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.
Forward-Looking Statements
Certain statements in this Form 8-K are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include expectations regarding FDA approval of the ANDA, timing of any such approval, and plans to enforce our intellectual property rights and litigation. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from our expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, risks related to regulatory approval, litigation, intellectual property rights and collaborations. Additional factors that could cause actual results to differ materially from those stated or implied by Arena’s forward-looking statements are disclosed in our filings with the Securities and Exchange Commission. These forward-looking statements represent our judgment as of the time of this Form 8-K. We disclaim any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.