Validity of a Supplementary Protection Certificate. Testing the boundaries in a new ruling by the Swiss Tribunal Federal
The two plaintiffs are Genzyme Corporation (holder of supplementary protection certificate No C00716606/01), and its licensee, Sanofi-Aventis (holder of the authorizations for the products Renagel and Renvela). The defendant, Salmon Pharma, commercializes a generic version of the product “Renvela”, which includes the same active ingredient and falls under the scope of protection for the SPC. After being sued for infringement, the defendant claimed the SPC is invalid, based on the fact that the plaintiff, having missed the deadline for filing an SPC, thereafter requested a reinstatement of the deadline. Although there is no statutory basis to reinstate the deadline for an SPC application, the Federal Institute of Intellectual Property (FIIP) did so, thereby allowing the application for the SPC to be submitted.
|"Is this really a valid SPC?"|
The core question is whether the list of grounds for nullity provided for in Article 140k of the Swiss Patent Act (PatA) are final. The provision in question has its origin in Article 15 of the EC Regulation No 469/2009. The only difference between these two provisions is that the former includes nullification of a certificate for plant protection products where the certificate was granted in violation of two transitional provisions (Articles 146(1) and 147(1) PatA). Thus, an SPC will be null and void if the product was not protected by a patent when the legislative amendment of October 9, 1998 came into force, or if the marketing authorization was granted prior to January 1, 1985.
The reference to the background of the Swiss provision explains why the text of the provision should be interpreted in light of the EU Regulation and the relevant CJEU case-law. The two relevant CJEU rulings, Hässle C127/00, N84-92, Synthon C-195/09, N56, do not in any way support the claim that the list of grounds for nullity according to Article 15 of the Regulation are exhaustive.
The Court concludes thus:
“The Appellant contends that the reinstatement has been made "arbitrarily and in breach of the decade-long practice of the FIIP". Whether the FIIP should indeed have rejected the request for reinstatement does not need to be decided here. Even if this was the case, it would not be a defect that leads to the invalidity of the SPC. Such defect [ie the wrongful reinstatement] was neither obvious nor easy to recognize [the Court explained above that for an administrative act to be considered invalid, the invalidity must be either obvious or easily recognizable]. The Patent Act provides for the possibility to reinstate whenever a deadline has been missed. The FIIP has decided that the conditions for the reinstatement were fulfilled pursuant to Art. 47 PatA. The Appellant does not share this view; this does not lead, however, to the invalidity of the administrative act."
This is an interesting case, not only because it provides an extensive discussion on the interpretation of the Swiss PatA under the light of the SPC Regulation, but also because it confirms that although the SPC application procedure has often been accused of being formalistic, it still seems to contain a number of flexibilities to the benefit of the patent holder.
Validity of a Supplementary Protection Certificate. Testing the boundaries in a new ruling by the Swiss Tribunal Federal Reviewed by Frantzeska Papadopoulou on Wednesday, February 13, 2019 Rating: