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

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

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Covid-19 roundup: Mer­ck­'s $356M sup­ply deal on hold as FDA asks for more da­ta; FDA ap­proves Pfiz­er/BioN­Tech vac­cine stor­age at stan­dard freez­er temps

Merck is pushing back plans to supply the US government with a Covid-19 drug after the FDA asked for more data to support an emergency use authorization.

The antibody, MK-7110, had looked promising in a Phase III study conducted by OncoImmune before Merck came along and bought the biotech for $425 million. At the interim analysis, investigators looked at data from 203 patients and concluded that a single dose of the drug cut the risk of death or respiratory failure by more than 50% among severe patients. And those taking the drug had a 60% higher chance of improvement in clinical status compared to placebo.

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CEO Fred Aslan (Artiva)

NK cell ther­a­py play­er Arti­va makes some more noise, pulling in $120M Se­ries B less than a month af­ter Mer­ck deal

Not even one month after Big Pharma took notice of Artiva when Merck signed a collaboration worth nearly $2 billion in milestones, the off-the-shelf NK cell biotech already has its next big fundraise.

Artiva returns from the venture well Friday with a $120 million Series B round, money they will use to get their first program into the clinic and to file INDs for another two candidates. The raise marks the latest development in a rapidly expanding footprint for Artiva, which, in addition to the Merck deal last month, has now raised almost $200 million since its Series A last June.

Fatty liver conceptual image, 3D illustration showing fatty liver silhouette made from micrograph of liver steatosis (Shutterstock)

The path to NASH: un­der­stand­ing the role of se­vere obe­si­ty in a com­plex, mul­ti-sys­tem dis­ease

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

We often think a person’s transition from a healthy to a diseased state is binary. But that’s often not the case. In reality, the onset of a disease is not something that occurs overnight, and the majority lie on a continuum that is impacted by a multitude of factors. Some of these factors are in a patient’s control. Others are not.

This is the case in nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), two of the most complex diseases that “live” on this proverbial continuum. The clinical onset of NAFLD — and ultimately NASH — is a complex process that is closely related to obesity, insulin resistance and impaired adipose tissue metabolism.