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Pregabalin judgment hasn't resolved pharmacists' wider patent concerns

The Supreme Court pregabalin judgment has not completely resolved whether pharmacists ever risk patent infringement for dispensing certain generic products, a lawyer has warned.

The court dismissed Pfizer’s attempt to prevent generic pregabalin from being used to treat certain types of pain, such as neuropathic pain, yesterday (November 14).

The National Pharmacy Association (NPA) warned that if Pfizer’s case had been successful, it “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”.

Charles Russell Speechlys senior associate Susan Hunneyball – who filed a written submission to the Supreme Court on the NPA’s behalf – said while yesterday’s judgment means pharmacists should continue to dispense pregabalin “in accordance with normal practice”, it is still not clear whether pharmacists would be liable for patent infringements of other drugs.

While the “position for pharmacists is much better than it could have been”, it is “still not as clear in relation to the infringement of second-medical use patents by pharmacists as we would like it to be”.

Yesterday’s judgment relates only to a specific type of patent, she explained, “although it points to how the court is likely to approach [patent] infringement” in future.

“Likely” position of the court

The court indicated its “likely” position on the issue, with judges’ opinions split on what the test for infringement by pharmacists would be, Ms Hunneyball said, although their comments were “not part of the binding judgment”.

Two judges suggested that a test could involve a “pharmacist essentially looking at the packaging and patient information for a generic product and telling from that whether they will infringe if they dispense it”, Ms Hunneyball said.

Other judges held that “the generic manufacturer’s intention when making the product should be part of the test” to determine whether a pharmacist is infringing a patent, she added.

The court also recognised that if it had upheld Pfizer’s patent claims for neuropathic pain, it would “stifle the generics market and pharmacists would not be willing to supply a generic version for any condition if there was a risk of being sued”, Ms Hunneyball added.

How often do you dispense pregabalin products for pain?

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