Pfizer's Lyrica patent fight in England puts NHS docs, pharmacists on defensive

Talk about unintended consequences of a patent ruling. Pfizer's ($PFE) unprecedented effort to fight Lyrica copies in England has doctors and pharmacists squabbling, and the National Health Service stepping in to keep the peace.

Early this year, Pfizer wrote health service officials across England, warning them to avoid using generic Lyrica willy-nilly. The company's exclusivity on the drug may have expired, but Pfizer still owns a patent covering Lyrica as a treatment for neuropathic pain, the letter noted. So, prescribe the generic for epilepsy and anxiety, but when it comes to pain, you'd better write Lyrica on your prescription pads.

An unprecedented move, health officials and lawyers said. But a court order--written by Justice Richard Arnold--backed up Pfizer. And when Pfizer asked the judge to instruct the National Health Service to officially recommend against generic Lyrica for that use, Arnold agreed. The two sides came up with a mutually acceptable guidance, which went out late last month.

"The decision to call on [NHS England] as an intermediary in the ongoing patent infringement proceedings against Actavis is not one that Pfizer took lightly," the company said in a statement at the time. "It followed months of liaison between Pfizer and NHSE. … Pfizer is confident that the outcome of this, with NHSE issuing central guidance that directs the prescription and dispensing of Lyrica by brand name only … for the treatment of neuropathic pain, will provide much-needed clarity."

That guidance apparently wasn't acceptable to NHS doctors, however. Physician practices were told to review all patients taking Lyrica (pregabalin) for chronic conditions, to make sure none would be prescribed generic versions of the drug. New scripts for Lyrica should be issued instead, the NHS guidance stated.

Not my job, said some local doctors. "Asking me to change a prescription for non-clinical reasons is not part of my professional duty of care or contractual obligation--I am not a contracted dispensor," Dr. Andrew Mimnagh told the U.K. trade pub Pulse, adding that, in his opinion, the NHS was using GPs as a "no-cost errand boy" to deal with Pfizer's patent rights.

The pharmacy's job, doctors said. And apparently, some pharmacists took that job very seriously as generics hit the market--so much so that they notified NHS officials every time a doctor prescribed generic Lyrica. NHS higher-ups stepped in--calling the pharmacies' vigilance an "over-reaction"--and the practice was halted.

Meanwhile, generics makers--including Actavis ($ACT)--have challenged that 2017 patent, with a trial set for June. Teva ($TEVA) has its own Lyrica patent fight going. If the English court orders Pfizer's patent to be revoked, then all bets are off. Generic Lyrica can take over. With Pfizer likely to appeal, however, the case could keep that 2017 patent in limbo for some time--perhaps even until 2017.

- see Arnold's most recent order
- check out the Pulse story
- get more, also from Pulse
- read the text of Pfizer's statement

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