Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....
By Dana A. Elfin
Jan. 26 — Amarin Corp. Plc said in a Jan. 25 securities filing that a federal district court granted the company's request to dismiss all patent infringement litigation related to abbreviated new drug applications (ANDAs) filed with the FDA to market generic copies of its lipid treatment Vascepa (icosapent ethyl capsules).
The court no longer had jurisdiction to hear the patent litigation because the Food and Drug Administration had changed the status of the generic filers' applications, Judge Mary L. Cooper of the U.S. District Court for the District of New Jersey said in a Jan. 22 unpublished opinion.
“There is nothing for this Court to adjudicate because the ANDA litigation process cannot proceed without the existence of a ‘received' ANDA,” Cooper wrote. “Therefore, this Court must grant the Motion to Dismiss because it lacks the authority to adjudicate the Consolidated Actions for want of an ANDA having been deemed as ‘received' by the FDA.”
Ireland-based Amarin sought dismissal of patent litigation it had filed against six different generic companies—including Apotex, Inc., Andrx Labs, LLC, Dr. Reddy's Laboratories, Inc., Roxane Laboratories, Inc., Teva Pharmaceuticals USA Inc. and Watson Laboratories, Inc.—on the grounds that the change in the generic applications' status to submitted but not accepted meant the court no longer had jurisdiction to hear the consolidated cases.
The grant of dismissal is advantageous for Amarin because the generic company defendants will have to restart the ANDA notification and litigation process, and that will further delay the onset of any generic competition to Vascepa. An appeal of the court's decision can be filed within 30 days.
In June 2015, the FDA changed the status of the Vascepa ANDAs to submitted but no longer accepted. The change in status followed a ruling from the U.S. District Court for the District of Columbia setting aside the FDA's decision to deny five-year, new chemical entity (NCE) exclusivity for Amarin's Vascepa (13 PLIR 798, 6/5/15).
NCE exclusivity protects pioneer drug companies from generic competition for five years after FDA approval of an eligible pioneer drug. It also prevents generic competitors from challenging the pioneer drug companies' patents for four years after FDA approval.
In 2014, Amarin had sued the FDA in the U.S. District Court for the District of Columbia, seeking to overturn its denial of a NCE exclusivity period for Vascepa (12 PLIR 299, 3/7/14).
In May 2015, Judge Randolph D. Moss vacated the FDA's denial of marketing exclusivity for Vascepa and remanded the exclusivity matter back to the FDA for proceedings consistent with his decision. However, the agency hasn't yet made a new exclusivity determination for Vascepa, Amarin said in its Jan. 25 8-K securities filing with the Securities and Exchange Commission.
Cooper addressed the exclusivity issue in her opinion.
Dismissing any pending counterclaims in the consolidated actions without prejudice, she wrote that any “counterclaims would be without merit until the FDA ultimately determines whether the exclusivity period for Vascepa should be three years or five years.”
Amarin NCE exclusivity would protect Vascepa through July 25, 2017, and Amarin has said that it would try to protect Vascepa until beyond 2030 with its patent portfolio.
The firms of Covington & Burling LLP in Washington and Robinson Miller LLC in Newark, N.J., represented Amarin in the now-dismissed patent litigation.
To contact the reporter on this story: Dana A. Elfin in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Allison Gatrone at email@example.com
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).
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 email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)