EPLAW PATENT BLOG

EU – Teva and Mylan v. Gilead

Posted: April 26th, 2018

Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd, Generics (UK) trading as ‘Mylan’ v. Gilead Sciences Inc. Request for a preliminary ruling, Opinion of Advocate General Wathelet, 25 April 2018, Case C-121/17, ECLI:EU:C:2018:278

“In the light of all the foregoing, I propose that the Court should answer the question referred for a preliminary ruling by the High Court of Justice (England and Wales), Chancery Division (Patents Court) (United Kingdom) as follows:

“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.”

A copy of the opinion can be read here.

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