Ed­i­tas’ ri­vals ap­peal a re­cent set­back on patent fight, map­ping a glob­al war for CRISPR su­prema­cy

Em­manuelle Char­p­en­tier

The gene edit­ing con­sor­tium that has sought to bot­tle up ri­val Ed­i­tas $ED­IT with claims of patent in­fringe­ment are mak­ing a fed­er­al case out of a re­cent set­back in the US.

In mid-Feb­ru­ary the US Patent Tri­al and Ap­peal Board ruled that there was no in­ter­fer­ence be­tween the two sides in the dis­pute, al­low­ing each to patent their work on CRISPR/Cas9 and car­ry on. But the Uni­ver­si­ty of Cal­i­for­nia, the Uni­ver­si­ty of Vi­en­na, and Dr. Em­manuelle Char­p­en­tier aren’t tak­ing no for an an­swer.

They have de­cid­ed to con­tin­ue the fight in fed­er­al court, ap­peal­ing the de­ci­sion to the U.S. Court of Ap­peals for the Fed­er­al Cir­cuit, tar­get­ing patents from The Broad In­sti­tute.

Jen­nifer Doud­na

The con­sor­tium in­cludes a group of biotech com­pa­nies found­ed on the IP es­tab­lished by Char­p­en­tier and her col­league Jen­nifer Doud­na: CRISPR Ther­a­peu­tics $CR­SP, In­tel­lia Ther­a­peu­tics $NT­LA, Cari­bou Bio­sciences and ERS Ge­nomics.

CRISPR/Cas9 re­search has ex­plod­ed in the last few years, spawn­ing a slate of biotech star­tups that are look­ing to use this new tech to ed­it dis­ease out of DNA. While still pre­clin­i­cal with years to go be­fore any prod­uct could con­ceiv­ably near the mar­ket, an­a­lysts and in­vestors have been whipped up by the rev­o­lu­tion­ary po­ten­tial of this tech­nol­o­gy, and the found­ing sci­en­tists have been at each oth­er’s throats over the IP.

Most patent fights in bio­phar­ma end with a sim­ple roy­al­ty agree­ment. But this time the fight is clear­ly per­son­al and the anger runs deep.

Feng Zhang

The group said to­day it is al­so wag­ing a glob­al patent bat­tle for CRISPR/Cas9 su­prema­cy over Ed­i­tas and its sci­en­tif­ic founder, Feng Zhang, who patent­ed the ri­val tech­nol­o­gy at The Broad.

They say they are “pur­su­ing ap­pli­ca­tions in the U.S. and oth­er ju­ris­dic­tions world­wide to ob­tain patents claim­ing the CRISPR/Cas9 tech­nol­o­gy and its use in non-cel­lu­lar and cel­lu­lar set­tings, in­clud­ing eu­kary­ot­ic cells. Cor­re­spond­ing patents have al­ready been grant­ed in the Unit­ed King­dom, and the Eu­ro­pean Patent Of­fice is al­so grant­i­ng a patent to UC, which will is­sue on May 10, 2017. UC’s ear­li­est patent ap­pli­ca­tion de­scrib­ing the CRISPR/Cas9 genome edit­ing tech­nol­o­gy and its use was filed on May 25, 2012, while the Broad’s ear­li­est patent ap­pli­ca­tion was filed more than six months lat­er, on De­cem­ber 12, 2012.”

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Am­gen chops 172 more staffers in R&D, op­er­a­tions and sales amid neu­ro­science ex­it, rev­enue down­turn

Neuroscience wasn’t the only unit that’s being hit by a reorganization underway at Amgen. As well as axing 149 employees in its Cambridge office, the company has disclosed that 172 others nationwide, including some from its Thousand Oaks, CA headquarters, are being let go.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 66,100+ biopharma pros reading Endpoints daily — and it's free.

Ahead of strate­gic up­date, new Sanofi CEO mulls op­tions for con­sumer health­care arm — re­ports

Big pharma has made moves to sharpen its focus on developing new medicines, while slow-growing consumer health divisions fall by the wayside. Looks like another large drugmaker is considering a similar move. On Thursday, reports citing sources indicated that Sanofi is reportedly mulling a joint venture, sale, or a public listing of its consumer health arm.

The French group is in discussions for options that could value the division at $30 billion, Bloomberg and Reuters reported, citing sources familiar with the matter.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 66,100+ biopharma pros reading Endpoints daily — and it's free.

The triple crown in biotech: An all-or-noth­ing bet on an FDA ap­proval of 3 drugs over 16 months starts to­day

Bristol-Myers Squibb’s $74 billion Celgene deal closed as expected Wednesday evening. And now a new clock has begun to tick down for Celgene shareholders who came away from the deal with CVRs — contingent value rights — worth $9 or nothing. Those CVRs start trading today as $BMYRT.

The new deadline they have is the end of March 2021, a little more than 16 months from now, when Bristol-Myers will need to gain approvals on 3 late-stage drugs it’s picking up in the buyout: Ozanimod and liso-cel (JCAR017) are due up at the end of 2020, with bb2121 deadlined at the end of Q1 in 2021.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 66,100+ biopharma pros reading Endpoints daily — and it's free.

Genap­sys fi­nal­ly un­veils vaunt­ed se­quencer, but can it dent Il­lu­mi­na?

Hesaam Esfandyarpour holds what looks like a mini-cooler up to the computer screen in his California office.

Esfandyarpour is in his late-30s, with crows feet creeping up against a youthful face. He wears a gray polo and the device in his hand — with its hard plastic-looking shell, blue-and-white pattern, and a white plastic paddle resembling a handle jutting out the front — might contain diced strawberries and peanut-butter sandwiches to meet mom and the kids at a SoCal park. Instead, Esfandyarpour tells me it’s going to change medicine and biopharma research.

Brii Bio backs in­fec­tious dis­ease start­up while ink­ing deal for its lead TB drug, dou­bling down on an­tibi­otics

Almost two years after leaving GSK to launch Brii Bio with a whopping $260 million in funding, Zhi Hong is seeing the trans-Pacific infectious disease specialist he set out to build take shape.

“Our pipeline is coming together,” he told Endpoints News, with 12 partnered assets plus some internal programs.

As its latest partner, AN2 Therapeutics, comes into the limelight for the first time with a $12 million seed round, so is Brii’s plans in the antibiotics space. Brii has obtained China rights to AN2’s antibacterial targeting mycobacterium tuberculosis for multi-drug resistant TB, which it says is in the clinical stage.

UP­DAT­ED: Make that 2 ap­proved RNAi drugs at Al­ny­lam af­ter the FDA of­fers a speedy OK on ul­tra-rare dis­ease drug

Seventeen years into the game, Alnylam’s pivot into commercial operations is picking up speed.
The bellwether biotech $ALNY has nabbed their second FDA OK for an RNAi drug, this time for givosiran, the only therapy now approved for acute hepatic porphyria. This second approval came months ahead of the February deadline — even after winning priority review following their ‘breakthrough’ title earlier.
AHP is an extremely rare disease, with some 3,000 patients in Europe and the US, not all diagnosed, and analysts have projected peak revenue of $600 million to $700 million a year. The drug will be sold as Givlaari.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 66,100+ biopharma pros reading Endpoints daily — and it's free.

David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 66,100+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis, Bay­er, Long­wood back ge­nomics start­up to speed search for im­munother­a­py tar­gets

Nearly a century passed between the first proto-immunotherapy attempts in cancer — crude and obscure but nonetheless with some scientific basis — and Jim Allison’s first T cell paper. Thirty-plus years flipped between the discovery of CTLA-4 as an off-switch and the approval of Yervoy. Twenty-two rolled between PD-1’s isolation and Opdiva and Keytruda. 

Longwood co-founder Lea Hachigian is betting she can hasten that. It’s a bet on newly established single-cell genomic analysis tech and the ability to crunch endless troves of data at a rate few others can, and investors including Leaps by Bayer and Novartis Venture Fund just put $39 million behind it. They call it Immunitas.