reduced by a period equal to the period during which an applicant failed to engage in reasonable efforts to conclude prosecution of the application. 35 U.S.C. § 154(b) expressly provides that with respect to patent term adjustment under 35 U.S.C. § 154(b)(1)(B), an applicant is deemed to have failed to engage in reasonable efforts to conclude processing or examination of the application for the cumulative total of any period in excess of three months taken to respond to any Office action or notice.

35 U.S.C. § 154(b) also directs and authorizes the USPTO to prescribe regulations establishing the circumstances that constitute a failure of the applicant to engage in reasonable efforts to conclude processing or examination of an application. The USPTO first prescribed by regulation that, with respect to any ground for patent term adjustment, applicant is deemed to have failed to engage in reasonable efforts to conclude processing or examination of the application for the cumulative total of any period in excess of three months taken to respond to any Office action or notice.

The USPTO then prescribed eleven other circumstances which are also considered a failure to engage in reasonable efforts to conclude prosecution. Examples of the other circumstances considered a failure to engage in reasonable efforts to conclude prosecution of an application are: (1) suspension of action or deferral of issuance of a patent at an applicant's request; (2) abandonment of an application or delay in the filing of a petition to withdraw the holding of abandonment; (3) conversion of a provisional application into a nonprovisional application; and (4) submission of most papers (including formal drawings) after allowance. Since the submission of papers after allowance will result in a reduction of any patent term adjustment, applicants should consider filing formal drawings prior to allowance (rather than waiting until an application is allowed to prepare formal drawings) and seeking correction of errors in the notice of allowance or notice of allowability by telephone (rather than a paper request submitted by mail) to avoid a reduction to the patent term adjustment. An information disclosure statement filed within thirty days of receipt of the information by a party required to disclose the prior art, however, will not be considered a failure to engage in reasonable efforts to conclude prosecution.

The USPTO has indicated that patent term adjustment will be reduced by any period during which the applicant failed to engage in reasonable efforts to conclude processing or examination of the application (as defined in 37 CFR § 1.704(b) and (c)), even if the failure to engage in reasonable efforts to conclude processing or examination of the application did not cause or contribute to any patent term adjustment. For example, if an applicant is entitled to a patent term adjustment due to successful appellate review but took longer than three months to reply to an Office action, the patent term adjustment resulting from the successful appellate review will be reduced by the period in excess of three months taken to reply to the Office action even when there is no causal relationship between the applicant's taking longer than three months to reply to the Office action and the length of the period of appellate review.

The USPTO has also indicated that it is the actual filing date of papers (and fees), and not the date indicated on a certificate of mailing under 37 CFR § 1.8, that will be used in the patent term adjustment calculations. This provision has two edges, in that the actual filing date of a reply by applicant (and not the date indicated on any certificate of mailing under 37 CFR § 1.8) is the date: (1) from which the four-month period for action by the USPTO is measured; and (2) that measures the end of the three-month period for reply by applicant. Thus, applicants desiring to maximize patent term adjustment may wish to consider filing replies to Offices actions: (1) under the "Express Mail" provisions of 37 CFR § 1.10; (2) by facsimile; (3) by hand-delivery; or (4) with sufficient time remaining in the three-month period to account to Postal Service delivery time.

The USPTO will make an initial determination of the patent term adjustment with the notice of allowance. The USPTO's initial determination will be made by a computer program that uses the information recorded in its automated patent application information (Patent Application Location and Monitoring or PALM) system. Because this initial determination is made before all of the events giving rise to patent term adjustment have occurred, this initial determination (prediction) will state, for example, that:

The patent term adjustment to date is 857 days. If the issue fee is paid on the date that is three months after the mailing date of this notice and the patent issues on the Tuesday before the date that is 28 weeks (six and a half months) after the mailing date of this notice, the term adjustment will be 1058 days.

The notice will also state that applicants may be able to obtain more information through the Patent Application Information Retrieval (PAIR) system. PAIR is a system that permits access to the USPTO's computer (PALM) records for patents and applications via the Internet. Information related to patents and published applications will be available to the public through PAIR. An applicant, however, will need a customer number and Public Key Infrastructure (PKI) software to obtain the information for an application that has not been published

After receiving the initial determination of the patent term adjustment, applicants have one opportunity to request reconsideration of the determination. Any request for reconsideration (an application for patent term adjustment) must be filed with or before payment of the issue fee. A request for reconsideration must be by way of an application for patent term adjustment and be accompanied by the required fee (currently $200). The application for patent term adjustment must state what the correct patent term adjustment should be, the relevant dates giving rise to patent term adjustment, whether the patent is subject to any terminal disclaimer, and either state any circumstances that may constitute a failure to engage in reasonable efforts to conclude prosecution, or state that there were no such circumstances. Accordingly, applicants should regularly check PALM records, either by use of PAIR or by calling the USPTO, to verify that papers have been accorded the proper date and avoid having to address a date error issue in a request for reconsideration ( e.g. , if a paper is not received by the USPTO and a petition to withdraw the holding of abandonment is filed with a duplicate of the paper, applicants should verify that the paper is recorded in USPTO computer records with the date the paper was originally filed in the USPTO). If an error in the PALM records is noted, applicant should contact the Technology center and have the error corrected before the application is allowed. Otherwise, the error may result in an erroneous patent term adjustment determination in the notice of allowance, which must then be corrected by a request for reconsideration of the patent term adjustment determination.

In addition, the patent term adjustment provisions of the American Inventors Protection Act of 1999 provide that the USPTO shall reinstate all or part of the period of a reduction for failure to reply to an Office action or notice within three months, if the applicant makes a showing that, in spite of all due care, the applicant was unable to reply within the three-month period. If an applicant requests reinstatement of all or part of the period of adjustment reduced for failure to reply within three months of the date of mailing of the Office action or notice, the application must include an additional fee of $400 (for a total of $600) and a showing that in spite of all due care the applicant was unable to reply within three months. The USPTO has set forth a number of exemplary circumstances that do not meet the "in spite of all due care" standard, and a few that may meet the "in spite of all due care" standard. Based upon the exemplary circumstances indicated as meeting and as failing to meet the "in spite of all due care" standard, few applicants are expected to be able to satisfactorily demonstrate that a delay was "in spite of all due care."

About two weeks before the patent is issued, a final PALM calculation will be made and printed on the Issue Notification. This final calculation will be made when the issue date of the patent is known ( i.e. , when it is known whether the patent is issued within four months of issue fee payment or within three years of the actual filing date of the application). The patent will also include the USPTO's final adjustment determination, and applicants will have thirty days after the date of patent grant to request reconsideration of the patent term adjustment due to the patent being issued on a date other than the issue date projected with the mailing of the notice of allowance. This short time period is necessary because 35 U.S.C. § 154(b)(4) provides that any applicant dissatisfied with the patent term adjustment determination may file a civil action in the United States District Court for the District of Columbia within 180 days after the grant of the patent. If requests for reconsideration were not required to be filed promptly after patent grant, the USPTO would not have time to evaluate the request and send applicant a decision and allow applicant a suitable amount of time to seek judicial review. Third parties may not challenge or appeal the patent term adjustment determination before the USPTO.

As a result of these new provisions, applicants will be faced with new options and choices that will have an impact on any patent term adjustment, such as: (1) whether to extend the period for reply to an Office action or notice and reply later than three months from the date of such action or notice; (2) whether to submit a preliminary or supplemental amendment; (3) whether to submit replies by facsimile, Express Mail, or hand-delivery; and (4) whether to have formal drawings made before the application is allowed. To minimize misunderstandings and avoid surprises, patent practitioners should consider including discussions as to the patent term consequences of patent prosecution decisions in any client engagement letter and in other correspondence with their clients.

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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.

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

AD Mitchell , ‘ A Legal Principle of Special and Differential Treatment for WTO Disputes ’ 2006   World Trade Review 5(3) 445

K Nowak , ‘ Staying Within the Negotiated Framework: Abiding by the Non-Discrimination Clause in TRIPs Article 27 ’ 2005   Michigan Journal of International Law 26(3) 899

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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 )

FM Scherer and J Watal , ‘ Post-TRIPS Options for Access to Patented Medicines in Developing Nations ’ 2002   Journal of International Economic Law 5(4) 913

D Shanker , ‘ The Vienna Convention on the Law of Treaties, the Dispute Settlement System of the WTO and the Doha Declaration on the TRIPs Agreement ’ 2002   Journal of World Trade 36(4) 721

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

M Taylor , International Competition Law: A New Dimension for the WTO? (Cambridge: Cambridge University Press, 2006 )

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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Test Data Exclusivity and Art 39(3) TRIPS

• First Online: 26 July 2016

Cite this chapter

• Owais H. Shaikh 4  

Part of the book series: Munich Studies on Innovation and Competition ((MSIC,volume 4))

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The TRIPS Agreement is the first multilateral IP treaty that obliges countries to confer protection to pharmaceutical test data. This protection is to be conferred according to Art 39, which relates to ‘Protection of Undisclosed Information’ and also addresses trade secrets generally. However, the obligation to protect test data has proved to be more controversial as compared to the protection of trade secrets. This is because the language of Art 39(3) is ambiguous and open to diverging interpretation especially with regard to the requirement of protecting test data against ‘unfair commercial use’. Opinions are divided as to whether this article of the TRIPS Agreement requires test data exclusivity, or only protection against acts contrary to honest commercial practices following a misappropriation approach. Moreover, commentators also fall into different camps with regard to the interpretation of certain conditions Art 39(3) spells out for the protection of test data. So far, Art 39(3) has not been interpreted by WTO Panels. A WTO dispute settlement panel came close to interpreting the minimum standard of protection under Art 39(3), but the parties to the dispute, the US and Argentina, settled the dispute.

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‘Before the entry into force of the TRIPS Agreement, countries had full latitude to determine whether or not to confer protection on test data. Said article introduced the first international standard on the subject. ’ (emphasis added) Carlos M. Correa, Trade Related Aspects of Intellectual Property Rights: A Commentary on the TRIPS Agreement 374 (2007) [hereinafter Correa (2007)].

TRIPS Agreement is the first multilateral treaty that explicitly requires protection of ‘undisclosed information,’ also known as trade secrets. See Trevor M. Cook, Special Report: The Protection of Regulatory Data in the Pharmaceutical and Other Sectors 4 (2000). Also see, Correa (2007) at 374, (‘[i]ndeed it is only since TRIPS that there has been any obligations on countries to have laws which protect confidential information....’); Daniel Gervais, The TRIPS Agreement: Drafting History and Analysis 424 (3 rd ed. 2008) [hereinafter Gervais (2008)]; UNCTAD-ICTSD, Resource Book on TRIPS and Development 522 (2005) [hereinafter TRIPS Resource Book).

Countries that provide for test data exclusivity, due to strong R&D pharmaceutical industry consider Art 39(3) as providing for test data exclusivity. For example, the USTR considers that, ‘TRIPS Agreement negotiators understood it [the term “unfair commercial use”] to mean that the data will not be used to support, clear or otherwise review other applications for marketing approval for a set amount of time unless authorized by the original submitter of the data. Any other definition of this term would be inconsistent with logic and the negotiating history of the provision.’ (original parenthesis). USTR, The Protection of Undisclosed Test Data in Accordance with TRIPS Article 39.3 , cited in IFPMA (2000) at footnote 7. Moreover, IFPMA also claims that ‘[t]here appears to be a United States-EU-Swiss consensus that protection of registration data against “unfair commercial use,” as reflected in TRIPS Article 39.3, requires governments to prevent reliance, by regulatory authorities or third parties, on the data for the marketing of subsequent versions of the drug during the period of exclusivity without the originator’s consent.’ IFPMA (2000) at 5.

‘Test data must be protected under the discipline of unfair competition […]’ Carlos M. Correa, Data exclusivity for pharmaceuticals: TRIPS standards and industry’s demands in free trade agreements , in Research Handbook on the Protection of Intellectual Property under WTO Rules: Intellectual Property in the WTO Volume I 713, 718 (Carlos M. Correa ed. 2010) [hereinafter Correa (2010)]; ‘TRIPS does not require Member parties to provide exclusivity protection to the first person who submits the marketing approval data with a drug regulatory authority.’ Jakkrit Kuanpoth, Intellectual Property Protection after TRIPS: An Asian experience , in Interpreting and Implementing the TRIPS Agreement: Is it Fair? 71, 88 (Justin Malbon & Charles Lawson ed. 2008) (internal citations omitted).

Argentina – Certain Measures on the Protection of Patents and Test Data: Request for Consultations by the United States , WT/DS196/1, IP/D/22 dated 6 June 2000 [hereinafter Request for Consultations by the US (2000)] available at https://docs.wto.org/dol2fe/Pages/FE_Search/FE_S_S006.aspx?Query=(@Symbol=%20wt/ds196/1)&Language=ENGLISH&Context=FomerScriptedSearch&languageUIChanged=true# (last visited 2 June 2016).

Notification of Mutually Agreed Solution, Argentina – Certain Measures on the Protection of Patents and Test Data , WT/DS171/3 &WT/DS196/4 dated 20 June 2002 available at http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds196_e.htm (last visited 2 June 2016).

Vienna Convention on the Law of Treaties, 23 May 1969, 1155 U.N.T.S. 331. [hereinafter VCLT].

Art 3(2) of the ‘Understanding on rules and procedures governing the settlement of disputes’, Annex 2 of the WTO Agreement, 1869 UNTS 401; 33 ILM 1226 (1994).

Even though the WTO Dispute Settlement panels and appellate bodies employ Arts 31 and 32 VCLT for the purposes of treaty interpretation, there have been calls for the ‘re-evaluation of the principles of treaty interpretation applicable to the WTO Agreements’. See for example, Asif H. Qureshi, Interpreting WTO Agreements: Problems and Perspectives 4–7 (2006) [hereinafter Qureshi (2006)].

See for example, United States – Section 110(5) of the US Copyright Act , Report of the Panel, WT/DS160/R at ¶ 6.43 et seq , available at http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds160_e.htm (last visited 2 June 2016); WTO Appellate Body Report on United States – Section 211 Omnibus Appropriations Act of 1998 , WT/DS176/AB/R at ¶ 338, [hereinafter US – Section 211] available at http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds176_e.htm (last visited 2 June 2016).

Article 31(1) VCLT (‘[a] treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose.’) Thus, the interpretation ‘must be based above all upon the text of the treaty’. WTO Appellate Body Report on Japan – Taxes on Alcoholic Beverages , WT/DS8/AB/R, WT/DS10/AB/R, WT/DS11/AB/R at 12, [hereinafter Japan – Alcoholic Beverages’ available at https://docs.wto.org/dol2fe/Pages/FE_Search/FE_S_S009-DP.aspx?language=E&CatalogueIdList=32900&CurrentCatalogueIdIndex=0&FullTextSearch = (last visited 2 June 2016). ‘In order to identify the ordinary meaning, a Panel may start with the dictionary definitions of the terms to be interpreted. But dictionaries, alone, are not necessarily capable of resolving complex questions of interpretation, as they typically aim to catalogue all meanings of words — be those meanings common or rare, universal or specialized’. (internal citations omitted) WTO Appellate Body Report on United States – Measures Affecting the Cross-Border Supply of Gambling And Betting Services , WT/DS285/AB/R ¶ 164, available at http://www.wto.org/english/tratop_e/dispu_e/285abr_e.pdf (last visited 2 June 2016); ‘It should be remembered that dictionaries are important guides to, not dispositive statements of, definition of words appearing in agreements and legal documents.’ WTO Appellate Body Report on United States – Continued Dumping and Subsidy Offset Act of 2000 , WT/DS217/AB/R at ¶ 248, available at http://www.wto.org/english/tratop_e/dispu_e/217_234_abr_e.pdf (last visited 2 June 2016) [hereinafter US – Gambling]. Art 31(2) VCLT clarifies what comprises the context of a treaty. According to the WTO Secretariat ‘“[c]ontext” refers to the kinds of conclusions that can be drawn on the basis of, for example, the structure, content or terminology in other provisions belonging to the same agreement, particularly the ones preceding and following the rule subject to interpretation.’ WTO Secretariat, A Handbook on the WTO Dispute Settlement System: A WTO Secretariat Publication 5 (2004). In this regard, it is opined that the text, preamble and annexes and the terms of the treaty must be read in the context of the treaty holistically and an agreement forming part of the context of the agreement is not simply of ‘evidential value’. Qureshi (2006) at 19. With regard to the ‘object and purpose’, treaty interpretation as per Art 31 VCLT take into consideration ‘object and purpose’ of the treaty as a whole as well as that of the individual terms, where taking into consideration of the ‘object and purpose’ of the specific terms ‘assists the interpreter in determining the treaty’s object and purpose on the whole’. (internal citation omitted) WTO Appellate Body Report on European Communities – Customs Classification of Frozen Boneless Chicken Cuts , WT/DS269/AB/R ¶ 238 available at http://www.wto.org/english/tratop_e/dispu_e/269_286abr_e.pdf (last visited 2 June 2016) [hereinafter EC – Chicken Cuts (AB)]. It is also argued that the objects and purpose of the Marrakesh Agreement ‘must stand at the apex of the configuration of objects and purposes set in the WTO Agreements’. Qureshi (2006) at 19.

Art 31(2) VCLT.

Art 31(2)(a) & (b) VCLT.

Art 31(3)(a) VCLT.

Art 31(3)(b) VCLT.

Art 31(3)(c) VCLT.

Art 31(4) VCLT.

The requirement of ‘effective interpretation’ stems from the duty of good faith , as per Art 31 VCLT, on the part of the interpreter. International Law Commission, Draft Articles on the Law of Treaties with commentaries , Yearbook of the International Law Commission 219 (1966) [hereinafter ILC Commentary (1966)] available at http://legal.un.org/ilc/texts/instruments/english/commentaries/1_1_1966.pdf (last visited 2 June 2016). Also see Qureshi (2006) at 13.

WTO Appellate Body Report on United States – Standards for Reformulated and Conventional Gasoline , WT/DS2/AB/R at p. 23 available at http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds2_e.htm (last visited 2 June 2016) [hereinafter US – Gasoline]. The Appellate Body in US – Section 211 also referred to the importance of the principle of effective interpretation. ‘To adopt the Panel’s approach would be to deprive Article 8 of the Paris Convention (1967), as incorporated into the TRIPS Agreement by virtue of Article 2.1 of that Agreement, of any and all meaning and effect.’ US – Section 211 at ¶ 19.

Art 32 VCLT.

This arrangement is for the purpose of analysis and does not imply any hierarchical relationship between these means of interpretation. Indeed, under the Art 31 VCLT analysis, no hierarchy exists: ‘the application of the means of interpretation in [Art 31 VCLT is] a single combined operation’. ILC Commentary (1966) at 219–20.

Oxford Dictionaries, http://oxforddictionaries.com/definition/english/use?q=use (last visited 2 June 2016).

Merriam-Webster, http://www.merriam-webster.com/dictionary/use?show=0&t=1343474140 (last visited 2 June 2016).

Oxford Dictionaries, http://www.oxforddictionaries.com/definition/english/use?q=use (last visited 2 June 2016).

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Susan Scafidi, The “Good Old Days” of TRIPS: The U.S. Trade Agenda and the Extension of Pharmaceutical Test data Protection , IV:2 Yale J. Health Pol’y L. Ethics, 341, 346 (2004).

According to Reichman, ‘it is the need to promote and ensure competition in the local marketplace that makes [indirect use of test data] both ‘fair’ and obligatory’. Reichman (2006) at 142.

The Trial Division held that ‘[t]he [approval authority] does not “rely” on the [originator’s test data] […] when considering an [application for a bioequivalent pharmaceutical product] for [approval], when the [approval authority] issues the [approval] solely on the information contained in the [application for the bioequivalent pharmaceutical product].’ Bayer Inc. v. Canada (Attorney General) , 87 CPR (3d) 293. The Federal Court of Appeal affirmed the ruling of the Trial Division holding that ‘[w]hen a generic manufacturer files an [application for a bioequivalent pharmaceutical product], the safety and effectiveness of the generic product may be demonstrated by showing that the product is the pharmaceutical and bioequivalent of the innovator’s product. If the generic manufacturer is able to do so solely by comparing its product with the innovator’s product which is being publicly marketed, the [approval authority] will not have to examine or rely upon [test data] filed as part of the innovator’s [application]’.

Correa also holds the opinion that where the authority ‘require[s] the second-entrant to prove that his product is ‘similar’ to an already registered product, without having to examine and rely upon the originator’s data […] there is no ‘use’ at all’ (internal citations omitted). Correa (2007) at 384. According to Reichman ‘it is not the confidential data [but] the health and safety outcome to which the data lead is being used […].’ Reichman (2006) at 142.

In a recent case, the Federal Court of Appeals in Argentina, implied that there is no use under Art 39(3) TRIPS when test data has not been submitted to the approval authority. Case No. 5.619/05, Novartis Pharma AG c/ Monte Verde SA s/ varios propiedad industrial e intelectual , dated 1 February 2011. Also see Pamela Andanda, Managing Intellectual Property Rights Over Clinical Trial Data to Promote Access and Benefit Sharing in Public Health , IIC, Vol. 44, Iss. 2, 140, 151–2 (2013).

For example, Fellmeth argues that ‘[t]he problem with the [Canadian] appellate court’s reasoning [in Bayer v. Canada ] is that the Ministry of Health does indeed “rely upon” the initial registrant’s confidential information whenever it grants marketing approval to subsequent applicants; if not for the initial registrant’s studies and subsequent disclosure of information, there would be no basis for concluding that bioequivalent generic drugs would satisfy the law’s efficacy and safety requirements. Only by relying upon the initial registrant’s trade secrets can the drug regulatory authority trust that bioequivalent generic drugs are effective and safe to market.’ Fellmeth (2004) at 459.

Besides these four uses of the test data, the originator of the test data may also use it to obtain an approval based on deceptive or manipulated test data . However, this case is not covered under Art 39(3) and could be a case falling under Art 10 bis of the Paris Convention. In this case, the originator tries to fraudulently get the marketing approval by either manipulating the test data or by suppressing the information that may be of vital importance for the approval authority’s consideration. The case of the pharmaceutical product Avandia is instructive in this regard. GlaxoSmithKline (GSK) was found guilty of suppressing important safety information relating to its diabetes drug Avandia, from the FDA. According to a US Department of Justice Press Release, ‘[t]he missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia’. Under the definition of the term unfair , such a commercial use can fall under the parameters of ‘unfair commercial use’ as per Art 39(3) TRIPS. Office of Public Affairs, Department of Justice, GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data: Largest Health Care Fraud Settlement in U.S. History , July 2, 2012 available at http://www.justice.gov/opa/pr/2012/July/12-civ-842.html (last visited 2 June 2016). GSK pleaded to failing to report the relevant data and agreed to pay a criminal fine to the tune of approximately $243 million. Id . GSK’s Paxil was embroiled in a similar controversy. See N. Y. Times, When Drug Companies Hide Data , June 6, 2004 at http://www.nytimes.com/2004/06/06/opinion/when-drug-companies-hide-data.html (last visited 2 June 2016). According to many commentators, the R&D pharmaceutical industry not only suppresses critical data from approval authorities, it also manipulates it when publishing the results of clinical studies in medical journals. Many trials, demonstrating lack of safety or efficacy of the product are not published. See for example, Kirby Lee, Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis , 5(9) PLoS Med., e191 (2008) and Erick H. Turner, Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy , 358(3) New Eng. J. Med., 252 (2008). Another allegation is the undue influence of industry on drug evaluation and conflict of interest of evaluators. See for example, Marcia Angell, Industry-Sponsored Clinical Research: A Broken System , 300(9) J. Am. Med. Ass’n 1069 (alleging ‘an unprecedented control [of the pharmaceutical industry] in the evaluation of its own products); Gisela Schott et al , The Financing of Drug Trials by Pharmaceutical Companies and Its Consequences , 107(16) Deutsches Ärzteblatt International, 279 (2010) (finding that ‘[p]ublished drug trials that were financed by pharmaceutical companies, or whose authors declared a financial conflict of interest, were found to yield favorable results for the drug manufacturer more frequently than independently financed trials whose authors had no such conflicts. The results were also interpreted favorably more often than in independently financed trials. Furthermore, there was evidence that pharmaceutical companies influenced study protocols in a way that was favorable to themselves.’); Roy H. Perlis et al, Industry Sponsorship and Financial Conflict of Interest in the Reporting of Clinical Trials in Psychiatry , 162(10) Am. J. Psychiatry, 1957 (2005) (concluding that ‘[a]mong the 162 randomized, double-blind, placebo-controlled studies examined, those that reported conflict of interest were 4.9 times more likely to report positive results; this association was significant only among the subset of pharmaceutical industry-funded studies.’)

Oxford Dictionaries, http://oxforddictionaries.com/definition/american_english/commercial?q=commercial (last visited 2 June 2016).

Merriam-Webster, http://www.merriam-webster.com/dictionary/commercial (last visited 2 June 2016).

Thesaurus.com, http://thesaurus.com/browse/commercial?s=t (last visited 2 June 2016).

Reichman presents two variations of this use. Accordingly, ‘[a] legitimate non-commercial use would presumably encompass use by various government departments to avoid any health or safety risks revealed by the data in the local environment. Similarly, the promotion of research and science in the public interest would presumably allow some uses of the data that would be both non-commercial and fair, consistent with any research exemption embodied in the domestic patent laws.’ Reichman (2006) at 141.

The US Supreme Court also considered, in respect of health, safety and environmental data submitted for approval of pesticides, that such use is a legitimate ‘government interest’. Ruckelshaus v. Monsanto Co. 467 U.S. 986 1007 (1984) [hereinafter Ruckelshaus v. Monsanto Co. ].

TRIPS Resource Book at 531 (‘If the regulatory body were not free, when assessing a file, to use all the knowledge available to it, including data from other files, a great deal of repetitive toxicological and clinical investigation will be required, which will be wasteful and ethically questionable.’) Moreover, such use is also important to achieve the policy objective of making affordable medicine to the public. TRIPS Resource Book at 531–2 (‘This position is also grounded on the pro-competitive effects of low entry barriers. for pharmaceutical product. The early entry of generic competition is likely to increase the affordability of medicines at the lowest possible price.’) According to Stoll et al, ‘[a]ny act of such authorities, whether passing on such data or simply relying on them without giving second entrants access to it may be qualified as use of them. However, this use is not a commercial use, since regulatory bodies do not have an economic interest in marketing pharmaceuticals or agrochemicals. Their role is to ensure the safety and efficacy of such products’. Stoll et al (2009) at 653 (internal citations omitted and original emphasis). Correa considers it a legitimate state practice. Correa (2007) at 367 citing Stephen P. Ladas, Patents, Trademarks and Related Rights: National and International Protection 1688 (Volume II, 1975). Wadlow argues that ‘the acts of the regulatory authority are not commercial, even if they amount to “use” of the relevant data. Nor do they become commercial in their own right simply because their objective is to evaluate a commercial application’. Christopher Wadlow, Regulatory data protection under TRIPs Article 39(3) and Article 10Bis of the Paris Convention: Is there a doctor in the house? 4 Intell. Prop. Q., 355 (2008).

de Carvalho (2008) at 271 (‘“ Commercial use” […] means to use the data for the single commercial purpose they can have, which is to support an application for marketing approval.’)

For affirmation of this use as commercial use see Skillington & Solovy (2003) at 29–30 (‘if a Member, at the request of a competitor of the originator of data, relied on data submitted by the originator in a manner that benefits the competitor, this would constitute an application or conversion of the data that helps the competitor to make a profit. Similarly, reliance by a Member on the data, absent a specific request by the competitor to rely on the data, also would be considered an application of the data designed to allow the competitor to make a profit. Both are “commercial uses” of the data’.); Meitinger opines that reliance on the test data to approve bioequivalent products is the only imaginable commercial use in the context of Art 39(3). ‘Since the data are specifically created and compiled for the purposes of documenting approval requests, no other commercial use of them can be imagined.’ (internal citations omitted). Ingo Meitinger, Implementation of Test Data Protection According to Article 39.3 TRIPS: The Search for a Fair Interpretation of the Term “Unfair Commercial Use,” in 8(2) The J. of World Intell. Prop. 123, 131 (2005) [hereinafter (Meitinger (2005)].

Oxford English Dictionary, http://www.oed.com/view/Entry/213174?result=1&rskey=qfw8JU&#x0026 ; (last visited 2 June 2016).

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Jayashree Watal, Intellectual Property rights in the WTO and Developing Countries 204 (2001) [hereinafter Watal (2001)].

Reichman (2006) at 142.

See IFPMA, Data Exclusivity: Encouraging Development of New Medicines 3 (2007) available at http://www.fifarma.org/cms/images/stories/Prop_Intelectual/ifpma_data%20exclusivity.pdf (last visited 2 June 2016).

See Sect. 8.2.2.4 for a discussion of this approach.

See Chap. 6 .

See Sect. 1.1.1 .

Also see note 37 and accompanying text in Chap. 1 .

Art 39(2) TRIPS

Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices so long as such information: (a) is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question; (b) has commercial value because it is secret; and (c) has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.

Footnote 10 of TRIPS specifies that for the purposes of Art 39 TRIPS ‘“a manner contrary to honest commercial practices” shall mean at least practices such as breach of contract, breach of confidence and inducement to breach, and includes the acquisition of undisclosed information by third parties who knew, or were grossly negligent in failing to know, that such practices were involved in the acquisition.

Art 39(1) TRIPS:

In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967) , Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3. (emphasis added)

See Jacquaes J. Gorlin, An Analysis of the Pharmaceutical-Related Provisions of the WTO TRIPS (Intellectual Property) Agreement , 44 (1999) [hereinafter Gorlin (1999)]; Stoll et al (2009) at 638; Marco Bronckers & Petr Ondrusek, Protection of Regulatory Data in the EU and WTO Law: The Example of REACH , 8 J. Intell. Prop. L. 579 586–7 (2005).

According to Correa ‘the Agreement subjects the legal treatment of ‘undisclosed information’ to the discipline of unfair competition, as regulated by Article 10 bis of the Paris Convention.’ Correa (2007) at 367.

de Carvalho asserts that ‘the purpose of the first sentence of Article 39.1 […] is to make clear that protection of trade secrets is not a new matter but rather an existing obligation under Paris Convention for those GATT Contracting Parties that were members of the Paris Union. The first sentence has, therefore, a declaratory function which goes beyond the simple incorporation of Article 10 bis of the Convention by Article 2.1 of the TRIPS Agreement.’ de Carvalho (2008) at 204.

Art 10 bis Paris Convention. In this sense, paragraphs 2 and 3 add to the list of examples in Art 10 bis (3) PC. This interpretation is exemplary of the approach that has been taken in international law with regard to unfair competition. The ‘act of competition contrary to honest practices in industrial or commercial matters’ has not been defined either in the Paris Convention or in the TRIPS Agreement. Instead, such acts are enumerated in a non-exhaustive list in Art 10 bis (3) PC. On a regional level the same approach has been taken in the Directive 2005/29/EC of the European Parliament wherein according to Annex 1 certain commercial practices are considered unfair ‘in all circumstances’. Moreover, the Model Provisions on Protection against Unfair Competition prepared by World Intellectual Property Organization adds the protection of trade secrets to its list of examples which is identical to that contained in Art 10 bis (3). See Art 6(4), WIPO, Model Provisions on Protection against Unfair Competition , (1996). See also WIPO, Protection Against Unfair Competition: Analysis of the Present World Situation , 48–68 Publication No. 725(E) (1994) [hereinafter WIPO Unfair Competition Study (1994)].

Correa writes: ‘The text is unusually clear in indicating that the obligations under Article 39 do not go beyond what is already contained in [the Paris] Convention. Since the Agreement, thus, only develops obligations prescribed in Article 10bis, any reading of Article 39 requiring Members to establish some form of exclusive rights […] is fundamentally inconsistent with the treaty language.’ (emphasis added) Correa (2007) at 368.

See note 18 and 19 accompanying text.

‘Members shall give effect to the provisions of this Agreement.’ First sentence, Art 1(1) TRIPS.

Third sentence, Art 1(1) TRIPS.

A WTO Panel, for example, held in a dispute between the European Communities and the United States regarding protection of geographical indications that ‘[i]n accordance with Article 1.1, the European Communities is free to determine the appropriate method of implementing the provisions of the Agreement within its own legal system and practice. It is not obliged to ensure that this particular Regulation implements Article 22.2 where it has other measures that do so.’ European Communities – Protection of Trademarks and Geographical Indications for Agricultural Products and Foodstuffs, Complaint by the United States, Report of the Panel, WT/DS174/R ¶ 7.746, dated 15 March 2005 available at https://www.wto.org/english/tratop_e/dispu_e/174r_e.pdf (last visited 2 June 2016). Nonetheless, the internal consistency of Art 1(1) TRIPS requires that Members cannot implement a lower standard than obligated in the TRIPS Agreement. In this regard, another Panel held in a dispute between China and United States regarding enforcement of IPRs that ‘[t]he third sentence of Article 1.1 does not grant Members freedom to implement a lower standard, but rather grants freedom to determine the appropriate method of implementation of the provisions to which they are required to give effect under the first sentence […] [A] coherent reading of the three sentences of Article 1.1 does not permit differences in domestic legal systems and practices to justify any derogation from the basic obligation to give effect to the provisions on enforcement.’ China – Measures Affecting the Protection and Enforcement of Intellectual Property Rights, Report of the Panel, WT/DS362/R ¶ 7.513 dated 26 January 2009 available at https://www.wto.org/english/tratop_e/dispu_e/cases_e/ds362_e.htm (last visited 2 June 2016).

‘[T]he [TRIPS] text [recognizes] the flexibility of countries implementing TRIPS vis-à-vis their legal systems and practices.’ Gervais (2008) at 87.

Second sentence, Art 1(1): ‘Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement, provided that such protection does not contravene the provisions of this Agreement.’

Reichman (2006) at 141–2.

It has been argued that as per Art 3(2) DSU the dispute settlement panel and appellate bodies of the WTO can only clarify the provisions of TRIPS but cannot ‘add to or diminish the rights and obligations’. In this regard Correa argues that ‘if the negotiating parties only left the Members the freedom to determine the duration of the exclusivity period, on what basis could a panel or the Appellate Body establish which is the ‘adequate’ duration without substituting the Member themselves and violating the basic rule of Article 3.2 of the Dispute Settlement understanding?’ Correa (2007) at 1 (original emphasis and internal citations omitted).

According to the Appellate Body, ‘[t]he legitimate expectations of the parties to a treaty are reflected in the language of the treaty itself.’ WTO Appellate Body Report on India- Patent Protection For Pharmaceutical and Agricultural Chemical Products , WT/DS50/AB/R ¶ 45 available at http://www.wto.org/english/tratop_e/dispu_e/tripab.pdf (last visited 2 June 2016). The Appellate Body further stated that ‘[the] principles of treaty interpretation (according to Art 31 VCLT) neither require nor condone the imputation into a treaty of words that are not there or the importation into a treaty of concepts that were not intended.’ Id. Contra see William J. Davey & Werner Zdouc, The Triangle of TRIPs, GATT and GATS 53, 57–8, in Intellectual Property: Trade, Competition, and Sustainable Development (Thomas Cottier & Petros C. Mavroidis eds. 2003).

Ian Sinclair, The Vienna Convention on the Law of Treaties, 130 (2 nd ed. 1984). (original emphasis)

Specifying that Art 31 VCLT contains three principles, the ILC commented that ‘[t]he third principle is one both of common sense and good faith; the ordinary meaning of a term is not to be determined in the abstract but in the context of the treaty and in the light of its object and purpose’. ILC Commentary (1966) at 221. The other two principles stated by ILC were interpretation in good faith and presumption of intention that appears from the ordinary meaning of the terms. Id . According to Dörr & Schmalenbach object and purpose refer to the ‘teleological or functional element’ in treaty interpretation and ‘bring[s] the principle of effectiveness into [Art 31(1) VCLT].’ Oliver Dörr & Kirsten Schmalenbach, Vienna Convention on the Law of Treaties: A Commentary 545 (2012) [hereinafter Dörr & Schmalenbach (2012)].

EC – Chicken Cuts (AB) ¶ 238.

Id at ¶ 239.

Japan – Alcoholic Beverages at footnote 20 and references therein.

Isabelle Van Damme, Treaty Interpretation by the WTO Appellate Body 258 (2009) [hereinafter Van Damme (2009)]; ‘Interpretations in the light of a treaty’s object and purpose finds its limits in the treaty text itself. One of the (originally many possible) ordinary meanings will eventually prevail. […] Article 31 avoids an extreme functional interpretation which may, in fact, lead to “legislation” or the revision of the treaty.’ Mark E. Villiger, Commentary on the 1969 Vienna Convention on the Law of Treaties 428 (2009) [hereinafter Villiger (2009)]; ‘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.’ (internal citations omitted) Dörr & Schmalenbach (2012) at 547.

See the examples of Jordan, Colombia and Guatemala in Sect. 2.3 .

‘There are various ways of determining the object and purpose of a treaty. Some treaties contain general clauses specifically stating their purposes, Art 1 UN Charter being the obvious example. Also, recourse to the title of the treaty may be helpful. Moreover, the preamble of a treaty is regularly a place where the parties list the purposes they want to pursue through their agreement. In other cases the type of treaty may itself attract an assumption of a particular object and purpose, such as boundary treaties (final and stable fixing of frontiers). Generally, however, a reading of the whole treaty, [i.e.,] of all its substantive provisions, will be required to establish the object and purpose with some certainty. Also, contrasting the treaty in question with relevant treaties of the same kind can assist in establishing the telos of the former.’ (internal citations omitted) Dörr & Schmalenbach (2012) at 546.

The Preamble of the WTO Agreement, instead of that of the FINAL ACT, is often referred to when discussing objectives of the WTO. See for example, Andrew D. Mitchell, Legal Principles in WTO Disputes, 36 (2008); Jan Wouters & Bart De Meester, The World Trade Organization: A legal and Institutional Analysis 19–20 (2007) [hereinafter Wouters & De Meester (2007)].

¶ 3, Preamble of the Marrakesh Agreement Establishing the World Trade Organization, April 15, 1994, The Legal Texts: The Results Of The Uruguay Round Of Multilateral Trade Negotiations 4 (1999), 1867 U.N.T.S. 154, 33 I.L.M. 1144 (1994) [hereinafter WTO Agreement].

According to Van den Bossche & Zdouc, these are the main instruments to achieve the objectives of the WTO. Peter Van den Bossche & Werner Zdouc, The Law and Policy of the World Trade Organization: Text, Cases and Materials 86 (2013) [hereinafter Van den Bossche (2013)].

WTO Agreement ¶ 1 of the Preamble.

Id (emphasis added).

Id at ¶ 2. Also see Van den Bossche (2013) at 85.

The WTO Agreement does not contain specific provisions on object and purpose with its text.

Correa (2007) at 1.

‘Several paragraphs of the [TRIPS Agreement’s] preamble […] confirm the need for achieving a balance, or perhaps more accurately, the need to arrive at a series of equilibriums: between intellectual property protection and free trade […]; between highly industrialized and developing nations; between the private rights of intellectual property owners and cases where the public interest may trump some aspects of the protection of intellectual property; and more broadly as the reflection of the “contract” that intellectual property represents: in exchange for a reward and incentive to further creativity and inventiveness (including necessary investment in research and development efforts), intellectual property owners receive a limited (in scope and time) monopoly. They may not abuse those rights.’ Daniel Gervais, The TRIPS Agreement: Drafting History and Analysis 81 (2 nd ed. 2003) [hereinafter Gervais (2003)]

It may be argued that in its entirety, TRIPS is an attempt by the developed countries to coerce their developing countries trading partners to comply with open-ended minimum standards of intellectual property as a membership fee for the club WTO. Xu Yi-Chong, Last Chance? Multilateralism, TRIPS and developing countries , in Interpreting and Implementing the TRIPS Agreement: Is it Fair? 46 (Justin Malbon & Charles Lawson eds. 2008). Nonetheless, as the analysis in this section shows, TRIPS provisions can and must be interpreted in a balanced way that furthers the objective of the WTO Agreement for which the TRIPS Agreement is simply an instrument in the likeness of other instruments alluded to in paragraph 3 of the preamble of the WTO Agreement. Peter K. Yu, The Objectives and Principles of the TRIPS Agreement 146, 158–9 in Correa (2010) [hereinafter Yu (2010)]. If the proposers of an agreement on intellectual property within the GATT framework wished to see a water-tight text for the protection and enforcement of IPRs, Arts 7 and 8 (discussed below) and the object & purpose of the WTO Agreement defeats that purpose, especially in areas where the Agreement contains accommodative language. Moreover, the holistic reading of TRIPS object and purpose with WTO Agreement’s object and purpose is not an attempt to introduce concepts important from the perspective of public health or other public policy objectives from the backdoor in the TRIPS Agreement. A failure to fully appreciate the objects and purposes of the WTO and annexed agreements runs the danger of failing to interpret these agreements in good faith as required in Art 31 VCLT.

According to Yu, resort to ‘Articles 7 and 8 become even more important in light of the many ambiguities built into the TRIPS Agreement. Because Articles 7 and 8 memorialize the hard-fought bargains less developed countries have won through the TRIPS negotiations, these provisions provide policymakers, WTO panels, and the Appellate Body with objective clues as to how ambiguous words in the TRIPS Agreement are to be interpreted.’ Yu (2010) at 173–4. According to Correa ‘Article 7 [and] Article 8 of the TRIPS Agreement [provide] important elements for the interpretation and implementation of the rights and obligations under the Agreement’. (internal parenthesis omitted) Correa (2007) at 92.

TRIPS Resource Book at 125–6.

Abdulqawi A. Yusuf, TRIPS: Background, Principles and General Provisions, in Intellectual Property and International Trade: The TRIPS Agreement 3, 13–5 (Carlos M. Correa & Abdulqawi A. Yusuf ed. 2008).

For example, Stoll et al state that, for a measure to meet the necessity requirement, it should meet three requirements: first, the measure is needed to achieve one of the goals of Art 8.1 (to protect public health, nutrition and/or to promote the public interest in sectors of vital importance); second, the measure is capable of serving that goal and finally, the measure should be least restrictive for interstate trade. Stoll et al (2009) at 197. de Carvalho on the other hand, considers the necessity requirement redundant in the presence of TRIPS consistency requirement. de Carvalho (2008) at 109.

‘Although Art 8(1) can be interpreted broadly to promote the development goals of less developed countries, the provision contains two major constraints, both of which were added at the request of developed countries in the last stages of the negotiations.’ Yu (2010) at 165. Also see Gervais (2008) at 209.

Henning Grosse Ruse – Khan, A Comparative Analysis of Policy Space in WTO Law , Max Planck Institute for Intellectual Property, Competition & Tax Law Research Paper Series No. 08-02, 35–6 (2008), available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1309526&download=yes (last visited 2 June 2016) [hereinafter Grosse Ruse – Khan Contemporary Analysis (2008)]. For explanation of the necessity test in WTO jurisprudence, see WTO Appellate Body Report, Korea – Measures Affecting Imports of Fresh, Chilled and Frozen Beef , ¶¶ 159–164, WT/DS161/AB/R, WT/DS169/AB/R (11 December 2002) available at http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds161_e.htm (last visited 2 June 2016); WTO Appellate Body Report, European Communities – Measures Affecting Asbestos and Products Containing Asbestos, ¶¶ 164–175, WT/DS135/AB/R, (12 March 2001) available at http://www.wto.org/english/tratop_e/dispu_e/135abr_e.pdf (last visited 2 June 2016).

Grosse Ruse – Khan Contemporary Analysis (2008) at 23–4. Contra see Gervais (2008) at 210–1 (‘A WTO Panel or the Appellate Body would be unlikely to challenge a Member’s determination of its public interest or a sector of vital importance, but it certainly could consider the adequacy of the measure in terms of the stated objective and its compatibility with TRIPS – and perhaps whether there were less inconsistent (compliant) measures available to achieve the same objective. It must be borne in mind that both paragraphs require that the measure be necessary (art. 8(2) uses “needed”). This echoes the wording in the chapeau of art. XX of the GATT, where “necessary” refers to the least trade-restrictive measure’).

Grosse Ruse – Khan Contemporary Analysis (2008) at 36.

Correa (2007) at 104.

World Trade Organization, Declaration on the TRIPS agreement and public health , WT/MIN(01)/DEC/2 (20 November 2001) available at http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm (last visited 2 June 2016) [hereinafter Doha Declaration]

Grosse Ruse – Khan Contemporary Analysis (2008) at 40–6. Also see discussion in Sect.  3.2.4 .

Van Damme (2009) at 348. Though the Declaration was welcomed by all Members of the WTO, including the US, there had been considerable debate about its legal status. For a detailed discussion see generally, James T. Gathii, The Legal Status of the Doha Declaration on TRIPS and Public Health Under the Vienna Convention on the Law of Treaties in 15(2) Harv. J.L. & Tech. 291 (2002) [hereinafter ‘Gathii (2002)] and Holger Hestermeyer, Human Rights and the WTO: The case of Patents and Access to Medicines 279–82 (2007) [hereinafter Hestermeyer (2007)]. The Doha Declaration was also welcomed by the IFPMA and European Federation of Pharmaceutical Industries and Associations (EFPIA), albeit with caution. The IFPMA considered the Doha Declaration to be ‘a political rather than a legal or binding instrument’. See The Pharma Letter, Pharma industry views WTO’s “political” Doha Declaration on TRIPs available at http://www.thepharmaletter.com/file/8393/pharma-industry-views-wtos-political-doha-declaration-on-trips.html (last visited 2 June 2016). Similarly, Robert Zoellick, the US Trade Representative also considered it a ‘landmark political declaration’. USTR, USTR Zoellick Says World Has Chosen Path of Hope, Openness, Development and Growth , available at http://www.ustr.gov/archive/Document_Library/Press_Releases/2001/November/USTR_Zoellick_Says_World_Has_Chosen_Path_of_Hope,_Openness,_Development_Growth.html (November 14, 2001) (last visited 2 June 2016). In the same vein, some authors consider that the Doha Declaration may not be used as an authoritative interpretation according to Art IX(2) of the WTO Agreement. See for example, Hestermeyer (2007) id at footnote 418 and accompanying text. On the other hand, some authors consider the Declaration to be legally binding. They consider that the Declaration is an Agreement between the WTO Members and hence can be used as an element of interpretation for TRIPS Agreement according to Art 31(3)(a) VCLT. Federick M. Abbott, The Doha Declaration on TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO , in 5 J. Int’l Econ. L. 469, 491 (2002) [hereinafter Abbott (2002)] and Gathii (2002) at 300-1. In its commentary on VCLT, the ILC stated that

it is well settled that when an agreement as to the interpretation of a provision is established as having been reached before or at the time of the conclusion of the treaty, it is to be regarded as forming part of the treaty […] Similarly, an agreement as to the interpretation of a provision reached after the conclusion of the treaty represents an authentic interpretation by the parties which must be read into the treaty for purposes of its interpretation.

ILC Commentary (1966) at 221 (emphasis added). Specifically, with regard to a declaration by the parties to a treaty, the ICJ ruled that ‘[a] Declaration that essentially presents interpretative context for a treaty may even be regarded as ‘integral part of [a] [t]reaty, even if this [is] not stated in [the] terms [of the Treaty]’. Ambatielos Case (jurisdiction) , Judgment of July 1 st 1952: I.C.J Reports, p. 28, 44 available at http://www.icj-cij.org/docket/files/15/1965.pdf (last visited 2 June 2016). The Doha Declaration fulfills all the requirements of Art 31(3)(a) VCLT: it is a subsequent agreement as it has been adopted by all the WTO Members, dealing with the interpretation and application of TRIPS and having been adopted subsequent to TRIPS. Moreover, the Declaration emerged from the legal framework of WTO after due process in the relevant councils of the WTO, representing, therefore, consensus of the WTO Members and an expression of their intention with regard to the wordings of the Declaration itself. Van Damme (2009) at 346 (‘The agreement needs to have been reached between “the parties” and, giving effect used in Article 31(2) and Article 31(3)(a) [VCLT], subsequent to the conclusion of the treaty.’)

See Abbott (2002) at 470.

Valbona Muzaka, The Politics of Intellectual Property Rights and Access to Medicines 85 (2011) [hereinafter Muzaka (2011)]. According to Grosse Ruse – Khan, Doha Declaration is not part of the WTO Agreements. Therefore, it cannot reduce, weaken or even nullify’ the obligations in the TRIPS Agreement. Grosse Ruse – Khan Contemporary Analysis (2008) at 43.

For example right to education (access to textbooks) and right to health (access to medicines) to mention two.

An elaborate history of events leading to the Doha Declaration can be found in Ellen F. M.’t Hoen, The Global Politics of Pharmaceutical Monopoly Power: Drug patents, access, innovation and the application of the WTO Doha Declaration on TRIPS and Public Health 19–31 (2009); Abbott (2002) and Muzaka (2011) at 85–6. For a brief overview see Hestermeyer (2007) at 256–7. Gathi holds that the Doha Declaration ‘was in part necessitated by these divergent perspectives’. Gathii (2002) at 292.

Indeed, both in paragraph 4 and 5 the WTO Members reaffirm and maintain their commitments to the existing provisions of the TRIPS Agreement. See Eric Noehrenberg, TRIPS, the Doha Declaration and Public Health , 6 J World Intell. Prop. 379, 379 (2003) (stating that ‘the Doha Declaration on [TRIPS] and Public Health did not add anything new; it did not weaken [TRIPS]; it did not change any of its obligations’); Hestermeyer (2007) at 261 (‘the Doha Declaration mostly reiterates the state of the law’); Muzaka (2011) at 86. The Doha Declaration in paragraph 4 clarified that the provisions can and should be interpreted in such a way that does not ‘prevent Members from taking measures to protect public health’. In the same paragraph, the WTO Members also reaffirmed their agreement ‘that the [TRIPS] Agreement can and should be implemented in a manner supportive of WTO Member’s right to protect public health and, in particular, to promote access to medicines for all’, while ‘reiterating [their] commitment to the TRIPS Agreement’. The Members recognized in paragraph 5 that the TRIPS included flexibilities for this purpose and incorporated a non-exhaustive list of such TRIPS flexibilities in the Doha Declaration. In paragraph 6, it was recognized that Members with no manufacturing capacity for pharmaceutical products ‘could face difficulties in making effective use of compulsory licenses under the TRIPS Agreement’. Therefore the Council for TRIPS was instructed to find an ‘expeditious solution to this problem’. Finally, paragraph 7 in the Declaration extended the transition period for LDCs till 2016 for the implementation of Section 5 and 7 of Part II of the TRIPS Agreement.

Carsten Fink, & Patrick Reichenmiller, Tightening TRIPS: Intellectual Property Provisions of U.S. Free Trade Agreements in Trade, Doha and Development: A Window into the Issues 289, 294 (Richard Newfarmer, ed. 2006) (‘Technically, the Doha Declaration […] [does] not address test-data exclusivity […]’); also see Ellen F. M. ‘t Hoen, TRIPS, Pharmaceutical Patents and Access to Essential Medicines: Seattle, Doha and Beyond in Economics of AIDS and Access to HIV/AIDS Care in Developing Countries: Issues and Challenges 39, 56 (Jean-Paul Moatti et al , ed. 2003).

¶ 5(a) Doha Declaration. Also see the discussion in Sect.  3.2.3 .

US – Gambling ¶ 192.

EC – Chicken Cuts (AB) ¶ 255.

See for example, Fellmeth (2004) at 461; de Carvalho (2008) at 278–80; Meitinger (2005) at 131.

USTR, USTR Announces Two Decisions: Title VII and Special 301 , (April 30, 1996) at page 11, available at http://keionline.org/sites/default/files/ustr_special301_1996.pdf (last visited 2 June 2016).

USTR, USTR Report on Special 301 Annual Review , (April 30, 1997) available at http://www.keionline.org/ustr/1997special301 (last visited 2 June 2016) [hereinafter ‘Special 301 Report (1997)]. Similarly, South Africa was also put on the Watch List in the 1998 Report as undisclosed data also [was] not adequately protected under South African Law.’ USTR, USTR Announces Results of Special 301 Annual Review , (May 1, 1998) at page 21 available at http://keionline.org/sites/default/files/ustr_special301_1998.pdf (last visited 2 June 2016) [hereinafter USTR Results] at 21.

Special 301 Report (1997).

USTR Results at 10.

Request for Consultations by the US (2000).

EC, Questions on TRIPs and Data Exclusivity: An EU Contribution , 20–21 [hereinafter EU Position on Data Exclusivity] at http://trade.ec.europa.eu/doclib/docs/2006/may/tradoc_122031.pdf (last visited 2 June 2016). Gorlin claimed in 1999 that ‘there […] appears to be a United States-EU consensus that Article 39.3 requires WTO Members to protect the data submitted for gaining marketing approval of new chemical entities against “unfair commercial use”, that is, the data may not be relied upon for the marketing of subsequent versions of the drug during the period of data exclusivity’. Gorlin (1999) at 48.

The above position was also taken in the paper submitted by the EU to the TRIPS Council in the special discussion on IP and access to medicines:

The view taken by the EC and their member States is that the Agreement does contain an obligation to protect test data against ‘unfair commercial use’, and that the most effective method of doing so is to deny the regulatory authorities the possibility of relying on such data for a reasonable period of time . Furthermore, data protection should be available whether or not the product subject to regulatory approval is protected by patent or not, since data protection is quite a different issue from patent protection. (emphasis added)

WTO, Communication from the European Communities and their Member States , IP/C/W/280 dated 12 June 2001 available at http://www.wto.org/english/tratop_e/trips_e/paper_eu_w280_e.htm (last visited 2 June 2016).

WTO, Submission by the Africa Group, Barbados, Bolivia, Brazil, Dominican Republic, Ecuador, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka, Thailand and Venezuela , IP/C/W/280 dated 19 June 2001 available at http://www.wto.org/english/tratop_e/trips_e/paper_develop_w296_e.htm (last visited 2 June 2016).

UNCTAD, The TRIPS Agreement and Developing Countries , UNCTAD/ITE/1 (1996) available at http://unctad.org/en/docs/ite1_en.pdf (last visited 2 June 2016).

The compendium contains around seventy (70) national laws. However, not all countries provide test data exclusivity protection. Prominent examples are Argentina and Brazil.

See Chap. 5 .

Carlos M. Correa, Test data protection: rights conferred under the TRIPS Agreement and some effects of TRIPS-plus standards , in The Law and Theory of Trade Secrecy: A Handbook of Contemporary Research 569, 582–3 (Rochelle C. Dreyfuss & Katherine J. Strandburg ed. 2011).

Working Party on the Accession of the Russian Federation, Report of the Working Party on the Accession of the Russian Federation to the World Trade Organization , ¶¶ 1291–6, WT/ACC/RUS/70, WT/MIN(11)/2 (17 November 2011).

Working Party on the Accession of China, Report of the Working Party on the Accession of China , ¶¶ 282–4, WT/ACC/CHN/49, 1 October 2001.

EC – Chicken Cuts (AB) ¶ 259.

See generally, Van Damme (2009) at 360–6; Qureshi (2006) at 23. Also see Villiger (2009) at 432–4 for brief explanation of certain terms used in the provision such as ‘rules’, ‘relevant’, ‘parties’ etc.

Van Damme (2009) at 367–73.

Id at 357. It has been defined as ‘a generally accepted principle that when several norms bear on a single issue they should, to the extent possible, be interpreted so as to give rise to a single set of compatible obligations.’ International Law Commission [ILC], Fragmentation of International Law: Difficulties Arising from the Diversification and Expansion of International Law: Report of the Study Group of the International Law Commission , 8, A/CN.4/L.702 (18 July 2006) [hereinafter ILC Fragmentation Report].

ILC Fragmentation Report at 14.

Van Damme (2009) at 358.

Villiger (2009) at 432; Van Damme (2009) at 360. The ICJ held that ‘an international instrument has to be interpreted and applied within the framework of the entire legal system prevailing at the time of the interpretation’. Legal Consequences for States of the Continued Presence of South Africa in Namibia (South West Africa) notwithstanding Security Council Resolution 276 (1970), Advisory Opinion, I.C.J Reports, 1971 16, 31.

US – Gasoline at ¶ 16.

European Communities – Measures Affecting the Approval and Marketing of Biotech Products , Report of the Panel, ¶7.67 WT/DS291/R, WT/DS292/R, WT/DS293/R (29 September 2006) available at https://www.wto.org/english/tratop_e/dispu_e/cases_e/ds291_e.htm (last visited 2 June 2016).

UN General Assembly, International Covenant on Economic, Social and Cultural Rights , 16 December 1966, United Nations, Treaty Series, vol. 993, p. 3, available at http://www.refworld.org/docid/3ae6b36c0.html (last visited 2 June 2016). This Covenant is a relevant rule of international law as it is applicable in the relationship between the parties that are almost invariably signatories to this Covenant at the same time being Members of the WTO.

UN General Assembly, Universal Declaration of Human Rights , 10 December 1948, 217 A (III), available at: http://www.refworld.org/docid/3ae6b3712c.html (last visited 2 June 2016).

Annette Kur & Henning Grosse Ruse – Khan, Enough is Enough – The Notion of Binding Ceilings in International Intellectual Property Protection , Max Planck Institute for Intellectual Property, Competition & Tax Law Research Paper Series No. 09-01 at footnote 72 and references therein.

‘Article 32 does not define exhaustively the supplementary means of interpretation to which an interpreter may have recourse. It states only that they include the preparatory work of the treaty and the circumstances of its conclusion. Thus, an interpreter has a certain flexibility in considering relevant supplementary means in a given case so as to assist in ascertaining the common intentions of the parties.’ EC – Chicken Cuts (AB) ¶ 283.

For a detailed background on the beginnings of the Uruguay Round of Multilateral Trade Negotiations see Gervais (2008) at 3–26; Watal (2001) at 19–47 and Michael Blakeney, Trade Related Aspects of Intellectual Property Rights: A Concise Guide to the TRIPs Agreement 1–7 (1996).

Suggestion by the United States for Achieving the Negotiation Objective , MTN.GNG/NG11/W/14/Rev.1 dated 17 October 1988. This proposal was quite elaborate, containing paragraphs on the scope and length of the right, rights conferred and requirement for maintenance of the right among others. Trade secrets were considered to be a form of property , owned by its owner rather than being held by a holder. Under the US law undisclosed data submitted to Environment Protection Agency is considered a property. The Supreme Court of the United States held ‘that Monsanto ha[d] a property interest in the data it ha[d] submitted to the EPA [supporting its application].’ Ruckelshaus v. Monsanto Co at 1004.

The paragraph read as follows:

III.D. […] 6. Conditions on Government Use Trade secrets submitted to governments shall not be disclosed or used for the benefit of third parties except in compelling circumstances involving major national emergencies posing an imminent unreasonable risk to health or the environment, or to facilitate required health and safety registrations. Government use or disclosure on the basis of a national emergency may only be made where other reasonable means are not available to satisfy the need for which the government seeks to disclose or use the trade secret, and the government may use it only for the duration of that emergency. Government use or disclosure to facilitate required health and safety registrations may only be made if the trade secret has not been submitted within the previous ten years and full compensation is made for the use or disclosure. In any case, a government shall not use or disclose a trade secret to an extent greater than required to achieve one of the above needs without providing the submitter with a reasonable opportunity to oppose the proposed use or disclosure, including the opportunity to secure judicial review, or without providing for the payment of full compensation as in the case of personal property.

Standards and Principles Concerning the Availability, Scope and Use of Trade-Related Intellectual Property Rights, Communication from Switzerland: Addendum on Proprietary Information , MTN.GNG/NG11/W/38/Add.1 dated 11 December 1989. Under the heading ‘Standards of Proprietary Information,’ it read,

2. Standards on Proprietary Information (i) […] (v) Proprietary information provided to a governmental agency in order to obtain permission to produce or market a product, such as results of clinical or safety tests, shall not be disclosed without the consent of the proprietor, except to other governmental agencies if necessary to protect human, plant or animal life, health or the environment. Governmental agencies shall not be entitled to use the information for commercial purposes. They may disclose it only to the extent indispensable to inform the general public about the actual or potential danger of a product.

Guidelines and Objectives Proposed by the European Community for the Negotiations on Trade-Related Aspects of Substantive Standards of Intellectual Property Rights , MTN.GNG/NG11/W/26 dated 7 July 1988. The proposal read,

g. Acts contrary to honest commercial practices Trade and business secrets shall be protected by law at least by providing their proprietor the right to prevent these secrets from becoming available to, or being used by, others in a manner contrary to honest commercial practices.

Also by using this phrase, the EC distanced itself with the proposal in the US submission conferring on the owner of the trade secret certain rights against actual or threatened misappropriation. Instead, it seems to propose that the principle of bones mores and good faith should be followed in line with the international practice as established by the regime under Art 10 bis Paris Convention.

Standards for Trade-Related Intellectual Property Rights – Submission from Canada, MTN.GNG/NG11/W/47 dated 25 October 1989.

Meeting of 30 October – 2 November 1989, Note by the Secretariat , MTN.GNG/NG11/16 dated 4 December 1989 ¶ 19.

Suggestion by Japan to Achieve the Negotiating Objective , MTN.GNG/NG11/W/17 dated 23 November 1987. A more detailed document submitted later by Japan, MTN.GNG/NG11/W/74 dated 15 May 1990, also did not contain protection of trade secrets, though, according to the Japanese representative ‘his Government recognized the importance of such protection, was seriously considering this matter and a final position in this regard would be made known at a later stage.’ Meeting of Negotiating Group of 14–16 May 1990, Note by the Secretariat , MTN.GNG/NG11/21 dated 22 June 1990 ¶ 50.

Standards and Principles for Negotiations on Trade-Related Intellectual Property Rights, Communication from New Zealand , MTN.GNG/NG11/W/49 dated 24 October 1989.

Meeting of 12 – 14 July 1989, Note by the Secretariat , MTN.GNG/NG11/14 dated 12 September 1989 ¶ 90.

MTN.GNG/NG11/16 ¶ 63. Also see MTN.GNG/NG11/14 ¶ 90 (‘[T]he fundamental basis of an intellectual property right was the disclosure, publication and registration of the subject matter of protection, whereas confidentiality and secrecy were fundamental to trade secrets.)

Meeting of Negotiating Group of 23–24 November 1987, Note by the Secretariat MTN.GNG/NG11/5 dated 14 December 1987 ¶ 22 and Meeting of Negotiating Group of 2, 4 and 5 April 1990, Note by the Secretariat MTN.GNG/NG11/20 dated 12 April 1990 ¶ 24. This divergence was also evident in the negotiations itself. For example see Meeting of Negotiating Group of 5–8 July 1988, Note by the Secretariat MTN.GNG/NG11/8 dated 29 August 1988 ¶ 43 (‘Another participant understood the proposal to suggest specific legislation and considered that his country and some other common law countries that already protected trade and business secrets under the common law or in other ways might be reluctant to legislate specifically.’) One delegation ‘saw many problems in prescribing in an international agreement uniform protection for trade secrets.’ MTN.GNG/NG11/14 ¶ 91. On the US position, that protection of trade secrets is important for technology transfer, MTN.GNG/NG11/16 ¶ 91, skepticism was shown as to ‘how the protection of trade secrets could help developing countries have access to technology if the know-how was not disclosed.’ MTN.GNG/NG11/16 ¶ 61. In one of the meetings of the negotiating group, the problems with inclusion of the protection of trade secrets in a future TRIPS Agreement were summarized in the following words:

First, there were difficulties associated with the criteria for defining trade secrets; if the criteria were too broad all kinds of information could be protected as trade secrets. Second, intellectual property protection involved a balance between private and public interests which in the case of trade secrets was not present, in view of the lack of disclosure requirements serving the public interest. Third, if trade secrets were treated as an intellectual property right, large parts of patentable subject matter were capable of being protected as trade secrets; IPR holders would thus be able to choose the kind of protection to seek, which could lead to considerable overlapping between different forms of protection. Another participant said that the option that would become available to IPR holders to choose either trade secrets or patent protection would be exercised in favour of the former, creating considerable difficulties in the form of lack of registration, lack of time limits on protection, and excessive freedom being conferred on the IPR holder to choose when to take action against an infringer.

Meeting of Negotiating Group of 11, 12 And 14 December 1989: Note by the Secretariat, MTN.GNG/NG11/17 dated 17 November 1987 ¶ 49.

See note 148 and accompanying text.

The EC representative acknowledged that its draft is ‘an important revision of its earlier proposals’ due to ‘Community’s internal reflections on this matter.’ MTN.GNG/NG11/20 ¶ 4. It is not unimaginable why the EC changed its position in this regard. At the time of its initial submission, the Community regime of protection of test data was quite nascent being introduced only in 1987. However, by 1990, the system had already been tested for almost three years and would be continued. See Sect. 4.2 .

Art 28, Draft Agreement on Trade-Related Aspects of Intellectual Property Rights , MTN.GNG/NG11/W/68 dated 29 March 1990. It read as

G. Acts contrary to honest commercial practices including protection of undisclosed information Article 28 In the course of ensuring effective protection against unfair competition as provided for in Article 10bis of the Paris Convention - (a) … (b) Contracting parties, when requiring the publication or submission of test or other data, the origination of which involves a considerable effort, shall protect such efforts against unfair exploitation by competitors. The protection shall last for a reasonable time commensurate with such efforts, the nature of the data required, the expenditure involved in their preparation and shall take account of the availability of other forms of protection.

See note 148 and the accompanying text.

Draft Agreement on the Trade-Related Aspects of Intellectual Property Rights: Communication from the United States , MTN.GNG/NG11/W/70 dated 11 May 1990.

Article 33: Exceptions

(1) Contracting parties which require that trade secrets be submitted to carry out governmental functions, shall not use the trade secrets for the commercial or competitive benefit of the government or of any person other than the right-holder except with the right-holder’s consent, on payment of the reasonable value of the use, or if a reasonable period of exclusive use is given the right-holder. (2) Contracting parties may disclose trade secrets to third parties, only with the right-holder’s consent or to the degree required to carry out necessary government functions. Wherever practicable, right-holders shall be given an opportunity to enter into confidentiality agreements with any non-government entity to which the contracting party is disclosing trade secrets to carry out necessary government functions. (3) Contracting parties may require right-holders to disclose their trade secrets to third parties to protect human health or safety or to protect the environment only when the right-holder is given an opportunity to enter into confidentiality agreements with any non-government entity receiving the trade secrets to prevent further disclosure or use of the trade secret.

See Sect.  3.3.1 .

Compare Art 31(1) with Art 33 in MTN.GNG/NG11/W/70.

Draft Amendment to the General Agreement on Tariffs and Trade on the Protection of Trade-Related Intellectual Property Rights: Communication from Switzerland , MTN.GNG/NG11/W/73 dated 14 May 1990.

Article 243: Exceptions

(1) Proprietary information submitted to a government agency for purposes of regulatory approval procedures such as clinical or safety tests, shall not be disclosed without the consent of the proprietor, except to other governmental agencies if necessary to protect human, plant or animal life, health or the environment. Governmental agencies shall not be entitled to use the information for commercial purposes. They may disclose it only with the consent of the proprietor or to the extent indispensable to inform the general public about the actual or potential danger of a product.

Art 243(2) provided that ‘[d]isclosure of any proprietary information to a third party, or other governmental agencies, in the context of an application for obtaining intellectual property protection, shall be subject to an obligation to hear the applicant and to judicial review.’

Under the Swiss law, test data was considered proprietary information, and was to be protected through the exclusivity regime. On the other hand, protection of proprietary information was linked to Art 10 bis. Hence, the language of the Swiss proposal was confusing similar to that of the EC draft.

The draft provision did not mention if the governmental agencies could use the information for other purposes. Similarly, the proposal was silent on the usage by third parties including competitors.

Communication from Argentina, Brazil, Chile, China, Colombia, Cuba, Egypt, India, Nigeria, Peru, Tanzania And Uruguay, MTN.GNG/NG11/W/71 dated 14 May 1990. Similarly the draft submitted by Japan, Main Elements of a Legal Text for TRIPS: Communication from Japan , MTN.GNG/NG11/W/74 dated 15 May 1990.

MTN.GNG/NG11/20 ¶ 24 (‘[A] participant said that […] considering [the] variety [of business secrets], it seemed more attractive to leave the protection to national legislation only.’) and MTN.GNG/NG11/21 dated 22 June 1990 ¶ 49 (‘[A] participant said that […] trade secret protection should be left to national law.’) Moreover, the proposals for trade secrets protection in other drafts also received criticism. For example, while commenting on the US draft, one participant indicated that ‘some specific points in this part of the proposal would render it difficult to implement in countries not providing for statutory protection in this field’. Another participant expressed ‘reservations about going beyond the provisions of Article 10bis of the Paris Convention and was concerned that the inclusion of detailed provisions on the protection of trade secrets might lead to difficulties in the enforcement area of a TRIPS agreement.’ Another participant remarked that ‘his delegation had no objection to the protection of trade secrets, but was of the view that […] any provisions should leave the form of protection to the discretion of signatory governments.’ As regards the protection of trade secrets submitted to the governmental agencies, one participant ‘questioned the necessity of dealing with [it], since this could open up a whole new area of negotiation, which did not in any case deal directly with the granting or enforcing of IPRs.’ MTN.GNG/NG11/21 dated 22 June 1990 ¶ 24. This reservation was also repeated with regard to the Swiss draft. Id ¶ 45.

Status of Work in the Negotiating Group: Chairman’s Report to the GNG , MTN.GNG/NG11/W/76 dated 23 July 1990 [hereinafter Chairman’s Report]. This document was the formal version of an informal paper drafted by the Chairman’s office and distributed informally among the members of the negotiating group.

The Chairman’s Report was ‘essentially a compilation of the options for legal commitments as they [had] emerged from a process of informal consultations. In this sense it [was] intended as a basis for further negotiation.’ MTN.GNG/NG11/W/76 at 1.

Section 7: Acts Contrary to Honest Commercial Practices Including Protection of Undisclosed Information

1. […] 3. Government Use 3Aa PARTIES, when requiring the publication or submission of undisclosed information consisting of test [or other] data, the origination of which involves a considerable effort, shall protect such data against unfair exploitation by competitors. The protection shall last for a reasonable time commensurate with the efforts involved in the origination of the data, the nature of the data, and the expenditure involved in their preparation, and shall take account of the availability of other forms of protection. 3Ab.1 PARTIES which require that trade secrets be submitted to carry out governmental functions, shall not use the trade secrets for the commercial or competitive benefit of the government or of any person other than the right holder except with the right holder’s consent, on payment of the reasonable value of the use, or if a reasonable period of exclusive use is given the right holder. 3Ab.2 PARTIES may disclose trade secrets to third parties, only with the right holder’s consent or to the degree required to carry out necessary government functions. Wherever practicable, right holders shall be given an opportunity to enter into confidentiality agreements with any non-government entity to which the PARTY is disclosing trade secrets to carry out necessary government functions. 3Ab.3 PARTIES may require right holders to disclose their trade secrets to third parties to protect human health or safety or to protect the environment only when the right holder is given an opportunity to enter into confidentiality agreements with any non-government entity receiving the trade secrets to prevent further disclosure or use of the trade secret. 3Ac.1 Proprietary information submitted to a government agency for purposes of regulatory approval procedures such as clinical or safety tests, shall not be disclosed without the consent of the proprietor, except to other governmental agencies if necessary to protect human, plant or animal life, health or the environment. Governmental agencies may disclose it only with the consent of the proprietor or to the extent indispensable to inform the general public about the actual or potential danger of a product. They shall not be entitled to use the information for commercial purposes. 3Ac.2 Disclosure of any proprietary information to a third party, or other governmental agencies, in the context of an application for obtaining intellectual property protection, shall be subject to an obligation to hear the applicant and to judicial review. Third parties and governmental agencies having obtained such information shall be prevented from further disclosure and commercial use of it without the consent of the proprietor.

The most prominent change was with regard to the EC proposal. Instead of protecting the effort of originating the data, as in the EC draft, protection was made available for test data thereby refocusing on the protection of undisclosed information itself. See discussion in note 154.

Meeting of Negotiating Group of 20 July 1990: Notes by the Secretariat , MTN.GNG/NG11/24 dated 22 August 1990 ¶ 5. It was observed in one of the subsequent meetings that inclusion of protection of trade secrets was an ‘expansion of the mandate’ of the Negotiating Group. Meeting of Negotiating Group of 10–21 September 1990: Notes by the Secretariat , MTN.GNG/NG11/25 dated 8 October 1990 ¶ 6. The fourteen countries that circulated a draft agreement were ready to negotiate on all aspects, except trade secrets, which they still did not consider an intellectual property right. Meeting of Negotiating Group of 8 & 18 October 1990: Notes by the Secretariat , MTN.GNG/NG11/26 dated 31 October 1990 ¶ 7.

In addition to the formal monthly meetings of the Negotiating Group, there were informal negotiation sessions, organized by the secretariat with the principal negotiating actors. Much of the subsequent progress on outstanding issues was achieved in such informal sessions though no minutes or notes were kept. Additional texts were prepared based on the consultations in these sessions, which were circulated to the whole Negotiating Group. See Gervais (2008) at 19–20.

MTN.TNC/W/35/Rev.1 dated 3 December 1990 at Annex III. [hereinafter Brussels’ Draft]

1A. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), PARTIES shall protect […] data submitted to governments or governmental agencies in accordance with paragraph 4 below.

Section 7: Protection Of Undisclosed Information

1A. […] 4A . PARTIES, when requiring, as a condition of approving the marketing of new pharmaceutical products or of a new agricultural chemical product, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall [protect such data against unfair commercial use. Unless the person submitting the information agrees, the data may not be relied upon for the approval of competing products for a reasonable time, generally no less than five years, commensurate with the efforts involved in the origination of the data, their nature, and the expenditure involved in their preparation. In addition, PARTIES shall] protect such data against disclosure, except where necessary to protect the public.]

Art 42(4A) contained a compromise from all parties including the EC, US and Switzerland. The complete prohibition on use of the test data, as proposed by the Swiss, was not adopted, neither was the ten-year long prohibition against such use, advocated by the US in its initial submission. The EC proposal based solely on the principle of proportionality with no minimum period of protection was also not adopted. The proposed period of generally not less than five years, hence, was a bandy between the different positions of these parties as well as adapted to appease the developing countries with the addition of the word ‘generally’, signaling that, at least, in some cases there may not be a prohibition on usage or reliance (as there were no notes of the informal sessions, it is difficult to claim how much of the negotiating objectives of either side were achieved). The EC was in the favor of retaining a more flexible language so that some of its members like Spain, Italy and Portugal, having a strong generic manufacturing base, could also comply with the future TRIPS requirement. de Carvalho (2008) at 258. There was also no reference to right-holder , owner or proprietor of the submitted information. Similarly, neither explicitly nor implicitly, there was property-like reference to undisclosed information. The reference was made to the submitter of the information to the government agency, who is assumed to be in legal control of the information in accordance with Art 42(1A) (however, in a meeting of the Negotiating Group subsequent to Brussels Ministerial, a participant believed that Art 42(3A), which related to voluntary licensing, ‘implied the recognition of a proprietary right without limitations and obligations of any sort […],’ Meeting of Negotiating Group of 16 and 22 October 1991: Note by the Secretariat, MTN.GNG/TRIPS/3 dated 18 November 1991 ¶ 9).

It was also provided that test data submitted, as a requirement by the government would be protected thus excluding voluntarily submitted data from the protection. The ‘considerable effort’ requirement was included in the provision from the EC draft.

See generally, the different submissions and drafts of the EU, the US and Switzerland and the provision relating to test data in the Chairman’s Report in Sect.  3.3.1.3 .

Employment of the concept of ‘reliance’ instead of ‘usage’ correctly reflected the actual activity both by the government and third parties for approval of subsequent generic pharmaceutical products.

The proposal in the US draft came closest when it required that the submitted trade secrets would not be used for the ‘commercial or competitive benefit of the government or of any person other than the right-holder […]’. There too was no clarification as to which usage would result in commercial or competitive benefit of the government or a third party. See Art 33(1) in the US draft proposal at Sect.  3.3.1.2.2 . In comparison, prohibition on reliance makes it abundantly clear that it’s the one way in which governments are not allowed use the submitted data.

The alternate liability rule based on adequate compensation proposed by the US was deleted from this provision, so was the prohibition of compulsory licensing of undisclosed information (including undisclosed test or other data).

See Sect.  3.3.1.2.1 .

It was stated in the commentary of the draft that

‘[s]quare brackets have been used to identify specific points on which further negotiation is necessary, but their absence from a particular provision cannot be taken as indicating that there is general agreement on it. Participants are therefore not committed to any provision and a number of participants have in addition made it clear that on certain provisions their positions are reserved pending further consideration in capitals.’

Brussels Draft at 193.

According to one delegation ‘paragraph 4A of […] Article [42] went far beyond the limits of reasonable protection which should actually be afforded under national legislation to test data submitted for marketing approval of pharmaceuticals and agro-chemicals.’ MTN.GNG/TRIPS/3 ¶ 9. This is the only direct reference to test data in all the notes of the meeting issued by the Secretariat.

Draft Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations, MTN.TNC/W/FA, dated 20 December 1991 at 58 et seq. [hereinafter The Final Draft]

3. PARTIES, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilise new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, PARTIES shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.

For a discussion on ‘new chemical entities’ in the context of TRIPS, see Sect.  3.5.2 .

‘The purpose of treaty interpretation is to establish the common intention of the parties to the treaty.’ WTO Appellate Body Report on EC – Computer Equipment (WT/DS62/AB/R, WT/DS67/AB/R, WT/DS68/AB/R) ¶ 93 [hereinafter EC – Computer Equipment (AB)] (original emphasis). For a critique of the concept of common intentions as developed in the WTO case law see Qureshi (2006) at 9–12.

In line with Art 32 VCLT, WTO Dispute Settlement boards have assessed circumstances of a treaty’s conclusion where the analysis under Art 31 VCLT leaves the meaning of a provision, or a term therein, ‘ambiguous or obscure, or leads to a result which is manifestly absurd or unreasonable’. See for example EC – Computer Equipment (AB) ¶ 86.

Maxwell A. Cameron & Brian W. Tomlin, The making of NAFTA: how the deal was done xiv (2002).

Bruce A. Lehman, the Assistant Secretary of Commerce and Commissioner of Patents and Trademarks in 1993, claimed that, ‘much of the NAFTA chapter seventeen text, particularly the enforcement section, was taken directly from the TRIPs’. Bruce A. Lehman, Intellectual Property under the Clinton Administration , 27 Geo. Wash. J. Int’l L. & Econ. 395, 408 (1993). Also see Charles S. Levy & Stuart M. Weiser, The NAFTA: A Watershed for protection of Intellectual Property , 27(3) Int’l Law. 671, 672 (1993) (‘[t]he NAFTA negotiators started with the Dunkel TRIPS Text’s provisions on intellectual property, but then built upon them . While certainly not perfect, the NAFTA is a watershed in the history of protection of intellectual property rights, standing on the shoulders of the Dunkel TRIPS Text and vastly increasing the level of protection afforded to holders of such rights ’) (emphasis added).

Art 1711(5) NAFTA

If a Party requires, as a condition for approving the marketing of pharmaceutical or agricultural chemical products that utilize new chemical entities, the submission of undisclosed test or other data necessary to determine whether the use of such products is safe and effective, the Party shall protect against disclosure of the data of persons making such submissions, where the origination of such data involves considerable effort, except where the disclosure is necessary to protect the public or unless steps are taken to ensure that the data is protected against unfair commercial use.

Art 1711(6) NAFTA

Each Party shall provide that for data subject to paragraph 5 that are submitted to the Party after the date of entry into force of this Agreement, no person other than the person that submitted them may, without the latter’s permission, rely on such data in support of an application for product approval during a reasonable period of time after their submission. For this purpose, a reasonable period shall normally mean not less than five years from the date on which the Party granted approval to the person that produced the data for approval to market its product, taking account of the nature of the data and the person’s efforts and expenditures in producing them. Subject to this provision, there shall be no limitation on any Party to implement abbreviated approval procedures for such products on the basis of bioequivalence and bioavailability studies.

Considering the MFN requirement of TRIPS Agreement in Art 4, this approach would spread test data exclusivity with the increase in US FTAs, albeit at a slower pace than if it would have been part of the TRIPS Agreement.

Many commentators of the TRIPS Agreement agree on this conclusion. See for example, de Carvalho: ‘[U]ndisclosed information that is voluntarily submitted is not entitled either to exclusive protection or to protection against disclosure […] This requirement means that test data must be protected only in those countries the governments of which maintain a pre-marketing approval system. Where pharmaceutical and agro-chemical products are not subject to pre-marketing approval […] there is nothing to protect.’ de Carvalho (2008) at 286–7; Correa: ‘[…] if a Member country opts not to require those data […] Article 39.3 does not apply.’ Correa (2007)at 377; TRIPS Resource Book, ‘This provision does not apply when it is not necessary to submit such data […]’ TRIPS Resource Book at 530; Meitinger: ‘It should be noted that Article 39.3 TRIPS only applies if countries require submission of test data during marketing approval procedures; however, nothing in TRIPS or other international agreements obliges countries to do so. If no obligatory submission of test data is foreseen for such purposes, the whole issue of Article 39.3 TRIPS becomes irrelevant.’ (internal citations omitted) Meitinger (2005) at 125, footnote 9.

Skillington and Solovy argue that ‘[…] a Member could require the submission of otherwise protectable data to an independent research facility for analysis, rather than requiring submission to a government entity. In such a case, the Member would never physically acquire or retain the data. Read literally, TRIPS Article 39.3 requires the Member to protect data submitted to that research facility because that Article does not specify to whom the data must be submitted […] As a policy matter, it would be illogical to place a requirement to protect data on a Member, and then allow a Member to avoid that requirement by simply delegating certain functions from it to a non-governmental entity.’ Skillington & Solovy (2003) at 24. Stoll et al opine that ‘in the light of the purpose of the provision the term governmental agency has to be interpreted broadly […] Therefore, a government agency is any entity to which the applicant has to submit the data to [sic] pursuant to the Member’s legislation or an administrative directive.’ Stoll et al (2009) at 650.

Reichman states ‘WTO Members have no duty to ‘require […] the submission of undisclosed test or other data […] If a state forgoes [the requirement of submission of undisclosed test or other data] – for example, by relying upon the health and safety decisions of other jurisdictions […] it arguably incurs no liability whatsoever under Article 39.3 [TRIPS].’ Reichman (2006) at 141. Arrivillaga claims that, ‘[a]ccording to [Art 39(3)], countries are not compelled to require test-data submission to national health authorities in their procedures for marketing authorization.’ Arrivillaga (2003) at 143.

‘In practice, the Members laws display in detail the required formats of such data.’ Stoll et al at 650 citing Andreas Sasdi, Innovationsschutz im TRIPS-Übereinkommen 209 (2004).

‘Under the Chilean statute (Law 19,996, of 2005), it is the duty of the originator, in its request for marketing approval, to expressly identify the data as undisclosed (Article 89, ¶ 4). However, Decree No. 135 of 2005, which establishes the mechanisms for the protection of data, requests the originator that he not only give notice to the authority of the confidentiality of the data but also that it identifies “precisely which studies in his views are undisclosed and in connection with which the following requirements have been met: that reasonable measures have been taken to keep them secret; and that those data are not generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question”.’ (original references) de Carvalho (2008) at 295 citing Decree No. 135, of 2005, Article 6(A) and (B) available at http://www.inapi.cl/portal/institucional/600/w3-propertyvalue-1426.html (last visited 2 June 2016).

‘Non-compliance with [the] formal requirements [of data submission] does not lead to a loss of protection as long as the data are substantially necessary for the marketing approval.’ Stoll et al (2009) at 650.

At another place, TRIPS Agreement requires that the enforcement of IPRs must not be unnecessarily complicated or costly. Art 41(2) TRIPS.

See for example, Fellmeth (2004) at 465–7; Gervais (2008) at 427; Stoll et al (2009) at 650–1; TRIPS Resource Book at 530; Arrivillaga (2003) at 145–7; Correa (2007) at 378–9.

It was held by a WTO Appellate Body that ‘[…] the fact that a particular treaty provision is “silent” on a specific issue “must have some meaning” […] Such silence does not exclude the possibility that the requirement was intended to be included by implication’. WTO Appellate Body Report on United States – Countervailing Duties on Certain Corrosion-Resistant Carbon Steel Flat Products from Germany , WT/DS213/AB/R, WT/DS213/AB/R/Corr.1 ¶ 65 available at https://docs.wto.org/dol2fe/Pages/FE_Search/FE_S_S006.aspx?Query=(@Symbol=%20wt/ds213/ab/r*%20not%20rw*)&Language=ENGLISH&Context=FomerScriptedSearch&languageUIChanged=true# (last visited 2 June 2016).

Some authors do suggest that the term ‘new chemical entity’ includes ‘new active substances’ normally used in relation to biotechnological products. According to de Carvalho ‘[T]he notion of chemical entities covers biotechnical products, including genes and genetically modified genes, for they constitute chemical organic molecules.’ de Carvalho (2008) at 287 (emphasis added).

Oxford English Dictionary, http://www.oed.com/view/Entry/31256?redirectedFrom=chemical#eid (last visited 2 June 2016).

Under the US law an ‘active moiety’ is defined as ‘the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance’. 21 CFR § 314.108(a). A ‘new chemical entity’ is defined as ‘a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the act’. 21 CFR § 314.108(a). In principle, the definition of the ‘new chemical entity’ also does not make any differentiation between chemical and biological entities. However, these two types of entities are regulated differently and at the time of the conclusion of the TRIPS agreement, even the US did not have a test data exclusivity system for biological entities. Hence, to argue that the concept of ‘new chemical entity’ also include biological entity cannot be deemed as reflecting the common intention of the negotiating parties.

The EMA uses the neutral term ‘substance’ defined as ‘[a]ny matter irrespective of the origin which may be human[,] animal[,] vegetable [or] chemical. Art 1(3) the amended Directive 2001/83/EC. However, the European law also makes a distinction between the evaluation of the two types of products. Biological products are mandatorily assessed under the Centralised Procedure of the EMEA. See Art 3 together with the Annex of Regulation 726/2005

At the time of the conclusion of the TRIPS Agreement, only the biological products regulated under the Hatch-Waxman Act, qualified for test data exclusivity protection. It was only in 2010, with the promulgation of the Biologics Price Competition and Innovation Act (BPCIA), the test data exclusivity scheme for biologics was enacted. See Sect. 4.1.2 . On the other hand, there was test data exclusivity protection for ten (10) years provided in the EU for certain ‘high technology medicinal products’. See generally, the discussion in Sect. 4.2.1 . Nonetheless, as discussed in Sect.  3.3.1 , the EU did not initially advocate for test data exclusivity in TRIPS during the Uruguay Round negotiations and when it did, there is no evidence that it also meant it for products containing new biological entities. Moreover, the EU still makes a distinction between products containing a chemical entity and those that contain biological entities. For example, in the FTA with Peru and Colombia (provisionally applied with Peru since 1 March 2013 and with Colombia since 1 August 2013), after providing for test data exclusivity for ‘pharmaceutical products’ in general, it is clarified in footnote 72 that for the EU and Colombia this protection includes ‘protection of biological and biotechnology products’. Apparently, Peru is not obliged under the FTA to extend the test data exclusivity protection to products containing biological entities. See Art 231(1) Peru-Colombia-EU FTA.

See the discussion in Sect. 4.1.2.2 .

For example, under the US law, pharmaceutical products that contain chemical entities are regulated under the FDCA and those that contain biological entities are regulated under the Biologics Price, Competition and Innovation Act (BPCIA). Similarly, the responsibility of assessing the chemistry-based products and biological products is also divided between the Center for Drug Evaluation and Research (CDER) (See the webpage ‘FAQs about CDER’ at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/FAQsaboutCDER/default.htm (last visited 2 June 2016) and the Center for Biologics Evaluation and Research (See the webpage ‘About CBER’ at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm123340.htm (last visited 2 June 2016). The test data exclusivity period for these two types of products also differs, with that for biologics, considerably longer.

Even though in many academic writings on Art 39(3) the word ‘novelty’ has been used in relation to new chemical entities, I will avoid its usage so as not to confuse it with the ‘novelty’ requirement in the patent system. However, when citing other writers, I will use the word as used in the original text. The meaning should be understood within the context of the respective quotation.

‘[…] there is no mandatory consistent interpretation of the term “new”’ in the TRIPS Agreement. Stoll et al (2009) at 651.

Arrivillaga states that ‘[s]ince Article 39.3 does not define what should be understood as “new”, the question is open to different interpretations by the various countries, and their legislation could have many different effects, and leave the way open for many goals by both the generic or the research-based industry.’ Arrivillaga (2003) at 145. de Carvalho opines that ‘[i]n the absence of a definition in Art 39.3, under 1.1 of the TRIPS Agreement, WTO Members may adopt whatever concept of novelty that fits their legal systems and practices.’ de Carvalho (2008) at 289.

Merriam-Webster, http://www.merriam-webster.com/dictionary/new?show=0&t=1332264572 (last visited 2 June 2016). The word ‘new’ can used both as an adjective and an adverb. However, as it is used as an adjective in Art 39(3) I define it as an adjective.

This definition is instructive of the rationale behind the priority period granted in the case of recently applied patent and trademark applications.

‘A review of the TRIPS Agreement reveals that in some instances, the word [new] is intended to mean experienced or used for the first time, but in others it is intended to mean “novel” in the patent sense.’ Skillington & Solovy (2003) at 25–6.

‘“Novelty,” for the purposes of Art 39.3 has nothing to do with patent protection. The fact that a chemical entity is “new” under Article 39.3 does not mean that it is necessarily patentable, because it either may not meet the strict requirements of novelty for patent purposes or it may not meet the condition of inventiveness.’ de Carvalho (2008) at 289. Arrivillaga, discussing in the context of the requirement of ‘considerable effort’, states that, ‘Article 39.3 does not grant protection on the grounds of novelty and inventiveness. Even if tests are performed on a new drug, the tests are not original or inventive by themselves. From this point of view, test data protection relies on a logic completely different from patent protection […]’. Arrivillaga (2003) at 147. Also see Skillington & Solovy (2003) at 27–8 and Stoll et al (2009) at 650–1. Gervais finds this ‘[a] possible approach based on internal coherence of the [TRIPS] Agreement and coherence of WTO Members’ intellectual property legislation.’ However, he considers it ‘difficult to conduct a patent-related search of the prior art in each case before deciding whether protection should apply.’ Gervais (2008) at 427. This standard also does not find much support from Correa who considers that ‘[p]resumably [Art 39(3) TRIPS] does not impose a patent standard of novelty, but nothing prevents a Member country from assimilating the concept of “new” used in this Article to the one applied under patent law.’ Correa (2007) at 378.

See de Carvalho at footnote 614 discussing absolute novelty in the context of Argentina.

An assessment of regulatory authorities of the countries of sub-Saharan Africa, commissioned by the World Health Organization (WHO) found that in most countries there was no capacity to assess new innovator (those for which test data is used for assessment of safety and efficacy) products and most countries had a shortage of adequately qualified assessors. World Health Organization (WHO), Assessment of medicines regulatory systems in sub-Saharan African countries: An overview of findings from 26 assessment reports 13-5 (2010) available at http://www.who.int/healthsystems/Assessment26African_countries.pdf (last visited 2 June 2016). Another study of two developed and eight developing countries, commissioned by the WHO, concluded that shortage of staff is one of the main issues faced by the countries analyzed. Moreover, many of the regulatory authorities also faced financial resource constraints. Sauwakon Ratanawijitrasin & Eshetu Wondemagegnehu, Effective Drug Regulation 137–9 (2002) available at http://apps.who.int/medicinedocs/pdf/s2300e/s2300e.pdf (last visited 2 June 2016).

A variation of this approach would be to require that the application for a new chemical entity should be filed within a specific period of time from the first approval any where in the world. The test data exclusivity laws of Costa Rica, Dominican Republic and Colombia, for example, require that the application for approval be filed within five years from the first registration elsewhere in the world. See Sect. 6.4.3.3 . Countries can also shorten this period to one year or less.

‘[T]he word “new” is frequently used to refer to the status of a chemical entity or a product vis-à-vis the marketing approval systems of various countries [,]’ citing the US, the EU and Canadian laws. Skillington & Solovy (2003) at 26. (internal citations omitted).

For example, see country studies cited in Sect. 2.3 .

The requirement to file early as mentioned above may also be employed.

Correa believes that Art 39(3) does not apply to such line extensions ‘since there would be no novel chemical entity involved’. Correa (2007) at 379. Moreover, expanding the definition of new chemical entities to include extensions will also be contrary to the plain language of Art 39(3) which requires that the chemical entity should be new in itself . See Fellmeth (2004) at 466–7.

Teva Canada Ltd. v. The Minister of Health and Sanofi-Aventis Canada Inc . 2012 FCA 106.

The Canadian Special Access Program is different from the normal drug approval procedure. See Id at 9–10.

Correa (2007) at 380; de Carvalho (2008) at 292.

Oxford Dictionaries, http://www.oxforddictionaries.com/definition/undisclosed?q=undisclosed (last visited 2 June 2016). Similarly, the online Collins Dictionary defines it as ‘not made known or revealed’. Collins Dictionary http://www.collinsdictionary.com/dictionary/english/undisclosed (last visited 2 June 2016),

The other two prongs of the definition of undisclosed information in Art 39(2) TRIPS are that it ‘has commercial value because it is secret [and] has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.’ For further discussion on relationship between the different paragraphs of Art 39, see Sect.  3.2.2.2 .

In practice, only the company conducting the trials has the knowledge of the data generated through clinical trials and results. In some cases, the data is also known to external contractors called contract research organizations (‘CRO’). Apart from that, the data is, generally, not revealed and remains within the closed circles of the originator or sponsoring company. Hence, it can be reasonably believed that in general such data is not known to any outsider except the DRA or to others under duty of confidentiality. The results of the clinical trials are published in medical journals and clinical trials registries like International Clinical Trials Registry Platform (ICTRP) of the WHO (at http://www.who.int/ictrp/en/ ) and http://clinicaltrials.gov/ also contain information about the clinical trials but extensive test data is not published.

de Carvalho (2008) at 294.

Correa (2007) at 380.

On the contrary, it is also argued that there is no requirement in Art 39(3) to stop the protection of data if it is disclosed after submission. Skillington & Solovy (2003) at 26. But this argument does not hold much water because once the data is disclosed, it automatically loses protection as per Art 39(3). The plain language of Art 39(3) puts no bar on ceasing the protection of such data both against disclosure and/or unfair commercial use. Skillington & Solovy’s argument makes sense only with respect to test data exclusivity.

Chilean Decree No. 153 of 2005 Article 6(A) and (B) cited in de Carvalho (2008) at 294. This approach is criticized on the ground that secrecy of information is an objective feature, which can only be determined by a DRA under the national law. Correa (2007) at 378. However, these two points-of-view can be regarded as complementary and not necessarily opposite. For reasons of administrative and judicial convenience, the originator must readily identify the undisclosed data, however, the claim has to be verified by the DRA in line with the requirements of Art 39(2). The DRA in the course of assessing the application will determine which parts of the test data can be protected.

According to Art 39(1), Members are required to protect undisclosed information according to Art 39(2) and data submitted to governments according to Art 39(3).

WTO Members still have the obligation to protect undisclosed information against disclosure in a marketing application as per Art 39(2) TRIPS.

Without making this distinction, the scope of protection under Art 39(3) will unreasonably expand in contravention of the purpose of the provision. For example, an application for a new chemical entity contains ‘an application form, an index, a summary, five or six technical sections, case report tabulations of patient data, case report forms, drug samples, and labeling, including, if applicable, any Medication Guide required under part 208 of this chapter.’ 21 CFR §314.50 (2003) available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.50 (last visited 2 June 2016). This section of the regulation uses the phrase ‘data and information’ three times clearly making a distinction between the two concepts.

Merriam-Webster Medical Dictionary available at http://c.merriam-webster.com/medlineplus/data (last visited 2 June 2016). Cambridge Dictionaries Online defines data as ‘information, especially facts or numbers, collected to be examined and considered and used to help decision-making…’ http://dictionary.cambridge.org/dictionary/british/data?q=data (last visited 2 June 2016). According to the Oxford Dictionaries, ‘data’ means ‘facts and statistics collected together for reference or analysis,’ at http://oxforddictionaries.com/definition/english/data?q=data (last visited 2 June 2016). As the definitions are similar and the one from Merriam-Webster broader than the other two, the latter is mentioned in the main text.

Cambridge Dictionary, http://dictionary.cambridge.org/dictionary/british/information?q=information (last visited 2 June 2016). Merriam Webster Medical Dictionary does not contain an entry on ‘information’.

Oxford Dictionaries, http://oxforddictionaries.com/definition/english/information?q=information (last visited 2 June 2016).

The above definitions also show that the relationship of ‘information’ and ‘data’ is that of genus and species. Therefore, Art 39(2) is also applicable on ‘data’ as used in Art 39(3).

‘[…] the term test data addresses the actual clinical and pre-clinical tests run in advance of the approval […],’ Stoll et al (2009) at 650 (original emphasis).

See Sect. 1.1 for a brief historic discussion of the protection of safety and efficacy data. For detailed historic recount, please see the references cited therein.

According to Correa ‘other data may include, for instance, manufacturing, conservation, and packaging methods and conditions […]’ Correa (2007) at 377.

Art 39(3) uses the word ‘origination’ with respect to test or other data. This is in contrast to the requirement of creativity and originality in the various areas of intellectual property rights. It is argued that this word has been used to contrast with ‘creativity’ ‘because test data are not necessarily creative.’ de Carvalho (2008) at 293. (For him the word ‘origination’ in the context of this article means ‘the making, the preparation, the obtaining.’) Indeed, data from clinical trials is obtained by employing prescribed observational techniques. See generally, J.R. Turner, New Drug Development: Design, Methodology, and Analysis 61–81 (2007) [hereinafter Turner (2007)]. For a discussion of the importance of obtaining quality clinical trial data see Turner (2007) 61–2. The sponsors of the trials as well as its conductors do not create such data. The data and results are obtained through clinical trials that are carefully designed and analyzed. This is done to ensure that the collected data is of high quality. Clinical trials are conducted according to a pre-defined Clinical Study Protocol. This Protocol defines how a clinical trial will be conducted and details all aspects of its design, adopted methodology and analysis. The Protocol is considered to be the most important document in the conduct of clinical trials. Another document, which is directly related to conducting clinical trials, is the Case Report Form (CRF). A CRF is a pre-defined and structured document that is used to collect data during the clinical trials. For a discussion of Clinical Study Protocol and Case Report Form see Turner (2007) at 71–4. It is therefore, clear that clinical trials are a structured exercise and the resultant data have no intellectual input in the sense of originality and creativity as treated in intellectual property. To avoid any potential confusion with the originality requirement for copyright protection in some countries, a better word in this regard, would have been ‘generated’ and/or ‘collected.’

Oxford Dictionaries, http://oxforddictionaries.com/definition/english/considerable?q=considerable (last visited 2 June 2016).

Correa (2007) at 379.

de Carvalho (2008) at 295; Arrivillaga (2003) at 148.

Critics already accuse the pharmaceutical industry of inflating the costs of drug discovery and development. See Donald W. Light & Rebecca N. Warburton, Extraordinary claims require extraordinary evidence, 24 J. Of Health Eco. 1030–33 (2005) and Timothy Noah, The Make-Believe Billion: How drug companies exaggerate research costs to justify absurd profits, Slate Magazine (2011) available at http://www.slate.com/articles/business/the_customer/2011/03/the_makebelieve_billion.html (last visited 2 June 2016).

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Shaikh, O.H. (2016). Test Data Exclusivity and Art 39(3) TRIPS. In: Access to Medicine Versus Test Data Exclusivity. Munich Studies on Innovation and Competition, vol 4. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-49655-8_3

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Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations, Apr. 15, 1994, 1867 U.N.T.S. 14, 33 I.L.M. 1143 (1994) [hereinafter Final Act].

WTO Agreement: Marrakesh Agreement Establishing the World Trade Organization, Apr. 15, 1994, 1867 U.N.T.S. 154, 33 I.L.M. 1144 (1994) [hereinafter Marrakesh Agreement or WTO Agreement].

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GATS: General Agreement on Trade in Services, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1B, 1869 U.N.T.S. 183, 33 I.L.M. 1167 (1994) [hereinafter GATS].

TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994) [hereinafter TRIPS Agreement].

DSU, Dispute Settlement Rules: Understanding on Rules and Procedures Governing the Settlement of Disputes, Marrakesh Agreement Establishing the World Trade Organization, Annex 2, 1869 U.N.T.S. 401, 33 I.L.M. 1226 (1994) [hereinafter DSU]

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Saracens to continue team-bonding trips despite Billy Vunipola incident

• Mark McCall says ‘case is closed’ over player’s arrest in Mallorca
• Saracens director of rugby believes in support over punishment

Saracens intend to continue their team-bonding social trips, with Mark McCall insisting the recent excursion to Mallorca was “really enjoyable” despite Billy Vunipola’s arrest.

McCall insisted that as far as Saracens are concerned “the case is closed” over Vunipola, who was twice stunned with a taser and arrested in Palma during a recent squad trip after a victory over Bath , then fined €240 (£205) by an express trial for resisting the law.

The 31-year-old issued a public apology and has since explained that he has a problem “knowing when to stop” drinking, with McCall stressing the importance of “support and help” rather than punishing indiscretions.

The Saracens director of rugby reflected positively on the trip, ­highlighting the beneficial impact they can have. In the past Saracens have embarked on mid-season trips to Barcelona, the ski slopes of St Anton and ­a pre-season jaunt to Bermuda and, asked if the Vunipola incident would lead to a rethink, McCall said: “I don’t think so, no. It was a really enjoyable, well organised trip away together after a tough game against Bath. With ­nothing the following weekend, it was an opportunity for us to ­connect in a ­different way and I am glad we did it.

“Just that weekend as a whole to travel down to the Rec which is a really hard place to go and get a result, which obviously kickstarted what turned out to be a really ­positive weekend for the group to spend some quality time together away from training. That’s something that the players look forward to doing as it has been part of what we have done for a long time.

“To be honest, I think other clubs are doing it as well. We’re just trying to connect the group a little bit more deeply than you can sometimes get in your day-to-day work. It was a really positive couple of days despite what happened.”

McCall stressed that it had been a “normal week” for the club after their return and while the Rugby Football Union could still charge Vunipola, the No 8 is considered available for selection against Bristol on Saturday.

“The case is closed as far as we are concerned and we just get on with the rugby now,” added McCall. “The only thing that I would add to what the club has said is that when someone does something wrong, the first reaction doesn’t always have to be to punish that person. Sometimes you’ve got to understand why what happened happened, to support and help. It doesn’t always have to be a punishment.

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“I just think we understand that people are human, and people make mistakes. Of course there’s a line, and there are things that you can’t condone. But more often than not if it’s appropriate then we would want to give people second chances, maybe even sometimes third chances if it’s clear that they’re remorseful, that they take ownership of it.”

Asked how they expected Vunipola, who is set to leave Saracens for Montpellier at the end of the season, to respond, McCall said: “Just what he always does, which is to give his all to his teammates.”

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Investigations

When judges get free trips to luxury resorts, disclosure is spotty.

Tom Dreisbach

Carrie Johnson

Many federal judges receive free rooms and subsidized travel to luxury resorts for legal conferences. NPR found that dozens of judges did not fully disclose the perks they got. Chelsea Beck for NPR hide caption

Many federal judges receive free rooms and subsidized travel to luxury resorts for legal conferences. NPR found that dozens of judges did not fully disclose the perks they got.

Dozens of federal judges failed to fully disclose free luxury travel to judicial conferences around the world, as required by internal judiciary rules and federal ethics law , an NPR investigation has found. As a result, the public remained in the dark about potential conflicts of interest for some of the United States' top legal officials.

Federal judges — occasionally with family members or even their dog in tow — traveled to luxury resorts in locations as far-flung as London; Palm Beach, Fla.; Bar Harbor, Maine; and the outskirts of Yellowstone National Park for weeklong seminars. The judges received free rooms, free meals and free money toward travel expenses, together worth a few thousand dollars.

Victims of harassment by federal judges often find the judiciary is above the law

At one event, a far-right German politician with a history of racially inflammatory and anti-immigrant statements made a presentation to dozens of judges. At others, judges heard from an advocacy group that uses lawsuits in federal court to change environmental policy, as well as from corporate CEOs in the oil and pharmaceutical industries.

For almost two decades, the federal judiciary has recognized that the combination of apparent luxury and ideological content can present the appearance of undue influence on the courts. In response, the judiciary has required more transparency in the form of public disclosure.

An NPR investigation found that the disclosure systems often fail to give the public timely information about the outside benefits that judges receive and from whom.

As a result, judicial ethics experts say, people with cases before these judges lack important information about a judge's potential biases. That information, if received in time, could be used to request that a judge recuse from a particular case.

"It also matters to the public, even if someone never shows up in a courtroom, to believe in the integrity of our judiciary and to trust in the decisions that are issued by judges," said Renee Knake Jefferson, a professor at the University of Houston Law Center. "Having disclosures of judicial financial interests goes directly to the public having confidence in the outcomes of the decisions — that they are free of any bias or influence."

Many judges defend these events as helpful forums to discuss important issues, and they reject criticism that a stay at a fancy hotel could influence their decisions. Critics call them "junkets" and glorified vacations that reward ideological allies.

Both sides agree that disclosure is needed.

There are two primary ways the public can view information about judicial education events and see which judges attended: One disclosure is filed soon after the event, and the other is submitted much later.

First, within 30 days of an event, judges are required to file a form that details the host of the event and the entities that provided funding, as well as the speakers and topics of discussion. This form, called a " Privately Funded Seminar Disclosure Report ," is posted on every federal court's website.

Second, federal law requires that judges report the reimbursements they received for the events on an annual financial disclosure report. That report also includes information like alternate sources of income (such as a book deal or teaching job) and what stocks a judge might own. Those reports are eventually posted on a centralized online database maintained by the Administrative Office of the U.S. Courts.

By closely examining the portion of these events subject to public records laws, NPR identified problems with both systems.

In nearly 40 instances, judges attended events at luxury resorts but failed to properly file a report within 30 days. In fact, the forms were uploaded months or even years late and only after NPR began asking questions.

In 13 cases, NPR found that judges failed to declare the benefits they received on their annual financial disclosure forms.

NPR contacted all those judges for comment.

And in another dozen cases, judges' financial disclosures for 2021 or 2022 were simply unavailable to the public. By all accounts, judges are filing those annual disclosure reports on time. The Administrative Office of the U.S. Courts bears responsibility for posting those reports online and has acknowledged delays in getting the system up to date.

There is no indication that the judges intentionally withheld information in order to deceive the public. And the office that administers the annual financial disclosure website told NPR that it struggles to work through a backlog of reports, as well as requests for redactions to protect judges' safety, but is making progress.

Ethics experts said delays and omissions in these reports undermine the entire purpose of the transparency rules.

"That information loses most of its value if it's a year and a half later," said Kedric Payne, the senior director of ethics at the nonprofit watchdog Campaign Legal Center. "It's just too distant from the potential conflict of interest."

Regardless of intention, the result is that the public is kept in the dark. And NPR's findings likely represent an undercount of the larger problem.

Events with ideological presentations and a side of luxury

Nonprofits, legal organizations and private universities all host judicial education events around the world. But those groups are generally not subject to public records laws. As a result, their full attendee lists are shielded from public scrutiny.

When it comes to the hosts of these events, George Mason University in Fairfax, Va., is exceptional in two ways.

George Mason University's campus in Fairfax, Va., in 2018. Education Images/Universal Images Group via Getty Images hide caption

George Mason University's campus in Fairfax, Va., in 2018.

For one, GMU — particularly the university's conservative-leaning Law & Economics Center — has long stood out as one of the most prolific hosts of judicial education events. Collectively, hundreds of judges have attended the university's events at luxury resorts over the years. GMU is quick to point out that the events are paid for by private donors. The Law & Economics Center's website lists donors that include major corporations like Amazon, Pfizer, Google and Facebook, as well as the business lobby group the U.S. Chamber of Commerce. According to the New York Times , conservative activist Leonard Leo helped gather $30 million in donations to rename the law school after late Supreme Court Justice Antonin Scalia.

GMU is a public university in Virginia, which means it is subject to the state's Freedom of Information Act. NPR requested attendee lists for eight of its judicial education events from 2021 to 2023. By comparing attendee lists with the publicly available records, NPR was able to identify dozens of missing disclosures.

That missing information may be relevant to both the public at large and people with cases in front of these judges.

For example, dozens of judges took part in a 2022 event that featured a speaker from the far-right Alternative für Deutschland (Alternative for Germany) political party. Germany has been rocked by massive protests in recent months over revelations about AfD's ties to right-wing extremism. A regional AfD leader is facing charges in Germany for allegedly using Nazi slogans, which he denies.

Gunnar Beck, a member of the European Parliament and an AfD member, spoke to the group of American federal judges about "European Jurisprudence." Beck has a history of anti-immigrant and racially inflammatory statements.

In 2021 — the year before his presentation to the judges — Beck took multiple photos of Black families, including young children in strollers, and posted them on social media. In one of the posts, he used the photo to criticize what he called the Afrikanisierung (Africanization) of Germany. (This post was deleted after NPR contacted Beck.) In another, Beck wrote that due to immigration, "Germany has no future as an industrial and cultural nation, but it does have a future as a welfare office."

Beck told NPR in an email that "each country and its people have a right to control their border with a view to safeguarding their maintenance of their national culture and identity" and that "I do not think these views are either fascist or racist."

The GMU events have also featured presentations from a nonprofit that says it uses lawsuits to promote a pro-market, as opposed to pro-regulation, approach to environmental policy; the CEO of a U.K.-based pharmaceutical company ; and the CEO of an energy company that is currently suing the federal government over financial regulations.

One recent event included a reading assignment on the "worst decisions ever handed down by the Supreme Court" as defined by conservative and libertarian legal scholars. Roe v. Wade , which established a constitutional right to abortion, was No. 2. Landmark cases establishing rights to same-sex marriage and the use of birth control also appeared among the top 10 "worst" decisions.

Given the power of judges to affect Americans' lives on issues from guns to abortion, the environment and crime, transparency about these events is critical, said Gabe Roth of the nonprofit watchdog group Fix the Court.

"The public has a right to know whether or not its top legal officials have any potential conflicts going into hearing cases," said Roth. "Sometimes they're small bore, but a lot of the times they have major national impact."

The agendas for the GMU events showed that the event programming often ended around noon, followed by a five- or six-hour "study break." In some instances, the agendas leave days completely free.

It's unclear exactly how judges spent that time. But attendees had the opportunity to enjoy the Ritz-Carlton's clay tennis courts, the Alyeska Resort's Nordic Spa or the short walk to Buckingham Palace from the May Fair Hotel in London. The agenda for GMU's 2022 Bar Harbor Colloquium in Maine reserved 90 minutes for a wine tasting .

The Alyeska Resort in Girdwood, Alaska, in 2009. John Greim/LightRocket via Getty Images hide caption

The Alyeska Resort in Girdwood, Alaska, in 2009.

A spokesperson for GMU did not respond to NPR's specific questions for this story.

"Topics are selected based on foundational concepts in the economic analysis of law relevant to judges and other areas of interest to the judiciary," wrote Ken Turchi, associate dean of GMU's Antonin Scalia Law School, in an email. "Every judge who attends has the option to complete and submit a disclosure form detailing expenses incurred and reimbursed."

Which judges have disclosure problems?

Problems plagued the paperwork for judges appointed by presidents of both major parties going back decades, including Presidents Ronald Reagan, George H.W. Bush, Bill Clinton, George W. Bush, Barack Obama and Donald Trump.

And the judges who failed to fully comply with the disclosure requirements include some notable names.

In this screenshot, Aileen Cannon speaks during a Senate Judiciary Committee nomination hearing to be a U.S. district judge for the Southern District of Florida on July 29, 2020. She was appointed to the position later that year. U.S. Senate via AP hide caption

In this screenshot, Aileen Cannon speaks during a Senate Judiciary Committee nomination hearing to be a U.S. district judge for the Southern District of Florida on July 29, 2020. She was appointed to the position later that year.

Judge Aileen Cannon of the Southern District of Florida is presiding over former President Donald Trump's criminal trial for allegedly mishandling classified documents. Cannon, herself a Trump appointee, attended two seminars at a luxury resort in Montana, but the privately funded seminar disclosures for both events were not posted online until NPR began making inquiries. Clerk of court Angela Noble told NPR in an email that the absence of the disclosures was due to technical issues and that "Any omissions to the website are completely inadvertent."

Judge Robert Conrad is the director of the Administrative Office of the U.S. Courts. U.S. Courts hide caption

Judge Robert Conrad is the current director of the Administrative Office of the U.S. Courts, which implements the policies of the federal judiciary. Conrad, who was appointed by George W. Bush to the Western District of North Carolina, attended three privately funded seminars from 2021 to 2023. He later included the events on his annual financial disclosure but did not file a publicly available disclosure for any of those events within the required 30-day time limit. "He inadvertently did not make the additional disclosure in the separate system for private seminar attendance," said Peter Kaplan, a spokesperson for the Administrative Office. "Judge Conrad appreciates your bringing this oversight to his attention."

Judge Leslie Gardner of the Middle District of Georgia, who is the sister of prominent Georgia Democrat Stacey Abrams, also failed to file a privately funded seminar disclosure on time. Additionally, NPR found that Gardner omitted the reimbursements she received for lodging, meals and travel on her annual financial disclosure. In a phone call to NPR, clerk of court David Bunt said that Gardner, an Obama appointee, was updating her annual financial disclosure and privately funded seminar disclosure, which were incomplete due to an "oversight."

"I don't have really an excuse for it, and I'm going to correct it"

Judges contacted by NPR largely described the issues with their disclosures as the result of an "inadvertent oversight" or an "accident." In a handful of cases, court clerks blamed technical issues with the online system for uploading paperwork. One judge appeared to be unaware of the requirement to file a disclosure report within 30 days. Several judges thanked NPR for contacting them and prompting them to update their disclosure reports.

"It looks like we blew it," said Judge Philip Gutierrez of the Central District of California in a phone call to NPR. Gutierrez failed to file a disclosure within 30 days of attending a judicial seminar at The Breakers, a resort in Palm Beach, Fla., in 2021. "I apologize. It's important. I'm embarrassed."

Gutierrez immediately uploaded the missing disclosure.

Judge Gary Fenner of the Western District of Missouri attended the same GMU 2021 seminar in Palm Beach but failed to file a privately funded seminar disclosure and omitted the event from his annual financial disclosure that year.

"I am really surprised that I did not report that," said Fenner, an appointee of Bill Clinton, in a phone message to NPR. "I'm going to rectify it. I'm embarrassed about the fact that somehow that was overlooked by me. But I don't have really an excuse for it, and I'm going to correct it."

Judge Keith Starrett of the Southern District of Mississippi, a George W. Bush appointee, said he had thought he marked his attendance at GMU's seminar at the Park Hyatt Beaver Creek Resort and Spa in Colorado in 2021 on his annual financial disclosure. He acknowledged that it was missing from the forms due to an "oversight."

"I'm going to do whatever I need to do to get it right," he said by phone.

In the District Court for the Southern District of Texas, NPR found three judges — Jeffrey Brown, Andrew Edison and Charles Eskridge — who had not filed the required privately funded seminar disclosure forms. After NPR contacted the court, the judges uploaded the forms, and clerk of court Nathan Ochsner said in an email, "At the direction of Chief Judge Randy Crane, my office will routinely remind all [Southern District of Texas] judges of this reporting requirement."

Meanwhile, the delays in getting access to annual financial disclosure reports appear to be the result of the time limits built into the transparency laws, as well as a combination of long processing times for redactions requested by judges and, in some cases, security concerns.

The law requires that judges file their annual financial disclosure reports for the previous year on May 15. Many judges request and receive a 90-day extension, pushing that deadline to mid-August. Judges can then request that the judiciary redact "personal or sensitive information that could directly or indirectly endanger" the judge or the judge's family, but then a committee has to review the request.

"So if you're a judge that asked for a 90-day extension and then, on top of that, you're asking for redactions," said Roth, of Fix the Court, the public release of the annual disclosure is "already well into the following year."

Former federal Judge Jeremy Fogel, who is now the executive director of the Berkeley Judicial Institute, evaluated some of these redaction requests when he served on the judiciary's Committee on Financial Disclosure.

"I don't think that the problem you described is one where the judiciary doesn't want to share the information," said Fogel. "I think the problem is that they have not been able to put the resources in place to get the information online and available to the public in a timely manner."

The Thurgood Marshall Federal Judiciary Building in Washington, D.C., houses the Administrative Office of the U.S. Courts. Andrew Harnik/AP hide caption

The Thurgood Marshall Federal Judiciary Building in Washington, D.C., houses the Administrative Office of the U.S. Courts.

NPR sent a list of judges to the Administrative Office of the U.S. Courts and asked why their annual financial disclosures for 2021 or 2022 were still unavailable. Kaplan, the Administrative Office spokesperson, said he "could not comment on specific judges' filings." In general, Kaplan blamed missing disclosures on backlogs in the system and reviews of filings for possible security issues.

"Currently, nearly all filings from 2021 and more than 80% of the filings from 2022 are available on the database," said Kaplan. "We are continuing to cut into the backlog of reports."

An ongoing debate over judges and luxury trips

Even if judges universally filed their disclosure reports on time and if the federal judiciary sped up the release of information, it would likely not end the ongoing debate over judges getting thousands of dollars in free perks, especially at ideologically slanted conferences.

Fogel said that in his time as a judge, he tended to avoid events that might be perceived as ideological.

"I wouldn't go so far as to say that it's unethical," said Fogel. "But I think it's better — it's a best practice — for judges to avoid programs that have a particular philosophical or ideological viewpoint."

Judge Starrett, of the Southern District of Mississippi, has attended five GMU legal events in the last three years and even brought his German shepherd to one of them.

He rejected the idea that his views could be swayed by a certain speaker's agenda or free perks.

"I've been called a liberal judge. I've been called a conservative judge. I've been called a son of a bitch. That comes with the territory," said Starrett. "I pay close attention to speakers that are politically biased one way or another. I listen to them, and I challenge some of them. I ask pointed questions."

Judge Gutierrez, of the Central District of California, has attended three GMU events in the last three years.

"Certainly, I think people have a slant. But for the most part, I found them to be interesting and educational," he said. He added that a group of federal judges will always tend to ask tough questions and get into spirited debates — whether in court or in a legal seminar.

"We want our judges out in the world learning and teaching. And we want our judges to have friendships. We want our judges to be able to travel," said Jefferson, the legal ethics expert at the University of Houston Law Center. "It's the disclosure that matters."

Nick McMillan and Hilary Fung contributed reporting and visuals, with graphic editing by Alyson Hurt. This story was edited by Barrie Hardymon with research by Barbara Van Woerkom. Photo editing by Emily Bogle.

• Leonard Leo
• Aileen Cannon
• Federal Courts
• George Mason University
• federal judges
• financial disclosure

Korea Box Office: ‘The Roundup: Punishment’ Passes $55 Million on Second Weekend, as ‘The Fall Guy’ Trips

By Patrick Frater

Patrick Frater

Asia Bureau Chief

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Locally-produced crime action thriller “ The Roundup: Punishment ” dominated the South Korea box office for a second weekend. In contrast, Hollywood’s “ The Fall Guy ” opened softly in third place.

Data from Kobis, the tracking service operated by the Korean Film Council (Kofic), showed “The Roundup: Punishment” grossed $13.8 million between Friday and Sunday, earned from 1.92 million ticket sales.

Popular on Variety

Over the latest weekend, “Kung Fu Panda 4” scored $1.17 million. Its aggregate score is now $11.1 million, earned since a release on April 10.

“The Fall Guy,” which also fell short of expectations on its North American debut , earned only $544,000 between Friday and Sunday, with a 3% market share. Over its full five-day opening in Korea, the film managed to pass the $1 million mark and finished Sunday with $1.12 million.

In fourth place, a new “Pokemon” film earned $440,000 over the weekend. Over its five opening days, its total was $660,000.

Fifth place belonged to rereleased Japanese drama title “The Last Ten Years,” which picked up $181,000. Its cumulative total is $3.43 million.

Box office champion, “Exhuma” earned an incremental $105,000 in sixth place. Its running total is $84.5 million earned from 11.9 million spectators.

European animation film “Richard the Stork and the Mystery of the Great Jewel” opened in seventh place. It earned $72,000 from the weekend and $108,000 over its full five-day opening run.

Bringing up tenth place was “Ghostbusters: Frozen Empire” with just $33,000. Since releasing on April 17, it has earned just $334,000.

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40 Facts About Elektrostal

Written by Lanette Mayes

Modified & Updated: 02 Mar 2024

Reviewed by Jessica Corbett

Elektrostal is a vibrant city located in the Moscow Oblast region of Russia. With a rich history, stunning architecture, and a thriving community, Elektrostal is a city that has much to offer. Whether you are a history buff, nature enthusiast, or simply curious about different cultures, Elektrostal is sure to captivate you.

This article will provide you with 40 fascinating facts about Elektrostal, giving you a better understanding of why this city is worth exploring. From its origins as an industrial hub to its modern-day charm, we will delve into the various aspects that make Elektrostal a unique and must-visit destination.

So, join us as we uncover the hidden treasures of Elektrostal and discover what makes this city a true gem in the heart of Russia.

Key Takeaways:

• Elektrostal, known as the “Motor City of Russia,” is a vibrant and growing city with a rich industrial history, offering diverse cultural experiences and a strong commitment to environmental sustainability.
• With its convenient location near Moscow, Elektrostal provides a picturesque landscape, vibrant nightlife, and a range of recreational activities, making it an ideal destination for residents and visitors alike.

Known as the “Motor City of Russia.”

Elektrostal, a city located in the Moscow Oblast region of Russia, earned the nickname “Motor City” due to its significant involvement in the automotive industry.

Home to the Elektrostal Metallurgical Plant.

Elektrostal is renowned for its metallurgical plant, which has been producing high-quality steel and alloys since its establishment in 1916.

Boasts a rich industrial heritage.

Elektrostal has a long history of industrial development, contributing to the growth and progress of the region.

Founded in 1916.

The city of Elektrostal was founded in 1916 as a result of the construction of the Elektrostal Metallurgical Plant.

Located approximately 50 kilometers east of Moscow.

Elektrostal is situated in close proximity to the Russian capital, making it easily accessible for both residents and visitors.

Known for its vibrant cultural scene.

Elektrostal is home to several cultural institutions, including museums, theaters, and art galleries that showcase the city’s rich artistic heritage.

A popular destination for nature lovers.

Surrounded by picturesque landscapes and forests, Elektrostal offers ample opportunities for outdoor activities such as hiking, camping, and birdwatching.

Hosts the annual Elektrostal City Day celebrations.

Every year, Elektrostal organizes festive events and activities to celebrate its founding, bringing together residents and visitors in a spirit of unity and joy.

Has a population of approximately 160,000 people.

Elektrostal is home to a diverse and vibrant community of around 160,000 residents, contributing to its dynamic atmosphere.

Boasts excellent education facilities.

The city is known for its well-established educational institutions, providing quality education to students of all ages.

A center for scientific research and innovation.

Elektrostal serves as an important hub for scientific research, particularly in the fields of metallurgy, materials science, and engineering.

Surrounded by picturesque lakes.

The city is blessed with numerous beautiful lakes, offering scenic views and recreational opportunities for locals and visitors alike.

Well-connected transportation system.

Elektrostal benefits from an efficient transportation network, including highways, railways, and public transportation options, ensuring convenient travel within and beyond the city.

Famous for its traditional Russian cuisine.

Food enthusiasts can indulge in authentic Russian dishes at numerous restaurants and cafes scattered throughout Elektrostal.

Home to notable architectural landmarks.

Elektrostal boasts impressive architecture, including the Church of the Transfiguration of the Lord and the Elektrostal Palace of Culture.

Offers a wide range of recreational facilities.

Residents and visitors can enjoy various recreational activities, such as sports complexes, swimming pools, and fitness centers, enhancing the overall quality of life.

Provides a high standard of healthcare.

Elektrostal is equipped with modern medical facilities, ensuring residents have access to quality healthcare services.

Home to the Elektrostal History Museum.

The Elektrostal History Museum showcases the city’s fascinating past through exhibitions and displays.

A hub for sports enthusiasts.

Elektrostal is passionate about sports, with numerous stadiums, arenas, and sports clubs offering opportunities for athletes and spectators.

Celebrates diverse cultural festivals.

Throughout the year, Elektrostal hosts a variety of cultural festivals, celebrating different ethnicities, traditions, and art forms.

Electric power played a significant role in its early development.

Elektrostal owes its name and initial growth to the establishment of electric power stations and the utilization of electricity in the industrial sector.

Boasts a thriving economy.

The city’s strong industrial base, coupled with its strategic location near Moscow, has contributed to Elektrostal’s prosperous economic status.

Houses the Elektrostal Drama Theater.

The Elektrostal Drama Theater is a cultural centerpiece, attracting theater enthusiasts from far and wide.

Popular destination for winter sports.

Elektrostal’s proximity to ski resorts and winter sport facilities makes it a favorite destination for skiing, snowboarding, and other winter activities.

Promotes environmental sustainability.

Elektrostal prioritizes environmental protection and sustainability, implementing initiatives to reduce pollution and preserve natural resources.

Home to renowned educational institutions.

Elektrostal is known for its prestigious schools and universities, offering a wide range of academic programs to students.

Committed to cultural preservation.

The city values its cultural heritage and takes active steps to preserve and promote traditional customs, crafts, and arts.

Hosts an annual International Film Festival.

The Elektrostal International Film Festival attracts filmmakers and cinema enthusiasts from around the world, showcasing a diverse range of films.

Encourages entrepreneurship and innovation.

Elektrostal supports aspiring entrepreneurs and fosters a culture of innovation, providing opportunities for startups and business development.

Offers a range of housing options.

Elektrostal provides diverse housing options, including apartments, houses, and residential complexes, catering to different lifestyles and budgets.

Home to notable sports teams.

Elektrostal is proud of its sports legacy, with several successful sports teams competing at regional and national levels.

Boasts a vibrant nightlife scene.

Residents and visitors can enjoy a lively nightlife in Elektrostal, with numerous bars, clubs, and entertainment venues.

Promotes cultural exchange and international relations.

Elektrostal actively engages in international partnerships, cultural exchanges, and diplomatic collaborations to foster global connections.

Surrounded by beautiful nature reserves.

Nearby nature reserves, such as the Barybino Forest and Luchinskoye Lake, offer opportunities for nature enthusiasts to explore and appreciate the region’s biodiversity.

Commemorates historical events.

The city pays tribute to significant historical events through memorials, monuments, and exhibitions, ensuring the preservation of collective memory.

Promotes sports and youth development.

Elektrostal invests in sports infrastructure and programs to encourage youth participation, health, and physical fitness.

Hosts annual cultural and artistic festivals.

Throughout the year, Elektrostal celebrates its cultural diversity through festivals dedicated to music, dance, art, and theater.

Provides a picturesque landscape for photography enthusiasts.

The city’s scenic beauty, architectural landmarks, and natural surroundings make it a paradise for photographers.

Connects to Moscow via a direct train line.

The convenient train connection between Elektrostal and Moscow makes commuting between the two cities effortless.

A city with a bright future.

Elektrostal continues to grow and develop, aiming to become a model city in terms of infrastructure, sustainability, and quality of life for its residents.

In conclusion, Elektrostal is a fascinating city with a rich history and a vibrant present. From its origins as a center of steel production to its modern-day status as a hub for education and industry, Elektrostal has plenty to offer both residents and visitors. With its beautiful parks, cultural attractions, and proximity to Moscow, there is no shortage of things to see and do in this dynamic city. Whether you’re interested in exploring its historical landmarks, enjoying outdoor activities, or immersing yourself in the local culture, Elektrostal has something for everyone. So, next time you find yourself in the Moscow region, don’t miss the opportunity to discover the hidden gems of Elektrostal.

Q: What is the population of Elektrostal?

A: As of the latest data, the population of Elektrostal is approximately XXXX.

Q: How far is Elektrostal from Moscow?

A: Elektrostal is located approximately XX kilometers away from Moscow.

Q: Are there any famous landmarks in Elektrostal?

A: Yes, Elektrostal is home to several notable landmarks, including XXXX and XXXX.

Q: What industries are prominent in Elektrostal?

A: Elektrostal is known for its steel production industry and is also a center for engineering and manufacturing.

Q: Are there any universities or educational institutions in Elektrostal?

A: Yes, Elektrostal is home to XXXX University and several other educational institutions.

Q: What are some popular outdoor activities in Elektrostal?

A: Elektrostal offers several outdoor activities, such as hiking, cycling, and picnicking in its beautiful parks.

Q: Is Elektrostal well-connected in terms of transportation?

A: Yes, Elektrostal has good transportation links, including trains and buses, making it easily accessible from nearby cities.

Q: Are there any annual events or festivals in Elektrostal?

A: Yes, Elektrostal hosts various events and festivals throughout the year, including XXXX and XXXX.

Elektrostal's fascinating history, vibrant culture, and promising future make it a city worth exploring. For more captivating facts about cities around the world, discover the unique characteristics that define each city . Uncover the hidden gems of Moscow Oblast through our in-depth look at Kolomna. Lastly, dive into the rich industrial heritage of Teesside, a thriving industrial center with its own story to tell.

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