'Tenofovir' Decision of the Federal Patent Court (Bundespatentgericht) 3 October 2017 - Case No. O2017_001

摘要

1. The statutory basis for the claim to the grant of a certificate according to the Patent Act is clear and beyond doubt. Article 140b(1)(a) of the Act requires the product to be protected by the basic patent, no more and no less. There is no scope for a situation-specific construction that departs from this principle, let alone scope for the imposition of additional conditions for protection certificates by judicial practice. The Medeva decision appears to lay down an additional – although negatively worded – condition for the infringement test. 2. Article 140l(2) of the Patent Act requires the Federal Council to take account of the regulations of the European Community when laying down the procedure for the grant of certificates, their entry in the patent register and the Institute’s publications, hence the regulation of the details at the level of statutory orders. Article 140l(2) of the Patent Act is not addressed to the civil courts with respect to the construction. For this reason, the civil courts are under no obligation to follow the judicial practice of the EU. 3. Switzerland is not automatically tied to the internal market with respect to medicinal products. Hence, the Medeva arguments with respect to the internal market cannot be transferred to Switzerland, and in particular not for pharmaceutical products such as here with state regulated prices. Furthermore, Switzerland does not participate in the parallel harmonisation of market authorisation, completed at the European level. The differences that result from the different market authorisations in Switzerland and in the EU lead to different protection certificates, irrespective of how the authorised product is to be classified with respect to the protection resulting from the basic patent. 4. The infringement test as confirmed by the Federal Supreme Court in the Fosinopril decision is simple and clear, and leads to a high level of legal certainty. In contrast, the judicial practice of the ECJ is not capable of determining simply and clearly whether a product can be granted a protection certificate in the light of the basic patent. For this reason, at least until the ECJ has established a judicial practice that increases legal certainty, it is by no means appropriate to adapt Swiss judicial practice. The strict preconditions for such a change are clearly not satisfied.