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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Common performs onstage, December 2020 (Getty Images)

Com­mon, Jamie Foxx among celebs stand­ing up for clin­i­cal tri­als in star-stud­ded can­cer group's pan­dem­ic push

Healthcare screenings and clinical trial enrollment were battered by the pandemic. But the well-known celebrity-backed Stand Up To Cancer non-profit, along with pharma and advocacy partners, has been working to reverse that and make up lost ground, by stepping up awareness campaigns.

Twelve campaigns launched in 2020 and another five in 2021 amplify the need for cancer screening and care, especially for underserved communities. While pharma companies have long been donors to the cancer research group, Covid brought new support — and increased awareness efforts.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

UP­DAT­ED: Am­gen halts some drug dis­counts for safe­ty net hos­pi­tals as SCO­TUS takes on 340B case

Amgen will soon be the 10th biopharma company to pull back on offering drug discounts to contract pharmacies of safety-net hospitals under a federal program. Like its peers, Amgen argues that the growth of these contract pharmacies has ballooned in recent years and needs to be reigned in.

Beginning Jan. 3, 2022, Amgen’s policy will only allow 340B covered hospitals to designate a single pharmacy location, with the exception of federal grantees and contract pharmacies wholly owned by a 340B hospital, or that have common ownership with a health system.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”