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Dosage regimen patent claims in Europe

By Martin Maclean of Mathys & Squire

Maximum patent term protection is key to maintaining market exclusivity for important commercial products. Typical vehicles for achieving this are second (and subsequent) medical use patent claims, supplementary protection certificates (SPCs), orphan drug provisions, and data & marketing exclusivity provisions. In this review, we look at the relevant European case law relating to second medical use claims and, in particular, to a subset of this claim category known as dosage regimen claims. The latter have attracted considerable interest and are the subject of a pending referral to the Enlarged Board of Appeal of the European Patent Office (EPO) - G2/08, which is expected to be published this summer.

Second medical use claims - overview

Second medical use claims were first held permissible by the EPO a quarter century ago (G5/83 - Eisai). Despite this, however, for much of the last 25 years the EPO has generally refused to grant dosage regimen claims on the basis that any perceived technical contribution constitutes nothing more than a method of medical treatment, which falls within the excluded subject-matter provisions of Article 53(c) EPC1 and is thus unpatentable.

More recently, with Genentech (T1020/03) providing the catalyst, we believe there has been a general trend towards a more favourable assessment by the EPO of dosage regimen claims. This pro-patent approach has been mirrored by the UK C...

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