Warner-Lambert Company LLC v Sandoz GmbH & Anor (Rev 1)

An interim injunction may be varied only where there has been a material change of circumstances. The court must then reconsider the balance of the risk of irremediable prejudice. Proportionality and the avoidance of barriers to legitimate trade apply to interim injunctions, but the primary task remains selecting the course least likely to cause irremediable harm before the merits have been finally determined. A patentee may protect a market affected by valid claims even where those claims cover only a small proportion of the overall market, provided the injunction is otherwise proportionate. The practical effect of an injunction, including the preservation of the status quo and the risk of a rapid market-wide launch, is relevant.

The claimant sought to maintain an interim injunction restraining the defendants from marketing a full-label generic pregabalin product pending determination of patent infringement proceedings. The injunction had been granted in Warner-Lambert Company LLC v Actavis Group PTC ehf and related proceedings, when the claimant relied on both broad and narrower patent claims.

Following the Court of Appeal’s decision, certain claims had been held invalid while claims 10, 11 and 12 remained valid. The claimant also stated that it no longer relied on the broader claim 3 for injunctive relief. The defendants applied to vary the injunction so that they could market the full-label product. The central issues were whether there had been a material change of circumstances, whether infringement raised a serious issue to be tried, and how the competing risks, proportionality and legitimate trade should be assessed.

1. Application dismissed. The claimant’s change of position, namely that it no longer relied on claim 3 for injunctive relief, was a material change of circumstances. The Court of Appeal’s decision, by itself, was not material because the validity issues remained subject to possible Supreme Court appeals and involved questions of law rather than concurrent findings of fact.
2. The governing approach was that stated in National Commercial Bank Jamaica Ltd v Olint Corp Ltd [2009] UKPC 16: the court should choose the course likely to cause the least irremediable prejudice. Proportionality also had to be considered. Article 3(2) of the Directive 2004/48/EC on the enforcement of intellectual property rights applied to interim measures, but proportionality did not displace the court’s primary interim-injunction task.
3. There was a strong serious issue to be tried on infringement of claims 10, 11 and 12. The defendants intended to package, label and market the product, and its product information expressly covered peripheral and central neuropathic pain, including the conditions covered by those claims.
4. The balance of the risk of irremediable harm favoured continuing the injunction. A full-label launch before expiry would likely be followed rapidly by other generic suppliers, causing price pressure and losses that would be difficult to quantify. The defendants’ losses from being denied a first-mover advantage were also difficult to quantify, but the status quo and the defendants’ failure to clear the path favoured continuation.
5. Proportionality did not require variation. Claims 10, 11 and 12 covered only a small part of the market, but the valid claims were entitled to protection and the defendants’ commercial preference for a full-label product created a risk to the wider full-label market. The injunction was proportionate on an interim basis, although the position might differ when final relief was considered.

• Court of Appeal: the judgment records that the Court of Appeal dismissed the parties’ appeals on insufficiency and dismissed the appeal concerning abuse of process in [2016] EWCA Civ 1006.
• High Court (Patents Court): the present application to vary the interim injunction was dismissed.