FTC files amicus brief challenging REMS patent listings in FDA’s Orange Book

Regulatory NewsRegulatory News | 14 November 2022 |  By 

The US Federal Trade Commission (FTC) has filed an amicus brief in US District Court in Delaware arguing against listing patents on pharmaceutical distribution systems in the Food and Drug Administration’s (FDA) Orange Book.
The amicus brief relates to the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals, an ongoing legal battle in which Jazz is alleging that Avadel infringed on its patent for the distribution system of the narcolepsy drug Xyrem under a risk evaluation and mitigation strategy (REMS). Avadel is seeking FDA approval of its own narcolepsy drug, Lumryz, and is countersuing Jazz in an effort to delist the Xyrem distribution patent (known as the ’963 patent) from the Orange Book on the basis that it does not claim Xyrem or a method for using it. In the meantime, the patent infringement suit triggered a 30-month stay on FDA’s approval of Lumryz under the Hatch-Waxman framework.
The FTC amicus brief takes “no position on the specific scope of Jazz’s ’963 patent” but asserts that, in general, patents that claim only a pharmaceutical distribution system do not meet the Orange Book criteria, which allows listing of patents that claim either a drug or a method of using a drug. “Thus, to the extent that the ’963 patent claims a REMS distribution system for dispensing a drug (not a method of using that drug), it should be delisted,” the FTC wrote in the amicus brief.
The FTC argues that a distribution system patent does not qualify for Orange Book listing because it is not a method for using the drug. While a method of use could apply to a new way to dose or administer a drug, a distribution system typically means following safety protocols when shipping, prescribing, and dispensing a drug. 
“Leveraging distribution safeguards to hinder competition was never what Congress intended. But providing a remedy for competitors blocked or delayed by an improperly listed patent is exactly what Congress intended with the delisting statute. If the Court determines that the ’963 patent covers only a REMS distribution system and does not claim an approved method of using Xyrem, the Court should order Jazz to delist it,” the FTC wrote.
The Commissioners voted 4-0 to file the amicus brief. In its brief, the FTC outlined how it views improper Orange Book listings as harming competition. While the Hatch-Waxman Act limits which types of patents can be listed in the Orange Book, the patents are not verified by FDA or any other agency. The only mechanism to remove a patent for improper listing is a delisting counterclaim. At the same time, a drug company that lists a patent in the Orange Book and sues for infringement triggers a 30-month stay on a competitor drug. (RELATED: FDA finalizes ANDA CRL, Orange Book Q&A guidances, Regulatory Focus 27 July 2022)
“Given the enormous profit margins of many brand drugs, even small delays in competition can be extremely lucrative to the brand company—but cause substantial detriment to consumers,” the FTC wrote in its amicus brief.
FTC Amicus Brief


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