Melinta Sues the FDA and HHS for Approving a Generic Drug With an Active Patent

On Monday, Melinta Therapeutics, LLC and Rempex Pharmaceuticals, Inc. filed a complaint in the District of Columbia against the Food and Drug Administration (FDA), Department of Health and Human Services (HHS) and its Secretary Xavier Becerra for granting Nexus Pharmaceuticals, Inc. an Abbreviated New Drug Application (ANDA) for a generic version of Melinta’s flagship drug while their patents are still active.

In 1984, Congress passed the Hatch-Waxman Amendments that required “generic drug companies to notify innovator drug companies of potential patent infringement by a proposed generic drug in order to allow the innovator to protect its patent rights in court before the generic receives FDA approval.” The generic drug company has the option to file a paragraph IV certification that challenges the patent and declares it invalid, but expressly warns the company that this action “constitutes an act of patent infringement.” According to the complaint, Nexus filed an ANDA and a paragraph IV certification claiming that Melinta’s patent was invalid but they “provided no registered or certified-mail return receipt, signature proof of delivery, or letter acknowledging receipt by Melinta at any point before March 31, 2021.”

However, March 31st was too late since the ANDA was filed in December 2020. As a result, Melinta sued Nexus which “statutorily barred from making its approval of Nexus’s application effective until October 1, 2023.” In spite of this, the FDA denied Melinta’s petition and approved Nexus’ ANDA on July 22nd, 2022. Nexus produced a sign letter delivered by Fedex to Melinta signed “A.MELNTA” which the plaintiffs claimed is not legitimate; however the FDA decided that this was “signature proof of delivery.” As a result, Melinta is suing for violations of the Administrative Procedure Act (APA).

Melinta is seeking declaratory relief enjoining the FDA to trigger the 30-month statutory stay, injunctive relief enjoining the FDA to withdraw Nexus’ ANDA and prevent them from selling their product, vacating of all related actions, attorney’s fees and costs, and other relief.

The plaintiffs are represented by King & Spalding LLP.