Samsung Bioepis UK Ltd v Janssen Biotech, Inc.
[2024] EWHC 2442 (Pat)
Teva Pharmaceutical Industries Limited & Anor v Astellas Pharma Inc
25 July 2023
[2023] EWCA Civ 880
Court of Appeal
Someone had an idea that a certain medicine (mirabegron) might help with bladder problems. A previous document hinted at this, but didn't show it would work. The new patent showed it worked in rats, but not in people. The judge said it wasn't obvious the medicine would work, even though there was a hint, because the prior info was weak and the new patent only tested on rats, so it wasn't a slam dunk that it would work on people. The appeals court agreed.
Key Facts
- •Appeal against dismissal of claim for revocation of European Patent (UK) No 1 559 427 ('the Patent') and Supplementary Protection Certificate, and grant of relief for infringement.
- •Patent claims mirabegron, or a salt thereof, for use in treating overactive bladder (OAB).
- •Appellants argued the claimed invention was obvious over Australian Patent Application AU 199889288 ('288').
- •The skilled team was a clinician and pharmacologist working on OAB treatments.
- •Key dispute centered on whether it was obvious to try mirabegron for OAB given the common general knowledge and the disclosure in '288'.
- •'288' disclosed mirabegron as a β3-adrenoceptor agonist but lacked data on its potency and selectivity for human β3 receptors, and did not mention OAB.
- •The Patent provided in-vitro and in-vivo data in rats showing mirabegron's efficacy in treating OAB, but no human data.
Legal Principles
Structured approach to obviousness assessment (Pozzoli).
Pozzoli SpA v BDMO SA [2007] EWCA Civ 588
A patent cannot be for something old or obvious, remaining equally difficult or impossible to do after reading the patent; the perceived problem must be plausibly solved (Philips).
Koninklijke Philips NV v Asustek Computer Inc [2019] EWCA Civ 2230
Obviousness is a multi-factorial evaluation; the Court of Appeal won't intervene without error of law or principle (Actavis).
Actavis Group PTC EHF v ICOS Corp [2019] UKSC 15
Patentability is justified when a patent demonstrates that an established prejudice is unfounded – that what was considered unfeasible does in fact work (Pozzoli).
Pozzoli SpA v BDMO SA [2007] EWCA Civ 588
Obviousness is determined by reference to the claim, not a vague paraphrase based on the disclosure; the specification doesn't need to demonstrate by experiment that the invention will work (Conor).
Conor Medsystems Inc v Angiotech Pharmaceuticals Inc [2008] UKHL 49
Outcomes
Appeal dismissed.
The judge's findings on common general knowledge, the disclosure in '288', and assessment of expert evidence were not challenged and supported the conclusion that it was not obvious to try mirabegron for OAB with a reasonable expectation of success. The Patent made a technical contribution by demonstrating mirabegron's efficacy in rats, even without human data.
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Samsung Bioepis UK Limited v Janssen Biotech, Inc
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