INSIGHTS | POLICY FORUM
700 17 FEBRUARY 2017 • VOL 355 ISSUE 6326
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).
Although CRISPR is not necessarily a
“research tool” in that its function is generally not to enable downstream research, it
is a broadly applicable “platform” technology—like stem cells or the Internet—that
could enable innumerable specific applications. To that end, foundational CRISPR
patents, like patents covering research
tools, should be licensed and disseminated
as widely as possible especially when developed with public funding by universities operating in the public interest (11–14).
To their credit, the UCB and the Broad
Institute have not sought to limit academic
research through their exclusive CRISPR
licenses (1). Both have made many of their
CRISPR research tools available freely or
cheaply through AddGene, a nonprofit
organization in service of academic and
nonprofit institutions (1, 14). Likewise, as
noted above, the institutions have granted
nonexclusive licenses in the area of tool
But the exclusive licenses granted to
the institutions’ surrogates for human
therapeutics limit access to CRISPR as a
platform technology, potentially hinder-
ing competition and creating innovation
bottlenecks. For example, the Broad’s sur-
rogate, Editas, has granted Juno Thera-
peutics an exclusive license to develop a
host of CRISPR therapies—across multiple
genes—using chimeric antigen receptor T
cell (CAR-T) technology (15). This broad
license threatens to complicate both re-
search and development for CRISPR-based
CAR-T technologies for gene targets cho-
sen by Juno, but that neither Editas nor
Juno have the bandwidth to pursue. In
other instances, overly broad exclusive li-
censes may hinder research into socially
such as those indicated for rare diseases
or treating illnesses prevalent in disadvan-
taged populations or regions, a separate
yet equally important principle advanced
in the Nine Points document.
Situations like these—in which exclusive licenses have the potential to extend
beyond that which can be developed—are
precisely what the NIH guidelines and the
Nine Points sought to avoid. Yet the surrogate licensing model adopted by the
CRISPR patent-holding institutions seemingly allows them to circumvent this proscription by ceding licensing authority to
private companies not bound by the guidelines and Nine Points.
RECONCEPTUALIZING CRISPR LICENSING
Given the potential bottlenecks created
by the current surrogate licensing model,
UCB, Harvard, and MIT should broaden
access to CRISPR technology for human
therapeutics. Given that the technology
is developing rapidly and,
in some instances, now being disputed among the
parties, there is still time
to do so. This dynamism in
CRISPR’s patent landscape
should provide the impetus
for these institutions—and
their surrogate companies—
both to amend their existing
agreements and to cross-license their respective patent rights to one
another. And these cross-licenses need not
As an example, Broad and UCB could
reserve their rights to license CRISPR to
other commercial firms engaged in therapeutic research on areas of the genome
that their surrogates do not have a reasonable plan to develop. The institutions could
thus open up larger swaths of the genome
to beneficial commercial research. Both
UCB and Broad have recently shown some
attraction to this approach by announcing
limited cross-licensing agreements with
other institutions, albeit not with one another (16, 17). A more flexible licensing approach would result in greater competition
and innovation in the marketplace—in the
spirit of the Nine Points agreement.
The emergence of CRISPR as an impor-
tant new platform technology should also
prompt NIH to update its guidelines re-
garding the licensing of federally funded
inventions. Platform technologies such
as CRISPR should be recognized as offer-
ing the same potential for industry-wide
innovation and discovery as traditional
research tools. A similar updating of, and
recommitment to, the Nine Points may
also be in order.
As the National Academies of Science
have noted, “the first goal of university
technology transfer involving (
intellectual property) is the expeditious and wide
dissemination of university-generated
technology for the public good” (12). The
institutions controlling patent rights in
CRISPR have delegated that responsibility
to surrogate companies, which determine
how many or few commercial firms will
be able to exploit it. We urge these institutions to rethink their use of exclusive, surrogate licenses across the entire genome.
Those institutions should ensure that any
exclusive licenses are narrowly drawn to
specific genes, to maximize competition in
the development of the revolutionary technology they have created. j
REFERENCES AND NOTES
1. J. S. Sherkow, Nature 532, 172 (2016).
2. J. S. Sherkow, Nat. Biotechnol. 33, 256 (2015).
3. H. Ledford, Nature 537, 460 (2016).
4. K. J. Egelie, G. D. Graff, S. P. Strand, B. Johansen, Nat.
Biotechnol. 34, 1025 (2016).
5. License agreement bet ween the President and Fellows
of Harvard College, the Broad Institute, Inc., and Editas
Medicine, Inc. (29 October 2014).
6. Exclusive License bet ween Caribou Biosciences, Inc., and
the University of Vienna and The Regents of the University
of California for methods and compositions for RNA-directed target DNA modification and for RNA-directed
modulation of transcription (16 April 2013).
7. L. Pressman et al ., Nat. Biotechnol. 24, 31 (2006).
8. J. Carter-Johnson, J. S. Carter-Johnson, J. L. Contreras,
in Bioinformatics Law: Legal Issues for Computational
Biology in the Post-Genome Era, J. L. Contreras, A. J.
Cuticchia, Eds. (American Bar Association, 2013), pp.
9. NIH, Fed. Regist. 64 (246), 72090 (1999).
10 Association of University Technology Managers, in the
Public Interest: Nine Points to Consider in Licensing
University Technology (AUTM, Washington, DC, 2007).
11. I. Ayres, L. L. Ouellette, Cornell Law Rev. 102, 271 (2017).
12. National Research Council, Managing University
Intellectual Property in the Public Interest, S. A. Merrill and
A.-M. Mazza, Eds. (National Academy Press, 2010).
13. A. K. Rai, R. S. Eisenberg, La w Contemp. Probl. 66, 289
14. L. McGuire,Nature 534, 37 (2016).
15. Collaboration and license agreement bet ween Editas
Medicine, Inc., and Juno Therapeutics, Inc. (25 May 2015).
16. Caribou Biosciences, CRISPR Therapeutics, Intellia
Therapeutics, Caribou Biosciences, and ERS Genomics
announce global agreement on the foundational intellectual property for CRISPR/Cas9 gene editing technology
[press release] (2016); http://bit.ly/2j Wnk ON.
17. Editas Medicine, Editas Medicine extends CRISPR genome
editing leadership through licensing of new CRISPR
technologies [news] (Editas Medicine, 2016); http://bit.
The authors thank M. Eixenberger for invaluable research
“Platform technologies such as CRISPR
should be recognized as offering the
same potential for industry-wide
innovation and discovery as traditional