Opinion of the Advocate General in Teva v Gilead SPC case

25 April 2018

On 25 April 2018, Advocate General Wathelet gave his opinion in Teva and others v Gilead Case C-121/17, referred to the CJEU by Arnold J last year. This important case, in which the CJEU sat, unusually, in a Grand Chamber, considered again the interpretation of Article 3(a) of the Supplementary Protection Certificate Regulation and the conditions for grant of a SPC.

The Advocate General recommended that Article 3(a) should be interpreted as precluding 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“.

He considered that “[t]he 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

He went on to propose that a product should be treated as protected by a patent within the meaning of Article 3(a) “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.

The Advocate General also made recommendations, subject to verification by the English court, as to how the test should be applied to the facts of the case. The decision of the CJEU will be eagerly awaited.

Several members of Chambers were involved in this case in the English court and before the CJEU: Daniel Alexander QCLindsay Lane and Jaani Riordan (for the claimants) and James Whyte for Gilead.

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