- 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
-
April 23, 2024David Martinez Recognized Among Top 100 Lawyers in Los Angeles by LA Business Journal
-
April 15, 2024Robins Kaplan Named to 2024 BTI Client Service A-Team
-
April 9, 2024Robins Kaplan LLP Files Complaint Against Social Media Giants Meta, Snap, TikTok on Behalf of Spirit Lake Nation, Menominee Indian Tribe of Wisconsin
-
April 30, 2024Navigating Generational Dynamics
-
May 2-3, 2024ACI Advanced Forum on Managed Care Disputes and Litigation
-
May 6, 2024Litigating with the Legends
-
March 2024e-Commerce: Pitfalls and Protections
-
March 22, 2024‘In re Cellect’:
-
March 14, 2024How Many Cases Have You Tried to a Verdict?
-
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.
Ferring Pharms., Inc. v. Burwell
FDA’s prior practice of refusing to grant five-year exclusivity to fixed-combination drug products containing a novel active drug substance was arbitrary and capricious.
October 25, 2016
Case Name: Ferring Pharms., Inc. v. Burwell, Case No. 15-0802 (RC), 2016 U.S. Dist. LEXIS 121826 (D.D.C. Sept. 9, 2016)
Drug Product and Patent(s)-in-Suit: Prepopik® (sodium picosulfate, magnesium oxide, anhydrous citric acid); N/A
Nature of the Case and Issue(s) Presented: Ferring sought a five-year exclusivity period for Prepopik because one of its constituent drugs, sodium picosulfate, had never been approved in a NDA. The FDA denied Ferring’s request because Prepopik also included other active ingredients that had previously been approved in other drug products. The FDA subsequently changed its interpretation of the law permitting a five-year exclusivity period for fixed-combination drug products consisting of novel drug substances as well as previously approved drug substances. The FDA also determined, however, that its new interpretation did not apply retroactively. Ferring challenged the FDA’s refusal to apply the new interpretation retroactively as arbitrary and capricious. The District Court for the District of Columbia found that the FDA’s prior interpretation was reasonable, but instructed the parties to file motions for summary judgment addressing the retroactivity issue. Ferring moved for reconsideration of the district court’s finding, which the court granted.
Why Ferring Prevailed: The court granted Ferring’s request for reconsideration. To support its arguments that reconsideration should be granted, and that the FDA’s prior interpretation was arbitrary and capricious, Ferring cited to three examples in which, like Prepopik, a novel drug was included in a fixed-combination drug product with other drug substances that had previously been approved and received exclusivity. In each of those instances, like Prepopik, the FDA did not provide five-year exclusivity to the fixed-combination drug. Subsequently, when a single-entity version of the novel drug substance was approved, the substance did not receive five-year exclusivity because it had previously been approved as part of the fixed-combination drug. Effectively, under this scheme, the novel drug substance was never able to receive the benefit of five year exclusivity if the fixed-combination product was approved first. If the single entity product was approved before the fixed-combination product, however, the single entity product was entitled to five year exclusivity.
The FDA was unable to present any “legitimate reason” for why it treated the single-entity and fixed-combination products differently. Because the FDA was treating similar drugs in a dissimilar manner based only on the order of approval, the court determined that Ferring’s motion for summary judgment that it was entitled to five year exclusivity should have been granted. Thus, the FDA’s prior interpretation was arbitrary and capricious.
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.