3. Test Data Exclusivity and Art 39(3) TRIPS

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

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

Argentina – Certain Measures on the Protection of Patents and Test Data: Request for Consultations by the United States, WT/DS196/1, IP/D/22 dated 6 June 2000 [hereinafter Request for Consultations by the US (2000)] available at https://​docs.​wto.​org/​dol2fe/​Pages/​FE_​Search/​FE_​S_​S006.​aspx?​Query=​(@Symbol=​%20​wt/​ds196/​1)&​Language=​ENGLISH&​Context=​FomerScriptedSea​rch&​languageUIChange​d=​true# (last visited 2 June 2016).

Notification of Mutually Agreed Solution, Argentina – Certain Measures on the Protection of Patents and Test Data, WT/DS171/3 &WT/DS196/4 dated 20 June 2002 available at http://​www.​wto.​org/​english/​tratop_​e/​dispu_​e/​cases_​e/​ds196_​e.​htm (last visited 2 June 2016).

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

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

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

See for example, United States – Section 110(5) of the US Copyright Act, Report of the Panel, WT/DS160/R at ¶ 6.43 et seq, available at http://​www.​wto.​org/​english/​tratop_​e/​dispu_​e/​cases_​e/​ds160_​e.​htm (last visited 2 June 2016); WTO Appellate Body Report on United States – Section 211 Omnibus Appropriations Act of 1998, WT/DS176/AB/R at ¶ 338, [hereinafter US – Section 211] available at http://​www.​wto.​org/​english/​tratop_​e/​dispu_​e/​cases_​e/​ds176_​e.​htm (last visited 2 June 2016).

Article 31(1) VCLT (‘[a] treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose.’) Thus, the interpretation ‘must be based above all upon the text of the treaty’. WTO Appellate Body Report on Japan – Taxes on Alcoholic Beverages, WT/DS8/AB/R, WT/DS10/AB/R, WT/DS11/AB/R at 12, [hereinafter Japan – Alcoholic Beverages’ available at https://​docs.​wto.​org/​dol2fe/​Pages/​FE_​Search/​FE_​S_​S009-DP.​aspx?​language=​E&​CatalogueIdList=​​32900&​CurrentCatalogue​IdIndex=​0&​FullTextSearch= (last visited 2 June 2016). ‘In order to identify the ordinary meaning, a Panel may start with the dictionary definitions of the terms to be interpreted. But dictionaries, alone, are not necessarily capable of resolving complex questions of interpretation, as they typically aim to catalogue all meanings of words — be those meanings common or rare, universal or specialized’. (internal citations omitted) WTO Appellate Body Report on United States – Measures Affecting the Cross-Border Supply of Gambling And Betting Services, WT/DS285/AB/R ¶ 164, available at http://​www.​wto.​org/​english/​tratop_​e/​dispu_​e/​285abr_​e.​pdf (last visited 2 June 2016); ‘It should be remembered that dictionaries are important guides to, not dispositive statements of, definition of words appearing in agreements and legal documents.’ WTO Appellate Body Report on United States – Continued Dumping and Subsidy Offset Act of 2000, WT/DS217/AB/R at ¶ 248, available at http://​www.​wto.​org/​english/​tratop_​e/​dispu_​e/​217_​234_​abr_​e.​pdf (last visited 2 June 2016) [hereinafter US – Gambling]. Art 31(2) VCLT clarifies what comprises the context of a treaty. According to the WTO Secretariat ‘“[c]ontext” refers to the kinds of conclusions that can be drawn on the basis of, for example, the structure, content or terminology in other provisions belonging to the same agreement, particularly the ones preceding and following the rule subject to interpretation.’ WTO Secretariat, A Handbook on the WTO Dispute Settlement System: A WTO Secretariat Publication 5 (2004). In this regard, it is opined that the text, preamble and annexes and the terms of the treaty must be read in the context of the treaty holistically and an agreement forming part of the context of the agreement is not simply of ‘evidential value’. Qureshi (2006) at 19. With regard to the ‘object and purpose’, treaty interpretation as per Art 31 VCLT take into consideration ‘object and purpose’ of the treaty as a whole as well as that of the individual terms, where taking into consideration of the ‘object and purpose’ of the specific terms ‘assists the interpreter in determining the treaty’s object and purpose on the whole’. (internal citation omitted) WTO Appellate Body Report on European Communities – Customs Classification of Frozen Boneless Chicken Cuts, WT/DS269/AB/R ¶ 238 available at http://​www.​wto.​org/​english/​tratop_​e/​dispu_​e/​269_​286abr_​e.​pdf (last visited 2 June 2016) [hereinafter EC – Chicken Cuts (AB)]. It is also argued that the objects and purpose of the Marrakesh Agreement ‘must stand at the apex of the configuration of objects and purposes set in the WTO Agreements’. Qureshi (2006) at 19.

Art 31(2) VCLT.

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

Art 31(3)(a) VCLT.

Art 31(3)(b) VCLT.

Art 31(3)(c) VCLT.

Art 31(4) VCLT.

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

WTO Appellate Body Report on United States – Standards for Reformulated and Conventional Gasoline, WT/DS2/AB/R at p. 23 available at http://​www.​wto.​org/​english/​tratop_​e/​dispu_​e/​cases_​e/​ds2_​e.​htm (last visited 2 June 2016) [hereinafter US – Gasoline]. The Appellate Body in US – Section 211 also referred to the importance of the principle of effective interpretation. ‘To adopt the Panel’s approach would be to deprive Article 8 of the Paris Convention (1967), as incorporated into the TRIPS Agreement by virtue of Article 2.1 of that Agreement, of any and all meaning and effect.’ US – Section 211 at ¶ 19.

Art 32 VCLT.

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

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

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

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

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

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

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

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

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

Oxford Dictionaries, http://​oxforddictionari​es.​com/​definition/​american_​english/​commercial?​q=​commercial (last visited 2 June 2016).

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

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

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

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

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

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

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

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

Oxford Dictionaries, http://​oxforddictionari​es.​com/​definition/​english/​unfair?​q=​unfair (last visited 2 June 2016).

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

Collins English Dictionary [hereinafter Collins Dictionary], http://​www.​collinsdictionar​y.​com/​dictionary/​english/​unfair?​showCookiePolicy​=​true (last visited 2 June 2016).

Cambridge Dictionary, http://​dictionary.​cambridge.​org/​dictionary/​american-english/​unfair?​q=​unfair (last visited 2 June 2016).

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

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

Reichman (2006) at 142.

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

See Sect. 8.​2.​2.​4 for a discussion of this approach.

See Chap. 6.

See Sect. 1.​1.​1.

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

Art 39(2) TRIPS

Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices so long as such information:

(a) is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question;

(b) has commercial value because it is secret; and

(c) has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.

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

Art 39(1) TRIPS:

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

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

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

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

See note 18 and 19 accompanying text.

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

Third sentence, Art 1(1) TRIPS.

A WTO Panel, for example, held in a dispute between the European Communities and the United States regarding protection of geographical indications that ‘[i]n accordance with Article 1.1, the European Communities is free to determine the appropriate method of implementing the provisions of the Agreement within its own legal system and practice. It is not obliged to ensure that this particular Regulation implements Article 22.2 where it has other measures that do so.’ European Communities – Protection of Trademarks and Geographical Indications for Agricultural Products and Foodstuffs, Complaint by the United States, Report of the Panel, WT/DS174/R ¶ 7.746, dated 15 March 2005 available at https://​www.​wto.​org/​english/​tratop_​e/​dispu_​e/​174r_​e.​pdf (last visited 2 June 2016). Nonetheless, the internal consistency of Art 1(1) TRIPS requires that Members cannot implement a lower standard than obligated in the TRIPS Agreement. In this regard, another Panel held in a dispute between China and United States regarding enforcement of IPRs that ‘[t]he third sentence of Article 1.1 does not grant Members freedom to implement a lower standard, but rather grants freedom to determine the appropriate method of implementation of the provisions to which they are required to give effect under the first sentence […] [A] coherent reading of the three sentences of Article 1.1 does not permit differences in domestic legal systems and practices to justify any derogation from the basic obligation to give effect to the provisions on enforcement.’ China – Measures Affecting the Protection and Enforcement of Intellectual Property Rights, Report of the Panel, WT/DS362/R ¶ 7.513 dated 26 January 2009 available at https://​www.​wto.​org/​english/​tratop_​e/​dispu_​e/​cases_​e/​ds362_​e.​htm (last visited 2 June 2016).

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

Reichman (2006) at 141–2.

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

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

EC – Chicken Cuts (AB) ¶ 238.

Japan – Alcoholic Beverages at footnote 20 and references therein.

Isabelle Van Damme, Treaty Interpretation by the WTO Appellate Body 258 (2009) [hereinafter Van Damme (2009)]; ‘Interpretations in the light of a treaty’s object and purpose finds its limits in the treaty text itself. One of the (originally many possible) ordinary meanings will eventually prevail. […] Article 31 avoids an extreme functional interpretation which may, in fact, lead to “legislation” or the revision of the treaty.’ Mark E. Villiger, Commentary on the 1969 Vienna Convention on the Law of Treaties 428 (2009) [hereinafter Villiger (2009)]; ‘The consideration of object and purpose finds its limits in the ordinary meaning of the text of the treaty. It may only be used to bring one of the possible ordinary meanings of the terms to prevail and cannot establish a reading that clearly cannot be expressed with the words used in the text.’ (internal citations omitted) Dörr & Schmalenbach (2012) at 547.

See the examples of Jordan, Colombia and Guatemala in Sect. 2.​3.

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

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

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

WTO Agreement ¶ 1 of the Preamble.

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

Correa (2007) at 1.

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

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

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

TRIPS Resource Book at 125–6.

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

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

Henning Grosse Ruse – Khan, A Comparative Analysis of Policy Space in WTO Law, Max Planck Institute for Intellectual Property, Competition & Tax Law Research Paper Series No. 08-02, 35–6 (2008), available at http://​papers.​ssrn.​com/​sol3/​papers.​cfm?​abstract_​id=​1309526&​download=​yes (last visited 2 June 2016) [hereinafter Grosse Ruse – Khan Contemporary Analysis (2008)]. For explanation of the necessity test in WTO jurisprudence, see WTO Appellate Body Report, Korea – Measures Affecting Imports of Fresh, Chilled and Frozen Beef, ¶¶ 159–164, WT/DS161/AB/R, WT/DS169/AB/R (11 December 2002) available at http://​www.​wto.​org/​english/​tratop_​e/​dispu_​e/​cases_​e/​ds161_​e.​htm (last visited 2 June 2016); WTO Appellate Body Report, European Communities – Measures Affecting Asbestos and Products Containing Asbestos, ¶¶ 164–175, WT/DS135/AB/R, (12 March 2001) available at http://​www.​wto.​org/​english/​tratop_​e/​dispu_​e/​135abr_​e.​pdf (last visited 2 June 2016).

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

Correa (2007) at 104.

World Trade Organization, Declaration on the TRIPS agreement and public health, WT/MIN(01)/DEC/2 (20 November 2001) available at http://​www.​wto.​org/​english/​thewto_​e/​minist_​e/​min01_​e/​mindecl_​trips_​e.​htm (last visited 2 June 2016) [hereinafter Doha Declaration]

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

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

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

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

See Abbott (2002) at 470.

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

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

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

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

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

US – Gambling ¶ 192.

EC – Chicken Cuts (AB) ¶ 255.

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

USTR, USTR Announces Two Decisions: Title VII and Special 301, (April 30, 1996) at page 11, available at http://​keionline.​org/​sites/​default/​files/​ustr_​special301_​1996.​pdf (last visited 2 June 2016).

USTR, USTR Report on Special 301 Annual Review, (April 30, 1997) available at http://​www.​keionline.​org/​ustr/​1997special301 (last visited 2 June 2016) [hereinafter ‘Special 301 Report (1997)]. Similarly, South Africa was also put on the Watch List in the 1998 Report as undisclosed data also [was] not adequately protected under South African Law.’ USTR, USTR Announces Results of Special 301 Annual Review, (May 1, 1998) at page 21 available at http://​keionline.​org/​sites/​default/​files/​ustr_​special301_​1998.​pdf (last visited 2 June 2016) [hereinafter USTR Results] at 21.

Special 301 Report (1997).

USTR Results at 10.

Request for Consultations by the US (2000).

EC, Questions on TRIPs and Data Exclusivity: An EU Contribution, 20–21 [hereinafter EU Position on Data Exclusivity] at http://​trade.​ec.​europa.​eu/​doclib/​docs/​2006/​may/​tradoc_​122031.​pdf (last visited 2 June 2016). Gorlin claimed in 1999 that ‘there […] appears to be a United States-EU consensus that Article 39.3 requires WTO Members to protect the data submitted for gaining marketing approval of new chemical entities against “unfair commercial use”, that is, the data may not be relied upon for the marketing of subsequent versions of the drug during the period of data exclusivity’. Gorlin (1999) at 48.

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

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

WTO, Communication from the European Communities and their Member States, IP/C/W/280 dated 12 June 2001 available at http://​www.​wto.​org/​english/​tratop_​e/​trips_​e/​paper_​eu_​w280_​e.​htm (last visited 2 June 2016).

WTO, Submission by the Africa Group, Barbados, Bolivia, Brazil, Dominican Republic, Ecuador, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka, Thailand and Venezuela, IP/C/W/280 dated 19 June 2001 available at http://​www.​wto.​org/​english/​tratop_​e/​trips_​e/​paper_​develop_​w296_​e.​htm (last visited 2 June 2016).

UNCTAD, The TRIPS Agreement and Developing Countries, UNCTAD/ITE/1 (1996) available at http://​unctad.​org/​en/​docs/​ite1_​en.​pdf (last visited 2 June 2016).

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

See Chap. 5.

EC – Chicken Cuts (AB) ¶ 259.

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

Van Damme (2009) at 367–73.

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

ILC Fragmentation Report at 14.

Van Damme (2009) at 358.

US – Gasoline at ¶ 16.

European Communities – Measures Affecting the Approval and Marketing of Biotech Products, Report of the Panel, ¶7.67 WT/DS291/R, WT/DS292/R, WT/DS293/R (29 September 2006) available at https://​www.​wto.​org/​english/​tratop_​e/​dispu_​e/​cases_​e/​ds291_​e.​htm (last visited 2 June 2016).

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

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

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

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

The paragraph read as follows:

III.D. […]

6. Conditions on Government Use

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

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

2. Standards on Proprietary Information

(i) […]

(v) Proprietary information provided to a governmental agency in order to obtain permission to produce or market a product, such as results of clinical or safety tests, shall not be disclosed without the consent of the proprietor, except to other governmental agencies if necessary to protect human, plant or animal life, health or the environment.

Governmental agencies shall not be entitled to use the information for commercial purposes. They may disclose it only to the extent indispensable to inform the general public about the actual or potential danger of a product.

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

g. Acts contrary to honest commercial practices

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

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

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

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

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

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

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

See note 148 and accompanying text.

The EC representative acknowledged that its draft is ‘an important revision of its earlier proposals’ due to ‘Community’s internal reflections on this matter.’ MTN.GNG/NG11/20 ¶ 4. It is not unimaginable why the EC changed its position in this regard. At the time of its initial submission, the Community regime of protection of test data was quite nascent being introduced only in 1987. However, by 1990, the system had already been tested for almost three years and would be continued. See Sect. 4.​2.

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

G. Acts contrary to honest commercial practices including protection of undisclosed information

Article 28

In the course of ensuring effective protection against unfair competition as provided for in Article 10bis of the Paris Convention -

(a) …

(b) Contracting parties, when requiring the publication or submission of test or other data, the origination of which involves a considerable effort, shall protect such efforts against unfair exploitation by competitors. The protection shall last for a reasonable time commensurate with such efforts, the nature of the data required, the expenditure involved in their preparation and shall take account of the availability of other forms of protection.

See note 148 and the accompanying text.

Article 33: Exceptions

(1) Contracting parties which require that trade secrets be submitted to carry out governmental functions, shall not use the trade secrets for the commercial or competitive benefit of the government or of any person other than the right-holder except with the right-holder’s consent, on payment of the reasonable value of the use, or if a reasonable period of exclusive use is given the right-holder.

(2) Contracting parties may disclose trade secrets to third parties, only with the right-holder’s consent or to the degree required to carry out necessary government functions. Wherever practicable, right-holders shall be given an opportunity to enter into confidentiality agreements with any non-government entity to which the contracting party is disclosing trade secrets to carry out necessary government functions.

(3) Contracting parties may require right-holders to disclose their trade secrets to third parties to protect human health or safety or to protect the environment only when the right-holder is given an opportunity to enter into confidentiality agreements with any non-government entity receiving the trade secrets to prevent further disclosure or use of the trade secret.

See Sect. 3.3.1.

Article 243: Exceptions

(1) Proprietary information submitted to a government agency for purposes of regulatory approval procedures such as clinical or safety tests, shall not be disclosed without the consent of the proprietor, except to other governmental agencies if necessary to protect human, plant or animal life, health or the environment.

Governmental agencies shall not be entitled to use the information for commercial purposes. They may disclose it only with the consent of the proprietor or to the extent indispensable to inform the general public about the actual or potential danger of a product.

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

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

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

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

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

1.

[…]

3. Government Use

3Aa

PARTIES, when requiring the publication or submission of undisclosed information consisting of test [or other] data, the origination of which involves a considerable effort, shall protect such data against unfair exploitation by competitors. The protection shall last for a reasonable time commensurate with the efforts involved in the origination of the data, the nature of the data, and the expenditure involved in their preparation, and shall take account of the availability of other forms of protection.

3Ab.1 PARTIES which require that trade secrets be submitted to carry out governmental functions, shall not use the trade secrets for the commercial or competitive benefit of the government or of any person other than the right holder except with the right holder’s consent, on payment of the reasonable value of the use, or if a reasonable period of exclusive use is given the right holder.

3Ab.2 PARTIES may disclose trade secrets to third parties, only with the right holder’s consent or to the degree required to carry out necessary government functions. Wherever practicable, right holders shall be given an opportunity to enter into confidentiality agreements with any non-government entity to which the PARTY is disclosing trade secrets to carry out necessary government functions.

3Ab.3 PARTIES may require right holders to disclose their trade secrets to third parties to protect human health or safety or to protect the environment only when the right holder is given an opportunity to enter into confidentiality agreements with any non-government entity receiving the trade secrets to prevent further disclosure or use of the trade secret.

3Ac.1 Proprietary information submitted to a government agency for purposes of regulatory approval procedures such as clinical or safety tests, shall not be disclosed without the consent of the proprietor, except to other governmental agencies if necessary to protect human, plant or animal life, health or the environment. Governmental agencies may disclose it only with the consent of the proprietor or to the extent indispensable to inform the general public about the actual or potential danger of a product. They shall not be entitled to use the information for commercial purposes.

3Ac.2 Disclosure of any proprietary information to a third party, or other governmental agencies, in the context of an application for obtaining intellectual property protection, shall be subject to an obligation to hear the applicant and to judicial review. Third parties and governmental agencies having obtained such information shall be prevented from further disclosure and commercial use of it without the consent of the proprietor.

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

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

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

Art 42

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

Article 42

1A. […]

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

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

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

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

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

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

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

See Sect. 3.3.1.2.1.

It was stated in the commentary of the draft that

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

Brussels Draft at 193.

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

Article 39

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

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

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

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

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

Art 1711(5) NAFTA

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

Art 1711(6) NAFTA

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

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

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

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

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

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

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

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

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

It was held by a WTO Appellate Body that ‘[…] the fact that a particular treaty provision is “silent” on a specific issue “must have some meaning” […] Such silence does not exclude the possibility that the requirement was intended to be included by implication’. WTO Appellate Body Report on United States – Countervailing Duties on Certain Corrosion-Resistant Carbon Steel Flat Products from Germany, WT/DS213/AB/R, WT/DS213/AB/R/Corr.1 ¶ 65 available at https://​docs.​wto.​org/​dol2fe/​Pages/​FE_​Search/​FE_​S_​S006.​aspx?​Query=​(@Symbol=​%20​wt/​ds213/​ab/​r*%20​not%20​rw*)&​Language=​ENGLISH&​Context=​FomerScriptedSea​rch&​languageUIChange​d=​true# (last visited 2 June 2016).

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

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

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

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

At the time of the conclusion of the TRIPS Agreement, only the biological products regulated under the Hatch-Waxman Act, qualified for test data exclusivity protection. It was only in 2010, with the promulgation of the Biologics Price Competition and Innovation Act (BPCIA), the test data exclusivity scheme for biologics was enacted. See Sect. 4.​1.​2. On the other hand, there was test data exclusivity protection for ten (10) years provided in the EU for certain ‘high technology medicinal products’. See generally, the discussion in Sect. 4.​2.​1. Nonetheless, as discussed in Sect. 3.3.1, the EU did not initially advocate for test data exclusivity in TRIPS during the Uruguay Round negotiations and when it did, there is no evidence that it also meant it for products containing new biological entities. Moreover, the EU still makes a distinction between products containing a chemical entity and those that contain biological entities. For example, in the FTA with Peru and Colombia (provisionally applied with Peru since 1 March 2013 and with Colombia since 1 August 2013), after providing for test data exclusivity for ‘pharmaceutical products’ in general, it is clarified in footnote 72 that for the EU and Colombia this protection includes ‘protection of biological and biotechnology products’. Apparently, Peru is not obliged under the FTA to extend the test data exclusivity protection to products containing biological entities. See Art 231(1) Peru-Colombia-EU FTA.

See the discussion in Sect. 4.​1.​2.​2.

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

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

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

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

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

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

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

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

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

An assessment of regulatory authorities of the countries of sub-Saharan Africa, commissioned by the World Health Organization (WHO) found that in most countries there was no capacity to assess new innovator (those for which test data is used for assessment of safety and efficacy) products and most countries had a shortage of adequately qualified assessors. World Health Organization (WHO), Assessment of medicines regulatory systems in sub-Saharan African countries: An overview of findings from 26 assessment reports 13-5 (2010) available at http://​www.​who.​int/​healthsystems/​Assessment26Afri​can_​countries.​pdf (last visited 2 June 2016). Another study of two developed and eight developing countries, commissioned by the WHO, concluded that shortage of staff is one of the main issues faced by the countries analyzed. Moreover, many of the regulatory authorities also faced financial resource constraints. Sauwakon Ratanawijitrasin & Eshetu Wondemagegnehu, Effective Drug Regulation 137–9 (2002) available at http://​apps.​who.​int/​medicinedocs/​pdf/​s2300e/​s2300e.​pdf (last visited 2 June 2016).

A variation of this approach would be to require that the application for a new chemical entity should be filed within a specific period of time from the first approval any where in the world. The test data exclusivity laws of Costa Rica, Dominican Republic and Colombia, for example, require that the application for approval be filed within five years from the first registration elsewhere in the world. See Sect. 6.​4.​3.​3. Countries can also shorten this period to one year or less.

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

For example, see country studies cited in Sect. 2.​3.

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

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

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

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

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

de Carvalho (2008) at 294.

Correa (2007) at 380.

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

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

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

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

Without making this distinction, the scope of protection under Art 39(3) will unreasonably expand in contravention of the purpose of the provision. For example, an application for a new chemical entity contains ‘an application form, an index, a summary, five or six technical sections, case report tabulations of patient data, case report forms, drug samples, and labeling, including, if applicable, any Medication Guide required under part 208 of this chapter.’ 21 CFR §314.50 (2003) available at https://​www.​accessdata.​fda.​gov/​scripts/​cdrh/​cfdocs/​cfcfr/​CFRSearch.​cfm?​fr=​314.​50 (last visited 2 June 2016). This section of the regulation uses the phrase ‘data and information’ three times clearly making a distinction between the two concepts.

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

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

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

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

See Sect. 1.​1 for a brief historic discussion of the protection of safety and efficacy data. For detailed historic recount, please see the references cited therein.

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

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

Correa (2007) at 379.

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

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