U.K. Could Seek Restitution from Pfizer if Legal Appeal Fails

Pfizer is fighting to preserve Lyrica’s use as the preferred physician’s treatment for nerve pain in the U.K.

Two years ago Pfizer Inc. was fined more than $100 million for overcharging the U.K.’s National Health Services for of its epilepsy drug Epanutin. It was the largest fine levied by Britain’s Competition and Markets Authority. Now the NHS could look at reclaiming additional monies from the pharma giant if the company is unable to maintain a patent protecting Lyrica as a preferred medicine in England.

Pfizer is fighting to preserve Lyrica’s use as the preferred physician’s treatment for nerve pain in the U.K. In 2015 NHS England told prescribers to use Lyrica (pregabalin) for neuropathic pain despite the availability of cheaper generics. The Telegraph reported that the “unusual directive” from the NHS was due to a patent Pfizer held that protected the drug as a treatment for neuropathic pain until July of 2017. After the ruling was handed down Pfizer increased the price of Lyrica in the U.K. by 25 percent, according to a study published by bioRXiv and The University of Oxford, Pulse Today reported.

The NHS directive was challenged in court and the courts initially ruled against Pfizer. However, the company has appealed the court’s ruling to the U.K.’s Supreme Court, which heard arguments earlier this month. No ruling has yet been handed down, but if the highest court agrees with previous decisions then Pfizer’s last attempts to hold off generic challenges to Lyrica in the U.K. will have failed.

If the court rules against Pfizer then the NHS could attempt to seek some financial restitution. Part of that study found that the NHS paid out quite a bit more for Lyrica than if physicians had been freer to prescribe cheaper generics. The difference in what the NHS paid out for Lyrica amounted to £502 million, about $698 million. That revelation could pave the way for the NHS to seek recovery of those monies, according to reports. Any attempt at seeking restitution from Pfizer hinges on whether or not the company is successfully able to appeal the court’s ruling.

Ben Goldacre, the lead author of the bioRXiv study, said the nearly $700 million the NHS could seek in restitution is significant. In an interview with Pulse Today Goldacre said the half-a-billion pounds the NHS may have overspent on Lyrica is a significant number when one takes into account that the U.K. government agency spends only about £8 billion, about $11 billion, annually on medications.

For its part, Pfizer is defending the patent protecting Lyrica as the preferred treatment for neuropathic pain.

‘We strongly believe in the validity and importance of the second medical use patent for the use of Lyrica in pain. The Supreme Court of the United Kingdom granted us permission to appeal a ruling issued by the Court of Appeal in October 2016, which upheld a decision by the High Court and found that the claims of the patent covering Lyrica® (pregabalin) directed generally to pain and neuropathic pain were invalid,” Pfizer said in a statement issued to Pulse.

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