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Government use rights under 37 CFR 404.7
I have a request to repost the citation to the federal regulations
on licensing of US government owned inventions, and in particular
37 CFR 404.7 (a)(2), which concerns the issue of giving the
World Health Organization (WHO) or a foreign government the right
to use a patent. This regulation applies to inventions like ddI or
ddC that are licensed from a government agency like NIH.
There is a separate statutory authority that applies to inventions
like d4T, 3TC or Ritonavir, where the patent is held by a non-
government entity (Such as Yale University, Emory or Abbott
Laboratories) but the government retains rights due to the use of a
federal grant or contract. I will also repost that citation.
Here is the relevant section of 37CFR404.7:
(2) In addition to the provisions of Sec. 404.5, the following terms
and conditions apply to domestic exclusive and partially exclusive
licenses;
(i) The license shall be subject to the irrevocable, royalty-free
right of the Government of the United States to
practice and have practiced the invention on behalf of the United States
and on behalf of any foreign government or international organization
pursuant to any existing or future treaty or agreement with the United
States.
(ii) The license shall reserve to the Federal agency the right to
require the licensee to grant sublicenses to responsible applicants, on
reasonable terms, when necessary to fulfill health or safety needs.
<--------------------37 CFR 404.7--------------------------------->
Here is the entire 37CFR404.7
[Code of Federal Regulations]
[Title 37, Volume 1]
[Revised as of July 1, 1998]
>From the U.S. Government Printing Office via GPO Access
[CITE: 37CFR404.7]
[Page 533-534]
TITLE 37--PATENTS, TRADEMARKS, AND COPYRIGHTS
CHAPTER IV--ASSISTANT SECRETARY FOR TECHNOLOGY POLICY, DEPARTMENT OF
COMMERCE
PART 404--LICENSING OF GOVERNMENT OWNED INVENTIONS--Table of Contents
Sec. 404.7 Exclusive and partially exclusive licenses.
(a)(1) Exclusive or partially exclusive domestic licenses may be
granted on federally owned inventions three months after notice of the
invention's availability has been announced in the Federal Register, or
without such notice where the Federal agency determines that expeditious
granting of such a license will best serve the interest of the Federal
Government and the public; and in either situation, only if;
(i) Notice of a prospective license, identifying the invention and
the prospective licensee, has been published in the Federal Register,
providing opportunity for filing written objections within a 60-day
period;
(ii) After expiration of the period in Sec. 404.7(a)(1)(i) and
consideration of any written objections received during the period, the
Federal agency has determined that;
(A) The interests of the Federal Government and the public will best
be served by the proposed license, in view of the applicant's
intentions, plans, and ability to bring the invention to practical
application or otherwise promote the invention's utilization by the
public;
(B) The desired practical application has not been achieved, or is
not likely expeditiously to be achieved, under any nonexclusive license
which has been granted, or which may be granted, on the invention;
(C) Exclusive or partially exclusive licensing is a reasonable and
necessary incentive to call forth the investment of risk capital and
expenditures to bring the invention to practical application or
otherwise promote the invention's utilization by the public; and
(D) The proposed terms and scope of exclusivity are not greater than
reasonably necessary to provide the incentive for bringing the invention
to practical application or otherwise promote the invention's
utilization by the public;
(iii) The Federal agency has not determined that the grant of such
license will tend substantially to lessen competition or result in undue
concentration in any section of the country in any line of commerce to
which the technology to be licensed relates, or to create or maintain
other situations inconsistent with the antitrust laws; and
(iv) The Federal agency has given first preference to any small
business firms submitting plans that are determined by the agency to be
within the capabilities of the firms and as equally likely, if executed,
to bring the invention to practical application as any plans submitted
by applicants that are not small business firms.
(2) In addition to the provisions of Sec. 404.5, the following terms
and conditions apply to domestic exclusive and partially exclusive
licenses;
(i) The license shall be subject to the irrevocable, royalty-free
right of the Government of the United States to
[[Page 534]]
practice and have practiced the invention on behalf of the United States
and on behalf of any foreign government or international organization
pursuant to any existing or future treaty or agreement with the United
States.
(ii) The license shall reserve to the Federal agency the right to
require the licensee to grant sublicenses to responsible applicants, on
reasonable terms, when necessary to fulfill health or safety needs.
(iii) The license shall be subject to any licenses in force at the
time of the grant of the exclusive or partially exclusive license.
(iv) The license may grant the licensee the right of enforcement of
the licensed patent pursuant to the provisions of Chapter 29 of Title
35, United States Code, or other statutes, as determined appropriate in
the public interest.
(b)(1) Exclusive or partially exclusive licenses may be granted on a
federally owned invention covered by a foreign patent, patent
application, or other form of protection, provided that;
(i) Notice of a prospective license, identifying the invention and
prospective licensee, has been published in the Federal Register,
providing opportunity for filing written objections within a 60-day
period and following consideration of such objections;
(ii) The agency has considered whether the interests of the Federal
Government or United States industry in foreign commerce will be
enhanced; and
(iii) The Federal agency has not determined that the grant of such
license will tend substantially to lessen competition or result in undue
concentration in any section of the United States in any line of
commerce to which the technology to be licensed relates, or to create or
maintain other situations inconsistent with antitrust laws.
(ii) The license shall be subject to any licenses in force at the
time of the grant of the exclusive or partially exclusive license.
(iii) The license may grant the licensee the right to take any
suitable and necessary actions to protect the licensed property, on
behalf of the Federal Government.
(c) Federal agencies shall maintain a record of determinations to
grant exclusive or partially exclusive licenses.
--
James Love, Director, Consumer Project on Technology
I can be reached at love@cptech.org, by telephone 202.387.8030,
by fax at 202.234.5176. CPT web page is http://www.cptech.org