Analysis of SPC regulation associated with pharmaceutical products in Europe

Janodia, Manthan D (2018) Analysis of SPC regulation associated with pharmaceutical products in Europe. Journal of Intellectual Property Rights, 23. pp. 233-242. ISSN 0971-7544

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Abstract

The purpose of the study is to understand SPC regulations associated with pharmaceutical products. The study focuses on the case laws associated with SPC regulation and decisions handed down by national IP courts across Europe. The study also provides some guidelines for patent claim drafting with improved chances of getting and identifying avenues for challenging SPCs, as well as possible solutions and loopholes in SPC regulation. The guidelines for predictions of generic drug entry into market are discussed. The data collected and analyzed for individual European Country provides useful insight into pattern of SPC filing, grant and SPC invalidity. It is observed that there is a need to amend SPC regulation to provide better clarity to both innovators and generic drug industry.

Item Type: Article
Uncontrolled Keywords: Supplementary protection certificate; patent term extension; court of justice for European union; new chemical entity; European free trade agreement; EMA; generic drug industry.
Subjects: Pharmacy > MCOPS Manipal > Pharmacy Management
Depositing User: KMC Library
Date Deposited: 10 Jun 2019 05:27
Last Modified: 10 Jun 2019 05:27
URI: http://eprints.manipal.edu/id/eprint/153886

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