Sandoz AG & Ors v Bayer Intellectual Property GmbH
[2024] EWHC 796 (Pat)
Sandoz Limited v Bristol-Myers Squibb Holdings Ireland Unlimited Company
4 May 2023
[2023] EWCA Civ 472
Court of Appeal
BMS had a patent for a medicine. A judge said the patent was bad because the paperwork didn't show good enough reasons to believe the medicine would work. The appeal court agreed, saying you need real evidence, not just guesswork, to get a patent.
Key Facts
- •Sandoz and Teva challenged the validity of BMS's European Patent (UK) No. 1 427 415 and its associated SPC for apixaban, a factor Xa inhibitor.
- •The central issue was whether the patent application (WO 03/026652) plausibly disclosed apixaban's factor Xa inhibitory activity.
- •The claimants argued that the lack of plausibility rendered the patent invalid for lack of inventive step and insufficient disclosure.
- •BMS appealed the judge's decision that the patent was invalid.
- •The appeal focused on the plausibility requirement in patent law, particularly in the context of a claim to a single chemical compound.
- •The case involved interpreting the concept of plausibility in light of UK and EPO case law, including the Enlarged Board of Appeal's decision in G 2/21.
Legal Principles
The scope of a patent monopoly must be justified by the technical contribution to the art.
Various EPO and UK cases, including Agrevo and Warner-Lambert.
Inventive step requires a plausible technical contribution; a mere assertion of utility is insufficient; plausibility must be assessed from the application as filed.
Warner-Lambert, G 2/21
Sufficiency requires a plausible disclosure enabling the skilled person to work the invention across the scope of the claim.
Warner-Lambert, G 2/21
Plausibility is not a distinct condition of patentability but a criterion for reliance on a purported technical effect. The key is whether the skilled person, considering common general knowledge, would understand the technical teaching of the application as filed to encompass the asserted effect.
G 2/21
Post-published evidence can support plausibility if the effect is already plausible from the application; it cannot substitute for insufficient disclosure in the application.
Warner-Lambert, G 2/21
Outcomes
The appeal was dismissed.
The court found that the patent application did not make it plausible that apixaban possessed the claimed factor Xa inhibitory activity. The application lacked sufficient disclosure to support the claimed invention, failing to provide a reasonable scientific basis for expecting the claimed therapeutic effect.
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