Europe & The UK
The Enlarged Board of Appeal of the European Patent Office (“EPO”) decided on 19th February 2010 in case G2/08 that claims directed to the second medical use of a known substance in the so-called “Swiss-type” claim format (“Use of substance X in the preparation of a medicament for the treatment of disease Y”) should no longer be allowed for new applications.
The decision follows the implementation of a revised European Patent Convention (EPC2000), which permits second medical use of a known substance to be claimed in the form “Substance X for use in the treatment of disease Y”. This purpose-limited product claim will be deemed novel if the indicated medical use has not been disclosed in the prior art.
The Enlarged Board introduced a grace period for the Swiss-type claim prohibition to come into effect. This grace period expires on 28th January 2011, which means that Swiss-type claims for second medical use indications will no longer be permitted by the EPO for European patent applications with an earliest effective filing date after that date. However, Swiss-type claims will be allowable for pending applications with an effective filing date on or before 28th January 2011. There is uncertainty as to whether Swiss-type claims and the new second medical use claims afford the same scope of protection once granted, so it is advisable to pursue both types of claims where possible. The validity of Swiss-type claims in granted European patents will not, according to the Enlarged Board, be affected by the G2/08 decision.
The UK Intellectual Property Office (IPO) issued a post-G2/08 practice note on 28th May 2010 and deemed that Swiss-type claims would not be allowed in any existing UK patent application. In other words, there has been no equivalent “grace period” in the UK following issuance of G2/08. Swiss-type claims in UK patent applications will be objected to by the UK IPO on the ground of lack of clarity, which is not a ground of revocation for granted UK (or EP(UK)) patents. Again, in theory Swiss-type claims in granted UK patents will not be affected by the UK IPO change in practice.
UK , European and other patent applicants who use the International Patent Co-operation Treaty (PCT) system might wonder whether they should still be including Swiss-type claims in new priority applications and PCT applications destined for territories other than EPC states. The answer is: yes. For example, Swiss-type claims are still allowable in Australia (as are method of treatment per se claims). In China and Mexico, Swiss-type claims are currently the only way of validly claiming second medical uses of known substances. In Israel and Japan, Swiss-type claims are allowable, as are the new EPC2000 second medical use claims.
With multi-jurisdictional protection in mind, a new patent application relating to new medical use of a known or new compound should – for the moment – include method of treatment claims, first medical use claims (where applicable), second medical use claims, and also Swiss-type claims. The allowability (and validity, if granted) of the various forms of claims will be different for different territories, so claims should be amended during national / regional prosecution to take current local patent law and practice into account.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking before any action in reliance on it.