Federal Circuit court halts delisting of Jazz narcolepsy drug patent from the Orange Book
The US Court of Appeals for the Federal Circuit yesterday ordered a halt to the delisting of a key patent for Jazz Pharmaceuticals’ narcolepsy drug in the FDA’s Orange Book, reversing a Delaware district court judge’s decision last month to remove the patent from the Orange Book.
The case at hand involves Avadel CNS Pharmaceuticals, which has sought to delist one of Jazz Pharmaceuticals’ patents related to the method for distributing its blockbuster narcolepsy drug Xyrem as part of a restricted distribution system under its REMS.
The district court’s order to remove the patent will now be put on pause for an unknown amount of time as the Federal Circuit said its decision rested on four key factors:
(1) whether the movant has made a strong showing of a likelihood of success on the merits; (2) whether the movant will be irreparably injured absent an injunction; (3) whether issuance of the injunction will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.
The reversal comes as Delaware district court judge Gregory Williams told Jazz in November that it must “delete the ‘963 patent from the Orange Book entry.”
“Here, the ‘936 patent does not belong in the Orange Book,” the judge explained, noting the patent does not claim “an approved method of using the drug” because “the claims of ‘963 patent are directed to systems, not methods.”
The decision follows shortly after the Federal Trade Commission wrote an amicus brief on the case and called to keep strict statutory limits on Orange Book patent listings, explaining that patents related to REMS distribution systems should not block generic or other competition.
Rutgers law professor Michael Carrier told Endpoints News about the Federal Circuit’s order:
At a minimum, it’s not atypical given the importance to Jazz of keeping its drug in the Orange Book. One of the factors the court considers is Jazz’s injury absent an injunction and Jazz could claim that they would be injured absent the pause of the delisting. Another factor is likelihood of success on the merits but there isn’t anything in the very short order that sheds light on this. In short, I don’t think this gives us much insight into the ultimate conclusion in the case.
Carrier co-authored an article explaining how patents that claim compliance with FDA-imposed REMS programs “pose two problems—one procedural, the other substantive. First, current practice is to list REMS patents in the Orange Book even though such listings may be invalid, with this conduct allowing the brand to obtain an automatic 30-month stay of generic approval. Second, because a REMS program appears on a product’s label and generics must copy that label, REMS patents threaten generics with claims of induced infringement.”
Sens. Maggie Hassan (D-NH) and Mike Braun (R-IN) introduced a bill in September that would enable the FDA to immediately approve generic drugs – instead of waiting 30 months – if the only barrier to approval is a REMS patent.
Jazz said in an emailed statement that it’s “pleased with the court’s decision. We look forward to continuing on the merits of our appeal and remain confident in the strength of our position.”