U.S. District Judge Lucy Koh, Northern District of California (Jason Doiy / The Recorder)
SAN FRANCISCO — A federal judge has cried foul over punches thrown by Takeda Pharmaceutical Co. in a patent brawl to decide the fate of a planned generic for its acid reflux drug.
In an order issued Friday afternoon, U.S. District Judge Lucy Koh of the Northern District of California rejected Takeda’s claims for declaratory judgment that Mylan Inc. will infringe its patents when it begins making a generic for Takeda’s Dexilant drug. Koh wrote that Takeda’s bid for declaratory judgment was overkill in light of other claims it had filed against Mylan under the Hatch-Waxman Act, which governs patent spats over generic drugs.
“The court finds that exercising jurisdiction over Count II serves no useful purpose and will not resolve any issues that adjudication of Count I will not also resolve,” Koh wrote in a 17-page order.
Koh granted Mylan’s motion to dismiss the declaratory judgment claims without prejudice. Munger Tolles & Olson lawyer Heather Takahashi, who represents Takeda, did not immediately respond to a request for comment. Mylan lawyer Ryan Koppelman, a partner at Alston & Bird, declined comment.
Shortly after filing an abbreviated new drug application to manufacture a generic for Dexilant, Mylan notified Takeda last year that it believed its product did not infringe Takeda’s patents. Later that year, Takeda declared war on Mylan in the Northern District, asserting a total of eight patents in three cases consolidated before Koh. Now that Takeda has wielded its patents, Mylan’s drug will be kept off the market until January 2016 unless it wins in the Northern District, according to court papers.
Koh wrote that Takeda’s litigation strategy raised questions about whether pharmaceutical patent holders may seek declaratory judgment while pursuing infringement claims under the Hatch-Waxman Act. The U.S. Court of Appeals for the Federal Circuit has yet to weigh in on the issue, and district courts have come to different conclusions, she added.
Takeda lawyers argued at the hearing that the declaratory judgment claims would allow them to pursue damages if Mylan infringed its patents before the litigation was resolved. But Koh found that the company’s other infringement claims would suffice.
“There is no apparent practical reason for Takeda to maintain Count II at this time,” she wrote.
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