Lyrica (pregabalin), a treatment for epilepsy and neuropathic pain, was responsible for worldwide sales of $1.13bn (€1bn) in the third quarter of this year, and $4.51bn in 2017 for Pfizer.
The main European patent, regarding the treatment’s use for epilepsy and general anxiety disorder (GAD), expired in May 2013, but Pfizer held another patent (EP 0934061), at the centre of this case, protecting the product for the treatment of pain.
Pfizer argued in court that those companies producing generics after the original patent protection had passed – in this case, Mylan and Actavis (now known as Allergan) – would likely see patent infringement for the second patent – despite generic products only being labelled as suitable for the treatment of epilepsy and GAD, known as skinny labelling.
The UK Supreme Court adjudged today that Pfizer’s claims “failed for insufficiency” and ruled the patent invalid.
The court announced, “The result of the judge’s decision was to remove patent protection for the manufacture of pregabalin for the treatment both peripheral and central neuropathic pain”.
In a statement, Pfizer responded by noting that it was “disappointed” and “strongly believed” in the validity of its patent.
It continued, “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.”
In regards to why these situations are likely to increase in frequency, a spokesperson for Pfizer explained that the pharma industry is diverting more R&D efforts into going back to existing medicines with new knowledge.
Researching Lyrica’s use in neuropathic pain conditions, the spokesperson revealed had involved “conduct[ing] 45 controlled clinical studies involving more than 12,000 patients, and an additional 21 uncontrolled studies, including over 4,000 patients.”
Pfizer’s spokesperson commented that it is too early to determine the next steps it will take in regards to the case.
UK may demand reimbursement
As a result of Pfizer's second patent protecting its product, NHS England issued advice to general practitioners to prescribe only Lyrica for the treatment of neuropathic pain.
According to research published in the BMJ, this saw the proportion of prescriptions for pregabalin being the branded, Lyrica version increase from 0.3%, prior to the announcement, to 25.7%.
The research estimates that the NHS could have saved £502m ($653m) had the product come entirely off patent in September 2015.
“This is an enormous blow to Pfizer. [It] face[s] claims running potentially into hundreds of millions of pounds if the NHS seeks to recover the excess costs incurred by having instructed doctors to prescribe Pfizer’s more expensive branded Lyrica, rather than a generic equivalent, for pain, as the patent which afforded Pfizer this exclusivity has now been declared invalid,” said Darren Smyth, partner at EIP, an international law firm.
Preparing for patent loss
Pfizer has been busy preparing for an expected loss of patent protection in Europe and in the US.
In Q3 financials, the company noted that it had submitted an application seeking paediatric exclusivity for Lyrica in the US, which would extend its market exclusivity from December 30, 2018, until June 30, 2019.
However, it projected an expected 17% operational decline in its Peri-LOE portfolio revenue – made up of products expected to go off patent – due to “expected declines in Lyrica in developed Europe”.
Frank D’Amelio, CFO of Pfizer signposted that the company regards its future for growth as pre- and post-loss of exclusivity (LOE) for Lyrica.
“Once we clear the Lyrica LOE, so think about that as the base year being 2020, when we get the full year effect of Lyrica LOE, beyond that we clearly believe there's an opportunity to expand our margins,” he said.