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.

Hal Barron and Rick Klausner (GSK, Lyell)

Ex­clu­sive: GSK’s Hal Bar­ron al­lies with Rick Klaus­ner’s $600M cell ther­a­py start­up, look­ing to break new ground blitz­ing sol­id tu­mors

LONDON — Chances are, you’ve heard little or nothing about Rick Klausner’s startup Lyell. But that ends now.

Klausner, the former head of the National Cancer Institute, former executive director for global health at the Gates Foundation, co-founder at Juno and one of the leaders in the booming cell therapy field, has brought together one of the most prominent teams of scientists tackling cell therapy 2.0 — highlighted by a quest to bridge a daunting tech gap that separates some profound advances in blood cancers with solid tumors. And today he’s officially adding Hal Barron and GlaxoSmithKline as a major league collaborator which is pitching in a large portion of the $600 million he’s raised in the past year to make that vision a reality.

“We’ve being staying stealth,” Klausner tells me, then adding with a chuckle: “and going back to stealth after this.”

“Cell therapy has a lot of challenges,” notes Barron, the R&D chief at GSK, ticking off the resistance put up by solid tumors to cell therapies, the vein-to-vein time involved in taking immune cells out of patients, engineering them to attack cancer cells, and getting them back in, and more. “Over the years Rick and I talked about how it would be wonderful to take that on as a mission.”

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First place fin­ish: Eli Lil­ly just moved to fran­chise leader with their sec­ond mi­graine drug OK in 1 year

In a rare twist for Eli Lilly’s historically slow-moving R&D group, the pharma giant has seized bragging rights to a first-in-class new drug approval. And all signs point to an aggressive marketing followup as they look to outclass some major franchise rivals hobbled by internal dissension.

The FDA came through with an OK for lasmiditan on Friday evening, branding it as Reyvow and lining it up — once a substance classification comes through from the DEA — for a major market release. The oral drug binds to 5-HT1F receptors and is designed to stop an acute migraine after it starts. That makes it a complementary therapy to their CGRP drug Emgality, which has a statistically significant impact on preventing attacks.

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Allogene HQ Open House on September 17, 2019 in South San Francisco. (Jeff Rumans, Endpoints News)

The next 10 years: Where is biotech head­ed?

The last 10 years have seen a revolution in drug development. Timelines have shortened, particularly in oncology. Regulators have opened up. Investment has skyrocketed. China became a player. Biotechs have multiplied as gene and cell therapy has exploded — offering major new advances in the way diseases are treated, and sometimes cured.

So where are we headed from here? I journeyed out to San Francisco in September to discuss the answer to that question at Allogene’s open house. If the last 10 years have been an eye-opener, what does the next decade hold in store?

Patrick Mahaffy, Getty Images

Court green-lights Clo­vis case af­ter de­tail­ing ev­i­dence the board ‘ig­nored red flags’ on false safe­ty and ef­fi­ca­cy da­ta

Clovis investors have cleared a major hurdle in their long-running case against the board of directors, with a Delaware court making a rare finding that they had a strong enough case against the board to proceed with the action.

In a detailed ruling at the beginning of the month that’s been getting careful scrutiny at firms specializing in biotech and corporate governance, the Delaware Court of Chancery found that the attorneys for the investors had made a careful case that the board — a collection of experts that includes high-profile biotech entrepreneurs, a Harvard professor and well-known investigator as well as Clovis CEO Patrick Mahaffy — repeatedly ignored obvious warnings that Mahaffy’s executive crew was touting inflated, unconfirmed data for their big drug Roci. Serious safety issues were also reportedly overlooked while the company continued a fundraising campaign that brought in more than a half-billion dollars. And that leaves the board open to claims related to their role in the fiasco.

The bottom line:

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Bill Gates backs Gink­go Biowork­s' $350M raise to fu­el the buzzy syn­thet­ic bi­ol­o­gy 'rev­o­lu­tion'

If you want to understand Ginkgo Bioworks, the name should suffice: Bioworks, a spin off “ironworks,” that old industrial linchpin devoted to leveraging scale as a wellspring for vast new industries capable of remaking society. Ginkgo wants to be the ironworks for the revolution it’s heralded with as much fanfare as they can, playing off of one of the buzziest technologies in biotech.

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UCB bags a ri­val to Soliris in $2.1B buy­out deal — but will an in­creas­ing­ly vig­i­lant FTC sign off?

UCB is buying out Ra Pharma $RARX, announcing an acquisition deal that rings up at $48 a share, or $2.1 billion net of cash, and puts them toe-to-toe with Alexion on a clinical showdown.

Ra shares closed at $22.70 on Wednesday.

There’s a small pipeline in play at Ra, but UCB is going for the lead drug — a C5 inhibitor called zilucoplan in Phase III for myasthenia gravis (MG) looking to play rival to Alexion’s Soliris. Soliris has the market advantage, though, with a much earlier approval in MG in late 2017 that UCB feels confident in challenging.

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A new play­er is tak­ing the field in a push for a he­mo­phil­ia A gene ther­a­py, and it’s a big one

BioMarin, the execs at Spark (and buyer-to-be Roche) as well as the Sangamo/Pfizer team have a new rival striding onto the hemophilia block. And it’s a big one.

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Stuck with a PhI­II gene ther­a­py fail­ure at 96 weeks, Gen­Sight prefers the up­beat as­sess­ment

Two years after treatment, the best thing that GenSight Biologics $SIGHT can say about their gene therapy for vision-destroying cases of Leber Hereditary Optic Neuropathy is that it’s just a bit better than a placebo — just maybe because one treatment can cover both eyes.

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George Scangos / Credit: Cornell University

ARCH, Soft­Bank-backed Vir Biotech­nol­o­gy un­der­whelms with $143 mil­lion IPO

George Scangos went back to Wall Street, and came back 700 million pennies short.

Scangos’ vaunted startup Vir Biotechnology raised $143 million in an IPO they hoped would earn $150 million. Shares were priced at $20, the low-end of the $20-$22 target.

Launched with backing from ARCH Venture’s Robert Nelsen, Masayoshi Son’s SoftBank Vision Fund, and the Bill & Melinda Gates Foundation, the infectious disease startup was one of a new wave of well-resourced biotechs that emerged with deep enough coffers to pursue a full R&D line rather than slowly build their case by picking off a single lead program.