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and opinions and related records indicating are a potential resource of great value to that a person, firm, or product is or is not in

the public health and welfare. It is the compliance with the law; records relating to

policy of the Department: factory inspections, sample collections, seafood inspection, and other examinations and

(a) To safeguard the public interest in investigations by the Food and Drug Admin- inventions developed by Department emistration; Investigational New Drug files; New ployees, contractors and grantees with Drug Applications and master Ales, other the aid of public funds and facilities; than final printed labeling; reports and rec

(b) To encourage and recognize indiords relating to individual adverse drug re

vidual and cooperative achievement in action(s); data in support of petitions relating to pesticide chemicals, food standards,

research and investigations; and food additives, and color additives, and (c) To establish a procedure, consistmaster files relating thereto; files relating to ent with pertinent statutes, Executive certification of insulin, antibiotics, and color orders and general Government regulaadditives, and master filles relating thereto; tions, for the determination of rights notices of hearing issued to individuals and

and obligations relating to the patenting firms under 21 U.S.C. 335 and records relating thereto; records relating to research in sup

of inventions. port of actions to further the law enforce

(20 F.R. 6747, Sept. 14, 1965. Redesignated ment or regulatory activities of the Food and

at 31 F.R. 12842, Oct. 1, 1966) Drug Administration.

$ 6.1 Publication or patenting of invenNOTE: Certain documents in some of the

tions. above files may be available upon request identifying the particular documents.

It is the general policy of the Depart12. Budget and legislative proposals and ment that the results of Department reall materials related thereto, other than those search should be made widely, promptly presented to Congress. 13. Opinions of the Office of General

and freely available to other research Counsel.

workers and to the public. This availa14. Records revealing names of persons

bility can generally be adequately preconsidered but not appointed to public ad

served by the dedication of a Governvisory Committees, unsuccessful job appli- ment-owned invention to the public. cants; records reflecting the identity of ex- Determinations to file a domestic patent perts, consultants, or other persons from

application on inventions in which the whom opinions, judgments, evaluations, or other data were obtained.

Department has an interest will be made 15. Records to the extent they reveal names

where the circumstances indicate that of complainants, drug abusers, or informers;

this is desirable in the public interest, audit, civil rights, disciplinary, grievance, se

and if it is practicable to do so. Departcurity, and other investigation files, including

ment determinations not to apply for a reports of interviews, signed or sworn state- domestic patent on employee inventions ments or other reports and related material. are subject to review and approval by the

16. Official personnel folders and related Commissioner of Patents. Except where files including grievance and disciplinary deemed necessary for protecting the files; confidential statement of employment and financial interest; performance evalua

patent claim, the fact that a patent aptions and test scores; internal mailing keys.

plication has been or may be filed will 17. Earnings record and claim files main- not require any departure from normal tained by Social Security Administration. policy regarding the dissemination of

the results of Department research. PART 6-INVENTIONS AND

(28 F.R. 2990, Mar. 27, 1963. Redesignated

at 31 F.R. 12842, Oct. 1, 1966) PATENTS (GENERAL) Sec.

8 6.2 General Responsibility. 6.0 General policy.

The Assistant Secretary (Health and 6.1 Publication or patenting of inventions. 6.2 General responsibility.

Scientific Affairs) is responsible for the 6.3 Government-owned patents; licensing;

administration of the invention and dedication to the public.

patent program of the Department and 6.4 Central records; confidentiality.

the determination of rights in inventions AUTHORITY: The provisions of this Part 6

and patents in which the Department has issued under Reorg. Plan No. 1 of 1953, 18

an interest. F.R. 2053; 3 CFR, 1953 Supp. E.O. 10096, 15 (31 F.R. 12842, Oct. 1, 1966) F.R. 391; 3 CFR, 1950 Supp.

8 6.3 Government-owned patents; li. $ 6.0 General policy.

censing; dedication to the public. Inventions developed through the re- Licenses to practice inventions covered sources and activities of the Department by patents and pending patent applica

tions owned by the U.S. Government as them would be impracticable or inequirepresented by this Department will be table, given the reasons therefor. A royalty free, revocable, and nonexclusive. person shall not be considered to be a Except in unusual cases when it is de part-time employee or part-time contermined that unconditional licensing sultant for this purpose unless the terms would be contrary to the public interest, of his employment contemplate that he licenses will be issued to all applicants shall work for less than the minimum and will contain no limitations or stand number of hours per day, or less than ards relating to the quality of the prod a minimum number of days per week, or ucts to be manufactured, sold, or dis less than the minimum number of weeks tributed thereunder. To reduce the need per year, regularly required of full-time for individual license applications, pat employees of his class. ents held for unconditional licensing

§ 7.1 Duty of employee to report invenshall be dedicated to the public as may

tions. be feasible. (31 F.R. 12842, Oct. 1, 1966)

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 of all licenses issued by the Department

duties or which was made in whole or in under such patents. Invention reports any part during working hours, or with required from employees or others for the any contribution of Government facilpurpose of obtaining determinations of ities, equipment, material, funds, or inownership, and documents and informa formation, or of time or services of other tion obtained for the purpose of prose

Government employees on official duty. cuting patent applications shall be con (31 F.R. 12842, Oct. 1, 1966) fidential and shall be disclosed only as

8 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 inter

est in and to an invention which is or may PART 7-EMPLOYEE INVENTIONS

be patentable, made by a Government Sec.

employee while under the administra7.0 Who are employees.

tive jurisdiction of the Department, shall 7.1 Duty of employee to report inventions.

be made in writing by the Assistant Sec7.3 Determination as to domestic rights.

retary (Health and Scientific Affairs), 7.4 Option to acquire foreign rights. 7.7 Notice to employee of determination.

in accordance with the provisions of 7.8 Employee's right of appeal.

Executive Order 10096 and Government

wide regulations issued thereunder by AUTHORITY: The provisions of this Part 7

the Commissioner of Patents as follows: issued under Reorg. Plan No. 1 of 1953, 18 F.R. 2053; 3 CFR, 1953 Supp. E.O. 10096, 15

(a) The Government as represented F.R. 391; 3 CFR, 1950 Supp. and E.O. 10930,

by the Assistant Secretary (Health 26 F.R. 2583; 3 CFR 1961 Supp.

and Scientific Affairs) shall obtain the SOURCE: The provisions of this part 7 ap

entire domestic right, title and interest pear at 27 F.R. 7986, Aug. 10, 1962, unless

in and to all inventions made by any otherwise noted.

Government employee (1) during work$ 7.0 Who are employees.

ing hours, or (2) with a contribution by

the Government of facilities, equipment, As used in this part, the term "Gov

materials, funds, or information, or of ernment employee" means any officer or

time or services of other Government ememployee, civilian or military, except

ployees on official duty, or (3) which such part-time employees or part-time bear a direct relation to or are made in consultants as may be excluded there

consequence of the official duties of the from by a determination made in writing

inventor. by the head of the employee's office or (b) In any case where the contribuconstituent organization, pursuant to an tion of the Government, as measured by exemption approved by the Commis any one or more of the criteria set forth sioner of Patents that to include him or in paragraph (a) of this section, 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

$ 7.4 Option to acquire foreign rights. ment has insufficient 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 in In case where the inventor is not required vention with power to grant licenses for to assign the patent rights in any foreign all governmental purposes, such reserva

country or countries to the Government tion to appear, where practicable, in any

or the Government fails to exercise its patent, domestic or foreign, which may option within such period of time as may issue on such invention.

be provided by regulations issued by the (c) In applying the provisions of para

Commissioner of Patents, any applicagraphs (a) and (b) of this section, to the tion for a patent which may be filed in facts and circumstances relating to the such country or countries by the invenmaking of any particular invention, it tor or his assignee shall nevertheless be shall be presumed that an invention subject to a nonexclusive, irrevocable, made by an employee who is employed royalty-free license to the Government or assigned (1) to invent or improve or for all governmental purposes, including perfect any art, machine, manufacture, the power to issue sublicenses for use in or composition of matter, (2) to conduct behalf of the Government and/or in furor perform research, development work, therance of the foreign policies of the or both, (3) to supervise, direct, coordi Government. nate, or review Government financed or

$ 7.7 Notice to employee of determinaconducted research, development work,

tion. or both, or (4) to act in a liaison capacity

The employee-inventor shall be notiamong governmental or nongovernmental agencies or individuals engaged

fied in writing of the Department's deterin such work, falls within the provisions

mination of the rights to his invention of paragraph (a) of this section, and it

and of his right of appeal, if any. Notice shall be presumed that any invention

need not be given if the employee stated made by any other employee falls within

in writing that he would agree to the dethe provisions of paragraph (b) of this

termination of ownership which was in section. Either presumption may be re

fact made. butted by a showing of the facts and (31 F.R. 12842, Oct. 1, 1966) circumstances and shall not preclude a § 7.8 Employee's right of appeal. determination that these facts and circumstances justify leaving the entire

An employee who is aggrieved by a right, title and interest in and to the

determination of the Department may invention in the Government employee,

appeal to the Commissioner of Patents, subject to law.

pursuant to section 4(d) of Executive (d) In any case wherein the Govern

Order 10096, as amended by Executive ment neither (1) obtains the entire do

Order 10930, and regulations issued mestic right, title and interest in and to

thereunder, by filing a written appeal an invention pursuant to the provisions

with the Commissioner, in duplicate, and of paragraph (a) of this section, nor (2)

a copy of the appeal with the Assistant reserves nonexclusive, irrevocable,

Secretary (Health and Scientific Affairs), royalty-free license in the invention, with

within 30 days (or such longer period as power to grant licenses for all govern

the Commissioner may, for good cause, mental purposes, pursuant to the provi fix in any case) after receiving written sions of paragraph (b) of this section, notice of such determination. the Government shall leave the entire [27 F.R. 7986, Aug. 10, 1962, as amended at right, title and interest in and to the 31 F.R. 12842, Oct. 1, 1966)

a

8.0

re

PART 8- INVENTIONS RESULTING the cooperative nature of such activities FROM RESEARCH GRANTS, FEL

to attribute a particular invention priLOWSHIP AWARDS, AND CON

marily to support received from any one

source. In all these cases the DepartTRACTS FOR RESEARCH

ment has a responsibility to see that the Sec.

public use of the fruits of the research Policy.

will not be unduly restricted or denied. 8.1 Conditions to be included in research

(d) The following conditions have been grants.

adopted to govern the treatment of in8.2 Determination as to domestic rights. 8.3 Licenses to the Government.

ventions made in these various types 8.4 Option to acquire foreign rights.

of situations. They are designed to af8.5 Fellowships.

ford suitable protection to the public in8.6 Contracts for research.

terest while giving appropriate recogni8.7 Cancer chemotherapy industrial tion to the legitimate interests of others search contracts.

who have contributed to the invention. AUTHORITY: The provisions of this Part 8

$ 8.1 Conditions to be included in reissued under Reorg. Plan No. 1 of 1953, 18

search grants. F.R. 2053; 3 CFR, 1953 Supp. E.O. 9865, 12 F.R. 3907; 3 CFR, 1947 Cum. Supp. E.O. 10096, Subject to legislative directives or Ex15 F.R. 391; 3 CFR, 1950 Supp.

ecutive orders providing otherwise, all SOURCE: The provisions of this part 8 ap

grants in aid of research shall provide as pear at 20 F.R. 6749, Sept. 14, 1955, unless

a condition that any invention arising otherwise noted.

out of the activities assisted by the grant

shall be promptly and fully reported, and $ 8.0 Policy.

shall provide either (a) The Department of Health, Edu- (a) That the ownership and manner cation, and Welfare each year is ex- of disposition of all rights in and to such pending large sums in the form of grants invention shall be subject to determinafor research. These grants are made tion by the Assistant Secretary (Health primarily by the Public Health Service and Scientific Affairs) or in carrying out its broad responsibility (b) That the ownership and disposiunder the Public Health Service Act to tion of all domestic rights shall be left promote and coordinate research in the for determination by the grantee instifield of health and to make available tution in accordance with the grantee's information concerning such research established policies and procedures, with and its practical application. The sci- such modifications as may be agreed entific and technological advances at- upon and specified in the grant, protributable, in varying degrees to this vided the Assistant Secretary (Health expenditure of public funds frequently and Scientific Affairs) finds that these include patentable inventions.

are such as to assure that the invention (b) The Department, as a matter of will be made available without unreapolicy, takes the position that the results sonable restrictions or excessive royalof research supported by grants of pub- ties, and provided the Government shall lic moneys should be utilized in the man- receive a royalty-free license, with a ner which would best serve the public right to issue sublicenses as provided in interest. It is believed that the public $ 8.3, under any patent applied for or interest will in general be best served if

obtained upon the invention. inventive advances resulting therefrom (c) Wherever practicable, any arare made freely available to the Gov

rangement with the grantee pursuant to ernment, to science, to industry, and to paragraph (b) of this section shall prothe general public.

vide in accordance with Executive Order (c) On the other hand, in some cases 9865 that there be reserved to the Govit may be advisable to permit a utiliza

ernment an option, for a period to be tion of the patent process in order to prescribed, to file foreign patent applifoster an adequate commercial develop- cations upon the invention. ment to make a new invention widely

[20 F.R. 6749, Sept. 14, 1965, as amended at available. Moreover, it is recognized 31 F.R. 12842, Oct. 1, 1966) that inventions frequently arise in the course of research activities which also

$ 8.2 Determination as to domestic receive substantial support from other

rights. sources, as well as from the Federal Rights in any invention not subject grant. It would not be consistent with to disposition by the grantee pursuant

to g 8.1(b) are for determination by the the invention in all or in any specified Assistant Secretary (Health and Scien foreign countries. In any case where the tific Affairs) as follows:

inventor is not required to assign the (a) If he finds that there is adequate patent rights in any foreign country or assurance that the invention will either countries to the Government, or the be effectively dedicated to the public, or Government fails to exercise its option that any patent which may be obtained within such period of time as may be thereunder will be generally available provided by regulations issued by the for royalty-free and nonexclusive li Chairman of the Government Patents censing, the effectuation of these results Board any application for a patent may be left to the grantee.

which may be filed in such country or (b) If he finds that the invention will countries by the inventor or his assignee thereby be more adequately and quickly shall nevertheless be subject to a nondeveloped for widest use and that there exclusive, irrevocable, royalty-free liare satisfactory safeguards against un cense to the Government for all governreasonable royalties and repressive prac mental purposes, including the power to tices, the invention may be assigned to a sublicense for all governmental purposes. competent organization for development

$ 8.5 Fellowships. and administration for the term of the patent or such lesser period as may be

In the discretion of the Assistant Secdeemed necessary.

retary (Health and Scientific Affairs), (c) If he finds that the interest of an

the award of a fellowship to a person not other contributing Government agency

a Government employee may provide for is paramount to the interest of the De the reporting of any invention made partment of Health, Education, and Wel. during the term thereof, and for its disfare, or when otherwise legally required

position in accordance with the proor in the public interest, the invention visions of $ 8.1(a) or for its disposimay be left for disposition by that agency

tion by the institution at which the in accordance with its own policy.

research was performed in accordance (d) In all other cases, he shall require

with its established policies, if applicable that all domestic rights in the invention to such an invention, which meet the shall be assigned to the United States un requirements of paragraph (b) of such less he determines that the invention is

section. of such doubtful importance or the Gov (22 F.R. 9695, Dec. 4, 1957, as amended at ernment's equity in the invention is so

31 F.R. 12842, Oct. 1, 1966) minor that protective measures, except 8 8.6 Contracts for research. as provided in § 8.3, are not necessary in the public interest.

(a) Contracts for research, with other

than nonprofit institutions, shall provide [20 F.R. 6749, Sept. 14, 1965, as amended at 31 F.R. 12842, Oct. 1, 1966)

that any invention first conceived or ac

tually reduced to practice in the course $ 8.3 Licenses to the Government.

of the performance of the contract shall Any arrangement or determination as be promptly and fully reported to the to the disposition of rights in inventions Assistant Secretary (Health and Scienpursuant to $ $ 8.1, 8.2, 8.5 or 8.6 shall tific Affairs) for determination by him require that there be reserved under any as to the manner of disposition of all patent application or patent thereon,

rights in and to such invention, includdomestic or foreign, a nonexclusive, ir ing the right to require assignment of revocable, royalty-free license to the all rights to the United States or dediGovernment with power to sublicense for cation to the public. In the exercise of all governmental purposes.

this power the organization head will be (22 F.R. 9696, Dec. 4, 1957)

guided by the policy specified in $ 8.2

with respect to grants. $ 8.4 Option to acquire foreign rights.

(b) Contracts for research with nonIn any case where it is determined profit institutions shall contain provithat all domestic rights should be as sions as in paragraph (a) of this section signed to the Government, there shall be except that, if it is determined that the reserved to the Government, pursuant to institution's policies and procedures are Executive Order 9865 (3 CFR, 1943–1948 acceptable as meeting the requirements Comp.) and Government-wide regu of $ 8.1(b) with respect to grants, the lations issued thereunder, an option contract may provide, with such special to require the assignment of all rights in stipulations in the contract as may be

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