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England and Wales decisions
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Generics (UK) Ltd & Ors v AstraZenica AB [2025] EWCA Civ 903 (16 July 2025)
The Court of Appeal dismissed AstraZeneca’s appeal and upheld invalidity findings on dapagliflozin’s patent and SPCs for lack of plausibility and arbitrary selection.
Court of Appeal upheld findings that AstraZeneca’s dapagliflozin patent was invalid for lack of inventive step and insufficiency, and was an arbitrary selection from prior art.
The High Court held AstraZeneca’s dapagliflozin patent and related SPCs invalid for insufficiency and lack of inventive step.
Generics (UK) Ltd Ltd v Astrazeneca AB [2025] EWHC 1012 (Pat) (28 April 2025)
The Patents Court held that AstraZeneca’s dapagliflozin patent and related SPCs were invalid because the claimed therapeutic effect was not made plausible.
Klemz v Comptroller-General of Patents, Designs and Trade Marks [2025] EWHC 650 (Pat) (21 March 2025)
Appeal from refusal of a patent application dismissed where the claimed apparatus was found inconsistent with conservation of momentum and Newton's laws.
The Application did not make it plausible that apixaban had useful factor Xa inhibitory activity. There was no data or reasoning in the Application linking apixaban to the asserted technical effect, and the skilled person would not infer from the Application that apixaban had been tested and found to have the required potency. The assertion of utility was speculative. Therefore, the patent was invalid for lack of inventive step and insufficiency.
Source excerpt
Sandoz Ltd v Bristol-Myers Squibb Holdings Ireland Unlimited Company (Re Patent - Plausibility when determining validity) [2023] EWCA Civ 472 (04 May 2023)
The Court of Appeal upheld invalidity of BMS’s apixaban patent, holding the application did not make factor Xa activity plausible at the filing date.
The Court of Appeal dismissed Mylan’s appeal, holding that EP443 plausibly disclosed melatonin’s claimed effect for treating non-restorative sleep in older patients.
Rockwool International A/S v Knauf Insulation Ltd [2020] EWHC 1068 (Pat) (07 May 2020)
The High Court dismissed Rockwool’s appeal over two patents for mineral wool binders, holding the claims inventive over prior art and rejecting added matter and plausibility challenges.
Regeneron Pharmaceuticals, Inc v Kymab Ltd & Anor [2018] EWCA Civ 671 (28 March 2018)
The Court of Appeal construed “in situ replacement” as positional replacement, found Kymab’s mice infringed, but upheld invalidity for insufficiency.
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