Warner-Lambert – a subsidiary of Pfizer – has been awarded an UK interim injunction preventing Sandoz from selling or supplying a generic version of Lyrica (pregabalin).
Pfizer has also announced that it has been given the go-ahead to appeal against the ruling made in the High Court in September 2015, when the company lost the secondary use patent protection for Lyrica for the treatment of neuropathic pain.
Warner-Lambert went to the Patents Court in London on 4 November 2015 to challenge the decision by the generic manufacturer Sandoz to sell and supply pregabalin as a ‘full-label’ generic product for the treatment of neuropathic pain, generalised anxiety and epilepsy, and the decision by LloydsPharmacy to dispense it.
Under the terms of the ruling, LloydsPharmacy was also prevented from dispensing the product in its possession.
The case is the latest move in an ongoing battle by Pfizer to protect its secondary use patent of Lyrica for the treatment of neuropathic pain, which runs out in 2017.
The Patents Court case focuses on the decision by Sandoz to launch a full-label generic pregabalin product.
In a statement, Pfizer says its decision to involve LloydsPharmacy in the litigation was not taken lightly. “This was our last resort and followed many attempts to reach an amicable resolution outside of the courtroom,” it says. “We had hoped to be able to reach agreement with LloydsPharmacy that they would cease dispensing ‘Pregabalin Sandoz’ which, with a full label, is indicated for neuropathic pain.”
LloydsPharmacy confirmed that Pfizer is taking action against the company in a case involving the supply of a full-label product but made no other comment.
In a statement, Sandoz confirmed that it had marketing authorisation for both full and ‘skinny’ label products for Pregabalin Sandoz. A skinny label excludes certain indications that are protected by patents.
It began supplying the full-label product — indicated for neuropathic pain, epilepsy and general anxiety disorder — in October 2015. The skinny label product is indicated for epilepsy and generalised anxiety disorder and has been available since June 2015.
“Pfizer initiated legal proceedings against Sandoz in respect of a supply of a full-label product,” says Sandoz. “Pending full trial of its claims, Pfizer has obtained an interim injunction preventing Sandoz from supplying or offering to supply the full-label product. Sandoz cannot comment further on the ongoing litigation. Recent legal developments do not affect the supply and dispensing of its skinny label product.”