Following an August 6, 2018 oral argument, the United States Court of Appeals for the Federal Circuit on September 6, 2018 unanimously affirmed the District of New Jersey's August 15, 2017 ruling that TWi Pharmaceuticals, Inc. and TWi International LLC (dba TWi Pharmaceuticals USA) infringed three patents owned by Haug Partners' client Supernus Pharmaceuticals, Inc. by seeking permission from FDA to market a generic version of Oxtellar XR® before the expiration of Supernus's patents. The Federal Circuit's judgment also confirms that Supernus's Oxtellar XR® patents are valid over multiple invalidity grounds argued by TWi. Oxtellar XR®—Supernus's once-a-day oxcarbazepine tablets used to treat partial seizures in adults and children—is one of two products marketed by Supernus, a Rockville, Maryland-based specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system disorders. This appellate victory should enable Supernus to realize the full value of its Oxtellar XR® patents, which the FDA's Orange Book lists as expiring on April 13, 2027.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
