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Innovative relief for second medical use patent holders

8 June 2015

In ongoing UK High Court litigation between Warner-Lambert and Actavis, Mr Justice Arnold has taken the unprecedented step of granting an order mandating the National Health Service (NHS) to issue guidance to doctors and pharmacists that the drug pregablin must only be prescribed for the treatment of neuropathic pain (a patented indication) under the brand name Lyrica® and not using the generic name pregablin.

Warner-Lambert (a member of the Pfizer group) markets Lyrica® for epilepsy, generalized anxiety disorder (GAD) and neuropathic pain. Patent protection for the drug itself has expired. However, Warner-Lambert holds a patent (EP 0934061) directed to the use of Lyrica/pregabalin for the treatment of pain, in particular, neuropathic pain.

Actavis applied for marketing authorisation to sell generic pregabalin (under the trade name Lecaent) for the treatment of epilepsy and GAD. These indications are not covered by the ‘061 patent and so sale for these indications would not infringe the patent. However, Warner-Lambert applied for an interim injunction asserting that Actavis needed to take various steps to ensure that Lecaent would not be prescribed for the patented indication of neuropathic pain. Whilst the parties agreed on some steps to be taken, there was disagreement on others and ultimately Mr Justice Arnold did not grant the injunction. Interestingly though, in his decision, Arnold pragmatically suggested an idea which neither party had put forward, this being that:

the best solution to the problem is for doctors to prescribe Lyrica for pain. If the NHS issues appropriate guidance, that is likely to happen“.

Following Mr Justice Arnold’s decision, Warner-Lambert wrote to the NHS Commissioning Board (NHS England) asking for it to issue such guidance to Clinical Commissioning Groups (CCGs). NHS England refused to do this, stating that it was an innocent bystander in the dispute. However, NHS England also said that they would not oppose Warner-Lambert applying for a court order to this effect. In view of this, Warner-Lambert applied to Mr Justice Arnold for a court order compelling NHS England to issue such guidance.

Arnold granted the application, stating:

I consider that the issuing of guidance by NHS England is the most efficacious, dissuasive and cheapest solution to the problem which confronts Warner-Lambert. Furthermore, it is the least onerous solution in the sense that the only other alternative open to Warner-Lambert is to pursue its applications for interim relief against the generic suppliers.

In complying with this court order, NHS England issued guidance to doctors and pharmacists indicating that:

Pregabalin should only be prescribed for the treatment of neuropathic pain under the brand name Lyrica® (unless there are clinical contra-indications or other special clinical needs e.g. patient allergic to an excipient, branded product unavailable, etc. which apply to Lyrica®, when you should not prescribe Lyrica® or pregabalin)“.

This decision is the first time that a UK court has granted an order that directly affects the prescribing practice of doctors. This should reduce the likelihood of generic pregabalin being prescribed ‘off label’ for the patented indication, thereby enforcing the patent. If this approach is followed in other cases, it could provide an effective tool for second medical use patent holders to prevent generic competitors from compromising sales of their branded drug for patented indications.


Justin Wilson
Life Sciences & Chemistry Group

If you require further information on anything covered in this briefing, please contact Justin Wilson (; +44 207 940 3600) or your usual contact at the firm.

This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.

© Withers & Rogers LLP, June 2015