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

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

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.

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