Supreme Court rejects Pfizer’s pregabalin pain patent claim
The UK’s Supreme Court has dismissed Pfizer’s attempt to prevent generic pregabalin from being used to treat certain types of pain.
The legal battle was last seen in the Court of Appeal in 2016, which upheld the previous year’s High Court decision that Pfizer’s patent for pregabalin – the active ingredient in its anticonvulsant Lyrica – for treating certain kinds of pain was “invalid”.
Pfizer took generics manufacturer Actavis to court in 2015 over Lecaent – its generic pregabalin capsules sold as an anxiety and epilepsy treatment – claiming the generic would inevitably be used to treat pain and infringe on Pfizer’s patent.
Pfizer has since appealed to the Supreme Court, arguing that its branded pregabalin should be the only version prescribed and dispensed for pain, including inflammatory and neuropathic pain.
This was rejected “by a majority” at the Supreme Court yesterday (November 14), which stated that it “supports the claims so far as they extend to inflammatory pain, but not to any kind of neuropathic pain”.
Pfizer’s claim that its branded pregabalin should cover treatment for “all neuropathic pain, including central neuropathic pain...failed for insufficiency”, the court concluded.
Result a “relief” for pharmacists
The National Pharmacy Association (NPA), which provided a written submission to the Supreme Court, said the judgment will “come as a relief to NPA members”.
If Pfizer’s case had been successful, it “would have meant that if a clinician wrote a generic drug name on a prescription and the pharmacist dispensed the generic product, the pharmacist would be liable for infringement if it transpired the drug had been prescribed to treat a condition covered by the patent”, it said.
NPA head of corporate affairs Gareth Jones added: “The wrong outcome would have meant pharmacists across the UK, who dispensed a generic product as directed by the prescriber, would still be found liable for patent infringement.
“This would have remained so even if the pharmacist had no knowledge of the patient’s condition for which the medication was prescribed.”
Pfizer said in a statement that it was “disappointed” by the court’s decision as “we strongly believed in the validity of our patent”.
The ruling has a “significant impact on innovation in public health”, it argued. “As patients increasingly benefit from ongoing research into new uses for existing medicines…it’s important for patients that pharmaceutical companies are able to protect patents, including second medical use patents.”
“Major ramifications for pharmacists”
The law firm that represented Actavis in the Supreme Court, Powell Gilbert, said the decision has “major ramifications for the pharmaceutical industry, as well as for…pharmacists prescribing and dispensing old drugs for new uses”.
The court had sought to balance the interests of patent holders with those of the NHS, partner Tim Powell said.