[Ip-health] Science: CRISPR, surrogate licensing, and scientific discovery

Zack Struver zack.struver at keionline.org
Fri Feb 17 10:42:47 PST 2017

Very thoughtful article from Contreras & Sherkow in Science that looks at
the reasons why exclusive licensing of CRISPR patents is contrary to the
public interest.


CRISPR, surrogate licensing, and scientific discovery
Jorge L. Contreras, Jacob S. Sherkow


We reviewed all of the CRISPR surrogate license agreements made publicly
available through filings with the U.S. Securities and Exchange Commission,
requests under state and federal “freedom-of-information” acts, and through
press releases and public announcements. In each of the principal surrogate
licenses that we reviewed, the patent-holding institution has granted its
surrogate the exclusive right to use CRISPR to develop human therapeutics
targeting any of the 20,000+ genes that comprise the human genome. Because
no single company could develop, test, and market therapeutics on the basis
of even a fraction of the entire human genome, the surrogates are
authorized and expected to sublicense their rights to others.

Despite this, it is still unlikely that any of the surrogate companies
could explore a significant fraction of the potential human health
applications that CRISPR could enable, even with a range of experienced
commercial partners and collaborators. If an unlicensed company has the
expertise and wherewithal to develop a novel human therapy using
CRISPR—even if that therapy concerns a previously unexplored gene—that
company might not be able to obtain the sublicense necessary to undertake
this work. In some instances, such as the license to Editas from the Broad
Institute of MIT and Harvard, the institution retains some right to
entertain proposals from other companies if the surrogate is not pursuing
work on a specific gene and does not plan to do so in the future. The scope
of this limitation, however, is narrow and still leaves all “unclaimed”
portions of the genome in the surrogate's hands.



CRISPR is a broadly applicable, enabling technology platform, similar in
many respects to “research tools”: equipment, reagents, and methods that
enable a broad range of downstream research (9). Exclusive rights in
research tools are generally unnecessary for commercialization of
downstream products developed using them. Rather, exclusive licenses are
only needed with respect to specific therapeutic uses discovered using
those tools. For example, a molecular drug target may be discovered using
research tools like the polymerase chain reaction (PCR) but then require
considerable and costly product development, clinical trials, and
regulatory approval before it can be marketed (9).

For this reason, in 1999 the U.S. National Institutes of Health (NIH)
recommended that patents on research tools developed using federal funding
be licensed nonexclusively to promote their greatest utilization,
commercialization, and public availability (9). In 2007, eleven major U.S.
research universities—including the University of California, Berkeley
(UCB), Harvard, and Massachusetts Institute of Technology (MIT), all of
which have made CRISPR patent claims—committed to a set of core licensing
values, known as the “Nine Points,” one of which states that universities
should make patented research tools as broadly available as possible (10).


Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428

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