Court of Appeal Judgment Defines Plausibility in the UK
The Court of Appeal has handed down its Judgment in the Generics (UK) v AstraZeneca AB case, marking an important step in defining plausibility, which is a new and significantly developing area of law.
Plausibility is not a statutory condition for the grant of a patent, but it is rapidly becoming a judge-made one. That is because the monopoly of an invention is supposed to be granted in consideration for the invention's contribution to the art as disclosed to the public. If no such contribution is apparent, or the disclosure is insufficient, a monopoly cannot be justified.
The facts of this case are particularly interesting. An application under the Patent Cooperation Treaty disclosed a large number of compounds that were potential treatments for Type 2 diabetes. One of those compounds, identified by the patent in suit, turned out to be dapagliflozin, a highly effective drug for treating diabetes. However, the patent contained no information as to how, why or even whether it could treat diabetes. Without such information, there was no technical contribution or even disclosure.
The patent in suit has now expired, but supplementary protection certificates (SPCs) based on the patent, were granted to the patentee. Generics (UK) Ltd and several other generic pharmaceutical companies sought the revocation of those SPCs on the ground that the patent was invalid. Dr Michael Tappin KC granted that relief on 28 April 2025. The patentee appealed with Dr Tappin's leave. Given the value of the market for dapagliflozin and the generic manufacturers' need for certainty, Lord Justice Arnold expedited the appeal.
The Court of Appeal considered each of the appellant's eight grounds of appeal but held that it had no option but to uphold Dr Tappin's judgment.
Case: GENERICS (UK) Limited-v-ASTRAZENICA AB [2025] EWCA Civ 903
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