By Jeffrey H. Brochin, J.D.
Although the FDA’s approval of Goprelto® provided the manufacturer with a five-year new drug submissionbar, that bar did not prohibit the FDA from approving a competitor’s already-submitted application for Numbrino®.
A federal district court in the District of Columbia has ruled that despite Genus Lifesciences, Inc. (Genus) having been granted FDA exclusivity for five years for a new chemical entity (NCE) and that such exclusivity barred the FDA from accepting competing new submissions, the FDA grant of exclusivity did not bar the agency from approving the application of Lannett Co., Inc. (Lannett) for a new drug whose application was already in the pipeline when Genus’s exclusivity was granted. The court did find, however, that the agency made a legal error, and declined to grant summary judgment to the FDA (Genus Lifesciences, Inc. v AzarSeptember 15, 2020, McFadden, T.).
FDA approval for Goprelto. Under the federal Food, Drug, and Cosmetic Act (FDC Act), the first developer of an NCE—a drug approved for the first time in the United States—receives a coveted period of exclusivity, during which time competing drugs generally cannot can enter the market. In November 2016, Genus submitted a new drug application (NDA) for Goprelto, a cocaine HCI topical solution, and after review of the application, the FDA found it to be sufficiently complete to permit a substantive review and accepted it for filing. The FDA did note however, that it had some concerns about Goprelto’s trials, labeling, and data that Genus would need to address before the FDA could approve the drug. Genus addressed those concerns and the FDA approved Goprelto on December 14, 2017.
Lannett’s overlapping application. While the FDA was conducting a substantive review of Genus’s application, Lannett submitted its application for its cocaine HCI topical solution, Numbrino. On November 29, 2017—15 days before approving Goprelto—the FDA filed Lannett’s application, conducted a substantive review of Lannett’s application, and issued Lannett a CRL letter describing deficiencies and recommendations for placing the application in condition for approval. Genus filed two citizen petitions, urging the FDA to rescind its acceptance of Lannett’s application or to stop accepting additional submissions from Lannett, given Genus’s NCE exclusivity, however, the FDA denied both petitions, and approved Numbrino in January 2020. Genus then filed the instant lawsuit.
The meaning of "exclusivity." The court determined that the main issue before it was deciding the breadth of an NCE exclusivity period. Genus argued that the FDA’s decision to approve Numbrino violated the FDC Act and its own regulations, and that the FDA applied inconsistent standards of review to Genus’s and Lannett’s NDAs. It further argued that the FDA infringed on its NCE exclusivity period when it approved Numbrino, and that under the FDC Act, it was entitled to a five-year period of complete market exclusivity, barring all approval and submission of applications for competing drugs. Both the FDA and Lannett countered that while Genus’s exclusivity period prohibited the FDA from accepting any NDAs for a competing drug, NCE exclusivity did not bar it from approving applications, like Lannett’s, that were already in the approval process.
NCE exclusivity does not bar approvals. The court agreed with the FDA that Genus’s NCE exclusivity did not cover approvals, however, it disagreed with the agency’s reasoning. The FDC Act prescribes timelines for approval of applications such as Lannett’s based on the type of patent certification in the application, and the agency admitted that it disregarded those timelines. The court found that the FDA misinterpreted the FDC Act, but then proceeded to reach the same conclusion via a different reading of the Act. The court noted that the Act, on its face, never provided that an application submitted under FDC Act §505(b)(2) may not be approved before the expiration of five years, rather it only barred competing NDA submissions.
No closing of Congress’s loophole. The only mention of approval in the FDC Act was that approval of an application such as Lannett’s had to be made effective in accordance with the referenced paragraph, and as the FDA and Lannett noted, that provision was significant. Congress could have easily expressly barred approvals, but it did not. For the court to more broadly interpret the Act’s provisions, would be to undermine Congress’s intent. Perhaps the FDC Act’s language provided Lannett and the FDA with a loophole, but if so, it was not the court’s loophole to close, rather, their role was strictly to interpret the language of the statute enacted by Congress, not to improve upon it.
Based on the foregoing reasons, the court concluded that the FDA correctly determined that Genus’s exclusivity period did not bar it from approving Numbrino, but by misinterpreting the approval clause of the FDC Act, the agency failed to provide a reasoned explanation to the court for when Lannett’s application could properly be approved under the Act. The court denied summary judgment for the FDA and Lannett and granted it, in part, to Genus.
The case is No.: 1:20-cv-00211-TNM.
Attorneys: Andrew D. Prins (Latham & Watkins LLP) for Genus Lifesciences, Inc. Kathleen Braun Gilchrist, U.S. Department of Justice, for Alex M. Azar, II.
Companies: Genus Lifesciences, Inc.
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