Sandoz AG & Ors v Bayer Intellectual Property GmbH & Ors
[2024] EWCA Civ 562
Sandoz AG & Ors v Bayer Intellectual Property GmbH
12 April 2024
[2024] EWHC 796 (Pat)
High Court
Bayer's patent for a new way to use a blood thinner was challenged. A judge decided that the new way wasn't really new because scientists already knew enough to try it. The patent was therefore cancelled.
Key Facts
- •Bayer's patent for rivaroxaban, a blood thinner, was challenged for invalidity.
- •The patent claimed the use of a rapid-release rivaroxaban tablet administered once daily for at least five days.
- •Claimants argued the patent lacked inventive step and was insufficient.
- •Bayer counterclaimed for patent infringement.
- •The court considered prior art, including Harder, Kubitza posters, and Perzborn.
- •The court assessed whether a skilled team would have found it obvious to conduct a Phase II trial with once-daily dosing based on the prior art.
- •The court also considered whether the patent specification was sufficiently clear and complete.
Legal Principles
Inventive step is habitually assessed by reference to one item of prior art at a time, with exceptions for cross-referencing disclosures.
Sharpe & Dohme Inc v Boots Pure Drug Co Ltd (1927) 44 RPC 367; (1928) 45 RPC 153, at 180
The skilled person may elucidate an item of prior art by referring to available information that he or she knows to exist.
Generics (UK) Ltd v Daiichi Pharmaceuticals Co Ltd [2009] EWCA Civ 646, at [25]
Information publicly disclosed but no longer available may be prior art.
AutoStore Technology AS v Ocado Group plc [2023] EWHC 716 (Pat) at [237] and Richter Gedeon Vegyeszeti Gyar RT v Generics (UK) Ltd [2016] EWCA Civ 410 at [14] to [16]
Inventive step is a multifactorial assessment considering factors like motive, avenues of research, effort, and expectation of success.
Pozzoli SpA v BDMO SA [2007] EWCA Civ 588 at [23]; Generics (UK) Ltd v H. Lundbeck A/S [2007] EWHC 1040 (Pat) at [72]; Conor Medsystems Inc v Angiotech Pharmaceuticals Inc [2008] UKHL 49 at [42]
The legal standard for obviousness of a dosing claim is the same as any other claim.
Actavis Group PTC EHF v ICOS Corporation [2019] UKSC 15 at [42]
A patent specification should be given a purposive construction, considering what a reasonable person skilled in the art would understand.
Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46
Principles of plausibility in patent law consider whether the claimed invention is rendered plausible by the specification.
Generics (UK) Ltd v Warner Lambert Company LLC [2018] UKSC 56, at [37]; Teva Pharmaceutical Industries Ltd v Grünenthal GmbH [2023] EWHC 1836 (Pat), at [338]-[347]
Outcomes
The patent was found invalid for lack of inventive step.
The court found that the skilled team would have considered a once-daily dosing regimen in a Phase II trial based on the prior art, with a reasonable expectation of success.
Bayer's application to amend the claims was dismissed.
The court found the claims were not insufficient.
Similar Cases
Sandoz Limited v Bristol-Myers Squibb Holdings Ireland Unlimited Company
[2023] EWCA Civ 472
Teva Pharmacuetical Industries Limited & Anor v Bayer Intellectual Property GmbH
[2023] EWHC 3276 (Pat)
Pfizer Inc v Uniqure Biopharma BV
[2024] EWHC 2672 (Pat)
Samsung Bioepis UK Ltd v Janssen Biotech, Inc.
[2024] EWHC 2442 (Pat)