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

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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H1 analy­sis: The high-stakes ta­ble in the biotech deals casi­no is pay­ing out some record-set­ting win­nings

For years the big trend among dealmakers at the major players has been centered on ratcheting down upfront payments in favor of bigger milestones. Better known as biobucks for some. But with the top 15 companies competing for the kind of “transformative” pacts that can whip up some excitement on Wall Street, with some big biotechs like Regeneron now weighing in as well, cash is king at the high stakes table.

We asked Chris Dokomajilar, the head of DealForma, to crunch the numbers for us, looking over the top 20 deals for the past decade and breaking it all down into the top alliances already created in 2019. Gilead has clearly tipped the scales in terms of the coin of the bio-realm, with its record-setting $5 billion upfront to tie up to Galapagos’ entire pipeline.

Dokomajilar notes:

We’re going to need a ‘three comma club’ for the deals with over $1 billion in total upfront cash and equity. The $100 million-plus club is getting crowded at 164 deals in the last decade with new deals being added towards the top of the chart. 2019 already has 14 deals with at least $100 million in upfront cash and equity for a total year-to-date of over $9 billion. That beats last year’s $8 billion and sets a record.

Add upfronts and equity payments and you get $11.5 billion for the year, just shy of last year’s record-setting $11.8 billion.

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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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John McHutchison in 2012. Getty Images

The $1.1M good­bye: Gilead CSO John McHutchi­son is out as Daniel O’Day shakes up the se­nior team

Just a little more than a year after John McHutchison grabbed a promotion to become CSO at Gilead in the wake of Norbert Bischofberger’s exit, he’s out amid a shakeup of the senior team that is also triggering the departure of two other top execs.

Gilead stated that McHutchison “has decided to step down” from the job as of August 2nd. And their SEC filing notes that he’ll be getting a $1.1 million check to settle up on his contract.

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Thomas Gajewski, David Steinberg. (CRI, Pyxis)

Bay­er, Long­wood back star re­searcher's deep dive in­to the tu­mor mi­croen­vi­ron­ment for new I/O tar­gets

From PD-1 targeting to the RAS pathway to the STING complex, Thomas Gajewski has spent the past two decades of his career decoding the various ways the immune system can be unleashed to defend against cancer. So when the University of Chicago professor comes around to putting all his findings into a new platform for finding new targets, VCs and pharma groups alike pay attention.

“He’s been studying T cells for 20 years, plus he’s one of the world’s leaders if not the world leader in the space,” David Steinberg, partner at Longwood Fund, said. “Furthermore, let me add he did a lot of the foundational research and also some of the seminal clinical trials in the existing set of I/O agents. He understands the space really well, he understands the current strengths, and I think he understood really well what was missing, so he knew where to look.”