We have previously reported on the flurry of references to Europe’s highest court, the Court of Justice of the European Union (CJEU), asking for clarity on how to determine whether a product is “protected” by a patent according to Article 3(a) of the SPC Regulation, one of the criteria which must be satisfied for obtaining an SPC. These references raise fundamental questions regarding the type of patent claims that can be used to obtain patent term extension for authorised medicinal products. The reference in Teva v Gilead C‑121/17, relating to combination claims underlying Gilead’s SPCs for Truvada (reported here), was quickly followed by the Sitagliptin case involving functionally worded claims (C-650/17) and Sandoz v Searle involving Markush claims (C-114/18, reported here).
A significant step was taken today with the publication of a legal opinion by Advocate General Wathelet relating to Teva v Gilead C‑121/17. An Advocate General is usually asked by the CJEU’s judges to prepare an advisory opinion about the legal issues at stake before the CJEU’s judges reach a decision.
In short, the opinion rejects the test proposed by Teva that the product must embody the core inventive advance of the patent, while also holding that it is necessary, but not sufficient, that the product falls within the scope of protection of the basic patent to comply with Article 3(a). Instead the Advocate General concluded that:
Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products precludes the grant of a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent. 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.
This opinion is not binding on the Court, and so it remains to be seen whether the Court will follow this opinion or take Article 3(a) in a completely different direction.
Although it is not pertinent to the underlying facts of the Teva v Gilead case, the opinion also suggests that post-grant amendments of patent claims are irrelevant for the purpose of obtaining an SPC because, in the Advocate General’s view, Article 3(a) is to be judged only on the wording (or an interpretation of the wording) of the claims of the granted patent. If this aspect of the opinion is followed by the Court, a number of pending and granted SPCs could be affected.
Gilead is a client of the firm, which is the agent of record for the UK SPC underlying C-121/17.