Supernus Pharmaceuticals, Inc. (Supernus) has filed suit against Riconpharma LLC (Ricon) and Ingenus Pharmaceuticals LLC (Ingenus) over allegations of patent infringement. Supernus produces Oxtellar XR, a product that is protected by a multitude of patents. The plaintiff alleges that nine of these patent laws were violated when Ricon and Ingenus jointly filed for an abbreviated new drug application (ANDA) and failed to adhere to patent policies surrounding the ANDA.
Oxtellar XR, which is patent protected by NDA No. 202810, is an epilepsy drug produced by Supernus that serves as “adjunctive therapy in the treatment of partial seizures in adults and children from 6 to 17 years of age.” Ricon and Ingenus are pharmaceutical companies which develop, manufacture, market, distribute, and sell “generic pharmaceutical products throughout the United States.”
In 2014, Ingenus entered into a merger agreement with Ricon, meaning that presently the companies “work together for the direct benefit of each other.” They filed an ANDA with the FDA in an effort to gain FDA approval to “engage in the commercial manufacture, use, sale, offer for sale, and/or importation into the United States of generic oxcarbazepine extended-release tablets (Ricon Product).” Within the ANDA, Ricon and Ingenus included a “paragraph IV seeking approval before the expiration of patents in suit,” alluding to the patents held by Supernus.
According to the complaint, the law requires ANDA-seeking companies to send a letter “notifying patent holder of the filing of an ANDA containing a paragraph IV certification,” wherein the company must detail “the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed.” They also must justify their belief that the patent is either invalid or unenforceable.
This letter was sent on April 20, but the plaintiffs argued that it did not cover all of the claims in the patent like it is supposed to and also did not include “any detailed statement of the factual and legal basis for Defendant’s opinion that the patents in the suit are unenforceable.”
Ultimately, the plaintiffs said the parties in this suit failed to reach agreement on “mutually acceptable terms for an Offer of Confidential Access.” Supernus is alleging nine counts of infringement for each of the nine violated patents. They are also seeking a judgement declaring that each of the patents in the suit are valid, enforceable and have been infringed on, as well as various damages and monetary relief.The plaintiff is represented by Saul Ewing Arnstein & Lehr.