Data Exclusivity: Pressing Issue

2010 ◽  
Author(s):  
Anu Bala
Keyword(s):  
Author(s):  
Renu Kadian ◽  
Arun Nanda

Background:: Protection of Intellectual Property Rights is a clear incentive to innovations; yet, several countries have provided further incentives to patents in pharmaceuticals because the full patent term of 20 years is largely exhausted, before marketing authorization. Objective:: The purpose of this article is to describe the various incentives to patents in the form of financial support, data exclusivity and most importantly extended market exclusivities and comparison of various incentives to patents in the United States of America, European Union and India. Methodology:: The detail of incentives is collected from various articles, latest topics, books, and newspapers. Result:: These incentives create a positive surrounding to encourage the drug development process, strengthen economic growth and improve a balance between new pharmaceuticals in the market and access of that medicine to general public at a reasonable price. Conclusion:: European Union and the United States of America are leading in the field of incentives to patenting in phar-maceuticals as compared to India. Indian Patent Act, 1970, needs to be re-looked in terms of data exclusivity and patent term extensions.


Author(s):  
Justine Pila ◽  
Paul L.C. Torremans

This chapter examines the law on data protection and data exclusivity. It focuses on the new GDPR Regulation. It covers rules on lawful processing of personal data, on the security of the processing, on the transparency of the processing, and on promoting compliance. It also discusses the rights of the data subject, the transfer of personal data to third countries, and the period of data exclusivity granted to the pharmaceutical sector independent of any form of patent protection.


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