AG Opinion in the Truvada SPC case: are the issues specifically and precisely identifiable for the CJEU?
AG Wathelet has given his opinion on the “thorny issue” of the criteria for determining whether an active ingredient or combination of active ingredients of a medicinal product is “protected by a basic patent in force” within the meaning of the SPC Regulation (Article 3(a) of Regulation No 469/2009).
The case was originally referred from the UK’s High Court in March 2017 - Gilead contended that the product described in the SPC in dispute was protected by a European Patent (UK) 0 915 894 in accordance with Article 3(a), but Teva and the other claimants disputed this. They contended that the SPC did not comply with Article 3(a) of the SPC Regulation. The conclusion of the AG’s opinion states that:
“The fact that a substance or combination of substances falls within the scope of protection of the basic patent is a necessary, but not sufficient, requirement for it to constitute a product protected by a patent within the meaning of Article 3(a) of Regulation No 469/2009. A product is protected by a patent within the meaning of Article 3(a) of that 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. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically, precisely and individually identifiable in the wording of the claims of the basic patent.”
It is interesting to note, that the AG opinion refers consistently to the priority date of the basic patent rather than the filing date. It is not unusual for patentees to add information to a priority application when a subsequent application relying on that priority application is filed. Therefore, if the CJEU follows the Opinion, the priority application as well as any future patents derived from it used as a basis for an SPC application, will need to meet the criteria set out for protection.
The Opinion is not binding on the CJEU, however, if it is adopted, it could become be more challenging for patent owners to base an SPC on a patent that does not specifically recite the approve medicinal product in the claims.
The February 2018 Sandoz referral C-114/18, also on SPCs within the meaning of the SPC Regulation (Article 3(a) of Regulation No 469/2009), is also looking at a similar question regarding the level of detail needed in Markush formulae used in patent claims for SPCs. Specifically, whether a compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims.