Abstract
This study has highlighted the current state of affairs with regard to test data exclusivity protection. The world is much different today as compared to the year 1995. The success of countries, supporting the ‘misappropriation approach’ finally adopted in Art 39(3) TRIPS, appears to have lived its life. The willingness of increasing number of WTO Members to introduce test data exclusivity in their national laws may gradually usher in a decisive interpretation of Art 39(3) TRIPS, one that is in conflict with its negotiating history; one that the GATT negotiators rejected 20 years ago.
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Notes
- 1.
Carlos M. Correa, A Model Law for the Protection of Undisclosed Data, in Intellectual Property and Sustainable Development: Development Agendas in A Changing World 370 (Ricardo Meléndez-Ortiz & Pedro Roffe eds. 2009) [hereinafter Correa (2009)].
- 2.
Robert Weissman, Data Protection: Options for Implementation, in Negotiating Health: Intellectual Property and Access To Medicines 151 (Pedro Roffe, Geoff Tansy & David Vivas Eugui eds., 2006).
- 3.
MPI IP Principles (2013) at 2.1.
- 4.
Wouters & De Meester (2007) at 34–44.
- 5.
See USTR, Generalized System of Preferences, http://www.ustr.gov/trade-topics/trade-development/preference-programs/generalized-system-preference-gsp (last visited 4 August 2015) and European Commission, Generalized Scheme of Preferences at http://ec.europa.eu/trade/policy/countries-and-regions/development/generalised-scheme-of-preferences/ (last visited 2 June 2016).
- 6.
A developing country negotiating the FTA may itself already be the beneficiary of such concessions. In such cases, it is even more important to assess the benefits of accepting TRIPS-plus conditions in exchange of market access.
- 7.
This is the case with Korea, Peru, Colombia etc.
- 8.
See discussion in Sect. 5.4.5.2.2.
- 9.
See Chap. 1.
- 10.
See for example, Art 4.20 Jordan-US FTA, Art 16.7.6(a) Singapore-US FTA and 17.9.7(a) Australia-US FTA.
- 11.
Reichman has been a vocal proponent of this approach in many areas of IP. His arguments for a liability regime instead of an exclusivity regime are well established in the intellectual property literature. See for example, Jerome H. Reichman, Legal Hybrids Between the Patent and Copyright Paradigms, [94(8)] Columbia L. Rev. 2432, 2505–58 (1994); Jerome H. Reichman, Charting the Collapse of the Patent-Copyright Dichotomy: Premises for a Restructured International Intellectual Property System, 13 Cardozo Arts & Ent. L. J. 475 (1995) and Jerome H. Reichman, Of Green Tulips and Legal Kudzu: Repackaging Rights in Subpatentable Innovation, 53 Vanderbilt L. Rev. 1743, 1776–1798 (2000). With regard to the application of liability rules to test data see Fellmeth (2004) at 479–99; Dinca (2005) at 549–61; Reichman (2006) at 133; Jerome H. Reichman, Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach, 13 Marquette Intell. Prop. L. Rev. 1, 29–36 (2009) [hereinafter Reichman (2009)]; Judit Rius Sanjuan, James Love & Robert Weissman, The Protection of Pharmaceutical Test Data: A Policy Proposal (21 November 2006), KEI Research Paper 2006:1, [hereinafter KEI Policy Proposal (2006)] available at http://keionline.org/print/book/export/html/438 (last visited 2 June 2016).
- 12.
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. §136 et seq.
- 13.
See Sect. 3.3.1.2.2.
- 14.
Dinca (2005) at 556–561.
- 15.
Reichman believes that the resistance to this approach by developing countries is mainly because of the perceived victory in the shape of a ‘misappropriation approach’ in Art 39(3) TRIPS. He argues that such a position is not helpful when countries accept ‘harsher exclusive rights clauses’ in FTAs regarding test data protection ‘without even attempting to fall back on counter proposals sounding in compensatory liability principles’. Reichman (2009) at 31.
- 16.
The recommendations relating to FTAs are also mutatis mutandis applicable in case of national laws.
- 17.
See note 2 and accompanying discussion in Chap. 6.
- 18.
See for example, Art 177(c) Decree 57-2000 as amended by Art 67 of Decree 11-2006 (Guatemala); Art 181-B, ¶2 Legislative Decree 912 of 14 December 2005 (El Salvador) and Art 181(2), Law No 20-2000 as amended by Art 32 of Law No 424-2006 (Dominican Republic).
- 19.
Art 4(e) Decree 2085 of 2002 (Colombia).
- 20.
Art 39(3) is clear on this point. It provides that a WTO Member does not need to provide protection against disclosure where adequate protection against unfair commercial use is provided. Test data exclusivity is the adequate protection in this regard. Hence, where developing countries provide test data exclusivity in their national laws, they are relieved of their obligation for protection of test data against disclosure.
- 21.
See for example, Fellmeth (2004) at 479–99; Dinca (2005) at 549–61 and KEI Policy Proposal (2006).
- 22.
See generally, the model provisions in Correa (2009). A potential problem with this option is that the funds generated from such fee may come to be seen as beneficial in their own sense for the approval authority or for the FTA party itself. This would overshadow the actual purpose of imposition of such fee, which is to require the originator to maintain its right of exclusivity during the period of protection.
- 23.
See generally, IFPMA (2011).
- 24.
A glaring example in this regard has been the FTA negotiations between India and EU. Test data exclusivity is considered to be a main hurdle in conclusion of the talks. See for example, Data Exclusivity Still Key Hurdle to India-EU FTA, Bus. Standard, 27 January 2011 available at http://www.business-standard.com/article/economy-policy/data-exclusivity-still-key-hurdle-to-india-eu-fta-111012700034_1.html (last visited 4 August 2015).
- 25.
EFPIA, The Pharmaceutical Industry in Figures 4 (2013) available at http://www.efpia.eu/uploads/Figures_Key_Data_2013.pdf (last visited 2 June 2016).
- 26.
According to IMS Health, ‘pharmerging’ countries include China, Brazil, Russia, India, Mexico, Turkey, Venezuela, Poland, Argentina, Saudi Arabia, Indonesia, Colombia, Thailand, Ukraine, South Africa, Egypt, Romania, Algeria, Vietnam, Pakistan and Nigeria. IMS Health, Pharmerging Shake-up: New Imperatives in a Redefined World 3 (2013), available at http://ficci.in/spdocument/20174/PHARMERGING%20SHAKE-UP.pdf (last visited 2 June 2016).
- 27.
IMS Inst. for Healthcare Informatics, The Global Use of Medicines: Outlook Through 2017 1 (2013) [hereinafter IMS (2013)], available at http://www.quotidianosanita.it/allegati/allegato1501906.pdf (last visited 2 June 2016).
- 28.
IMS (2013) at 24.
- 29.
Warren A. Kaplan et al, The Market Dynamics of Generic Medicines in the Private Sector of 19 Low and Middle Income Countries Between 2001 and 2011: A Descriptive Time Series Analysis, 8 PLoS One 1, 7 (2013), doi:10.1371/journal.pone.0074399 (last visited 2 June 2016).
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Shaikh, O.H. (2016). Conclusions and Recommendations. In: Access to Medicine Versus Test Data Exclusivity. Munich Studies on Innovation and Competition, vol 4. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-49655-8_8
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