In Teva v Gilead (C-121/17), the CJEU has given its answer to the question of when a drug composed of several active ingredients will be considered to be ‘protected by a basic patent in force’ under Article 3(a) of Regulation (EC) No 469/2009 (the SPC Regulation).
A Supplementary Protection Certificate (SPC) extends the period of protection conferred by a patent to a medicinal product for up to five years after patent expiry. One of the conditions for the grant of an SPC, as set out in Article 3(a) of the SPC Regulation, is that the product must be ‘protected by a basic patent in force’.
While Article 3(a) has been the subject of several previous references to the CJEU, the answer provided by the CJEU in this case provides further guidance on the application of that Article specifically in relation to combination products (i.e. products containing several active ingredients which together have a combined effect).
Gilead is the manufacturer of the HIV drug TRUVADA, which is a combination product containing Tenofovir Disoproxil (TD) and Emtricitabine. TD is expressly mentioned in claim 25 of Gilead's patent EP 0 915 894, and claim 27 of the same patent claims: ‘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’. Emtricitabine is not expressly mentioned or disclosed anywhere in EP '894.
On the basis of claim 27 of EP '894, Gilead obtained an SPC for a ‘composition containing [TD], optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine.’
High Court Action
Before the High Court, Teva and other generics manufacturers sought to invalidate Gilead's SPC on the basis that Emtricitabine was not specified in the wording of claim 27 in any way, and that the words ‘other therapeutic ingredients’ in that claim did not specify any active ingredient but instead covered a virtually unlimited range of active ingredients for the treatment of many diseases.
Gilead, on the other hand, argued that the combination of TD and Emtricitabine fell within the scope of protection of claim 27 of EP '894, which was sufficient for it to be ‘protected’ by EP '894 under Article 3(a) of the SPC Regulation.
While Mr Justice Arnold considered it clear from previous CJEU case law that a product would not be protected by an SPC simply because it fell within a claim of the basic patent, and that ‘something more’ was required, it was unclear to him what this further requirement was. Accordingly, he considered that the test to be applied under Article 3(a) remained unclear, and felt it necessary to ask the CJEU the same question as in Actavis v Sanofi (Case C-443/12) again:
‘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 judgment, Arnold J suggested an answer to the above question and expressed his view that in addition to simply falling within a claim of the basic patent, there was a further requirement for the product to contain an active ingredient, or a combination of active ingredients, which embodied the ‘inventive advance’ (or technical contribution) of the basic patent.
The CJEU considered previous decisions on Article 3(a) of the SPC Regulation and the rationale behind the creation of the SPC system, and concluded that for a product which is the subject of an SPC to be ‘protected’ by a basic patent under Article 3(a), it must be identifiable specifically by the skilled person in the light of all the information disclosed by the basic patent and the prior art at the filing or priority date of that patent. It did not, however, consider Arnold J's proposed 'inventive advance' test.
On this basis, it provided the following answer to the question posed by Arnold J:
‘Article 3(a) of [the SPC Regulation], 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.’
In its judgment the CJEU expressed its view that it was apparent that the skilled person, on the basis of the prior art at the filing or priority date of EP '894, would not be able to understand that the combination of emtricitabine with TD necessarily fell under the invention covered by that patent.
However the final decision on the matter rests with the High Court, and the case will now be sent back to Arnold J for him render his final decision on whether to uphold or revoke Gilead's SPC.