A suit was filed in the District of Delaware by plaintiff Hope Medical Enterprises, Inc. against defendants Accord Healthcare, Inc. and Intas Pharmaceuticals LTD on Tuesday. The complaint for patent infringement pertains to the plaintiff’s product, Sodium Thiosulfate Injection.
The defendants recently submitted an abbreviated new drug application, or ANDA, with the FDA in which they sought approval to manufacture and market a generic version of the plaintiff’s Sodium Thiosulfate Injection product prior to the expiration of the four patents (patents-in-suit) protecting the product.
The FDA approved the plaintiff’s new drug application for their Sodium Thiosulfate Drug was approved in 2012 for “sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening.” The plaintiff’s product is covered under each of the patents-in-suit. All four of the patents-in-suit are listed in the FDA’s orange book, or their Approved Drug Products with Therapeutic Equivalence Evaluations publication.
The defendant informed the plaintiff of their ANDA filing through a notification letter dated June 13, 2022. They explained their intent to produce and sell a generic version of the plaintiff’s Sodium Thiosulfate Injection product upon obtaining FDA approval. Within the letter, the plaintiff explains that the defendant acknowledged the presence of the plaintiff’s product as a reference listed drug for their ANDA, meaning that the two products are bioequivalent.
The letter also alleged that the claims of the patents-in-suit were either invalid, unenforceable, and would not be infringed when the defendant took their ANDA product further after obtaining FDA approval.
The plaintiff contends that if their ANDA is approved and they begin to manufacture and market the ANDA product, the defendant will infringe upon the patents-in-suit, whose claims are both valid and enforceable.
The complaint cites four counts of infringement. The plaintiff is seeking favorable judgment on each count, an order that the ANDA product will not be produced until the expiration of the patents-in-suit, an injunction preventing further infringement, damages in the event that the defendant goes forward with the ANDA product, and more.
The plaintiff is represented by Ashby & Geddes.
