Journal of Intellectual Property Law & Practice Advance Access originally published online on July 28, 2009
Journal of Intellectual Property Law & Practice 2009 4(9):658-664; doi:10.1093/jiplp/jpp110
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© The Author (2009). Published by Oxford University Press. All rights reserved.
Patent term extensions for human drugs under the US Hatch–Waxman Act
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.
Correspondence: * Vice President, Intellectual Property, Covidien, 675 McDonnell Boulevard, Hazelwood, MO 63042, USA. Email: jeffrey.boone{at}covidien.com