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Journal of Intellectual Property Law & Practice Advance Access published online on November 11, 2008
Journal of Intellectual Property Law & Practice, doi:10.1093/jiplp/jpn208
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© The Author (2008). Published by Oxford University Press. All rights reserved.

The battle over global drug markets: enforcement of pharmaceutical patents in the United States, Europe, and Japan

Katherine A. Helm *

Legal context: Pharmaceutical patent litigation is on the rise. The focal point of this increasingly contentious area of litigation is the surge in pharmaceutical patent challenges mounted by generic drug manufacturers. Pharmaceutical companies need to identify viable enforcement strategies that can survive these challenges and effectively manage the life cycle of their pharmaceutical products around the world.

Key points: The degree to which pharmaceutical companies can capitalize upon the value of their second generation patents to extend the protection given to existing drug products depends in part on the patent landscape, country by country, and also on the regulatory landscape for generic drug products and their entry into the marketplace.This paper will examine the patent laws, drug approval regulations, and court decisions on the validity and enforceability of later stage or second generation patents directed to combination compounds, selection inventions, and new indications, in three major jurisdictions: The United States, Europe/UK, and Japan.

Practical significance: Successful pharmaceutical companies can maintain a competitive advantage in the global pharmaceutical industry by evaluating and strengthening the way existing drug products are protected and, in many cases, changing the nature of protection under the patent laws by improving upon the pharmaceutical product itself.

* Katherine A. Helm, J.D. Fordham University School of Law, 2008; Ph.D. The Johns Hopkins University, 2003; M.A. The Johns Hopkins University, 2001; A.B. Princeton University, 1999. The author would like to thank John Richards for his valuable insight into this article. Dr Helm is clerking for a United States District Court judge and United States Court of Appeals for the Federal Circuit judge over the next 2 years.


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