Preserving the Status Quo Pending FOO Hearing: Adequacy of Damages in Interim Injunctions in AstraZeneca AB & Anor v Glenmark Pharmaceuticals Europe Ltd

1. Introduction

AstraZeneca AB & Anor (“AstraZeneca”) appealed the dismissal of their application for an interim injunction to restrain Glenmark Pharmaceuticals Europe Ltd (“Glenmark”) from launching a generic dapagliflozin product “at risk” pending the form-of-order (“FOO”) hearing in underlying revocation proceedings. The Patent and SPCs protecting dapagliflozin had expired or were near expiry, but supplementary protection certificates (“SPCs”) remained in force until May 2028. Three generic challengers (Viatris, Teva and Glenmark) had sought revocation of those SPCs on invalidity grounds. On the eve of the March 2025 trial, Glenmark secured a marketing authorisation and threatened immediate launch. AstraZeneca applied, confidentially, for an interim injunction; the High Court refused, finding damages to be an adequate remedy and the balance of convenience against injunctive relief. On expedited appeal, the Court of Appeal allowed AstraZeneca’s appeal and granted relief until the FOO hearing.

2. Summary of the Judgment

Key holdings of the Court of Appeal were:

The judge had erred in concluding damages were plainly an adequate remedy for AstraZeneca, failing to account for:

The now-certain rapid entry of at least three generic suppliers before the FOO hearing;
The likelihood of a downward price spiral;
The practical impossibility of restoring originator prices once NHS reference pricing and resistance to price increases set in;
Damage manifesting after the FOO hearing, including impediments to obtaining an injunction pending appeal.

The judge also failed to give proper weight to the importance of preserving the status quo when the generics had not “cleared the path” by timely revocation actions, and by seeking to launch mid-trial.
When the adequacy of damages for both parties was in doubt, and the relevant period was short, it was prudent to preserve the status quo—that is, maintain the existing exclusive market until the FOO hearing.
The appeal court granted the interim injunction restraining Glenmark from marketing its dapagliflozin product until conclusion of the FOO hearing.

3. Analysis

3.1 Precedents Cited

American Cyanamid Co v Ethicon Ltd [1975] AC 396 – the foundational four-stage test for interim injunctions: (1) serious question to be tried; (2) adequacy of damages to claimant; (3) adequacy of cross-undertaking damages to defendant; (4) balance of convenience/status quo.
Factortame (No 2) [1991] 1 AC 603 – emphasised that American Cyanamid guidelines are not a rigid code but provide broad judicial discretion.
National Commercial Bank of Jamaica v Olint Corp [2009] UKPC 16 – underscored the holistic assessment of irremediable prejudice when damages adequacy is uncertain.
SmithKline Beech plc v Apotex Europe Ltd [2003] EWCA Civ 132 – generic challengers must “clear the path” by revocation proceedings to justify launching at risk; failure to do so weighs in favour of injunction.
Neurim Pharmaceuticals (Neurim I, II, III) [2020–2022] – illustrates application of damages adequacy and status quo in generics context, including evaluation of price-spiral risk and market entry evidence.
Bayer IP v Aspire Pharma Ltd [2024] EWHC 711 (Pat) – interim injunction granted for a 9-day period to preserve status quo pending FOO hearing in a generic rivaroxaban dispute.
Terrell on the Law of Patents – commentary on sequential versus holistic applications of American Cyanamid tests; note of evolving practice in UK and Irish jurisprudence.

3.2 Legal Reasoning

The Court of Appeal applied the American Cyanamid principles but emphasised their flexible, holistic operation where:

Adequacy of damages for the claimant: The judge had concluded damages were quantifiable and adequate based on a sole-entrant scenario. The appeal court, with additional evidence, found that:

At least two other generics (Teva and “Generic X”) were certain to enter swiftly;
This would trigger price erosion and a downward spiral;
AstraZeneca would likely feel forced to reduce actual prices or rebates, and once lower prices became standard under NHS reference pricing, restoration would be highly improbable;
Damage would accrue not only before but after the FOO hearing, hindering future injunctive relief or price recovery.

Adequacy of cross-undertaking damages: The judge had found assessment more difficult for Glenmark and the NHS, but the appeal court held that when damages adequacy is in doubt for both, the balance of convenience and status quo principle governs.
Status quo and clearing the path: Glenmark had failed to accelerate revocation proceedings and sought a mid-trial launch, undermining the orderly conduct of litigation. In a short interim period, preserving the status quo prevents irreversible market disruption.
Balance of convenience: When the risk of irremediable prejudice is finely balanced or uncertain, especially over a brief interval, preserving the existing market arrangement is the prudent course.

3.3 Impact

The decision clarifies and extends interim relief principles in pharmaceutical patent/SPC disputes:

Court must consider not only pre-FOO harm but also post-FOO effects on pricing and injunctive options.
Certainty of multiple generic entrants and rapid price erosion tip the adequacy-of-damages analysis against the patentee, but overall status-quo preservation can still favor injunction.
Parties must “clear the path” by timely revocation challenges or risk losing interim relief; disruptive “jumping the gun” is disfavored.
The case reinforces a holistic, flexible application of American Cyanamid in complex, fast-moving markets with evolving evidence.
Future interim injunction applications will likely require up-to-date intelligence on other generic MA holders and launch plans, and careful analysis of NHS pricing mechanics.

4. Complex Concepts Simplified

SPC (Supplementary Protection Certificate): Extends patent protection for medicinal products beyond patent expiry, up to five years.
MA (Marketing Authorisation): Regulatory approval to market a medicinal product in the UK.
FOO Hearing: Hearing on the form of order after judgment, determining the precise relief granted (e.g., injunction period).
Price Spiral: Generic entry triggers successive price cuts by competitors, leading to lower market-wide prices.
Drug Tariff Category C: Pharmacist reimbursement price set at originator’s list price, regardless of actual purchase cost.
Clearing the Path: Bringing revocation proceedings sufficiently early to secure judgment before launch, mitigating the risk of “at-risk” launches.
Adequacy of Damages: Whether monetary compensation can fully or adequately redress a party’s loss if the interim injunction is incorrectly granted or denied.
Status Quo Principle: When in doubt, preserve the existing situation pending trial or further court order, to minimize irreparable prejudice.

5. Conclusion

AstraZeneca AB & Anor v Glenmark Pharmaceuticals Europe Ltd establishes that in high-value pharmaceutical disputes:

Courts must assess adequacy of damages both for the pre- and post-FOO periods, particularly where generics will swiftly enter and depress prices;
Certainty of rapid multi-party launch and price erosion creates real doubt as to damages adequacy, justifying interim relief;
When both parties face uncertain damages remedies, the balance of convenience and status-quo preservation prevail;
“Clearing the path” by timely revocation actions is critical to securing or resisting injunctive relief;
Parties should not attempt to gain an unmerited commercial advantage by launching mid-trial or pre-empting judgment.

This decision will guide practitioners in strategizing both patent/SPC revocation timetables and interim injunction applications in fast-moving generic markets.