- Acumen Powered by Robins Kaplan LLP®
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Entertainment and Media Litigation
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Fiduciary Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
March 26, 2024Ronald Schutz, Brendan Johnson Named to Forbes Top 200 Lawyers in the United States
-
March 21, 2024Robins Kaplan Firm Members Appointed to Law360 Editorial Boards
-
March 20, 2024Brandon Vaughn Inducted into The International Society of Barristers
-
April 5, 2024Mass Torts Made Perfect
-
April 17, 2024American Antitrust Institute Virtual CLE Lunch & Learn
-
May 2-3, 2024ACI Advanced Forum on Managed Care Disputes and Litigation
-
March 14, 2024How Many Cases Have You Tried to a Verdict?
-
March 2024Do We Have to Share That Information? Attorney-Client Privilege in the Multi-Entity Context
-
March 2024Sellers of a Business: Know Thyself.
-
September 16, 2022Uber Company Systems Compromised by Widespread Cyber Hack
-
September 15, 2022US Averts Rail Workers Strike With Last-Minute Tentative Deal
-
September 14, 2022Hotter-Than-Expected August Inflation Prompts Massive Wall Street Selloff
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
Amarin Pharma, Inc. v. Apotex, Inc.
ANDA must be “received” by FDA for district court litigation to proceed.
April 07, 2016
Case Name: Amarin Pharma, Inc. v. Apotex, Inc., Civil Action No. 14-2250 (MLC), 2016 U.S. Dist. LEXIS 7555 (D.N.J. Jan 22, 2016) (Cooper, J.)
Drug Product and Patent(s)-in-Suit: Vascepa® (icosapent ethyl); U.S. Patents Nos. 8,293,728 (“the ’728 patent”), 8,318,715 (“the ’715 patent”), 8,357,677 (“the ’677 patent”), 8,367,652 (“the ’652 patent”), 8,377,920 (“the ’920 patent”), 8,399,446 (“the ’446 patent”), 8,415,335 (“the ’335 patent”), 8,426,399 (“the ’399 patent”), 8,431,560 (“the ’560 patent”), 8,440,650 (“the ’650 patent”), 8,501,225 (“the ’225 patent”), 8,518,929 (“the ’929 patent”), 8,524,698 (“the ’698 patent”), 8,546,372 (“the ’372 patent”), 8,551,521 (“the ’521 patent”), and 8,617,594 (“the ’594 patent”)
Nature of the Case and Issue(s) Presented: Amarin owns various patents that cover Vascepa, which is used to reduce triglyceride levels in adults. Amarin brought suit against the Defendants asserting that the Defendants infringed those patents by seeking approval to sell generic Vascepa. The Defendants moved to dismiss the claims against them for a lack of case or controversy because the FDA had not deemed any of the related ANDAs to be “received.” The court agreed and dismissed the case.
Why Defendants Prevailed: The FDA originally issued a determination providing for a three-year exclusivity period for Vascepa, and then accepted ANDAs from the Defendants. Subsequently, the District Court for the District of Columbia vacated the determination and remanded to the FDA. On remand, the FDA ruled that a five year exclusivity period was more appropriate, and advised the Defendants that it considered their ANDAs submitted, but not yet “received.”
The Court granted the Defendants’ motion to dismiss based on the fact that the ANDAs were not deemed “received” by the FDA. Indeed, the court ruled that the ANDA litigation process cannot even begin until the corresponding ANDA is “received” by the FDA, not merely delivered or submitted to the FDA. Thus, the court was required to dismiss the case because it lacked the authority to adjudicate the matter.
Related Publications
Related News
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.