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.”

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

The DC Circuit Court has struck a blow against the pharmaceutical lobbying group PhRMA and other plaintiffs’ attempt to stop states from importing drugs from Canada.

Joined alongside public health group Partnership for Safe Medicines and advocacy group Council for Affordable Health Coverage, PhRMA was rebuffed by Judge Timothy Kelly on Monday, who dismissed the civil suit due to a lack of standing.

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”