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not require any departure from normal PART 7-EMPLOYEE INVENTIONS policy regarding the dissemination of

Sec. the results of Department research.

7.0 Who are employees. [28 F.R. 2990, Mar. 27, 1963. Redesignated 7.1 Duty of employee to report inventions. at 31 F.R. 12842, Oct. 1, 1966)

7.3 Determination as to domestic rights.

7.4 Option to acquire foreign rights. $ 6.2 General Responsibility.

7.7 Notice to employee of determination. The Assistant Secretary Health and 7.8 Employee's right of appeal. Scientific Affairs) is responsible for the AUTHORITY: The provisions of this Part 7 administration of the invention and issued under Reorg. Plan No. 1 of 1953, 18 patent program of the Department and F.R. 2053; 3 CFR, 1953 Supp. E.O. 10096, 15 the determination of rights in inventions F.R. 391; 3 CFR, 1950 Supp. and E.O. 10930, and patents in which the Department bas

26 F.R. 2583; 3 CFR 1961 Supp. an interest.

SOURCE: The provisions of this part 7 ap(31 F.R. 12842, Oct. 1, 1966)

pear at 27 F.R. 7986, Aug. 10, 1962, unless

otherwise noted. $ 6.3 Licensing of Government-owned

8 7.0 Who are employees. patents.

As used in this part, the term “Gov. Licenses to practice inventions covered

ernment employee" means any officer or by patents and pending patent applica

employee, civilian or military, except tions owned by the U.S. Government as

such part-time employees or part-time represented by this Department will gen

consultants as may be excluded thereerally be royalty free, revocable and non from by a determination made in writing exclusive. They will normally be issued by the head of the employee's ofice or to all applicants and will generally con constituent organization, pursuant to an tain no limitations or standards relating exemption approved by the Commisto the quality or testing of the products sioner of Patents that to include him or to be manufactured, sold, or distributed them would be impracticable or inequithereunder.

table, given the reasons therefor. A Where it appears however that the

person shall not be considered to be a public interest will be served under the

part-time employee or part-time concircumstances of the particular case by

sultant for this purpose unless the terms

of his employment contemplate that he licenses which impose conditions, such

shall work for less than the minimum as those relating to quality or testing of

number of hours per day, or less than products, requirement of payment of

a minimum number of days per week, or royalties to the Government, etc., or by less than the minimum number of weeks the issuance of limited exclusive licenses

per year, regularly required of full-time by the Assistant Secretary for Health employees of his class. and Scientific Affairs after notice and

$ 7.1 Duty of employee to report invenopportunity for hearing thereon, such

tions. licenses may be issued. (34 F.R. 15560, Oct. 7, 1969)

Every Department employee is re

quired to report to the Assistant Secre$ 6.4 Central records; confidentiality. tary (Health and Scientific Affairs) in Central files and records shall be

accordance with the procedures estabmaintained of all inventions, patents,

lished therefor, every invention made by and licenses in which the Department

him (whether or not jointly with others) has an interest, together with a record

which bears any relation to his official

duties or which was made in whole or in of all licenses issued by the Department under such patents. Invention reports

any part during working hours, or with

any contribution of Government facilrequired from employees or others for the

ities, equipment, material, funds, or inpurpose of obtaining determinations of

formation, or of time or services of other ownership, and documents and informa

Government employees on official duty. tion obtained for the purpose of prose

131 F.R. 12842, Oct. 1, 1966) cuting patent applications shall be confidential and shall be disclosed only as $ 7.3 Determination as to domestic required for official purposes or with the

rights. consent of the inventor.

The determination of the ownership (20 F.R. 6747, Sept. 14, 1965)

of the domestic right. title, and interest in and to an invention which is or mayor both, or (4) to act in a liaison capacity be patentable, made by a Government among governmental or nongovernemployee while under the administra- mental agencies or individuals engaged tive jurisdiction of the Department, shall in such work, falls within the provisions be made in writing by the Assistant Sece of paragraph (a) of this section, and it retary (Health and Scientific Affairs), shall be presumed that any invention in accordance with the provisions of made by any other employee falls within Executive Order 10096 and Government the provisions of paragraph. (b) of this wide regulations issued thereunder by section. Either presumption may be rethe Commissioner of Patents as follows: butted by a showing of the facts and

(a) The Government as represented circumstances and shall not preclude a by the Assistant Secretary (Health determination that these facts and cirand Scientific Affairs) shall obtain the cumstances justify leaving the entire entire domestic right, title and interest right, title and interest in and to the in and to all inventions made by any invention in the Government employee, Government employee (1) during working hours, or (2) with a contribution by (d) In any case wherein the Governthe Government of facilities, equipment, ment neither (1) obtains the entire domaterials, funds, or information, or of

mestic right, title and interest in and to time or services of other Government em an invention pursuant to the provisions ployees on official duty, or (3) which of paragraph (a) of this section, nor (2) bear a direct relation to or are made in reserves a nonexclusive, irrevocable, consequence of the oficial duties of the royalty-free license in the invention, with Inventor.

power to grant licenses for all govern(b) In any case where the contribu mental purposes, pursuant to the provition of the Government, as measured by

sions of paragraph (b) of this section, any one or more of the criteria set forth

the Government shall leave the entire In paragraph (&) of this section, to the

right, title and interest in and to the Invention is insufficient equitably to jus invention in the Government employee, tify a requirement of assignment to the subject to law. Government of the entire domestic right, (27 F.R. 7986, Aug. 10, 1962, as amended at title and interest in and to such Inven- 31 F.R. 12842, Nov. 1, 1966) tion, or in any case where the Govern. 8

$ 7.4 Option to acquire foreign rights. ment has insuficient interest in an invention to obtain the entire domestic

In any case where it is determined right, title, and interest therein (al that all domestic rights should be asthough the Government could obtain signed to the Government, it shall fursame under paragraph (a) of this sec ther be determined, pursuant to Execution, the Department, subject to the ap tive Order 9865 and Government-wide proval of the Commissioner, shall leave

regulations issued thereunder, that the title to such invention in the employee,

Government shall reserve an option to subject, however, to the reservation to

require the assignment of such rights in the Government of a nonexclusive, ir

all or in any specified foreign countries. revocable, royalty-free license in the invention with power to grant licenses for

In case where the inventor is not required all governmental purposes, such reserva

to assign the patent rights in any foreign tion to appear, where practicable, in any

country or countries to the Government patent, domestic or foreign, which may or the Government fails to exercise its Issue on such invention.

option within such period of time as may (c) In applying the provisions of para be provided by regulations issued by the graphs (a) and (b) of this section, to the Commissioner of Patents, any applicafacts and circumstances relating to the tion for a patent which may be filed in making of any particular invention, it such country or countries by the invenshall be presumed that an invention

tor or his assignee shall nevertheless be made by an employee who is employed

subject to a nonexclusive, irrevocable, or assigned (1) to invent or improve or

royalty-free license to the Government perfect any art, machine, manufacture, or composition of matter, (2) to conduct

for all governmental purposes, including or perform research, development work,

the power to issue sublicenses for use in or both, (3) to supervise, direct, coordi- behalf of the Government and/or in furnate, or review Government financed or therance of the foreign policies of the conducted research, development work, Government.

§ 7.7 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. 131 F.R. 12842, Oct. 1, 1968] $ 7.8 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 F.R. 7986, Aug. 10, 1962, as amended at 31 F.R. 12842, Oct. 1, 1966)

PART 8-INVENTIONS RESULTING

FROM RESEARCH GRANTS, FEL-
LOWSHIP AWARDS, AND CON-

TRACTS 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 ro

search contracts. 8.8 Screening of compounds generated un

der DHEW grants and awards. AUTHORITY: The provisions of this Part 8 Issued under Reorg. Plan No. 1 of 1958, 18 F.R. 2053; 3 CFR, 1963 Supp. E.O. 9865, 12 F.R. 3907; 3 CFR, 1947 Cum. Supp. E.O. 10096, 15 F.R. 391; 3 CFR, 1950 Supp.

SOURCE: The provisions of this part 8 appear at 20 F.R. 6749, Sept. 14, 1955, unless otherwise noted. $ 8.0 Policy.

(a) The Department of Health, Education, and Welfare 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 support received from any one source. In all these cases the Department has a responsibility 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. $ 8.1 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 royalty-free 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 arrangement with the grantee pursuant to paragraph (b) of this section shall provide in accordance with Executive Order 9865 that there be reserved to the Gov. ernment an option, for a period to be prescribed, to file foreign patent applications upon the invention. 120 F.R. 6749, Sept. 14, 1965, as amended at 31 F.R. 12842, Oct. 1, 1966) $ 8.2 Determination as 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 11censing, the effectuation of these results may be left to the grantee.

(b) If he finds that the invention will thereby be more adequately and quickly developed for widest use and that there are 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, Education, and Welfare, 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 F.R. 6749, Sept. 14, 1965, as amended at 31 F.R. 12842, Oct. 1, 1966) § 8.3 Licenses to the Government.

Any arrangement or determination as to the disposition of rights in inventions pursuant to $$ 8.1, 8.2, 8.5 or 8.6 shall require that there be reserved under any patent application or patent thereon, domestic or foreign, a nonexclusive, irrevocable, royalty-free license to the Government with power to sublicense for all governmental purposes. (22 F.R. 9696, Dec. 4, 1957) $ 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. § 8.5 Fellowships.

In the discretion of the Assistant Sec. retary (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 disposttion 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 F.R. 9695, Dec. 4, 1957, as amended at 31 F.R. 12842, Oct. 1, 1966) § 8.6 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 $ 8.2 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 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. 123 F.R. 1215, Feb. 27, 1958, as amended at 31 F.R. 12842, Oct. 1, 1966) § 8.7 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. 122 FR, 9696, Dec. 4, 1957, as amended at 31 F.R. 12842, Oct. 1, 1966) $ 8.8 Screening of compounds gener

ated under DHEW grants and awards. (a) General policy. (1) Chemical compounds having potential medicinal and other ultilities are often synthesized or identified during the course of research

financed under DHEW 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 a 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 thui 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 the Walter Reed Army Institute of Research.

(2) It is the policy of the Department notwithstanding anything to the contrary under patent law of the United States or requirements of U.S. Patent Office practice, to acquire no ownership rights to inventions claiming novel methods of using compounds, where such use inventions are first conceived and reduced to practice solely by the screening or testing organization without the use of grant funds.

(b) Screening performed with use of grant funds. Where nongovernmental facilities are utilized for screening services to be performed and paid for by the grantee (as used in this section, the term "grantee" refers to awardees in addition grantee (as used in this section, the term to grantee institutions with grant funds, the grantee shall obtain an agreement with the screening organization providing that the screener shall promptly report to the grantee the details of any positive findings of utility for the compound and that all invention rights relating to the compound and its utility shall, as between the grantee and the screener, vest in the grantee. Upon receipt of such report of positive findings, the grantee shall promptly forward copies to DHEW. Ownership of all invention rights to the compound or reported utilities shall be subject to the disposition by the Assistant Secretary (Health and Scientific Affairs) as provided by the terms of the grant or award in accordance with $ 8.2, except that where the grantee institution has entered into an

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