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Takeda’s Take On Patent Certification Rules In Colchicine Dispute Rejected

 
• By Brenda Sandburg

A federal judge tosses Takeda’s suit against FDA, finding Hikma did not need to reference Takeda’s Colcrys or certify Colcrys patents to obtain approval of its colchicine product.

A federal court has rejected Takeda Pharmaceuticals USA Inc.’s contention that FDA improperly approved Hikma Pharmaceuticals PLC colchicine product Mitigare. The ruling could have implications for other pharma companies as it confirms the process for patent certification.

Takeda filed suit against HHS Secretary Sylvia Burwell and FDA Commissioner Margaret Hamburg on Oct. 6 alleging FDA’s approval of...

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