Journal Article

Patent term extensions for human drugs under the US Hatch–Waxman Act

Jeffrey S. Boone

in Journal of Intellectual Property Law & Practice

Volume 4, issue 9, pages 658-664
Published in print September 2009 | ISSN: 1747-1532
Published online July 2009 | e-ISSN: 1747-1540 | DOI:
Patent term extensions for human drugs under the US Hatch–Waxman Act

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  • Arbitration
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Legal context

The US Drug Price Competition and patent Term Restoration Act of 1984 was a major revision to US pharmaceutical law. A significant provision of that law was the ability, under specific circumstances, to obtain an extension of the term of a patent that claims a new drug. The determination of eligibility for a patent extension is a complex matter that has been subject to differing interpretations by the courts and regulatory agencies.

Key points

This article reviews the circumstances under which a patent can be extended, how an application for extension is submitted, and how the term of extension is calculated. A case study is presented to further illustrate the procedures.

Practical significance

By limiting when a generic product can be launched, the determination of whether a patent is eligible for a patent term extension can have a major economic impact on both the innovator company and generic competitors. An understanding of patent term extension eligibility is a critical part of the life-cycle analysis of pharmaceuticals.

Journal Article.  5299 words. 

Subjects: Arbitration ; Intellectual Property Law

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