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.”

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