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SPC Update: AG Opinion in Teva v Gilead (C-121/17)

Advocate General of CJEU suggests precision needed for a patent to protect a product.


In the first of three pending referrals to the CJEU relating to Article 3(a) of the SPC Regulation, the Advocate General (AG) has today proposed a revised test for assessing whether a product is protected by a basic patent. The proposed test is that a product is protected by the patent 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 case at issue in this particular referral relates to an SPC for a combination therapy, Gilead’s Truvada®, and the AG has suggested that:


“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.” 


The AG’s opinion is not binding.  However, if the CJEU endorses this opinion, then the need for precision may support the current practice of the more stringent national patent offices in Europe.  Currently, for example, the UK tends to take a more generous view that allows for SPCs based on relatively broad claims. 


Article 3(a) of the SPC Regulation requires that an SPC for a product shall be granted if, among other requirements, the product is “protected by a basic patent in force”.  Previous decisions of the CJEU have confirmed that “protected” means that the product must be specified (Medeva C-322/10) or identified (Daiichi Sankyo C-6/11) in the wording of the claims of the patent.  The requirement for protection is therefore not an infringement test. 


However, exactly what is required for a product to be “identified” or “specified” has remained difficult to determine in practice.  In Eli Lilly (C-493/12), the CJEU was asked to consider whether a broad functional claim to an antibody was enough to specify a particular antibody product.  The Court answered that functional claims can specify the product, provided that the “claims relate, implicitly but necessarily and specifically, to the active ingredient in question”. 


The AG’s opinion in Teva v Gilead focuses on the requirement for specificity in the wording of the claims, adding the need for the product to be “precisely identifiable”.  The AG rejects proposals that any other test should be used, in particular the proposed criterion for the product to represent “the inventive advance of the patent”.


Although not directly relevant to the facts of the current case, the AG also appears to look unfavourably upon claims that have been amended post-grant to identify a particular product.


It remains to be seen how much of the AG’s opinion the final decision of the CJEU will adopt.  We can expect the final Judgment in the coming months. 


There are two further pending referrals at the CJEU relating to Article 3(a), Royalty Pharma (C'650/17) relating to a functional definition of a small molecule, and Sandoz v Searle (C'114/18) relating to a Markush formula.  Time will tell whether this triplet of cases may, finally, provide clarity on this point of law.

Meet the expert
Glyn Truscott
Glyn's practice spans a wide range of biotechnology subject-matter, from combination immunotherapies to PCR-based diagnostic assays.