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Sandoz AG & Ors v Bayer Intellectual Property GmbH & Ors
Factual and Procedural Background
This appeal arises from an order of His Honour Judge Hacon sitting as a High Court Judge on 12 April 2024, which revoked European Patent (UK) No. 1 845 961 ("the Patent"). The Appellants ("Company A") are the owner and alleged exclusive licensees of the Patent, which claims the use of rivaroxaban for treating thromboembolic disorders by once daily administration. The Respondents ("Company B" and others) are suppliers of generic medicines seeking to market generic rivaroxaban. The Respondents initiated proceedings for revocation of the Patent, and Company A counterclaimed for threatened infringement.
The Patent protects the once daily administration regimen of rivaroxaban, marketed by Company A under a well-known trademark, and is significant commercially. The prior protection expired on 1 April 2024, prompting interest from generic suppliers. The appeal hearing was expedited due to the commercial urgency. The Court dismissed the appeal, with this judgment providing detailed reasons.
Legal Issues Presented
- Whether, based on the prior art and common general knowledge at the priority date, it would have been obvious to the skilled team to include a once daily dosing regimen of rivaroxaban in a Phase II clinical trial with a reasonable expectation of success, meaning efficacy and safety sufficient for trial inclusion.
- Whether the judge erred in his assessment of expert evidence and factual findings relating to the obviousness of the claimed once daily dosing regimen.
- Whether the judge properly applied the legal principles governing inventive step and obviousness in the context of pharmaceutical dosing claims.
Arguments of the Parties
The opinion does not contain a detailed account of the parties' legal arguments.
Table of Precedents Cited
| Precedent | Rule or Principle Cited For | Application by the Court |
|---|---|---|
| Generics (UK) Ltd v H. Lundbeck A/S [2007] EWHC 1040 (Pat) | Legal test for obviousness and inventive step in patent law. | Confirmed the multi-factorial approach to obviousness applied in this case. |
| Conor Medsystems Inc v Angiotech Pharmaceuticals Inc [2008] UKHL 49 | Obviousness includes consideration of whether a solution was "obvious to try" with a reasonable prospect of success. | Supported the court’s approach to evaluating whether the skilled team would have had a reasonable expectation of success in trying once daily dosing. |
| Actavis Group PTC EHF v ICOS Corporation [2019] UKSC 15 | Clarification of the obviousness test, including the relevance of "obvious to try" and the expectation of success. | Guided the court’s assessment of obviousness in the context of dosing regimen claims. |
| Volpi v Volpi [2022] EWCA Civ 464 | Standard for appellate review of factual findings: findings must be rationally insupportable to be overturned. | Applied in refusal to overturn the judge’s factual findings regarding the status of authors and expert credibility. |
Court's Reasoning and Analysis
The court began by summarising the factual and technical background, including the nature of thromboembolic disorders, the pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban, and the common general knowledge of the skilled team at the priority date. The key question was whether it was obvious to include a once daily dosing regimen in a Phase II trial with a reasonable expectation of success in terms of safety and efficacy.
The court analysed the prior art, notably a poster presentation ("Harder") and two related posters ("the Kubitza posters"), which reported Phase I clinical data on rivaroxaban. These showed pharmacodynamic effects suggesting suitability for once daily dosing, including sustained anticoagulant activity up to 24 hours at certain doses. The court found that the skilled team would have understood this data and considered it supportive of testing once daily dosing in Phase II trials.
The court noted that the skilled team would have been cautious given the unknown therapeutic window and the risks of under- or overdosing. However, it was common practice to test a range of dosing regimens in Phase II trials to identify optimal dosing. The court rejected the notion of a technical barrier preventing the skilled team from including once daily dosing, identifying instead an ethical barrier related to patient safety, which would be addressed through ethics committee approval.
The judge’s factual findings, supported by expert evidence, favoured the Respondents’ experts who opined that the skilled team would have had a reasonable expectation of success with a 30 mg once daily dose. The court found no error in preferring this evidence over Company A’s experts, particularly as Company A’s counsel did not support the primary position of their experts that no Phase II trial would have been conducted.
The court rejected arguments that the judge applied an incorrect legal standard or failed to address the key question of reasonable expectation of success. The judge’s reasoning was detailed, nuanced, and legally sound, correctly applying established principles of obviousness and inventive step.
Finally, the court considered and refused Company A’s application to amend grounds of appeal and unpleaded grounds, finding no merit in these challenges to the judge’s findings and reasoning.
Holding and Implications
The court DISMISSED the appeal, upholding the revocation of the Patent for lack of inventive step due to obviousness.
The direct effect is that the Patent is revoked, allowing the Respondents and other generic suppliers to market rivaroxaban for once daily administration without infringement concerns. The decision does not establish new legal precedent but applies settled law on obviousness in the context of pharmaceutical dosing claims.
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