Journal of Intellectual Property Law & Practice Advance Access published online on January 25, 2008
Journal of Intellectual Property Law & Practice, doi:10.1093/jiplp/jpm249
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© The Author (2008). Published by Oxford University Press. All rights reserved
IP in Review |
Review of Protection of Regulatory Data under Article 39.3 of TRIPs: The Indian Context
Protection of Regulatory Data under Article 39.3 of TRIPs: The Indian Context
Shamnad Basheer
Intellectual Property Institute, 2006
ISBN: 1-874001-91-X, Soft cover, pp. 22
£20.00
| The first 10% of the full text of this article appears below. |
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