CJEU confirms Art 3(a) criteria for determining SPC protection
In order for an SPC to be valid the relevant product must be “protected by” the basic patent. The meaning of “protected by” has been the subject of much debate, especially in relation to combination products.
In case C-121/17 (Teva UK Ltd and others v Gilead Sciences Inc), the CJEU has now held that where the SPC covers a product comprised of several active ingredients with a combined effect it is protected by the basic patent if (i) the combination of those active ingredients falls under the invention covered by the basic patent; and (ii) each active ingredient is specifically identifiable in light of all the information disclosed by the patent.
The basic patent held by Gilead Sciences Inc, which expired in 2017, covers a series of molecules helpful in the therapeutic treatment of viral infections, including HIV. The description included pharmaceutical formulae which may be envisaged for the compounds claimed, without specific reference to individual compounds or use for those compounds. The description also provides those compounds may be associated with ‘other therapeutic ingredients’, without definition nor explanation of those ingredients in the patent.
The applicants sought to challenge the validity of an SPC obtained by Gilead, relating to a ‘composition containing [TD], optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine’. The SPC was obtained on the basis of claim 27 of the patent, ‘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.’
Whilst claim 25 claims TD, emtricitabine is not specified in claim 27 whilst the expression ‘other therapeutic ingredients’ does not specify any active ingredient, whether structurally or functionally. Further, there appeared to be no evidence that emtricitabine was known as an agent for the treatment of HIV in humans to the skilled person at the priority date.
The applicants therefore submitted the TD/emtricitabine combination could not be claimed as the product was not specified in the wording of the claims, nor did the claim relate necessarily and specifically to the product. Gilead however asserted that 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. Gilead also submitted that ‘other therapeutic ingredients’ in claim 27 of the basic patent at issue relates implicitly but necessarily to emtricitabine.
The CJEU therefore had to decide the criteria for determining whether “the product is protected by a basic patent in force” as required by Article 3(a) of Regulation No 469/2009, concerning SPCs.
The CJEU held that Article 3(a) of Regulation No 469/2009 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 must relate necessarily and specifically to that combination.
This must be assessed from the viewpoint of the skilled person on the basis of the prior art, requiring that 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 basic patent contained no information as to the possibility that it could relate specifically to a combined effect of TD and emtricitabine for the treatment of HIV. The CJEU therefore found it unlikely that a skilled person would be able to understand how emtricitabine, in combination with TD, on the basis of the prior art, necessarily falls under the patent invention.
The UK court will now need to confirm whether this is indeed the case and determine whether emtricitabine is specifically identifiable by the skilled person in the light of all the information contained in that patent, on the basis of the prior art.