Knowledge Ecology International (KEI) filed comments with the National Institutes of Health (NIH) on March 16, 2022 regarding the “Prospective Grant of an Exclusive Patent License: Development and Commercialization of Chimeric Antigen Receptor T-Cell Therapies (CAR-T) That are Specific to CD22 and Other B-Cell Antigens for the Treatment of B-Cell Malignancies” (87 FR 11451). The technology is to be licensed on an exclusive, worldwide basis to Syncopation Life Sciences. There was a previous Federal Register notice for a CAR therapy for B-cell malignancies to Syncopation in July 2021. KEI commented on that previous notice as well.
As noted in our previous comments, Syncopation was incorporated in May 2021, and one of the three founders listed is Nancy Goodman, who is better known to some for her charity Kids v Cancer, and her role in lobbying for the pediatric priority review voucher. KEI reached out to Nancy Goodman requesting a call regarding this prospective license, but received no response.
KEI reached out to the NIH in advance of the comment deadline to ask about the Federal Register notice at hand, and how it related to the previously noticed prospective exclusive license. KEI asked:
- “Can you please clarify the differences between the prospective license noticed in 86 FR 33326 (July 2021) and the current open notice 87 FR 11451? I note there are differences in the lists of intellectual property to be licensed (largely the same, but with the addition of E-017-2017-0 in the new notice) and fields of use – can you please clarify?
- Was the previous license noticed in July 2021 executed? And if so, is the current notice an amendment to the existing license or considered a new, additional license to Syncopation?”
The NIH responded promptly, stating that:
- “Your assessment is accurate, the fields of use and IP families are different. These differences necessitated a new posting in the Federal Register.
- The previous posting in the federal register has not yet been executed.”
The current notice then, is an expansion of the previously announced prospective license to Syncopation, in both fields of use and intellectual property to be exclusively licensed. KEI’s comments regarding the license follow below.
March 16, 2022
Jim Knabb
Senior Technology Transfer Manager
NCI Technology Transfer Center
National Cancer Institute
National Institutes of Health
Email: jim.knabb@nih.gov
Dear Jim,
KEI would like to incorporate by reference the comments made last year on the notice to Syncopation Life Sciences, on the web here: https://www.keionline.org/36436
As an aside, I would note that Niels Reimers recently defended the practice of Xtandi being priced at 3 x 6 times higher in the United States than in other high income countries.
Reimbers is the former director of the Office of Technology Licensing (OTL) at Stanford. and as you know, many of the decision makers for Syncopation Life Sciences are affiliated with Stanford. We are concerned that this company may make no effort to address the requirements in the Bayh-Dole act to make the benefits of inventions “available to the public on reasonable terms, or to address the PHS policy of addressing access and affordability in developing countries.
Has Syncopation Life Sciences been asked by the NIH to address any of the measures we proposed on reasonable terms or developing countries?
—
James Love