Following two-and-a-half years of litigation, a four-day bench trial, and extensive post-trial briefing, Judge Renée Marie Bumb of the United States District Court for the District of New Jersey issued an 87-page opinion ruling that TWi Pharmaceuticals, Inc. and its subsidiary 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. As part of the ruling, Judge Bumb rejected all invalidity arguments advanced by TWi.

Oxtellar XR®-Supernus’s once-a-day antiepileptic drug 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 is the second generic challenger to Supernus’s Oxtellar XR® franchise fended off by Haug Partners. In a February 2016 decision-affirmed by the Federal Circuit in December 2016-Judge Bumb found that Actavis and its subsidiaries infringed two of the same Supernus patents. We are particularly pleased that we could help Supernus protect this important franchise against a second round of generic infringement. This victory will 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 Court’s opinion is currently sealed but we will attach the public version once it is available.

To read the Law360 article, please click here.