Pfizer Loses Lyrica Patent Case
/By Pat Anson, Editor
A British judge has strongly rebuked Pfizer for making "groundless threats" against doctors and pharmacies in the UK to prevent them from prescribing or selling cheaper generic versions of Lyrica for pain relief.
Judge Richard Arnold ruled against Pfizer in a patent protection case, saying emails and letters the U.S. drug maker sent to British healthcare providers were “calculated to have a chilling effect on the willingness of pharmacies to stock and dispense generic pregabalin.”
Pregabalin is the generic version of Lyrica, a blockbuster drug that generates over $5 billion in sales annually for Pfizer.
The company's patent on Lyrica for the treatment of epilepsy and anxiety expired last year, but a secondary patent for pain is good until 2017. However, that didn't stop British doctors from prescribing pregabalin "off-label" for pain. According to Pharmalot, about 80% of UK patients on pregabalin are using it to treat pain -- amounting to about $386 million in lost Lyrica sales for Pfizer.
Arnold's ruling that doctors and pharmacists were not infringing on the patent does not impact Pfizer's patent rights outside of the UK. The company said it would appeal the decision.
“Our intention was only ever to communicate the existence and importance of our second medical use patent for the use of Lyrica in pain," Pfizer said in a statement. “With the benefit of hindsight and having navigated particularly challenging and complex legal issues, we wish we had been able to explain this better and sooner."
Ironically, Pfizer paid $2.3 billion dollars in 2009 to settle criminal and civil charges in the U.S. for the off-label marketing of Lyrica and other medications – the very sort of off-label use it was trying to stop in the U.K.
Lyrica is one of only three drugs approved by the U.S. Food and Drug Administration to treat fibromylagia. Although it is the most widely prescribed medication for fibromyalgia, many patients have written to Pain News Network warning about its side effects.
"I have memory loss and bad vision from Lyrica. Some of my memory will never be restored," said Dana.
"Lyrica made me fat, extremely fat, I was depressed on this drug too. No thanks," said Freda.
"I have tried Lyrica. I was falling on the floor. Could not walk without holding onto a cane," said Nancy. "It's time for researchers to find medications that are meant to treat Fibromyalgia, and not second or third off label uses of other meds that were never intended for FM. After 25 years, I'm really tired of waiting!"
