The vexed question of how to enforce second medical use patents has dominated the headlines in the last half year. The case of Warner-Lambert v Actavis1 in the English High Court highlighted the serious difficulties innovators face in enforcing these patents, which protect new uses for existing medicines. For example, in this case, the active ingredient pregabalin, originally developed for treating epilepsy and generalised anxiety disorder, was later found to be useful in treating neuropathic pain too. If, as here, a generic version of the medicine is available for the original use, cost-saving mechanisms within the National Health Service direct medical practitioners and pharmacists to cheaper generic versions and inevitably lead to these being supplied for the new use too. This happens despite the fact that the generic medicine is not authorised – or advertised – for the new use, because medical professionals know that it is equivalent. The patentee finds itself cut out o f the loop.
In interim injunction proceedings the question arose as to what form of interim order would be appropriate in such a case. In a move he described as the “best solution to the problem” – Arnold J in the High Court turned to case law recently developed in relation to blocking orders against internet service providers and made a novel interim order requiring NHS England to arrange for guidance to be given to the effect that doctors and pharmacists should prescribe and dispense by reference to the brand name (Lyrica®) for the patented indication and generically for non-patented uses.
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