Patent extension for human drugs in the US: a fresh critique

Patent term extension is not a solely European preoccupation, though readers of this weblog might sometimes wonder whether Europe ("the home of the SPC") was the only theatre of war between those who seek to extend their chance of enjoying their hard-earned patent protection and those who, in the name of competition, fight them tooth and nail. There's plenty going on in the United States too. That this is so is evident from an article published this month: "Patent term extensions for human drugs under the US Hatch–Waxman Act". It's written by Jeffrey S. Boone (Vice President, Intellectual Property, Covidien, based in Hazelwood, MO) and you can find it in the Oxford University IP flagship publication, the peer-reviewed Journal of Intellectual Property Law & Practice 2009 4(9):658-664. The abstract reads as follows:

"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".