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

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Prescription drug discount provider GoodRx will no longer be allowed to share its users’ sensitive health data with advertisers after the Federal Trade Commission charged the online coupon provider with failing to notify consumers of such disclosures to Facebook, Google, and other companies.

GoodRx agreed to pay a $1.5 million civil penalty for violating the FTC’s Health Breach Notification Rule after the FTC said it repeatedly violated a 2017 promise to not share sensitive personal health information. The FTC alleged that the company shared users’ prescription medications and personal health conditions with third party advertisers and platforms like Facebook, Google, Criteo, Branch and Twilio.

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.