Sandoz AG & Ors v Bayer Intellectual Property GmbH

For inventive step, the question is whether the skilled team would have pursued the claimed clinical trial with a reasonable expectation of success. In a drug-development case, that assessment includes the balance between efficacy and safety, including the risk that an ethics committee would regard the proposed trial as unacceptable. Phase I data need not predict clinical efficacy with certainty. It may provide a sufficient basis for a phase II trial where the risks are tolerable and the evidence gives reasonable grounds for expecting a safe and effective regimen. Prior art may be read with another disclosure where it expressly refers to that disclosure and the skilled person would be motivated to consult it, even if the additional material was only temporarily available.

The claimants sought revocation of European Patent (UK) No. 1 845 961, concerning once-daily administration of rapid-release rivaroxaban for treating thromboembolic disorders. Bayer counterclaimed for threatened infringement, but infringement was conceded for the trial, leaving validity as the sole issue.

The claimants alleged lack of inventive step over Harder together with the Kubitza posters and, alternatively, over Perzborn and the Blood Abstracts. They also alleged insufficiency because the claims contained no dose limitation and covered disorders beyond thromboembolic disorders. Bayer conditionally sought amendments. The central questions were whether the claimed once-daily regimen was obvious and whether the claims were insufficient.

1. Inventive step. The court applied the multifactorial approach to obviousness and accepted that the relevant criterion on the facts was whether the skilled team would have had a reasonable expectation of success. The assessment concerned whether the team would have sought approval for a phase II trial including once-daily dosing, and whether that trial would have been regarded as sufficiently safe and effective.
2. Phase I assays could not predict antithrombotic efficacy with certainty. They nevertheless provided important guidance. The skilled team would have recognised the clinical and commercial advantages of once-daily treatment, while treating patient safety as paramount. The combined Harder and Kubitza disclosures showed sustained pharmacodynamic effects and gave reasonable grounds for believing that a 30 mg once-daily dose could maintain an effect over 24 hours without an unacceptable risk of bleeding.
3. Harder expressly referred to the Kubitza posters. The posters had been publicly displayed without confidentiality restrictions, so their temporary nature did not prevent them forming part of the state of the art. The skilled team would have been motivated to read them with Harder. It followed that a phase II trial including a 30 mg once-daily regimen was obvious.
4. Insufficiency and construction. The claims were not insufficient merely because they contained no express dose limitation. The skilled team would understand that only a limited range of doses could be safe and effective, and routine phase II and III trials could identify that range. The reference to inflammatory, microvascular and Alzheimer’s disease in the specification’s list of thromboembolic disorders was an obvious mistake. The skilled team would disregard those entries rather than construe the claims nonsensically.
5. The Patent was therefore invalid for lack of inventive step over Harder plus the Kubitza posters. The insufficiency allegations failed, and Bayer’s conditional amendment application fell away.