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(1) Sandoz Ltd (2) Hexal AG v (1) G.D. Searle LLC (2) Janssen Sciences Ireland UC [2017] EWHC 987 (Pat)

Case Summary  |  Judgment  |   3 May 2017


Charlotte May QC and William Duncan represented the claimants in an action concerning the defendants’ supplementary protection certificate (SPC) for the drug darunavir (marketed as “Prezista”).

The case raised a question about the correct application of article 3(a) of Regulation 469/2009/EC (the “SPC Regulation”) – which states that a product the subject of an SPC must be protected by a “basic patent in force” – to products covered by Markush formulae.

It was common ground that the Patent in question did not specify darunavir by name, but that it did fall within the scope of the Markush formulae specified by various of the claims. The claimants contended that darunavir was nevertheless not “protected” within the meaning of 3(a), but that because the correct interpretation of article 3(a) in this respect was not clear, a reference should be made to the CJEU.

The judge held that it was sufficient for a claim to specify a product by means of a Markush formula that covered it, in order for that product to be “protected” pursuant to article 3(a). Darunavir was therefore protected by the Patent and the SPC was valid. The CJEU case law was sufficiently clear in this respect, so reference to the CJEU was unnecessary.