Mepha AG, Helvepharm AG and Streuli Pharma AG vs. Merck & Co. Inc., Swiss Supreme Court, 4 March 2011, Case Nos. 4A_435/2010 and 4A_437/2010
In March 2009, the generics distributors Mepha, Helvepharm and Streuli Pharma sued Merck before the Commercial Court of Zurich for declaration of nullity of the Swiss part of Merck’s EP 1 175 904. The patent – which has been litigated in many European countries, for example in France, the Netherlands (as reported on the IPKat here), Sweden and the UK (as reported on the IPKat here) – claims an allegedly novel once weekly dosage regime of a known substance (alendronate) for a known indication (osteoporosis).
In April 2009, the Commercial Court of Zurich declared the patent invalid for lack of patentable subject matter, noting that the case law of the European Patent Office on second medical use claims concerning a novel dosage regime was unsettled. According to the Commercial Court, a dosage regime was a “method for treatment of the human body by therapy” in the sense of art. 2(2)(a) Swiss Patent Act, which corresponds to art. 53(c) EPC 2000. Since Swiss law knows no specific exception excluding physicians from patent liability, the patent put physicians at risk of being sued for patent infringement, which was what the drafters of the art. 53(c) EPC wanted to avoid.