On 20 February, the CJEU heard argument in relation to the latest SPC referral from Arnold J (Teva and others v Gilead, C-121/17). As reported, the reference related to the correct approach to article 3(a) of the SPC Regulation and whether a product is "protected by a basic patent". Specifically, the question in issue was whether or not Truvada (a combination of tenofovir disoproxil and emtricitabine) was protected by a patent claiming tenofovir disoproxil and "optionally other therapeutic ingredients". When making the reference, Arnold J asked the CJEU a general question about the correct test to adopt under article 3(a) and proposed the answer to be the core inventive advance test. For the first time in an SPC referral, the Grand Chamber comprising 15 judges was convened and the parties were specifically asked to address the Court on the criteria which, in addition to the reference to the wording of the claims, should be used to determine in a consistent and workable way whether a product is "protected by a basis patent in force".

Oral submissions were made by six parties: Gilead, Teva and others, the UK, Greece, Latvia and the Commission. Gilead proposed that the correct approach was to adopt the "extent of protection" rules and simply to construe the claim of the patent in accordance with Article 69 EPC. Evergreening, they argued is avoided by article 3(c) as explained by the Court in Actavis v Sanofi (C-443/12). The other parties all supported, to varying degrees, the core inventive advance test proposed by Arnold J. The UK put forward a three stage test which was the subject of a number of questions from the Court:

  • does the product fall within the scope of at least one claim. The claims relating explicitly or implicitly (but necessarily and specifically) to the active ingredient in question;
  • what is the core inventive advance of the patent; and
  • does the product or combination embody the core inventive advance of the patent?

It will be interesting to see what test is adopted by the Court and whether it is consistent and workable. Avocat-Général Wathelet will give his opinion on 25 April 2018 with the judgment of the Court to follow thereafter.