Jen­nifer Doud­na

Em­manuelle Char­p­en­tier and Jen­nifer Doud­na have their No­bel prizes in chem­istry for their CRISPR-Cas9 DNA scis­sors, but the US Patent and Trade­mark Of­fice made clear late Mon­day that Har­vard-MIT’s Broad In­sti­tute and su­per­star re­searcher Feng Zhang con­trol the patents in­volv­ing claims to CRISPR-Cas9 sys­tems for use in eu­kary­ot­ic (have a nu­cle­us) cells.

The de­ci­sion was an­oth­er huge le­gal blow to the No­bel prize win­ners, as well as the Uni­ver­si­ty of Cal­i­for­nia and Uni­ver­si­ty of Vi­en­na, and com­pa­nies like In­tel­lia Ther­a­peu­tics and Char­p­en­tier-found­ed CRISPR Ther­a­peu­tics, which do not have li­cens­es with the Broad In­sti­tute. In­tel­lia, which al­so re­leased some ear­ly CRISPR da­ta on Mon­day, saw its stock price fall by about 9% af­ter hours on Mon­day.

Oth­er com­pa­nies like Ed­i­tas Med­i­cine, which has li­censed IP from the Broad, cel­e­brat­ed the de­ci­sion.

Em­manuelle Char­p­en­tier

“The de­ci­sion reaf­firms the strength of our foun­da­tion­al in­tel­lec­tu­al prop­er­ty as we con­tin­ue our work to de­vel­op life-chang­ing med­i­cines for peo­ple liv­ing with se­ri­ous dis­eases,” Ed­i­tas CEO James Mullen said in a state­ment.

The de­ci­sion Mon­day al­so reaf­firms sev­er­al past court de­ci­sions. Back in 2018, the US Court of Ap­peals for the Fed­er­al Cir­cuit de­cid­ed that the piv­otal IP be­longed to the Broad, up­hold­ing a 2017 de­ci­sion by the USP­TO.

The patent in ques­tion, orig­i­nal­ly grant­ed in 2014, be­gan with work at the Broad and MIT in ear­ly 2011, and cul­mi­nat­ed in a pub­li­ca­tion in Sci­ence in Jan. 2013.

Jim Mullen

“This marked the world’s first en­gi­neer­ing of CRISPR-Cas9 to be de­liv­ered and used to achieve mam­malian genome edit­ing. Zhang was the first to file a patent ap­pli­ca­tion that de­scribed and en­abled such a method,” the Broad ex­plains.

De­spite the patent, and le­gal tus­sle, Zhang, Doud­na and Char­p­en­tier have sought to make their in­ven­tions more wide­ly ac­ces­si­ble. Since 2013, the in­sti­tute says that Zhang’s lab has open­ly shared CRISPR reagents and tools with more than 3,000 in­sti­tu­tions in 75 coun­tries through the non­prof­it Ad­dgene.

Uni­ver­si­ty of Illi­nois law pro­fes­sor Ja­cob Sherkow, who has been fol­low­ing the le­gal ter­rain around CRISPR-Cas9 close­ly over the years, shared his thoughts in a long thread on the re­sult yes­ter­day, adding, “I don’t think an ap­peal is go­ing any­where.”

So: what does this all mean? Well, it's pro­vid­ed some clar­i­ty to who owns the *eu­kary­ot­ic* Cas9 #CRISPR #patent es­tate: *the Broad.* An in­ter­est­ing de­vel­op­ment giv­en that the clin­i­cal tri­al com­pa­nies far­thest along—name­ly, $NT­LA and $CR­SP—*do not* have Broad #patent li­cens­es. /15

— Ja­cob S. Sherkow 🦆💊🏸⚫ (@jsh­erkow) Feb­ru­ary 28, 2022

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.