On 25 July 2018, the ECJ delivered its much-anticipated judgment in the case between Teva and Gilead (C 121/17) regarding the supplementary protection certificate (“SPC”) covering Gilead’s HIV inhibitor, Truvada®. The judgment provides clarification on the interpretation of article 3(a) of the SPC Regulation, i.e. the question of whether “the product is protected by a basic patent in force”.
The request to the ECJ for a preliminary ruling was made in a UK case, in which Teva (and Accord, Lupin and Mylan) claimed invalidity of an SPC held by Gilead for the combination of the active ingredients tenofovir disoproxil (TD) and emtricitabine, which is marketed by Gilead under the trademark Truvada. Gilead’s SPC is based on a European patent explicitly specifying TD in its claims while not containing any mentioning of emtricitabine. The patent does, however, contain a claim covering “a pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients”.
Teva argued that emtricitabine is not specified in the wording of claim 27 of the basic patent at issue and that the expression “other therapeutic ingredients” used in that claim does not specify any active ingredient, whether structurally or functionally. Consequently, the TD/emtricitabine combination cannot be considered to be protected by a basic patent in force within the meaning of article 3(a) of the SPC Regulation.
Gilead, on the other hand, argued that in order to check whether a “product is protected by a basic patent” within the meaning of article 3(a), it is necessary and sufficient that the product in question falls within the extent of the protection conferred under at least one claim of the basic patent. In this regard, Gilead argued that the expression “other therapeutic ingredients” used in claim 27 implicitly but necessarily relates to emtricitabine and, for that reason, the TD/emtricitabine combination satisfies the condition laid down in in article 3(a).
The Grand Chamber of the ECJ held that a combination product is protected by a basic patent, “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”.
In this regard, the ECJ laid down two cumulative criteria which must be met stating that “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.”
Although it will be up to the referring UK court to apply the above test to the facts of the case, the ECJ, notably, states in its judgment that “it does not seem possible that a person skilled in the art, on the basis of the prior art at the filing date or priority date of that patent, would be able to understand how emtricitabine, in combination with TD, necessarily falls under the invention covered by that patent”. Hereby, the ECJ seems to indicate that Gilead’s SPC does not meet the above criteria.
With this decision, the ECJ takes a big step towards clarification of the conditions for obtaining SPC protection for combination products as the new ruling adds to previous rulings from the ECJ on this subject.
Accura notes that further clarification on SPCs is on its way as, at this moment, two other SPC cases are pending before the ECJ, namely C-650/17 and C-114/18.