In his judgment handed down this morning in Warner-Lambert Company LLC v Actavis Group PTC EHF & Ors  EWHC 72 (Pat), Mr Justice Arnold has held that there is no serious issue to be tried with regard to Warner-Lambert's claim that Actavis will infringe its second medical use patent – claiming the use of pregabalin in the treatment of pain, and in particular neuropathic pain – by marketing Lecaent. Actavis's marketing authorization for Lecaent will be restricted to epilepsy and GAD, when granted shortly.
Warner-Lambert had also sought relief, requiring Actavis to:
- make it a condition of any oral or written agreement entered into with a pharmacy for the supply of Lecaent that the pharmacy shall use reasonable endeavours not to supply or dispense Lecaent to patients who have been prescribed pregabalin for the treatment of pain;
- inform Warner Lambert’s solicitors of the name of any intermediary supplied, prior to supply;
- write a letter, in the form prescribed by Warner-Lambert, to the superintendent pharmacist responsible for the pharmacy to which Lecaent is to be supplied;
- ensure that each pack of Lecaent supplied to a pharmacist is accompanied by removable notification that is easily legible stating that the product is not authorized for the treatment of pain;
- write to NICE Medicines and Prescribing Centre informing it that Lecaent should not be prescribed or dispensed for the treatment of pain;
- write a letter, in the form prescribed, to all Clinical Commissioning Groups in the UK.
Arnold J has held that, even if there was a serious issue to be tried, the balance of the risk of injustice would favour refusal of this relief.
This decision is particularly significant, because it is the first time a UK court has comprehensively dealt with the issue of infringement of second medical use claims; an issue on which both patentees and generic companies have wanted guidance for a long time.
Taylor Wessing will be commenting on this judgment in more detail in due course.