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13 October 2016Big Pharma

Pfizer loses appeal in patent battle over Lyrica

Pfizer has lost a battle against Actavis in a second medical use patent case centring on the drug Lyrica.

The English Court of Appeal ruled against Pfizer today, October 13.

Pfizer said it was “disappointed with the decision” and will seek to appeal against it.

The court affirmed a 2015 decision by the High Court, which held that a patent covering the use of pregabalin to treat pain was not infringed by Actavis.

It also found that the patent's claims directed to pain and neuropathic pain were invalid on the ground of insufficiency.

Some of Pfizer’s patent claims directed to other types of pain, including acute herpetic pain, postherpetic pain and causalgia pain, were upheld as valid.

Lyrica was originally developed for epilepsy, but research found that it also had the ability to treat neuropathic pain.

After Lyrica’s original patent expired, Pfizer pursued a new patent for the drug covering pain.

In addition, generic companies including Actavis (Allergan) brought products to market carrying a skinny-label which limited the drugs' use to epilepsy and generalised anxiety disorder.

But Pfizer filed a complaint against Actavis initially asking for an interim injunction requiring Actavis to take a number of steps to ensure that its product was not dispensed for pain relief.

The ruling today follows several decisions on the case dating back to January 2015.

Pfizer added today that it maintains its “strong belief in the validity and importance of the second medical use patent for the use of Lyrica to treat pain, and intends to seek permission to appeal against the decision to the UK Supreme Court.

It said: “Following the Court of Appeal’s judgment, and pending the outcome of its appeal to the Supreme Court, Pfizer will now seek to have the NHS England pregabalin guidance on prescribing and dispensing by brand name Lyrica limited to prescribing and dispensing for the types of pain in those patent claims upheld as valid by the Court of Appeal.”