The US Court of Ap­peals for the Fed­er­al Cir­cuit is up­hold­ing an in­junc­tion that states that a patent re­lat­ed to Jazz Phar­ma­ceu­ti­cals’ nar­colep­sy drug should be delist­ed from the FDA’s gener­ic drug com­pendi­um known as the Or­ange Book.

The patent in ques­tion, called the ‘963 patent, is re­lat­ed to Jazz’s “sin­gle-phar­ma­cy dis­tri­b­u­tion sys­tem” which is de­signed to con­trol ac­cess to drugs pre­scribed to nar­colep­sy pa­tients, which can be abused. The patents in­clude a cen­tral phar­ma­cy and com­put­er data­base that can track pre­scrip­tions and pa­tients.

Avadel CNS Phar­ma­ceu­ti­cals orig­i­nal­ly sought to delist the patent in ques­tion, as it re­lat­ed to the sys­tem un­der its REMS. And af­ter list­ing the patent in the Or­ange Book, Jazz filed a patent in­fringe­ment law­suit against Avadel, drop­ping a 30-month stay that blocked the fi­nal FDA ap­proval of Avadel’s nar­colep­sy drug.

How­ev­er, in No­vem­ber, the judge in the Delaware case ruled that the FDA should delete the patent from the Or­ange Book, claim­ing that the ‘963 patent’s claims were “di­rect­ed to sys­tems, not meth­ods.”

But, in the ap­peal, Jazz stat­ed that the dis­trict court had “abused” its dis­cre­tion in find­ing that “the ’963 patent is not a method-of-use patent for list­ing and delist­ing pur­pos­es un­der the FD­CA,” the ap­peals court case stat­ed. Jazz al­so stat­ed that even if the patent was not a method-of-use patent, the court still had abused its “dis­cre­tion” in de­ter­min­ing the delist­ing.

How­ev­er, the ap­peals court’s de­ci­sion not­ed:

As the dis­trict court cor­rect­ly an­a­lyzed in its Mark­man Or­der, these claims re­cite ‘an as­sem­blage of com­po­nents,’ defin­ing a sys­tem. Jazz has not iden­ti­fied any de­scrip­tion in the patent spec­i­fi­ca­tion or pros­e­cu­tion his­to­ry to al­ter that con­clu­sion. The claims to a sys­tem com­pris­ing com­put­er mem­o­ries and a da­ta proces­sor are not claims to a method.

Jazz fur­ther con­tend­ed that in 2014, the reg­u­la­to­ry en­vi­ron­ment al­lowed Jazz to list the patent which fell in­to a cat­e­go­ry of patents that were nei­ther re­quired nor for­bid­den to be list­ed. And be­cause it list­ed the patent, that does not pro­vide Avadel with the pow­er to re­quest an or­der for delist­ing. How­ev­er, the court dis­agrees and finds that the Delaware court’s de­ci­sion is cor­rect.

“As the ’963 patent claims nei­ther and has been as­sert­ed in a patent in­fringe­ment ac­tion against Avadel, pro­vides Avadel with a delist­ing rem­e­dy. The dis­trict court there­fore cor­rect­ly or­dered Jazz to seek delist­ing of the ’963 patent from the Or­ange Book,” the court de­ci­sion said.

The de­ci­sion from the ap­peals court fur­ther stat­ed that it found Jazz’s re­main­ing ar­gu­ments “un­per­sua­sive” and is ask­ing the FDA to delist the ‘963 patent.

In an email to End­points News, a Jazz Phar­ma­ceu­ti­cals spokesper­son said:

While we con­tin­ue to be­lieve that the ‘963 patent was prop­er­ly list­ed in the FDA’s Or­ange Book as a mat­ter of FD­CA law, in­clud­ing FDA reg­u­la­tions, we in­tend to ful­ly com­ply with the or­der to re­quest delist­ing of the ‘963 patent. We re­main con­fi­dent in the strength of our patent port­fo­lio and will con­tin­ue to ap­pro­pri­ate­ly de­fend our in­tel­lec­tu­al prop­er­ty as we con­tin­ue to fo­cus on en­sur­ing the safe­ty of pa­tients on oxy­bate ther­a­py.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.