LONDON, Dec 30 (APM) - Pfizer has defended a letter sent to UK clinicians warning of the potential consequences of prescribing generic Lyrica (pregabalin) for pain, noting that it is already fighting legal action challenging the validity of the analgesia patent in the High Court.
In an emailed statement to APM on Monday, the company said: “Pfizer's position is that the patent is valid, and Pfizer is also enforcing the patent in infringement proceedings.”
Doctors last week hit back at the company on social media after the letter was shared online. In it, Pfizer said generic pregabalin should only be prescribed for Lyrica’s other indications - epilepsy and generalised anxiety disorder. It said the pain indication was “unusual” since it was discovered later, and therefore the pain patent does not expire until July 2017. (APMMA 40950)
Pfizer in its letter advised healthcare commissioners to “influence” clinicians’ prescribing of Lyrica in pain by developing information, guidance and solutions to avoid “an unlawful act”.
In its statement, the company said the letter followed meetings with interested parties across the National Health Service “to discuss the relatively unusual legal situation surrounding the partial loss of patent exclusivity for Lyrica”.
“This is a legal matter not a clinical one,” and the letter was “to provide clarity and guidance around this patent situation and to ensure prescribers and dispensers of medicines are aware that generic pregabalin should not be used for the treatment of pain,” it said.
The company also pointed out it has “no issue with the use of generic pregabalin for epilepsy or generalised anxiety disorder (GAD),” because Lyrica is no longer patent protected in these indications.
But in pain, Pfizer said it “expects that generic manufacturers will generally only seek marketing authorisation of their pregabalin products for use in the treatment of epilepsy and GAD”.
It noted however, ongoing legal proceedings regarding patent infringement, as well as High Court proceedings challenging the validity of the pain patent.
The company argued health systems should uphold protection of intellectual property, “to support investment in scientific research and development”.
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