Warner-Lambert Company LLC v Sandoz GmbH & Ors

On an application for an interim patent injunction, the court should adopt the course likely to cause the least irremediable prejudice. The assessment must account for the strength of the serious issue, the competing risks of uncompensable harm, the preservation of the status quo and the consequences of allowing a generic product onto the market before trial.

A generic supplier may fail to clear the path where it launches a product raising a distinct infringement issue without first seeking appropriate declaratory relief. An injunction may also be granted against a downstream dispenser where dispensing would itself arguably infringe the patent. An equitable protective jurisdiction does not extend to restraining a non-infringing intermediary merely to prevent possible future infringement by patients.

Warner-Lambert sought interim injunctions against Sandoz, restraining supplies of a full-label generic pregabalin product, and against Lloyds, restraining dispensing of packs already supplied. The applications followed earlier patent proceedings involving Mylan and Actavis, in which claims had been found partly invalid and non-infringement had been found on other claims. Appeals and a conditional patent-amendment application remained pending.

The central issues were whether there was a serious issue to be tried, how the competing risks of irremediable harm should be assessed, whether Sandoz had failed to clear the path, and whether the court had jurisdiction to restrain Lloyds absent a pleaded infringement claim against it.

1. Interim injunction against Sandoz. The applicable approach was that stated in National Commercial Bank Jamaica Ltd v Olint Corp Ltd [2009] UKPC 16, namely to adopt the course likely to cause the least irremediable prejudice. There was a serious issue to be tried. Warner-Lambert had an arguable case that packaging and labelling constituted preparation and that Sandoz could foresee intentional administration of the product for patented pain indications.
2. The NHS prescribing guidance was not yet fully effective throughout the United Kingdom. There was therefore a significant risk that unrestricted full-label generic supply would cause difficult-to-quantify and irreparable loss through market entry, price depression and possible further generic launches.
3. Sandoz would suffer difficult-to-quantify loss, including loss of a first-mover advantage, if restrained and ultimately successful. That risk was less serious than Warner-Lambert’s risk, particularly because Sandoz could continue selling its skinny-label product. Preservation of the status quo also favoured relief. Sandoz had not cleared the distinct infringement issue raised by the full-label product, although it did not need to bring separate revocation proceedings.
4. The injunction could properly extend in practical effect to the packs already supplied to AAH and Lloyds. Differentiating those packs would reward Sandoz’s failure to give prior notice and would expose Warner-Lambert to substantial interim harm.
5. Interim injunction against Lloyds. The equitable protective principle described in Norwich Pharmacal Co v Customs & Excise Commissioners [1974] AC 133 did not apply where Lloyds would not itself infringe and patients’ private, non-commercial acts would not infringe under section 60(5)(a) of the Patents Act 1977. There was no principled basis for restraining Lloyds solely to prevent third-party wrongdoing.
6. Warner-Lambert’s alternative infringement claim against Lloyds did raise a serious issue. If Sandoz had carried out the claimed process by manufacturing, packaging and labelling the packs, Lloyds would arguably infringe by dispensing them regardless of its state of mind. The balance of risk favoured an injunction, which was proportionate and preserved the status quo.
7. Interim injunctions were granted against both Sandoz and Lloyds. Further argument would be heard if the precise terms could not be agreed.

Not an appeal. The judgment records earlier related proceedings and pending appeals, but determines this interim-injunction application at first instance.