Sandoz AG & Ors v Bayer Intellectual Property GmbH
[2024] EWHC 796 (Pat)
Sandoz AG & Ors v Bayer Intellectual Property GmbH & Ors
24 May 2024
[2024] EWCA Civ 562
Court of Appeal
A company (Bayer) had a patent for using a drug (rivaroxaban) once a day. Other companies challenged the patent, saying it was obvious to try giving the drug once a day based on earlier research. The court agreed and said the patent was invalid because it was obvious to a skilled scientist to test once-daily dosing.
Key Facts
- •Appeal against revocation of European Patent (UK) No. 1 845 961 ('the Patent') for rivaroxaban's once-daily use in treating thromboembolic disorders.
- •Bayer (Appellants) owns/licenses the Patent; Respondents are generic medicine suppliers.
- •The Patent's validity hinges on whether once-daily rivaroxaban administration was obvious given prior art (Harder poster and Kubitza posters).
- •Prior art comprised Phase I trials data on rivaroxaban (then BAY 59-7939) showing its pharmacokinetic (PK) and pharmacodynamic (PD) properties.
- •Key dispute centered on whether the prior art provided a reasonable expectation of success for once-daily rivaroxaban in a Phase II trial (considering efficacy and safety).
Legal Principles
Obviousness requires assessment of whether an invention would be obvious to a skilled person considering prior art and common general knowledge. The 'obvious to try' test is relevant, but doesn't necessitate a manifest expectation of success.
Generics (UK) Ltd v H. Lundbeck A/S [2007] EWHC 1040 (Pat), Conor Medsystems Inc v Angiotech Pharmaceuticals Inc [2008] UKHL 49, Actavis Group PTC EHF v ICOS Corporation [2019] UKSC 15
The same legal standard applies to obviousness in dosing claims as in other claims.
Actavis v ICOS
Outcomes
Appeal dismissed.
The court found the once-daily use of rivaroxaban was obvious based on the prior art, which suggested suitability for once-daily dosing and provided some supporting data. The skilled team would have a reasonable expectation of success (efficacy and safety) with a 30mg once-daily dose in a Phase II trial.
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