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Md. Rizwanul Islam, Review of Protection of Regulatory Data under Article 39.3 of TRIPs: The Indian Context, Journal of Intellectual Property Law & Practice, Volume 3, Issue 2, February 2008, Pages 140–141, https://doi.org/10.1093/jiplp/jpm249
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Extract
The development of pharmaceutical materials from innovation to finally entering the marketplace is a tedious and expensive one. A vital step in this development is obtaining statutory authorization to offer the product to the public. This entails the creation of substantial amounts of regulatory data to show the safety and effectiveness of the pharmaceutical. There is no agreement among WTO members or the scholarly community as to the level of protection that Article 39.3 of the Trade Related Aspects of Intellectual Property (TRIPs), which requires protection of any data provided to regulatory authorities to obtain market approval to be protected from unauthorized disclosure, accords to such data. Shamnad Basheer, an associate of Oxford Intellectual Property Research Institute of the University of Oxford, analyses the Article and its implementation or otherwise in the Indian legal system.
This short book is divided into seven well-structured parts. Part I explains the terms of reference; Part II provides a succinctly drafted summary; Part III gives a brief overview of the issues; Part IV simulates a WTO panel approach, ie what could possibly be the issues if the same were decided by a WTO panel and categorically enumerates the issues covered by the book; Part V is sub-divided into two parts: the first analyses the level of protection required by Article 39.3 and the second whether Indian law is consistent with it; Part VI then concludes with a synopsis of the issues which is followed by Part VII which provides a list of references.
