Patent board tells CRISPR sci­en­tists to back off from a nasty fight over gene edit­ing tech

The lat­est round in the ti­tle patent fight be­tween The Broad and UC Berkele­ly over CRISPR/Cas9 tech goes to … Ed­i­tas Med­i­cine.

The US Patent Tri­al and Ap­peal Board has ruled:

In light of the de­ter­mi­na­tion that the par­ties’ claims do not in­ter­fere (see 2 De­ci­sion on Mo­tions, Pa­per 893), we en­ter judg­ment of no in­ter­fer­ence-in-fact, 3 which nei­ther can­cels nor fi­nal­ly re­fus­es ei­ther par­ties’ claims.

Quick­ly trans­lat­ed, that means that the work they each com­plet­ed on the gene edit­ing tech doesn’t over­lap and can be sep­a­rate­ly patent­ed.

Jen­nifer Doud­na

Berke­ley has fought hard to es­tab­lish pre­em­i­nent con­trol of CRISPR, the faster, eas­i­er way to do gene edit­ing which has been spread­ing like wild­fire at aca­d­e­m­ic groups and star­tups. Berke­ley’s Jen­nifer Doud­na and Em­manuelle Char­p­en­tier have been cred­it­ed with much of the work, which has been used to found a group of star­tups like In­tel­lia $NT­LA, down 10% this af­ter­noon, and CRISPR Ther­a­peu­tics — $CR­SP down 8%.

A for­mer col­league, Feng Zhang at the Broad, was ac­cused of us­ing their work to back patents used to start up Ed­i­tas $ED­IT.

Berke­ley is not the least bit hap­py:

We con­tin­ue to main­tain that the ev­i­dence over­whelm­ing­ly sup­ports our po­si­tion that the Doud­na/Char­p­en­tier team was the first group to in­vent this tech­nol­o­gy for use in all set­tings and all cell types, and was the first to pub­lish and file patent ap­pli­ca­tions di­rect­ed to­ward that in­ven­tion, and that the Broad In­sti­tute’s patents di­rect­ed to­ward use of the CRISPR-Cas9 sys­tem in par­tic­u­lar cell types are not patentably dis­tinct from the Doud­na/Char­p­en­tier in­ven­tion.

And they may ap­peal.

Feng Zhang

In­vestors, though, called it a clear win for Ed­i­tas, swift­ly dri­ving up its stock by 29%.

It’s still ear­ly days in the CRISPR world, but gene edit­ing has opened a door to cre­at­ing a whole new gen­er­a­tion of ther­a­pies that can fix some ter­ri­ble ail­ments. And the po­ten­tial pay­off is huge.

Ed­i­tas CEO Ka­trine Bosley is sat­is­fied by the de­ci­sion. Her com­ment:

This im­por­tant de­ci­sion af­firms the in­ven­tive­ness of the Broad’s work in trans­lat­ing the bi­ol­o­gy of the nat­ur­al world in­to fun­da­men­tal build­ing blocks to cre­ate un­prece­dent­ed med­i­cines. At Ed­i­tas Med­i­cine, we are con­tin­u­ing to in­vest in this tech­nol­o­gy to build our busi­ness for the long-term and to cre­ate genome edit­ing ther­a­pies for pa­tients suf­fer­ing from ge­net­i­cal­ly-de­fined and ge­net­i­cal­ly-treat­able dis­eases.

Ka­trine Bosley, Ed­i­tas

In­tel­lia, CRISPR and Cari­bou, an­oth­er al­ly in the patent fight, say they can ac­tu­al­ly step up a fight along a much broad­er front now. In a joint re­sponse, they not­ed:

The PT­AB dis­con­tin­ued the cur­rent in­ter­fer­ence find­ing that the claim sets pre­sent­ed by the two par­ties were con­sid­ered “patentably dis­tinct” from each oth­er be­cause UC’s cur­rent claims are broad­er in scope in that they are not re­strict­ed to use in eu­kary­ot­ic cells, where­as Broad’s claims are all lim­it­ed to use in eu­kary­ot­ic cells. As a re­sult of the de­ci­sion, UC’s broad­er case, which was pre­vi­ous­ly con­sid­ered al­low­able but for the in­ter­fer­ence, is now re­leased from the in­ter­fer­ence and may be pros­e­cut­ed to po­ten­tial is­suance by UC, while a new in­ter­fer­ence can be sought with re­spect to eu­kary­ote claims, cur­rent­ly pend­ing in a sep­a­rate UC patent ap­pli­ca­tion once they are deemed al­low­able. Al­ter­na­tive­ly, UC could ap­peal the cur­rent de­ci­sion, which is cur­rent­ly un­der con­sid­er­a­tion.

Patent fights rarely cap­ture the at­ten­tion of the in­dus­try the way this one has. Most ei­ther don’t go very far or end up be­ing re­solved in a side deal that doesn’t have a huge in­flu­ence on the play­ers or the tech­nol­o­gy in­volved. As pas­sion­ate as these in­di­vid­u­als are about CRISPR, though, we prob­a­bly haven’t heard the last about this squab­ble.

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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UP­DAT­ED: Pan­el of neu­ro­science ex­perts lays out the com­pli­ca­tions with us­ing Bio­gen's new Alzheimer's drug

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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J&J’s Rem­i­cade — the poster child for how to block biosim­i­lars — fi­nal­ly set­tles Pfiz­er suit

Biosimilars have proven time and again (although mostly in Europe) that competition works to bring down the cost of a once-pricey biologic, and can even expand its use.

J&J’s Remicade, however, has always proven to be an outlier.

Back in 2016, Pfizer won FDA approval for its infliximab biosimilar, known as Inflectra, but when the launch foundered, the company sued J&J, claiming that the company’s plan to block biosimilar competition worked incredibly well. Pfizer even went on to win FDA approval for a second infliximab biosimilar in 2017, known as Ixifi, but decided to never launch it.

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