CJEU Rules On SPCs For Combination Products

On the morning of 25 July 2018, the Court of Justice of the European Union (the CJEU) handed down judgment in Case C-121/17 Teva UK and Others v Gilead concerning the validity of Supplementary Protection Certificate (SPC) protection for Gilead's combination HIV treatment TRUVADA (tenofovir disoproxil and emtricitabine). The CJEU held that an SPC can only be granted for a product if, in the basic patent on which the SPC is sought, that product "is either expressly mentioned in the claims of that patent or those claims relate to that product necessarily and specifically." It is for the English High Court, as the referring court, to determine whether that test is met by Gilead's patent in this case; however, the CJEU stated (on the basis of the information provided by the referring court) that it does not seem possible that the combination of tenofovir disoproxil and emtricitabine necessarily falls under the invention covered by Gilead's patent.

Gilead's Truvada is a combination of the active ingredients tenofovir disoproxil and emtricitabine. In 2008, Gilead obtained an SPC to extend patent protection for Truvada, on the basis of its patent EP (UK) 0 915 894 (the Basic Patent). The claims of the Basic Patent only expressly mention tenofovir disoproxil, and not emtricitabine; the relevant claim of the Basic Patent is to "A pharmaceutical composition comprising a compound according to any one of claims 1-25 [i.e. tenofovir disoproxil] together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients." Pursuant to Article 3(a) of Regulation (EC) No 469/2009 (the SPC Regulation), an SPC may only be granted if the relevant product is "protected by a basic patent in force." The question before the CJEU, referred by the English High Court following a validity challenge to Gilead's SPC by Teva and others, was whether the Truvada combination is "protected" by the relevant claim of Gilead's Basic Patent, which only expressly mentions tenofovir disoproxil.

Gilead argued that it is both necessary and sufficient for an SPC to be granted that Truvada falls within the extent of the protection conferred by the Basic Patent, and that the expression "other therapeutic ingredients" in the claim relates implicitly but necessarily to emtricitabine. Teva and the other challengers argued that, in accordance with previous CJEU case law, both active ingredients in the Truvada combination must be "specified in the wording of the claims"...