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Dapagliflozin: Patents Court reaffirms Warner-Lambert plausibility for sufficiency and inventive step; arbitrary selection renders claim obvious; no reliance on post-filed evidence; divergence from EPO post G 2/21

Published on: 15 May 2025

Published by a LexisNexis IP expert
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Article summary

The decision in Generics (UK) Ltd v AstraZeneca AB [2025] EWHC 1012 (Pat) highlights the growing divergence between UK patent law and the European Patent Office’s approach, particularly in the aftermath of the Enlarged Board of Appeal’s G 2/21...

Reassertion of the plausibility standard

At the centre of the dispute was AstraZeneca’s patent for dapagliflozin, an inhibitor of the sodium-dependent glucose co-transporter protein SGLT2, employed to reduce blood glucose for treating type II diabetes...

Although EP1506211 expired in May 2023, Generics UK, Teva and Glenmark pursued declarations of invalidity and the revocation of the related Supplementary Protection Certificates, SPC/GB13/021 and SPC/GB14/050. They argued that...

  • the patent did not make it plausible that dapagliflozin is a (selective) SGLT2 inhibitor or is useful in the treatment of diabetes...
  • the patent offered no technical contribution over the prior art (WO 01/27128), instead arbitrarily choosing dapagliflozin from a disclosed class of compounds...

The court reaffirmed that both inventive step and sufficiency are grounded in the basic requirement that a patent must disclose a genuine technical contribution to the art. The decision provides useful commentary on the evolution of UK...

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