Sun Pharma takes Pfizer to court over Lyrica
India-based drugmaker Sun Pharma has accused Pfizer of infringing a patent with a new extended-release formulation of Lyrica (pregabalin).
Filed at the US District Court for the District of New Jersey on Friday, April 5, the suit claimed that Pfizer was infringing US patent number 9,393,205, which covers a gastroretentive tablet comprising pregabalin.
In October 2017, Pfizer announced Food and Drug Administration approval of Lyrica CR extended-release tablets as a once-daily therapy for the management of neuropathic pain.
Lyrica is used in the treatment of fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain, and partial onset seizures in adults.
Pfizer hasn’t sought a licence to the ‘205 patent, according to the claim.
In February this year, Sun informed Pfizer of its alleged infringement and demanded that Pfizer stop the sale of the extended-release Lyrica tablets.
Claim 1 of Sun’s patent recites a “gastroretentive tablet comprising pregabalin, at least one swellable polymer, and other pharmaceutically acceptable excipients”.
Under the patent, swellable polymer includes cellulose polymers, gums, polyethylene oxide, carbomer, superdisintegrant polymers, and combinations of these.
Lyrica’s extended-release tablets contain pregabalin, along with Kollidon SR (polyvinyl acetate, povidone, sodium lauryl sulphate, and silica), along with other ingredients including polyethylene oxide.
“The continued unlicensed use, marketing and sale of Lyrica CR extended-release tablets in the US by defendants is in violation of Sun’s rights as the holder of the ’205 patent and causes damage to Sun,” said the suit.
Sun is seeking a judgment that its patent is being infringed, compensatory damages, a reasonable royalty and triple damages.
A spokesperson for Pfizer said: “We are aware of the lawsuit and believe the lawsuit is without merit.”
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