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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 “disappointed”

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.

The pregabalin story

July 2014 – The patent confusion starts

The general patent for Lyrica expires, but Pfizer retains the product’s patent for the treatment of pain until July 2017. The Pharmaceutical Services Negotiating Committee explains that until this happens, Lyrica will remain the only pregabalin-based product licensed for treating pain, as well as epilepsy and generalised anxiety disorder.

February 2015 – Numark raises concerns

Independent support group Numark raises concerns that pharmacists who run out of Lyrica may be “tempted” to disobey the patent restrictions and dispense generic pregabalin instead. Pfizer reassures pharmacists that it does not think this will be an issue because it constantly manages stock supplies.

March 2015 – NHS produces guidance on pain medication

Pharmacy Voice chief executive Rob Darracott says NHS guidance on pregabalin – which advises that dispensers should supply Lyrica for pain “as far as reasonably possible” – reduces the risk of pharmacists falling foul of Pfizer’s existing patent. Mr Darracott points out that the guidance will ensure pharmacists are not “unfairly placed in a difficult position” of having to decide whether to follow a prescription to treat pain with a generic version.

June 2015 – Pfizer defends its patent

In an open letter to pharmacists and other healthcare professionals, Pfizer highlights that it holds pregabalin’s patent to treat pain until 2017. “We wish we had been able to explain this patent situation earlier and better. This is new territory for all of us and there was no system or policy in place to deal with it,” the manufacturer’s UK medical directors Berkeley Phillips and Seema Patel write.

September 2015 – High Court rules Pfizer “went too far”, but confusion remains

The High Court appears to rule that pharmacists can supply generic pregabalin to treat pain, and labels some of Pfizer’s attempts to enforce its patent as amounting to “threats”. But patent lawyer Jonathan Radcliffe – partner at Charles Russell Speechlys – tells C+D that it is “still unclear” whether pharmacists can dispense pregabalin in this way.

October 2016 – Court of Appeal backs High Court decision

The Court of Appeal upholds the High Court's decision that Pfizer's patent for pregabalin was “invalid”. But Pfizer highlights that the patent for treating certain types of pain – including “acute herpetic, post-herpetic and causalgia pain” – still stands. It vows to continue the legal battle and take the decision to the UK's Supreme Court.

November 2018 – UK Supreme Court rejects Pfizer's appeal

The UK's Supreme Court dismisses Pfizer's appeal, stating that the claim that branded pregabalin should cover treatment for “all neuropathic pain, including central neuropathic pain...failed for insufficiency”. Charles Russell Speechlys senior associate Susan Hunneyball tells C+D that while the position for pharmacists is “much better than it could have been”, it is still unclear whether pharmacists will be liable for other patent infringements in future.

What do you make of the judgment?

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