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

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

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Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

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Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
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Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
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The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

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Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

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