[Ip-health] Joint Comments Regarding “Prospective Grant of an Exclusive Patent License: Development and Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies[,]” 85 FR 328
james.love at keionline.org
Tue Jan 28 06:03:40 PST 2020
Joint Comments Regarding “Prospective Grant of an Exclusive Patent License:
Development and Commercialization of CD19/CD22 Chimeric Antigen Receptor
(CAR) Therapies for the Treatment of B-Cell Malignancies[,]” 85 FR 328
On January 21, 2020 five groups and two individuals filed comments on a
proposed NIH license for CAR therapies to CJ Healthcare.
Knowledge Ecology International
Union for Affordable Cancer Treatment
Social Security Works
Health GAP (Global Access Project)
Professor Brook K. Baker
A company based in Korea. Another entity, the non-profit group Kids v
Cancer, has also expressed interest in the license. The comment are in the
attached zip file.
>From the introduction to the comments:
Knowledge Ecology International (KEI), Union for Affordable Cancer
Treatment, Public Citizen, Social Security Works, Health GAP (Global Access
Project), Professor Brook K. Baker, and Clare Love are writing to comment
on “Prospective Grant of an Exclusive Patent License: Development and
Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR) Therapies
for the Treatment of B-Cell Malignancies[,]” 85 FR 328.
The license concerns two CAR therapies that were developed at the National
Cancer Institute (NCI) and treat relapsed B-cell acute lymphoblastic
leukemia (ALL)—the leading cause of cancer death in children—and other
hematological cancers. Clinical research that contributed to the cell
therapies was sponsored by the National Institutes of Health (NIH) and
pediatric cancer charities. The first therapy is being tested in three
Phase I clinical trials, one conducted by the NIH, and the other two by the
Stanford Cancer Institute with funding from the NIH and the California
Institute of Regenerative Medicine (CIRM). Early results have been
The NIH is proposing to license the inventions to CJ Healthcare Corp., a
large, Korea-based company known for marketing the country’s “No.1
It is our understanding that Kids v. Cancer, a US-based charity, is also
interested in bringing the invention to practical application, and that
this effort is supported by Crystal Mackall, the Ernest and Amelia Gallo
Family Professor of Pediatrics and Medicine at Stanford University, and
until 2016, the Chief of the Pediatric Oncology Branch (POB) at the NCI.
Mackall is one of the inventors of the cell therapies and is overseeing the
two Stanford clinical trials.
We note the Bayh-Dole Act has a preference for US-based manufacturers and
small businesses. 35 U.S.C. § 209(b)-(c). The prospective licensee is
neither small nor based in the US.
We object to the license unless the NIH performs the analysis required by
the Bayh-Dole Act. Under that statute, a federal agency may not license a
government-owned technology on an exclusive basis unless “granting the
license is a reasonable and necessary incentive to . . . call forth the
investment capital and expenditures needed to bring the invention to
practical application[,]” and the “scope of exclusivity” is “not greater
than reasonably necessary to provide the incentive for bringing the
invention to practical application[.]” 35 U.S.C. § 209(a)(1)-(2).
We are concerned that the NIH has not undertaken the appropriate analysis
to determine if an exclusive license is required, and, perhaps more
important, if exclusivity is necessary, the proper limitations on the scope
of rights. A license that is appropriate in scope will limit the
restrictions on competition that an exclusive license imposes and will
ensure that the benefits of the inventions are “available to the public on
reasonable terms,” a requirement included in the statutory definition of
“practical application” of an invention.
The NIH is also required by 40 U.S.C. § 559 to seek the advice of the
Attorney General with respect to antitrust law before licensing
In the event that the NIH grants the license we urge that it incorporate
provisions designed to safeguard the public interest and promote the policy
objectives of the Bayh-Dole Act and the Public Health Service (PHS)
Technology Transfer Policy Manual.
James Love. Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
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