Actavis Group PTC EHF v ICOS Corporation

An interim injunction pending an intended appeal requires a real prospect of success and an assessment of all relevant post-judgment circumstances. The court should not normally rank the strength of the appeal once that threshold is met. It must balance the parties’ likely hardship, including losses that may be difficult to quantify, and consider the period before the appeal is heard. An injunction is not confined to cases in which refusal would render the appeal nugatory. In a patent case, a routine clinical investigation may be obvious even if its results are unpredictable and the claimed therapeutic effect would be surprising. A later unexpected benefit does not make routine testing inventive.

The claimants, generic manufacturers, sought to launch 2.5 mg and 5 mg daily tadalafil for erectile dysfunction. The patent protecting the low-dose daily regimen had been held invalid for lack of inventive step by the Court of Appeal, which overturned the first-instance finding of inventiveness and refused permission to appeal. The Court of Appeal permitted the patentee and its associated company to apply for interim injunctive relief pending an application for permission to appeal to the Supreme Court.

The issue was whether the patentee had a real prospect of success on a further appeal and, if so, whether the balance of hardship and other relevant circumstances justified restraining the generic launch.

1. Applicable principles. The court applied the principles summarised in Novartis v Hospira [2013] EWCA Civ 583. The applicant had to show a real prospect of success. If that threshold was met, the court would ordinarily avoid ranking the strength of the appeal. It had to assess all relevant circumstances after judgment, including the likely time before the appeal and the balance of hardship. The remedy was not confined to cases where refusal would render the appeal nugatory. (para [4])
2. Prospects of appeal. The Court of Appeal had applied settled obviousness principles to the facts found by the first-instance judge. The routine Phase IIb dose-ranging programme was very likely to test 5 mg daily tadalafil in order to identify a dose response. The absence of a reasonable expectation that 5 mg would be efficacious did not prevent the routine investigation from being obvious, because efficacy was not the objective of that investigation. The unexpected useful effect and reduced side effects were a bonus discovered through routine testing and did not make the enquiries inventive. (paras [7]–[11])
3. Balance of hardship. Lilly did not establish unquantifiable loss if the injunction was refused. The relevant market was settled, the prices were fixed, the patent had only a short remaining term, and lost sales and profit could be calculated. Conversely, an injunction would create substantial difficulties in quantifying the generic manufacturers’ losses because they would lose the advantages of early entry and later market conditions would differ materially. (paras [13]–[21])
4. Public interest and order. The public interest in clearing the way and obtaining lower-cost medicines was considered, but the decision did not depend on those points. The application for an interim injunction was refused. (paras [22]–[24])

• Court of Appeal: The Court of Appeal overturned the first-instance finding that the patent was inventive: [2017] EWCA Civ 1671. Permission to appeal to the Supreme Court was refused, although an application for permission remained pending.
• High Court (Patents Court): The interim injunction application was refused.