Pfizer lost the final round in a lengthy patent battle after the Supreme Court ruled against it in a case involving its $5 billion-a-year pain drug Lyrica, exposing the company to possible financial claims.
The Supreme Court decision is a blow for the U.S. drugmaker – which had sought to affirm a secondary medical use patent for the product – and a win for generic drug companies Actavis, now renamed Allergan, and Mylan.
The Pfizer proposal would have placed impractical requirements on pharmacists and left them liable for patent infringement, National Pharmacy Association (NPA), who was a respondent in the case, remarked in statement after last Wednesday’s (14 November) ruling.
NPA said the verdict would come as a relief to pharmacists.
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.
Gareth Jones, head of corporate affairs at NPA, said: “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.
The case was part of a long-running dispute between the Pfizer subsidiary, Warner-Lambert, and generics manufacturers Mylan and Actavis.
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.
Mylan, Actavis and interveners, including the the Secretary of State for Health, successfully argued the test for direct infringement of a second medical use patent should hinge on whether the generic product was deliberately intended to treat a patented indication.
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.
The judgment was handed down today by Lords Mance, Sumption, Reed, Hodge and Briggs.