Tenofovir + Emtricitabine - Switzerland

On June 11, 2018, the Federal Supreme Court dismissed Mepha’s appeal & affirmed Validity of Gilead’s Swiss TRUVADA® SPC.

By submission of 3 Jan 2017 to the Federal Patent Court, Mepha (Plaintiff) requested Swiss SPC to be declared invalid. The Plaintiff claimed that the Swiss practice should be disregarded and adapted to the case law of the Court of Justice of the EU (CJEU). Following the so-called Medeva practice, the Gilead’s SPC was to be declared valid, according to the Plaintiff. With its decision of 3 Oct. 2017, the Federal Patent Court dismissed the revocation action. The court came to the conclusion that the Gilead’s SPC was valid under the so-called “infringement test”, applied in Switzerland since long. There was no reason for a change in case law according to this decision, since the CJEU's practice was not clear with respect to interpretation of Article 3(a).

Mepha filed appeal. Supreme Court said that the endeavor to align Swiss regulations to the law of neighboring EU states to the extent possible is considered in the interpretation of the corresponding legal provisions according to consistent practice of the Federal Supreme Court, particularly in the context of teleological and historical interpretation. As a result of a consultation process, a letter from the IPI of 13 January 2017 which contained principles for the planned amendment of the relevant Granting Directive (13.2.1); the interested parties have essentially agreed to this proposal, believing that the proposed new Directive will enable the criteria of the CJEU's "Medeva" decision to be implemented in a manner that provides sufficient legal certainty and consistency. Since the CJEU practice now appears to be established, there are genuine reasons for changing Swiss case-law in order to adapt it to the concept pursued by the CJEU, specifically for combination products.

On the validity of SPC, Supreme Court held that the supplementary protection certificate for the contested product (Tenofovir + Emtricitabine) was granted to the Gilead with a formal and legally binding decision. It was not granted contrary to Art. 140b PatA and therefore there is no ground for invalidity according to Art. 140k PatA.  Accordingly, the legally binding nature and consequences of acts which took place before the commencement hereof, remain subject to the law which was applicable at the time. If a change of law had occurred after the grant of the supplementary protection certificate, in principle the certificate could not be taken away from the entitled party. In principle, legally binding administrative orders cannot be reconsidered or revised due to a change in case law.

On 29 August 2008 the Gilead was formally and lawfully granted the supplementary protection certificate. Such certificate could not be revoked even in case the requirement provided for in respect of the granting at hand, namely "protected by a patent" within the meaning of Art. 140b PatA according to the now changed practice was no longer met. As a result, the appeal was dismissed.

Thus, in conclusion the Federal Supreme Court decided that while the infringement test shall still apply to existing SPCs, new SPCs for combination products shall be examined in light of the Medeva ruling and other decisions of the CJEU.