Tuesday, 10 March 2015

Lyrica or generic pregabalin? An innovative court order

Warner-Lambert Company, LLC v Actavis Group PTC EHF and others [2015] EWHC 485 (Pat) is a Patents Court, England and Wales ruling of Mr Justice Arnold on 2 March which has already received substantial attention on the IPKat blog, thanks to Darren Smyth, here. 02 March 2015

In short, in January 2015, in an action for patent infringement the Patents Court dismissed Warner-Lambert's application for an interim injunction. The problem before the court was that doctors, when prescribing pregabalin as a painkiller for neuropathic pain (the sole use that remained within the scope of patent protection), weren't prescribing it by reference to its brand name LYRICA but rather by reference to its generic name, i.e. pregabalin. Said Arnold J, it did not lie within the power of Warner-Lambert, or indeed of Actavis (which was poised to launch its own generic version of pregabalin) to ensure that doctors prescribed the drug only as LYRICA when treating neuropathic pain, since this was an outcome that depended entirely on the behaviour of the doctors as prescribers.

Subsequently both Warner-Lambert and Actavis sought orders that prescribers be given clear guidance by the National Health Service (NHS England), to the effect that the brand name should be used for the patented indication while the generic name should be used for non-patented indications. The parties also wanted prescription software suppliers to alter their software in order to make it easier for doctors to prescribe pregabalin by brand name. Meanwhile. the parties agreed that Warner-Lambert should give a cross-undertaking in damages, but they could not agree as to its ambit: should it only be given to Actavis or should it also cover other generic manufacturers, in this case Teva and Dr Reddy.

Arnold J's conclusions, in brief, were as follows:

On the evidence, the issuing of guidance by NHS England was the most efficacious, dissuasive and cheapest solution to the problem, especially since the alternative from Warner-Lambert's point of view would be to pursue its applications for interim relief against all the generic suppliers.

The benefit of the cross-undertaking should be extended to the other generic companies for two reasons: (i) if Warner-Lambert's patent later turned out to be invalid, the companies ought not to be prevented from making sales of generic pregabalin, and (ii) even if the patent was valid, the effect of LYRICA being prescribed and dispensed at the expense of generic pregabalin in circumstances that did not amount to an infringement of the patent could not be discounted.

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