The Broad wins an­oth­er — per­haps fi­nal — bat­tle in the war over Feng Zhang's CRISPR patents

Ed­i­tas $ED­IT and its ri­vals’ long run­ning le­gal bat­tle over the IP for the CRISPR/Cas9 tech used to ed­it genes may well be over.

A fed­er­al ap­peals court has ruled in fa­vor of the Broad In­sti­tute, con­firm­ing an ear­li­er US patent board de­ci­sion that their patents from the lab of in­ves­ti­ga­tor Feng Zhang did not “in­ter­fere” with the ones sought by UC.

And the judges came down so solid­ly in fa­vor of the Broad that there’s like­ly lit­tle hope for any con­tin­u­ing ap­peals moves — though the UC sys­tem quick­ly put out a state­ment say­ing they’re still eval­u­at­ing their op­tions on lit­i­gat­ing the is­sue.

The Broad, which quick­ly her­ald­ed the rul­ing, not­ed that their patents “are for genome edit­ing in eu­kary­ot­ic (in­clud­ing an­i­mal, hu­man, and plant) cells, while the claims in UCB’s ap­pli­ca­tion were based on stud­ies in cell-free sys­tems and not di­rect­ed to genome edit­ing in eu­kary­ot­ic cells.” The in­sti­tute con­tin­ued:

It is time for all in­sti­tu­tions to move be­yond lit­i­ga­tion. We should work to­geth­er to en­sure wide, open ac­cess to this trans­for­ma­tive tech­nol­o­gy.

Ed­i­tas, which has been di­rect­ly in­volved in pro­tect­ing these patents, will sec­ond that mo­tion. But it’s un­like­ly that the biotechs sup­port­ed by UC’s Jen­nifer Doud­na and her col­league Em­manuelle Char­p­en­tier — in­clud­ing CRISPR Ther­a­peu­tics $CR­SP — will be hap­py about the news.

From to­day’s rul­ing:

The Board per­formed a thor­ough analy­sis of the fac­tu­al ev­i­dence and con­sid­ered a va­ri­ety of state­ments by ex­perts for both par­ties and the in­ven­tors, past fail­ures and suc­cess­es in the field, evi- dence of si­mul­ta­ne­ous in­ven­tion, and the ex­tent to which the art pro­vid­ed in­struc­tions for ap­ply­ing the CRISPR- Cas9 tech­nol­o­gy in a new en­vi­ron­ment. In light of this ex­haus­tive analy­sis and on this record, we con­clude that sub­stan­tial ev­i­dence sup­ports the Board’s find­ing that there was not a rea­son­able ex­pec­ta­tion of suc­cess, and the Board did not err in its de­ter­mi­na­tion that there is no in­ter­fer­ence-in-fact.

We have con­sid­ered UC’s re­main­ing ar­gu­ments and find them un­per­sua­sive.

The UC sys­tem, though, may not be done wran­gling over the sub­ject. They of­fered this state­ment on Mon­day af­ter­noon:

We are eval­u­at­ing fur­ther lit­i­ga­tion op­tions. We al­so look for­ward to prov­ing that Drs. Doud­na and Char­p­en­tier first in­vent­ed us­age in plant and an­i­mal cells – a fact that is al­ready wide­ly rec­og­nized by the glob­al sci­en­tif­ic com­mu­ni­ty – as the Doud­na-Char­p­en­tier team’s sev­er­al pend­ing patent ap­pli­ca­tions that cov­er use of CRISPR-Cas9 in plant and an­i­mal cells are now un­der ex­am­i­na­tion by the patent of­fice.

And af­ter the mar­ket closed Mon­day af­ter­noon, CRISPR, In­tel­lia and Cari­bou — all al­lied with the Doud­na/Char­p­en­tier side — of­fered a col­lec­tive har­rumph.

“The Fed­er­al Cir­cuit, like the PT­AB, did not de­cide whether UC or the Broad ac­tu­al­ly first in­vent­ed the CRISPR/Cas9 genome edit­ing tech­nol­o­gy,” they not­ed. “The Fed­er­al Cir­cuit opin­ion al­so does not pre­clude oth­er pro­ceed­ings, ei­ther at the USP­TO or in the courts, to de­ter­mine which re­search group is the ac­tu­al in­ven­tor and, thus, the prop­er own­er of the tech­nol­o­gy.”


Im­age: Feng Zhang. MIT

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,000+ biopharma pros reading Endpoints daily — and it's free.

Pfizer, South San Francisco — Jeff Rumans for Endpoints News

Pfiz­er takes aim at a flag­ship fran­chise at Sanofi and Re­gen­eron — and scores a few di­rect hits

Count Pfizer in as a top player in the blockbuster game of JAK1 inhibitors.

Over the weekend the pharma giant posted some stellar Phase III efficacy data for their heavyweight contender abrocitinib in atopic dermatitis (eczema) that lines up ahead of a booming Dupixent (dupilumab), a blockbuster in the portfolios of Regeneron and Sanofi. And they put some real distance ahead of Eli Lilly’s trailing Olumiant, which made a delayed initial arrival on the market for rheumatoid arthritis after the FDA hobbled it with some additional hurdles on safety concerns.

JADE-MONO-1 scores well for Pfizer, teeing up what will be an intensely followed breakdown of the JADE MONO-2 data, which the pharma giant recently top-lined as “similar” to the first Phase III when tested against a placebo — a control group that has been easily outclassed by all the drugs in this market niche.

As of now, Pfizer looks to be equipped to run into the review stage — advantaged by a breakthrough therapy designation that is intended to speed up the regulatory process.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,000+ biopharma pros reading Endpoints daily — and it's free.

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:

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,000+ biopharma pros reading Endpoints daily — and it's free.