Astrazeneca AB & Anor v Glenmark Pharmaceuticals Europe Ltd

Factual and Procedural Background

This appeal arises from an order of a Deputy High Court Judge dated 28 March 2025 dismissing the Claimants' application for an interim injunction against the Defendant. The injunction sought to restrain the Defendant from marketing a dapagliflozin product at risk of infringing Supplementary Protection Certificates (SPCs) held by the Claimants. The application was made just before the trial of related revocation proceedings involving the Claimants, the Defendant, and two other generic companies. The trial took place in March 2025, with judgment reserved. The Claimants applied for an interim injunction until the form of order (FOO) hearing following the forthcoming judgment. The Defendant intended to launch its product on 17 March 2025 but gave an undertaking not to market it prior to determination of the injunction application. The judge refused the injunction, and the Claimants appealed. Permission to appeal was granted and expedited.

Legal Issues Presented

1. Whether damages would be an adequate remedy for the Claimants if the injunction was refused, considering the risk of price erosion and market changes prior to the FOO hearing.
2. Whether damages would be an adequate remedy for the Defendant and other parties affected by an injunction, particularly regarding the difficulty of quantifying lost sales and first-mover advantage.
3. The proper application of the American Cyanamid guidelines for interim injunctions, including whether adequacy of damages should be considered sequentially or holistically as part of the balance of risk of injustice.
4. The impact of new evidence on the risk assessments made by the judge, including the certainty and timing of multiple generic entrants to the market before the FOO hearing.
5. Whether the failure of the Defendant to "clear the path" for launch by timely revocation proceedings affects the balance of convenience and the preservation of the status quo.

Arguments of the Parties

Appellant's Arguments

• The judge applied too high a threshold in assessing whether damages would be an adequate remedy for the Claimants, failing to properly consider the uncertainties and rapid market growth.
• The judge should have considered adequacy of damages as part of the overall balance of risk of injustice rather than in a rigid sequential manner.
• The judge failed to consider damage to the Claimants that would arise after the FOO hearing, including the difficulty of obtaining an injunction pending appeal if multiple generics were already on the market.
• The judge incorrectly assessed the adequacy of damages for the Defendant, underestimating the certainty and speed of entry by other generics and the implications for first-mover advantage.
• The new evidence, including communications from other generic companies, demonstrates that multiple generic entrants will enter the market before the FOO hearing, increasing the risk of irreparable harm to the Claimants.
• The Defendant failed to clear the path by not seeking an expedited trial, and sought to launch its product prematurely, disrupting the orderly resolution of the dispute and justifying preservation of the status quo.

Respondent's Arguments

• The judge properly exercised discretion and based his decision on a careful assessment of the evidence.
• The new evidence does not materially affect the judge’s conclusions regarding adequacy of damages or the balance of convenience.
• The Defendant’s readiness to launch was not unduly premature given the trial schedule and the lack of commercial reasons for expedition.

Table of Precedents Cited

Court's Reasoning and Analysis

The court began by reaffirming the established principles governing interim injunctions, primarily the American Cyanamid guidelines, which require consideration of whether there is a serious issue to be tried, adequacy of damages for both parties, and the balance of convenience including preservation of the status quo.

The judge below had found that damages would be an adequate remedy for the Claimants because the likely losses could be quantified with reasonable accuracy, particularly if the Defendant was the sole generic entrant before the FOO hearing. He also concluded that damages would not be adequate for the Defendant or the NHS due to difficulties in quantifying lost sales and counterfactuals.

The judge accepted there was a real risk of multiple generic entrants causing a price spiral but did not find sufficient evidence that the Claimants would reduce prices or be unable to restore them. He also discounted the Defendant's failure to clear the path and its early launch as insignificant to the balance of convenience.

On appeal, the court considered new evidence that showed multiple generic entrants (including the Defendant, Teva, and another generic) would enter the market before the FOO hearing, making multiple entry a certainty rather than a risk. This heightened the likelihood of a rapid downward price spiral, increasing uncertainty and potential irreparable harm to the Claimants.

The court found the judge's assessment of adequacy of damages for the Claimants was too optimistic, failing to properly account for the rapid market growth, the inevitability of multiple entrants, and the difficulty of restoring prices once eroded, supported by the Claimants' evidence.

The court agreed that damages would also be inadequate for the Defendant and NHS, and that it was not possible to reliably assess which party was more at risk of an inadequate remedy. Given the short period until the FOO hearing and the uncertainty, the court held it prudent to preserve the status quo by granting the injunction.

The court further held that the Defendant's failure to clear the path by seeking an expedited trial and its attempt to launch during ongoing proceedings were relevant factors supporting preservation of the status quo. The court emphasized the importance of orderly dispute resolution and the avoidance of commercial advantage through premature launches.

Overall, the court exercised its discretion in light of the new evidence and the principles governing interim injunctions to reverse the judge's refusal and grant the injunction until the FOO hearing.

Holding and Implications

The court ALLOWED THE APPEAL and granted the interim injunction sought by the Claimants until the conclusion of the form of order hearing.

This decision preserves the status quo pending final determination of the patent validity and related proceedings, preventing the Defendant and other generics from entering the market prematurely and causing potentially irreparable harm through price erosion and market disruption.

The court clarified that this ruling does not predetermine the outcome of any future applications for injunctions pending appeal or final relief, which must be considered on their merits at the relevant time.

No new legal precedent was established; rather, the decision applies established principles to the evolving factual context, particularly in light of new evidence concerning market entry and competition dynamics.