Supernus Wins Oxtellar XR Patent Litigation

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By Dana A. Elfin

Feb. 8 — A federal judge's ruling in patent litigation over Supernus Pharmaceuticals Inc.'s anticonvulsant drug Oxtellar XR likely means that Supernus will be able to protect the lucrative franchise from generic competition until 2027, Supernus President and Chief Executive Officer Jack Khattar told Bloomberg BNA Feb. 8.

In a 136-page opinion, Judge Renee Marie Bumb of the U.S. District Court for the District of New Jersey on Feb. 5 ruled that Actavis Inc.'s application to make a generic version of Oxtellar XR before Supernus's patents covering the drug expire infringed two Supernus patents that don't expire until 2027.

The judge also ruled that the patents were valid.

Unless Actavis successfully appeals Bumb's ruling, generic versions will be blocked from entering the market until 2027, Khattar told Bloomberg BNA in a Feb. 8 telephone interview.

“This victory should enable Supernus to realize the full value of its Oxtellar XR patents,” Nicholas F. Giove, of Frommer Lawrence & Haug LLP in New York, who represents Supernus, told Bloomberg BNA in a Feb. 8 e-mail.

Oxtellar XR, a medication used to treat epilepsy and seizures in adults and children, is one of two products Supernus markets, Giove said.

In 2014, net product revenue for Oxtellar XR totaled $24.7 million. Year-end figures for 2015 won't be released until March, Khattar said.

Patent Infringement

After a seven-day bench trial, Bumb ruled Feb. 5 that Actavis's application to make a generic version of Oxtellar XR before Supernus's patents expired infringed two of Supernus's patents, U.S. Patent Nos. 7,722,898 (modified-release preparations containing oxcarbazepine and derivatives thereof) and 7,910,131 (method of treating seizures using modified release formulations of oxcarbazepine). Those patents don't expire until April 13, 2027.

Bumb also ruled that those patents and a third patent, U.S. Patent No. 8,617,600 (the '600 patent) (modified release preparations containing oxcarbazepine and derivatives thereof) are valid. The '600 patent also expires April 13, 2027.

“We are pleased with the court's ruling that Actavis will infringe two of our patents on Oxtellar XR, and the finding that all three patents are valid,” Khattar said in a company statement issued Feb. 8.

Supernus said that there are two additional patents listed in the Food and Drug Administration's Orange Book that also protect Oxtellar XR.

The Orange Book (formally titled “Approved Drug Products with Pharmaceutical Equivalence Evaluations”) is a listing of patents that innovator drug companies claim cover their drug products.

The law firms of Frommer Lawrence & Haug LLP in New York and Saul Ewing LLP in Newark, N.J., represented Supernus.

The law firms of Holland & Knight, New York, and Connell Foley LLP in Newark, N.J., represented Actavis.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Nancy Simmons at nsimmons@bna.com