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.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 7 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff.

KalVis­ta's di­a­bet­ic mac­u­lar ede­ma da­ta falls short — will Mer­ck walk away?

Merck’s 2017 bet on KalVista Pharmaceuticals may have soured, after the UK/US-based biotech’s lead drug failed a mid-stage study in patients with diabetic macular edema (DME).

Two doses of the intravitreal injection, KVD001, were tested against a placebo in a 129-patient trial. Patients who continued to experience significant inflammation and diminished visual acuity, despite anti-VEGF therapy, were recruited to the trial. Typically patients with DME — the most frequent cause of vision loss related to diabetes — are treated with anti-VEGF therapies such as Regeneron’s flagship Eylea or Roche’s Avastin and Lucentis.

Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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Ob­sE­va makes case for best-in-class hor­mone sup­pres­sive ther­a­py in pos­i­tive uter­ine fi­broid study

About a month after the Swiss biotech disclosed a failed late-stage study in its IVF program, ObsEva on Monday unveiled positive pivotal data on its experimental treatment for heavy menstrual bleeding triggered by uterine fibroids.

ObsEva in-licensed the drug, linzagolix, from Japan’s Kissei Pharmaceutical in 2015. Two doses of the drug (100 mg and 200 mg) were tested against a placebo in the 535-patient Phase III study, dubbed PRIMROSE 2, in patients who were both on and off hormonal add-back therapy (ABT).

Samit Hirawat. Bristol-Myers Squibb

Bris­tol-My­ers is mak­ing a bee-line to the FDA with pos­i­tive liso-cel da­ta — but is it too late in the CAR-T game?

Bristol-Myers Squibb came to ASH this past weekend with a variety of messages on the new cancer drugs they had acquired in the big Celgene buyout, including liso-cel, the lead CAR-T program picked up in the $9 billion Juno acquisition. And one of the most important was that they had the pivotal efficacy and safety data needed to snag an approval from the FDA next year, with the BLA on track for a filing this month.

J&J team shows off 'break­through' BC­MA CAR-T da­ta, and that could cause a big headache at blue­bird and Bris­tol-My­ers

Just hours after J&J’s oncology team bragged about scoring a breakthrough therapy designation for their BCMA CAR-T drug, they pulled the wraps off of the multiple myeloma data for JNJ-4528 that impressed the FDA. And it’s easy to see why they may well be on a short path to a landmark approval — which may well be making the rival team at bluebird/Bristol-Myers more than a little nervous.

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Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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