Last week, Pfizer told C+D it will take the step after the Court of Appeal upheld last year’s High Court decision that its patent for pregabalin – the active ingredient of its anticonvulsant Lyrica – for treating certain kinds of pain was “invalid”.
Pfizer took Actavis to court in 2015 over Lecaent – the latter’s generic pregabalin capsules that are sold as an anxiety and epilepsy treatment, Actavis told C+D.
Pfizer objected to Lecaent on the grounds that it would inevitably be used to treat pain, Actavis added.
The judge, Richard David Arnold, who made the High Court ruling in September 2015, was also critical of Pfizer’s enforcement of its patent.
In his written ruling, Mr Justice Arnold said some of Pfizer’s actions to stop Lecaent being prescribed and dispensed – for example, sending a letter to superintendent pharmacists in December 2014 – amounted to making “groundless threats” of taking legal action for patent infringement.
Pfizer’s patent for pregabalin to treat anxiety disorders and epilepsy has expired. But its patent covering its use for pain relief is not due to expire until July 2017.
Pfizer said it is “disappointed” by the Court of Appeal’s ruling last week, which also found its patents relating to some forms of pain are invalid. But it highlighted that the ruling means pregabalin’s patent for treating certain types of pain – including “acute herpetic, post-herpetic and causalgia pain” – still stands.
Pfizer said it will ask NHS England to update its prescribing guidance for pregabalin to reflect this.
“Pfizer maintains its strong belief in the validity and importance of the second medical use patent for the use of Lyrica in pain and intends to seek permission to appeal the decision to the Supreme Court,” it said in a statement.
Tim Powell, of Powell and Gilbert, who represented Actavis during the hearing, welcomed the Court of Appeal’s ruling as a “pragmatic way forward”.
The story so far...
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 – Pfizer’s branded product – 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.