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3 CFR. 1950 Supp. and E.O. 10930, 26 FR 2583; 3 CFR 1961 Supp.

$6.3 Licensing of Government-owned

patents. (a) Licenses to practice inventions covered by patents and pending patent applications owned by the U.S. Government as represented by this Department will generally be royalty free, revocable and nonexclusive. They will normally be issued to all applicants and will generally contain no limitations or standards relating to the quality or testing of the products to be manufactured, sold, or distributed thereunder.

(b) Where it appears however that the public interest will be served under the circumstances of the particular case by licenses which impose conditions, such as those relating to quality or testing of products, requirement of payment of royalties to the Government, etc., or by the issuance of limited exclusive licenses by the Assistant Secretary for Health and Scientific Affairs after notice and opportunity for hearing thereon, such licenses may be issued. (34 FR 15560, Oct. 7, 1969)

87.0 Who are employees.

As used in this part, the term Government employee means any officer or employee, civilian or military, except such part-time employees or part-time consultants as may be excluded therefrom by a determination made in writing by the head of the employee's office or constituent organization, pursuant to an exemption approved by the Commissioner of Patents that to include him or them would be impracticable or inequitable, given the reasons therefor. A person shall not be considered to be a part-time employee or part-time consultant for this purpose unless the terms of his employment contemplate that he shall work for less than the minimum number of hours per day, or less than a minimum number of days per week, or less than the minimum number of weeks per year, regularly required of full-time employees of his class. (27 FR 7986, Aug. 10, 1962)

86.4 Central records; confidentiality.

Central files and records shall be maintained of all inventions, patents, and licenses in which the Department has an interest, together with a record of all licenses issued by the Department under such patents. Invention reports required from employees or others for the purpose of obtaining determinations of ownership, and documents and information obtained for the purpose of prosecuting patent applications shall be confidential and shall be disclosed only as required for official purposes or with the consent of the inventor.

87.1 Duty of employee to report inven.

tions. Every Department employee is required to report to the Assistant Secretary (Health and Scientific Affairs) in accordance with the procedures established therefor, every invention made by him (whether or not jointly with others) which bears any relation to his official duties or which was made in whole or in any part during working hours, or with any contribution of Government facilities, equipment, material, funds, or information, or of time or services of other Government employees on official duty. (31 FR 12842, Oct. 1, 1966)

[20 FR 6747, Sept. 14, 1955)

PART 7-EMPLOYEE INVENTIONS

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Sec. 7.0 Who are employees. 7.1 Duty of employee to report inventions. 7.3 Determination as to domestic rights. 7.4 Option to acquire foreign rights. 7.7 Notice to employee of determination. 7.8 Employee's right of appeal.

AUTHORITY: Reorg. Plan No. 1 of 1953, 18 FR 2053; 3 CFR 1953 Supp. E.O. 10096, 15 FR 391;

87.3 Determination to domestic

rights. The determination of the ownership of the domestic right, title, and interest in and to an invention which is or may be patentable, made by a Government employee while under the administrative jurisdiction of the Department, shall be made in writing by the Assistant Secretary (Health and Scientific Affairs), in accordance with the

provisions of Executive Order 10096 and nongovernmental agencies or individGovernment-wide regulations issued uals engaged in such work, falls within thereunder by the Commissioner of the provisions of paragraph (a) of this Patents as follows:

section, and it shall be presumed that (a) The Government as represented any invention made by any other emby the Assistant Secretary (Health and

ployee falls within the provisions of Scientific Affairs) shall obtain the en

paragraph (b) of this section. Either tire domestic right, title and interest

presumption may be rebutted by a in and to all inventions made by any

showing of the facts and circumstances Government employee (1) during work

and shall not preclude a determination ing hours, or (2) with a contribution by that these facts and circumstances justhe Government of facilities, equip

tify leaving the entire right, title and ment, materials, funds, or information,

interest in and to the invention in the or of time or services of other Govern

Government employee, subject to law. ment employees on official duty, or (3)

(d) In any case wherein the Governwhich bear a direct relation to or are

ment neither (1) obtains the entire domade in consequence of the official du

mestic right, title and interest in and ties of the inventor. (b) In any case where the contribu

to an invention pursuant to the provition of the Government, as measured

sions of paragraph (a) of this section, by any one or more of the criteria set

nor (2) reserves a nonexclusive, irrevforth in paragraph (a) of this section,

ocable, royalty-free license in the into the invention is insufficient equi

vention, with power to grant licenses tably to justify a requirement of as

for all governmental purposes, pursusignment to the Government of the en

ant to the provisions of paragraph (b) tire domestic right, title and interest

of this section, the Government shall in and to such invention, or in any case

leave the entire right, title and interwhere the Government has insufficient

est in and to the invention in the Govinterest in an invention to obtain the ernment employee, subject to law. entire domestic right, title, and inter

[27 FR 7986, Aug. 10, 1962, as amended at 31 est therein (although the Government

FR 12842, Nov. 1, 1966) could obtain same under paragraph (a) of this section), the Department, sub- 87.4 Option to acquire foreign rights. ject to the approval of the Commissioner, shall leave title to such inven

In any case where it is determined tion in the employee, subject, however,

that all domestic rights should be asto the reservation to the Government

signed to the Government, it shall furof a nonexclusive, irrevocable, royalty

ther be determined, pursuant to Execufree license in the invention with

tive Order 9865 and Government-wide power to grant licenses for all govern

regulations issued thereunder, that the mental purposes, such reservation to

Government shall reserve an option to appear, where practicable, in any pat

require the assignment of such rights ent, domestic or foreign, which may

in all or in any specified foreign counissue on such invention.

tries. In case where the inventor is not (c) In applying the provisions of para

required to assign the patent rights in graphs (a) and (b) of this section, to the any foreign country or countries to the facts and circumstances relating to the

Government or the Government fails to making of any particular invention, it

exercise its option within such period shall be presumed that an invention

of time as may be provided by regulamade by an employee who is employed tions issued by the Commissioner of or assigned (1) to invent or improve or Patents, any application for a patent perfect any art, machine, manufacture, which may be filed in such country or or composition of matter, (2) to con- countries by the inventor or his asduct or perform research, development signee shall nevertheless be subject to work, or both, (3) to supervise, direct, a nonexclusive, irrevocable, royaltycoordinate, or review Government fi- free license to the Government for all nanced or conducted research, develop- governmental purposes, including the ment work, or both, or (4) to act in a li- power to issue sublicenses for use in beaison capacity among governmental or half of the Government and/or in fur

therance of the foreign policies of the Government.

[27 FR 7987, Aug. 10, 1962)

87.7 Notice to employee of determina

tion. The employee-inventor shall be notified in writing of the Department's determination of the rights to his invention and of his right of appeal, if any. Notice need not be given if the employee stated in writing that he would agree to the determination of ownership which was in fact made. (31 FR 12842, Oct. 1, 1966)

87.8 Employee's right of appeal.

An employee who is aggrieved by a determination of the Department may appeal to the Commissioner of Patents, pursuant to section 4(d) of Executive Order 10096, as amended by Executive Order 10930, and regulations issued thereunder, by filing a written appeal with the Commissioner, in duplicate, and a copy of the appeal with the Assistant Secretary (Health and Scientific Affairs), within 30 days (or such longer period as the Commissioner may, for good cause, fix in any case) after receiving written notice of such determination. (27 FR 7986, Aug. 10, 1962, as amended at 31 FR 12842, Oct. 1, 1966)

88.0 Policy.

(a) The Department of Health and Human Services each year is expending large sums in the form of grants for research. These grants are made primarily by the Public Health Service in carrying out its broad responsibility under the Public Health Service Act to promote and coordinate research in the field of health and to make available information concerning such research and its practical application. The scientific and technological advances attributable, in varying degrees to this expenditure of public funds frequently include patentable inventions.

(b) The Department, as a matter of policy, takes the position that the results of research supported by grants of public moneys should be utilized in the manner which would best serve the public interest. It is believed that the public interest will in general be best served if inventive advances resulting therefrom are made freely available to the Government, to science, to industry, and to the general public.

(c) On the other hand, in some cases it may be advisable to permit a utilization of the patent process in order to foster an adequate commercial development to make a new invention widely available. Moreover, it is recognized that inventions frequently arise in the course of research activities which also receive substantial support from other sources, as well as from the Federal grant. It would not be consistent with the cooperative nature of such activities to attribute a particular invention primarily to sypport received from any one source. In all these cases the Department has a responsiblity to see that the public use of the fruits of the research will not be unduly restricted or denied.

(d) The following conditions have been adopted to govern the treatment of inventions made in these various types of situations. They are designed to afford suitable protection to the public interest while giving appropriate recognition to the legitimate interests of others who have contributed to the invention.

PART 8-INVENTIONS RESULTING

FROM RESEARCH GRANTS, FELLOWSHIP AWARDS, AND CONTRACTS FOR RESEARCH

Sec. 8.0 Policy. 8.1 Conditions to be included in research

grants. 8.2 Determination as to domestic rights. 8.3 Licenses to the Government. 8.4 Option to acquire foreign rights. 8.5 Fellowships. 8.6 Contracts for research. 8.7 Cancer chemotherapy industrial re

search contracts. 8.8 Screening of compounds generated under

DHHS grants and awards. AUTHORITY: Reorg. Plan No. 1 of 1953, 18 FR 2053; 3 CFR, 1953 Supp. E.O. 9865, 12 FR 3907; 3 CFR, 1947 Cum. Supp. E.O. 10096, 15 FR 391; 3 CFR, 1950 Supp.

[20 FR 6749, Sept. 14, 1955)

are

88.1 Conditions to be included in re

search grants. Subject to legislative directives or Executive orders providing otherwise, all grants in aid of research shall provide as a condition that any invention arising out of the activities assisted by the grant shall be promptly and fully reported, and shall provide either:

(a) That the ownership and manner of disposition of all rights in and to such invention shall be subject to determination by the Assistant Secretary (Health and Scientific Affairs) or

(b) That the ownership and disposition of all domestic rights shall be left for determination by the grantee institution in accordance with the grantee's established policies and procedures, with such modifications as may be agreed upon and specified in the grant, provided the Assistant Secretary (Health and Scientific Affairs) finds that these are such as to assure that the invention will be made available without unreasonable restrictions or excessive royalties, and provided the Government shall receive a royaltyfree license, with a right to issue sublicenses as provided in $8.3, under any patent applied for or obtained upon the invention.

(c) Wherever practicable, any rangement with the grantee pursuant to paragraph (b) of this section shall provide in accordance with Executive Order 9865 that there be reserved to the Government an option, for a period to be prescribed, to file foreign patent applications upon the invention. [20 FR 6749, Sept. 14, 1955, as amended at 31 FR 12842, Oct. 1, 1966)

(b) If he finds that the invention will thereby be more adequately and quickly developed for widest use and that there

satisfactory safeguards against unreasonable royalties and repressive practices, the invention may be assigned to a competent organization for development and administration for the term of the patent or such lesser period as may be deemed necessary.

(c) If he finds that the interest of another contributing Government agency is paramount to the interest of the Department of Health and Human Services, or when otherwise legally required or in the public interest, the invention may be left for disposition by that agency in accordance with its own policy.

(d) In all other cases, he shall require that all domestic rights in the invention shall be assigned to the United States unless he determines that the invention is of such doubtful importance or the Government's equity in the invention is so minor that protective measures, except as provided in $8.3, are not necessary in the public interest. [20 FR 6749, Sept. 14, 1955, as amended at 31 FR 12842, Oct. 1, 1966)

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$ 8.2 Determination to domestic

rights. Rights in any invention not subject to disposition by the grantee pursuant to $8.1(b) are for determination by the Assistant Secretary (Health and Scientific Affairs) as follows:

(a) If he finds that there is adequate assurance that the invention will either be effectively dedicated to the public, or that any patent which may be obtained thereunder will be generally available for royalty-free and nonexclusive licensing, the effectuation of these results may be left to the grantee.

$ 8.4 Option to acquire foreign rights.

In any case where it is determined that all domestic rights should be assigned to the Government, there shall be reserved to the Government, pursuant to Executive Order 9865 (3 CFR, 1943–1948 Comp.) and Government-wide regulations issued thereunder, an option to require the assignment of all rights in the invention in all or in any specified foreign countries. In any case where the inventor is not required to assign the patent rights in any foreign country or countries to the Government, or the Government fails to exercise its option within such period of time as may be provided by regulations issued by the Chairman of the Government Patents Board any application for a patent which may be filed in such country or countries by the inventor or his assignee shall nevertheless be subject to a nonexclusive, irrevocable, royalty-free license to the Government for all governmental purposes, including the power to sublicense for all governmental purposes. [20 FR 6750, Sept. 14, 1955)

are acceptable as meeting the requirements of $8.1(b) with respect to grants, the contract may provide, with such special stipulations in the contract as may be deemed necessary in the public interest, for leaving the ownership and disposition of all domestic rights for determination by the contracting institution in accordance with such policies and procedures. (23 FR 1215, Feb. 27, 1958, as amended at 31 FR 12842, Oct. 1, 1966)

88.5 Fellowships.

In the discretion of the Assistant Secretary (Health and Scientific Affairs), the award of a fellowship to a person not a Government employee may provide for the reporting of any invention made during the term thereof, and for its disposition in accordance with the provisions of $8.1(a) or for its disposition by the institution at which the research was performed in accordance with its established policies, if applicable to such an invention, which meet the requirements of paragraph (b) of such section. [22 FR 9695, Dec. 4, 1957, as amended at 31 FR 12842, Oct. 1, 1966)

88.7 Cancer chemotherapy industrial

research contracts. Notwithstanding the provisions of $8.6, the Surgeon General in the negotiation of contracts with other than nonprofit organizations for the cancer chemotherapy research program shall be subject only to such limitations and alternatives as the Assistant Secretary (Health and Scientific Affairs) may approve for such program. (22 FR 9696, Dec. 4, 1957, as amended at 31 FR 12842, Oct. 1, 1966)

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88.6 Contracts for research.

(a) Contracts for research, with other than nonprofit institutions, shall provide that any invention first conceived or actually reduced to practice in the course of the performance of the contract shall be promptly and fully reported to the Assistant Secretary (Health and Scientific Affairs) for determination by him as to the manner of disposition of all rights in and to such invention, including the right to require assignment of all rights to the United States or dedication to the public. In the exercise of this power the organization head will be guided by the policy specified in 88.2 with respect to grants.

(b) Contracts for research with nonprofit institutions shall contain provisions as in paragraph (a) of this section except that, if it is determined that the institution's policies and procedures

88.8 Screening of compounds gen.

erated under DHHS grants and

awards. (a) General policy. (1) Chemical compounds having potential medicinal and other utilities are often synthesized or identified during the course of research financed under DHHS research grants and awards. Reporting, filing patent applications on, and determining ownership in inventions relating to such compounds pose problems which require special attention. After compound has been synthesized, it generally will not constitute a patentable invention under the patent laws of the United States until a specific utility for the compound has been established. It is the policy of the Department that all compounds synthesized or identified during the course of grant-supported research should be adequately screened and tested in Government or non-Government facilities in order that all possible utilities may be ascertained and that any promising compounds may be fully developed for widest possible use. The Department encourages the utilization, whenever appropriate, of the screening services of the Cancer Chemotherapy National Service Center and

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