Supreme Court Refuses to Hear Patent Challenges From Daiichi Sankyo, Mylan
The U.S. Supreme Court has refused to hear patent infringement cases brought by two drugmakers against Apotex, paving the way for the Canadian company to produce a generic version of Benicar.
In a Nov. 9 order, the high court denied petitions from Daiichi Sankyo and Mylan Pharmaceuticals, both of which alleged patent infringement in an effort to bar Apotex from developing a generic version of the popular hypertension drug. The court did not give an explanation for denying the petitions, which sought to overturn an April panel ruling by the U.S. District Court for the Federal Circuit in Apotex’s favor.
The case stems from a 2012 lawsuit Apotex filed trying to circumvent patent protection rules established under Hatch-Waxman that granted Mylan 180 days of marketing exclusivity after it challenged Daiichi Sankyo’s patent on Benicar (olmesartan medoxomil). Daiichi Sankyo responded by disclaiming the challenged patent in an effort to contend that Mylan and Apotex lacked grounds to file suit.
A district court sided with Daiichi Sankyo in the dispute, but the federal circuit panel overturned that decision in April. Both Daiichi Sankyo and Mylan requested a rehearing in front of the full federal circuit, but were rebuffed.
Apotex already has tentative FDA approval to produce a generic of Benicar.