High Court patents judgment on Samsung’s 5G patent. The court addressed skilled person, inventive step, collocation, and plausibility arguments over an NR initial-access claim.
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.
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.
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.
The High Court dismissed patent revocation and invalidity actions over enzalutamide, holding the claims not obvious over the Poster or Slides and the patent sufficient and plausible.
Both EP258 and EP710 are invalid for obviousness over the cited prior art (Yin, Jardetzky disclosures, ASV Abstract, WO456). The skilled team, comprising a vaccinologist and a structural biologist, would have found it obvious to stabilise the RSV F protein in the prefusion conformation using a trimerisation domain, and to use such an antigen as a vaccine. The patents are not insufficient or implausible, but even if valid, would not be infringed by Pfizer's RSVPreF product due to the construction of 'polypeptide'. Arrow declaratory relief is justified to provide commercial certainty for Pfizer…