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Reviewed 26 May 2010

Patents Act 1977: Second medical use claims

1. This Practice Notice sets out the practice of the Intellectual Property Office on the way in which inventions concerning a specific medical use of a substance or composition ("second medical use") may be claimed, in the light of the recent EPO Enlarged Board of Appeal decision External Link in G 02/08 ABBOTT RESPIRATORY/Dosage regime.

Background

2. Prior to 13 December 2007, inventions relating to a specific medical use of a substance or composition, already used in medicine for a different purpose, could only be protected using the "Swiss-type" claim form of "the use of substance X for the manufacture of a medicament to treat disease Y". On this date the Patents Act 2004 implemented the provisions of the revised European Patent Convention (EPC 2000) relating to medical use claims, and introduced Section 4A(4) to the Patents Act 1977. This allows a simpler and more direct second medical use claim, of the form "substance X for use in the treatment of disease Y".

3. Since then, applicants have been allowed to claim inventions relating to second medical uses using either the new, direct second medical use claim format, the Swiss-type format, or both, pending guidance from the UK courts and/or the EPO Boards of Appeal.

4. On 19 February 2010, the EPO Enlarged Board of Appeal issued its decision on G 02/08 ABBOTT RESPIRATORY/Dosage regime. This decided (amongst other things) that applicants may no longer claim second medical use inventions in the Swiss format.

Allowable forms of second medical use claim

5. Subsequent to the decision of the Enlarged Board in G 02/08, only second medical use claims of the form "substance X for use in the treatment of disease Y" will be allowed. Swiss-type second medical use claims will be objected to as lacking clarity. Specifically, Swiss-type claims are considered to be unclear because, although they define a method of manufacturing a medicament, the invention does not in fact relate to the method of production but instead relates to the intended use of the medicament. As stated in G 02/08, there is no functional relationship between the feature conferring novelty (the intended use) and the claimed manufacturing process. As Section 4A(4) now allows a simpler and clearer form of second medical use claim, there is no longer a reason to allow the more ambiguous Swiss form of claim.

6. In G 02/08, the Enlarged Board held that Swiss-type claims were previously accepted (in G 05/83 EISAI/Second medical indication External Link) as the only possible means of protecting inventions relating to second medical uses in order to fill a loophole in the provisions of the EPC 1973. The new Article 54(5) (equivalent to Section 4A(4)) fills this loophole by explicitly allowing claims to the further specific use of a known drug, and so the reason for this special, "judge-made" law no longer exists. The recent Court of Appeal decision in Actavis v Merck External Link [2008] RPC 26 reaffirmed the desirability of maintaining conformity with EPO practice as established in Board of Appeal decisions in this field, and so Swiss-type claims to second medical uses will no longer be allowed.

Effect of this change - pre-grant applications

7. With immediate effect, Swiss-type claims will be objected to as lacking clarity. Amendment of a patent application to replace a Swiss-type claim with the new form of second medical use claim will be allowed since regardless of the wording or scope of the claim, the technical disclosure (i.e., a new medical use for a substance or composition) is the same.

8. This objection will be made to both new and pending patent applications. While it is recognised that this is inconsistent with EPO practice following G 02/08, whereby Swiss claims will only be objected to for new applications with a priority date of three months or more after publication of the decision in the Official Journal, there is no clear legal basis for such a transitional provision under UK patent law.

Effect of this change - granted patents

9. There is no change in practice in relation to patents already granted and including Swiss-type claims. A request to make a post-grant amendment to replace Swiss-type claims with the new form of second medical use claim is unlikely to succeed, particularly as the Enlarged Board in G 02/08 suggested that the new form of claim may have a broader scope than Swiss-type claims.

Enquiries

10. If you have any enquiries about this Practice Notice, please contact: Richard Sewards

Intellectual Property Office
Concept House
Cardiff Road
Newport
South Wales
NP10 8QQ
United Kingdom

Tel: +44 (0) 1633 813536
Fax: +44 (0) 1633 814491

Sean Dennehey
Director of Patents
Intellectual Property Office
26 May 2010