SPC regulation, analysis of SPC case laws and roadmap for pharmaceutical industry

Omkar Joshi, Archna Roy, Manthan Janodia

Research output: Contribution to journalArticle

Abstract

The purpose of the study is to understand Supplementary Protection Certificate (SPC) regulations associated with pharmaceutical products. In this study the case laws associated with SPC regulation and decisions handed down by national IP courts across Europe have been reviewed. On one hand, this study provided insights into innovator strategies in managing product lifecycles and on the other hand, it also helped in studying perspective of generic drug industry. A survey amongst IP experts about SPC regulation have also been carried out. It is observed that there is a need to amend the SPC regulation to provide better clarity to both innovators and generic drug industry.

Original languageEnglish
Pages (from-to)5-20
Number of pages16
JournalJournal of Intellectual Property Rights
Volume24
Issue number1-2
Publication statusPublished - 01-01-2019

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pharmaceutical industry
case law
certification
regulation
innovator
drug
industry
pharmaceutical
expert

All Science Journal Classification (ASJC) codes

  • Law

Cite this

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SPC regulation, analysis of SPC case laws and roadmap for pharmaceutical industry. / Joshi, Omkar; Roy, Archna; Janodia, Manthan.

In: Journal of Intellectual Property Rights, Vol. 24, No. 1-2, 01.01.2019, p. 5-20.

Research output: Contribution to journalArticle

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