Orexo Claims Competitor Infringed Its Pharmaceutical Patents for Opioid Dependency Medication

Orexo AB and Orexo US, Inc filed a lawsuit against Sun Pharmaceutical Industries Limited, Sun Pharma Global FZE, and Sun Pharmaceutical Industries, Inc. alleging the company infringed its patents for Zubsolv, a drug designed to treat opioid dependency. 

The lawsuit, which was filed last Friday in the District of New Jersey, follows Sun’s filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA). The plaintiffs claimed that Sun is seeking approval to produce and market a generic version of their medication, Zubsolv, prior to the expiration of the patents protecting it.

Zubsolv is reportedly a unique medication that comes in tablet form, and the tablets are intended “for the maintenance treatment of opioid dependence and for the induction of buprenorphine maintenance therapy in patients suffering from opioid dependence.” The United States Patent and Trademark Office issued two patents to Orexo protecting the manufacturing and marketing of Zubsolv.

According to the complaint, Sun filed an ANDA with the FDA requesting “approval to engage in the commercial manufacture, use, sale, offer for sale, or importation into the United States of Sun’s ANDA Products before the Patents-in-suit expire.” The plaintiffs explained that this is indicative of their intentions with their product if they do gain approval. Sun also gave a written claim to the FDA, citing that the patents protecting Zubsolv are invalid, unenforceable, “and/or will not be infringed by the activities described in Sun’s ANDA.”

The defendant additionally provided two notice letters to the plaintiff communicating their belief that none of the patents-in-suit would be infringed by the subsequent activities by Sun. The letters informed the plaintiff of Sun’s intent to seek approval to market the products pending in the ANDA.

Ultimately, the plaintiffs argued that the ANDA did constitute infringement of both of its patents for Zubsolv, and that it led to this lawsuit against Sun. In addition to a favorable judgement regarding patent infringement, Orexo is seeking a permanent injunction enjoining Sun from infringing the patents prior to their expiration, a judgement that the patents are valid and enforceable, litigation costs, and any other relief deemed proper by the Court.The plaintiffs are represented by Gibbons P.C.