Vanda Pharmaceuticals filed two separate complaints on Wednesday in the District of Delaware against MSN Pharmaceuticals and Apotex, alleging infringement of Vanda’s patent for sleep-wake disorder drug Hetlioz.
Vanda holds new drug application No. 205677 for Hetlioz and owns U.S. Patent No. 10,829,465 for the compound in Hetlioz, tasimelteon, issued on Nov. 10, 2020. The plaintiff claimed that both MSN and Apotex filed abbreviated new drug applications (ANDAs) for the generic compound before the expiration of Vanda’s patent, as stated in written notices sent by Apotex and MSN on Jan. 14 and 21, respectively. The defendants’ notices both claimed that “the ’465 patent is invalid, unenforceable, and/or will not be infringed” by the defendants’ ANDA products.
The plaintiff disagreed, arguing that both of the companies’ products knowingly infringe on the Hetlioz patent and that the defendants’ “opinion(s) regarding the invalidity and noninfringement of the ’465 patent (are) devoid of an objective good faith basis in either the facts or the law,” according to Vanda.
“Vanda will be irreparably harmed” if the defendants are “not enjoined from infringing or actively inducing or contributing to infringement of one or more claims of the ’465 patent,” according to the plaintiff.
Vanda is seeking declarations that the defendants’ ANDA products infringe on the patent-in-suit, an order stating that the effective date of any approval by the Food and Drug Administration of the ANDA products be no earlier than the expiration date of the patent-in-suit, and injunctive relief barring anyone acting to manufacture, market, sell, and distribute the ANDA products from doing so, among other relief.
Morris, Nichols, Arsht & Tunnell is representing Vanda.