In a recent decision, the Technical Board of Appeal of the European Patent Office ruled that Swiss-type claims pertaining to the use of a known medicament in the treatment of a further disease cannot be changed to Compound-for-Use claims.
The original European Patent Convention (EPC) from 1977 did not contain a specific regulation for inventions pertaining to the use of a known medicament in the treatment of a further disease (second medical indication). To fill this gap in the EPC the Enlarged Board of Appeal in their decision G 3/85 introduced by legal fiction the possibility to obtain a patent for a second medical indication using the so called Swiss-Type claim, which is drafted in the form: “use of a compound x in the manufacture of a medicament for the treatment of disease y”. Since the revision of the EPC in 2007, Article 54(5) EPC explicitly allows claims to second medical indications when using the claim wording: “compound x for use in the treatment of disease y” (Compound-For-Use claim). There was much debate in the field about whether Swiss-Type claims and the new Compound-For-Use claim for second medical indications confer an identical or a different scope of protection. In previous decisions regarding the problem of double-patenting the Technical Board of Appeal (TBoA) indicated that the scope of both claim formats are most likely not identical, because it is an established understanding that method and use claims have a smaller scope compared to product claims – a fairly cursory analysis of this question.
Now in the decision T 1673/11 the TBoA decided a case where a patent proprietor during opposition proceedings amended the granted claims by changing from Swiss-Type to Compound-For-Use claims, while maintaining all remaining claim features with respect to the compound and the medical indication. Whereas the opposition division allowed the amendment and maintained the patent in amended form, the TBoA decided that a change of claim format in the direction Swiss-Type to Compound-For-Use constitutes an inadmissible extension of scope of protection of a patent according to Article 123(3) EPC. The patent was revoked.
The outcome is not overly surprising, since in previous cases the TBoA indicated that there indeed is a difference in scope of protection between Swiss-Type claims and Compound-For-Use claims. However, the exact nature of this difference was not discussed until today. Under item 9.4 of the decision the Board reasoned that a so called off-label use of a packaged medicament in a patented indication falls under the scope of protection of a Compound-For-Use claim, while a Swiss-Type claim would not cover such a use. Whether this analysis will be reiterated in national infringement courts or in the upcoming Unified Patent Court is questionable. There are already national court decisions which analyse the issue of off-label or skinny-label uses differently and with more appreciation for the complexity of the problem (LG Hamburg 327 O 67/15; Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others  EWHC 72 (Pat)).
Nevertheless, the decision underlines that applicants for European patents more than ever should include Compound-For-Use claims during examination proceedings in their claim sets to protect their second medical indication invention exhaustively. A later conversion from the Swiss-Type format to Compound-For-Use during opposition or limitation proceedings is not possible at the EPO.