Swiss IP office issues SPC clarification
The Swiss Federal Institute of Intellectual Property has issued a notice covering a change in the practice for granting supplementary protection certificates (SPCs), following a landmark decision by Switzerland’s highest court.
In June this year, the Swiss Federal Supreme Court held that new SPCs for combination products should be governed by the relevant EU law, in a dispute over a Swiss SPC owned by Gilead Sciences.
The validity of Gilead’s SPC C00915894/01, granted in 2008 for HIV/AIDS drug Truvada (a combination of tenofovir disoproxil fumarate and emtricitabine), was at the centre of the case.
In January 2017, the Swiss subsidiary of Teva, Mepha Pharma, filed an application to revoke Gilead’s Swiss SPC for Truvada. It argued that Switzerland’s infringement test should no longer be used to assess SPCs in Switzerland, and instead that EU case law on SPCs should be applied.
Article 3(a) of regulation 469/2009 governs SPCs in the EU. However, Switzerland is not part of the EU, and the country is therefore not governed by its harmonised SPC rules.
Court of Justice of the European Union (CJEU) case law requires that the active ingredient of a product covered by an SPC is specified in the wording of the patent’s claims, following Medeva v Comptroller General of Patents, Designs and Trade Marks in 2011.
In its June ruling, Switzerland’s highest court noted that the country’s SPC legislation was intended to be materially similar to that of the EU so, from now, new SPCs for combination products will be considered in the context of the Medeva ruling rather than the infringement test.
The Swiss IP office’s notice stated that it is no longer essential that the product to be protected falls within the scope of protection of the basic patent.
Now, it is essential that the product is detailed in the patent claims in a form recognisable for a person skilled in the art.
The notice also stated that SPC applications that were pending on June 11, 2018 (the date of the decision) must be examined under the new approach.
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