Pfizer’s unsuccessful patent appeal may mean the NHS can recoup £502 million, according to new article

Researchers from the University of Oxford in collaboration with an intellectual property law firm have revealed (article in preprint in bioRXiv) that the NHS may be able to recoup over half a billion pounds from Pfizer if its Supreme Court patent appeal is unsuccessful.

Back in 2015, general practitioners across England were told by NHS England to prescribe the branded form of pregabalin — Lyrica — for neuropathic pain management in patients. This guidance was set in line with court instructions as a result of litigation that was taking place over secondary-use medical patent of the drug.

However, the patent at issue (use of pregabalin for neuropathic pain) was found invalid by a lower court. This in turn has led to appeals and is now in the hands of the Supreme Court, which is expected to reach a decision this month (February 2018).

If the Supreme Court rules against Pfizer’s appeal, the authors of ‘The clinician impact and financial cost to the NHS of litigation over pregabalin: a cohort study in English primary care’ write that NHS England will be able to seek reimbursement for excess prescribing costs to the tune of £502 million.

To come to this conclusion the authors assessed the variances in prescriptions of pregabalin across English GP surgeries both before and after receiving the instructions to prescribe only the branded version in cases of neuropathic pain. Looking at prescriptions between September 2014 and February 2015 (before instruction) and April to September 2015 (after instruction) the authors found an increase in prescriptions of Lyrica from 0.3% to 25.7%.

It was estimated from their findings that if Lyrica had become completely off-patent back in 2015 and GPs were able to prescribe generic forms of pregabalin for neuropathic pain there would have been half a billion pounds less spent on the drug up until July 2017.

“If Pfizer lose in their final appeal, and their patent for Lyrica in pain is indeed found to be invalid, then this will mean that the NHS has potentially overpaid by £502 million for the drug in England alone,” specified lead author on the paper Dr Ben Goldacre when speaking to Pulse. “We think it's useful to use the prescribing data to model this excess spend, because if Pfizer do lose their appeal, then this is money that the NHS is entitled to seek reimbursement on. It's always important to give context for large numbers, but however you look at it, £502 million is very large [given that] we only spend around £8 billion a year on all drugs, in total, in NHS Primary Care across the whole of England.”

But a spokesperson from Pfizer told Pulse in the same article: “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.”