Oxcarbazepine – USA

On Aug. 15, 2017, Judge Renée Marie Bumb of the United States District Court for the District of New Jersey issued an opinion ruling that TWi Pharmaceuticals, Inc. infringed three patents owned by Supernus Pharmaceuticals, Inc. by seeking permission from FDA to market a generic version of Oxtellar XR® before the expiration of patents. U.S. District Judge also rejected all invalidity claims brought by TWi Pharmaceuticals.

Supernus Inc. holds an approved New Drug Application ("NDA") for Oxtellar XR® (Oxcarbazepine) extended-release tablets in 150, 300 & and 600 mg dosage strengths, Oxtellar XR® was approved by the United States Food and Drug Administration ("FDA") in October 2012 for the treatment of partial seizures in adults and children. There are total 07 patents listed in orange book (OB) expiring in Apr 2027.

TWi Pharmaceuticals filed Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of Oxtellar XR®.  On Jan 16, 2015 Supernus sued TWi in New Jersey District Court. Following a four-day bench trial on Apr 06, 2017, the New Jersey  district court ruled that TWi Pharmaceuticals, Inc. and its subsidiary infringed U.S. Patent Nos. 7,722,898, 7,910,131, and 8,821,930. In addition to the three patents that were the subject of the District Court’s decision, Oxtellar XR® is further protected by four other patents that are also listed in the Orange Book.

In another case with generic drug maker Actavis, the New Jersey district court issued its 136 page Opinion on February 5, 2016 concluding that Actavis product infringed two of the patents (7,722,898 and 7,910,131); it did not infringe the third (8,617,600). In addition, the Court concluded that all of the patents were valid, overcoming defenses of obviousness, written description, and indefiniteness. Actavis promptly appealed & in Dec 2016 the Court of Appeals affirmed without opinion.