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

This decision is about what happens after a business has already lost an appeal, but still wants the market held in place for a little longer.

AstraZeneca had lost its appeal against revocation of two supplementary protection certificates linked to dapagliflozin. It then asked the Court of Appeal to stop generic competitors from launching while it urgently tried to take the dispute to the Supreme Court.

The court refused the wider injunction because it said there was no real prospect of success in any further appeal step. But it still granted a short 14-day injunction so the Supreme Court could decide whether any urgent relief should continue.

For business owners, the practical lesson is that an injunction does not automatically roll on after you lose on the merits. Appeal prospects, timing and the need to preserve the status quo all matter.

The product at the centre of the dispute was dapagliflozin, marketed by AstraZeneca under the trade mark Forxiga. The judgment says it is used to treat diabetes and other conditions and was AstraZeneca’s biggest-selling product in the UK.

Viatris, Teva and Glenmark brought revocation claims against AstraZeneca’s SPCs in October, November and December 2023. No expedition was sought, and the trial was listed for March 2025. Dr Michael Tappin KC heard the trial between 10 and 20 March 2025.

Before the revocation judgment was handed down, Glenmark had already notified AstraZeneca on 20 February 2025 that it had obtained a marketing authorisation for a generic dapagliflozin product and was prepared to launch at risk on 17 March 2025. AstraZeneca responded by applying for an interim injunction and starting infringement proceedings.

The first feasible hearing date for that application was 27 March 2025. Glenmark gave an undertaking not to market its product before the application was decided, in return for a cross-undertaking in damages from AstraZeneca. The judge refused the application on 28 March 2025, but the Court of Appeal later allowed AstraZeneca’s appeal, with reasons handed down on 16 April 2025.

At the same time, it became clear that Teva and Viatris were also preparing to launch generic dapagliflozin products. AstraZeneca started infringement proceedings against them too and obtained undertakings that they would not launch before judgment on the revocation claims, again backed by the usual cross-undertakings.

On 28 April 2025, Dr Tappin KC gave judgment revoking the SPCs because the underlying patent was invalid. AstraZeneca applied for permission to appeal and also sought an interim injunction to restrain Glenmark, Teva and Viatris from marketing dapagliflozin until the appeal was decided.

Then Sandoz launched immediately after the revocation judgment and supplied 75,000 packs to Bestway. Bestway started selling on 29 April 2025. AstraZeneca applied for an interim injunction against Sandoz and Bestway on 30 April 2025, which led to similar undertakings. Most of the product sold by Bestway was recalled.

By the time HHJ Hacon heard the matter, the substantive appeal had been expedited and listed for 25 and 26 June 2025. On 28 May 2025, HHJ Hacon granted an injunction against Glenmark, Teva, Viatris, Sandoz and Bestway until determination of the appeal.

On 16 July 2025, the Court of Appeal dismissed AstraZeneca’s substantive appeal and refused permission to appeal to the Supreme Court. That changed the question. The issue was no longer whether AstraZeneca should be protected until its appeal was heard. The issue became whether the market should stay closed to generics while AstraZeneca urgently asked the Supreme Court to intervene.

The commercial stakes were high. The judgment records current sales of around 1 million packs per month, worth over £400 million per year, and says 12 other companies also held marketing authorisations for generic dapagliflozin products. As at 16 July 2025, AstraZeneca still retained its monopoly in the UK market because of the existing injunctions and undertakings.

The Court of Appeal said it still had jurisdiction, as a court of equity, to grant an injunction where it was just and convenient to do so. That included an interim injunction pending an appeal to the Supreme Court, pending an application for permission to appeal, or pending an application to the Supreme Court for interim relief.

The court said the applicable principles mirrored those used when considering an injunction pending an appeal from the High Court to the Court of Appeal. The basic aim was to arrange matters so that the appellate court could still do justice between the parties when the next stage was heard.

The judgment relied on the approach summarised in Novartis and said that, when considering the balance of hardship in this kind of case, the court would normally adopt the American Cyanamid approach.

In practical terms, the court had to answer two linked questions. First, did AstraZeneca have a real prospect of success in a Supreme Court appeal or in an application for permission to appeal? Secondly, even if the answer was no, should the court still preserve the status quo for a short period so the Supreme Court could decide for itself whether urgent relief should be granted?

That distinction is important for businesses. A longer injunction based on the merits of a further appeal is different from a short holding injunction designed to keep the position stable for a few days while the next court decides what to do.

The court was also dealing with a procedural problem. The evidence filed by both sides had been prepared on the assumption that a Supreme Court permission application might take between three and six months from 16 July 2025, and that any appeal, if permission were granted, might take between 15 and 23 months. It was not built around a 14-day period.

The Court of Appeal refused AstraZeneca’s application for an interim injunction pending either a Supreme Court appeal or the determination of an application for permission to appeal.

The central reason was simple. The court said there was no real prospect of success. It also said there was no arguable point of law that would enable AstraZeneca to succeed on an appeal.

The judgment added that even if AstraZeneca persuaded the Supreme Court that the correct standard for plausibility was the ab initio implausibility standard, that would not help because the patent did not satisfy even that standard. The court also said arbitrary selection was an independent objection to validity, and that Dr Tappin KC’s decision on that point had been affirmed.

Because there was no real prospect of success, the court said that in this context there was no serious issue to be tried for the purposes of the American Cyanamid approach. It therefore did not need to decide the parties’ rival arguments on adequacy of damages or the overall balance of the risk of injustice for the longer period AstraZeneca wanted.

But that was not the end of the matter. The court said it had to allow for the possibility that its own assessment might be wrong, especially on AstraZeneca’s prospects of obtaining permission to appeal from the Supreme Court. On that basis, it granted a further 14-day injunction until 4pm on 30 July 2025.

The court explained that the Supreme Court was best placed to decide whether AstraZeneca’s application for permission to appeal had a real prospect of success and whether expedition was warranted. So the Court of Appeal treated the short injunction as a way of preserving the status quo while the Supreme Court decided what order, if any, was just and convenient.

The court also explained why it declined to hear full oral argument on adequacy of damages for that short period. The evidence from both sides did not address a 14-day window. The court said the blind spot was common to all parties and that it was doubtful strong evidence could realistically have been produced about the likely effects of granting or refusing an injunction for so short a period.

For that reason, the overriding consideration for the 14-day period was to hold the ring by preserving the status quo, rather than to decide highly contested damages issues on evidence that was not granular enough for that short timeframe.

Most businesses will never be involved in an SPC dispute about a medicine. But the operating lesson is wider than pharmaceuticals. If your business depends on stopping a competitor launch through court orders, or on launching once a right has been revoked, you need to separate the merits fight from the emergency timing fight.

This case shows that a business can lose the main appeal and still get a very short period of protection. It also shows that a business that has won on the merits may still be kept out of the market briefly while the higher court is approached. In sectors where timing matters, that short period can still be commercially important.

The judgment is especially relevant in markets where launch timing affects stock, customer switching, pricing, reimbursement, tenders or supply chain commitments. A 14-day pause may sound minor, but in a large market it can still affect revenue, market share and operational planning.

The case also highlights the importance of evidence planning. If you may need emergency relief for a short period, your evidence should address what happens over that exact period. If your evidence only addresses a months-long appeal window, the court may decide the short-term position on broader fairness grounds instead of a detailed damages analysis.

That matters for both sides. A rights-holder should not assume an existing injunction will continue after an adverse judgment. A challenger should not assume that a win on the merits means immediate launch on the same day. Both sides need launch and no-launch plans that can be activated quickly.

If your business is in a launch-sensitive IP dispute, the judgment is a reminder that emergency applications are often shaped by practical documents and conduct as much as by legal argument.

In this case, the court’s reasoning was influenced by launch notices, undertakings, cross-undertakings, evidence about market size, evidence about likely timing in the Supreme Court, and the fact that one generic supplier had already launched and product had already been supplied and then mostly recalled.

That means businesses should keep a close record of what has happened in the market and what each party has promised to do. If the court has to decide whether to preserve the status quo, those details can matter a lot.

The timeline below helps show how quickly the dispute moved from revocation claims to launch threats, interim injunctions, a substantive appeal and then a short holding injunction pending an urgent Supreme Court step.