Title : Review of Protection of Regulatory Data under Article 39.3 of TRIPs: The Indian Context


Authors : Shamnad Basheer


Book Review Title: Journal of Intellectual Property Law & Practice Volume Number: 3 Publication Year : 2008 Issue Number: 2
Index: scopus ISSN (Print): 1747-1532 Publisher Name: Oxford University Press
Pages : 140–141
ISSN (Online): 1747-1540
Reviewer : Md. Rizwanul Islam
Funding Information:
Funding Source : None
Other Information:
Direct Sustainable Development Goals :
SDG3 Good Health & Well-being
SDG9 Industry, Innovation & Infrastructure
SDG16 Peace, Justice & Strong Institutions
Indirect Sustainable Development Goals :
SDG10 Reduced Inequality
SDG17 Partnership for the Goals
Sustainable Development Sub Goals :
Support R&D and universal access to medicines/vaccines
Enhance scientific research & technological capacity
Promote rule of law and equal access to justice
Ensure equal opportunity and reduce inequalities of outcome
Enhance policy coherence for sustainable development
Impact statement: Oxford’s extract shows that the review addresses the contested meaning of Article 39.3 of TRIPS in relation to regulatory data submitted for pharmaceutical market approval. That makes the review important for understanding debates over data exclusivity, intellectual property protection, pharmaceutical regulation, and the legal policy choices facing developing countries. Collaboration: None Keywords: TRIPS, regulatory data, data exclusivity, pharmaceutical regulation, intellectual property, India