Actavis v. Merck: A Dosage Regime is not Patentable
By a judgement dated 28 September 2010, the Tribunal de Grande Instance of Paris held that claims 1, 2 and 3 of the French designation of Merck & Co. Ltd’s Patent EP 0 724 444 were invalid for being excluded from the scope of patentability in accordance with the provisions of Article 53(c) EPC 2000 (former Article 52 (4) EPC 1973). The court held that the invention the subject-matter of main claim 1 was only a new dosage regime ranging from 0.05 to 1 mg) of an already known compound (finasteride) in an already known therapeutic application (the treatment of hyperandrogenic conditions and especially the treatment of androgenic alopecia). A mere new dosage regime is not a second medical use but a therapeutic method excluded from patentability pursuant to Article 53 (c) EPC 2000.