This case concerned Warner-Lambert’s second medical use patent EP (UK) No. 0934061 with claims in Swiss form. The claims were directed to the use of the compound pregabalin for the treatment of pain. Warner-Lambert marketed pregabalin under the trade mark Lyrica for the treatment of neuropathic pain. Mylan and Actavis challenged the validity of the patent on the grounds of obviousness and insufficiency in relation to all of the types of pain described in the patent, with the exception of inflammatory pain. Warner-Lambert commenced a claim for infringement against Actavis, including a claim for infringement in relation to Actavis’ “skinny label” product (for epilepsy and anxiety). As well as defending the infringement claim, Actavis counterclaimed in respect of threats allegedly made by Pfizer.
Arnold J rejected the obviousness attack and held that the patent was insufficient in respect of central neuropathic pain which fell within the scope of the claim for neuropathic pain. He has since rejected an application to amend the patent post trial.
In relation to infringement, in an earlier decision the Court of Appeal held that a Swiss form patent was infringed if it was foreseeable to the manufacturer that the product would be intentionally administered for the treatment of pain. Arnold J held that Actavis did not infringe under the Court of Appeal’s test. Neither the doctor nor the patient had the necessary intention to administer the Actavis product for pain. Instances of the pharmacist having the relevant intention, i.e. dispensing Actavis’ product despite knowing that pregabalin had been prescribed to treat pain, were regarded as de minimis.
Arnold J granted declarations of non-infringement in respect of Actavis, wholesalers of Lecaent, doctors, pharmacists and patients. He also found Pfizer liable for making groundless threats of patent infringement proceedings albeit not in all the cases alleged by Actavis.
The judgment is the subject of an ongoing appeal in relation to validity and infringement.