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Patent dispute

Prescribing rules for generic pregabalin to change from July

High court london

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In October 2016, the Court of Appeal in London upheld the High Court ruling against Pfizer’s patent claim. The company was told it had made groundless threats to pharmacists to prevent them from dispensing generic pregabalin.

NHS England has announced that from 17 July 2017 doctors can prescribe generic pregabalin for neuropathic pain, replacing its March 2015 advice that recommended prescribing only brand name Lyrica (Pfizer) for the condition. 

It follows a patent dispute between Warner-Lambert Company LLC, a subsidiary of pharmaceutical giant Pfizer, which manufactures Lyrica, and suppliers of pregablin generic medicine, Actavis and Mylan.

In a letter distributed to GP practices this week, David Geddes, director of primary care commissioning at NHS England, said: “When dispensing pregabalin for the treatment of any condition, you should dispense in accordance with your normal practice.”

Pfizer’s compound patent for treating generalised anxiety disorder and epilepsy with Lyrica, which contains the active ingredient pregabalin, expired in 2013, with regulatory data protection for Lyrica continuing until July 2014. However, the company claimed it retained a patent for the treatment of neuropathic pain until 16 July 2017.

In December 2014, Pfizer took drug manufacturers Actavis and Mylan, developers of generic pregabalin, to court for patent infringement but, in September 2015, the High Court ruled against Pfizer, noting that six claims of its patent were invalid and that the drug company had made groundless threats to pharmacists to prevent them from dispensing generic pregabalin.

In October 2016, the Court of Appeal in London upheld the High Court decision but the pharmaceutical giant has vowed to appeal the decision in the UK’s Supreme Court.

Citation: The Pharmaceutical Journal URI: 20203047

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