86 For the industry, global competitive pressures meant a similar
reluctance to tolerate regulatory slowdowns for long.
87 Eventually both
industry and academic researchers aligned to reduce NIH power and return
to so-called self-regulation.
The story of CRISPR is likely to follow the path of rDNA technology of
the 70s and 80s. The ferocious frenzy created by a new technology such as
CRISPR that promises patents, riches, and academic fame and celebrity
status is hard to resist. The promises of such a tool tend to suppress long term
efforts at mindful reflection about pace and risks, and cancels out objectivity
even among the best of scientists who hope to benefit from the remarkable
efficiency of CRISPR.
We cannot say that CRISPR does not present a range of risks, and we
cannot safely feel comfortable with the claims of researchers to self-regulatory autonomy in such a case. We need even more with CRISPR – a
systematic theory of institutional regulation of research hazards is required
for differing levels of hazards. The CRISPR controversy, just like the rDNA
controversy before it,
89 requires outside oversight to deal with the problem of
research uncertainty in its many dimensions.
2. Patent Licenses Have Potential. . .and Limits.
CRISPR is still free to be used by industry and academia with few legal or
regulatory constraints, given the slow pace of regulatory developments. This
is changing rapidly as patents are developed for various CRISPR
technologies. Patent disputes and their resolution may affect which of the
commercial entities pursing CRISPR research benefits win and which are
forced to stop.
90 The same result may occur with academic research
91 Additionally, litigation over and enforcement of patent rights
may shift the functions of research universities from pure research to
commercialization and profit.
92 In the words of one commentator, “[t]aken
together, these shifts may complicate the future of gene editing.”
One response to the above critique is to suggest that the use of CRISPR
86. Id. at 454.
87. See id. at 454 (“[T]he most powerful factor, the structure of global industrial
competition, transmitted by corporations that are free to move personnel and capital across
national boundaries, set nations in competition to attract and keep new sources of innovation,
industry, and employment.”).
90. Jacob S. Sherkow, Who Owns Gene Editing? Patents in the Time of CRISPR, 38
BIOCHEMIST 26, 28 (2016).
91. Id. at 28–29.