By Owais H. Shaikh
This ebook explores the idea that of attempt facts exclusivity defense for prescribed drugs. concentrating on paintings 39(3) of the WTO contract on Trade-Related facets of highbrow estate Rights (TRIPS contract) and appropriate provisions in chosen loose alternate agreements (FTA) and nationwide legislation, it combines normative, historic, comparative and fiscal research of try info exclusivity protection.At the guts of this ebook is the unconventional and unique Index of knowledge Exclusivity and entry (IDEAS), which analyzes the effectiveness of attempt info exclusivity provisions in FTAs and nationwide legislation either at the power of exclusivity in addition to on entry to drugs. principles offers a framework for the overview of present try facts exclusivity safeguard criteria at the foundation in their proximity to Article 39(3) of the journeys contract, the scope of exclusivity and the flexibilities in FTAs, and to that end in nationwide legislation. This ebook goals to expand nationwide and foreign coverage makers’ grab of a number of the nuances of try out info exclusivity safeguard. moreover, it offers useful options with reference to designing a suitable felony approach with a powerful specialize in selling entry to drugs for all.
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Extra resources for Access to Medicine Versus Test Data Exclusivity: Safeguarding Flexibilities Under International Law
Art 3(2) Regulation 726/2005. See Sect. 2 for further discussion. Under patent law, the industrial applicability or utility requirement is present but there too there criteria is not that the pharmaceutical invention should be an advancement over existing products. 20 There may be cases where some novelty and non-obviousness is present in line extensions. In such a case, further patenting for another 20 years could be possible. 21 Fackelmann (2013) at 172–9. 22 This may be seen as similar to the practice of ever-greening of protection of pharmaceutical products.
But is it right to assume that test data would not be produced if not specifically incentivized? Moreover, is it necessary to confer an exclusive right as an incentive to produce such data? 12 In fact in the present case, test data is a public good that is, at best, an intermediate product, necessary for the production of the end product, the pharmaceuticals. This is by virtue of the legal requirement to provide proof for safety and efficacy of the pharmaceutical product. 15 11 Holcombe (1997) at 7 (using the example of television and radio broadcasts).
16 For an overview of alternatives to patent incentives, see generally, Stephen M. Maurer, When Patents Fail: Finding New Drugs for the Developing World in Pharmaceutical Innovation: Incentives, Competition and Cost-Benefit Analysis in International Perspective 108 (Frank A. Salon & Chee-Ruey Hsieh ed. 2007). 17 See notes 47–50 in Chap. 1. 18 To be fair, there is a quasi-novelty requirement for pharmaceutical products containing new chemical entities. The US law grants five years of test data exclusivity protection only to pharmaceutical products that contain a new chemical entity.