AstraZeneca AB & Anor v Generics (UK) Ltd & Ors

Factual and Procedural Background

This opinion concerns an appeal by the Defendant, Company A, against an order revoking UK Supplementary Protection Certificates (SPCs) Nos. SPC/GB13/021 and SPC/GB14/050 based on European Patent (UK) No. 1 506 211 ("the Patent"). The Patent relates to a compound marketed by Company A for treating diabetes and other conditions. The Court of Appeal dismissed Company A's appeal and refused permission to appeal to the Supreme Court, finding no arguable point of law.

Prior to the appeal decision, Company A sought an interim injunction to restrain the Claimants (Company B, Company C, and Company D) and two other respondents (Company E and Company F) from marketing generic versions of the compound until the Supreme Court determined an appeal or application for permission to appeal. The Court granted an interim injunction until 30 July 2025 but refused the substantive application.

The procedural history involves multiple revocation claims brought by the Claimants in late 2023, with a trial held in March 2025. Company A applied for interim injunctions and commenced infringement proceedings against various generic companies, obtaining undertakings preventing marketing prior to judgment. After the revocation judgment, some generic companies launched products, leading to further injunction applications and undertakings.

Subsequent injunctions were granted pending the substantive appeal, which was expedited and heard in June 2025. Applications for permission to appeal injunction orders were refused due to lack of real prospects of success. Company A then filed an application for relief pending the Supreme Court’s consideration of permission to appeal.

The Secretary of State for Health and Social Care was permitted to intervene, providing evidence on the National Health Service’s position regarding price rises by patentees. Issues around jurisdiction for certain respondents were resolved by granting permission to intervene and binding undertakings.

At the time of the judgment, Company A retained a monopoly on the market due to interim injunctions, despite multiple generic companies being ready to launch. The evidence assumed that Supreme Court determination of permission to appeal would take three to six months, and a substantive appeal, if granted, would take 15 to 23 months.

Legal Issues Presented

1. Whether Company A’s application for an interim injunction pending determination of an appeal or application for permission to appeal to the Supreme Court should be granted.
2. Whether Company A has a real prospect of success on appeal or on an application for permission to appeal to the Supreme Court.
3. The appropriateness of granting an interim injunction to preserve the status quo pending the Supreme Court’s decision.

Arguments of the Parties

Appellant's Arguments

• Company A sought an interim injunction to prevent generic competitors from marketing the compound pending the Supreme Court’s determination of its appeal or permission to appeal.
• Company A contended that there were arguable points of law, including the correct standard for plausibility, which could lead to success on appeal.

Respondents' Arguments

• The Claimants and other respondents argued that no interim injunction should be granted, even for a short period, because damages would be an adequate remedy for Company A.
• They contended that damages would be an even less adequate remedy for themselves if an injunction were granted.
• They maintained that the overall balance of the risk of injustice favored refusal of an injunction.

Table of Precedents Cited

Court's Reasoning and Analysis

The Court recognized its equitable jurisdiction to grant interim injunctions pending appeals to the Supreme Court. It applied established principles from key precedents, emphasizing that an appeal must have a real prospect of success to justify such relief.

In this case, the Court found no real prospect of success for Company A’s appeal or application for permission to appeal, as the patent was held invalid on multiple grounds, including arbitrary selection, affirmed by this Court. Even if Company A persuaded the Supreme Court on legal standards, the patent would still fail.

Given the absence of a serious issue to be tried, the Court deemed it unnecessary to consider adequacy of damages or balance of hardship in detail. However, acknowledging the possibility of error in its assessment, the Court granted a short interim injunction of 14 days to preserve the status quo and allow Company A to seek urgent relief from the Supreme Court.

The Court declined to hear full oral argument on damages adequacy for the short period, noting the evidence was insufficiently granular and that the injunction merely maintained the status quo pending the Supreme Court’s decision. The Court also considered the prior decisions granting interim injunctions and the importance of preserving the market position until the substantive appeal.

The respondents’ argument that Company A’s repeated losses precluded an injunction was rejected in this context, as the Court must allow for potential error in its merits assessment when granting short-term relief.

Holding and Implications

The Court REFUSED Company A's application for an interim injunction pending the determination of its appeal or application for permission to appeal to the Supreme Court on the merits, finding no real prospect of success.

However, the Court GRANTED an interim injunction for a limited period of 14 days to preserve the status quo and allow Company A to make an urgent application to the Supreme Court. This decision does not set new precedent but ensures procedural fairness by enabling the Supreme Court to address the issue of permission to appeal and any related expedition.