[Ip-health] US regulations on grant of exclusive licenses on government owned patents

Jamie Love james.love at keionline.org
Sat Mar 5 10:20:19 PST 2016


The granting of exclusive rights in government owned patents is governed by
this regulation:

37 CFR 404.7 - Exclusive, co-exclusive and partially exclusive licenses.

Note conditions 57 CRF 404.7 (a)(1)(ii)(A-B).

(A) The public will be served by the granting of the license, in view of
the applicant's intentions, plans and ability to bring the invention to the
point of practical application or otherwise promote the invention's
utilization by the public.

(B) Exclusive, co-exclusive or partially exclusive licensing is a
reasonable and necessary incentive to call forth the investment capital and
expenditures needed to bring the invention to practical application or
otherwise promote the invention's utilization by the public; and

(C) The proposed scope of exclusivity is not greater than reasonably
necessary to provide the incentive for bringing the invention to practical
application, as proposed by the applicant, or otherwise to promote the
invention's utilization by the public;

  Really hard to answer these questions when the NIH gives ZERO information
out about the technology, the stage of development,  or the license terms.

Jamie

--------------------
37 CFR 404.7 - Exclusive, co-exclusive and partially exclusive licenses.

§ 404.7 Exclusive, co-exclusive and partially exclusive licenses.

(a) (1) Exclusive, co-exclusive or partially exclusive domestic licenses
may be granted on Government owned inventions, 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 at least a 15-day period;

(ii) After expiration of the period in § 404.7(a)(1)(i) and consideration
of any written objections received during the period, the Federal agency
has determined that;

(A) The public will be served by the granting of the license, in view of
the applicant's intentions, plans and ability to bring the invention to the
point of practical application or otherwise promote the invention's
utilization by the public.

(B) Exclusive, co-exclusive or partially exclusive licensing is a
reasonable and necessary incentive to call forth the investment capital and
expenditures needed to bring the invention to practical application or
otherwise promote the invention's utilization by the public; and

(C) The proposed scope of exclusivity is not greater than reasonably
necessary to provide the incentive for bringing the invention to practical
application, as proposed by the applicant, or otherwise to promote the
invention's utilization by the public;

(iii) The Federal agency has not determined that the grant of such a
license will tend substantially to lessen competition or create or maintain
a violation of the Federal 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
capability of the firms and as having equal or greater likelihood as those
from other applicants to bring the invention to practical application
within a reasonable time.

(2) In addition to the provisions of § 404.5, the following terms and
conditions apply to domestic exclusive, co-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 or 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, co-exclusive or partially exclusive license.

(b) (1) Exclusive, co-exclusive or partially exclusive foreign licenses may
be granted on a Government owned invention provided that;

(i) Notice of the prospective license, identifying the invention and
prospective licensee, has been published in the Federal Register, providing
opportunity for filing written objections within at least a 15-day period
and following consideration of such objections received during the period;

(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 a
license will tend substantially to lessen competition or create or maintain
a violation of the Federal antitrust laws.

(2) In addition to the provisions of § 404.5, the following terms and
conditions apply to foreign exclusive, co-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 be subject to any licenses in force at the time of
the grant of the exclusive, co-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, co-exclusive or partially exclusive licenses.

[71 FR 11513, Mar. 8, 2006]

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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