Pfizer has lost its protracted patent battle in the UK for big-selling drug Lyrica, potentially exposing it to claims for hundreds of millions of pounds from the NHS.
A Supreme Court ruling handed down this week dismissed Pfizer’s last-ditch attempt to uphold a second use patent covering the use of Lyrica (pregabalin) as a treatment for neuropathic pain, and says the drugmaker tried to force a monopoly position – on insufficient evidence – when it tried to block generic manufacturers from selling their pregabalin drugs for this use.
NHS England could now attempt to recoup as much as £500 million in overspending on the drug, according to some estimates. Lyrica is still a massive earner for Pfizer, bringing in $3.4 billion in sales in the first nine months of this year.
After being awarded the EP(UK) 0934061 patent for use of the drug in pain, Pfizer obtained a court order to compel clinical commissioning groups in the UK to issue guidance that, when used for pain, pregabalin should be prescribed by reference to their trademarked brand Lyrica, rather than generically.
Now, at all three levels – Patents Court, Court of Appeal, and Supreme Court – the neuropathic pain patent has been held to be invalid, while in the latest judgement the Supreme Court has held that even if its claims were valid, they would not have been infringed.
Lyrica’s original UK patent expired in 2013, at which point generic drugmakers Mylan and Actavis (now Allergan) entered the market and started selling low-cost Lyrica alternatives for epilepsy and anxiety, uses covered by that patent, with a so-called ‘skinny label’ that excluded pain.
The second patent provided protection until July 2017, and the NHS overspend reflects sales of Lyrica for pain between September 2015 and that date.
Lord Sumption, Justice of the Supreme Court, said in a summation yesterday that the Supreme Court agreed with the lower courts’ view that while the disputed patent “showed sufficiently why pregabalin could be expected to work with peripheral neuropathic pain, it didn’t show any scientific reason why it could be expected to work for central neuropathic pain. Since the patent covered both, the disclosure was therefore insufficient.”
Actavis and Mylan’s cross-appeal, which claimed that the patent application insufficiently disclosed pregabalin’s efficacy in treating peripheral neuropathic pain, was also granted.
Patent experts have suggested that the case sets a precedent that could make pharmaceutical patents harder to obtain and easier to break down as it introduces a higher threshold of plausibility.
In a statement, Pfizer said the ruling “has 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.”
It continues: “As situations such as these are expected to become more common, it’s important for patients that pharmaceutical companies are able to protect patents, including second medical use patents.”
Pfizer recently filed for a six-month extension to the patent life for Lyrica in the US based on paediatric exclusivity and says it expects a verdict from the FDA on that before the end of the year. If approved, Lyrica’s US protection will expire on June 30 next year.