VANDA PHARMACEUTICALS INC. (NASDAQ:VNDA) Files An 8-K Other EventsItem 8.01.
As previously disclosed, in 2015 Vanda Pharmaceuticals Inc. (the “Company”) filed separate patent infringement lawsuits in the United States District Court for the District of Delaware against Roxane Laboratories, Inc. (“Roxane”), Inventia Healthcare Pvt. Ltd. (“Inventia”), and Lupin Ltd. and Lupin Pharmaceuticals, Inc. (“Lupin”) (collectively, the “Defendants”) seeking an adjudication that the respective Defendants infringed one or more claims of the Company’s U.S. Patent No. 9,138,432 (the “‘432 Patent”) and/or the Company’s U.S. Patent No. 8,586,610 (the “‘610 Patent”) by submitting to the U.S. Food and Drug Administration an Abbreviated New Drug Application for a generic version of Fanapt® prior to the expiration of the ‘432 Patent in September 2025 or the ‘610 Patent in November 2027, as applicable. A trial on these matters was scheduled to begin on May 15, 2017.
On December 15, 2016, following a submission by the parties suggesting that it may be appropriate to remove the May 15, 2017 trial from the District Court’s calendar pending the Federal Circuit decision in Roxane’s appeal of the District Court’s August 25, 2016 ruling finding that Roxane’s proposed products infringed the asserted claims of the ‘610 Patent (as previously disclosed), the District Court removed the May 15, 2017 trial from the calendar and adopted a new schedule for discovery. Additionally, within fourteen days after any decision on the merits in the Roxane appeal, the parties will submit to the District Court a status report and request a schedule for trial. Vanda and Inventia have entered into a confidential stipulation regarding any potential launch date of Inventia’s generic ANDA product. Vanda and Lupin have also entered into a confidential stipulation regarding any potential launch date of Lupin’s ANDA Product.
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