On July 25, 2018, the Court of Justice of the European Union (CJEU) handed down its newest SPC decision in re Truvada (C-121/17). The case relates to the interpretation of Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products. As to this, the CJEU concludes:
Article 3(a) must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
- the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
- each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.
The case was referred to the CJEU by the UK High Court of Justice. The dispute arose with respect to a patent and SPC concerning the medicinal product Truvada. This product contains two active ingredients, namely tenofovir disoproxil (TD) and emtricitabine. Gilead owned a basic patent, essentially relating to a series of molecules which are helpful in the therapeutic treatment of viral infections, particularly HIV. In one of the claims (claim 25), Gilead’s patent expressly mentions the active ingredient TD. There is no claim expressly mentioning emtricitabine. However another claim of the basic patent (claim 27) refers to a pharmaceutical composition inter alia comprising the compound of claim 25 (TD) and “optionally other therapeutic ingredients”. Based on said claim 27, Gilead obtained an SPC for the composition containing TD together with emtricitabine. Several companies intending to launch a generic Truvada-product on the UK market brought an action before the referring court in order to challenge the validity of the SPC
In light of the ECJ decision, the issue at stake in the Truvada-case is now whether from the point of view of a person skilled in the art, (1) the combination of TD and emtricitabine necessarily falls under the invention covered by said basic patent in light of the description and the drawings of said patent and whether (2) each of those active ingredients – i.e. TD and emtricitabine – is specifically identifiable on the basis of the prior art at the filing date or priority date of that patent. This is now for the referring court to decide.