Gilead´s blockbuster anti-HIV drug TRUVADA® contains two active ingredients, namely tenofovir disoproxil and emtricabine. Gilead has a supplementary protection certificate (SPC) for TRUVADA®. The basic patent for the SPC explicitly mentions tenofovir disoproxil in the claims. However, it does not explicitly mention emtricabine or the combination of tenofovir disoproxil and emtricabine. In the above-mentioned ruling it is stated that there is no evidence that at the priority date of the basic patent at issue, emtricitabine was an effective agent known to the person skilled in the art for the treatment of HIV in humans.
For the purpose of marketing generic versions of TRUVADA on the UK market, in 2016 Teva, Accord, Lupin and Generics UK (t/a Mylan) challenged the validity of the SPC at issue by bringing an action against Gilead before the High Court of Justice (England & Wales), Chancery Division (Patents Court). The High Court of Justice then referred the following question to the CJEU for a preliminary ruling:
What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of Regulation No 469/2009?
For the first time the Grand Chamber of the CJEU with 15 judges ruled as follows.
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, 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 CJEU also clarified that the rules for determining what is “protected by a basic patent in force” within the meaning of Article 3(a) of Regulation No 469/2009 are those in Article 69 of the EPC and the Protocol on the interpretation of that provision, and in this context recourse may not be had to the rules governing infringement proceedings.