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Extending the Limits of Protection of Pharmaceutical Patents and Data Outside the EU – Is There a Need to Rebalance?

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Abstract

The European Union (EU) has instituted internal and external measures aimed at protecting and enforcing intellectual property rights. In the area of pharmaceutical patents, the Union has also sought to protect its industries through patent term extension and data exclusivity. Recent EU Free Trade Agreements (FTAs) with developing countries contain chapters on intellectual property that extend patent terms and data exclusivity for pharmaceutical products. Such acts further prolong the lifespan of protection given to existing products and limit generic market entry. This article identifies the issue as one of “cross-pollination” of laws and argues that since similar laws exist in the internal regime of the EU, incorporating them into the EU would not be technically too difficult. However, to an extent this regime is simulated in developing countries, implementation will bring major difficulties to the health sector and economies of these countries. The article thus proposes that developing countries should not be forced to adopt such laws through FTAs, and if they are, there should be the compulsory inclusion of both (1) a clause on transitional arrangements for developing countries specific to intellectual property; and (2) a clause that clearly links the objectives for intellectual property protection and enforcement (in this context, patent term extension and data exclusivity) to balancing between the promotion of technological innovation and access to medicines.

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Notes

  1. Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The TRIPS Agreement is Annex 1C to the Marrakesh Agreement Establishing the World Trade Organization (WTO), 15 April 1994, 33 I.L.M 1125, 869 U.N.T.S. 299 (Hereinafter, the TRIPS Agreement).

  2. Ho (2011a), p. 262. (emphasis added).

  3. For a working definition of (“multilateral”, “plurilateral” and “regional” Agreements), Flynn et al. (2012); Yu (2012); Grosse Ruse-Khan (2011a); Okediji (2003–2004); Helfer (2004).

  4. TRIPS Art. 1.1 permits contracting countries to adopt more extensive IP laws domestically than is required by the Agreement provided that “such protection does not contravene the provisions of this Agreement.” For a varied opinion on how this clause could lead to “ceiling rules” in international IP, see Kur and Grosse Ruse-Khan (2008); also, Grosse Ruse-Khan (2009).

  5. It is, however, worth noting that in 2007, the US Congress and the Bush administration reached a bipartisan compromise on a “New Trade Policy for America”, which called for more balance on the position of the US in FTA negotiations regarding issues related to IP, labour standards, and the environment. In response to concerns over US FTAs undermining TRIPS flexibilities, the provisions on data exclusivity, patent extensions, and the linkage between patent protection and drug approval were relaxed substantially, while the new template for FTAs now also includes specific provisions on public health. (See Grosse Ruse-Khan (2011a), at 331, emphasis added). However, it may seem the US is turning its back on this compromise at the Trans-Pacific Partnership Agreement (TTP) negotiations as it is reported that the US tabled two IP chapter proposals to TPP negotiators in 2011. Included in those proposals are provisions dealing with traditional data exclusivity for pharmaceutical products involving new chemical entities and a placeholder for biologics (see Flynn et al. (2012), at 149–183).

  6. Broadly, Supplementary Protection Certificate (SPC) is the EU equivalent to patent term extensions under the US Hatch-Waxman Act. Contrary to patent term extension, an SPC is not an extension of the respective patent as such, but an exclusive right per se which refers to a given basic patent. For convenience, I use patent term extension to mean both throughout this article.

  7. By internal, I mean the EU level of regulation (regional) and by external, I mean the EU’s bi/multilateral agreements with state entities and international organisations.

  8. Used here to refer to both Developing Countries and Least Developed Countries (LDCs).

  9. See Arts. 1709(12) and 1711(5)–(7) respectively of NAFTA.

  10. See Art. 39.3 TRIPS.

  11. Mulaje et al. (2013).

  12. Di Masi et al. (1994, 2003); see also Grabowski (2007). Available at: http://www.econ.duke.edu/Papers/PDF/DataExclusivityWorkingPaper.pdf.

  13. Di Masi et al. (1994, 2003); Grabowski (2007).

  14. This also includes “provisional patent protection” as known in the US or, “right of priority” under the European Patent Convention (EPC). A provisional patent protection in the US is a one-year placeholder offering no rights other than the filing date priority claim. During that year, the United States Patent and Trademark Office (USPTO) ignore the application until the applicant takes some additional steps – typically filing a non-provisional application or an international PCT application. At the end of the year, the provisional application is automatically abandoned. In Europe, Art. 87(1) EPC states: “A person, [or his successors in title], who has duly filed in or for any State party to the Paris Convention for the Protection of Industrial Property, an application for a patent or for the registration of a utility model or for a utility certificate or for an inventor's certificate, shall enjoy, for the purpose of filing a European patent application in respect of the same invention, a right of priority during a period of 12 months from the date of filing of the first application”.

  15. Patents protect inventions and not data. However, during its lifetime, patents grant an exclusive market monopoly that prevents others from competing on the market. In this sense, firms with strong patent portfolios do not actually benefit from data exclusivity unless they go beyond the patent term. Data exclusivity becomes truly beneficial when there is no patent protection, a patent has expired, or a patent is found invalid, etc.

  16. Pugatch (2005), p. 21.

  17. Higgins and Graham (2009).

  18. The relevance of this question lays in the fact that to date, most developing countries still lack manufacturing capacity, and are struggling to fully implement the TRIPS Agreement. This explains why there have been series of extensions on implementation deadlines for least developed and developing countries, the most recent being the (Decision by the Council for TRIPS of 11 June, 2013 [Extension of the Transition Period Under Art. 66.1 for Least Developed Country Members, IP/C/64]) which further extends until 1 July 2021 the deadline for least developed countries to protect IP under the WTO TRIPS Agreement, with a further extension possible when the deadline comes. This follows from earlier decisions (see, e.g. Council for TRIPS, Extension of the Transition Period Under Art. 66.1 for Least Developed Country Members, IP/C/40, [Decision by the Council for TRIPS of 29 November, 2005] to extend the transition period for least developed countries to July 2013 from originally 1 January 2006). By the decision of 27 June 2002 (Council for TRIPS, Decision by the Council of TRIPS of 27 June 2002, IP/C/25), the transition period for least developed countries in regard to the introduction of patent protection for pharmaceutical and agricultural products had already been extended to 2016. Subscribing to FTAs with TRIPS-plus provisions on IP will simply render these extensions void.

  19. See the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585, 1585–1605 (codified as amended at 21 U.S.C. Sec. 355 [2006]).

  20. Until the Hatch-Waxman Act of 1984, patents had a term of 17 years from grant in the US whereas it is now 20 years from application. See note 23 infra.

  21. Soehnge (2003); see also, Sanjuan (2006), available at: http://www.keionline.org/miscdocs/.

  22. Baker (2008). (Also, the use of animals and humans for clinical trials raise ethical questions).

  23. This was so because the 17-year patent term was measured from the date that the patent was granted (see 35 U.S.C. Sec. 154(a)(2)). The time that the USPTO took to issue a patent was three years or less, measured from the earliest referenced application, and the fact that a patentee’s rights do not begin until a patent issues from that application (see 35 U.S.C. Sec. 154(a)(1)).

  24. See 21 U.S.C. Secs. 355(c)(3)(E)(ii), (j)(5)(F)(ii) (Supp. 2005). The actual length of marketing exclusivity is usually 6.5 years because of the 18 months it takes the FDA to approve a generic application. See Baker (2008), at footnote 21.

  25. See 21 U.S.C. Secs. 355(c)(3)(E)(iii), (j)(5)(F)(iii). Also, see Baker (2008), at footnote 23 where he explains that the pharmaceutical industry gained another six-month period of data exclusivity as a reward for conducting pediatric trials on drugs via the Food and Drug Administration Modernization Act of 1997. 21 U.S.C. Sec. 355a(b).

  26. See 35 U.S.C. Sec. 156. Subsection (a) describes the basic requirements to be met before a patent can be extended. For a list of these, refer to note 50 in Soehnge (2003).

  27. Fisher (1986); also, Baker (2008), at 306; Soehnge (2003), at 53.

  28. The Hatch-Waxman Act reversed the decision of the Court of Appeals for the Federal Circuit in Roche Products v. Bolar Pharmaceuticals Co., 733 F.2d 858 (Fed. Cir. 1984). The U.S. “Bolar” exception is found in Sec. 35 USC 271(e)(1), which reads in part: “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention… solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products”. The underlying logic of the Bolar provision is that it reduces delays in the launch of a generic product, because the generics industry is entitled to conduct the necessary bioequivalence and quality manufacturing studies while the reference product is still under patent protection.

  29. See Soehnge (2003), at 53.

  30. See Soehnge (2003), at 53. Citing Atkinson (2002).

  31. Gitter (2008). (Follow-on biologics are the generic alternative of biologics. Biologics are drugs generally derived from living materials, including blood-derived products, vaccines, and most protein products. They cannot be described in simple terms or using simple formulae because they are the output of a highly complex and nuanced laboratory processes). See FDA, “Frequently Asked Questions About Therapeutic Biological Products”: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113522.htm.

  32. See Patient Protection and Affordable Care Act, Pub. L. No. 111-148, Secs. 7001-03, 124 Stat.119 (2010) (enacting Biologics Price Competition and Innovation Act of 2009, H.R. 3590, 111th Cong. (2009)). The BPCIA provides for the licensing of “biosimilar” and “interchangeable” biological products.

  33. Sheryl Gay Stolberg and Robert Pear, “Obama Signs Health Care Overhaul Bill, With a Flourish”, N.Y. Times, 23 March 2010, available at http://www.nytimes.com/2010/03/24/health/policy/24health.html (accessed 1 November 2013).

  34. The FDA’s refusal to permit follow-on biologics manufacturers to utilise the abbreviated Hatch-Waxman pathway stemmed from the inherent difficulty of meeting the statutory requirement of “bioequivalence” in the context of large bio-molecules. Given the nature of biological products and the complexity of the science involved, it has been difficult for lawmakers to reach a consensus on approval standards and IP protections for innovators. For more on this, see Vernon et al. (2010).

  35. See Vernon et al., id.

  36. Di Masi and Grabowski (2007); also, Grabowski (2008).

  37. On the difference in regulation and history of biologics in the US, see Vernon et al. (2010), at 57.

  38. Maxwell (2010).

  39. See 42 U.S.C. Sec. 362(K) generally and Sec. 362(7)(A) specifically with respect to the period of exclusivity.

  40. Simoens et al. (2011).

  41. See http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2011/01/bpcias-principal-authors-seek-to-clarify-congressional-intent-with-respect-to-12-year-exclusivity-pe.html.

  42. See Office of Budget and Management, Fiscal Year 2014: Budget of the United States Government, 40, available at: http://www.whitehouse.gov/sites/default/files/omb/budget/fy2014/assets/budget.pdf.

  43. Lourie (1985), making reference to the Patents Act 1949, Secs. 23–25.

  44. Lourie (1985), making reference to the Patents Act 1949, Secs. 23–25.

  45. Lourie (1985), making reference to the Patents Act 1949, Secs. 23–25, (citing Patents Act 1977, Sec. 25).

  46. Law No. 27 of 1987, reprinted in Official Gazette, 28 May 1987, at 2. These statutes became effective on 1 January 1988 in Japan.

  47. Moore (1998).

  48. See French Law No. 90-5 10 of 25 June 1990, and French Implementing Decree No. 91-1180 of 19 November 1991; Italian Law No. 349 of 19 October 1991; also Mazer (1993).

  49. See Council Regulation (EEC) No. 1768/92, OJ EC of 2 July 1992 No. L 182/1 concerning the creation of a supplementary protection certificate for medicinal products (Hereinafter, Patent Term Extension Law).

  50. Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, 1 O.J. (L 152) (2009).

  51. See Recital 10 and Art. 13(2) of Regulation (EC) No. 469/2009.

  52. Recital 10 and Art. 13(2) of Regulation (EC) No. 469/2009, Art. 4.

  53. Recital 10 and Art. 13(2) of Regulation (EC) No. 469/2009, Art. 4, Art. 21.

  54. Council Directive 87/21/ECC of 22 December 1986, amending Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products.

  55. Council Directive 65/65/EEC.

  56. See Sanjuan (2006), at 8 (emphasis added).

  57. See Mazer (1993), at 571.

  58. See Ho (2011a) at 261. In particular, Greece, Spain and Portugal did not provide product patents to pharmaceuticals at that time. (See also supra note 53.)

  59. See Council Directive 87/21/ECC, supra note 54.

  60. Until the new Directive in 2004, data exclusivity of ten years applied for biologics applications filed before the European Medicines Agency (EMA), while for national applications or mutual recognition procedures, a data exclusivity period of six years applied, with some countries (the United Kingdom, Belgium, France, Germany, the Netherlands, Italy, Luxembourg and Sweden) expanding this term to ten years. (See Storz 2012). For an overview of high-technology medicinal products, see the annex of Council Directive 87/22/EC (Council of the European Communities 1987b).

  61. Council Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.

  62. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

  63. Article 10.4 Directive 2004/27/EC.

  64. See Sanjuan (2006) at 12.

  65. Adamini et al. (2009).

  66. Article 10(2)(b) of Directive 2004/27/EC defines “generic medicinal product” as a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies … bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines.

  67. For a review, see Adamini et al. (2009), at 979–1007; Mazer (1993), at 571–576.

  68. Case C-414/11, Daiichi Sankyo Co. Ltd, Sanofi-Aventis Deutschland GmbH v. DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon (18 July 2013).

  69. See Case C-414/11, Daiichi Sankyo Co. Ltd, Sanofi-Aventis Deutschland GmbH v. DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon (18 July 2013), paras. 15 and 21. Greece ratified the Convention on the Grant of European Patents (EPC) in 1986, but it was only from 1992, on the expiry of a reservation previously expressed, that Greece also recognised the patentability of pharmaceutical products.

  70. See Case C-414/11, Daiichi Sankyo Co. Ltd, Sanofi-Aventis Deutschland GmbH v. DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon (18 July 2013), paras. 15 and 21. Greece ratified the Convention on the Grant of European Patents (EPC) in 1986, but it was only from 1992, on the expiry of a reservation previously expressed, that Greece also recognised the patentability of pharmaceutical products, para. 83 (emphasis added).

  71. TRIPS-plus refers to provisions that either exceed the requirements of TRIPS or eliminate flexibilities in implementing TRIPS. For a review, see Sell (2007); Abbott (2002); Drahos (2001); Tandon (2008); Ho (2011a), at 2; Kur and Grosse Ruse-Khan (2008).

  72. On a challenge to this assumption, see Grosse Ruse-Khan (2009). He laments how this concept, although seldom used in the treaty language of international agreements on IP protection, has almost universally been perceived. Obligations emerging from international IP Agreements such as TRIPS, create a “floor” consisting of a minimum level of protection, which is available to all WTO Members – with presumably the sky being the only limit as to the further extension of IP protection.

  73. See Paris Convention for the Protection of Industrial Property, 20 March 1883, 21 U.S.T. 1583, 828 U.N.T.S. 305 (as last revised in Stockholm, 14 July 1967) (hereinafter Paris Convention).

  74. Roffe and Vea (2008); see also WIPO, document HL/CE/IV/INF/1, prepared for the consideration of the Committee of Experts on the harmonization of certain aspects of laws protecting inventions, fourth meeting, 14 October 1987; see also, Walker (2001), available at http://data.iucn.org/dbtw-wpd/edocs/EPLP-041.pdf.

  75. For details, refer to supra notes 3 and 18.

  76. El Said (2010).

  77. For a thorough review, see El Said (2010).

  78. Sell (2011); also, Sell, supra note 67.

  79. This theme is apparent in many of the documents often circulated by the EU Commission on the need to strengthen IP enforcement, for example, the European Commission Staff Working Document, “Report on the Protection and Enforcement of Intellectual Property Rights in Third Countries”, SWD (2013) 30 final. Available: http://trade.ec.europa.eu/doclib/docs/2013/march/tradoc_150789.pdf; Directorate General for Taxation and Customs Union of the European Commission, Customs Controls – A serious problem for everyone (2010). Available at http://ec.europa.eu/taxation_customs/customs/customs_controls/counterfeit_piracy/combating/index_en.htm; The Union’s Strategy for the Enforcement of Intellectual Property Rights in Third Countries (2005/C 129/03).

  80. This theme is apparent in many of the documents often circulated by the EU Commission on the need to strengthen IP enforcement, for example, the European Commission Staff Working Document, “Report on the Protection and Enforcement of Intellectual Property Rights in Third Countries”, SWD (2013) 30 final. Available: http://trade.ec.europa.eu/doclib/docs/2013/march/tradoc_150789.pdf; Directorate General for Taxation and Customs Union of the European Commission, Customs Controls – A serious problem for everyone (2010). Available at http://ec.europa.eu/taxation_customs/customs/customs_controls/counterfeit_piracy/combating/index_en.htm; The Union’s Strategy for the Enforcement of Intellectual Property Rights in Third Countries (2005/C 129/03); also, Correa (2001).

  81. Govaere (2008).

  82. See for instance Daniel Gervais, “TRIPS and Development”, Selected Works (2013), available http://works.bepress.com/daniel_gervais/42; also, Dommen (2005) (who insinuates that even staunch World Trade Organization supporters agree that, during the negotiations creating the WTO, developing countries agreed to substantially more obligations than developed countries did).

  83. Known as “forum-shifting”, the term is used in contemporary legal writings to refer to L.R. Helfer’s “regime shifting” in his paper (supra note 3, at 14) where he defines the term to mean an “attempt to alter the status quo ante by moving treaty negotiations, lawmaking initiatives, or standard setting activities from one international venue to another”.

  84. Okediji (2003–2004), at 136. (Often, these agreements are negotiated in secret and without proper consultations enabling the front-runners to push for IP laws that put third countries in a situation where they could violate their obligations under international human rights law).

  85. Sell (2010); also Sell (2011), at 469–505.

  86. The 45 Adopted Recommendations under the WIPO Development Agenda are available at http://www.wipo.int/ip-development/en/agenda/recommendations.html.

  87. World Trade Organization, the Doha Declaration on the TRIPS Agreement and Public Health, WTO Ministerial Conference Declaration of 14 November 2001, WT/MIN(01)/DEC/2 (hereinafter, the Doha Declaration).

  88. TRIPS Art. 33.

  89. TRIPS Arts. 7 and 8.1 read in conjunction with Art. 1.1. The key areas of TRIPS flexibilities for public health include: compulsory licenses (Art. 31), parallel importation (Art. 8.1), and the Doha Declaration waivers.

  90. See Sell (2007), at 51 and 58.

  91. See Kur and Grosse Ruse-Khan (2008).

  92. See Kur and Grosse Ruse-Khan (2008), at p. 14 et seq. (Kur and Grosse Ruse-Khan observe that this concept might offer a way to ensure and maintain a balanced approach towards IP protection, and to protect member States’ autonomy in preserving public policy goals vis-à-vis pressure exerted against them in FTAs. The weakness of this proposal however is the risk that, a principle of maximum rules might reduce instead of enhance member States’ ability to utilise TRIPS flexibilities – as well as institutional and procedural questions such as how this would fit with the current WTO/TRIPS system).

  93. TRIPS only laid down minimum standards for IP protection and gave room for “optional” flexibilities, which member States could either choose to implement or choose not to. Thus, in case of a conflict, applying the notion of “contravening” in Art. 1.1 TRIPS so as to prevent a WTO member from deciding how to exercise this flexibility in effect turns the optional rule into a mandatory one. Also, given the very general terms used in the balancing objectives and public interest principles of TRIPS Arts. 7 and 8, it may be difficult to say that TRIPS-plus FTAs cannot derogate from TRIPS flexibilities taking into account the language of Art. 41 VCLT. (See Grosse Ruse-Khan 2011a) at 338 et seq).

  94. TRIPS only laid down minimum standards for IP protection and gave room for “optional” flexibilities, which member States could either choose to implement or choose not to. Thus, in case of a conflict, applying the notion of “contravening” in Art. 1.1 TRIPS so as to prevent a WTO member from deciding how to exercise this flexibility in effect turns the optional rule into a mandatory one. Also, given the very general terms used in the balancing objectives and public interest principles of TRIPS Arts. 7 and 8, it may be difficult to say that TRIPS-plus FTAs cannot derogate from TRIPS flexibilities taking into account the language of Art. 41 VCLT. (See Grosse Ruse-Khan 2011a at 338 et seq), at 348.

  95. Enshrined in Art. 25 of the Universal Declaration of Human Rights (UDHR), adopted and proclaimed by the UN General Assembly in resolution 217 A (III) of 10 December 1948 at Paris. It is further incorporated in Art. 12 of the International Covenant on Economic Social Cultural Rights (ICESCR) where states recognise the “right of everyone to the enjoyment of the highest attainable standard of physical and mental health”.

  96. See Kur and Grosse Ruse-Khan (2008).

  97. See Kur and Grosse Ruse-Khan (2008), at 22.

  98. See Kur and Grosse Ruse-Khan (2008), at 10.

  99. See Kur and Grosse Ruse-Khan (2008), pp. 10, 23–24 (emphasis added). Generally speaking, any treaty must be applied with a presumption in favour of continuity and against conflict in the sense that all pre-existing international rules continue to apply unless there is clear evidence that the parties to the treaty wished to depart from a specific pre-existing rule. Only if the relevant norms are not sufficiently open to allow such a mutual supportive understanding, the conflict has to be resolved by means of the relevant conflict norms of either treaty (if any) or those of general international law, in this case, the VCLT Arts. 30 or 41 applies.

  100. Reichman (2009) et seq.

  101. Adamini et al. (2009) at 987.

  102. Reichman (2009); also, Ho (2011a); Sanjuan (2006).

  103. See Sanjuan (2006); Ho (2011a).

  104. TRIPS Art. 39(3), Introduction: terminology, definition and scope, p. 520 et seq.

  105. Negotiations were launched in June 2007; after 11 full rounds, negotiations are now in a phase where negotiators meet in smaller more targeted clusters rather than full rounds, i.e. expert level inter-sessionals, chief negotiator meetings and meetings at Director General level. Following the EU–India Summit on 10 February in Delhi negotiations are currently in an intense phase focusing on the hard core issues but work remains to be done. Important issues include market access for goods (improve coverage of both sides' offers), the overall ambition of the services package and achieving a meaningful chapter on government procurement and Data Exclusivity; also, David (2010).

  106. See Medecins Sans Frontieres, Briefing Paper “How A Free Trade Agreement Between the European Union and India Could Threaten Access to Affordable Medicines for Millions of People Worldwide” (9 Feb. 2012), available at: http://www.msfaccess.org/content/how-fta-between-eu-and-india-could-threaten-access-affordable-medicines.

  107. TRIPS Art. 4.

  108. TRIPS Art. 3.

  109. The GATT Art. XXIV permits further liberalisation of trade through Customs Union and Free Trade Areas whiles the GATS does not prevent any of its Members from being a party to or entering into an agreement liberalising trade in services between or among the parties to such an agreement.

  110. See Kur and Grosse Ruse-Khan (2008) at note 23: Inter se agreements or modifications refer to situations where some of the parties to a multilateral treaty conclude an agreement which modifies the treaty amongst themselves. Under general international (treaty) law, Art. 41:1 of the Vienna Convention on the Law of Treaties (VCLT) allows two or more of the parties to a multilateral treaty to “conclude an agreement to modify the treaty as between themselves”.

  111. Grosse Ruse-Khan (2011b); see also Kur and Grosse Ruse-Khan (2008).

  112. Ho (2011b); also Ho (2011a).

  113. Ho (2011c).

  114. For a general overview, see Ho (2011c).

  115. See http://trade.ec.europa.eu/doclib/docs/2012/november/tradoc_150129.pdf.

  116. For the FTA between the EU–Korea, see http://www.consilium.europa.eu/policies/agreements/search-the-agreementsdatabase?command=details&id=&lang=en&aid=2010036&doclang=EN; Concerning that of Peru, http://trade.ec.europa.eu/doclib/press/index.cfm?id=873; and for Colombia, see http://trade.ec.europa.eu/doclib/press/index.cfm?id=953.

  117. Article 230.4. Peru–Colombia.

  118. Correa (2006).

  119. Correa (2006), pp. 399–402.

  120. Article 4 of Regulation (EC) No. 469/2009 clearly stipulates that “within the limits of the protection conferred by the basic patent, the protection conferred by the certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.” Article 1(c) defines the “basic patent” as meaning a patent that protects a product as such, a process to obtain a product or an application of a product, and that is designated by its holder for the purpose of the procedure for grant of a certificate. Article 1(b) defines a “product” to mean the active ingredient or combination of active ingredients of a medicinal product. What is not clear is whether this definition extends to cover new uses of drugs. These Articles, read in conjunction with Art. 3(c) and (d) of the regulation, place enormous limitations on the possibility for “evergreening”, in the EU at least, with respect to patent term extensions.

  121. See Art. 216(2) TFEU.

  122. See Art. 207(3)(2) TFEU; also, Drexl (2012).

  123. See Art. 207(3)(2) TFEU; also, Drexl (2012).

  124. For an overview see Mylly (2014); also, Drexl (2012).

  125. See Moore (1998), at 139.

  126. See Moore (1998), at 139.

  127. See supra note 116.

  128. Article 21 of Regulation (EEC) No. 1768/92. Even though the law would take effect in those countries as of 1998, it was not until 2012, when patents on pharmaceutical products which were registered in 1992 are expired, that the full benefits of patent term extensions were realised.

  129. Simoens and De Coster (2006).

  130. Either side of the story will go strongly against developing countries. About a third of all drugs are produced by India. See http://www.indiainbusiness.nic.in/industry-infrastructure/industrial-sectors/drug-pharma.htm. India produces a large number of high-quality, affordable generic medicines in part due to competition stemming from Indian generics. The price of first-line ARVs dropped from more than US$10,000 per person per year in 2000 to around $150 per person per year to date. This significant price decrease has helped to facilitate the massive expansion of HIV treatment worldwide. More than 80 % of the HIV medicines used to treat 6.6 million people in developing countries comes from Indian producers, and 90 % of paediatric HIV medicines are Indian-produced. MSF and other treatment providers also rely on Indian generic medicines to treat other diseases and conditions. Credit: http://www.msfaccess.org/content/how-fta-between-eu-and-india-could-threaten-access-affordable-medicines.

  131. See Art. 15(2) of Regulation (EC) No. 469/2009.

  132. Drahos (2007).

  133. Dahrendorf (2009).

  134. Article 10.36(3) EU–Korea.

  135. See footnote 78 to Art. 231(1) Peru–Colombia.

  136. As already noted, the said FTAs are provisionally being applied in the EU-pending ratification by all Member States. It therefore remains to be seen the impact implementation will have on existing laws. Refer to supra note 116.

  137. Ho (2011a), at 269.

  138. Abbott (2004). It must however be noted that there is an exception to this in the Peru–Colombia Agreement (Art. 231.4[a]), where parties may regulate “exceptions for reasons of public interest, situations of national emergency or extreme urgency, when it is necessary to allow access to these data to third parties”.

  139. Ho (2011a), at 269 et seq.

  140. Ho (2011a), at 269 et seq., citing Shaffer and Brenner (2009); and Baker (2008) at 310–311.

  141. Ho (2011a) at 269 et seq.

  142. Ho (2011a) at 269 et seq.

  143. Ho (2011a) at 269 et seq.

  144. This is without prejudice to the counter argument that research into less innovative drugs that may not necessarily meet patentability criteria but are nonetheless, promising drug candidates should be encouraged. However, such a conception also raises questions about the relevance of the patent system-- as it is believed the patent system is tailored to ensure that the government-imposed market barrier is only granted to those who have earned the reward by giving something of value back to society? It is also a question about how much investment go into the development of such drugs, how they should be priced and how much that benefits developing countries (which goes beyond the scope of this paper).

  145. Article 1 of Data Protection Decree No. 2085 of 19 September 2002 of Colombia and Art. 2 of Legislative Decree 1072 of Peru on the Protection of Undisclosed Test Data or Other Undisclosed Data Related to Pharmaceutical Product.

  146. Love (1997).

  147. Medecins Sans Frontieres, (9 February 2012), Briefing Document “How a Free Trade Agreement between the European Union and India could threaten access to affordable medicines for millions of people worldwide”, available at: http://www.msfaccess.org/content/how-fta-between-eu-and-india-could-threaten-access-affordable-medicines; see also Oxfam International, “All Costs, No Benefits: How TRIPS Plus IP Rules in the US Jordan FTA Affect Access to Medicine” pp. 7–8 (Oxfam Briefing Paper No. 102, 2007), available at http://www.oxfam.org.uk/resources/issues/health/downloads/bp102_trips.pdf.

  148. Oxfam and Health Action International (October 2009), “Trading away access to medicines. How the European Union’s trade agenda has taken a wrong turn”, http://www.oxfam.org/sites/www.oxfam.org/files/bp-trading-away-access-to-medicines.pdf.

  149. For a review of such reforms, see Adamski et al. (2010). (It must, however, be emphasised that data exclusivity and patent term extension laws were not the only prevailing reasons for such mitigating measures; other important health-related factors such as the instigation of stricter clinical targets, launch of new expensive drugs, rising patient expectations and ongoing demographic changes stood tall among the reasons).

  150. For example, see Clarke (2003).

  151. Godman et al. (2010); see also Vogler et al. (2011).

  152. Simeons (2008); also, Godman et al. (2010).

  153. Godman et al. (2008); Seeley and Kanavos (2008).

  154. Cameron et al. (2009).

  155. WHO (2004).

  156. Cameron et al. (2009), at 1.

  157. Mazer (1993), at 571.

  158. See the Transatlantic Trade and Investment Partnership (TTIP) available at http://ec.europa.eu/trade/policy/in-focus/ttip/. Touted as the biggest bilateral trade deal ever negotiated, first round talks took place in Washington, D.C. between 8 and 12 July 2013. The negotiations are set cover about 20 various areas.

  159. See supra note 42.

  160. Ho (2011b), at 251.

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  1. Turun Yliopisto, Turku, Finland

    Daniel Acquah (Faculty of Law, University of Turku)

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This article was written within the framework of the research project “Ecoherence – Reconciling economic and non-economic values in a multi-polar society”, financed by the Academy of Finland.

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Acquah, D. Extending the Limits of Protection of Pharmaceutical Patents and Data Outside the EU – Is There a Need to Rebalance?. IIC 45, 256–286 (2014). https://doi.org/10.1007/s40319-014-0183-1

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