[Ip-health] Your tax dollars at work: Licencing of patents on US government owned inventions: concerns about transparency, protection of public interest

Zack Struver zack.struver at keionline.org
Fri Mar 11 12:18:20 PST 2016


Your tax dollars at work: Licencing of patents on US government owned
inventions: concerns about transparency, protection of public interest
By James Love

On February 23, I provided a few notes
<https://medium.com/@jamie_love/nih-owned-patents-852e9fdf1fbf#.b7k530981> on
our work monitoring the NIH licensing of four inventions, (1) patents on a
new class of drugs to treat the HCV virus (to a company without a web page,
address or known principals), (2) a new drug for HER2+ breast cancer (a
license apparently never issued), (3) patents on a diagnostic testing
technology to a small Irish firm, and (4) licenses to a large portfolio of
patents for attenuated respiratory syncytial virus (RSV) vaccines, to the
French firm Sanofi.

We ended up filing 10 pages of comments <http://www.keionline.org/node/2445> on
the RSV vaccine patents, with MSF, in response to a notice in the Federal

The RSV comments were signed by myself, Diane Singhroy, the KEI Scientific
and Technical Advisor, and Judit Rius, the U.S. Manager and Legal Policy
Adviser for the Access Campaign at Medecins Sans Frontieres/ Doctors
Without Borders (MSF).

The NIH apparently does not make the comments on licenses public, but a
copy of our March 8, 2016 filing is available here:

In preparing the RSV comments, we were met with even more secrecy from the
NIH, which prompted our colleague Claire Cassedy to write to the White
House Office of Science and Technology Policy (OSTP
<http://keionline.org/sites/default/files/KEI-letter-OSTP-03-04-16.pdf>) to
register a complaint.

The licensing contact at the NIH, whose name was listed on the Federal
Register notice as the person to contact for information, told us he was
not allowed to talk to KEI, and we would have to direct our questions to
the Office of Communications and Government Relations (OCGR). We reached
out to the OCGR, which asked us to contact someone else, and in the end,
the NIH would not answer any questions about the vaccine license, or even
share the patent applications, which, according to the Federal Register
Notice, are supposed to be available.

The NIH has spent more than 25 years developing a vaccine for RSV, and has
taken the vaccine into trials with humans. KEI and MSF want the NIH to
address pricing and affordability issues, before we give the vaccine away
to Sanofi, and we also want the NIH to consider doing the remaining trials
itself, so that the vaccine technology would be available to any
manufacturer, and could be made available to the public at the cost of
production, instead of whatever monopoly price Sanofi will end up charging.

Our comments on the RSV vaccine also pushed the NIH to address the
obligations in federal regulations for such licenses, including in
particular 37 C.F.R. § 404.7(a)(1)(ii)(B-C), which requires the agency to
limit the use of exclusive rights, so that the rights granted are “not
greater than reasonably necessary to provide the incentive for bringing the
invention to practical application.”

While we were working on the RSV vaccine patents, KEI also asked the U.S.
Army about a notice of intent for an exclusive license to patents on the
Digital Optical Method (DOMTM), or United States Patent No. 7,495,767. In
the DOMTM case, we asked the Army <http://keionline.org/node/2439> the
following question:

"Did the Army do any analysis to determine if the public is better off with
an exclusive or non-exclusive license for this technology? As you know, the
point of an exclusive license is to create a monopoly on the technology.
Did the Army determine that the public benefits from creating a monopoly in
this case, and if so, will the Army share that analysis with Knowledge
Ecology International (KEI) so we can publish that analysis and provide

Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428

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