On August 27, 2018, Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) filed comments to the NIH regarding the prospective grant of two separate exclusive licenses to Sinotau Pharmaceutical Group and Molecular Targeting Technologies, Inc. (MTTI), respectively. These prospective exclusive licenses were announced in the Federal Register notices 83 FR 35667 and 83 FR 35663.
Sinotau Pharmaceutical is a company headquartered in Beijing, China. Molecular Targeting Technologies, Inc. (MTTI) is a Delaware corporation. The co-founder and CEO of MTTI, Koon Yan “Chris” Pak, Ph.D, has served as the President of the Chinese American Society of Nuclear Medicine, and Chairman of the Chinese Entrepreneur Association, which he co-founded.
A PDF of the two comments filed yesterday are available here:
https://www.keionline.org/wp-content/uploads/2018/08/KEI-UACT-NIH-MTTI-27Aug2018.pdf
https://www.keionline.org/wp-content/uploads/2018/08/KEI-UACT-NIH-Sinotau-27Aug2018.pdf
According to the Federal Register notice 83 FR 35667, the prospective exclusive license to Sinotau Pharmaceutical Group “would be granted worldwide” and for a field of use “not broader than radiotherapeutics for metastatic castration-resistant prostate cancer,” the same indication as Xtandi. The Federal Register notice 83 FR 35663 states that the prospective exclusive license to MTTI “will be granted worldwide” and for a field of use “not broader than radiotherapeutics for somatostatin-receptor expressing neuroendocrine tumors.”
Nevertheless, in each case the Federal Register notice only describe one patent document and states that the license will include “all continuing U.S. and foreign patents/patent applications thereof.” Neither of these Federal Register notice explain how many additional “continuing U.S. and foreign” applications the NIH has filed or plans to file based on the same priority documents, nor whether the NIH plans to file applications claiming these inventions in developing countries.
Moreover, a Clinicaltrials.gov search for the two inventions described in the Federal Register notice, “PSMA-617” and “EB-TATE”, suggests that the NIH has funded one of the eight ongoing clinical trials related to PSMA-617 for the treatment of prostate cancer and the two clinical trials concerning the use of EB-TATE for the treatment of neuroendocrine tumors. These two indications are the same one described in the Federal Register notices 83 FR 35667 and 83 FR 35663. Despite this, neither of the Federal Register notices have a discussion of the role of government agencies in funding research related to the inventions the NIH plans to license, nor the expected costs of bringing a new treatment to market.
KEI and UACT opposes the granting of an exclusive license, on the grounds that the NIH have not provided sufficient information to evaluate a request for an exclusive license. However, in the event that the NIH does issue these exclusive licenses, KEI and UACT also proposed several conditions on the exclusive licenses to ensure that the benefits of the invention are available to the public on reasonable terms, and that the scope of the exclusive rights are limited to that which are reasonably necessary to induce the investment necessary to achieve practical application of the invention.
The following is a statement attributable to James Packard Love, Director of KEI:
August 27, 2018
“This seems to be a case where a former Chinese national working for the NIH have a close relationship with Chinese researchers and businesses with Chinese investors, and these licenses can be seen to be one manifestation of those relationships. We are asking the NIH to include provisions in the licenses to ensure that the US funded inventions are available to US residents at prices no higher than other high income countries, that the NIH ensure that the term of the monopoly is related to the revenues earned on the licenses, that developing country access is addressed, and that the public be given greater transparency of the costs of R&D and revenues relating to these NIH owned inventions.”