Accord Healthcare Limited v Novartis AG

Facts

Accord Healthcare Limited sought a declaration that European Patent (UK) No. 1 467 728 B1, owned by Novartis AG, was invalid, with a view to clearing the way for a competing product to be launched after Novartis' data exclusivity expires on 23 November 2026. The patent, whose unchallenged priority date is 17 January 2002, expired in January 2023, but Novartis also holds supplementary protection certificate SPC/GB16/025, based on the patent, which runs until 2028. Both were asserted to protect Entresto, a combination of the angiotensin receptor blocker valsartan and the neutral endopeptidase inhibitor sacubitril, presented in Entresto as a crystalline co-complex and a globally successful heart failure treatment, also approved for hypertension in some territories. Accord's intended product is a simple mixture of two separate salts. Accord attacked the patent for lack of plausibility (leading to insufficiency or obviousness), classical obviousness over Ksander and over Trippodo read with Ksander, obviousness as a mere collocation, and lack of technical contribution over Darrow or Trippodo; it also contended that the SPC was independently invalid and denied infringement. Novartis counterclaimed for threatened infringement of the SPC. The Dutch designation of the patent had earlier been held valid, but neither side relied on that decision.