Jazz urges Fed Circuit to undo delisting injunction
Delisting affects a blockbuster narcolepsy drug | Orange book has specific listing criteria | Avadel.
Jazz Pharmaceuticals has attempted to persuade the US Court of Appeals for the Federal Circuit to vacate a lower court’s injunction that forced Jazz to delist a patent from the Orange Book.
In a brief filed Friday, December 16, Jazz asked the court to undo the injunction which ordered the delisting of US patent number 8,731,963 from the US Food and Drug Administration’s (FDA) approved drug list.
The patent involves the implementation of a distribution system that Jazz uses to ensure its blockbuster narcolepsy drug Xyrem (sodium oxybate) product is dispensed only to patients with a valid prescription.
Jazz had accused Avadel of infringing the ‘963 patent in July 2022, after Avadel submitted a New Drug Application for a sodium oxybate product to treat narcolepsy. 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.
In November this year, the US Federal Trade Commission (FTC) waded into the dispute, claiming that the patent should be delisted from the Orange Book to the extent that it includes the implementation of a distribution system for Xyrem.
According to the FTC, only patents that claim either a drug or a “method of using” a drug can be listed in the Orange Book.
“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.”
Later that month, the US District Court for the District of Delaware found in favour of Avadel and ordered Jazz to submit a request to the FDA to delete the ’963 patent from the Orange Book.
Jazz subsequently appealed against the decision to the Federal Circuit and, last week, the court granted the pharmaceutical company’s motion for a stay pending appeal.
“That injunction rests on an erroneous interpretation of the governing statutes (and one contrary to FDA’s own views, reflected in authoritative regulations), as well as an erroneous construction of the patent’s claims. The district court’s order should be vacated,” said Jazz in its brief.
Jazz argued that, even if the district court was correct in finding that the ‘963 patent is a system patent, a patent containing system claims can also recite “an approved method of using the drug”.
"A Risk Evaluation and Mitigation Strategy-based distribution plan falls comfortably within the ordinary meaning of ‘method of using [a] drug’ because the distribution plan specifies how physicians can prescribe, how pharmacists can dispense, and how patients can use, the drug,” said the brief.
Additionally, Jazz claimed that the injunction should be vacated because (even if the patent doesn’t claim a “method using the drug”) it was properly listed in the Orange Book in the first instance and should not now be subject to delisting.
"The delisting statute offers no basis to delist patents that—like the ’963 patent—were appropriately included in the Orange Book under the law that applied when they were listed,” Jazz argued.
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