Oppositions & Appeals: We helped shape the debate on medical use claim patentability

Case 7 – T 879/12 (EPO Board of Appeal, 27 August 2014)            

Find out why Swiss-type patent claims remain as relevant as ever, following this instrumental decision on subject-matter.

With one of the strongest life sciences’ patent teams in Europe, we’ve always played an active role at the EPO – and in some of the most important legal decisions of the Boards of Appeal cited in the “White Book” or in the EPO Guidelines for Examination. In this series, we’re reviewing the ones we feel are most memorable in terms of making the law.

The European Patent Convention (EPC) includes provisions against patenting medical methods. This means that medical uses of compositions are, in principle, patentable, but only in specified “medical use claim” formats. For years, the scope of such claims and the differences between various formats remained an open topic of debate.

T 879/12 shed some much-needed light on this issue.

Medical use claim formats in focus

Claim 1 of the contested application was in the EPC2000 format. Introduced in 2007, this format adheres to the template: “substance X for use in the treatment of condition Y”. The application was a second-generation divisional of an earlier granted patent which contained a claim in the “Swiss-type” format. The Swiss-type formula follows the template: "use of substance X for the manufacture of a medicament for the treatment of condition Y". The claims were otherwise identical.

Although the EPC2000 format was introduced to replace the Swiss-type format, there was a period during which both styles were permissible under the EPC. Nonetheless, the examining division viewed these two claims as directed towards the same subject-matter. Because divisional applications may not have identical scope to their parents, it therefore refused the application under the prohibition against double-patenting.

On appeal, Life Sciences Partner Simon Kiddle argued that the subject-matter of a claim is not only determined by the technical features of the claim but also by claim category. Since the categories of the claims at issue were different and there was at least one difference in the technical features defining the claimed subject matter (the manufacturing step), the subject matter defined by the claims was not identical and therefore allowable.

The Board of Appeal (BoA) agreed, viewing EPC 2000 claims as directed towards a purpose-restricted product, while Swiss-type claims include the additional features of the manufacturing step.

Courting controversy

Interestingly, the BoA commented that the category of claim and its technical features not only determine the subject matter of a claim, but the scope of protection conferred. This was controversial, as scope of protection is normally a matter for national courts, which disagree in their approach to interpreting scope of medical use claims.

"The Board commented that the category of claim and its technical features not only determine the subject matter of a claim, but the scope of protection conferred.”

Recent developments from the UK Supreme Court in Warner Lambert vs Generics (UK) Ltd t/a Mylan appear to agree with the BoA’s view and highlight the uncertainty that remains around the scope of Swiss-type claims. There, the Court was divided as to under which circumstances a medicament used off-label would be “for the treatment” of a claimed condition.

Though Swiss-type claims are available in many jurisdictions around the world, they are no longer allowable in Europe for applications with a priority date after 29 January 2011 (OJ EPO 2010, 514). However, as pending European patent applications originating before this date may still be granted with Swiss-type claims, and the final patents in this format will be enforceable until 2032, they remain as relevant as ever. The approaches to medical use claims taken in Europe – and interpretations adopted by Europe’s national courts – therefore have the potential to shape practice for years to come. 

Find the decision here.

This blog was originally drafted by Andrew Tindall.