Pfizer apologises for confusion following Lyrica NHS ruling
Pfizer has apologised to UK-based healthcare providers for any confusion or increased workload following the English High Court’s decision on a patent infringement case centring on its epilepsy drug Lyrica (pregabalin).
Two of Pfizer’s medical directors, Berkeley Phillips and Seema Patel, sent an open letter to doctors and pharmacists yesterday (June 8).
The letter, published on the BMJ (British Medical Journal) website, references the fact that the court asked the UK’s National Health Service (NHS) to issue guidance on how to prescribe the drug without infringing a second medical use patent owned by Pfizer.
Lyrica was originally developed to treat epilepsy. After Pfizer discovered that the drug could also be used to treat neuropathic pain, it was awarded a second medical use patent to cover that indication.
That patent is due to expire in July 2017.
But after finding out that pharma company Actavis’s generic version of Lyrica, called Lacaent, may have been prescribed for treating neuropathic pain, Pfizer filed for an interim injunction asking that Actavis take steps to prevent the prescription of Lacaent for the patented indication.
In February this year, Judge Richard Arnold instead ordered the NHS to provide guidance on how to prescribe pregabalin without infringing Pfizer’s second medical use patent.
Phillips and Patel wrote in yesterday’s letter: “There has been some discussion and media reporting about our patent for the use of Lyrica in pain over recent months. We recognise this has been the cause of concern for some of you; and we apologise if this has been the case.
“We hope this letter will help to bring further clarity and reassurances to all concerned.”
They admitted that the situation was “new territory”, and that the company was “finding [its] way, as was the NHS”.
Patients will benefit from research into uses for existing medicines, the letter continued, so Pfizer continues not only to research new molecules, but to return to existing molecules to discover if they can effectively treat other conditions.
“We need to make sure this avenue is open for scientists to continue to explore,” the letter said.
“This means that we have to be able to protect our patents, including our second medical use patents. It is the core of any pharmaceutical business.”
But Phillips and Patel said that they recognise that this model is not without its challenges for the NHS and industry.
The letter said that Pfizer had been working with senior government officials and NHS policy makers to identify the best way of communicating a “relatively unusual and complex patent situation”.
Pfizer has also been in talks with software providers to find a way of adapting electronic prescribing systems to help implement the NHS guidance, the letter said.
