Can drug dosage regimes provide patentable subject matter in Europe?

One appeal board at the European Patent Office, Biotech Appeal Board 3.3.4, in a recently-issued decision (T 1020/03; the Genentech Decision), has said "yes" and, in so doing, has strongly criticized previous interpretations of the leading EPO Decision on second medical use claims (Enlarged Board Decision G 5/83). Board 3.3.4 has unusually made a forceful case that there can be no justification for a referral of the matter to the EPO Enlarged Board.

It is a highly respected board having heard the majority of EPO appeals concerning biotechnology cases. Hence, there is cause for optimism that the view of that Board on patentability of dosage regimes will be influential, although even at the EPO it is not a binding precedent for other boards. Moreover, it remains to be seen whether it will have any influence outside the EPO in national courts.

In the UK, two earlier Appeal Court decisions held that claims in second medical use form relying on a dosage regime are in essence disguised medical treatment claims and hence impermissible. While the door is evidently re-opened to achieving patentability of dosage regimes at the EPO, rush to file such claims may well be tempered by continuing concern over enforceability. However, the coming into force of the revised European Patent Convention (EPC 2000), scheduled for 13th December 2007 at the latest, will create new opportunity for harmonization of approach to second medical use protection both within and outside the EPO.