Dr. Reddy's Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that On February 14, 2017, the United States District Court for the District of New Jersey issued its opinion regarding Helsinn Healthcare's patent infringement claims against Dr. Reddy's Laboratories' proposed palonosetron product, pursuant to a "paper" NDA under Section 505(b)(2) of the Food, Drug and Cosmetic Act.
The court found that Dr. Reddy's proposed palonosetron hydrochloride 0.25 mg / 5 ml product infringes certain claims of U.S. Patent Nos. 7,947,724, 8,729,094 and 9,066,980, and that the asserted claims of the 094 and 980 Patents were not invalid.
A company spokesperson stated "We are disappointed in the decision and intend to pursue an appeal in due course."
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