US gov­ern­ment, Pfiz­er and oth­ers side with Sanofi and Re­gen­eron in Supreme Court patent case

Pfiz­er, Vi­a­tris, the US gov­ern­ment and oth­ers on Fri­day sub­mit­ted briefs to the Supreme Court back­ing Sanofi and Re­gen­eron in their fight against Am­gen over patents that cov­er their PC­SK9 in­hibitors to con­trol cho­les­terol.

SCO­TUS will ad­dress what’s re­ferred to as the “en­able­ment” re­quire­ment, which es­sen­tial­ly spells out how a patent should in­clude both a writ­ten de­scrip­tion of an in­ven­tion, and the man­ner and process of mak­ing and teach­ing skilled ar­ti­sans “to make and use” the in­ven­tion.

The US De­part­ment of Jus­tice made clear in its brief that Am­gen’s in­abil­i­ty to in­voke the es­tab­lished pro­tec­tions that patent law of­fers “pro­vides no jus­ti­fi­ca­tion for” up­hold­ing their “broad genus claims against re­spon­dents’ en­able­ment chal­lenge.”

“Am­gen and its am­i­ci sug­gest that the Court need not wor­ry about broad func­tion­al claim­ing’s hold up of in­no­va­tion un­der a weak­ened en­able­ment stan­dard, giv­en the pos­si­bil­i­ty of li­cens­ing,” Genen­tech, As­traZeneca, Bay­er, Gilead and John­son & John­son wrote in their brief. “The sug­ges­tion is mis­placed. Li­cens­ing is hard­ly a fore­gone con­clu­sion, par­tic­u­lar­ly when it comes to bio­phar­ma­ceu­ti­cal patents.”

Pfiz­er sim­i­lar­ly said that Am­gen’s claims “should fail un­der any test for en­able­ment,” adding:

Pfiz­er does not ob­ject to an in­no­va­tor ob­tain­ing broad claims for gen­uine “break­through” in­ven­tions that sat­is­fy the statu­to­ry re­quire­ments and are based on a dis­clo­sure that is com­men­su­rate in scope with the claims. How­ev­er, the claims at is­sue are not com­men­su­rate with the in­ven­tors’ con­tri­bu­tion. They are a naked at­tempt to pre­empt fu­ture in­no­va­tion and an un­war­rant­ed ex­ten­sion of the patent mo­nop­oly.

Gener­ic com­pa­ny Vi­a­tris al­so said in its brief that SCO­TUS “should tread very care­ful­ly be­fore up­set­ting the ‘del­i­cate bal­ance’ of the patent law.”

In re­sponse to the sup­port, Sanofi and Re­gen­eron said in a joint state­ment via email:

It has been our long­stand­ing be­lief that all of Am­gen’s as­sert­ed U.S. PC­SK9 patent claims are in­valid. Am­gen’s at­tempt to di­lute the le­gal stan­dard for en­able­ment would sti­fle in­no­va­tion in all in­dus­tries. We are pleased by the sup­port from the U.S. Gov­ern­ment, as well as from in­di­vid­u­als and com­pa­nies in dif­fer­ent in­dus­tries that be­lieve, among oth­er things, the abil­i­ty to in­no­vate must be pro­tect­ed. We look for­ward to oral ar­gu­ment.

Am­gen, which filed the ini­tial pe­ti­tion to SCO­TUS in No­vem­ber 2021, claims that a pri­or Fed­er­al Cir­cuit de­ci­sion in­cor­rect­ly re­quires patent own­ers to iden­ti­fy and make all or near­ly all pos­si­ble vari­a­tions of the in­ven­tion — with­out “sub­stan­tial time and ef­fort.”

“The Fed­er­al Cir­cuit iden­ti­fied no rea­son why patent va­lid­i­ty should de­pend on the cu­mu­la­tive ef­fort re­quired to fer­ret out every con­ceiv­able im­ple­men­ta­tion of the in­ven­tion,” Am­gen wrote. “That test de­fies this Court’s prece­dents, which rec­og­nize that ‘it is ob­vi­ous­ly im­pos­si­ble to spec­i­fy in a patent the pre­cise treat­ment’ for each of the po­ten­tial­ly ‘in­fi­nite[]’ vari­a­tions of a claimed in­ven­tion.”

The case stems from a patent dis­pute be­tween Am­gen and Sanofi (which worked with Re­gen­eron) over their in­de­pen­dent­ly de­vel­oped but sim­i­lar PC­SK9 in­hibitor an­ti­body drugs, Repatha and Pralu­ent, which both re­duce low-den­si­ty lipopro­tein cho­les­terol. The an­ti­bod­ies dif­fer in amino acid se­quence and where they bind to PC­SK9.

Am­gen scored a win in 2019 in an ini­tial tri­al, but a fed­er­al judge in Delaware lat­er over­turned that ver­dict and ruled in fa­vor of Sanofi and Re­gen­eron. That de­ci­sion was then up­held in the Court of Ap­peals for the Fed­er­al Cir­cuit.

Am­gen said in a state­ment to End­points:

Am­gen’s patents claim a pi­o­neer­ing dis­cov­ery of a class of an­ti­bod­ies that low­er bad cho­les­terol, there­by pre­vent­ing life-threat­en­ing heart at­tacks and strokes.  We ful­ly be­lieve that the patents meet the statu­to­ry re­quire­ments for en­able­ment as the patents dis­close the in­ven­tors’ work in pro­duc­ing dozens of an­ti­bod­ies and a teach­ing of how to get the full scope of an­ti­bod­ies claimed.  Two ju­ries heard all the ev­i­dence and up­held the patents.  To in­cen­tivize re­searchers to pur­sue such life-chang­ing, ground­break­ing in­ven­tions, patents must pro­vide a mean­ing­ful scope of pro­tec­tion broad­er than just the spe­cif­ic ex­am­ples the in­ven­tors dis­close. With­out this broad­er pro­tec­tion, the patent sys­tem in­cen­tivizes copy­ists, not the next big break­through. This view is shared by many oth­ers in our in­dus­try and be­yond, both large and small com­pa­nies, and re­search-based in­sti­tu­tions. We look for­ward to the Supreme Court weigh­ing in on this im­por­tant is­sue and restor­ing the law to the statu­to­ry re­quire­ments for en­able­ment.

Ed­i­tor’s note: Ar­ti­cle up­dat­ed with com­ment from Am­gen.

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

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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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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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Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

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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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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.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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