Pharmaceutical manufacturers such as Pfizer have huge amounts of money tied up in their branded products. They use the courts actively to try to protect their patent rights. They are out to make money, not friends. And pharmacies are increasingly being caught in the crossfire between manufacturers of branded products and generics companies.
A few years ago, when the main patent for Lipitor (atorvastatin) was about to expire, Pfizer's UK arm sued not only Teva, which had launched a generic version of the drug, but also pharmacy multiples, including Rowlands and Asda, that had stocked the generic version in readiness for the expiry of the patent.
At the time, it seemed like Pfizer had sued these pharmacies tactically to create tension between Teva and its customers. The case was eventually settled when Teva agreed not to sell generic atorvastatin until the patent for Lipitor expired.
A few weeks ago, Pfizer again took legal action, this time over Lyrica, the company’s pregabalin product. Lyrica can be used to treat epilepsy, anxiety disorders and certain types of pain.
The high court ruled earlier this year that the patent on Lyrica was only valid in relation to the treatment of peripheral neuropathic pain. This led to NHS guidance that Lyrica should be dispensed if a pharmacist has reason to believe that a pregabalin prescription is for the treatment of pain, but otherwise generic pregabalin can be dispensed.
Then, in October, Sandoz departed from the practice – common to generics companies – of including only mentions of epilepsy and anxiety, not pain, on pregabalin labels. It sold 100,000 packs to AAH, which were sold on to Lloydspharmacy.
In response, Pfizer rushed to the high court to obtain an emergency interim injunction against Lloydspharmacy, requiring it to send instructions to all its pharmacists and store managers insisting that pregabalin should not be dispensed if the label referred to pain. Mr Justice Birss decided that granting the injunction would preserve the status quo until the court could determine the legal rights of the parties.
There seems to be a constant stream of patent cases going through the courts. The Lyrica case suggests that pharmacy owners and pharmacists will remain at risk of becoming tangled up in the battles between the manufacturers of branded and generic medicines.
David Reissner is senior healthcare partner at law firm Charles Russell Speechlys ([email protected])
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