Recent European Legal Developments on Second Medical Uses and Dosage Regimes

The document discusses the evolution of European patent law regarding second medical uses and dosage regimes of known pharmaceutical compounds. Initially, under the European Patent Convention (EPC) 1973, second medical uses were thought to be unpatentable, but the Enlarged Board of Appeal of the European Patent Office (EPO) ruled in the Eisai case that they were patentable if phrased in a specific way, known as 'Swiss'-type claims. The EPC 2000 further clarified the patentability of second medical uses by introducing Article 54(5), which explicitly allowed for patenting specific new therapeutic uses of known substances. The document also discusses the Kos Life Sciences case, where the Enlarged Board confirmed that dosage regimes are subject to the same patentability criteria as other inventions. However, the document notes that judicial attitudes towards patents for second medical uses and dosage regimes vary across different European countries, as seen in the case of the pharmaceutical ingredient finasteride. The document concludes that while the EPC 2000 aimed to simplify the patenting process for second medical uses, the actual scope of protection conferred by the new claim format compared to the old Swiss form remains uncertain, and patent attorneys must be mindful of this when drafting claims.