Patents for CRISPR-Cas-9-Technology

Mer­ck announced that two of its CRISPR-Cas-9-assist­ed genome-edit­ing patents have been allowed in the Unit­ed States. These allowances pro­vide Mer­ck with the oppor­tu­ni­ty to sup­port U.S. sci­en­tists and researchers in their work to advance and pro­tect gene ther­a­py devel­op­ment pro­grams. The com­pa­ny is in active dis­cus­sions to license its foun­da­tion­al tech­nol­o­gy for ther­a­peu­tic and oth­er uses and is seek­ing col­lab­o­ra­tion part­ners for research and prod­uct development.

“This is impor­tant news for researchers, as CRISPR-based DNA cleav­age and inte­gra­tion are fun­da­men­tal for many genome-edit­ing appli­ca­tions and can be used to devel­op per­son­al­ized ther­a­pies,” said Udit Batra, mem­ber of the Mer­ck Exec­u­tive Board and CEO, Life Sci­ence. “As a lead­ing inno­va­tor of CRISPR tech­nol­o­gy, we will license this tech­nol­o­gy to ensure that the full poten­tial of this pow­er­ful tool is real­ized, respon­si­bly and eth­i­cal­ly, through­out the sci­en­tif­ic com­mu­ni­ty. We look for­ward to con­tin­u­ing our work with aca­d­e­m­ic and indus­tri­al part­ners to bring the best of our col­lec­tive inno­va­tions to fight the tough­est dis­eases and improve human health.”

These lat­est allowances cov­er Merck’s CRISPR-Cas‑9 cleav­age and inte­gra­tion tech­nol­o­gy, which  allows researchers to replace a dis­ease-asso­ci­at­ed muta­tion with a ben­e­fi­cial or func­tion­al sequence, or delete such a muta­tion, com­mon­ly referred to as “knock in” and “knock out,” crit­i­cal meth­ods for the cre­ation of dis­ease mod­els and devel­op­ment of gene therapy.

These grants mark the 25^th and 26^th CRISPR patents world­wide belong­ing to Mer­ck and the third and fourth in the U.S. The com­pa­ny has CRISPR patents grant­ed in Aus­tralia, Cana­da, Chi­na, Europe, Israel, Sin­ga­pore and South Korea with relat­ed patent fil­ings in Brazil, India and Japan.

CRISPR tech­nol­o­gy is a core com­pe­ten­cy for Mer­ck, which has 16 years’ expe­ri­ence with genome edit­ing, span­ning dis­cov­ery to man­u­fac­tur­ing. The com­pa­ny devel­ops tech­nolo­gies in a range of genome-edit­ing appli­ca­tions, includ­ing gene knock­out, gene inte­gra­tion and CRISPR libraries for genet­ic screens. Mer­ck received its first U.S. patent in Feb­ru­ary 2019 for its proxy-CRISPR tech­nol­o­gy, which makes genome edit­ing more effi­cient, flex­i­ble and specific.

Mer­ck con­sid­ers that now is the time for the key CRISPR intel­lec­tu­al prop­er­ty stake­hold­ers to come togeth­er to sim­pli­fy tech­nol­o­gy access for com­pa­nies con­duct­ing CRISPR-based research via patent pool­ing agree­ments. Mer­ck and The Broad Insti­tute announced their col­lab­o­ra­tion agree­ment for CRISPR patent licens­ing in July 2019.

The com­pa­ny rec­og­nizes that genome edit­ing has result­ed in major advance­ments in bio­log­i­cal research and med­i­cine. At the same time, the grow­ing poten­tial of genome-edit­ing tech­nolo­gies has led to sci­en­tif­ic, legal and soci­etal con­cerns. Mer­ck sup­ports research with genome edit­ing under care­ful con­sid­er­a­tion of eth­i­cal and legal stan­dards. Mer­ck has estab­lished an inde­pen­dent, exter­nal Bioethics Advi­so­ry Pan­el to pro­vide guid­ance for research in which its busi­ness­es are involved, includ­ing research on or using genome edit­ing and has devel­oped, defined and trans­par­ent­ly pub­lished a clear Genome-Edit­ing Tech­nol­o­gy Prin­ci­ple tak­ing into account sci­en­tif­ic and soci­etal issues to inform promis­ing ther­a­peu­tic approach­es for use in research applications.