[Ip-health] KEI and UACT comments on the prospective grant of exclusive licenses to Sinotau and MTTI

Luis Gil Abinader luis.gil.abinader at keionline.org
Tue Aug 28 07:50:24 PDT 2018


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 (
https://www.federalregister.gov/d/2018-16066) and 83 FR 35663 (
https://www.federalregister.gov/d/2018-16065).

Sinotau Pharmaceutical (
https://web.archive.org/web/20180827151941/http://www.sinotau.com/english/about.html)
is a company headquartered in Beijing, China. Molecular Targeting
Technologies, Inc. (MTTI) (
https://web.archive.org/web/20180808003041/http://www.mtarget.com/) is a
Delaware corporation. The co-founder and CEO of MTTI, Koon Yan “Chris” Pak,
Ph.D, (
https://web.archive.org/web/20180826003534/http://www.mtarget.com/ABUS.html)
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” (
https://web.archive.org/web/20180828141338/https://clinicaltrials.gov/ct2/results?cond=PSMA-617&term=&cntry=&state=&city=&dist=)
and “EB-TATE” (
https://web.archive.org/web/20180828141513/https://clinicaltrials.gov/ct2/results?cond=EB-TATE&term=&cntry=&state=&city=&dist=),
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:

FOR IMMEDIATE RELEASE 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.”


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