The supplementary protection certificate (SPC) granting practice in Switzerland is being challenged at the Federal Patent Court – in particular, whether and if so how the granting practice should be brought in line with recent European Court of Justice (ECJ) case law.
The case involves the nullity of SPC C00915894 (Case O2017 001). The basic patent is European Patent 0915894B1 (see the European Patent Register and Swissreg), which concerns Gilead’s Truvada – a medication used to treat and prevent HIV/AIDS.
The question of whether a product is protected by a basic patent is decisive for an SPC, both in the European Union (Regulation 469/2009, Article 3a) and Switzerland (Article 140b(1)a PatA). However, the question is currently assessed differently in these jurisdictions.
The so-called ‘infringement test’ has been applied in Switzerland since the Supreme Court’s decision in Fosinopril (BGE 124 III 375) in 1998. However, the ECJ explicitly disapproved the infringement test with its decision in Medeva (ECJ C-322/10) in 2011. Consequently, SPC applications which would not be allowable in the European Union can proceed to grant in Switzerland.
In 2015 the Swiss Federal Institute of Intellectual Property (FIIP) intended to change its practice in order to bring it in line with ECJ case law, and some commentators felt that this would add much confision to Switzerland's SPC granting practice in the future. However, no change of practice has yet been implemented – the FIIP still applies the infringement test.
The main hearing took place on August 21 2017; the case has not yet been decided.
The judgment may not only affect the prospects of pending and future SPC applications, but may also have consequences for the validity of already granted SPCs. Applicants are well advised to check back with counsel to revisit their Swiss SPC portfolio and strategy.
For further details please see www.patentlitigation.ch.
This article first appeared in IAM. For further information please visit www.IAM-media.com.