Merck KGaA v Merck Sharp [2025] EWCA Civ 343

28 March 2025

Ø  Application for declaration, instead of committal, for breach of injunction

For breach of an injunction, the aggrieved party may apply for a declaration under CPR 40.20 that the other had breached the injunction (which requires a civil
standard proof only) – the low-key approach – instead of making a CPR 81 contempt application (which requires a criminal standard proof) – the high-stake approach, when such a declaration would serve a useful purpose.

The court has the “jurisdiction” to grant the declaration, and the only question is whether the court should exercise the “discretion” to grant the declaration.

Basingstoke & Deane Borough Council v Persons unknown [2025] EWHC 738 (KB)

28 March 2025

Ø  Newcomers Traveller injunction

A Traveller injunction may be granted against newcomer persons unknown, subject Wolverhampton test, namely (i) compelling need, (ii) procedural protection,
(iii) most stringent disclosure duty, (iv) territorial and temporal limits, and (v) “just and convenient” consideration. Such an injunction being a “precautionary relief”, the court might also consider Vastint test, namely (i) sufficiently real and imminent risk of serious conduct, and (ii) harm envisaged by the claimant is serious enough to justify the injunction.

Such an injunction is neither an interim injunction to hold the ring nor a final injunction with notice. Renewing such an injunction is not “tick box” exercise and should not be listed as a “review application”, but rather must be considered de novo.

A local authority would not be required to give cross-undertaking in damages for obtaining such an injunction.

Astrazeneca AB v Glenmark Pharmaceuticals Europe [2025] EWHC 748 (Pat)

28 March 2025

Ø  Adequacy of damages for claimant

A generic pharmaceutical company (Glenmark) had commenced a claim to invalidate two SPCs for dapagliflozin (dapag) products held by its rival (AZ). The trial of the claim completed and the judgment was reserved, and a consequential ‘form of order’ hearing was expected in 1-3 months. In the meantime, Glenmark notified AZ of the intended launch of its generic dapag product. AZ applied for an interim injunction pending the ‘form of order’ hearing.

The judge found that AZ was unlikely to reduce its price if Glenmark (and possibly other generic companies) entered the market for the subject period between now and the ‘form of order’ hearing. AZ had an established profit margin per pack of their dapag product. Hence, if the injunction is refused and it turns out later that Glenmark was not entitled to enter the market, then the loss to AZ would be their established profit margin per pack of their dapag multiplied by the packs of Glenmark’s product sold. Accordingly, the judge found that damages would be an adequate remedy to AZ, hence the stage 2 of the American Cyanamid test would be satisfied if Glenmark provided suitably security to secure any “damages” that may be awarded to AZ in the event it later turns out that Glenmark was not entitled to enter the market.

As to security, the judge refused Glenmark’s parent company’s comfort letter, albeit substantial market capitalisation of the parent company. But the judge accepted Glenmark’s undertaking to pay into a separate bank account AZ’s established profit margin per pack for every pack of Glenmark’s product sold. The judge refused the demand for an undertaking from Glenmark to instead pay into the account the profit margin of Glenmark per pack.

As to stage 3 of the test, it was not necessary for the judge to consider it because stage 2 was satisfied in favour of refusing the injunction. However, considered the stage 3 factors. He found that damages would not be an adequate remedy for Glenmark because assessing the damages would involve the determination of the “counterfactual”, which would be impractical to establish with any degree of accuracy. The said counterfactual was what would have happened if Glenmark had been on the market for the subject period, how many sales it would have made and at what price, which questions would get even more complicated if other generics entered the market, resulting in an unknown level of competition at unknown prices between the generics.

As to stage 4 of the test, which was not triggered in this case, the judge commented that the uncertainties involved in assessing the damages for Glenmark were significantly greater than those involved in assessing the damages for AZ, and that status quo would be maintained only if all factors were evenly balance, which was far from reality in this case.

Accordingly, the judge refused the injunction.