Astrazeneca AB & Anor v Glenmark Pharmaceuticals Europe Limited

On an interim injunction application, the court must apply the American Cyanamid guidelines to the evidence available, while assessing only the period and relief actually in issue. Damages may be adequate where the claimant’s losses can be calculated from known sales and margins, particularly if the defendant provides security. By contrast, damages under a cross-undertaking may be inadequate where they depend on a disputed and uncertain counterfactual involving multiple market entrants, prices and volumes. The balance of risk of injustice remains relevant, but the status quo is decisive only where the other factors are evenly balanced.

The claimants sought an interim injunction preventing Glenmark from launching a generic dapagliflozin product in the United Kingdom pending the form of order hearing after a reserved validity trial concerning supplementary protection certificates. Glenmark conceded that its proposed sales would infringe and the parties accepted that validity raised a serious question to be tried.

The court considered the likely effect of a launch on prices, market share, other generic entrants, the NHS and the parties’ ability to recover damages. The central issue was whether damages were an adequate remedy for either side during the period before the form of order hearing.

1. Application refused. The court refused the interim injunction pending the form of order hearing in the validity proceedings.
2. The court applied the four-stage guidelines in American Cyanamid v Ethicon [1975] AC 396: serious question to be tried; adequacy of damages for the claimant; adequacy of damages under the cross-undertaking for the defendant; and, if necessary, the balance of convenience or risk of injustice. The court must do the best it can on the written evidence. The assessment concerns the actual relief sought and the period for which it would operate.
3. There was a serious question to be tried because validity remained contested and Glenmark accepted that its proposed sales would infringe. If Glenmark were allowed to launch, AZ’s losses could be calculated with reasonable accuracy by reference to the number of sales and AZ’s profit margin. There was no sufficient evidence that AZ would reduce its list price, materially increase rebates, make irreversible supply-chain changes or abandon its longer-term NHS projects during the relevant period. Security for AZ’s potential losses was required, and Glenmark’s proposed payment into a separate account was sufficient.
4. Damages would not be an adequate remedy for Glenmark or the NHS under the cross-undertaking. The counterfactual would require assessment of uncertain entry by other generics, timing, prices, volumes, first-mover advantage and possible patent issues. The information asymmetry would also make recovery by NHS bodies more difficult.
5. Had it been necessary to reach the fourth stage, the balance of risk of injustice would have favoured refusing the injunction. The status quo favoured an injunction only if the factors were evenly balanced, which they were not. Glenmark’s late readiness to launch did not materially alter the balance.