The NHS could have spent up to £500 million unnecessarily by ordering doctors to prescribe a product from one of the world's largest pharmaceutical companies over cheaper similar drugs.
The health service took the “unprecedented” step of issuing guidance to all GPs and pharmacists stating that when prescribing the drug pregabalin for neuropathic pain they should stipulate that it must be the brand Lyrica, produced by Pfizer.
The unusual directive was due to a 'second medical patent’ held by the company and meant the NHS had to reimburse pharmacists far more per capsule than a cheaper generic version of the same drug.
But a High Court ruling, backed by the Court of Appeal, found that Pfizer’s patent was not fully valid. The company disputed the decision and is awaiting a ruling from the Supreme Court.
A detailed study analysing the financial cost to the NHS of the protracted legal action, seen by the Sunday Telegraph, suggests that if the final appeal is unsuccessful, the NHS should be able to reclaim from Pfizer the money it would have saved by prescribing a cheaper version of the drug.
The research, which has been submitted to the BMJ Open for publication, said there was no clinical difference between Pfizer’s Lyrica and the generic version of the drug.
It concluded: “If Lyrica had come off patent in September 2015, and Pfizer had not appealed, we estimate that the NHS would have spent approximately £502m less on pregabalin to July 2017.
“If the final appeal on the patent is unsuccessful the NHS can seek reimbursement of their excess costs which we estimate at £502m.”
Dr Andrew Green, the British Medical Association's GP clinical and prescribing policy lead, said Pfizer has a "moral duty" to repay the money if the court rules against it.
"The NHS should absolutely get this money back, " he said.
"Pfizer has made an absolute fortune off this drug - taking money from the NHS that should have been spent on patient care."
An NHS England spokesperson said: "We are closely tracking this legal case and once it has concluded the NHS will take whatever action the courts permit so as to safeguard patients and taxpayers’ interests.”
Pfizer’s main patent for Lyrica in the UK expired in July 2014 but its second medical use patent for the drug when prescribed specifically for neuropathic pain continued.
Pfizer launched the legal action in 2015 against generics manufacturer Actavis over its pregabalin capsules called Lecaent, sold as an anxiety and epilepsy treatment. Pfizer objected on the grounds that it would inevitably be used to treat pain.
In February 2015, NHS England issued guidance to all GPs and pharmacists stating that, “so far as reasonably possible’, they should stipulate Lyrica when prescribing pregabalin for neuropathic pain.
The following month, an interim legal judgment found in favour of Pfizer and said the NHS should not promote generic pregabalin.
But that September, a second High Court ruling concluded that Pfizer’s “second patent” claim covering neuropathic pain was invalid.
In October 2016, Pfizer’s appeal was rejected and they took the battle to the Supreme Court.
Dr Ben Goldacre, a senior clinical research fellow at Oxford University and the author of Bad Science, co-authored the study said its most “extraordinary” finding was that the majority of GPs largely ignored the NHS instructions, prescribing Lyrica infrequently, if at all.
“Nothing like this has ever happened before,” he said. “What is fascinating is that doctors largely ignored the NHS advice to prescribe a named brand.
“One of the reasons is no doubt the incredible cost. Even when a drug is under patent, British doctors almost always prescribe the generic; it is considered safer and more informative because all the drugs in one family have the same name.
“Doctors adhered to the universal norm of prescribing which is heartening.”
Yet despite best intentions, the NHS continued to reimburse pregabalin prescriptions at the full Lyrica cost regardless of which brand was dispensed, meaning that it derived no financial benefit.
Dr Goldacre, director of the Evidence-Based Medicine DataLab at Oxford University, joined forces with pharmacist Richard Croker, head of medicines optimisation at the Northern, Eastern and Western Devon CCG, to analyse at the data then issued an appeal on Twitter for a lawyer with knowledge about pharmaceutical patents, which resulted in the involvement of lawyer Darren Smyth.
The report said the case raised several important issues including the background of how drug patents operate, the value of generic prescribing and the reimbursement of costs to the NHS.
It noted that there was social value in patents being upheld as they provide an incentive to generate profits through innovation.
A spokesman for the company said: "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.
"We await the decision from the Supreme Court and are unable to provide further comment until after this is received. "During the life of the patent, Pfizer has always made clear that it was not seeking to prevent the use of generic pregabalin to treat generalised anxiety disorder or epilepsy, which are not patent protected."