pxl.store / Shutterstock.com (The Royal Courts of Justice, where the English High Court is based.)
1 June 2015

English court grants Warner’s appeal in Lyrica second medical use case

The English Court of Appeal has said pharmaceutical company Warner-Lambert has a viable argument that Actavis indirectly infringed a second medical use patent covering Warner’s drug Lyrica (pregabalin).

Earlier this year, Justice Arnold of the English High Court refused to send the case to trial, finding that the case for indirect infringement was not arguable.

On Thursday (May 28), the appeals court, led by Lord Justice Floyd, found that the case could be argued and let Warner proceed with its appeal.

It also laid out a new test for determining direct infringement of second medical use patent claims. Floyd also said that Warner has an arguable case of direct infringement.

“Applying the law as I believe it to be, it is plain that Warner-Lambert have an arguable case of infringement,” he said.

Warner has a second medical use European patent for Lyrica, which treats neuropathic pain. Its first patent for the drug, which covers the use of pregabalin to treat epilepsy and generalised anxiety disorder (GAD), expired in 2013.

Actavis markets a generic version of Lyrica, called Lecaent, for the treatment of epilepsy and GAD. Warner accused Actavis of indirectly infringing its second medical use patent after asserting that some pharmacists were dispensing the generic to treat neuropathic pain, the use of the drug that is covered by Warner’s patent.

Warner moved for an injunction ordering Actavis to prevent the generic from being prescribed to treat neuropathic pain, which earlier this year Arnold refused.

In a later judgment, he also struck out Warner’s claims of indirect infringement.

However, he ordered the UK’s National Health Service (NHS) to issue guidelines on how to prescribe pregabalin, in a move aimed at stopping pharmacists from dispensing the generic drug for patented indications.

Thursday’s decision means that this move could be rendered unnecessary, and the secretary of state for health’s application to intervene in the case was dismissed. The secretary oversees the NHS’s activities.

Floyd said that the test for direct infringement in this (and other second medical use cases) should be whether it was known or “foreseeable” that the generic pregabalin would be intentionally dispensed for the treatment of pain. This is the test that will be applied at the main trial of the case.

He said: “How does one tell whether a manufacturer is using the manufacturing process of the claim, and therefore rendering himself liable for patent infringement? The answer must be when he manufactures pregabalin when he knows or foresees that users will intentionally administer it for pain.”

Laying out his thoughts on indirect infringement of second medical use patents, Floyd said that the key question would be whether and if so when a patented invention was "put into effect".

After the appeals court allowed the appeal to go ahead, an infringement trial is set to be heard at the end of June.

Arty Rajendra, a partner at law firm Rouse Legal, said: “The trial later this month will be a big battle between both parties. The case has potentially wide-ranging ramifications for the pharma industry, the NHS, doctors and patients alike.”

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