Reference for a preliminary ruling from Court of Appeal (England & Wales) (Civil Division) made on 14 February 2018 – Sandoz Ltd,
Hexal AG v G.D. Seale LLC,
Janssen Sciences Ireland
(Case C-114/18)
Language of the case: English
Referring court
Court of Appeal (England & Wales) (Civil Division)
Parties to the main proceedings
Applicants: Sandoz Ltd, Hexal AG
Defendants: G.D. Seale LLC, Janssen Sciences Ireland
Question referred
Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation]1 is a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?
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1 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 (OJ 2009, L 152, p. 1).