Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
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.
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 email@example.com
To contact the editor responsible for this story: Nancy Simmons at firstname.lastname@example.org
A copy of the ruling is at http://www.bloomberglaw.com/public/document/SUPERNUS_PHARMACEUTICALS_INC_v_ACTAVIS_INC_et_al_Docket_No_113cv0.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)