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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