It is “still unclear” whether a High Court ruling means pharmacists can supply the generic version of Lyrica for pain, a lawyer has said.

The court ruling earlier this month (September 10), which found Pfizer had gone too far in enforcing its patent, could leave pharmacists in a difficult position for months, said patent law expert Jonathan Radcliffe.

Pfizer said it intends to appeal the court's decision that it was wrong to prevent the use of generic version of Lyrica, pregabalin, to treat all forms of pain. It also stressed that the court upheld its right to prevent the generic from being prescribed for certain types of pain, including acute herpetic, postherpetic and causalgia, was upheld.

Mr Radcliffe told C+D he expects Pfizer to ask the court for the full patent – which only allows the generic to be prescribed for epilepsy and anxiety disorder – to be enforced until the appeal process is completed.

“Unfortunately for pharmacists, this means [they] will still be unclear about what exactly they can do for many months to come,” said Mr Radcliffe, who is a partner at law firm Charles Russell Speechlys.

Court verdict

The High Court ruling appeared to allow pharmacists to dispense pregabalin for most forms of pain.

It found that Actavis – who brought the case to court – had not infringed the patent in regards to a range of pain-related conditions, including neuropathic and cancer pains. The judge said – as sections of the patent are invalid – no pharmacist who dispensed the generic for these conditions had violated it.

PSNC and Community Pharmacy Scotland reported last week that the ruling means pharmacists are free to dispense pregabalin when prescribed for pain.

But Pfizer told C+D that, until its appeal is heard, pharmacists should continue to follow NHS England guidance from earlier this year, which said patients with neuropathic pain should be supplied with Lyrica “as far as reasonably possible”.
 

"Amounting to threats"

The judge was critical of Pfizer's enforcement of its Lyrica patent. Some of Pfizer’s “extensive steps” to prevent generic pregabalin being prescribed and dispensed – which included a letter to superintendent pharmacists in December – “amounted to threats”, the court found.

The manufacturer told C+D that “with the benefit of hindsight” it wishes it had explained the situation “better and sooner”. “Our intention was only ever to communicate the existence and importance of our second medical use patent for the use of Lyrica in pain, and nothing more,” it said.

Pfizer UK's medical director Berkeley Phillips said the "absence of any national policy or framework for second medical use patents in the UK has been a cause of concern and confusion for many, including us".

Concluding the ruling, the judge called for a “centralised and authoritative" system to keep healthcare professionals informed about whether to prescribe a generic version of a drug or a patented, branded version. “Prescribers cannot be expected to know when this is required, nor should they be required to take steps to find out,” he added.

Click here to read the High Court judgment in full.

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