Jazz los­es ap­peal, will have patent delist­ed from the Or­ange Book

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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

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 re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

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.”

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

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.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

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.