Today (25.07), the Court of Justice of the European Union ("CJEU") has rendered a long awaited decision in a dispute revolving around the supplementary protection certificate ("SPC") protecting the hiv inhibitor Truvada. With its judgment rendered (to be found here), the CJEU has now provided much needed clarification on the question of whether "the product is protected by a basic patent in force" within the meaning of Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (the "SPC Regulation"), which affords drugs an additional term of protection on top of the standard twenty years provided by the European Patent Convention ("EPC").
Summarised, a combination product is eligible for an SPC, if the claims in the underlying patent relate necessarily and specifically to that combination of active ingredients (even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent).
Background and reference to the CJEU
The background leading up to the CJEU decision is as follows. Teva, Accord, Lupin and Mylan (the "Generics") commenced invalidity proceedings in the UK against an SPC held by Gilead for the anti-retroviral drug marketed under the trade mark Truvada. Truvada is used in the treatment of HIV and contains the two active ingredients (both reverse transcriptase inhibitors) known as tenofovir disoproxil ("TD") and emtricitabine.
The Truvada SPC is based on EP 0 915 894 ("EP 894"). The parties agreed that EP 894 discloses TD; however, the patent (i) contains no examples of TD in combination with any other therapeutic ingredient and (ii) emtricitabine is not mentioned in it at all. The patent does contain a claim (27) 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". The crucial question to be determined was whether a product containing both TD and emtricitabine is protected by EP 894.
Outside of the UK, the question of whether an SPC for Truvada could be granted based on EP 894 was not exactly answered in a consistent way: some national authorities (patent offices or courts) had granted (or maintained) an SPC for Truvada (including Belgium and Germany) whereas some had not (including the Netherlands, France and Sweden), with litigation still pending in a number of those countries. In the UK, the SPC was initially rejected, but this was overturned in a later decision. Still, as mentioned the Generics decided to initiate an attack aimed at invalidating the SPC.
The Generics relied, inter alia, on the Medeva decision in which the CJEU had ruled that the active ingredients should be "specified in the wording of the claims of the basic patent" (CJEU 24 November 2011, C-322/10, EU:C:2011:773 (Medeva)). The Generics argued that the words "other therapeutic ingredients" do not specify any active ingredient (whether structurally, functionally or otherwise). On the contrary, they said that these words cover a virtually unlimited range of active ingredients for the treatment of many diseases. Moreover, they also deemed relevant that emtricitabine was not approved for clinical use until seven years after the priority date of the patent. Gilead, on the other hand, essentially argued that all that was required was that emtricitabine falls within the scope of protection of claim 27 of the patent (relying on CJEU 12 December 2013, C-493/12, EU:C:2013:835 (Eli Lilly)).
Arnold J ruled in his decision that the law was not sufficiently clear (in spite of, or as a consequence of, a number of earlier CJEU decisions) and he referred the following question to the CJEU: "What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of the SPC Regulation?" In his view, the test should be whether the product falls within the claim and embodies the inventive advance (or technical contribution) of the claim (whilst referring to CJEU 12 December 2013, C-443/12, EU:C:2013:833 (Actavis/Sanofi) and CJEU 12 March 2015, C-577/13, EU:C:2015:165 (Actavis/Boehringer)).
In his advisory opinion, A-G Wathelet introduces a new test to determine whether a product is protected by a basic patent. He states that a product is only protected under the SPC Regulation "(…) if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent".
The CJEU however takes a different direction and holds 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 context, the CJEU provides further guidance by formulating two cumulative criteria: "[f]or 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 furthermore seems to suggest that the Truvada SPC does not meet the above criteria ("…it does not seem possible that a person skilled in the art (…) would be able to understand how emtricitabine, in combination with TD, necessarily falls under the invention covered by that patent"). However, of course it will be up to the referring court to apply the test to the facts of the case.
All in all, today's decision adds another building brick to the SPC edifice which the CJEU has been building, which is something that should be applauded. Needless to say, further clarification remains desirable. This may in fact already become reality soon, since another two other SPC cases are pending before the CJEU (C‑650/17 and C‑114/18).