CA-2025-001040-A - [2025] EWCA Civ 924

Viatris, Teva and Glenmark brought claims for revocation of the SPCs on 9 October, 24 November and 21 December 2023 respectively. No application was made for expedition of the trial of these claims, and they were listed for trial in March 2025. The trial was heard by Dr Tappin KC between 10 and 20 March 2025, and judgment was reserved.

On 20 February 2025 Glenmark notified AstraZeneca that it had obtained a marketing authorisation for a generic dapagliflozin product and was prepared to launch that product “at risk” (i.e. to take the risk that AstraZeneca would bring proceedings for infringement of the SPCs and the consequences which that might entail) on 17 March 2025. On 6 March 2025 AstraZeneca applied for an interim injunction to restrain Glenmark from marketing dapagliflozin until the conclusion of the form of order hearing after the delivery of the judgment, and subsequently it commenced infringement proceedings. The first date on which it proved feasible for the judge to hear the application was 27 March 2025. Glenmark gave an undertaking not to market its product prior to the determination of the application in return for a cross-undertaking in damages from AstraZeneca. The judge refused the application for the reasons given in his judgment of 28 March 2025 ([2025] EWHC 748 (Pat)), but on 9 April 2025 this Court (Coulson LJ, Warby LJ and myself) allowed AstraZeneca’s appeal for the reasons given in judgments handed down on 16 April 2025 ([2025] EWCA Civ 480).

In the meantime it had become clear that Teva and Viatris were also preparing to launch generic dapagliflozin products. AstraZeneca commenced infringement proceedings against Teva and Viatris, and obtained undertakings from Teva and Viatris that they would not launch prior to judgment on the revocation claims, again subject to the usual cross-undertakings.

On 1 May 2025 AstraZeneca applied to Dr Tappin KC for permission to appeal against his decision to revoke the SPC, having already applied for an interim injunction to restrain Glenmark, Teva and Viatris from marketing dapagliflozin until the determination of the appeal on 29 April 2025. Dr Tappin KC subsequently granted AstraZeneca permission to appeal. The application for an interim injunction was adjourned, with undertakings being given in the meantime, and in due course came before HHJ Hacon sitting as a High Court Judge.

In the meantime Sandoz launched a generic dapagliflozin product immediately after the revocation judgment was handed down, and supplied 75,000 packs of it to Bestway, which Bestway started selling on 29 April 2025. On 30 April 2025 AstraZeneca applied for an interim injunction against Sandoz and Bestway, which led to Sandoz and Bestway giving similar undertakings to those which had been given by Glenmark, Teva and Viatris. Most of the product sold by Bestway was recalled.

By the time of the hearing before Judge Hacon, I had expedited the substantive appeal and it had been listed for hearing on 25 and 26 June 2025. On 28 May 2025 Judge Hacon granted the injunction sought by AstraZeneca against Glenmark, Teva, Viatris, Sandoz and Bestway until the determination of the appeal for the reasons given in his judgment of that date ([2025] EWHC 1339 (Pat)).

Glenmark, Teva, Viatris, Sandoz and Bestway all applied for permission to appeal against Judge Hacon’s order. On 13 June 2025 I refused all five applications to appeal on the grounds that the appeals had no real prospect of success and there was no other compelling reason to hear them (on the contrary, the imminence of the substantive appeal was a compelling reason not to hear the appeals unless they had a real prospect of success). I included the following direction in my order:

“The parties should discuss with each other their respective plans with respect to an application for permission to appeal to the Supreme Court, and an application for an injunction or stay of an injunction pending the determination of that application, in advance of the hearing on 25 and 26 June 2025, and should make enquiries with the Court of Appeal List Office as to when in July 2025 any such application could be heard. Preparations should be made to enable the Court to deal with any such application in an orderly fashion.”

This led to 16 July 2025 being identified as a date by which the substantive judgments on the appeal should be available and which would be convenient for the hearing of any such application, and to a timetable for the filing of evidence being directed. On 25 June 2025 AstraZeneca filed an application notice for the relief described in paragraph 2 above. Glenmark, Teva and Viatris subsequently notified AstraZeneca that, if the appeal were to be allowed, they would not seek a stay of a final injunction pending an appeal to, or application for permission to appeal to, the Supreme Court.

On 3 July 2025 I granted the Secretary of State for Health and Social Care (“the SSHSC”) permission to intervene in the application and to file evidence from Susan Grieve, who is head of the Medicines Framework and Reimbursement team within the Medicines Directorate in the Department of Health and Social Care. The SSHSC is neutral with respect to AstraZeneca’s application, but is concerned that, in paragraphs 24 and 73 of my judgment of 16 April 2025, this Court misunderstood the position of the National Health Service with respect to price rises by patentees (and SPC holders). It is not appropriate to comment on that concern, but it is nevertheless worth recording, because it is often misunderstood, an important point made by Ms Grieve, which is that “the NHS is not a body; it is a service, in the provision of which many different public bodies have different roles, often circumscribed by statute”. NHS England is, at present, one of these bodies, but there are many others. The SSHSC also has an interest as a beneficiary of the various cross-undertakings given by AstraZeneca.

In the run-up to the hearing on 16 July 2025, Sandoz and Bestway pointed out that there was a potential jurisdictional problem in that, although they were respondents to AstraZeneca’s application dated 25 June 2025, they were not parties to the revocation proceedings and hence would not be parties to any application by AstraZeneca for permission to appeal to the Supreme Court. This problem was resolved partly by Sandoz and Bestway helpfully undertaking to be bound by the outcome of the application against Glenmark, Teva and Viatris and partly by my granting Sandoz and Bestway permission to intervene if and to the extent necessary. At the hearing Glenmark, Teva, Viatris, Sandoz and Bestway presented a united front in opposing AstraZeneca’s application.

It should be appreciated that Glenmark, Teva, Viatris and Sandoz are not the only generic pharmaceutical companies interested in the dapagliflozin market. 12 other companies currently hold marketing authorisations for generic dapagliflozin products, 11 of which are for dapagliflozin monotherapy. It is not known how close any of them may be to launching dapagliflozin products, but all have given undertakings or assurances to AstraZeneca not to launch for so long as Glenmark, Teva, Viatris, Sandoz and Bestway are enjoined. The reason for all this interest is not hard to discern. Dapagliflozin is currently AstraZeneca’s biggest-selling product in the UK. The current sales volume is around 1 million packs per month, worth over £400 million per annum, and sales are increasing.

It will be understood that, as at 16 July 2025, the status quo was that, by virtue of the interim injunctions and undertakings previously granted or given, AstraZeneca retained its monopoly of the dapagliflozin market in the UK. Although Glenmark, Teva, Viatris and Sandoz were all ready to launch generic dapagliflozin products, they had been prevented from doing so.

The final point to note is that the evidence filed by both sides for the purposes of the present application was predicated upon the assumptions that: (i) determination by the Supreme Court of an application by AstraZeneca for permission to appeal would take between three and six months from 16 July 2025; and (ii) if permission were granted, determination of the appeal would take between 15 and 23 months from 16 July 2025.