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What are the criteria for granting a SPC – final clarity?

02. maj 2018

The opinion from Advocate General Wathelet has now been delivered in case C-121/17 Teva v Gilead. The question from the High of Justice (England and Wales) is: “What are 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 Article 3(a) of Regulation No 469/2009 concerning supplementary protection certificate (“SPC”) for medicinal products.

The Advocate General proposes the following ruling to the Court of Justice of the European Union:

“Article 3(a) precludes the grant of SPC 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 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).

A product is 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.”

Time will show if the Court of Justice of the European Union will follow the proposal from the Advocate General Wathelet and if this ruling will provide the clarity to the many issues that have arisen from interpretation of Article 3(a) of Regulation No 469/2009. Please see the opinion here: