AstraZeneca v Glenmark Pharmaceuticals (EWCA, [2025] EWCA Civ 480, 2025)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The Court of Appeal reversed the Patents Court and granted AstraZeneca an interim injunction restraining Glenmark from launching generic dapagliflozin until the conclusion of the form of order hearing following judgment on the validity of the supplementary protection certificate (SPC) (paras 1 and 91). In the light of new evidence showing that two further generic companies would enter the market if no injunction were granted (para 58), the court found real doubt as to the adequacy of damages for both sides and preserved the status quo for this short period (paras 81, 86 and 87). The judgment underlines the weight to be given to a failure to clear the path and to a launch in the middle of the validity trial (paras 88 and 89).

Facts and procedure

AstraZeneca AB is the proprietor of SPC/GB13/021 for dapagliflozin, based on European Patent (UK) No. 1 506 211, which expired on 15 May 2023; the SPC is due to expire on 13 May 2028 (para 5). Generics (UK) (Viatris), Teva and Glenmark brought claims for revocation of the SPCs between October and December 2023 on the ground that the patent was invalid (para 7). A joint request for a January 2025 trial, unsupported by any commercial reason, was refused and the trial took place from 10 to 20 March 2025 (paras 8 and 9). On 20 February 2025 Glenmark notified AstraZeneca that it could launch at risk from 17 March 2025 (para 10); it accepted that the launch would infringe the SPC if valid (para 11). On 28 March 2025 Michael Tappin KC refused the injunction, finding that damages would be an adequate remedy for AstraZeneca (paras 1 and 49). On appeal, AstraZeneca adduced new evidence that Teva and another company, referred to as Generic X, were ready to launch (para 56).

The applicable law

The power to grant an interim injunction derives from the High Court’s equitable jurisdiction, confirmed by section 37(1) of the Senior Courts Act 1981 (para 16). The American Cyanamid guidelines raise four questions: a serious question to be tried, the adequacy of damages for the claimant, the adequacy of damages on the cross-undertaking for the defendant and, finally, the balance of convenience (para 18). The court recalled that it should take the course likely to cause the least irremediable prejudice (Olint) (paras 20 and 36), and the features of at risk generic launches: a downward price spiral, NHS resistance to price restoration and the possibility of clearing the path by an early revocation claim (paras 22 to 26).

Question

Was the judge entitled to refuse the interim injunction on the basis that damages would adequately compensate AstraZeneca up to the form of order hearing?

Decision

The new evidence turned a real risk of further generic entry into a certainty, sooner than anticipated, making a downward price spiral inevitable, and tempered the deference owed to the judge (paras 58 and 59). The evidence of AstraZeneca’s witness showed that it was likely to reduce its actual price and would struggle to restore it given NHS resistance, contrary to the judge’s reading (paras 65, 67 and 70); there was therefore room for doubt about the adequacy of damages even before the hearing (para 73). The judge had also failed to address damage arising after that hearing, since generic presence on the market would alter the status quo for any injunction pending appeal (paras 76, 80 and 81). For Glenmark, first mover advantage was limited and the counterfactual clearer; there was real doubt for both parties and for the NHS (paras 82, 83 and 86). The court declined to follow the Irish Supreme Court’s approach, being bound by American Cyanamid (para 74). Given the short period, it was prudent to preserve the status quo, reinforced by Glenmark’s failure to give any reason for an earlier trial and its attempt to launch mid trial without awaiting judgment (paras 87 to 89). The injunction was granted until the conclusion of the form of order hearing, without dictating the outcome of any later application (para 91).

Key points for practice

• New evidence on appeal may reduce the deference owed to the first instance exercise of discretion (para 59).
• The damage to be assessed includes damage manifesting itself after the period covered by the injunction, in particular the effect of a changed status quo on an application for an injunction pending appeal (paras 75 and 80).
• A generic company which has not cleared the path, having given no reason for expedition, or which launches ahead of an imminent judgment, risks the status quo being preserved (paras 88 and 89).
• Practical point: a generic company planning an at risk launch should bring its revocation claim early enough and give reasons for any expedition; the patentee should evidence the effect of multiple entry on its actual prices and the difficulty of restoring them (paras 70 and 88).

Provisions applied

National law

Senior Courts Act 1981, section 37(1)

Case law cited

American Cyanamid Co v Ethicon Ltd [1975] AC 396; R v Secretary of State for Transport ex p. Factortame Ltd (No 2) [1991] 1 AC 603; National Commercial Bank of Jamaica Ltd v Olint Corp Ltd [2009] UKPC 16; Neurim Pharmaceuticals v Generics UK [2020] EWCA Civ 793 and [2022] EWCA Civ 370; SmithKline Beecham plc v Apotex Europe Ltd [2003] EWCA Civ 132; Bayer Intellectual Property GmbH v Aspire Pharma Ltd (HHJ Hacon, 2024); Sandoz Ltd v Bristol-Myers Squibb Holdings Ireland [2023] EWCA Civ 472; Merck Sharp & Dohme Corp v Clonmel Healthcare Ltd [2019] IESC 65

Related decisions

• Generics (UK) v AstraZeneca, 16 July 2025, the appeal on the validity of the patent and SPCs in issue.
• Neurim v Generics UK, 24 June 2020, authority on the adequacy of damages discussed by the court.
• Sandoz v Bristol-Myers Squibb, 4 May 2023, cited in relation to apixaban pricing.

Prepared by Dhenne Avocats from the text of the decision (National Archives, Find Case Law), consulted on 11 October 2026. Only the official text is authoritative.