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
- Public Citizen
- Social Security Works
- Health GAP (Global Access Project)
- Professor Brook K. Baker
- Clare Love
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 promising.
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 Anti-hangover drink.”
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 government-owned inventions.
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.