Sandoz Ltd & Teva Pharmaceuticals Industries Ltd v Bristol-Myers Squibb Holdings [2023] EWCA Civ 472
This was the first occasion on which a UK court considered the recent EPO decision in G2/21 on the law of plausibility. Bristol-Myers Squibb (BMS) appealed an order of Meade J revoking European Patent (UK) No. 1 427 415 and, with it, the UK Supplementary Protection Certificate No. SPC/GB11/042 (concerning the use of lactam-containing compounds and derivatives thereof, and, in particular, apixaban, as factor Xa inhibitors used to treat thromboembolic disorders) for the reasons given in [2022] EWHC 822 (Pat). The Judge’s decision was made following a trial in which Sandoz and Teva contended that the Patent is invalid because its specification did not make it plausible that apixaban would have any useful factor Xa inhibitory activity.
The appeal was heard by Lord Justices Arnold, Nugee and Warby on 19-20 April 2023. The Court unanimously dismissed the appeal. Lord Justice Arnold’s judgment contains a careful analysis of the most important European and domestic decisions on “plausibility” as a standard for sufficiency and inventive step. The Court applied the plausibility test in Warner-Lambert Co LLC v Generics (UK) Ltd [2018] UKSC 56 and restated the following principles on the subject: (i) the requirement for plausibility applies with equal force to claims to a single chemical compound, and there is no invention in merely identifying a new compound without disclosing its utility; (ii) the correct standard is the one laid down by the majority in Warner-Lambert; (iii) it is not sufficient for the Application to encourage the PSA to carry out simple tests even if such test would indeed show the product is likely to be efficacious – subsequent data cannot substitute sufficient disclosure, as supported by G2/21; (iv) there is no additional requirement for the judge to consider the ‘patent bargain’ as a way to circumvent the plausibility test.
The Court also upheld Meade J’s finding that neither the higher quantity of apixaban made, nor the existence of additional processing steps, nor even the two together are enough, without more, to suggest to the PSA that apixaban was an effective factor Xa inhibitor. The existence of assay test results not specifically linked to apixaban cannot lead to more than speculation.
The Court mostly found that G2/21 was consistent with the UK authority in Warner-Lambert. However, Lord Justice Arnold did express his obiter view that the different results of the majority and the minority judgments in Warner-Lambert evidence the fact that, contrary to G2/21, the “ab initio plausibility” and “ab initio implausibility” tests are, in fact, not the same, and that the Enlarged Board in G2/21 itself seemed to have substantially preferred the former.
Anna Edwards-Stuart appeared as junior counsel for BMS, instructed by Hogan Lovells International LLP and Wilmer Cutler Pickering Hale and Dorr LLP.