New 8k $ARNA and Eisai file patent infringement lawsuit against Lupin Limited.
Item 8.01 Other Events.
We and Eisai Inc. (Eisai) filed a patent infringement lawsuit against Lupin Limited and Lupin Pharmaceuticals, Inc. in the U.S. District Court for the District of Delaware in response to a “Paragraph IV certification” notification received from Lupin Limited in August 2016. The notification advised that Lupin Limited submitted an abbreviated new drug application (ANDA) requesting approval to engage in the commercial manufacture, use, importation, offer for sale or sale of a generic version of BELVIQ® (lorcaserin hydrochloride tablets, 10 mg).
The lawsuit claims infringement of U.S. Patent Nos. 6,953,787; 7,514,422; 7,977,329; 8,207,158; 8,273,734; 8,546,379; 8,575,149; 8,999,970 and 9,169,213. In accordance with the Hatch-Waxman Act, as a result of filing a patent infringement lawsuit within 45 days of receipt of Lupin Limited’s notification, the FDA cannot approve the ANDA any earlier than 7.5 years from NDA approval unless a District Court finds that all of the asserted claims of the patents-in-suit are invalid, unenforceable or not infringed.
While we and Eisai plan to vigorously enforce our intellectual property rights, we cannot predict the outcome of any litigation matter.
