By Owais H. Shaikh
This e-book explores the idea that of attempt info exclusivity safety for prescription drugs. targeting 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 out information exclusivity protection.At the center of this publication 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 energy of exclusivity in addition to on entry to drugs. rules offers a framework for the review of present attempt information exclusivity security 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 for that reason in nationwide legislation. This publication goals to expand nationwide and foreign coverage makers’ seize of many of the nuances of attempt information exclusivity safeguard. moreover, it offers sensible thoughts in regards to designing a suitable felony approach with a powerful specialise in selling entry to drugs for all.
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Additional info for Access to Medicine Versus Test Data Exclusivity: Safeguarding Flexibilities Under International Law
In addition to the above, patents are also prone to validity challenges, whereas this threat does not exist for test data exclusivity. Moreover, in order to stop infringement of a patented invention, the right holder has to take legal action. On the other hand, in case of test data exclusivity, enforcement is not a concern as there is no possibility of launching a competing product in the market without a marketing approval. During the period of test data exclusivity, such approval will not be granted.
59 Since the entry into force of the TRIPS Agreement, not only the number of FTA containing specific IP chapters increased,60 these chapters also introduced higher standards than the TRIPS Agreement, commonly known as WTO Member on average is party to thirteen preferential trade agreements (PTAs) as of 2010. See World Trade Organization, World Trade Report 2011, 47 (2011) [hereinafter World Trade Report (2011)]. ) Countries of varied development levels may enter into FTAs with each other for different reasons.
8 Randall G. Holcombe, A Theory of the Theory of Public Goods, 10(1) Rev. Austrian Econ. 1, 1 (1997) [hereinafter Holcombe (1997)]. 9 Bentley & Sherman (2001) at 35. 10 Non-rivalry is an inherent quality of a public good (in the present case, information or knowledge). The creator can reproduce another copy as many times as it wants without consuming the original. On the other hand, privately created knowledge is initially excludable. It only acquires the characteristic of non-excludability, once it is disclosed or can be or is visited.
Access to Medicine Versus Test Data Exclusivity: Safeguarding Flexibilities Under International Law by Owais H. Shaikh