Journal Article

Managing generic competition and patent strategies in the pharmaceutical industry

Brian Whitehead, Stuart Jackson and Richard Kempner

in Journal of Intellectual Property Law & Practice

Volume 3, issue 4, pages 226-235
Published in print April 2008 | ISSN: 1747-1532
Published online February 2008 | e-ISSN: 1747-1540 | DOI: http://dx.doi.org/10.1093/jiplp/jpn013
Managing generic competition and patent strategies in the pharmaceutical industry

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Legal context

The income streams of originating pharmaceutical manufacturers are under pressure as never before, from increasing R&D costs, regulatory pressures, and competition from generic manufacturers. This article examines the various strategies which originating pharmaceutical manufacturers have adopted in response to these threats.

Key points

The authors consider various strategies, including Supplementary Protection Certificates, life-cycle management (‘evergreening’), second pharmaceutical use claims, trade marks, and the use of data exclusivity and interim injunctions, in order to prolong the protection given to existing products, and to manage competition from generic manufacturers.

Practical significance

The authors also include two real-life case studies in order to illustrate the practical applications of the strategies discussed in the article.

Keywords: Since pharmaceutical patents are often short-lived in terms of their commercial utility and highly vulnerable to a validity challenge, they represent an asset that must be treated with care when building any business strategy around them.; The law provides various devices that effectively enable pharmaceutical patent proprietors to extend the commercial advantage conferred by a patent beyond the obvious parameters of its protection.; This article examines, from a British and European perspective, the options that are available for originating pharmaceutical companies in their battle against competition from generic manufacturers, emphasizing the need to take a strategic view of the manner in which patent assets are deployed and managed.

Journal Article.  7142 words. 

Subjects: Arbitration ; Intellectual Property Law

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