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CRISPR-Cas is a suite
of genetic engineering tools with wide-ranging technical applications and worrisome
ethical implications, the latter of which I’ve provided Journal covers on the
cover page to posit.  This suite of tools
utilizes a nucleic acid-based targeting molecule and a single enzyme, Cas,
which can itself be modified and engineered – albeit, not as readily – to affect
various outcomes.  While less efficient
in DNA editing than previous state of the art methods such as TAL-Endonucleases
(TALENs) and Zinc Finger Nucleases (ZFNs), CRISPR-Cas is cheap, pliable, and
accessible to moderately skilled molecular engineers lending credence to the
phrase bandied about that it is democratizing biomolecular engineering.  The promise of such a tool is vast, yet two
scientific figures, and their representative institutions, went head-to-head
over the exclusive rights to utilize CRISPR-Cas technology in human
therapeutics and other biotechnology related applications.  This battle spurs or renews many interesting
questions surrounding life sciences patent law, specifically, how the societal benefits
and personal disadvantages of collaborating versus siloing in the sciences and
tech development arena should be treated as a nuanced balancing act or whether,
which is currently the case, exclusive rights ought to be granted on the binary
basis of first-to-file over first-to-invent.  To set the scene, in 2012, Jennifer Doudna,
Professor at UC Berkeley together with Emmanuelle Charpentier, Martin Jinek,
Krzysztof Chylinki, Ines Fonfara, and Michael Hauer published in the journal
Science their discovery of the mechanism behind an ancient form of adaptive
immunity discovered in E. coli published
as “A programmable dual-RNA-guided DNA
endonuclease in adaptive bacterial immunity.”  In 2011, prior to the seminal publication Doudna
founded Caribou Biosciences, Inc., whose sweeping “singular focus is – the advancement
of new applications for CRISPR-Cas gene editing that will help bring the
tremendous promise this technology holds for patients and consumers to reality.” (Caribou
Biosciences Inc., 2018)  Feng Zhang, one of now twelve core faculty members
at The Broad Institute, a joint MIT-Harvard multidisciplinary biomedical research
institute in Cambridge, MA, had simultaneously switched from TAL- and light-based
genome engineering to CRISPR-Cas systems, publishing 58 papers since 2013
directly related to CRISPR-Cas biology and applications as counted under the ‘publications’
link on his laboratory’s website (The Zhang
Lab, 2015).  Briefly, this covers basic molecular
structure elucidation, the discovery and engineering of variant Cas and Cpf
enzymes, viral delivery of the genetic components to specific tissues – importantly
including human cells – as well as exploring various screening and therapeutic
applications.  In 2013, Editas Medicine was
founded and both Doudna and Zhang sat on the Board of Directors.  Despite the fact that Doudna applied for the
CRISPR patent first, Zhang/MIT-Harvard was awarded the patent (No. 8,697,359)
in 2014 as a result of applying for an expedited review process which cost $70,
following up on a 299-page provisional filed in 2012.  Doudna left Editas soon thereafter and founded
Intellia Therapeutics Inc.  In 2015,
Berkeley filed a claim on behalf of Doudna, entering into litigation with Zhang
and the Broad.  As Robert Kolker stated
with all the grandiosity he could muster, “Doudna and Zhang may have
to take the stand, each asserting under oath that she or he deserves the patent
for what may well be the biological advancement of our age. The stakes are
sky-high. Billions of dollars in revenue. Control over entire industries yet to
be born. And, perhaps, the future of human evolution.”   In 2016,
Editas raised $120M in Series B funding and went public with an IPO valued at
$94.5M. Intellia goes public the same year, netting $108M. Charpentier, coauthor
to Doudna’s seminal paper founded Crispr Therapeutics, which raised $198M in
venture capital, and an additional $440M in contracts with industry partners.  (Kolker, 2016)

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