Journal Article

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

Katherine A. Helm

in Journal of Intellectual Property Law & Practice

Volume 4, issue 1, pages 39-50
Published in print January 2009 | ISSN: 1747-1532
Published online November 2008 | e-ISSN: 1747-1540 | DOI: http://dx.doi.org/10.1093/jiplp/jpn208
The battle over global drug markets: enforcement of pharmaceutical patents in the United States, Europe and Japan

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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.

Journal Article.  9928 words. 

Subjects: Arbitration ; Intellectual Property Law

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