Teva Pharmaceutical Industries Limited & Anor. v Novartis AG & Anor.
[2022] EWHC 2847 (Pat)
Astellas Pharma Industries Limited v Teva Pharmaceutical Industries Limited & Ors
17 October 2023
[2023] EWHC 2571 (Pat)
High Court
Astellas has a patent for a special pill that doesn't react badly with food. A company called Sandoz made a similar pill, but the judge decided Astellas didn't prove Sandoz's pill broke their patent. Another company, Teva, needs to have a separate trial to see if their pill breaks the patent.
Key Facts
- •Astellas Pharma Industries Limited (Claimant) alleged infringement of EP(UK) 2,345,410 ('EP410' or 'the Patent') by Teva Pharmaceutical Industries Limited, Teva UK Limited, Sandoz AG, and Sandoz Limited (Defendants).
- •The Patent concerns a modified-release pharmaceutical composition containing mirabegron.
- •Teva did not contest infringement of its original product but claimed non-infringement for its new product.
- •Sandoz denied infringement.
- •Defendants counterclaimed for revocation based on obviousness, insufficiency, and added matter, relying on Fix, Michel, and Chapple as prior art.
- •Astellas applied to amend the Patent.
- •Key disputes involved insufficiency, obviousness, and the composition of the skilled team.
Legal Principles
Obviousness assessment should consider the problem the invention solves, the established field, and the combined skills of real research teams.
Alcon v AMO [2022] EWHC 955 (Pat), Garmin (Europe) Ltd v Koninklijke Philips N.V. [2019] EWHC 107 (Pat), Medimmune v Novartis [2013] RPC 27, Fujifilm v Abbvie [2017] EWHC 395 (Pat), Illumina Cambridge Ltd v Latvia MGI Tech SLA & Ors [2021] EWHC 57 (Pat)
For sufficiency, a patent must disclose a principle of general application, meaning it can reasonably be expected to work with anything falling within the claim's scope.
Regeneron v Genentech [2013] EWCA Civ 93, Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46
The plausibility criterion requires the specification to disclose some reason for supposing the claimed efficacy is true.
Warner-Lambert Co LLC v Generics (UK) Ltd [2018] UKSC 56
Obviousness assessment involves identifying what falls within the claimed class, defining 'working', and determining if reasonable prediction of the invention's success across the claim scope is possible.
FibroGen v Akebia [2021] EWCA Civ 1279
In obviousness assessment, 'obvious to try' must be coupled with a fair expectation of success.
Actavis v ICOS [2019] UKSC 15, MedImmune Ltd v Novartis Pharmaceuticals UK Ltd [2012] EWCA Civ 1234
Arbitrary, non-technical limitations cannot support patentability in obviousness cases.
Actavis v Novartis [2010] EWCA Civ 82, Philip Morris v Nicoventures [2021] EWHC 537
Outcomes
EP410 (as unconditionally amended) is valid.
The court rejected the Defendants' insufficiency and obviousness arguments. The court found that the Patent's teaching on reducing food effects through controlled drug release for 4 hours or more, primarily in the small intestine, was plausible and not obvious over the prior art.
EP410 is not infringed by Sandoz Mirabegron.
Astellas failed to prove that Sandoz's product reduced food effects, a necessary element of infringement on the court's construction of the claim.
Infringement by Teva's revised product remains to be determined.
This issue was not fully addressed at trial.
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