Take that Ed­i­tas: CRISPR Ther­a­peu­tics and col­leagues win a Eu­ro­pean round in the IP tug-of-war over gene edit­ing tech

Jen­nifer Doud­na

Still boil­ing over the lat­est patent de­ci­sion on CRISPR/Cas 9 IP in the US, CRISPR Ther­a­peu­tics $CR­SP says its sci­en­tif­ic founders have won a broad patent cov­er­ing their work in Eu­rope.

The Eu­ro­pean Patent Of­fice has come through with patent no. 13793997, says the biotech. And the UK’s patent of­fice fol­lowed through, tak­ing the same po­si­tion.

Em­manuelle Char­p­en­tier

“We and the li­cen­sors of these foun­da­tion­al cas­es for CRISPR/Cas9 gene edit­ing have long ap­pre­ci­at­ed that Em­manuelle Char­p­en­tier, Jen­nifer Doud­na, and their doc­tor­al and post-doc­tor­al col­leagues pro­vid­ed es­sen­tial teach­ings that ef­fec­tive­ly en­abled and fa­cil­i­tat­ed the CRISPR field, which has al­lowed both re­searchers and gene edit­ing com­pa­nies to eas­i­ly and pre­cise­ly mod­u­late tar­get DNA se­quences in any cell type and set­ting, in­clud­ing in hu­man cells for po­ten­tial ther­a­peu­tic ap­pli­ca­tions,” said Dr. Tyler Dy­lan-Hyde, the chief le­gal of­fi­cer of CRISPR Ther­a­peu­tics. “We al­so ap­pre­ci­ate that, de­spite at­tempts by third par­ties try­ing to de­lay or pre­vent these grants through TPOs or po­ten­tial op­po­si­tions, patent of­fices are be­gin­ning to rec­og­nize both the fun­da­men­tal sig­nif­i­cance of the teach­ings by the Char­p­en­tier-Doud­na team and their wide ap­plic­a­bil­i­ty to the CRISPR field. We look for­ward to pur­su­ing sim­i­lar find­ings in the U.S. un­der the first-to-in­vent sys­tem, and through­out the ap­prox­i­mate­ly 80 oth­er coun­tries our fil­ings cov­er world­wide, all of which are on a first-to-file pri­or­i­ty sys­tem.”

Feng Zhang

Ed­i­tas Med­i­cines $ED­IT came out on top re­cent­ly in the lat­est US matchup. The ri­val biotech re­lies in part on patents held by The Broad, which orig­i­nat­ed in work done by Feng Zhang, a one-time col­lab­o­ra­tor with Doud­na and Char­p­en­tier.

Back in De­cem­ber, just days af­ter CRISPR Ther­a­peu­tics and a group of ri­vals formed an IP al­liance around CRISPR/Cas9 gene edit­ing tech, Ed­i­tas fired back in the patent war by bag­ging an ex­clu­sive li­cense to what was be­ing billed as an up­grade to im­prove re­searchers’ abil­i­ty to ed­it genes and fight dis­ease.

How does this new patent af­fect Ed­i­tas?

Sam Kulka­rni, Crispr

Sam Kulka­rni, the chief busi­ness of­fi­cer at CRISPR Ther­a­peu­tics, tells me in an email that the Eu­ro­pean patent sets up a key IP road­block for any com­pa­ny look­ing to com­mer­cial­ize CRISPR/Cas9 on the con­ti­nent.

The de­ci­sion of the EPO to grant the patents with broad claims for CRISPR/Cas9 genome edit­ing across all cell types means that ac­cess to the CRISPR/UC Foun­da­tion­al IP will like­ly be nec­es­sary for any par­ty try­ing to com­mer­cial­ize CRISPR-based ther­a­peu­tics in Eu­rope.  The patents grant­ed to the Broad In­sti­tute in Eu­rope are lim­it­ed in na­ture and al­so the sub­ject of pro­ceed­ings chal­leng­ing their va­lid­i­ty and is­suance at the Op­po­si­tion Di­vi­sion of the EPO.

A spokesper­son for Ed­i­tas, though, doesn’t sound too wor­ried.

Our strat­e­gy from day one has been to build a strong IP po­si­tion that is fun­da­men­tal, broad, and mul­ti­fac­eted. It’s an im­por­tant in­vest­ment for Ed­i­tas and is part of build­ing the lead­ing ge­nom­ic med­i­cine com­pa­ny for the long-term. Ed­i­tas’ foun­da­tion­al IP in­cludes patents is­sued by both the US and Eu­rope Patent Of­fices cov­er­ing the use of CRISPR/Cas9 in eu­kary­ot­ic cells.  Con­se­quent­ly, we are con­fi­dent in our IP po­si­tion, which we be­lieve is a nec­es­sary fac­tor for mak­ing CRISPR med­i­cines for peo­ple.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

Bio­haven adds near­ly $1B in Nurtec deal with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Monday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

AbbVie has resolved a California lawsuit alleging insurance fraud in the promotion of its cash cow Humira, paying $24 million to settle things with the state’s insurance regulator.

The settlement comes almost four years after a whistleblower first reported AbbVie’s practice of deploying registered nurses to visit patients at home or call them by phone to ensure that Humira prescriptions are filled. AbbVie was also charged with providing illegal kickbacks to doctors in an attempt to encourage them to prescribe Humira for a range of anti-inflammatory diseases.

Per­cep­tive fields SPAC #3 as an­oth­er group of biotechs scoops up $364M in lat­est Nas­daq romp

There’s no sign that the windfall of cash dropping biotech’s way on Wall Street is abating. Three more biopharmas priced IPOs on Thursday and Friday morning, riding a historic boom with a $364 million payoff.

London-based biotech Freeline Therapeutics took home the lion’s share of the cash with $159 million after pricing 8,823,529 shares at $18 a pop. Checkmate Pharmaceuticals, of Cambridge, MA, raised $75 million with an offer of 5 million shares at $15 — right at the midpoint of its range. And Arya Sciences Acquisition Corp III, the third in a series from Perceptive, priced 13,000,000 shares at $10 per share.

President Trump (AP Images)

UP­DAT­ED: FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as phar­ma warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Alexion has carved out a new position for chief diversity officer and filled it with an inside promotion.

Uzair Qadeer will now be responsible for their “diversity, inclusion and belonging” strategy, looking to reshape the biotech’s corporate culture. A veteran of Deloitte and Bristol Myers Squibb, Qadeer was working on executive coaching and helping create the diversity program he now leads.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.