Gilead successfully defends and enforces its SPC for Truvada

In two recent decisions, the Swiss Federal Patent Court upheld the validity of Gilead’s Supplementary Protection Certificate (SPC) for Truvada®, a combination preparation of tenofovir disoproxil fumarate and emtricitabine used with other HIV-1 medicines to treat HIV-1 infection, and subsequently preliminarily enjoined Teva from distributing its Truvada® generic in Switzerland.

In proceedings on the merits, Teva (or rather Mepha, its Swiss subsidiary) sought a declaration of invalidity of Gilead’s Swiss SPC. It did not attack the validity of the basic patent EP 0 915 894. Neither was it disputed that a generic of Truvada® would infringe the (expired) basic patent and that Gilead’s SPC was therefore valid under the infringement test.

The basic patent explicitly mentions tenofovir disoproxil, but not emtricitabine. Teva argued that Switzerland should abandon the infringement test traditionally employed (BGE 124 III 375 – Fosinopril) in favour of the new ECJ’s case law concerning combination products. Applied to the combination of tenofovir disoproxil and emtricitabine, this would, according to Teva’s point of view, lead to the nullity of the SPC.

The Federal Patent Court sided with Gilead, which argued inter alia that legal certainty – at the time of application of the Swiss SPC in 2006, the ECJ’s Medeva decision (EU:C:2011:773) had not yet issued – demanded that the SPC be judged under the infringement standard. Harmonization of Swiss law with European Union law did not compel adopting the ECJ’s case law after Medeva. While it was correct that the Swiss SPC was introduced to harmonize Swiss law with the (then) relevant European legislation regarding Supplementary Protection Certificates, harmonization was unnecessary because it would not lead to better market access (free movement of goods). Switzerland was not part of the EU regulatory framework for the approval of pharmaceuticals. Drugs approved in Switzerland need separate approval in the EU, and vice-versa. Regulatory law therefore impeded the free movement of pharmaceuticals irrespective of whether SPC law was harmonized.

The court could have left it at this, but it went on to assess whether applying the ECJ’s case law would benefit legal certainty. The court summarizes the various decisions of the ECJ concerning SPCs and concludes that the ECJ’s jurisprudence in this area of law was a “terminological mess” (“terminologisches Durcheinander”). The court also notes that the ECJ’s case law was apparently so unclear that Arnold J, “a renowned expert in the area of SPC law” was forced yet again to submit a question to the ECJ (referring to [2017] EWHC 13 (Pat)). Legal certainty would therefore suffer if Switzerland abandoned the (comparatively easy to apply) infringement test.

Gilead then sought a preliminary injunction prohibiting Teva (Mepha) from distributing its Truvada® generic on the Swiss market. This case presented another interesting first: Gilead’s Swiss SPC describes the combination of tenofovir disoproxil fumarate and emtricitabine as product. Teva’s generic uses the tenofovir disoproxil phosphate salt. Teva argued that the generic was therefore not the same product (Erzeugnis) as the one covered by the SPC.

The Federal Patent Court held that different salt forms of an active pharmaceutical ingredient were the “same product” for purposes of SPC law, provided they have the same pharmacological effect. The definition of the term product reads thus plausible as follows: Emtricitabine plus tenofovir disoproxil fumarate and all derivatives thereof (i.e. in particular all salt forms), to the extent that they have the same pharmacological effects and are covered by the basic patent EP 0 915 894. In the case at hand, it was undisputed that the fumarate and phosphate salt forms of tenofovir disoproxil had the same pharmacological effect, as evidenced by the fact that Teva’s generic had been approved in a simplified marketing authorisation proceeding with Truvada® as reference preparation.

The judgment on the merits in the nullity action is under appeal at the Federal Supreme Court. The proceedings on the merits in the infringement action are ongoing.

A copy of judgment O2017_001 of 3 October 2017 (in English) can be read here and a copy of judgment S2017_006 of 10 October 2017 (in English) can be read here.

Meyerlustenberger Lachenal Ltd. (Michael Ritscher, Simon Holzer and Kilian Schärli) advised Gilead in both proceedings.