FTC wades into escalating ‘Orange Book’ clash
Jazz accused a rival of infringement | Avadel filed a counterclaim seeking to delist the patent from the Orange Book.
The US Federal Trade Commission (FTC) has urged the US District Court for the District of Delaware to remove a Jazz-owned patent from the Orange Book.
In an amicus brief filed on November 10, the FTC said that the patent should be delisted from the US Food and Drug Administration’s (FDA) approved drug list to the extent that it includes the implementation of a distribution system for Jazz’s blockbuster treatment Xyrem (sodium oxybate).
In July 2022, Jazz accused Avadel of infringing the ‘963 patent after Avadel submitted a New Drug Application for a sodium oxybate product to treat narcolepsy.
In response, Avadel filed a counterclaim seeking to delist the patent from the Orange Book on the basis that it does not claim Xyrem or a method of using Xyrem.
While the FDA had granted tentative approval for Avadel’s drug Lumryz it is barred from granting final approval while the 30-month stay (which was automatically triggered with the patent suit) remains in effect.
The FTC has now waded into the dispute with its own brief, noting that only patents that claim either a drug or a “method of using” a drug can be listed in the Orange Book.
However, while the Hatch-Waxman Act strictly limits the types of patents that can be listed in the Orange Book, neither the FDA nor any other entity verifies that listed patents meet those criteria, explained the FTC.
“The FTC takes no position on the scope or claim construction of the ‘963 patent. As a general matter, however, patents that claim a distribution system do not meet the Orange Book listing criteria; to the extent they claim a method at all, it is a method of distributing a drug rather than a method of using one,” said the brief.
The ‘963 patent involves the implementation of a distribution system that Jazz uses to ensure its Xyrem product is dispensed only to patients with a valid prescription.
“To the extent that the ‘963 patent claims only a distribution system, it does not meet the statutory criteria for listing in the Orange Book and should be delisted,” said the FTC. “A contrary result may cause substantial harm to consumers of sodium oxybate products and encourage other brand companies to improperly list distribution patents to block competition for other drugs.”
According to the brief, an “improper listing harms competition and consumers”.
“By listing a patent in the Orange Book and then filing an infringement suit, a brand can block competition for up to two-and-a-half years regardless of the scope or validity of the patent and regardless of whether it meets the statutory listing criteria,” warned the FTC.
The brief added that if the ‘963 patent is improperly listed, it seems to be causing significant harm to competition.
“The entry of Avadel’s product would not only potentially introduce price competition, but also increase consumer choice by offering a different and more favourable dosing regimen that does not require the patient to wake up in the middle of the night,” said the FTC.
It concluded: “Thus, to the extent the ’963 patent is improperly listed, the only way to remedy a potentially significant harm to consumers is for this court to order it removed from the Orange Book.”
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