By Dana A. Elfin
Oct. 2 --In a loss for AstraZeneca AB, a federal appeals court Sept. 30 vacated a temporary injunction order that barred Hamni USA Inc. from entering the market with a version of AstraZeneca's popular heartburn treatment Nexium (AstraZeneca AB v. Hanmi USA, Inc., Fed. Cir., No. 2013-1490, 9/30/13).
In a Sept. 30 nonprecedential order, the U.S. Court of Appeals for the Federal Circuit said Hanmi could launch its esomeprazole strontium pharmaceutical product while AstraZeneca pursues its appeal.
“The party requesting an injunction pending appeal bears the burden of showing that the circumstances justify an exercise of that discretion,” Judge Timothy B. Dyk wrote. “In evaluating whether that burden has been met, this court 'assesses the movant's chances of success on the merits and weighs the equities as they affect the parties and the public.' ,” he continued. In this case, he said, “we conclude based upon the papers submitted that Astra Zeneca has not met the standards for an injunction pending appeal.”
According to the Food and Drug Administration's website, Section 505(b)(2) of the food and drug law expressly permits FDA to rely, for approval of a new drug application, on “data not developed by the applicant--such as published literature or the agency's finding of safety and/or effectiveness of a previously approved drug product.”
Bloomberg BNA Oct. 2 sent Hanmi an email asking whether it planned to launch its product while the appeal proceeds, but did not receive a response.
In July, AstraZeneca filed an appeal with the Federal Circuit, seeking to reverse a December 2012 opinion on claim construction issues issued by the U.S. District Court for the District of New Jersey in the patent infringement litigation.
The briefing schedule in the appeals court case is set, according to the docket, with oral argument yet to be scheduled.
In an Aug. 8 statement, Hanmi said it hoped to become “the sole challenger to Nexium's No. 1 throne in the [United States] market.” In 2012, branded Nexium sales in the United States totaled $6 billion. Nexium is scheduled to go off-patent in May 2014.
In addition to Dyk, Judges Kimberly A. Moore and Richard G. Taranto heard the appeal
AstraZeneca is represented by the law firms of Covington & Burling LLP, in Washington, and Fitzpatrick, Cella, Harper & Scinto, in New York. Hanmi is represented by the law firm of Sughrue Mion PLLC, in Washington; McDermott Will & Emery LLP, in Washington; and Lite, DePalma, Greenberg & Rivas LLC, in Newark, N.J.
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 firstname.lastname@example.org.
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).