SPCs for combination products – The CJEU sets out the criteria for combinations of active ingredients being “protected by a basic patent” (by Dr. Ulrike Herr)

On July 25, 2018, the Court of Justice of the European Union (the CJEU) handed down its judgement in C-121/17 Teva v Gilead eagerly awaited by the SPC community. In the referral, the UK High Court asked the CJEU once again to provide clear guidance on the criteria for deciding whether the product of an SPC is protected by the basic patent in the sense of Art. 3(a) of the SPC Regulation. The product of an SPC means the active ingredient or a combination of active ingredients of a medicinal product.

Specifically, the case concerns Gilead’s Truvada SPC for the combination of the two active ingredients tenofovir disoproxil and emtricitabine. The anti-HIV drug Truvada is a fixed-dose co-formulation of tenofovir disoproxil and emtricitabine in one pill. Gilead’s basic patent of the SPC (EP 0 915 894 B1) expired end of July 2017. The main issue to be clarified is whether the Truvada combination product is “protected by the basic patent” by the relevant claim of Gilead’s basic patent which expressly mentions only tenofovir disoproxil, and optionally other therapeutic ingredients.

The CJEU limited the answer to the referral question to combination products and ruled as follows:

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.

Again, the onus is on the national patent offices and courts to assess whether the active ingredients of a combination product “fall under the invention covered by the patent” and whether said active ingredients are “specifically identifiable, in the light of all the information disclosed by that patent”.

Our Munich partners Fritz Lahrtz and Ulrike Herr are representing one of the claimants in the parallel German nullity proceedings of Gilead’s German Truvada SPC together with an attorney-at-law from the Munich office of an international law firm (http://thespcblog.blogspot.com/2018/05/germany-gileads-spc-for-truvada.html).

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