Pfizer has come up short in a long-running patent battle in the U.K. over its blockbuster Lyrica, and the loss could come with a significant financial hit for the drugmaker.
In a judgment on Wednesday, the U.K.’s Supreme Court ruled that Lyrica’s neuropathic pain patent claims were invalid, handing Pfizer a loss in the battle that’s stretched over several years.
With the ruling, NHS England could attempt to recoup up to £502 million on overspending for the drug, researchers said earlier this year. The government healthcare system spent that amount more on Lyrica between September 2015 and July 2017 than it would have if Pfizer hadn't challenged a lower court's patent ruling.
Lyrica’s original patent in the U.K. expired in 2014, which allowed generics companies to launch knockoffs featuring a “skinny label” to treat epilepsy or general anxiety. At the time, Pfizer still carried patent protections for Lyrica to treat neuropathic pain, and the company sought to aggressively defend the key market. The company sent a letter to providers warning them of legal action if they prescribed Lyrica generics to treat pain. NHS England also sent out guidance to warn against using Lyrica copies to treat pain.
But in September 2015, a lower court ruled that the pain patent—originally set to expire in July 2017—was invalid. The judge scolded the company for "groundless" threats to doctors. Since then, Pfizer has appealed to protect its drug several times.
In a statement on Tuesday, Pfizer said it’s disappointed in the Supreme Court decision, which will have a “significant impact on innovation in public health.”
"The period that a medicine is under patent is a critical phase in its lifecycle that fuels innovation—as science evolves and knowledge grows, patients increasingly benefit from ongoing research into new uses for existing medicines,” the drugmaker said. Similar situations “are expected to become more common,” Pfizer continued, so “it’s important for patients that pharmaceutical companies are able to protect patents, including second medical use patents.”
A representative for NHS England said "clinical commissioning groups and the NHS nationally have been tracking this legal case and will be deciding on the right next steps on behalf of patients and taxpayers.”
Pfizer is coming up to the end of its Lyrica patent protections in the U.S. as well. The megablockbuster is set to lose exclusivity in December unless Pfizer can win a six-month pediatric exclusivity extension from the FDA.
Lyrica is one of Pfizer's biggest-selling products, generating $5 billion last year around the world.