Mallinckrodt Pharmaceuticals Sues Zydus Pharmaceuticals and Cadila Healthcare for Patent Infringement

On Monday, Mallinckrodt Pharmaceuticals Ireland Limited filed a lawsuit in the District of New Jersey against Zydus Pharmaceuticals, Inc. and Cadila Healthcare Limited alleging patent infringement. 

According to the complaint, Mallinckrodt is an Irish company and the assignee of four U.S. patents for “Reduced Dose Intravenous Acetaminophen.” The complaint states the four patents were legally issued by USPTO between 2016 and 2019. Additionally, the complaint purports that the patents-in-suit are used in Mallinckrodt’s new drug Ofirmev and listed in the Food and Drug Administration’s (FDA) s required publication.According to Mallinckrodt, the drug is the first intravenous formulation of acetaminophen available in the United States and approved by the FDA. 

The complaint states Zydus is a New Jersey corporation and a wholly-owned subsidiary of Cadila Healthcare, an entity organized and existing under the laws of India. Further, the complaint alleges that the defendants submitted an Abbreviated New Drug Application (ANDA) seeking approval from the FDA to commercially manufacture and sell a generic version of Ofirmev in the United States. 

Mallinckrodt states it became aware of the defendants’ ANDA product on February, 7 2022, when Zydus sent Mallinckrodt a Notice Letter regarding its ANDA and use of the patents-in-suit. Mallinckrodt states it commenced the present action within 45 days of receiving the Notice Letter from Zydus. 

Mallinckrodt alleges that the defendants’ generic version of Ofirmev infringes on its patents-in-suit and argues that the defendants’ ANDA cannot be approved until the latest expiration date of each of the patents-in-suit. Additionally, Mallinckrodt alleges that the defendants were and are aware that their ANDA application and any commercial manufacture, use, offer for sale, or sale within the United States of its generic Ofirmev product constitutes patent infringement. 

The plaintiff states it will be irreparably harmed by the defendants’ infringing activities and therefore brings the present suit with a single count of patent infringement. The plaintiff seeks declaratory, injunctive and monetary relief along with attorney’s fees and costs. The plaintiff is represented by Saul Ewing Arnstein & Lehr LLP