Assistant Secretary for Technology Policy; Licensing of Government Owned Inventions, 11510-11514 [06-2166]
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Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Rules and Regulations
Code of Federal Regulations is amended
as follows:
PART 223—SALE AND DISPOSAL OF
NATIONAL FOREST SYSTEM TIMBER
Subpart B—Timber Sale Contracts
advertised value, that is, the amount by
which the advertised value exceeds the
appraised value.
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I 6. Amend § 223.84 by revising the
section heading to read as follows:
1. The Authority citation for part 223
continues to read as follows:
Authority: 90 Stat. 2958, 16 U.S.C. 472a; 98
Stat. 2213; 16 U.S.C. 618, 104 Stat. 714–726,
16 U.S.C. 620–620j, unless otherwise noted.
§ 223.84 Small business bid form
provisions on sales with specified road
construction.
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2. Revise § 223.41 to read as follows:
§ 223.41 Payment when purchaser elects
government road construction.
Each contract having a provision for
construction of specified roads with
total estimated construction costs of
$50,000 or more shall include a
provision to ensure that if the purchaser
elects government road construction,
the purchaser shall pay, in addition to
the price paid for the timber or other
forest products, an amount equal to the
estimated cost of the roads.
I 3. Revise § 223.63 to read as follows:
§ 223.63
Advertised rates.
Timber shall be advertised for sale at
its appraised value. The road
construction cost used to develop
appraised value means the total
estimated cost of constructing all
permanent roads specified in the timber
sale contract, estimated as if
construction is to be accomplished by
the timber purchaser. The advertised
rates shall be not less than minimum
stumpage rates, except that sales of
insect-infested, diseased, dead, or
distressed timber may be sold at less
than minimum rates when harvest of
such timber is necessary to protect or
improve the forest or prevent waste of
usable wood fiber.
I 4. Revise § 223.82 (b) introductory text
to read as follows:
§ 223.82
Contents of advertisement.
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(b) For each timber sale which
includes specified road construction
with total estimated construction costs
of $50,000 or more, the advertisement
shall also include:
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I 5. Amend § 223.83 by revising
paragraphs (a)(16) and (a)(17)(i) to read
as follows:
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§ 223.83
Contents of prospectus.
(a) * * *
(16) The estimated road construction
cost and the estimated public works
construction cost.
(17) For deficit sales:
(i) An estimate of the difference
between fair market value and
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Dated: March 2, 2006.
Dale N. Bosworth,
Chief.
[FR Doc. 06–2161 Filed 3–7–06; 8:45 am]
BILLING CODE 3410–11–P
DEPARTMENT OF COMMERCE
37 CFR Part 404
[Docket No. 040305084–5095–02]
RIN 0692–AA19
Assistant Secretary for Technology
Policy; Licensing of Government
Owned Inventions
Assistant Secretary for
Technology Policy, Department of
Commerce (DOC).
ACTION: Final rule.
AGENCY:
SUMMARY: The Assistant Secretary for
Technology Policy, DOC issues this
final rule with respect to the granting of
licenses by Federal agencies on
Federally owned inventions. This rule is
intended to incorporate changes made
by the Technology Transfer
Commercialization Act of 2000 and
streamlines the licensing procedures to
focus primarily on statutory
requirements. This final rule responds
to comments received in response to a
proposed rule published on January 7,
2005 (70 FR 1403).
DATES: This rule is effective on April 7,
2006.
FOR FURTHER INFORMATION CONTACT: Mr.
John Raubitschek, Patent Counsel, at
telephone: (202) 482–8010 and e-mail:
JRaubits@doc.gov.
Under the
authority of 35 U.S.C. 208 and the
delegation by the Secretary of
Commerce in section 3(d)(3) of DOO 10–
18, the Assistant Secretary of Commerce
for Technology Policy may issue
revisions to 37 CFR part 401.
SUPPLEMENTARY INFORMATION:
Background
The Technology Transfer
Commercialization Act of 2000 (TTCA)
made several changes to the law for
licensing Government-owned
inventions in 35 U.S.C. 207 and 209,
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which are implemented in this rule.
This rule also streamlines the licensing
procedures to focus primarily on
statutory requirements. DOC published
a proposed rule in the Federal Register
on January 7, 2005 (70 FR 1403) seeking
public comment on changes to §§ 404.1,
404.3, 404.4, 404.5, 404.6, 404.7, 404.9,
404.10, 404.11, 404.12 and 404.14. The
comment period closed on February 7,
2005. The basis for this rulemaking was
described in the preamble to the
proposed rule and is not repeated here.
Summary of Public Comments Received
by DOC in Response to the January 7,
2005 Proposed Rule and DOC’s
Response to Those Comments
DOC received seven responses to the
request for comments. Four responses
were from Federal government agencies.
One was from a not-for-profit institution
and two were from private individuals.
Several responses made more than one
comment. An analysis of the comments
follows.
Comment: One comment suggested
adding ‘‘formal’’ before ‘‘patent
disputes’’ in § 404.1(c) to narrow the
exemption from the licensing
requirements in Part 404.
Response: DOC doubts that an agency
will use this exemption to resolve a
trivial or contrived dispute. Further, the
addition of the word ‘‘formal’’ may not
avoid this problem.
Comment: One comment suggested
adding ‘‘,for example’’ after
‘‘protectable’’ in § 404.3(a).
Response: This definition is taken
from 35 U.S.C. 201(d) and should
remain as written for the sake of
consistency.
Comment: Two comments noted a
typographical error in § 404.5(a)(2) that
‘‘license’’ should be ‘‘licensee.’’
Response: DOC agrees with the
comments and has made the suggested
change.
Comment: One comment suggested
replacing ‘‘However’’ in 404.5(a)(2) with
‘‘For example.’’
Response: No change has been made
in response to this comment. The stated
bases for waiving the domestic
manufacturing requirement are not
merely examples but the only reasons
for the agency making the waiver.
Comment: One comment was
concerned that § 404.5(a)(2) required an
agency to find one or more companies
which would refuse a license with the
domestic manufacturing requirement in
order to grant a waiver of such a
requirement. The comment suggested
adding ‘‘or no such candidates are
known.’’
Response: The waiver language was
taken from 35 U.S.C. 204, which has
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proven effective for universities and
small business firms seeking a waiver.
The intent is that the licensing agency
should make an effort to find a company
that will accept such a requirement. If
there is only one company interested in
a license and that company is unwilling
to accept the domestic manufacturing
requirement, the agency may waive the
requirement if it has made reasonable
efforts to find other potential licensees.
Thus, DOC does not accept the
proposed language because it would not
impose a duty on the agency to look for
other companies which may accept the
requirement.
Comment: One comment felt that the
public notice requirement in § 404.4
was not clearly limited to inventions
that the agency had determined were
available for license and suggested that
‘‘available’’ be added before inventions
of which the public is to be notified.
Response: DOC agrees with the
comment and has made the suggested
change.
Comment: One comment was
concerned that the explanation in
paragraph no. 5 of the proposed rule
about the abbreviated development plan
for a research license in § 404.5(a)(1)
implied that background inventions
could be licensed in a cooperative
research and development agreement
(CRADA) only on for research purposes.
Another comment supported the
concept of an abbreviated development
plan for small mom-and-pop research
entities.
Response: The suggestion that a
background invention be licensed for
research purposes under a CRADA was
not intended to preclude it from being
commercially licensed. Further, there is
no limitation in § 404.5(a)(1) for
background inventions.
Comment: One comment
recommended that all references be to
Title 5 instead of title 5.
Response: DOC agrees with this
comment and made the suggested
change in §§ 404.3 and 404.14.
Comment: One comment questioned
whether the new basis for terminating a
license in § 404.5(b)(8)(v) for an
adjudicated violation of the antitrust
laws imposed an additional
responsibility on the agency granting an
exclusive license. The comment was
concerned that if the agency did not
meet such a duty, it might be liable and
recommended that the license contain a
disclaimer of such liability.
Response: The additional basis for
termination has nothing to do with the
granting of a license although there is a
requirement in § 404.7(a)(iii) that the
agency has not determined that the
grant of the license will tend
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substantially to lessen competition or be
in violation of the antitrust laws. As far
as a disclaimer goes, many Government
licenses include one based on the
language in § 404.5(b)(11).
Comment: One comment criticized
the criterion ‘‘in the public interest’’ as
being vague for permitting in
§ 404.5(b)(2) a nonexclusive licensee the
right to enforce a Government owned
patent. The comment questioned who
was going to make the determination of
public interest: The agency or the
Department of Justice and suggested
language that would include the right of
enforcement as an amendment to the
license as approved by the parties and
the Department of Justice at the time the
enforcement issue arises. Another
comment supports the concept of letting
a nonexclusive licensee enforce the
patent against infringers but suggests
that the licensee provide notice to the
agency before filing suit so that the
agency could advise if the party to be
sued already has a license.
Response: With respect to the first
comment about the vagueness of ‘‘in the
public interest,’’ DOC notes that this
phrase also appears in 35 U.S.C.
207(a)(2) and § 404.7(a)(2)(iv). The
determination of allowing the licensee
the right to enforce is made by the
agency and the licensee. With respect to
prior notice to the agency, there is
nothing in this section that precludes
requiring such notice in a license
agreement and in fact, many agencies
have such a requirement for exclusive
licensees.
Comment: One comment questioned
the desirability of entering into coexclusive licenses to resolve
competition between two applicants for
a license.
Response: The regulation does not
require an agency to enter into coexclusive licenses for any reason. The
regulation merely recognizes that some
agencies may grant co-exclusive
licenses, which must follow the rules
applicable to exclusive licenses.
Comment: Two comments questioned
the scope of licensing unpatented
inventions and whether it could include
know-how or unpatentable inventions
and be subject to royalty sharing with
the inventor. One comment wondered if
the rights under such a license would be
different than obtaining information
under the Freedom of Information Act
(FOIA).
Response: The authority to license
inventions is contained in 35 U.S.C.
207(a)(2). An invention is defined in 35
U.S.C. 201(d) as ‘‘any invention or
discovery which is or may be patentable
or otherwise protectable under this
title’’ or a novel plant variety ‘‘which is
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or may be protectable under the Plant
Variety Protection Act.’’ This language
preceded the Bayh-Dole Act and
appeared in the definition of invention
in the Presidential Memoranda and
Statements of Government Patent Policy
in 1963 and 1971. However, the
meaning of this phrase is not certain.
See Steven Robert Fuscher, ‘‘A Study of
How the Government obtains Patent
Rights under the DAR and the FPR
Patent Rights Clauses,’’ 10 Pub. Cont. L.
J. 296, 339 (1978) (‘‘there appears to be
an unspoken agreement to let reason
and equity govern the application of this
phrase’’). DOC interprets the term to
mean that the invention must have the
potential of being protected and so
could include computer software and
biological materials or any other subject
matter in 35 U.S.C. 101. If know-how
includes an invention, then it can be
licensed. Any royalties must be shared
with the inventors as required by 15
U.S.C. 3710c which applies to the
licensing or assignment of Government
owned inventions.
The licensing of an invention which
is not protected by any intellectual
property can be considered as creating
a bailment of the personal property
which is subject to certain conditions of
use. Those terms may be enforced as a
matter of contract. In the absence of any
underlying intellectual property, there
are no rights available to enforce against
third parties.
With respect to an invention which
has been in public use or on sale for
more than a year because of a license,
it may not be patentable under 35 U.S.C.
102(b). In addition, an invention may
not be patentable because it would have
been obvious under 35 U.S.C. 103. Since
sections 102 and 103 both contain
conditions for patentability, they are not
considered to affect the licensability of
unpatented inventions. All that is
required is that the invention have
patentable subject matter.
Further, the licensing of an invention
may not be a bar under section 102(b)
if the invention is leased but not sold
and if there are secrecy requirements
associated with providing access to the
invention. There are also other
requirements for an ‘‘on sale’’ bar, such
as the invention must be ‘‘ready for
patenting.’’ See Pfaff v. Wells Elec., Inc.,
525 U.S. 55, 67–68 (1998). Finally, we
note that under the old 35 U.S.C. 207,
an agency could license a patent
application which might never issue as
a patent because the Patent and
Trademark Office determined that it was
unpatentable.
FOIA raises an issue with respect to
inventions which have an information
content because under FOIA that
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information may be available for free or
for the cost of reproduction. This would
obviously complicate the licensing of
inventions. However, the invention may
not be a record which is subject to
FOIA. Biological materials are not a
record subject to FOIA.
On the other hand, there is a question
whether software is a government
record subject to FOIA. See Gilmore v.
DOE, 4 F. Supp. 2d 912, 920 (N.D. Cal.
1998) (‘‘Even if DOE actually owned and
controlled CLERVER [video
conferencing software created by Sandia
National Laboratories under contract
with DOE] at the time of Gilmore’s FOIA
request, CLERVER still would not be an
agency record subject to FOIA because
CLERVER does not illuminate the
structure, operation, or decision making
structure of DOE.’’ On the other hand in
DeLorme Pub. Co. v. NOAA, 907 F.
Supp. 10 (D. Me. 1995), software was
held to be a record but later found to be
protectable under the FTTA, DeLorme
Pub. Co. v. NOAA, 917 F. Supp. 867 (D.
Me. 1996). Further, even if software is
subject to FOIA, the agency is not
limited to charging only for the cost of
reproduction under 5 U.S.C.
552(a)(4)(vi) when other fees are
authorized by statute. See Jack Wade
Warren, Jr v. Department of Commerce,
Civil Action No. 96–0717 RMU (D.D.C.
Feb. 25, 1998).
Changes From the Proposed Rule
In response to comments, editorial
changes were made to §§ 404.3,
404.5(a)(2) and 404.14. In addition, the
word ‘‘available’’ was added to § 404.4
as proposed by a comment. Finally,
‘‘Federally owned’’ in §§ 404.3, 404.4,
404.5, 404.7 and 404.12 was replaced by
‘‘Government owned’’ to make it
consistent with the title of the
regulation.
Classification
Regulatory Flexibility Act
Because a notice of proposed
rulemaking and an opportunity for
public comment are not required to be
given for this rule pursuant to 5 U.S.C.
553(b)(A), or by any other law, this rule
is not subject to the analytical
requirements of the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.).
Paperwork Reduction Act
The rule was changed to include a
utilization report requirement in
404.5(a)(6) and so imposes a new
collection of information requirement
under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.). Office of
Management and Budget (OMB)
approval was sought and obtained for
the application for a license in 404.8
and the utilization report in 404.5(a)(6)
and the approval (number 0692–0006)
has been extended until January 31,
2009. The time to complete the license
application and the utilization report is
estimated to be 2 hours and 1 hour,
respectively.
Notwithstanding any other provision
of law, no person is required to respond
to, nor shall any person be subject to a
penalty for failure to comply with a
collection of information subject to the
requirements of the PRA, unless that
collection of information displays a
currently valid OMB control number.
However, this collection of information
does not include a document to display
the OMB Control No. 0692–0006.
List of Subjects in 37 CFR Part 404
Inventions, Patents, Licenses.
Dated: February 13, 2006.
Daniel W. Caprio, Jr.,
(Acting) Assistant Secretary of Commerce for
Technology Policy.
For the reasons set forth in the
preamble, 37 CFR Part 404 is amended
as follows:
I
Executive Order 12866
This final rule has been determined to
be not significant for purposes of E.O.
12866.
PART 404—LICENSING OF
GOVERNMENT OWNED INVENTIONS
I
1. The authority citation for Part 404
is revised to read as follows:
Authority: 35 U.S.C. 207–209.
Executive Order 13132
2. Section 404.1 is revised to read as
follows:
I
This rule does not contain policies
with Federalism implications as that
term is defined in E.O. 13132.
§ 404.1
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Administrative Procedure Act
This rule involves rules of agency
practice and procedure under 5 U.S.C.
553(b)(A) and prior notice and an
opportunity for public comment are,
therefore, not required by the
Administrative Procedure Act, or any
other statute or regulation, for this rule.
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Scope of part.
This part prescribes the terms,
conditions, and procedures upon which
a federally owned invention, other than
an invention in the custody of the
Tennessee Valley Authority, may be
licensed. This part does not affect
licenses which:
(a) Were in effect prior to April 7,
2006;
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(b) May exist at the time of the
Government’s acquisition of title to the
invention, including those resulting
from the allocation of rights to
inventions made under Government
research and development contracts;
(c) Are the result of an authorized
exchange of rights in the settlement of
patent disputes, including interferences;
or
(d) Are otherwise authorized by law
or treaty, including 35 U.S.C. 202(e), 35
U.S.C. 207(a)(3) and 15 U.S.C. 3710a,
which also may authorize the
assignment of inventions. Although
licenses on inventions made under a
cooperative research and development
agreement (CRADA) are not subject to
this regulation, agencies are encouraged
to apply the same policies and use
similar terms when appropriate.
Similarly, this should be done for
licenses granted under inventions where
the agency has acquired rights pursuant
to 35 U.S.C. 207(a)(3).
I 3. In § 404.3, paragraph (a) is revised
to read as follows:
§ 404.3
Definitions.
(a) Government owned invention
means an invention, whether or not
covered by a patent or patent
application, or discovery which is or
may be patentable or otherwise
protectable under Title 35, the Plant
Variety Protection Act (7 U.S.C. 2321 et
seq.) or foreign patent law, owned in
whole or in part by the United States
Government.
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I 4. Section 404.4 is revised to read as
follows:
§ 404.4
Authority to grant licenses.
Federally owned inventions shall be
made available for licensing as deemed
appropriate in the public interest and
each agency shall notify the public of
these available inventions. The agencies
having custody of these inventions may
grant nonexclusive, co-exclusive,
partially exclusive, or exclusive licenses
thereto under this part. Licenses may be
royalty-free or for royalties or other
consideration. They may be for all or
less than all fields of use or in specified
geographic areas and may include a
release for past infringement. Any
license shall not confer on any person
immunity from the antitrust laws or
from a charge of patent misuse, and the
exercise of such rights pursuant to this
part shall not be immunized from the
operation of state or federal law by
reason of the source of the grant.
I 5. In Section 404.5, paragraph (a),
paragraph (b)(2) and paragraphs (b)(4)
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through (b)(9) are revised to read as
follows:
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§ 404.5 Restrictions and conditions on all
licenses granted under this part.
(a)(1) A license may be granted only
if the applicant has supplied the Federal
agency with a satisfactory plan for
development or marketing of the
invention, or both, and with information
about the applicant’s capability to fulfill
the plan. The plan for a non-exclusive
research license may be limited to
describing the research phase of
development.
(2) A license granting rights to use or
sell under a Government owned
invention in the United States shall
normally be granted only to a licensee
who agrees that any products
embodying the invention or produced
through the use of the invention will be
manufactured substantially in the
United States. However, this condition
may be waived or modified if reasonable
but unsuccessful efforts have been made
to grant licenses to potential licensees
that would be likely to manufacture
substantially in the United States or if
domestic manufacture is not
commercially feasible.
(b) * * *
(1) * * *
(2) Any patent license may grant the
licensee the right of enforcement of the
licensed patent without joining the
Federal agency as a party as determined
appropriate in the public interest.
(3) * * *
(4) The license may provide the
licensee the right to grant sublicenses
under the license, subject to the
approval of the Federal agency. Each
sublicense shall make reference to the
license, including the rights retained by
the Government, and a copy of such
sublicense with any modifications
thereto, shall be promptly furnished to
the Federal agency.
(5) The license shall require the
licensee to carry out the plan for
development or marketing of the
invention, or both, to bring the
invention to practical application
within a reasonable time as specified in
the license, and continue to make the
benefits of the invention reasonably
accessible to the public.
(6) The license shall require the
licensee to report periodically on the
utilization or efforts at obtaining
utilization that are being made by the
licensee, with particular reference to the
plan submitted but only to the extent
necessary to enable the agency to
determine compliance with the terms of
the license.
(7) Where an agreement is obtained
pursuant to § 404.5(a)(2) that any
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products embodying the invention or
produced through the use of the
invention will be manufactured
substantially in the United States, the
license shall recite such an agreement.
(8) The license shall provide for the
right of the Federal agency to terminate
the license, in whole or in part, if the
agency determines that:
(i) The licensee is not executing its
commitment to achieve practical
application of the invention, including
commitments contained in any plan
submitted in support of its request for
a license and the licensee cannot
otherwise demonstrate to the
satisfaction of the Federal agency that it
has taken, or can be expected to take
within a reasonable time, effective steps
to achieve practical application of the
invention;
(ii) Termination is necessary to meet
requirements for public use specified by
Federal regulations issued after the date
of the license and such requirements are
not reasonably satisfied by the licensee;
(iii) The licensee has willfully made
a false statement of or willfully omitted
a material fact in the license application
or in any report required by the license
agreement;
(iv) The licensee commits a
substantial breach of a covenant or
provision contained in the license
agreement, including the requirement in
§ 404.5(a)(2); or
(v) The licensee has been found by a
court of competent jurisdiction to have
violated the Federal antitrust laws in
connection with its performance under
the license agreement.
(9) The license may be modified or
terminated, consistent with this part,
upon mutual agreement of the Federal
agency and the licensee.
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I 6. Section 404.6 is revised to read as
follows:
§ 404.6
Nonexclusive licenses.
Nonexclusive licenses may be granted
under Government owned inventions
without a public notice of a prospective
license.
I 7. Section 404.7 is revised to read as
follows:
§ 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
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11513
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.
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(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.
§ 404.9
[Removed and reserved]
8. Section 404.9 is removed and
reserved.
I 9. Section 404.10 is revised to read as
follows:
I
erjones on PROD1PC68 with RULES
§ 404.10 Modification and termination of
licenses.
Before modifying or terminating a
license, other than by mutual
agreement, the Federal agency shall
furnish the licensee and any sublicensee
of record a written notice of intention to
modify or terminate the license, and the
licensee shall be allowed 30 days after
such notice to remedy any breach of the
license or show cause why the license
shall not be modified or terminated.
VerDate Aug<31>2005
15:23 Mar 07, 2006
Jkt 208001
10. Section 404.11 is revised to read
as follows:
ENVIRONMENTAL PROTECTION
AGENCY
§ 404.11
40 CFR Part 52
I
Appeals.
(a) In accordance with procedures
prescribed by the Federal agency, the
following parties may appeal to the
agency head or designee any decision or
determination concerning the grant,
denial, modification, or termination of a
license:
(1) A person whose application for a
license has been denied;
(2) A licensee whose license has been
modified or terminated, in whole or in
part; or
(3) A person who timely filed a
written objection in response to the
notice required by § 404.7(a)(1)(i) or
§ 404.7(b)(1)(i) and who can
demonstrate to the satisfaction of the
Federal agency that such person may be
damaged by the agency action.
(b) An appeal by a licensee under
paragraph (a)(2) of this section may
include a hearing, upon the request of
the licensee, to address a dispute over
any relevant fact. The parties may agree
to Alternate Dispute Resolution in lieu
of an appeal.
11. Section 404.12 is revised to read
as follows:
I
§ 404.12 Protection and administration of
inventions.
A Federal agency may take any
suitable and necessary steps to protect
and administer rights to Government
owned inventions, either directly or
through contract.
12. Section 404.14 is revised to read
as follows:
I
§ 404.14
Confidentiality of information.
Title 35, United States Code, section
209, requires that any plan submitted
pursuant to § 404.8(h) and any report
required by § 404.5(b)(6) shall be treated
as commercial or financial information
obtained from a person and privileged
and confidential and not subject to
disclosure under section 552 of Title 5
of the United States Code.
[FR Doc. 06–2166 Filed 3–7–06; 8:45 am]
BILLING CODE 3510–18–P
PO 00000
[EPA–R03–OAR–2006–0123; FRL–8042–3]
Approval and Promulgation of Air
Quality Implementation Plans;
Pennsylvania; RACT Determinations
for Thirteen Individual Sources
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: The Environmental Protection
Agency (EPA) is approving State
Implementation Plan (SIP) revisions
submitted by the Commonwealth of
Pennsylvania (Pennsylvania). The
revisions impose reasonably available
control technology (RACT) on thirteen
major sources of volatile organic
compounds (VOC) or nitrogen oxides
(NOX) located in the Commonwealth of
Pennsylvania. EPA is approving these
revisions to establish RACT
requirements in the SIP in accordance
with the Clean Air Act (CAA or the Act).
DATES: This final rule is effective on
April 7, 2006.
ADDRESSES: EPA has established a
docket for this action under Docket ID
Number EPA–R03–OAR–2006–0123. All
documents in the docket are listed in
the www.regulations.gov Web site.
Although listed in the electronic docket,
some information is not publicly
available, i.e., confidential business
information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically through
www.regulations.gov or in hard copy for
public inspection during normal
business hours at the Air Protection
Division, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
Copies of the State submittal are
available at the Pennsylvania
Department of Environmental
Protection, Bureau of Air Quality, P.O.
Box 8468, 400 Market Street, Harrisburg,
Pennsylvania 17105.
FOR FURTHER INFORMATION CONTACT:
Marcia Spink (215) 814–2104 or by email at spink.marcia@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On April 18, 2000 (65 FR 20788), EPA
published a direct final rule approving
RACT determinations submitted by the
Frm 00010
Fmt 4700
Sfmt 4700
E:\FR\FM\08MRR1.SGM
08MRR1
Agencies
[Federal Register Volume 71, Number 45 (Wednesday, March 8, 2006)]
[Rules and Regulations]
[Pages 11510-11514]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-2166]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
37 CFR Part 404
[Docket No. 040305084-5095-02]
RIN 0692-AA19
Assistant Secretary for Technology Policy; Licensing of
Government Owned Inventions
AGENCY: Assistant Secretary for Technology Policy, Department of
Commerce (DOC).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Assistant Secretary for Technology Policy, DOC issues this
final rule with respect to the granting of licenses by Federal agencies
on Federally owned inventions. This rule is intended to incorporate
changes made by the Technology Transfer Commercialization Act of 2000
and streamlines the licensing procedures to focus primarily on
statutory requirements. This final rule responds to comments received
in response to a proposed rule published on January 7, 2005 (70 FR
1403).
DATES: This rule is effective on April 7, 2006.
FOR FURTHER INFORMATION CONTACT: Mr. John Raubitschek, Patent Counsel,
at telephone: (202) 482-8010 and e-mail: JRaubits@doc.gov.
SUPPLEMENTARY INFORMATION: Under the authority of 35 U.S.C. 208 and the
delegation by the Secretary of Commerce in section 3(d)(3) of DOO 10-
18, the Assistant Secretary of Commerce for Technology Policy may issue
revisions to 37 CFR part 401.
Background
The Technology Transfer Commercialization Act of 2000 (TTCA) made
several changes to the law for licensing Government-owned inventions in
35 U.S.C. 207 and 209, which are implemented in this rule. This rule
also streamlines the licensing procedures to focus primarily on
statutory requirements. DOC published a proposed rule in the Federal
Register on January 7, 2005 (70 FR 1403) seeking public comment on
changes to Sec. Sec. 404.1, 404.3, 404.4, 404.5, 404.6, 404.7, 404.9,
404.10, 404.11, 404.12 and 404.14. The comment period closed on
February 7, 2005. The basis for this rulemaking was described in the
preamble to the proposed rule and is not repeated here.
Summary of Public Comments Received by DOC in Response to the January
7, 2005 Proposed Rule and DOC's Response to Those Comments
DOC received seven responses to the request for comments. Four
responses were from Federal government agencies. One was from a not-
for-profit institution and two were from private individuals. Several
responses made more than one comment. An analysis of the comments
follows.
Comment: One comment suggested adding ``formal'' before ``patent
disputes'' in Sec. 404.1(c) to narrow the exemption from the licensing
requirements in Part 404.
Response: DOC doubts that an agency will use this exemption to
resolve a trivial or contrived dispute. Further, the addition of the
word ``formal'' may not avoid this problem.
Comment: One comment suggested adding ``,for example'' after
``protectable'' in Sec. 404.3(a).
Response: This definition is taken from 35 U.S.C. 201(d) and should
remain as written for the sake of consistency.
Comment: Two comments noted a typographical error in Sec.
404.5(a)(2) that ``license'' should be ``licensee.''
Response: DOC agrees with the comments and has made the suggested
change.
Comment: One comment suggested replacing ``However'' in 404.5(a)(2)
with ``For example.''
Response: No change has been made in response to this comment. The
stated bases for waiving the domestic manufacturing requirement are not
merely examples but the only reasons for the agency making the waiver.
Comment: One comment was concerned that Sec. 404.5(a)(2) required
an agency to find one or more companies which would refuse a license
with the domestic manufacturing requirement in order to grant a waiver
of such a requirement. The comment suggested adding ``or no such
candidates are known.''
Response: The waiver language was taken from 35 U.S.C. 204, which
has
[[Page 11511]]
proven effective for universities and small business firms seeking a
waiver. The intent is that the licensing agency should make an effort
to find a company that will accept such a requirement. If there is only
one company interested in a license and that company is unwilling to
accept the domestic manufacturing requirement, the agency may waive the
requirement if it has made reasonable efforts to find other potential
licensees. Thus, DOC does not accept the proposed language because it
would not impose a duty on the agency to look for other companies which
may accept the requirement.
Comment: One comment felt that the public notice requirement in
Sec. 404.4 was not clearly limited to inventions that the agency had
determined were available for license and suggested that ``available''
be added before inventions of which the public is to be notified.
Response: DOC agrees with the comment and has made the suggested
change.
Comment: One comment was concerned that the explanation in
paragraph no. 5 of the proposed rule about the abbreviated development
plan for a research license in Sec. 404.5(a)(1) implied that
background inventions could be licensed in a cooperative research and
development agreement (CRADA) only on for research purposes. Another
comment supported the concept of an abbreviated development plan for
small mom-and-pop research entities.
Response: The suggestion that a background invention be licensed
for research purposes under a CRADA was not intended to preclude it
from being commercially licensed. Further, there is no limitation in
Sec. 404.5(a)(1) for background inventions.
Comment: One comment recommended that all references be to Title 5
instead of title 5.
Response: DOC agrees with this comment and made the suggested
change in Sec. Sec. 404.3 and 404.14.
Comment: One comment questioned whether the new basis for
terminating a license in Sec. 404.5(b)(8)(v) for an adjudicated
violation of the antitrust laws imposed an additional responsibility on
the agency granting an exclusive license. The comment was concerned
that if the agency did not meet such a duty, it might be liable and
recommended that the license contain a disclaimer of such liability.
Response: The additional basis for termination has nothing to do
with the granting of a license although there is a requirement in Sec.
404.7(a)(iii) that the agency has not determined that the grant of the
license will tend substantially to lessen competition or be in
violation of the antitrust laws. As far as a disclaimer goes, many
Government licenses include one based on the language in Sec.
404.5(b)(11).
Comment: One comment criticized the criterion ``in the public
interest'' as being vague for permitting in Sec. 404.5(b)(2) a
nonexclusive licensee the right to enforce a Government owned patent.
The comment questioned who was going to make the determination of
public interest: The agency or the Department of Justice and suggested
language that would include the right of enforcement as an amendment to
the license as approved by the parties and the Department of Justice at
the time the enforcement issue arises. Another comment supports the
concept of letting a nonexclusive licensee enforce the patent against
infringers but suggests that the licensee provide notice to the agency
before filing suit so that the agency could advise if the party to be
sued already has a license.
Response: With respect to the first comment about the vagueness of
``in the public interest,'' DOC notes that this phrase also appears in
35 U.S.C. 207(a)(2) and Sec. 404.7(a)(2)(iv). The determination of
allowing the licensee the right to enforce is made by the agency and
the licensee. With respect to prior notice to the agency, there is
nothing in this section that precludes requiring such notice in a
license agreement and in fact, many agencies have such a requirement
for exclusive licensees.
Comment: One comment questioned the desirability of entering into
co-exclusive licenses to resolve competition between two applicants for
a license.
Response: The regulation does not require an agency to enter into
co-exclusive licenses for any reason. The regulation merely recognizes
that some agencies may grant co-exclusive licenses, which must follow
the rules applicable to exclusive licenses.
Comment: Two comments questioned the scope of licensing unpatented
inventions and whether it could include know-how or unpatentable
inventions and be subject to royalty sharing with the inventor. One
comment wondered if the rights under such a license would be different
than obtaining information under the Freedom of Information Act (FOIA).
Response: The authority to license inventions is contained in 35
U.S.C. 207(a)(2). An invention is defined in 35 U.S.C. 201(d) as ``any
invention or discovery which is or may be patentable or otherwise
protectable under this title'' or a novel plant variety ``which is or
may be protectable under the Plant Variety Protection Act.'' This
language preceded the Bayh-Dole Act and appeared in the definition of
invention in the Presidential Memoranda and Statements of Government
Patent Policy in 1963 and 1971. However, the meaning of this phrase is
not certain. See Steven Robert Fuscher, ``A Study of How the Government
obtains Patent Rights under the DAR and the FPR Patent Rights
Clauses,'' 10 Pub. Cont. L. J. 296, 339 (1978) (``there appears to be
an unspoken agreement to let reason and equity govern the application
of this phrase''). DOC interprets the term to mean that the invention
must have the potential of being protected and so could include
computer software and biological materials or any other subject matter
in 35 U.S.C. 101. If know-how includes an invention, then it can be
licensed. Any royalties must be shared with the inventors as required
by 15 U.S.C. 3710c which applies to the licensing or assignment of
Government owned inventions.
The licensing of an invention which is not protected by any
intellectual property can be considered as creating a bailment of the
personal property which is subject to certain conditions of use. Those
terms may be enforced as a matter of contract. In the absence of any
underlying intellectual property, there are no rights available to
enforce against third parties.
With respect to an invention which has been in public use or on
sale for more than a year because of a license, it may not be
patentable under 35 U.S.C. 102(b). In addition, an invention may not be
patentable because it would have been obvious under 35 U.S.C. 103.
Since sections 102 and 103 both contain conditions for patentability,
they are not considered to affect the licensability of unpatented
inventions. All that is required is that the invention have patentable
subject matter.
Further, the licensing of an invention may not be a bar under
section 102(b) if the invention is leased but not sold and if there are
secrecy requirements associated with providing access to the invention.
There are also other requirements for an ``on sale'' bar, such as the
invention must be ``ready for patenting.'' See Pfaff v. Wells Elec.,
Inc., 525 U.S. 55, 67-68 (1998). Finally, we note that under the old 35
U.S.C. 207, an agency could license a patent application which might
never issue as a patent because the Patent and Trademark Office
determined that it was unpatentable.
FOIA raises an issue with respect to inventions which have an
information content because under FOIA that
[[Page 11512]]
information may be available for free or for the cost of reproduction.
This would obviously complicate the licensing of inventions. However,
the invention may not be a record which is subject to FOIA. Biological
materials are not a record subject to FOIA.
On the other hand, there is a question whether software is a
government record subject to FOIA. See Gilmore v. DOE, 4 F. Supp. 2d
912, 920 (N.D. Cal. 1998) (``Even if DOE actually owned and controlled
CLERVER [video conferencing software created by Sandia National
Laboratories under contract with DOE] at the time of Gilmore's FOIA
request, CLERVER still would not be an agency record subject to FOIA
because CLERVER does not illuminate the structure, operation, or
decision making structure of DOE.'' On the other hand in DeLorme Pub.
Co. v. NOAA, 907 F. Supp. 10 (D. Me. 1995), software was held to be a
record but later found to be protectable under the FTTA, DeLorme Pub.
Co. v. NOAA, 917 F. Supp. 867 (D. Me. 1996). Further, even if software
is subject to FOIA, the agency is not limited to charging only for the
cost of reproduction under 5 U.S.C. 552(a)(4)(vi) when other fees are
authorized by statute. See Jack Wade Warren, Jr v. Department of
Commerce, Civil Action No. 96-0717 RMU (D.D.C. Feb. 25, 1998).
Changes From the Proposed Rule
In response to comments, editorial changes were made to Sec. Sec.
404.3, 404.5(a)(2) and 404.14. In addition, the word ``available'' was
added to Sec. 404.4 as proposed by a comment. Finally, ``Federally
owned'' in Sec. Sec. 404.3, 404.4, 404.5, 404.7 and 404.12 was
replaced by ``Government owned'' to make it consistent with the title
of the regulation.
Classification
Executive Order 12866
This final rule has been determined to be not significant for
purposes of E.O. 12866.
Executive Order 13132
This rule does not contain policies with Federalism implications as
that term is defined in E.O. 13132.
Administrative Procedure Act
This rule involves rules of agency practice and procedure under 5
U.S.C. 553(b)(A) and prior notice and an opportunity for public comment
are, therefore, not required by the Administrative Procedure Act, or
any other statute or regulation, for this rule.
Regulatory Flexibility Act
Because a notice of proposed rulemaking and an opportunity for
public comment are not required to be given for this rule pursuant to 5
U.S.C. 553(b)(A), or by any other law, this rule is not subject to the
analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601
et seq.).
Paperwork Reduction Act
The rule was changed to include a utilization report requirement in
404.5(a)(6) and so imposes a new collection of information requirement
under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.).
Office of Management and Budget (OMB) approval was sought and obtained
for the application for a license in 404.8 and the utilization report
in 404.5(a)(6) and the approval (number 0692-0006) has been extended
until January 31, 2009. The time to complete the license application
and the utilization report is estimated to be 2 hours and 1 hour,
respectively.
Notwithstanding any other provision of law, no person is required
to respond to, nor shall any person be subject to a penalty for failure
to comply with a collection of information subject to the requirements
of the PRA, unless that collection of information displays a currently
valid OMB control number. However, this collection of information does
not include a document to display the OMB Control No. 0692-0006.
List of Subjects in 37 CFR Part 404
Inventions, Patents, Licenses.
Dated: February 13, 2006.
Daniel W. Caprio, Jr.,
(Acting) Assistant Secretary of Commerce for Technology Policy.
0
For the reasons set forth in the preamble, 37 CFR Part 404 is amended
as follows:
PART 404--LICENSING OF GOVERNMENT OWNED INVENTIONS
0
1. The authority citation for Part 404 is revised to read as follows:
Authority: 35 U.S.C. 207-209.
0
2. Section 404.1 is revised to read as follows:
Sec. 404.1 Scope of part.
This part prescribes the terms, conditions, and procedures upon
which a federally owned invention, other than an invention in the
custody of the Tennessee Valley Authority, may be licensed. This part
does not affect licenses which:
(a) Were in effect prior to April 7, 2006;
(b) May exist at the time of the Government's acquisition of title
to the invention, including those resulting from the allocation of
rights to inventions made under Government research and development
contracts;
(c) Are the result of an authorized exchange of rights in the
settlement of patent disputes, including interferences; or
(d) Are otherwise authorized by law or treaty, including 35 U.S.C.
202(e), 35 U.S.C. 207(a)(3) and 15 U.S.C. 3710a, which also may
authorize the assignment of inventions. Although licenses on inventions
made under a cooperative research and development agreement (CRADA) are
not subject to this regulation, agencies are encouraged to apply the
same policies and use similar terms when appropriate. Similarly, this
should be done for licenses granted under inventions where the agency
has acquired rights pursuant to 35 U.S.C. 207(a)(3).
0
3. In Sec. 404.3, paragraph (a) is revised to read as follows:
Sec. 404.3 Definitions.
(a) Government owned invention means an invention, whether or not
covered by a patent or patent application, or discovery which is or may
be patentable or otherwise protectable under Title 35, the Plant
Variety Protection Act (7 U.S.C. 2321 et seq.) or foreign patent law,
owned in whole or in part by the United States Government.
* * * * *
0
4. Section 404.4 is revised to read as follows:
Sec. 404.4 Authority to grant licenses.
Federally owned inventions shall be made available for licensing as
deemed appropriate in the public interest and each agency shall notify
the public of these available inventions. The agencies having custody
of these inventions may grant nonexclusive, co-exclusive, partially
exclusive, or exclusive licenses thereto under this part. Licenses may
be royalty-free or for royalties or other consideration. They may be
for all or less than all fields of use or in specified geographic areas
and may include a release for past infringement. Any license shall not
confer on any person immunity from the antitrust laws or from a charge
of patent misuse, and the exercise of such rights pursuant to this part
shall not be immunized from the operation of state or federal law by
reason of the source of the grant.
0
5. In Section 404.5, paragraph (a), paragraph (b)(2) and paragraphs
(b)(4)
[[Page 11513]]
through (b)(9) are revised to read as follows:
Sec. 404.5 Restrictions and conditions on all licenses granted under
this part.
(a)(1) A license may be granted only if the applicant has supplied
the Federal agency with a satisfactory plan for development or
marketing of the invention, or both, and with information about the
applicant's capability to fulfill the plan. The plan for a non-
exclusive research license may be limited to describing the research
phase of development.
(2) A license granting rights to use or sell under a Government
owned invention in the United States shall normally be granted only to
a licensee who agrees that any products embodying the invention or
produced through the use of the invention will be manufactured
substantially in the United States. However, this condition may be
waived or modified if reasonable but unsuccessful efforts have been
made to grant licenses to potential licensees that would be likely to
manufacture substantially in the United States or if domestic
manufacture is not commercially feasible.
(b) * * *
(1) * * *
(2) Any patent license may grant the licensee the right of
enforcement of the licensed patent without joining the Federal agency
as a party as determined appropriate in the public interest.
(3) * * *
(4) The license may provide the licensee the right to grant
sublicenses under the license, subject to the approval of the Federal
agency. Each sublicense shall make reference to the license, including
the rights retained by the Government, and a copy of such sublicense
with any modifications thereto, shall be promptly furnished to the
Federal agency.
(5) The license shall require the licensee to carry out the plan
for development or marketing of the invention, or both, to bring the
invention to practical application within a reasonable time as
specified in the license, and continue to make the benefits of the
invention reasonably accessible to the public.
(6) The license shall require the licensee to report periodically
on the utilization or efforts at obtaining utilization that are being
made by the licensee, with particular reference to the plan submitted
but only to the extent necessary to enable the agency to determine
compliance with the terms of the license.
(7) Where an agreement is obtained pursuant to Sec. 404.5(a)(2)
that any products embodying the invention or produced through the use
of the invention will be manufactured substantially in the United
States, the license shall recite such an agreement.
(8) The license shall provide for the right of the Federal agency
to terminate the license, in whole or in part, if the agency determines
that:
(i) The licensee is not executing its commitment to achieve
practical application of the invention, including commitments contained
in any plan submitted in support of its request for a license and the
licensee cannot otherwise demonstrate to the satisfaction of the
Federal agency that it has taken, or can be expected to take within a
reasonable time, effective steps to achieve practical application of
the invention;
(ii) Termination is necessary to meet requirements for public use
specified by Federal regulations issued after the date of the license
and such requirements are not reasonably satisfied by the licensee;
(iii) The licensee has willfully made a false statement of or
willfully omitted a material fact in the license application or in any
report required by the license agreement;
(iv) The licensee commits a substantial breach of a covenant or
provision contained in the license agreement, including the requirement
in Sec. 404.5(a)(2); or
(v) The licensee has been found by a court of competent
jurisdiction to have violated the Federal antitrust laws in connection
with its performance under the license agreement.
(9) The license may be modified or terminated, consistent with this
part, upon mutual agreement of the Federal agency and the licensee.
* * * * *
0
6. Section 404.6 is revised to read as follows:
Sec. 404.6 Nonexclusive licenses.
Nonexclusive licenses may be granted under Government owned
inventions without a public notice of a prospective license.
0
7. Section 404.7 is revised to read as follows:
Sec. 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 Sec. 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 Sec. 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.
[[Page 11514]]
(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 Sec. 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.
Sec. 404.9 [Removed and reserved]
0
8. Section 404.9 is removed and reserved.
0
9. Section 404.10 is revised to read as follows:
Sec. 404.10 Modification and termination of licenses.
Before modifying or terminating a license, other than by mutual
agreement, the Federal agency shall furnish the licensee and any
sublicensee of record a written notice of intention to modify or
terminate the license, and the licensee shall be allowed 30 days after
such notice to remedy any breach of the license or show cause why the
license shall not be modified or terminated.
0
10. Section 404.11 is revised to read as follows:
Sec. 404.11 Appeals.
(a) In accordance with procedures prescribed by the Federal agency,
the following parties may appeal to the agency head or designee any
decision or determination concerning the grant, denial, modification,
or termination of a license:
(1) A person whose application for a license has been denied;
(2) A licensee whose license has been modified or terminated, in
whole or in part; or
(3) A person who timely filed a written objection in response to
the notice required by Sec. 404.7(a)(1)(i) or Sec. 404.7(b)(1)(i) and
who can demonstrate to the satisfaction of the Federal agency that such
person may be damaged by the agency action.
(b) An appeal by a licensee under paragraph (a)(2) of this section
may include a hearing, upon the request of the licensee, to address a
dispute over any relevant fact. The parties may agree to Alternate
Dispute Resolution in lieu of an appeal.
0
11. Section 404.12 is revised to read as follows:
Sec. 404.12 Protection and administration of inventions.
A Federal agency may take any suitable and necessary steps to
protect and administer rights to Government owned inventions, either
directly or through contract.
0
12. Section 404.14 is revised to read as follows:
Sec. 404.14 Confidentiality of information.
Title 35, United States Code, section 209, requires that any plan
submitted pursuant to Sec. 404.8(h) and any report required by Sec.
404.5(b)(6) shall be treated as commercial or financial information
obtained from a person and privileged and confidential and not subject
to disclosure under section 552 of Title 5 of the United States Code.
[FR Doc. 06-2166 Filed 3-7-06; 8:45 am]
BILLING CODE 3510-18-P