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| Item 8.01. | Other Events. |
As previously announced, Vanda Pharmaceuticals Inc. (the “Company”) brought suit in the United States District Court for the District of Delaware (the “Delaware District Court”) against Teva Pharmaceuticals USA, Inc. (“Teva”) and Apotex Inc. (“Apotex”) asserting infringement of patents covering HETLIOZ® (tasimelteon) 20 mg capsules. A trial was held in March 2022. On December 13, 2022, the Delaware District Court ruled that Teva and Apotex did not infringe U.S. Patent No. RE46,604, and that the asserted claims of U.S. Patent Nos. RE46,604; 9,730,910; 10,149,829; and 10,376,487 were invalid. On December 14, 2022, the Company appealed the Delaware District Court’s decision to the United States Court of Appeals for the Federal Circuit (the “Court of Appeals”) and requested an injunction prohibiting market entry by Teva and Apotex while the appeal was pending. On December 16, 2022, the Court of Appeals granted a temporary injunction to prohibit market entry by Teva and Apotex until the Court of Appeals entered its order on the Company’s motion for a stay pending appeal, which would have been January 6, 2023 at the earliest, the date on which the final brief from the parties was due. On December 22, 2022, the Court of Appeals expedited the briefing schedule, such that Teva and Apotex must file their briefs by December 23, 2022 and the Company must file its reply by December 28, 2022, meaning that the temporary injunction could be lifted as soon as December 28, 2022.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: December 22, 2022 | VANDA PHARMACEUTICALS INC. | |||||
| By: | /s/ Timothy Williams | |||||
| Name: Timothy Williams | ||||||
| Title: Senior Vice President, General Counsel and Secretary | ||||||