Generics (UK) Ltd, Glenmark Pharmaceuticals Europe Ltd & Anor v AstraZeneca AB [2025] EWCA Civ 903
AstraZeneca held two supplementary protection certificates (SPCs) protecting dapagliflozin, an inhibitor of sodium-dependent glucose co-transporter proteins, used for treating Type II diabetes. The patent underlying the SPCs had expired and the Claimants wished to clear the way for launch of their own dapagliflozin products. The validity of the SPCs was challenged on the grounds that the basic patent was invalid for lack of plausibility and/or lack of technical contribution over the prior art (WO 128). Dr Tappin KC had held the SPCs invalid, finding for the Claimants on both of the invalidity attacks. AstraZeneca appealed to the Court of Appeal.
The Court of Appeal dismissed AstraZeneca’s appeal on all grounds. Applying Sandoz v BMS, the Judge had correctly concluded that the Patent did not make it plausible that dapagliflozin would be useful for the treatment of diabetes, and therefore the claims were invalid for both lack of inventive step and insufficient disclosure. Even if the standard applicable when considering inventive step for a product claim were to be “whether the skilled team would have legitimate reason to doubt that dapagliflozin would be useful for the treatment of diabetes”, on the Judge’s findings the skilled team would have legitimate reason to doubt this. Regarding arbitrary selection, the Judge was correct to hold that the Patent claims a compound arbitrarily selected from the prior art because the Patent makes no technical contribution compared to the prior art.
Adam Gamsa appeared for Generics and Kathryn Pickard for Glenmark