Journal of Intellectual Property Law & Practice Advance Access originally published online on February 19, 2008
Journal of Intellectual Property Law & Practice 2008 3(4):226-235; doi:10.1093/jiplp/jpn013
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© The Authors (2008). Published by Oxford University Press. All rights reserved
Practice Point |
Managing generic competition and patent strategies in the pharmaceutical industry
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.
Key Words: 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.
* Dr Brian Whitehead, solicitor, holds an MA in chemistry (Oxford) and a PhD in biochemistry (Sheffield). Prior to becoming a solicitor, he worked as a research scientist and academic publisher in the Netherlands. Stuart Jackson, solicitor and Director of Patent Litigation with Addleshaw Goddard, holds BSc (Imperial College) and MSc (Oxford) degrees in chemistry. Prior to becoming a solicitor, he worked in industry as a chemist in R&D for 17 years, and is a Chartered Chemist. Richard Kempner, Partner and National Head of Intellectual Property with Addleshaw Goddard, has acted extensively on cases involving pharmaceutical patents, including BASF AG v SmithKline Beecham and Mayne Pharma v Teva.