Meaning of 'product' in US patent extensions

"An ‘active ingredient’ of a drug must be present when the drug is administered" is the title of a Current Intelligence note by Bart A. Gerstenblith (Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC) on the US decision in PhotoCure ASA v Kappos, 603 F.3d 1372 (Fed. Cir. 2010). This District Court, Eastern District of Virginia, decision concerns the interpretation of the patent term extension provisions of the Drug Price Competition and Patent Term Restoration Act 1984 (the ‘Hatch-Waxman Act’).  It considers the term ‘product’ in 35 USC §156(a), explaining that it means the active ingredient that is present in a drug when administered, not necessarily the ‘active moiety’ of the drug.

This note has been published on the Advance Access service of the Journal of Intellectual Property Law & Practice (JIPLP), but has been made fully available to all on the jiplp weblog here.

Hatch-Waxman extensions: PowerPoint now available

The PowerPoint notes which supported the presentation by Jeffrey S. Boone (Covidien), "Patent Term Extensions under the US Hatch-Waxman Act", which was given at the seminar hosted by The SPC Blog on 13 January 2010, are now available online. You can access them here.

CORRECTION Human drug extensions in the US: article now available online

Correction: the wrong link to the article was added to the earlier version of this post.

Further to our previous post, Oxford University Press has very kindly agreed to allow readers of The SPC Blog to gain free access to Jeffrey S. Boone's article, "Patent term extensions for human drugs under the US Hatch–Waxman Act". You can read his excellent piece in full here. The SPC Blog thanks OUP for its kindness.

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".