By Owais H. Shaikh
Read or Download Access to Medicine Versus Test Data Exclusivity: Safeguarding Flexibilities Under International Law (Munich Studies on Innovation and Competition) PDF
Similar commercial books
Significant adjustments have happened within the previous few years within the equipment of slicing and production outerwear. mild garments businesses at the moment are production those heavy clothing a result of improvement of fusible interlinings and new production thoughts that have led to the deskilling of conventional tailoring equipment.
This choice of essays contains a few of Rudolf Richter’s very important contributions to investigate on New Institutional Economics (NIE). It bargains with the significant thought, rules, and method of recent Institutional Economics and explores its relation to sociology and legislations. different chapters learn purposes of NIE to numerous microeconomic and macroeconomic concerns within the face of uncertainty, from entrepreneurship to the euro situation.
- Legal Environment of Business, The (6th Edition)
- Untreue zum Nachteil der GmbH: Versuch einer strafunrechtsbegründenden Rekonstruktion der Rechtspersonalität der Korporation (German Edition)
- Sizing in Clothing: Developing Effective Sizing Systems for Ready-To-wear Clothing (Woodhead Publishing Series in Textiles)
- Q&A Commercial Law 2003-2004 (Questions and Answers) (English and Mandarin Chinese Edition)
- Drybar Guide to Good Hair for All: How to Get the Perfect Blowout at Home
- Homo Oeconomicus: The Economic Model of Behaviour and Its Applications in Economics and Other Social Sciences (The European Heritage in Economics and the Social Sciences)
Additional info for Access to Medicine Versus Test Data Exclusivity: Safeguarding Flexibilities Under International Law (Munich Studies on Innovation and Competition)
See Sect. 2 for a detailed discussion of newness requirement of Art 39(3) TRIPS and also in the context of test data exclusivity. 19 For the grant of five year test data exclusivity protection in the US, there is no requirement of proving that the underlying pharmaceutical product is better than the existing therapies. 108(b)(2) (2003). Similarly, three year exclusivity is available where new clinical studies that are essential to the approval of the application are conducted. There too, a requirement of therapeutic advancement is absent.
59 The study also presented price comparison of a sample of pharmaceutical products with test data exclusivity with non-data protected products made available by the Ministry of Health. pdf +html (last visited 2 June 2016) [hereinafter Shaffer & Brenner (2009)]. 58 Id at w961. ’ Id at w964-5. 60 Id at w963-4 (see Exhibit 3). 61 Miguel E. C. Gamba et al, Impacto de 10 a~ nos de protecci on de datos en medicamentos en Colombia, Serie Buscando Remedio No. pdf (last visited 2 June 2016). 62 According to the English abstract of the report which is only available in Spanish, ‘[t]his figure was calculated from the total spending on protected new chemical entities during the period, compared with “theoretical” spending at competitive prices.
1. Legal exclusivities attempt to restore some of the initial excludability of the public good, enabling private appropriation of the the benefits of its exploitation. 24 2 Test Data Exclusivity: Raison d’eˆtre will be under-produced without appropriate incentives. 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.