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# DC Court Rules Against FDA in 5-year Exclusivity Decisions
- URL: https://www.fdaweb.com/dc-court-rules-against-fda-in-5-year-exclusivity-decisions/
- Published: 2016-09-12T12:00:00.000Z
- Updated: 2026-09-14T21:31:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136775

The Washington DC District Court has [ruled](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=5&cad=rja&uact=8&ved=0ahUKEwj4-aP8lYrPAhVCNiYKHYHmBoUQFgg6MAQ&url=http%3A%2F%2Flaw.justia.com%2Fcases%2Ffederal%2Fdistrict-courts%2Fdistrict-of-columbia%2Fdcdce%2F1%3A2015cv00802%2F172019%2F60%252) against FDA in granting a Ferring motion for reconsideration over how FDA decided not to retroactively apply a 2014 interpretation on five-year new chemical entity (NCE) exclusivity awarded to certain fixed-combination drug products ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5130089&searchWords=fixed-combination&cate=S&stid=%241%243m0.Of0.%24yFPVaPpyomyBjtVzPmWe8.&ref=fdaweb.com)). An agency [guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM386685.pdf?ref=fdaweb.com) outlined the change, and noted that in the past, combination drug products were barred from obtaining five-year exclusivity if they contained a previously approved active moiety, even if the product also contained a new active moiety. Under the new interpretation, a five-year NCE exclusivity determination will be made for each drug substance in a drug product, not for the drug product as a whole.

Ferring’s complaint said FDA’s new position is the correct one, but the problem is that it “prospectively” applied this to drugs approved after its decision. “That line-drawing excluded a few drugs from receiving the benefit of FDA’s shift in position,” the company said. “One of them was Prepopik. FDA’s decision to continue to apply its erroneous construction of the statute to only a handful of approved drugs, while simultaneously announcing its decision to apply the statute correctly for all pending and future new drug applications, was erroneous, arbitrary, capricious, an abuse of discretion, and not in accordance with law.”

In granting Ferring’s motion, the court said the “relevant point is that certain drug substances received a five-year period of marketing exclusivity — in which later fixed-combination drug products that included those drug substances were able to share, as a consequence of the umbrella policy — while others were denied thes ame marketing exclusivity period because a fixed-combination drug product was approved first. And the FDA fails to provide a ‘legitimate reason’ for treating those drug substances differently from ones that were first approved in their single-entity forms... If a drug substance is sufficiently novel to warrant protection under a five-year exclusivity period — and sufficiently novel that other products containing that drug substance should also be protected through the umbrella policy — it is not apparent why timing, or the order in which the drugs were approved, should alter that assessment.” It added that the agency failed to offer any scientific, technical, economic, or other explanation for why Congress would intend market exclusivity to depend on the temporal sequence in which applications were approved.

The court remanded the action to FDA for further proceedings that will be consistent with its opinion.