Hanmi Can Launch 505(b)(2) Nexium Product While Appeal Proceeds, Federal Circuit Says

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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In a Sept. 30 nonprecedential order, the U.S. Court of Appeals for the Federal Circuit said Hanmi could launch its esomeprazole strontium pharmaceutical product while AstraZeneca pursues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.”

AstraZeneca Could Get Damages
In an Oct. 2 press release, AstraZeneca said that if Hanmi were to launch its product during the pendency of Astra's appeal at the Federal Circuit, it could be “at risk of owing AstraZeneca patent-infringement damages” depending on the outcome of the appeal. Moreover, AstraZeneca said, “Hanmi's [505(b)(2) new drug application] esomeprazole strontium product is not AB-rated and is not automatically substitutable for Nexium.”

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.

FDA Approval in August
The Food and Drug Administration Aug. 6 gave final approval to Hanmi's esomeprazole strontium product, but AstraZeneca asked the appeals court to enjoin Hanmi from launching its product while Astra pursued its appeal of the New Jersey district court's claim construction decisions with the Federal Circuit.

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.

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