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Interpreting the Flexibilities Under the TRIPS Agreement

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• Carlos M. Correa 3  

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

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1 introduction.

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

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

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

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

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

2 Defining the TRIPS Flexibilities

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

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

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

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

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

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

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

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

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

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

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

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

Box 1 Public health-related TRIPS flexibilities

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

3 TRIPS Flexibilities in WTO Jurisprudence

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

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

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

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

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

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

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

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

4 Interpretation of the TRIPS Agreement

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

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

4.1 Precedential Value of GATT/WTO Jurisprudence

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

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

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

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

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

4.2 Ordinary Meaning

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

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

In China—Intellectual Property Rights , the panel observed that

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

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

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

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

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

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

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

4.3 Context

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

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

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

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

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

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

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

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

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

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

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

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

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

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

4.4 Object and Purpose

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

4.4.1 Legal Weight of the Doha Declaration

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

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

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

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

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

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

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

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

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

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

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

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

5 Conclusions

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

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

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

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

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

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

Shaikh ( 2016 ).

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

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

Minn ( 2016 ).

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

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

Article 4(d) of the TRIPS Agreement.

Article 20 of the TRIPS Agreement.

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

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

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

Emphasis added.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Idem, para. 7.199.

Para 7.602.

Australia—Tobacco Plain Packaging , para. 7.100.

Idem, para. 7.2408.

Idem, para. 7.2391 and 2387.

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

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

Para. 7.19.

Para. 6.185.

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

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

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

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

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

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

Para 7.558.

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

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

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

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

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

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

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

See, para. 7.135.

See, e.g., para. 7.2398.

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

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

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

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

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

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

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

See, e.g., Danish and Aileen Kwa, op. cit.

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

Canada—Patent Protection for Pharmaceutical Products, supra note 23, para. 7.55.

See, paragraph 4 of the Doha Declaration.

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

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

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

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

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

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

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

See, United States—Section 110(5) of the U.S. Copyright Act , para. 6.55, n. 68.

Para. 7.581.

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

See, e.g., Stefan Kadelbach ( 2018 ). http://www.qil-qdi.org/international-law-commission-and-role-of-subsequent-practice-as-a-means-of-interpretation-under-articles-31-and-32-vclt/ .

United Nations ( 2018 ). https://legal.un.org/ilc/reports/2018/english/a_73_10_advance.pdf .

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

USTR Fact Sheet Summarizing Results from WTO Doha Meeting, 15 November 2001.

Gathii ( 2002 ), p. 315. https://pdfs.semanticscholar.org/a3a6/65016915476d1088fea2e7f4e97baf2f0f03.pdf .

See, e.g., Carlos Correa, op cit., 2002; Velasquez, Correa, and Ido, op. cit, 2020; UNDP ( 2015a ). https://www.undp.org/content/undp/en/home/librarypage/hiv-aids/doha10yearson.html .

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

See, e.g., Sellin ( 2015 ), pp. 445–473. https://link.springer.com/article/10.1007/s40802-015-0047-5 .

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The Breeding Exception to Patent Rights: Analysis of Compliance with Article 30 of the TRIPS Agreement

(1) Max Planck Institute for Innovation and Competition, Munich, Germany   This following sections aim at examining in detail article 30 of the TRIPS Agreement in order to assess whether the breeding exception might be deemed permissible. The importance of this analysis stems from the applicability of TRIPS in a large number of countries. 1 Whenever these countries decide to exempt particular activities from patent infringement, they should conform their laws with TRIPS provisions. In this respect, article 30 is designed to provide specific guidance since it explicitly provides for exceptions to patent rights. This article requires states to allow for exceptions to patent rights only when they are limited , do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner , taking account of the legitimate interests of third parties. Obviously, this formulation does not proffer a clear guidance. The language used in delineating the conditions under which an exception is permissible appears as a compromise to accommodate the diverging interests of WTO countries. Therefore, interpretation is required in order to concretize its meaning. The following paragraphs will first offer a brief explanation of interpretation issues in the WTO and afterward clarify the meaning of article 30. The analysis will focus on the compliance of both a limited and a comprehensive breeding exception. As explained elsewhere in this study, the limited exception, already adopted in the Dutch, French, German, and Swiss patent laws, allows breeders to commercialize varieties obtained by using patented elements in their breeding processes, whereas the comprehensive exception would permit breeders to freely commercialize varieties containing patented traits. 6.1 Principles of Interpretation The interpretative task of TRIPS articles appertains to the WTO dispute settlement mechanism. 2 Article 3.2 of the DSU recites: The dispute settlement system of the WTO is a central element in providing security and predictability to the multilateral trading system. The Members recognize that it serves to preserve the rights and obligations of Members under the covered agreements, and to clarify the existing provisions of those agreements in accordance with customary rules of interpretation of public international law. Recommendations and rulings of the DSB cannot add to or diminish the rights and obligations provided in the covered agreements. This article recognizes the role of the dispute settlement mechanism in clarifying TRIPS provisions. 3 Clarification of provisions necessitates interpretation of the text in order to arrive at a determinate meaning. A clear and precise meaning creates legal certainty and thus, provides for ‘security and predictability to the multilateral trading system’. By virtue of this requirement, the dispute settlement body cannot create new rights and obligations other than those provided in TRIPS. This means that interpretation operates within the limits provided by the agreement itself. As indicated in the above provision, this process is guided by the customary rules of interpretation of public international law. The customary rules of interpretation comprise a set of codified and non codified principles. 4 Codified principles are found in articles 31 and 32 of the Vienna Convention on the Law of Treaties (VCLT). Article 31 sets general rules of interpretation. Its first paragraph recognizes the principle of good faith in treaty interpretation. This principle aims at ensuring a balanced interpretation of the treaty terms in order to avoid unfair advantages of one party over another. 5 The same paragraph requires the interpreter to give to the terms their ordinary meaning in their context and in the light of treaty’s object and purpose. This necessitates both a textual and a teleological interpretation. Indeed, the purpose and the object of the treaty have an instrumental role in interpretation since their ‘use never exclusively determines the meaning of a treaty’. 6 Therefore, their role has to be assessed together with the context. The second paragraph clarifies that the context comprises the text, its preamble, and annexes; any agreement between parties in connection with the conclusion of the treaty; and any instrument made by at least one party in connection with the conclusion of the treaty and accepted by others as an instrument related to the treaty. This provision allows the interpreter to take account of every element that might shed light on the context. Additionally, paragraph 3 of the same article expands the interpretative scope by referring to subsequent agreements between parties, subsequent practices related to treaty interpretation, and relevant rules of international law applicable between parties. 7 This means that the interpreter should consider any additional element relevant for the interpretation of the terms of the treaty. If the application of these instruments leaves the meaning ‘ambiguous or obscure; or it leads to a result which is manifestly absurd or unreasonable’, article 32 suggests to apply supplementary means of interpretation, including the preparatory work of the treaty and the circumstances of its conclusion. Besides these codified principles of interpretation, other non codified principles play a role in treaty interpretation. 8 Among them, the principle of effectiveness developed under WTO judgments is the most important. 9 This principle requires the interpreter to ensure the integrity of the text of the treaty by opting for a reading that enables the realization of the purposes of the treaty to the highest extent possible. Effectiveness of interpretation helps to keep focus on a coherent interpretation. The above described interpretative principles guide WTO panels to give a determinate meaning to a term. In terms of article 30 of TRIPS, the interpretative function of the panels becomes relevant whenever a member state challenges another state’s measure adopted under article 30. 6.2 The Interpretation of Article 30 in the EC-Canada Case 10 Since TRIPS has entered into force, only one WTO panel has addressed the issue of interpretation of article 30 while examining the EC-Canada case. Following a complaint of the EC and its Member states in 1998, the panel analyzed the compliance of section 55.2 (1) and (2) of the Canadian Patent Act. Section 55.2 (1) concerns the regulatory review exception or the so-called Bolar exception, while section 55.2 (2) is referred to as the stockpiling exception. The Bolar exception, firstly established in US law, allows pharmaceutical firms to start the necessary studies, tests, and trials before the patent expires, in order to obtain regulatory approval. 11 The stockpiling exception was subject to the successful implementation of regulatory requirements. Afterward, competitor firms could start manufacturing and stockpiling of patented goods in the 6 months preceding patent expiry. The rationale of this exception was that of permitting competitors to place their products into the market immediately after patent expiry. The WTO panel rejected this second exception, but upheld the compliance of the Bolar exception. In its reasoning, the panel refers to articles 31 and 32 of the Vienna Convention on the Law of Treaties. While applying these articles, the panel recalls the objectives and principles of TRIPS, its preamble and preparatory works, and the preparatory works of the Berne Convention. The interpretative outcome of the panel on article 30 can be deemed quite limited since it did not clearly specify the meaning and the content of each step, but provided a general argumentation instead. Several aspects of this approach have been questioned in respect to each step. 12 Here it is worth mentioning that the panel’s reasoning has been mostly criticized for neglecting the specificities of national innovation systems. 13 An additional remark is addressed to the failure to take account of TRIPS principles and objectives. 14 These comments suggest that the panel’s viewpoint might refrain countries from adopting flexible solutions for their differing and evolving socio-economic systems. 15 Despite these controversial aspects, the panel’s report might offer some guidance for countries which need to assess the compliance of their exceptions with the TRIPS Agreement. 16 The panel, indeed, offered some useful indications on the meaning of the terms of article 30. In specific, it affirmed that the conditions of article 30 should be cumulatively satisfied. 17 In order to better understand the analysis of these conditions in the context of the breeding exception, the panel’s interpretation will be proffered in the following paragraphs. 6.3 A Limited Breeding Exception Under Article 30 The aim of this section is to explain the wording of article 30 and in addition, analyze the compliance of the breeding exception in light of the panel’s findings. It should be noted that the compliance analysis mainly builds upon the findings of the WTO panel in spite of the fact that it does not create a binding precedent for future decisions. 18 This choice is based on the assumption that the panel’s report reflects the political will of WTO dispute settlement body to adopt exceptions to patent rights. Therefore, an elaborated analysis of articles 31 and 32 of the VLCT will be purposely omitted. Nevertheless, relevant principles of interpretation, such as the objectives and principles of TRIPS will be taken into consideration whenever it is necessary for the purpose of the analysis. 6.3.1 First Condition: Limited Exception In the panel’s view, a ‘limited exception’ is an exception that makes only a small diminution of the rights of the patent holder under article 28 of TRIPS. 19 The panel explicitly indicated that the legal text should be read literally, focusing on the extent to which legal rights have been restricted. Considerations such as the degree of the economic impact or the number of the curtailed rights were explicitly excluded with respect to the ‘limited exception’ requirement (para. 7.31). Only the level of impairment caused to patent rights in legal terms was deemed relevant for determining the ‘narrowness’ of patent exceptions. 20 The term ‘limited’, however, may lend itself to a vague interpretation. Dictionaries may help us to further shed light on the term. 21 Although ‘limited’ may have several definitions, the one that indicates a restriction on ‘size, amount or extent’ 22 seems to be the most appropriate in this context. The online Merriam Webster dictionary further clarifies this term by offering an understanding of ‘limited’ as ‘confined within limits’. 23 This last definition better helps us to comprehend scholars’ interpretation of ‘limited exceptions’. Prof. Correa, for example, argues that exceptions are limited when their boundaries are specifically set. In his view, boundaries can be defined by the purpose of the exception (research exception), the purpose of the use (private or commercial), the acts involved (importation, exportation) etc. 24 In terms of the issue at hand, the rights of the patent holder should be first identified in order to assess the ‘narrowness’ of the breeding exception. The TRIPS Agreement lists patentees’ rights in its article 28. The first part of paragraph one provides for rights on patented products. 25 It allows the patentee to exclude third parties from making, using, offering for sale, selling, or importing patented products without his consent. In this respect, the breeding exception curtails the right of the patentee to authorize the use of protected products. The second paragraph of the same article grants to patent holders the ‘right to assign, or transfer by succession, the patent and to conclude licensing contracts’. The breeding exception does not limit these rights, but it might limit the revenues accruing from the exercise of such rights. Based on the panel’s argumentation, the issue here is the extent of the curtailment, not the number of rights and their economic impact. Thus, the limited breeding exception does not impair the right of the patentee to commercialize or license its products for commercial goals. This means that it is confined only to ‘breeding’ purposes. Further commercialization of varieties bred with patented elements necessarily requires the consent of the patent holder. The limits posed by the breeding exception can be further qualified by the acts involved: ‘breeding’ and ‘discovering or developing’ a new variety. The first activity refers to the process of changing the genetic of plants by crossing and selecting, or using new techniques to obtain improved varieties, while the second contemplates those situations when one simply ‘finds’ a deviant plant in a variety. For example, a deviant plant may differ in color but retain all the other characteristics of the variety. The change of color is due to genetic mutations normally occurring in nature. The breeding exception, thus, authorizes breeders to use the discovered mutant for further developing a new plant variety. Whoever makes use of patented genetic material in order to carry out the above described activities falls under the breeding exception. The ‘limited’ nature of the breeding exception may, however, be arguable when it is employed by companies for breeding varieties that are subsequently commercialized in the market. The use of the patented material in this case is limited to breeding activities, but the original intent of these activities is the commercialization of the final products. The free use and exploitation of patented biological material permits breeders to better identify the economic value and potential markets for their new varieties. In this way, they can create actual or potential competitive products. In this regard, the panel recalled that the analysis of the first step should focus only on the legal effects of the patent exceptions. Therefore, the above economic considerations should be ignored. Even if we take the commercial intent into consideration, a limited breeding exception allows only for a ‘breeding’ use. Further commercialization of varieties would require an explicit authorization from the patent holder. Therefore, based on an understanding of ‘limited’ as proffered by the panel, the dictionary, and scholars’ proposals, the breeding exception should be deemed a limited exception since its boundaries are specifically set by breeding purposes and the acts involved. 6.3.2 Second Condition: Not Unreasonably Conflict with a Normal Exploitation of the Patent The interpretation of this condition firstly requires an assessment of the term ‘normal exploitation’. If the exception is found to be conflicting with the ‘normal exploitation’ of the patent, the further examination of ‘unreasonableness’ would be necessary. 26 The panel explained ‘normal exploitation’ but did not offer any indication on the meaning of the term ‘unreasonably’ since it found that the exceptions of Canadian patent law were not in conflict with the normal exploitation of the patent. In the Panel’s view, ‘normal exploitation’ combines an empirical approach about ‘what is common within a relevant community’ with a normative understanding of what is accepted by community’s values. The panel did not further clarify these concepts, but we may find some guidance in the literature. Senftleben, for example, sustains that exploitation is common within a relevant community if most patent owners use this area to extract value from their patents. If this type of exploitation is also essential to the achievement of goals of patent policy, then the exploitation should be considered as normal. 27 In addition, the panel argued that ‘the normal practice of exploitation by patent owners, as with owners of any other intellectual property right, is to exclude all forms of competition that could detract significantly from the economic returns anticipated from a patent’s grant of exclusivity’. 28 As Prof. Correa notes, the normal exploitation of patent rights consists of ‘the acts of making, using or commercializing the inventions without third parties’ competition.’ This means that the exclusion of competition is not a form of exploitation of the patent, ‘but a legal power established by law that may be exercised or not.’ 29 Prof. Correa further questions the exclusion of ‘all forms of competition’ since improved patented products may legitimately compete with the original ones. In terms of the issue at hand, this reasoning can be better understood by referring to the concept of essentially derived varieties (EDVs) explained in Chap. 4 . UPOV 1991 requires a minimum genetic distance between EDVs and the original variety in order to grant protection to EDVs. The distinction between original varieties and EDVs is therefore based on genetic differences. When the genetic differences 30 satisfy the requirements set by UPOV, the improved variety (EDV) legitimately competes with the original one. Patent rights, on the other hand, may exclude improved products from competition. This is because the scope of patent rights often covers all material where the patented element is incorporated or where it performs its function. With regard to plant breeding, patent rights extend to all those varieties that contain a patented genetic construct. Patented biological material may be used (and crossed out in the breeding process) for creating varieties with different traits from the patented material. In this case, the new variety does not enter into direct competition with the first innovator. The commercialization of these improved varieties would foster two main objectives of competition law: consumer welfare and the opportunity of breeders to legitimately compete in the market. Undoubtedly, new and improved varieties increase consumer welfare. The opportunity to compete in the plant breeding market is equally relevant since competition motivates breeders to invest in plant variety creation. This reasoning implies that excluding all forms of competition from ‘normal exploitation’ does not respond to the rationale of patent law to foster innovation and diffusion of knowledge. In the panel’s view, however, ‘normal exploitation’ should be in line with the changing forms of competition due to technological progress and evolution of marketing practices. It is unclear whether this reasoning refers to actual or potential exploitations of patented inventions. If the latter is considered as prevalent, patent exceptions risk losing their effectiveness. As one author reasonably argues, new technical findings open up new possibilities for exploiting the patented invention. 31 It is opinion of the author of this book that only the profit derived from the actual application of patents as ordinarily employed by patent holders, should qualify as ‘normal’. An ordinary use of patents involves acts such as, making, using, selling, offering for sale, importing and licensing patented products. 32 The interpretation issue here is whether the breeding exception conflicts with the normal understanding of such exploitation. Building upon Senftleben’s reasoning, it is argued that exploitation is common within a relevant community if most patent owners use this area to extract value from their patents. If this type of exploitation is also essential to the achievement of goals of patent policy, then the exploitation should be considered as normal. Thus, the following paragraphs first look at how inventors generate profits and then assess the public policy pursued by national laws. With regard to the empirical element, the normal practice of deriving value from patent rights is that of selling patented products or rights, or licensing patent rights. The breeding exception does not detract the profits obtained by commercializing patented products, but it diminishes the profits that patentees might obtain by licensing their rights for breeding purposes. Here the matter is that of defining if profit detraction is significant so as to impede investments on innovative products. Considering that patentees maintain the right to commercial licensing, they might increase the licensing fee and still capture a high profit if this is deemed necessary for recouping the incurred R&D costs. Hence there is no reason to see the breeding exception as a significant detractor of patentee’s profit. With regard to the normative aspect, the goals of national patent policies come under scrutiny. Dutch, German, French, and Swiss laws grant a temporal right of 20 years to exclude competitors, but at the same time they establish maintenance fees for patents. 33 When fees are not paid, patent protection lapses. As a consequence, protected knowledge becomes publicly accessible before the expiry term. This reasoning seems to recognize the fact that patents are a cost on the society. Indeed, studies have shown that not all patents make it through their entire term. In Germany, for example, the average patent life is less than 8 years. 34 Moreover, if the patentee declares his willingness to grant licenses, maintenance fees are halved in Germany. Considering that licenses allow other parties to improve the original invention, this provision shows the intention of the German legislator to promote follow-on innovations. All these considerations indicate that the public policy goal followed by the concerned countries is that of enabling follow-on innovations. An exception to patent rights for breeding purposes fully supports this objective. In the EC-Canada case, the panel also clarified whether the market exclusivity following the expiry of a patent was ‘normal’. Adopting a flexible approach, the panel stated that: Some of the basic rights granted to all patent owners, and routinely exercised by all patent owners, will typically produce a certain period of market exclusivity after the expiration of a patent. For example, the separate right to prevent ‘making’ the patented product during the term of the patent often prevents competitors from building an inventory needed to enter the market immediately upon expiration of a patent. There is nothing abnormal about that more or less brief period of market exclusivity after the patent has expired. 35 The interpretation of ‘more or less brief’ further complicates drawing a clear line between ‘normal’ and ‘abnormal’. The panel, however, neglected the definition of the relevant ‘normal’ period. It solved this problem by determining that the additional period of de facto market exclusivity is: an unintended consequence of the conjunction of the patent laws with product regulatory laws, where the combination of patent rights with the time demands of the regulatory process gives a greater than normal period of market exclusivity to the enforcement of certain patent rights. 36 This greater period of protection was considered to be not normally employed by most patent owners. An accurate examination of the breeding exception further requires an investigation of the erosion of patentee’s market exclusivity. Patent holders enjoy de jure market exclusivity during the 20 years of the patent term and a de facto exclusivity after patent expiry. We can define the period of de facto exclusivity by looking at the development time of plant varieties. Breeding is a lengthy process that may take from 7 to 15 years. 37 This means that in absence of a breeding exception, the de facto market exclusivity may range from 27 to 35 years. The exclusive protection is further extended in case of varieties containing or resulting from genetically modified organisms. Commercializing new genetically modified varieties may take several years since an assessment of compliance with biosafety regulations is required under national and international regulations. 38 This procedure can significantly delay the entry of plant varieties in the market. In this case, the ex post monopoly may exceed 20 years by doubling the normal patent life. In terms of the issue at hand, it is worth drawing the attention of the reader to the fact that the first patentee faces the same hurdles. Long regulatory approvals reduce his market exclusivity. If competitors put varieties containing the patented element into the market, patent exclusivity could be even more significantly limited. The problem, however, might emerge only when competitors commercialize varieties containing patented elements that significantly deprive patent holders from recouping the initial R&D costs. 39 R&D investments may be recovered by selling the products and licensing. But depending on the market conditions (free entry, high competition), products sales and licensing fees might not be sufficient for compensating R&D costs. Economic theory considers the recoup of R&D costs as a basic element for the patents to work as an incentive for innovations. 40 In this view, optimal patent term should be long enough to compensate the innovator for the R&D expenditures. But the definition of the optimal length is still an open question. 41 The optimal patent term might vary for different technological sectors and for different type of patents (processes or products). Hence it is difficult to assess whether the introduction of the breeding exception will undermine the returns on R&D. Some innovations might require a patent term of 5 years, others 10, 15 or 20 years, while others might not necessitate patents to recoup the initial R&D investments (e.g. the lead-time gained by the innovator may be sufficient, as it is often the case). 42 If patents were not relevant for recovering R&D costs for some innovations, the deadweight loss for the society would be significant. The society would not have access to new information and follow-on innovators would not be able to build upon the patented invention. In this case, the breeding exception would compensate some of the negative effects of these types of patents. The same logic applies in cases where the patent term is longer than the term required to recoup R&D investments. Problematic aspects will arise when a 20-years patent term will be necessary for recovering the initial investments. If this were the case, biotechnological companies would speak up against the breeding exception. To the author’s knowledge, this has not yet happened. Ten years have passed since the first breeder’s exception was adopted by the French parliament in 2004. If the exception had had significantly deprived patent holders from recouping the initial R&D costs, concerns would had already been voiced by biotechnological companies. Therefore, introducing an exception to patent rights might not necessarily undermine the incentive to invent. 43 6.3.3 Third Condition: Not Unreasonably Prejudice the Legitimate Interests of the Patent Owner, Taking Account of the Legitimate Interests of the Third Parties In order to determine whether the exception prejudices the interests of patent owners and third parties, it is first important to clarify the meaning of ‘legitimate interests’. In order to take account of interests of both parties—those of right holders and third parties—the panel adopted a broad interpretation of ‘legitimate interest’. 44 It dismissed the European Communities’ understanding of ‘legitimate interests’ as strictly defined within the legal meaning of article 28.1 of TRIPS. The WTO judges stated that this term ‘must be defined in the way that it is often used in legal discourse – as a normative claim calling for protection of interests that are ‘justifiable’ in the sense that they are supported by relevant public policies or other social norms’. For illustrative purposes, the panel brought the attention to the experimental use exception already established in most of national patent laws. In this respect, it argued that the absence of such an exception would frustrate part of the nature that the invention be disclosed to the public. Disclosing patented knowledge for further supporting the advance of science and technology is considered to be a ‘legitimate interest’ of both society and the scientists. 45 Third parties, indeed, are parties who do not have a legal claim with respect to the patented invention. Only a broad interpretation of ‘legitimate interests’ allows us to take their interests into consideration. 6.3.3.1 The Legitimate Interests of Patent Owners Although the main concern of patentees is profit maximization, the recoup of R&D costs seems to be a legitimate interest. According to utilitarian theory and some empirical studies, recouping R&D costs is essential for firms in order to preserve the economic incentive to innovate. 46 If this were not possible, firms would face great financial losses. Consequently, inventions may be impeded from coming into the market. The breeding exception, thus, should permit patent holders to recover R&D expenses. The difficulty of proving a direct correlation between patents and R&D decisions, however, does not allow drawing definite conclusions. Empirical studies have shown that the effect of patents on R&D decisions vary across industries and countries. 47 Moreover, a study of 26 OECD countries showed that patent rights are fragile determinants of R&D decisions. 48 As the head IP of Syngenta—Michael Kock—notes, it is not clear whether patents directly provide an incentive to invest into yield or yield is caused by an increased use of technology, which causes a higher use of patents. Nevertheless, the role of patents in biotechnological innovation is deemed to be important. 49 But modern economists believe that weakening patent rights is not necessarily counterproductive. Evidence suggests that patent rights are not very important as a prerequisite for R&D. 50 Moreover, in the long run, patents increase returns, but make follow-on innovations more costly. 51 This means that patents increase returns for the first innovator but create barriers for follow-on innovators who need to access patented inventions. In the first case patents might increase the incentives for R&D investments, whereas in the second they might decrease the willingness to invest in R&D. In light of these considerations, the introduction of a breeding exception might appear as a measure to facilitate innovations in plant breeding. The breeding exception, indeed, allows breeders to invent around the patented element, use the patented element and its genetic background to create new varieties. Undoubtedly, this deprives patentees from obtaining a profit from ex ante licensing. But profit-making is not the objective pursued by patent law. Patents are a tool to incentivize innovations. As such, they should be used in line with the public policy of facilitating plant breeding innovations. The above argumentation is further supported by the findings of an ad hoc qualitative field research undertaken between December 2012 and February 2013. The aim of this qualitative research was to understand whether the introduction of the breeding exception is detrimental to innovation. The investigation was organized in the form of semi-structured in-depth interviews with stakeholders in the plant breeding sector representing private companies and industry associations in Germany, the Netherlands, and Switzerland. In the Netherlands, interviews also included relevant professional figures in the breeding sector. 52 The central result of this investigation is that the breeding exception seems to play no role on the R&D decisions of biotechnological companies. Industry representatives have no data on the innovativeness effect of its introduction, but they don’t see it as a deterrent for R&D. One of the interviewees affirmed that the innovativeness of biotech companies operating in France, Germany, and Switzerland was not affected by the breeding exception. Although biotechnological companies point out that the breeding exception reduces a portion of their profits, they accept its introduction in order to enlarge the genetic background and further plant breeding. Some companies (KWS, for example) believe that the breeding exception drives innovation, whereas others (Syngenta) claim that the rationale of this exception is that of avoiding the problem of accessing genetic material rather than fostering innovation. On the other hand, plant breeders of major food crops make wide use of this exception and consider it essential for plant breeding innovations. 53 Most importantly, business firms themselves have no objections to the introduction of the breeding exception. Both small and big companies consider the breeding exception as an important means to access genetic material. Although they are aware that the introduction of a breeding exception to patent rights reduces their profits, they do not see it as a hindrance for innovation activities. Thus, the breeding exception does not prejudice the rights of patent holders. 6.3.3.2 The Legitimate Interests of Third Parties Third parties are those that have a direct or indirect interest in plant breeding. According to the panel, a legal relation with the patentee is not necessary. Therefore, follow-on innovators (plant breeders, public breeding institutions, research centers, universities) and the society at large (governments, consumers) should all be considered as interested third parties. 54 The relevance of their interests stems from the significance of plant breeding for the whole society. International agreements, such as the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) and the Convention on Biological Diversity (CBD) offer further evidence of the importance of societal interests. 55 One of the aims of the ITPGRFA and the CBD, for example, is to provide access to plant genetic resources. 56 By allowing breeders to freely access and improve patented genetic material, the breeding exception is instrumental for realizing the goals of the above treaties. In addition, the introduction of a breeding exception to patent rights could lower what is now a high entry barrier for new companies wishing to enter the plant breeding sector. This would stimulate innovation and competition in plant breeding and society as a whole would benefit. Studies, indeed, have shown that patent amendments that facilitate entry and encourage competition might be an effective mechanism to encourage innovation. 57 6.3.4 The Non-discrimination Clause of Article 27.1 In addition to article 30, the panel argued in the EC-Canada case, that patent exceptions are TRIPS-compliant when they satisfy the non-discrimination clause of article 27.1. Thus, the breeding exception is TRIPS-compliant when it does not discriminate ‘as to the place of invention, the field of technology and whether products are imported or locally produced’. Considering that the breeding exception is specifically conceived for the plant breeding industry, it seems plausible to raise a conflict with the non-discrimination clause. The use of ‘biological material’ for plant breeding, in particular, may discriminate against other industrial sectors. ‘Biological material’ involves the use of plant material as well as additional material such as bacteria, viruses etc. 58 These types of materials are used in other industries as well (for example, some bacteria used to produce antibiotics can be used in plant breeding). An explicit use of such material for the purpose of creating other plant innovations may create discrimination with regard to other sectors such as pharmaceuticals and biofuels. The first question to ask in this regard is that of the meaning of ‘non-discrimination’. Given the broadness of the term, the panel explicitly refrained from giving a definition, 59 but it distinguished between de jure and de facto discrimination. With regard to the de jure discrimination, it examined whether the patent exception was legally available to every product that was subject to marketing approval requirements. 60 In the case of de facto discrimination, it explained that it occurs when the actual effect of the norm is to impose differentially disadvantageous consequences on certain parties, and because those differential effects are found to be wrong or unjustifiable. 61 Additionally, the panel clarified that the word ‘discrimination’ is to be distinguished from ‘differentiation’ and that the WTO Members can adopt different rules for particular product areas, provided that the differences are adopted for bona fide purposes. 62 Third parties in the proceeding also suggested that not all differential treatment is ‘discrimination’. 63 It appears, thus, that a key issue for understanding the meaning of ‘discrimination’ is defining the term ‘differentiation’. The terms used by the panel ‘differentially disadvantageous consequences’ which are ‘wrong or unjustifiable’ are important in order to distinguish ‘discrimination’ from ‘differentiation’. The above terms denote a value of judgment about the consequences of the exception. Thus, ‘discrimination’ arises whenever it produces unjustifiable negative effects. ‘Differentiation’, on the other hand, seems to have a neutral meaning because it simply refers to the act of recognizing or ascertaining differences. Dictionaries, for example, always relate one of the definitions of ‘discrimination’ with prejudice, but suggest no similar connection with regard to ‘differentiation’. 64 This suggests that ‘discrimination’ arises when there is ‘differentiation’ without justification. In terms of the issue at hand, the question to be posed is whether there is a justification for a differential treatment of the plant breeding sector. To this purpose, article 27.1 itself can help us to shed light on the issue. The second sentence of article 27.1 restricts the applicability of the non-discrimination clause to the provisions of paragraph 3. In the context of the breeding exception, the second sentence of paragraph 3.b is extremely relevant. Here, TRIPS allows for patents or a sui generis 65 system or a combination thereof for the protection of plant varieties. This paragraph seems to be designed for the plant breeding industry. Taking into account the characteristics of plant breeding, TRIPS recognizes the peculiarities in the economic development of countries in this sector and provides for a special protection. Therefore, the justification for differentiating the plant breeding sector can be found in the body of TRIPS. To further support the reasoning of the panel, the exception should be issued on good purposes. Thus, the question becomes whether the breeding exception is a bona fide exception that deals with problems that may exist in plant breeding. 66 The answer is affirmative. As already explained in the beginning of this chapter, the very purpose of the breeding exception is that of overcoming the difficulties of accessing patent material relevant for plant breeding purposes. The need to overcome this problem is particularly compelling given the crucial role of plant breeding in food supply. However, questions may arise as to the extent to which bona fide may justify exceptions to patent rights. Some guidelines can be found in the Doha Declaration on the TRIPS Agreement and Public Health which advises a differential treatment for public health-related patents. 67 The rationale of this special treatment is linked to the importance of health for human life. This choice can be better understood if we keep in mind that law is an instrument at the service of our society and it could never take precedence over basic principles that protect human life. Therefore, superior principles that guide the adoption of the law should motivate the bona fide of patent exceptions. The same logic can be applied in plant breeding. Given the renowned importance of these activities in food security, it appears reasonable to differentiate in the treatment of patent rights in the plant breeding sector. In order to better comprehend the role of plant breeding in this regard, it appears necessary to clarify the concept of food security. ‘Food security’ was first coined during the 1996 World Food Summit. It was explicitly stated that ‘food security exists when all people, at all times, have physical and economic access to sufficient, safe and nutritious food that meets their dietary needs and food preferences for an active and healthy life.’ It is widely accepted that this concept of ‘food security’ involves four dimensions: food availability, food access, utilization, and stability. 68 Plant breeding plays a direct or indirect role in all of these dimensions. With regard to food availability and stability, it ensures the basis for sufficient quantities of food resources at all times. A sufficient quantity of food indirectly facilitates access and utilization of food. Undoubtedly, the full realization of these dimensions of food security requires an adequate socio-economic environment. 69 But the role of the breeding exception should not be underestimated. The breeding exception can represent an important legal instrument for implementing the policy concept of food security. The importance of the exception is inherent in its capacity of providing a constant and sufficient source of food supply. This role of the breeding exception is particularly relevant given the interdependence of countries on genetic resources for food and agriculture (GRFA). Climate change is envisaged as a decisive factor in increasing countries’ interdependence on GRFA. Local self-sufficiency might not be possible in view of climate changes impact on the suitability of currently adapted landraces and varieties. 70 Therefore, the breeding exception plays a crucial role in realizing the abovementioned dimensions of food security in the present and in the future. The role of the exception in the future is inevitably linked to the concept of ‘intergenerational equity’ explained in Chap. 3 of this study. A comprehensive approach to ‘intergenerational equity’ should take account of the breeding exception as a means for achieving food security. Turning to the analysis of article 27.1, it should be further noted that the option to combine patent protection with a sui generis system opens up opportunities for countries to adapt the patent regime to their specific needs of food security. 71 As already illustrated in Chap. 4 of this study, some Asian countries have adopted plant variety protection regimes that differ from UPOV. The Indian legislation, for example, provides for specific rights for farmers. In this case, the combination of patent rights with the Indian sui generis regime might support the introduction of other amendments to patent law that allow farmers to save, use, exchange and sell farm saved seed. A similar provision is foreseen under article 11 of the EU directive on the legal protection of biotechnological inventions, which combines patent rights with the farmers’ privilege envisaged in article 15.2 of the UPOV. 6.3.5 The Reasonableness Test The last two conditions of article 30 require the interpreter to assess whether the breeding exception is reasonable if it were found in conflict with the normal exploitation of the patent or with the legitimate interests of the patent holder and the interests of third parties. The panel did not offer any indication on the meaning of this requirement since it found that the Bolar exception was not in conflict with the requirements of article 30. 72 The literature suggests that a conflictual exception is reasonable when it is proportionate to the objective that it intends to achieve. 73 The achievement of such an objective should produce social benefits capable of overcoming the harm to patentees and third parties’ interests. For example, providing more innovative plant varieties creates social benefits that go beyond the economic loss of all economic actors. With these important considerations in mind, this chapter elaborates a broader legal framework for analyzing ‘reasonable exceptions’. It first starts with a textual interpretation based on a literal reading of terms. The Oxford dictionary defines ‘reasonable’ as ‘having sound judgment; fair and sensible’; ‘not as much as is appropriate or fair; moderate’. In these terms, a reasonable exception is the one that is fair and appropriate, that does not excessively impair the rights of the patent holder. Applying these general terms to the breeding exception is, however, not an easy task. It requires a judgment of balance based on TRIPS goals and principles. The preamble of TRIPS gives indication of these goals and principles, which further serve as a source of interpretation. 74 The fifth paragraph of the preamble, for instance, recognizes ‘the underlying public policy objectives of national systems for the protection of intellectual property, including developmental and technological objectives’. This paragraph has been incorporated in articles 7 and 8 of the TRIPS Agreement. Article 7, jointly with article 8 and the preamble are considered of particular importance for interpreting the rights enshrined in the body of TRIPS. 75 In addition, the panel in the EC-Canada case, affirmed that ‘both the goals and limitations stated in articles 7 and 8.1 must obviously be borne in mind when doing so as well as those of other provisions of the TRIPS Agreement which indicate its object and purposes’. 76 An understanding of ‘reasonable exceptions’, therefore, should take these articles into consideration. In addition, article 1.1 which allows WTO Members to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice is relevant. Article 1.1 provides some flexibility for complying with the obligations stemming from TRIPS. The qualification of a ‘reasonable’ or ‘unreasonable’ measure would, thus, require an investigation of ‘the conceptual framework that underpins the granting of patents in a given jurisdiction and at a certain point in time’. 77 This necessitates a weighing of different interests involved in the light of the proportionality principle. The limit that a ‘reasonable’ exception should face in this respect is its scope. 78 Only exceptions that restrict patent rights as much as necessary as to achieve their objectives may be admissible. The following paragraphs will deepen these considerations in relation to the breeding exception. If the breeding exception satisfies the requirements of the above provisions, it will be deemed a ‘reasonable’ measure even if it conflicts with the normal exploitation of the patent. Article 7 (Objectives) The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. Although the vague language of this article reflects developing countries’ concerns about the impact of IPRs on their economic and social development, it may serve as a fertile ground for identifying its role in several areas. One role of article 7, for example, may be that of facilitating the development of future exceptions and limitations. 79 The applicability of this provision on patents can be deducted from its explicit reference to ‘technology’ and ‘innovation’ on patent protection. 80 While defining the objectives of TRIPS, 81 article 7 highlights the promotion of technological innovation and the transfer and dissemination of technology as the guidelines for protecting intellectual property rights. ‘Technological innovation’ is a term broader than ‘technical invention’. The latter refers only to technical knowledge, while the former covers the whole period of R&D up to implementation, leading to commercial maturity. 82 Article 7, thus, promotes innovation beyond simple inventions. If we look at the breeding exception, we see that its main purpose is that of enabling ‘technological innovation’ by facilitating access to patented knowledge. With a breeding exception, breeders develop new products which further commercialize into the market. Besides, the breeding exception furthers the ‘transfer and dissemination of technology’ defined in general terms as availability of technical knowledge. Indeed, the breeding exception makes freely available the use of patented technical knowledge in the breeding process. If the breeding exception were not adopted, breeders would be forced to enter into long and costly licensing negotiations which would delay (or prohibit in case of license denial) the transfer and dissemination of technology. This reasoning implies an inherent economic trade-off in patent law between the interest to incentivize and ensure access to innovations. The breeding exception weakens patent rights to counterbalance the negative effects of patents on the transfer and dissemination of technology and therefore, facilitate access to innovation. The exception, on the other hand, should not undermine the incentive to invest in new technology. Indeed, article 7 of the TRIPS Agreement explicitly requires that IP protection should lead to the ‘mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations’. These broad and general terms reflect a compromise between the diverging opinions of developed and developing countries. 83 The balance of rights and obligations, therefore, should be understood in a large social context, disregarding their legal meaning. In these terms, the balance would lay in reconciling the economic interests embedded in patent rights with the moral obligation of disclosing the patented invention for the larger benefit of the society. But the ‘balance between rights and obligations’ is understood by some as relevant for promoting individual interests as well. 84 In these terms, the quest for ‘balance’ may require to strengthen the position of follow-on innovators (breeders) who build on earlier patented inventions. The term ‘balance’ has been traditionally associated to a ‘desirable equilibrium between at least two forces that is characterized by cancellation of all forces by equal opposing forces’. 85 Within this definition, the term ‘equilibrium’ as used by economists promotes ‘efficiency’ matters. This means that policymakers focus on providing the right incentives to economic actors rather than on the distributive values of the patent system. This is mainly due to the complexities and the inaptness of the present institutional design to achieve a balance through distributive decisions. Legal scholars, on the other hand, offer a more comprehensive approach of ‘balance’ that takes account of weak parties’ interests in view of development objectives. 86 The introduction of the breeding exception supports both understandings of ‘balance’. From an efficiency point of view, the exception provides incentives to newcomers to enter the plant breeding market and innovate. At the same time, it preserves the incentives to innovate of patent holders since it maintains their right to sell the protected subject matter and to grant commercial licenses, and thus, the recoup of their investment cost. In view of the development objectives perspective, the breeding exception brings about more innovation into the market by making biological material freely available. In addition, it supports the interests of ‘weak’ breeders who do not have the necessary financial resources to identify the relevant infringing patents and ask for a patent license. This undoubtedly increases the benefits for the society. A balance of rights and obligations, though, should be imposed on both parties since both patent holders and breeders can be producers and users of technological knowledge. The balance resides in the obligation of patent holders to inhibit the exercise of their rights with regard to the use of the invention for breeding activities, combined with their right to prevent the use of the invention for commercializing final breeding products. Article 8.1 (Principles) 1 . Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement. This provision does not clearly state rights and obligations, but adopts an open and all-comprehensive language. This allows a large margin of discretion for its interpretation. Commentators, indeed, argue that article 8.1 may have several interpretative functions. 87 Among these, its role in the interpretation of TRIPS is relevant for the purpose of this analysis. As already argued above, the panel stated that both the goals and the limitations of Article 8.​1 must obviously be borne in mind when interpreting the words of the conditions in art. 30. 88

WTO/GATT Research: Citing the WTO agreements

• Selected books, databases & websites
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• Status of the WTO Agreements
• Citing the WTO agreements
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• GATT and early WTO documents, 1940-2000
• WTO documents, 1995-present
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• U.S. regulations & tariff schedules
• U.S. government websites, etc.
• U.S. legislative history
• Rules, procedure, process, etc.
• Find disputes by topic, article number, etc.
• Dispute settlement reporters & citation
• Documents & submissions in dispute settlements
• Selected books about dispute settlement
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• Other research guides

Bluebook citation of the WTO Agreements

To cite a multilateral convention, Rule 21.4.5(a)(ii) of The Bluebook: A Uniform System of Citation , 20th ed., requires a U.S. source, if therein, with an optional parallel citation to a multilateral source. If neither of those can be obtained, Rule 21.4.5(c) requires a cite to I.L.M. or another unofficial source. Rule 21.11(d) has examples for some WTO and former GATT-era agreements. NOTE: Bluebook rules can change, so please check the latest edition at the time of your writing. 

The suggested citations below do not contain any U.S. treaty sources because the U.S. did not ratify the Uruguay Round agreements as treaties, but instead implemented them through legislation and administrative action. See Citing official U.S. sources . 

Instead, the citations below use U.N.T.S. and I.L.M. To locate U.N.T.S. see here and I.L.M. here . Unlike the United Nations, there is no separate GATT or WTO treaty series. In less recent publications, you may also see a citation to a WTO publication called  The Legal Texts: The Results of the Uruguay Round of Multilateral Trade Negotiations  (Cambridge, U.K.; New York, N.Y.: Cambridge University Press, [2010] 1999)  Reserve K4600.A35 R473 2010 .  

SUGGESTED CITATIONS:

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].

GATT 1994:General Agreement on Tariffs and Trade 1994, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, 1867 U.N.T.S. 187, 33 I.L.M. 1153 (1994) [hereinafter GATT 1994].

Agreement on Agriculture, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, 1867 U.N.T.S. 410. [Not reproduced in I.L.M.]

TRIMS Agreement: Agreement on Trade-Related Investment Measures, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, 1868 U.N.T.S. 186 [hereinafter TRIMS Agreement]. [Not reproduced in I.L.M.]

Agreement on Subsidies and Countervailing Measures, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, 1869 U.N.T.S. 14. [Not reproduced in I.L.M.]

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]

U.S. sources for the WTO Agreements & the GATT 1947

See Citing official U.S. sources  in this guide. 

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Southwest passengers now get a $75 voucher for big flight disruptions

Customers who are delayed for more than three hours can fill out a form online to request the voucher

Southwest Airlines has launched a new compensation fund for inconvenienced fliers, offering $75 vouchers to passengers whose flights are significantly delayed or canceled for a reason within the airline’s control.

The compensation fund is part of the airline’s $140 million settlement with the Transportation Department, following Southwest’s operational meltdown in December 2022. A mix of winter weather, holiday travel and failing Southwest scheduling systems resulted in nearly 17,000 canceled or significantly delayed flights, affecting some 2 million passengers. Southwest agreed to pay the government $35 million and create a $90 million voucher fund for future fliers affected by operational errors, on top of the some $600 million it paid out in refunds and reimbursements to customers affected by the holiday debacle.

While the original agreement terms slated the voucher program to start Tuesday, Southwest rolled out the fund April 16. Any passenger who arrives at their final destination three or more hours after the scheduled arrival time for domestic flights or six hours for international flights can request a $75 voucher. The money is available only for fliers facing issues within Southwest’s control, such as a mechanical problem or swapping planes.

To receive the money, customers can fill out a form online . The request must be submitted within one year from the delayed or canceled flight. Southwest should get back to customers within 30 days, according to Southwest spokeswoman Laura Swift. The compensation fund is expected to run for three years.

Last week, the Biden administration announced new rules for airlines to strengthen passenger protection and increase transparency in the industry. Under the new regulations, airlines are required to streamline the refund process for canceled flights and abandon hidden fees by disclosing the price of surcharges for luggage and changes to reservations upfront.

While announcing those rules, Transportation Secretary Pete Buttigieg also mentioned Southwest’s vouchers as a customer service measure that could influence other airlines.

“This is the month when those vouchers as part of the Southwest settlement kick in, and Southwest will now, because we are making them, really lead the market on that,” Buttigieg said. “It’ll be very interesting to see what other airlines respond — not as punishment, but by way of competition.”

In a statement Tuesday, DOT officials said they will be “closely monitoring” Southwest’s program, requiring the airline to submit an annual report documenting the voucher expenditures over the next three years.

Hannah Sampson contributed to this report.

More travel news

How we travel now: More people are taking booze-free trips — and airlines and hotels are taking note. Some couples are ditching the traditional honeymoon for a “buddymoon” with their pals. Interested? Here are the best tools for making a group trip work.

Bad behavior: Entitled tourists are running amok, defacing the Colosseum , getting rowdy in Bali and messing with wild animals in national parks. Some destinations are fighting back with public awareness campaigns — or just by telling out-of-control visitors to stay away .

Safety concerns: A door blew off an Alaska Airlines Boeing 737 Max 9 jet, leaving passengers traumatized — but without serious injuries. The ordeal led to widespread flight cancellations after the jet was grounded, and some travelers have taken steps to avoid the plane in the future. The incident has also sparked a fresh discussion about whether it’s safe to fly with a baby on your lap .

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At Brown, a Rare Agreement Between Administrators and Protesters

Brown students took down their tents on campus after the university in Rhode Island agreed to discuss their demands for divestment from support for the Israeli military.

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By Jacey Fortin

• April 30, 2024

As pro-Palestinian protests continued to escalate across the country, officials and students at Brown University set a rare example on Tuesday: They made a deal.

Demonstrators agreed to dismantle their encampment at Brown, which had been removed by Tuesday evening, and university leaders said they would discuss, and later vote on, divesting funds from companies connected to the Israeli military campaign in Gaza.

The agreement came even as scenes of chaos continued to overtake U.S. universities, with protesters at Columbia in New York and Portland State in Oregon occupying buildings, and demonstrators at the University of North Carolina at Chapel Hill replacing an American flag at the center of campus with a Palestinian one.

More than a thousand people have been arrested over the past two weeks after a crackdown on a pro-Palestinian encampment at Columbia in New York resulted in a cascade of student activism across the country.

At Brown, in Providence, R.I., students began pitching tents on the main campus lawn on Wednesday. Many said they would stay until they were forced out, adding that they were concerned about trying to end the violence in Gaza — not about violating university policies.

After discussions with administrators, Brown Divest Coalition, along with other pro-Palestinian organizations including Jewish Voice for Peace, said in a post on Instagram that they had reached an agreement with the university, which “would not have been possible without the hard work of university encampments across the country, whose collective power has forced university administrators to acknowledge the overwhelming support for Palestine on their campuses.”

The agreement lays out a series of steps for the months ahead:

In May, five students will meet with five members of the Corporation of Brown University to argue for divesting funds from companies connected to the Israeli military.

In September, Brown’s advisory committee on resource management will be expected to advise the university on the same issue.

In October, the committee’s recommendation will be brought to the corporation for a vote.

“Although the encampment will end, organizing to ensure that the Brown administration fulfills our calls to act on divestment will continue until the corporation vote in October,” the Brown Divest Coalition said in a statement on Tuesday.

“This feels like a real moment of realizing our collective power,” said Rafi Ash, a sophomore at Brown who participated in the protests. “This is something that demonstrates that the mobilization of the student body can force the university to listen.”

Administrators and student activists at Northwestern University struck a similar deal on Monday.

A spokesman for Brown, Brian Clark, said that divestment was not as simple as some students might perceive, though. The university doesn’t invest its endowment directly, he said. Instead, it relies on “external specialist investment managers, all with the highest level of ethics and all whom we believe share the values of the Brown community.”

Administrators said in a statement that it would still hold disciplinary proceedings related to the encampment, which broke the university’s rules. Reports of harassment and discrimination will also be investigated, the statement said.

“The devastation and loss of life in the Middle East has prompted many to call for meaningful change, while also raising real issues about how best to accomplish this,” Christina H. Paxson, Brown’s president, said in the statement, adding that she did not condone the encampment and had been concerned about inflammatory rhetoric.

“I appreciate the sincere efforts on the part of our students to take steps to prevent further escalation,” she said.

Gaya Gupta contributed reporting.

Jacey Fortin covers a wide range of subjects for the National desk of The Times, including extreme weather, court cases and state politics all across the country. More about Jacey Fortin

Our Coverage of the U.S. Campus Protests

News and Analysis

Columbia : After weeks of student protests, Columbia University announced that it would be canceling its main commencement ceremony .

UChicago : The University of Chicago, which says that free speech is sacred, has allowed protest encampments. But they have also disrupted campus life, and the school’s leaders want the tents down .

U.S.C.:  The Los Angeles Police Department and campus police removed a pro-Palestinian encampment for the second time  at the University of Southern California.

Outside Agitators:  Officials in New York City have blamed “external actors” for escalating demonstrations at Columbia, but student protesters reject the claim .

Clashes at U.C.L.A.: A New York Times examination of more than 100 videos from clashes at the University of California, Los Angeles, shows how counterprotesters provoked the violence .

Reactions Abroad:  The world is watching what is happening on American campuses with shock, pride, relish and alarm. Here is a selection of views from outside the United States .

A Spotlight on Student Journalists:  Columbia’s radio station and other student-led news outlets have provided some of the most detailed coverage  of the turmoil engulfing campuses.

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Overview: the TRIPS Agreement

The TRIPS Agreement, which came into effect on 1 January 1995, is to date the most comprehensive multilateral agreement on intellectual property.

> General provisions > Standards of protection > Copyright > Related rights > Trademarks > Geographical indications > Industrial designs > Patents > Integrated circuits > Undisclosed information > Anti-competitive licences > Enforcement > General obligations > Procedures and remedies > Provisional measures > Border measures > Criminal procedures > Other provisions > Acquiring and maintaining rights > Transitional arrangements > Protecting existing matter

The three main features of the Agreement are:

• Standards . In respect of each of the main areas of intellectual property covered by the TRIPS Agreement, the Agreement sets out the minimum standards of protection to be provided by each Member. Each of the main elements of protection is defined, namely the subject-matter to be protected, the rights to be conferred and permissible exceptions to those rights, and the minimum duration of protection. The Agreement sets these standards by requiring, first, that the substantive obligations of the main conventions of the WIPO, the Paris Convention for the Protection of Industrial Property (Paris Convention) and the Berne Convention for the Protection of Literary and Artistic Works (Berne Convention) in their most recent versions, must be complied with. With the exception of the provisions of the Berne Convention on moral rights, all the main substantive provisions of these conventions are incorporated by reference and thus become obligations under the TRIPS Agreement between TRIPS Member countries. The relevant provisions are to be found in Articles 2.1 and 9.1 of the TRIPS Agreement, which relate, respectively, to the Paris Convention and to the Berne Convention. Secondly, the TRIPS Agreement adds a substantial number of additional obligations on matters where the pre-existing conventions are silent or were seen as being inadequate. The TRIPS Agreement is thus sometimes referred to as a Berne and Paris-plus agreement.
• Enforcement . The second main set of provisions deals with domestic procedures and remedies for the enforcement of intellectual property rights. The Agreement lays down certain general principles applicable to all IPR enforcement procedures. In addition, it contains provisions on civil and administrative procedures and remedies, provisional measures, special requirements related to border measures and criminal procedures, which specify, in a certain amount of detail, the procedures and remedies that must be available so that right holders can effectively enforce their rights.
• Dispute settlement . The Agreement makes disputes between WTO Members about the respect of the TRIPS obligations subject to the WTO's dispute settlement procedures.

In addition the Agreement provides for certain basic principles, such as national and most-favoured-nation treatment, and some general rules to ensure that procedural difficulties in acquiring or maintaining IPRs do not nullify the substantive benefits that should flow from the Agreement. The obligations under the Agreement will apply equally to all Member countries, but developing countries will have a longer period to phase them in. Special transition arrangements operate in the situation where a developing country does not presently provide product patent protection in the area of pharmaceuticals.

The TRIPS Agreement is a minimum standards agreement, which allows Members to provide more extensive protection of intellectual property if they so wish. Members are left free to determine the appropriate method of implementing the provisions of the Agreement within their own legal system and practice.

Certain general provisions 

As in the main pre-existing intellectual property conventions, the basic obligation on each Member country is to accord the treatment in regard to the protection of intellectual property provided for under the Agreement to the persons of other Members. Article 1.3 defines who these persons are. These persons are referred to as “nationals” but include persons, natural or legal, who have a close attachment to other Members without necessarily being nationals. The criteria for determining which persons must thus benefit from the treatment provided for under the Agreement are those laid down for this purpose in the main pre-existing intellectual property conventions of WIPO, applied of course with respect to all WTO Members whether or not they are party to those conventions. These conventions are the Paris Convention, the Berne Convention, International Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organizations (Rome Convention), and the Treaty on Intellectual Property in Respect of Integrated Circuits (IPIC Treaty).

Articles 3, 4 and 5 include the fundamental rules on national and most-favoured-nation treatment of foreign nationals, which are common to all categories of intellectual property covered by the Agreement. These obligations cover not only the substantive standards of protection but also matters affecting the availability, acquisition, scope, maintenance and enforcement of intellectual property rights as well as those matters affecting the use of intellectual property rights specifically addressed in the Agreement. While the national treatment clause forbids discrimination between a Member's own nationals and the nationals of other Members, the most-favoured-nation treatment clause forbids discrimination between the nationals of other Members. In respect of the national treatment obligation, the exceptions allowed under the pre-existing intellectual property conventions of WIPO are also allowed under TRIPS. Where these exceptions allow material reciprocity, a consequential exception to MFN treatment is also permitted (e.g. comparison of terms for copyright protection in excess of the minimum term required by the TRIPS Agreement as provided under Article 7(8) of the Berne Convention as incorporated into the TRIPS Agreement). Certain other limited exceptions to the MFN obligation are also provided for.

The general goals of the TRIPS Agreement are contained in the Preamble of the Agreement, which reproduces the basic Uruguay Round negotiating objectives established in the TRIPS area by the 1986 Punta del Este Declaration and the 1988/89 Mid-Term Review. These objectives include the reduction of distortions and impediments to international trade, promotion of effective and adequate protection of intellectual property rights, and ensuring that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade. These objectives should be read in conjunction with Article 7, entitled “Objectives”, according to which the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. Article 8, entitled “Principles”, recognizes the rights of Members to adopt measures for public health and other public interest reasons and to prevent the abuse of intellectual property rights, provided that such measures are consistent with the provisions of the TRIPS Agreement.

Substantive standards of protection 

Copyright Back to top

During the Uruguay Round negotiations, it was recognized that the Berne Convention already, for the most part, provided adequate basic standards of copyright protection. Thus it was agreed that the point of departure should be the existing level of protection under the latest Act, the Paris Act of 1971, of that Convention. The point of departure is expressed in Article 9.1 under which Members are obliged to comply with the substantive provisions of the Paris Act of 1971 of the Berne Convention, i.e. Articles 1 through 21 of the Berne Convention (1971) and the Appendix thereto. However, Members do not have rights or obligations under the TRIPS Agreement in respect of the rights conferred under Article 6 bis of that Convention, i.e. the moral rights (the right to claim authorship and to object to any derogatory action in relation to a work, which would be prejudicial to the author's honour or reputation), or of the rights derived therefrom. The provisions of the Berne Convention referred to deal with questions such as subject-matter to be protected, minimum term of protection, and rights to be conferred and permissible limitations to those rights. The Appendix allows developing countries, under certain conditions, to make some limitations to the right of translation and the right of reproduction.

In addition to requiring compliance with the basic standards of the Berne Convention, the TRIPS Agreement clarifies and adds certain specific points.

Article 9.2 confirms that copyright protection shall extend to expressions and not to ideas, procedures, methods of operation or mathematical concepts as such.

Article 10.1 provides that computer programs, whether in source or object code, shall be protected as literary works under the Berne Convention (1971). This provision confirms that computer programs must be protected under copyright and that those provisions of the Berne Convention that apply to literary works shall be applied also to them. It confirms further, that the form in which a program is, whether in source or object code, does not affect the protection. The obligation to protect computer programs as literary works means e.g. that only those limitations that are applicable to literary works may be applied to computer programs. It also confirms that the general term of protection of 50 years applies to computer programs. Possible shorter terms applicable to photographic works and works of applied art may not be applied.

Article 10.2 clarifies that databases and other compilations of data or other material shall be protected as such under copyright even where the databases include data that as such are not protected under copyright. Databases are eligible for copyright protection provided that they by reason of the selection or arrangement of their contents constitute intellectual creations. The provision also confirms that databases have to be protected regardless of which form they are in, whether machine readable or other form. Furthermore, the provision clarifies that such protection shall not extend to the data or material itself, and that it shall be without prejudice to any copyright subsisting in the data or material itself.

Article 11 provides that authors shall have in respect of at least computer programs and, in certain circumstances, of cinematographic works the right to authorize or to prohibit the commercial rental to the public of originals or copies of their copyright works. With respect to cinematographic works, the exclusive rental right is subject to the so-called impairment test: a Member is excepted from the obligation unless such rental has led to widespread copying of such works which is materially impairing the exclusive right of reproduction conferred in that Member on authors and their successors in title. In respect of computer programs, the obligation does not apply to rentals where the program itself is not the essential object of the rental.

According to the general rule contained in Article 7(1) of the Berne Convention as incorporated into the TRIPS Agreement, the term of protection shall be the life of the author and 50 years after his death. Paragraphs 2 through 4 of that Article specifically allow shorter terms in certain cases. These provisions are supplemented by Article 12 of the TRIPS Agreement, which provides that whenever the term of protection of a work, other than a photographic work or a work of applied art, is calculated on a basis other than the life of a natural person, such term shall be no less than 50 years from the end of the calendar year of authorized publication, or, failing such authorized publication within 50 years from the making of the work, 50 years from the end of the calendar year of making.

Article 13 requires Members to confine limitations or exceptions to exclusive rights to certain special cases which do not conflict with a normal exploitation of the work and do not unreasonably prejudice the legitimate interests of the right holder. This is a horizontal provision that applies to all limitations and exceptions permitted under the provisions of the Berne Convention and the Appendix thereto as incorporated into the TRIPS Agreement. The application of these limitations is permitted also under the TRIPS Agreement, but the provision makes it clear that they must be applied in a manner that does not prejudice the legitimate interests of the right holder.

Related rights Back to top

The provisions on protection of performers, producers of phonograms and broadcasting organizations are included in Article 14. According to Article 14.1, performers shall have the possibility of preventing the unauthorized fixation of their performance on a phonogram (e.g. the recording of a live musical performance). The fixation right covers only aural, not audiovisual fixations. Performers must also be in position to prevent the reproduction of such fixations. They shall also have the possibility of preventing the unauthorized broadcasting by wireless means and the communication to the public of their live performance.

In accordance with Article 14.2, Members have to grant producers of phonograms an exclusive reproduction right. In addition to this, they have to grant, in accordance with Article 14.4, an exclusive rental right at least to producers of phonograms. The provisions on rental rights apply also to any other right holders in phonograms as determined in national law. This right has the same scope as the rental right in respect of computer programs. Therefore it is not subject to the impairment test as in respect of cinematographic works. However, it is limited by a so-called grand-fathering clause, according to which a Member, which on 15 April 1994, i.e. the date of the signature of the Marrakesh Agreement, had in force a system of equitable remuneration of right holders in respect of the rental of phonograms, may maintain such system provided that the commercial rental of phonograms is not giving rise to the material impairment of the exclusive rights of reproduction of right holders.

Broadcasting organizations shall have, in accordance with Article 14.3, the right to prohibit the unauthorized fixation, the reproduction of fixations, and the rebroadcasting by wireless means of broadcasts, as well as the communication to the public of their television broadcasts. However, it is not necessary to grant such rights to broadcasting organizations, if owners of copyright in the subject-matter of broadcasts are provided with the possibility of preventing these acts, subject to the provisions of the Berne Convention.

The term of protection is at least 50 years for performers and producers of phonograms, and 20 years for broadcasting organizations (Article 14.5).

Article 14.6 provides that any Member may, in relation to the protection of performers, producers of phonograms and broadcasting organizations, provide for conditions, limitations, exceptions and reservations to the extent permitted by the Rome Convention.

Trademarks Back to top

The basic rule contained in Article 15 is that any sign, or any combination of signs, capable of distinguishing the goods and services of one undertaking from those of other undertakings, must be eligible for registration as a trademark, provided that it is visually perceptible. Such signs, in particular words including personal names, letters, numerals, figurative elements and combinations of colours as well as any combination of such signs, must be eligible for registration as trademarks.

Where signs are not inherently capable of distinguishing the relevant goods or services, Member countries are allowed to require, as an additional condition for eligibility for registration as a trademark, that distinctiveness has been acquired through use. Members are free to determine whether to allow the registration of signs that are not visually perceptible (e.g. sound or smell marks).

Members may make registrability depend on use. However, actual use of a trademark shall not be permitted as a condition for filing an application for registration, and at least three years must have passed after that filing date before failure to realize an intent to use is allowed as the ground for refusing the application (Article 14.3).

The Agreement requires service marks to be protected in the same way as marks distinguishing goods (see e.g. Articles 15.1, 16.2 and 62.3).

The owner of a registered trademark must be granted the exclusive right to prevent all third parties not having the owner's consent from using in the course of trade identical or similar signs for goods or services which are identical or similar to those in respect of which the trademark is registered where such use would result in a likelihood of confusion. In case of the use of an identical sign for identical goods or services, a likelihood of confusion must be presumed (Article 16.1).

The TRIPS Agreement contains certain provisions on well-known marks, which supplement the protection required by Article 6 bis of the Paris Convention, as incorporated by reference into the TRIPS Agreement, which obliges Members to refuse or to cancel the registration, and to prohibit the use of a mark conflicting with a mark which is well known. First, the provisions of that Article must be applied also to services. Second, it is required that knowledge in the relevant sector of the public acquired not only as a result of the use of the mark but also by other means, including as a result of its promotion, be taken into account. Furthermore, the protection of registered well-known marks must extend to goods or services which are not similar to those in respect of which the trademark has been registered, provided that its use would indicate a connection between those goods or services and the owner of the registered trademark, and the interests of the owner are likely to be damaged by such use (Articles 16.2 and 3).

Members may provide limited exceptions to the rights conferred by a trademark, such as fair use of descriptive terms, provided that such exceptions take account of the legitimate interests of the owner of the trademark and of third parties (Article 17).

Initial registration, and each renewal of registration, of a trademark shall be for a term of no less than seven years. The registration of a trademark shall be renewable indefinitely (Article 18).

Cancellation of a mark on the grounds of non-use cannot take place before three years of uninterrupted non-use has elapsed unless valid reasons based on the existence of obstacles to such use are shown by the trademark owner. Circumstances arising independently of the will of the owner of the trademark, such as import restrictions or other government restrictions, shall be recognized as valid reasons of non-use. Use of a trademark by another person, when subject to the control of its owner, must be recognized as use of the trademark for the purpose of maintaining the registration (Article 19).

It is further required that use of the trademark in the course of trade shall not be unjustifiably encumbered by special requirements, such as use with another trademark, use in a special form, or use in a manner detrimental to its capability to distinguish the goods or services (Article 20).

Geographical indications Back to top

Geographical indications are defined, for the purposes of the Agreement, as indications which 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). Thus, this definition specifies that the quality, reputation or other characteristics of a good can each be a sufficient basis for eligibility as a geographical indication, where they are essentially attributable to the geographical origin of the good.

In respect of all geographical indications, interested parties must have legal means to prevent use of indications which mislead the public as to the geographical origin of the good, and use which constitutes an act of unfair competition within the meaning of Article 10 bis of the Paris Convention (Article 22.2).

The registration of a trademark which uses a geographical indication in a way that misleads the public as to the true place of origin must be refused or invalidated ex officio if the legislation so permits or at the request of an interested party (Article 22.3).

Article 23 provides that interested parties must have the legal means to prevent the use of a geographical indication identifying wines for wines not originating in the place indicated by the geographical indication. This applies even where the public is not being misled, there is no unfair competition and the true origin of the good is indicated or the geographical indication is accompanied be expressions such as “kind”, “type”, “style”, “imitation” or the like. Similar protection must be given to geographical indications identifying spirits when used on spirits. Protection against registration of a trademark must be provided accordingly.

Article 24 contains a number of exceptions to the protection of geographical indications. These exceptions are of particular relevance in respect of the additional protection for geographical indications for wines and spirits. For example, Members are not obliged to bring a geographical indication under protection, where it has become a generic term for describing the product in question (paragraph 6). Measures to implement these provisions shall not prejudice prior trademark rights that have been acquired in good faith (paragraph 5). Under certain circumstances, continued use of a geographical indication for wines or spirits may be allowed on a scale and nature as before (paragraph 4). Members availing themselves of the use of these exceptions must be willing to enter into negotiations about their continued application to individual geographical indications (paragraph 1). The exceptions cannot be used to diminish the protection of geographical indications that existed prior to the entry into force of the TRIPS Agreement (paragraph 3). The TRIPS Council shall keep under review the application of the provisions on the protection of geographical indications (paragraph 2).

Industrial designs Back to top

Article 25.1 of the TRIPS Agreement obliges Members to provide for the protection of independently created industrial designs that are new or original. Members may provide that designs are not new or original if they do not significantly differ from known designs or combinations of known design features. Members may provide that such protection shall not extend to designs dictated essentially by technical or functional considerations.

Article 25.2 contains a special provision aimed at taking into account the short life cycle and sheer number of new designs in the textile sector: requirements for securing protection of such designs, in particular in regard to any cost, examination or publication, must not unreasonably impair the opportunity to seek and obtain such protection. Members are free to meet this obligation through industrial design law or through copyright law.

Article 26.1 requires Members to grant the owner of a protected industrial design the right to prevent third parties not having the owner's consent from making, selling or importing articles bearing or embodying a design which is a copy, or substantially a copy, of the protected design, when such acts are undertaken for commercial purposes.

Article 26.2 allows Members to provide limited exceptions to the protection of industrial designs, provided that such exceptions do not unreasonably conflict with the normal exploitation of protected industrial designs and do not unreasonably prejudice the legitimate interests of the owner of the protected design, taking account of the legitimate interests of third parties.

The duration of protection available shall amount to at least 10 years (Article 26.3). The wording “amount to” allows the term to be divided into, for example, two periods of five years.

Patents Back to top

The TRIPS Agreement requires Member countries to make patents available for any inventions, whether products or processes, in all fields of technology without discrimination, subject to the normal tests of novelty, inventiveness and industrial applicability. It is also required that patents be available and patent rights enjoyable without discrimination as to the place of invention and whether products are imported or locally produced (Article 27.1).

There are three permissible exceptions to the basic rule on patentability. One is for inventions contrary to ordre public or morality; this explicitly includes inventions dangerous to human, animal or plant life or health or seriously prejudicial to the environment. The use of this exception is subject to the condition that the commercial exploitation of the invention must also be prevented and this prevention must be necessary for the protection of ordre public or morality (Article 27.2).

The second exception is that Members may exclude from patentability diagnostic, therapeutic and surgical methods for the treatment of humans or animals (Article 27.3(a)).

The third is that Members may exclude plants and animals other than micro-organisms and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, any country excluding plant varieties from patent protection must provide an effective sui generis system of protection. Moreover, the whole provision is subject to review four years after entry into force of the Agreement (Article 27.3(b)).

The exclusive rights that must be conferred by a product patent are the ones of making, using, offering for sale, selling, and importing for these purposes. Process patent protection must give rights not only over use of the process but also over products obtained directly by the process. Patent owners shall also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts (Article 28).

Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties (Article 30).

The term of protection available shall not end before the expiration of a period of 20 years counted from the filing date (Article 33).

Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application (Article 29.1).

If the subject-matter of a patent is a process for obtaining a product, the judicial authorities shall have the authority to order the defendant to prove that the process to obtain an identical product is different from the patented process, where certain conditions indicating a likelihood that the protected process was used are met (Article 34).

Compulsory licensing and government use without the authorization of the right holder are allowed, but are made subject to conditions aimed at protecting the legitimate interests of the right holder. The conditions are mainly contained in Article 31. These include the obligation, as a general rule, to grant such licences only if an unsuccessful attempt has been made to acquire a voluntary licence on reasonable terms and conditions within a reasonable period of time; the requirement to pay adequate remuneration in the circumstances of each case, taking into account the economic value of the licence; and a requirement that decisions be subject to judicial or other independent review by a distinct higher authority. Certain of these conditions are relaxed where compulsory licences are employed to remedy practices that have been established as anticompetitive by a legal process. These conditions should be read together with the related provisions of Article 27.1, which require that patent rights shall be enjoyable without discrimination as to the field of technology, and whether products are imported or locally produced.

Layout-designs of integrated circuits Back to top

Article 35 of the TRIPS Agreement requires Member countries to protect the layout-designs of integrated circuits in accordance with the provisions of the IPIC Treaty (the Treaty on Intellectual Property in Respect of Integrated Circuits), negotiated under the auspices of WIPO in 1989. These provisions deal with, inter alia , the definitions of “integrated circuit” and “layout-design (topography)”, requirements for protection, exclusive rights, and limitations, as well as exploitation, registration and disclosure. An “integrated circuit” means a product, in its final form or an intermediate form, in which the elements, at least one of which is an active element, and some or all of the interconnections are integrally formed in and/or on a piece of material and which is intended to perform an electronic function. A “layout-design (topography)” is defined as the three-dimensional disposition, however expressed, of the elements, at least one of which is an active element, and of some or all of the interconnections of an integrated circuit, or such a three-dimensional disposition prepared for an integrated circuit intended for manufacture. The obligation to protect layout-designs applies to such layout-designs that are original in the sense that they are the result of their creators' own intellectual effort and are not commonplace among creators of layout-designs and manufacturers of integrated circuits at the time of their creation. The exclusive rights include the right of reproduction and the right of importation, sale and other distribution for commercial purposes. Certain limitations to these rights are provided for.

In addition to requiring Member countries to protect the layout-designs of integrated circuits in accordance with the provisions of the IPIC Treaty, the TRIPS Agreement clarifies and/or builds on four points. These points relate to the term of protection (ten years instead of eight, Article 38), the applicability of the protection to articles containing infringing integrated circuits (last sub clause of Article 36) and the treatment of innocent infringers (Article 37.1). The conditions in Article 31 of the TRIPS Agreement apply mutatis mutandis to compulsory or non-voluntary licensing of a layout-design or to its use by or for the government without the authorization of the right holder, instead of the provisions of the IPIC Treaty on compulsory licensing (Article 37.2).

Protection of undisclosed information Back to top

The TRIPS Agreement requires undisclosed information -- trade secrets or know-how -- to benefit from protection. According to Article 39.2, the protection must apply to information that is secret, that has commercial value because it is secret and that has been subject to reasonable steps to keep it secret. The Agreement does not require undisclosed information to be treated as a form of property, but it does require that a person lawfully in control of such information must have the possibility of preventing it from being disclosed to, acquired by, or used by others without his or her consent in a manner contrary to honest commercial practices. “Manner contrary to honest commercial practices” includes breach of contract, breach of confidence and inducement to breach, as well as 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.

The Agreement also contains provisions on undisclosed test data and other data whose submission is required by governments as a condition of approving the marketing of pharmaceutical or agricultural chemical products which use new chemical entities. In such a situation the Member government concerned must protect the data against unfair commercial use. In addition, Members must 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.

Control of anti-competitive practices in contractual licences Back to top

Article 40 of the TRIPS Agreement recognizes that some licensing practices or conditions pertaining to intellectual property rights which restrain competition may have adverse effects on trade and may impede the transfer and dissemination of technology (paragraph 1). Member countries may adopt, consistently with the other provisions of the Agreement, appropriate measures to prevent or control practices in the licensing of intellectual property rights which are abusive and anti-competitive (paragraph 2). The Agreement provides for a mechanism whereby a country seeking to take action against such practices involving the companies of another Member country can enter into consultations with that other Member and exchange publicly available non-confidential information of relevance to the matter in question and of other information available to that Member, subject to domestic law and to the conclusion of mutually satisfactory agreements concerning the safeguarding of its confidentiality by the requesting Member (paragraph 3). Similarly, a country whose companies are subject to such action in another Member can enter into consultations with that Member (paragraph 4).

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Netanyahu vows to invade Rafah ‘with or without a deal’ as cease-fire talks with Hamas continue

U.S. Secretary of State Antony Blinken said Washington’s views on a Rafah incursion are “very well-known,” as Israeli Prime Minister Benjamin Netanyahu pledged on Tuesday it would happen. Netanyahu said Israel would enter Rafah, which Israel says is Hamas’ last stronghold, regardless of whether a truce-for-hostages deal is struck.

Israeli Prime Minister Benjamin Netanyahu pledged Tuesday to launch an incursion into a Gaza city sheltering hundreds of thousands of Palestinians.

At least one person was killed in an Israeli airstrike in central Gaza, according to journalists from The Associated Press at a nearby hospital. (April 30)

Aid was airdropped into northern Gaza on Tuesday, while international pressure grows to reach a ceasefire deal between Hamas and Israel. (April 30)

Dozens of Palestinians gathered to receive water in Gaza’s makeshift tent camp of Muwasi, which became home to hundreds of thousands who fled from the northern region of the enclave when the Israeli military operation began in October. (AP video: Mohammad Jahjouh)

FILE - Israeli Prime Minister Benjamin Netanyahu attends a press conference in the Kirya military base in Tel Aviv, Israel on Oct. 28, 2023. Netanyahu pledged Tuesday, April 30 to launch an incursion into the southern Gaza city of Rafah, where hundreds of thousands of Palestinians are sheltering from the almost 7-month-long war, just as cease-fire negotiations between Israel and Hamas appear to be gaining steam. (Abir Sultan/Pool Photo via AP, File)

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Mourners carry the bodies of members of the Abu Taha family who were killed in an Israeli airstrike, during their funeral at Al-Salam cemetery, east of Rafah, Gaza Strip. Monday, April 29, 2024. (AP Photo/Mohammad Jahjouh)

Palestinians look at the destruction after an Israeli airstrike in Rafah, Gaza Strip. Monday, April 29, 2024. (AP Photo/Mohammad Jahjouh)

TEL AVIV, Israel (AP) — Israeli Prime Minister Benjamin Netanyahu pledged Tuesday to launch an incursion into the southern Gaza city of Rafah , where hundreds of thousands of Palestinians are sheltering from the almost 7-month-long war, just as cease-fire negotiations between Israel and Hamas appear to be gaining steam.

Netanyahu’s comments came hours before U.S. Secretary of State Antony Blinken was to arrive in Israel to advance the truce talks — which appear to be one of the most serious rounds of negotiations between Israel and Hamas since the war began. The deal is meant to free hostages, bring some relief to the population and avert an Israeli offensive into Rafah and the potential harm to civilians there.

Netanyahu said Israel would enter Rafah, which Israel says is Hamas’ last stronghold, regardless of whether a truce-for-hostages deal is struck. His comments appeared to be meant to appease his nationalist governing partners but it was not clear whether they would have any bearing on any emerging deal with Hamas.

“The idea that we will stop the war before achieving all of its goals is out of the question,” Netanyahu said, according to a statement from his office. “We will enter Rafah and we will eliminate Hamas’ battalions there — with or without a deal, to achieve the total victory.”

The U.S. has repeatedly said it opposes the Rafah operation until Israel presents a credible plan for evacuating and protecting the estimated 1.5 million people seeking shelter there.

Blinken, speaking in Jordan before flying to Israel, said the “focus” right now is on improving the humanitarian situation and reaching a cease-fire deal that brings Israeli hostages home. He said Israel has offered a “strong proposal” and called on Hamas to respond.

“No more delays. No more excuses. The time to act is now,” he said. “We want to see in the coming days this agreement coming together.”

Netanyahu has faced pressure from his governing partners not to proceed with a deal that might prevent Israel from invading Rafah. His government could be threatened if he agrees to a deal because hardline Cabinet members have demanded an attack on Rafah.

Netanyahu met on Tuesday with one of those partners, National Security Minister Itamar Ben-Gvir, according to the minister’s office, who said Netanyahu promised him that “Israel will enter Rafah, promised that we are not stopping the war and promised that there won’t be a reckless deal.”

With more than half of Gaza’s 2.3 million people sheltering in Rafah , the international community, including Israel’s top ally, the United States, has warned Israel against any offensive that puts civilians at risk.

Netanyahu on Tuesday was addressing the Tikva Forum , a small group of families of hostages that’s distinct from the main group representing the families of captive Israelis. The forum has indicated that it prefers to see Hamas crushed over the freedom of their loved ones. Most families and their supporters have demonstrated in the thousands every week for a deal that would bring the hostages home, saying it should take precedence over military action.

Netanyahu’s coalition is made up of ultranationalist and conservative religious parties, and critics of the Israeli leader say his decision-making during the war has been driven by political considerations rather than national interests, a charge Netanyahu denies. His government could collapse if one of the parties opposed to a deal pulls out, a scenario Netanyahu would try to avoid considering his support has plummeted in opinion polls since the war began, although it has seen a slight gradual uptick.

Finance Minister Bezalel Smotrich, who heads the ultranationalist Religious Zionist party, said Monday that he was seeking “total annihilation” of Israel’s enemies, appearing to refer to Hamas, in a recorded portion of his remarks at an event marking the end of the Passover holiday which were aired in Israeli media.

“You can’t do half a job,” he said.

The current deal being discussed, brokered by the U.S., Egypt and Qatar, would see the release of dozens of hostages in exchange for a six-week halt in fighting as part of an initial phase, according to an Egyptian official and Israeli media. Hundreds of Palestinian prisoners held by Israel would also be released, including some serving long sentences.

Blinken, who was meeting with regional leaders in Saudi Arabia and Jordan before landing in Tel Aviv later Tuesday, urged Hamas on Monday to accept the latest proposal, calling it “extraordinarily generous” on Israel’s part.

But a sticking point remains over what happens next. Hamas has demanded assurances that an eventual release of all hostages will bring a complete end to Israel’s nearly seven-month assault in Gaza and a withdrawal of its troops from the devastated territory. Israel has offered only an extended pause, vowing to resume its offensive once the first phase of the deal is over. The issue has repeatedly obstructed efforts by the mediators during months of talks.

The Israel-Hamas war was sparked by the unprecedented Oct. 7 raid into southern Israel in which militants killed around 1,200 people, mostly civilians, and abducted around 250 hostages. Israel says the militants are still holding around 100 hostages and the remains of more than 30 others.

The war in Gaza has killed more than 34,000 Palestinians, according to local health officials . The war has driven around 80% of Gaza’s population of 2.3 million from their homes, caused vast destruction in several towns and cities and pushed northern Gaza to the brink of famine .

Lee reported from Amman, Jordan.

Follow AP’s coverage of the war at https://apnews.com/hub/israel-hamas-war