The National Pharmacy Association (NPA) has described the Supreme Court’s decision to reject Pfizer’s claim that only its branded drug pregabalin should be prescribed and dispensed for pain including central and peripheral neuropathic pain as a “relief.”
A lengthy legal battle which started in the High Court three years ago concluded with Lord Sumption ruling the pharmaceutical company’s patent for Lyrica, which contains the active ingredient pregabalin, was invalid.
That, Lord Sumption said, was because Pfizer’s case was based on “insufficient evidence” since it had failed to “show any scientific reason why it would be expected to work for central neuropathic pain.”
Lyrica can be used to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles.
The NPA, who were respondents in the case, said: “The proposals 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.
“This would have remained so even if the pharmacist had no knowledge of the patient’s condition, known as the indication, for which the medication was prescribed.
“In many circumstances it is not possible to establish the condition of the patient because the prescriber cannot be contacted and patients’ representative, or even the patients themselves, simply do not know.”
The ruling could pave the way for the NHS to reclaim more than £500 million in prescribing costs.
NPA head of corporate affairs Gareth Jones: “The proposed test for infringement would have operated unfairly and in an unbalanced way, with detrimental results for pharmacists, patients, the NHS and taxpayers.
“The wrong outcome today would have meant pharmacists across the UK, who dispensed a generic product in good faith as directed by the prescriber, would still be found liable for patent infringement.
“We were determined to make the voices of community pharmacists heard in this case and the court’s verdict will come as a relief to NPA members.”
Pfizer said in a statement: “This ruling has significant impact on innovation in public health. The period that a medicine is under patent is a critical phase in its lifecycle that fuels innovation – as science evolves and knowledge grows, patients increasingly benefit from ongoing research into new uses for existing medicines.
“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.
“This is why Pfizer is disappointed with the decision issued by the Supreme Court in London regarding the second medical use patent covering Lyrica (pregabalin) for pain.
“We had appealed the October 2016 ruling of the Court of Appeal as we strongly believed in the validity of our patent but on 14th November 2018, the Supreme Court handed down its judgment finding the patent claims relevant to the neuropathic pain indications were invalid.”
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