Astrazeneca AB & Anor v Glenmark Pharmaceuticals Europe Limited

On an application for an interim injunction pending an appeal in a patent validity action, the court should apply the American Cyanamid guidelines sequentially. The court must assess the competing risks of irreparable harm, giving particular attention to market effects that damages may not adequately quantify.

In generic pharmaceutical cases, likely multiple entry may produce a price spiral or substantial price undercutting. The patentee’s practical inability to restore its price after the appeal may constitute irreparable harm. Where the risks on both sides are real and cannot be accurately compared, preserving the factual status quo is a powerful consideration, especially where the appeal is imminent. The fact that some generic companies cleared the path does not necessarily justify allowing them to launch while restraining others.

AstraZeneca owned supplementary protection certificates covering dapagliflozin. Following a trial, the court found the underlying patent invalid, with the result that the certificates were invalid and generic suppliers could lawfully market their products, subject to interim relief pending appeal.

AstraZeneca appealed and sought interim injunctions restraining Glenmark, Teva, Generics (U.K.) Ltd trading as Viatris, Sandoz and Bestway from marketing generic dapagliflozin until the Court of Appeal decided the appeal. Teva, Viatris and Glenmark had sought to revoke the certificates before marketing; Sandoz and Bestway had not. The central issues were the competing risks of irreparable harm, the significance of clearing the path and the proper characterisation of the status quo.

The application was granted. The five respondents were restrained from marketing generic dapagliflozin pending the Court of Appeal’s decision.

1. Applicable approach. The four American Cyanamid guidelines remain binding and were properly approached sequentially. In an application pending appeal, an overriding consideration is arranging matters so that the Court of Appeal can do justice between the parties itself.
2. Standing. The absence of a direct financial interest in the claimant holding the SPCs was not necessarily a legal bar to interim relief where there was a cause of action protecting a recognised property right. In any event, the grant of an exclusive licence resolved the point.
3. Clearing the path and status quo. Clearing the path was a relevant consideration, but the evidence concerning irreparable harm carried substantially greater weight. The relevant status quo was the factual position on the ground at the hearing, namely who was actually on the market, rather than a date selected by reference to the issue of a claim form.
4. Irreparable harm. The more likely outcome without an injunction was saturation of the generic market, followed by significant price competition and a substantial reduction in AstraZeneca’s price. Although the VPAG scheme did not prevent discounts or later restoration of the actual price, the evidence established that restoration would probably be difficult in practice because of NHS and supply-chain relationships. The resulting loss, including possible effects on an NHS joint project, was potentially irreparable.
5. Respondents’ harm and balance. The respondents might suffer uncompensated loss because the counterfactual sales during the injunction period would be uncertain. However, both sides faced irreparable harm, which could not be compared with precision. In those circumstances, and because the appeal was due shortly, maintaining the status quo favoured granting the injunction.

High Court (Patents Court): The trial judge found the patent invalid and therefore the SPCs invalid.

Court of Appeal: An earlier interim injunction appeal was allowed on 9 April 2025, with reasons given on 16 April 2025. The present court continued the restraints pending determination of AstraZeneca’s forthcoming appeal.