> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Suit Questions FDA Patent Certification Authority
- URL: https://www.fdaweb.com/suit-questions-fda-patent-certification-authority/
- Published: 2022-08-11T12:00:00.000Z
- Updated: 2026-09-14T17:55:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152486

An Avadel CNS Pharmaceuticals suit filed in July challenges FDA’s authority to compel patent certifications when a section viii statement has been submitted. Attorney **Sara Koblitz** (Hyman, Phelps & McNamara) [writes](https://www.thefdalawblog.com/2022/08/new-lawsuit-challenges-fdas-authority-to-compel-patent-certifications/?ref=fdaweb.com) in her firm’s *FDA Law Blog* that the case involves Avadel’s Lumryz, a sodium oxybate drug product citing Jazz Pharmaceuticals’ Xyrem as the reference-listed drug.

Koblitz says Xyrem is listed in the *Orange Book* with multiple patents, including a method-of-use patent describing Jazz’ single, centralized REMS (Risk Evaluation and Mitigation Strategy) drug distribution database.

Avadel intended to use its own REMS with four computer databases, Koblitz writes, and so filed a Section viii statement that the patent “does not claim a use for such drug for which the applicant is seeking approval.”

More than 18 months later, the post says, FDA ordered Avadel to certify to the patent based on its conclusion that the Lumryz REMS use of four computer databases for distribution overlaps with the Jazz patent. Koblitz says Avadel certified to the patent under protest. When Jazz sued Avadel for patent infringement, triggering a 30-month stay, Avadel sued FDA, alleging that the agency violated the Administrative Procedure Act by requiring certification to the patent and delaying final approval.

Koblitz lists Avadel’s arguments, which include challenging the propriety of listing REMS patents in the *Orange Book*. She notes that the agency has been wrestling for several years with questions about what patents should be listed and still has not reached any definitive conclusions.

“If a patent shouldn’t trigger a certification,” Koblitz concludes, “it follows then that that patent shouldn’t be in the *Orange Book*. Thus, it seems that this lawsuit implicitly challenges FDA’s current approach, or lack thereof, to listing in the *Orange Book* (and thereby requiring certification to) patents that don’t explicitly claim the drug substance.”