Sandoz AG & Ors v Bayer Intellectual Property GmbH & Ors

Obviousness of a pharmaceutical dosing claim is assessed by the same fact-sensitive, multi-factorial standard as any other claim. The question is whether the skilled team, reading the prior art with common general knowledge, would have undertaken the relevant research with a reasonable or fair prospect of success. Certainty or manifest predictability is unnecessary. For a Phase II trial, the relevant expectation may concern whether a proposed regimen would be sufficiently efficacious and safe, even though Phase I data cannot predict clinical efficacy. Ethics committee approval is not part of the strict legal test, although safety risks may inform the assessment. On appeal, a court should not interfere with a trial judge’s evaluation of obviousness absent an error of law or principle.

Generic medicine suppliers sought revocation of a patent claiming the use of rivaroxaban for treating thromboembolic disorders by once-daily administration. His Honour Judge Hacon, sitting as a High Court Judge, revoked the patent on the ground that the claimed regimen was obvious in light of Phase I data reported in the Harder and Kubitza posters: [2024] EWHC 796 (Pat).

Bayer appealed, arguing that the judge had applied the wrong obviousness standard, had relied improperly on ethical approval and the authors’ status, and had failed to assess whether the prior art gave a reasonable expectation of a therapeutically useful 24-hour effect. The central issue was whether the skilled team would have included a 30 mg once-daily regimen in a Phase II trial with a reasonable expectation of sufficient efficacy and safety.

Disposition. The Court of Appeal unanimously dismissed the appeal. It also refused permission to amend the grounds of appeal and to raise the unpleaded ground.

1. Applicable principles. An invention lacks an inventive step if it would have been obvious to the skilled person or team having regard to the prior art read with common general knowledge. The assessment is fact-sensitive and multi-factorial. Relevant considerations include the motive to find a solution, the number and extent of possible research avenues, the effort involved and the expectation of success. The same standard applies to dosing claims. The obvious-to-try consideration asks whether it was obvious to undertake specific research with a reasonable or fair prospect of success; it does not require that success be manifestly predictable. These principles were stated in Generics (UK) Ltd v H. Lundbeck A/S [2007] EWHC 1040 (Pat), approved in Conor Medsystems Inc v Angiotech Pharmaceuticals Inc [2008] UKHL 49, [2008] RPC 28, and reaffirmed in Actavis Group PTC EHF v ICOS Corporation [2019] UKSC 15, [2019] Bus LR 1318.
2. Correct inquiry. The relevant question was whether the skilled team, having read Harder and the Kubitza posters, would reasonably expect that a 30 mg once-daily regimen would be sufficiently efficacious and safe to include in a Phase II trial. Phase I data could not predict clinical efficacy, but it could provide reasonable grounds for proceeding. The reference to ethics committee approval was strictly irrelevant to the legal test, but did not undermine the assessment because, on the facts, safety and ethical acceptability reflected the same risks of under-dosing and over-dosing.
3. Application. Harder expressly indicated suitability for once-daily dosing. The posters supplied supporting pharmacodynamic data, including evidence capable of indicating sustained activity after 24 hours. The judge was entitled to prefer the evidence of Professors Hirsh and Wilkins. The evidence gave reasonable grounds for believing that 30 mg once daily would have a sustained antithrombotic effect without an unacceptable risk of bleeding. The conventional inclusion of a range of regimens in a Phase II trial also meant that actual surprise at the eventual result was irrelevant.
4. Appellate review and ancillary grounds. Obviousness involves a multi-factorial evaluation, so appellate intervention requires an error of law or principle: Actavis Group PTC EHF v ICOS Corporation [2019] UKSC 15. Bayer’s complaints were disagreements with the judge’s evaluation of the evidence and disclosed no such error. The challenged finding about the authors of Harder was rationally supportable and did not materially affect the result. The manner in which the inventors actually arrived at the invention was legally irrelevant, and the judge had not relied on the absence of that evidence.

1. Court of Appeal (Civil Division) — dismissed Bayer’s appeal and refused permission to amend the grounds or raise the unpleaded ground: [2024] EWCA Civ 562.
2. High Court, Patents Court — His Honour Judge Hacon revoked European Patent (UK) No. 1 845 961 for obviousness: [2024] EWHC 796 (Pat).