The Swiss Federal Patent Court has in its most recent decision (O2017_001) confirmed that it adheres to the so-called "infringement test" in relation to Supplementary Protection Certificates ("SPC") and does not harmonize its case law with that of the Court of Justice of the European Union ("CJEU"). The CJEU had abandoned the "infringement test" in 2011 in its Medeva decision (C-322/10).
One of the biggest generics manufacturers of Switzerland, Mepha, had brought an invalidity action against an SPC which protects a combination of the two active ingredients tenofovir disoproxilfumarate + emtricitabine. This combination can be used for antiviral medication that is applied in the treatment of HIV infection.
It was undisputed between the parties that the subject-matter of the SPC was protected by the basic patent and that the "infringement test", which is applied in Switzerland (Fosinopril decision of the Swiss Federal Supreme Court dated 10 July 1998, BGE 124 III 375), was met. Mepha had based its invalidity action solely on the ground that Swiss Courts should harmonize their case law on SPCs with the case law of the CJEU and that the "infringement test" should therefore no longer apply in Switzerland.
The Federal Patent Court held that there was no need for harmonization with European Union law. In Medeva, the CJEU had abandoned the "infringement test" as it was based on the different patent laws of the EU Member States and thus created an obstacle to the free movement of medicinal products within the EU. As Switzerland was not part of the internal market of the EU and has its own market authorization procedure for medicinal products that is different to those of the EU, harmonization with CJEU case law would not automatically lead to harmonization on the grant of SPCs.
Even if harmonization was to be considered at all, it would be in any case too early, as the CJEU case law following Medeva had not been consistent and the solution proposed in Medeva results "in more questions than answers" (note 36 of the judgment). It was therefore at the moment not possible to reach a clear decision on a case like the present one by using the criteria developed by the CJEU in Medeva.
As a side remark, the Swiss Patent Court's decision on the costs is notable in this case too. Generally, the loser pays principle applies. Even though the claimant had lost the case, it was only ordered to pay the court fees (in amount of CHF 60'000) and the defendant's attorney fees (in the amount of CHF 50'000) but not the defendant's patent attorney's fees. This is because the defendant had failed to specify and substantiate its costs for the patent attorney.
The decision is not final. It can be appealed to the Swiss Federal Supreme Court within 30 days.