June 27, 2017

US District Court rejects Dr Reddy's Laboratories patent

17 February 2017, 11:59 | Melvin Schneider

Dr Reddy's said it did not infringe three of the claims, adding that the remaining ten were invalid but that it would have infringed them should they be found valid. The Swiss company said these drug makers infringed its patent by filing a new drug application and abbreviated new drug application with the regulator to market and sell generic versions of Aloxi, used to prevent nausea and vomiting in chemotherapy patients.

The pharmaceutical company has declared that the United States District Court for the District of New Jersey issued its opinion regarding Helsinn Healthcare patent infringement.

Drug major Dr Reddy's Laboratories on Friday said there are no claims against the company for monetary damages after it received an unfavourable ruling in a U.S. court regarding a patent infringement case over anti-nausea injection Aloxi. "7,947, 8,729,094 and 9,066,980, and that the asserted claims of '094 patents were not valid". "Helsinn Healthcare filed an infringement claims against DRL's proposed palonosetron product, pursuant to a 'paper" NDA under section 505 (b) (2) of the Food, Drug and Cosmetic Act.

The drug is estimated to have a market size of almost $500 million in the U.S., Surajit Pal, analyst, Prabhudas Lilladher told BloombergQuint.

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A favourable ruling would have allowed Dr. Reddy's to replace the patented drug, which has an estimated size of $650 million in the US market, say analysts.

The company said it intends to pursue an appeal in due course of time. Later, DRL received an approval from the USFDA for generic Aloxi in March 2016 after it settled patent litigations relating to its anti-nausea injection Aloxi.

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