On Tuesday judges ruled against Warner-Lambert, a subsidiary of Pfizer, in its bid to strengthen patent protection of Lyrica and other medicines. The case was part of a long-running dispute between the Pfizer subsidiary, Warner-Lambert, and generics manufacturers Mylan and Actavis.
Proposals that would have placed impractical requirements on pharmacists and left them liable for patent infringement have been thrown out by the Supreme Court. The National Pharmacy Association (NPA) was a respondent in the case. In addition to the NPA, nine other third parties were granted permission to intervene, including the Secretary of State for Health.
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 Supreme Court was asked to consider the tests for the direct and indirect infringement of second medical use patents and to determine which test should be applied to such patents.
Warner-Lambert unsuccessfully argued infringement should be found where it is known or foreseeable that the generic product will be used to treat patients with a patented indication.
NPA head of corporate affairs, Gareth Jones, said today:
“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.”