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Pfizer warns UK doctors not to prescribe generic Lyrica for pain Posted 27/02/2015

Pharma giant Pfizer is fighting hard to protect one of its brand-name products, this time its epilepsy treatment Lyrica (pregabalin).

The company has sent a letter to Clinical Commissioning Groups (CCGs), the National Health Service (NHS) organizations that organize the delivery of NHS services in England, warning them that even though the patent on Lyrica expired in July 2014, a patent on its use for neuropathic pain remains in effect.

Lyrica was first approved for generalized anxiety disorder (GAD) and epilepsy, for which the patent expired in July 2014. However, the pain indication for Lyrica was disclosed and claimed in a later patent, European patent EP 0 034-061, that does not expire until July 2017. That patent does not cover the use of Lyrica to treat epilepsy or GAD.

Pfizer therefore points out that generics of pregabalin are expected to be approved only for the GAD and epilepsy indications, and treatment of neuropathic pain with generic pregabalin would be an ‘off-label’ use that would be an act of patent infringement.

The drugmaker therefore recommends that physicians who want to use pregabalin to treat pain should prescribe Lyrica by brand-name to avoid ‘potentially unwittingly’ infringing its patent on the use of Lyrica for neuropathic pain.

Pfizer did acknowledge that Actavis is challenging the validity of the medical use patent in the English patents court, with a trial set for June 2015. Pfizer said it believes the pain-use patent is valid and ‘will be contesting the case vigorously’.

As of January 2015, the European Medicines Agency (EMA) is reviewing six generics of Lyrica (pregabalin) [1], although until they are approved it is not clear in which indications EMA is considering the applications.

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1.   GaBI Online - Generics and Biosimilars Initiative. Generics applications under review by EMA – December 2014 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Generics/General/Generics-applications-under-review-by-EMA-December-2014 

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Source: Bloomberg, Patent Docs

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