Jurisdiction(s):
United Kingdom

Court of Appeal (England and Wales) affirms invalidity of AstraZeneca’s dapagliflozin patent; plausibility arguments rejected; SPCs fall; interim injunction refused

Published on: 18 July 2025

Published by a Law360 reporter

Legal News

Article summary

A three-judge panel affirmed the conclusions of Michael Tappin KC, who sat as a deputy High Court judge, dismissing AstraZeneca’s attempt to overturn his ruling that its dapagliflozin patent added nothing beyond an earlier international patent application. Justice Richard Arnold, writing for the court, said specialists reading AstraZeneca’s claims would have a ‘legitimate reason to doubt’ that dapagliflozin would serve as an effective therapy for diabetes. The row centres on AstraZeneca’s patent for the dapagliflozin molecule, which lapsed in May 2023. AstraZeneca had obtained supplementary protection certificates for the compound, due to run until May 2028. A number of generic manufacturers — including Teva Pharmaceutical Industries Ltd, Glenmark Pharmaceuticals Europe Ltd and Generics (UK) Ltd — petitioned the High Court to revoke the patent and, by extension, the supplementary protections, seeking to pave the way to market their own dapagliflozin before 2028. The High Court first backed the generics in April 2025, observing that AstraZeneca appeared to have selected the compound through an ‘arbitrary selection’ from options already outlined in the international application known as WO 128, which predated AstraZeneca’s filing in question...

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