Posted: February 27th, 2019
SPCs cannot be revoked on the grounds of a wrongfully granted re-establishment of rights. The Swiss list of grounds for nullity for SPCs is exhaustive.
The Federal Supreme Court (FSC) provided valuable clarification regarding the grounds for nullity of SPCs in its recent judgment 4A_415/2018 of 7 December 2018.
In the case underlying this judgment, Genzyme Corporation (holder of the SPC No C00716606/01 (SPC)) together with the exclusive licensee Sanofi-Aventis (Suisse) SA (holder of the authorization for the product Renvela®) enforced their SPC against the Swiss pharmaceutical company Salmon Pharma GmbH which had started marketing a generic version of Sanofi-Aventis’ medicament Renvela®.
Salmon Pharma GmbH, in turn, only alleged that the SPC was invalid because the Swiss Federal Institute of Intellectual Property (IPI) wrongfully allowed re-establishment of rights (Art. 47 PatA) with respect to the time limit for filing the SPC application under Art. 140f PatA.
In the first-instance judgment by the Swiss Federal Patent Court (FPC) O2017_016 of 12 June 2018, the FPC essentially approved the action as Salmon Pharma GmbH could have challenged the IPI’s interim ruling and that the grant had become formally final. Further, the FPC held that the invalidity of the SPC could not be assumed even if the re-establishment was unlawful, since the list of grounds for invalidity pursuant to Art. 140k PatA is exhaustive.
Salmon Pharma GmbH subsequently filed an appeal against this decision. The FSC expressly confirmed the finding of the FPC that the list of grounds for nullity of an SPC recited in Art. 140k PatA is exhaustive, just like the list of grounds for nullity of a patent in Art. 26 PatA is exhaustive as well. The FSC held that this is particularly important in view of legal certainty and stressed that this judgment is in full accordance with the corresponding case law of the CJEU.
Finally, the FSC noted that SPCs and patents are granted by order of the IPI. Neither a transgression of the time limit for filing an SPC nor a wrongfully granted re-establishment of rights with respect to this time limit can be argued under any of the grounds for nullity listed in Art. 140k PatA.
Interestingly, the FSC did not answer the question whether the decision to grant of the SPC (or the earlier decision of 4 April 2005 concerning reinstatement) could have been challenged by Salmon Pharma GmbH, as the FPC had stated.
Summary: Kilian Schärli and Hélène Heinecke, Meyerlustenberger Lachenal