Bayer Intellectual Property GmbH & Ors v Aspire Pharma Limited & Ors

On an application for an interim injunction, the court applies the American Cyanamid principles by assessing the adequacy of damages and, where necessary, the balance of likely irreparable harm. The relevant period must be identified precisely; the court should not assume that an application concerning a short period will determine a later appeal application. Where the competing losses over a period of only a few days can be assessed with reasonable accuracy, damages may be an adequate remedy. Nevertheless, preservation of the practical market status quo may carry particular weight, especially where allowing generic competition to begin would alter the position before a later injunction application.

The applicants owned a patent protecting rivaroxaban for once-daily administration. The patent protecting rivaroxaban as a compound was due to expire on 1 April 2024, while the relevant patent was due to expire in January 2026. The respondents wished to market generic rivaroxaban and most had challenged the validity of the relevant patent at trial.

The applicants sought an interim injunction lasting until the order following judgment in the validity trial, a period of approximately 9–10 days. The principal issue was whether the balance of irreparable harm favoured restraining generic sales during that period.

1. Applicable principles. The court applied the principles in American Cyanamid Co v Ethicon Ltd [1975] AC 396: whether there is a serious issue to be tried; whether damages would adequately compensate either side; and, if not, where the balance of convenience lies, with preservation of the status quo as a counsel of prudence where the balance is equal. The discussion in National Commercial Bank Jamaica Ltd v Olint Corp Ltd [2009] UKPC 16 did not alter the result.
2. Relevant period and status quo. The application concerned only the 9–10 days before judgment on the validity trial. It could not be treated as determining the position until judgment on a possible appeal, although the possibility of a later application was relevant because the present order might change the practical status quo. The relevant status quo was the reality on the ground, namely which products were being sold, rather than simply which patents remained in force.
3. Assessment of harm. Generic competition from several suppliers could produce a price spiral and lasting price depression, as explained in Neurim Pharmaceuticals (1991) Limited v Generics (UK) Limited [2002] EWCA Civ 370. However, over 9–10 days the applicants’ counterfactual sales were sufficiently identifiable from existing sales, and the respondents’ losses could likewise be estimated by notionally shifting their sales curves. The uncertainties identified in longer-period cases, including Teva Pharmaceutical Industries Limited v Actavis UK Limited [2015] EWHC 2604 (Pat), did not have the same force.
4. Clearing the way. The respondents had not delayed without taking action. They had brought claims challenging validity, so the consideration identified in SmithKline Beecham plc v Apotex Europe Ltd [2003] EWCA Civ 137 did not count against them.
5. Disposition. Although the potential losses over the short period were modest and reasonably calculable, changing the status quo before any later application could create significant irreparable harm. The interim injunction was therefore granted until resolution of the order following judgment in the validity trial. The terms of the injunction were to be settled after further submissions.