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.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Sen. Eliz­a­beth War­ren urges FTC to 'scru­ti­nize' two phar­ma buy­outs

Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.