US-based drug maker Bristol-Myers Squibb Company has filed patent infringement case against Dr Reddy's Laboratories (DRL) over the cancer drug Ixempra. Bristol-Myers in its petition filed in the United States District Court of New Jersey alleged that the Indian drug maker has infringed the patents of its drug on three counts.
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According to the petition, by a letter dated November 13, 2012, DRL notified Bristol-Myers that the Indian drug major had submitted Abbreviated New Drug Application (ANDA) concerning its proposed drug product of Ixabepilone for injection, as required by the FDA rules.
DRL's letter further notified that Ixabepilone injection patents are invalid and or will not be infringed by the commercial manufacture, use, offer for sale, or sale of DRL's ANDA product, the petition said.
Ixempra, used in the treatment of metastatic or locally advanced breast cancer in patients after failure of an anthracycline and a taxane (chemotherapy agents) has nearly USD 120 million sales, according to market reports. When contacted, a DRL spokesperson said, "Our intellectual properties (IP) teams keep working on patent infringement cases and engage in related legal activities."
"A permanent injunction enjoining DRL, its affiliates and subsidiaries, and all persons and entities acting in concert with DRL from commercially manufacturing, using, offering for sale, or selling DRL's ANDA product within the US .. until the expiration of the '384 ( 330, 393 ) patent..." Bristol Myers urged the court.
Besides, the US drug maker requested the court to award damages or other relief if DRL engages in commercial manufacture or sale of DRL's Abbreviated New Drug Application product, or any product that infringes the patents of the drug.