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35 U.S.C. § 200 — Policy and objective

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35 U.S.C. § 200 — Policy and objective

§ 200. Policy and objective It is the policy and objective of the Congress to use the patent system to promote the utiliza- tion of inventions arising from federally sup- ported research or development; to encourage maximum participation of small business firms in federally supported research and development efforts; to promote collaboration between com- mercial concerns and nonprofit organizations, including universities; to ensure that inventions Page 88 TITLE 35—PATENTS § 201 1 See References in Text note below. made by nonprofit organizations and small busi- ness firms are used in a manner to promote free competition and enterprise without unduly en- cumbering future research and discovery; to pro- mote the commercialization and public avail- ability of inventions made in the United States by United States industry and labor; to ensure that the Government obtains sufficient rights in federally supported inventions to meet the needs of the Government and protect the public against nonuse or unreasonable use of inven- tions; and to minimize the costs of admin- istering policies in this area. (Added Pub. L. 96–517, § 6(a), Dec. 12, 1980, 94 Stat. 3018; amended Pub. L. 106–404, § 5, Nov. 1, 2000, 114 Stat. 1745.) Editorial Notes AMENDMENTS 2000—Pub. L. 106–404 substituted ‘‘enterprise without unduly encumbering future research and discovery;’’ for ‘‘enterprise;’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective July 1, 1981, but implementing regu- lations authorized to be issued earlier, see section 8(f) of Pub. L. 96–517, set out as an Effective Date of 1980 Amendment note under section 41 of this title. SHORT TITLE This chapter is popularly known as the Bayh-Dole Act. Section 6(a) of Pub. L. 96–517, Dec. 12, 1980

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Page 87 TITLE 35—PATENTS § 200 § 186. Penalty Whoever, during the period or periods of time an invention has been ordered to be kept secret and the grant of a patent thereon withheld pur- suant to section 181, shall, with knowledge of such order and without due authorization, will- fully publish or disclose or authorize or cause to be published or disclosed the invention, or mate- rial information with respect thereto, or who- ever willfully, in violation of the provisions of section 184, shall file or cause or authorize to be filed in any foreign country an application for patent or for the registration of a utility model, industrial design, or model in respect of any in- vention made in the United States, shall, upon conviction, be fined not more than $10,000 or im- prisoned for not more than two years, or both. (July 19, 1952, ch. 950, 66 Stat. 807; Pub. L. 100–418, title IX, § 9101(b)(3), Aug. 23, 1988, 102 Stat. 1568; Pub. L. 112–29, § 20(j), Sept. 16, 2011, 125 Stat. 335.) HISTORICAL AND REVISION NOTES Based on Title 35, U.S.C., 1946 ed., § 156 (Feb. 1, 1952, ch. 4, § 6, 66 Stat. 5, 6). Language is changed. Editorial Notes AMENDMENTS 2011—Pub. L. 112–29 struck out ‘‘of this title’’ after ‘‘181’’ and after ‘‘184’’. 1988—Pub. L. 100–418, which directed the insertion of ‘‘willfully’’ after second reference to ‘‘whoever’’, was executed by making the insertion after ‘‘or whoever’’, as the probable intent of Congress. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2011 AMENDMENT Amendment by Pub. L. 112–29 effective upon the expi- ration of the 1-year period beginning on Sept. 16, 2011, and applicable to proceedings commenced on or after that effective date, see section 20(l) of Pub. L. 112–29, set out as a note under section 2 of this title. EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100–418 applicable, subject to certain qualifications and exceptions, to all United States patents, and to all licenses under section 184 of this title, regardless of the date such patents or li- censes are granted, and to all applications for such pat- ents pending on or filed after Aug. 23, 1988, see section 9101(d) of Pub. L. 100–418, set out as a note under sec- tion 184 of this title. § 187. Nonapplicability to certain persons The prohibitions and penalties of this chapter shall not apply to any officer or agent of the United States acting within the scope of his au- thority, nor to any person acting upon his writ- ten instructions or permission. (July 19, 1952, ch. 950, 66 Stat. 808.) HISTORICAL AND REVISION NOTES Based on Title 35, U.S.C., 1946 ed., § 157 (Feb. 1, 1952, ch. 4, § 7, 66 Stat. 6). Language is changed. § 188. Rules and regulations, delegation of power The Atomic Energy Commission, the Sec- retary of a defense department, the chief officer of any other department or agency of the Gov- ernment designated by the President as a de- fense agency of the United States, and the Sec- retary of Commerce, may separately issue rules and regulations to enable the respective depart- ment or agency to carry out the provisions of this chapter, and may delegate any power con- ferred by this chapter. (July 19, 1952, ch. 950, 66 Stat. 808.) HISTORICAL AND REVISION NOTES Based on Title 35, U.S.C., 1946 ed., § 158 (Feb. 1, 1952, ch. 4, § 8, 66 Stat. 6). Language is changed. Statutory Notes and Related Subsidiaries TRANSFER OF FUNCTIONS Atomic Energy Commission abolished and functions transferred by sections 5814 and 5841 of Title 42, The Public Health and Welfare. See, also, Transfer of Func- tions notes set out under those sections. Executive Documents DEFENSE AGENCIES Department of Justice designated as a defense agency of United States for purposes of this chapter by Execu- tive Order No. 10457, May 27, 1953, 18 F.R. 3083. CHAPTER 18—PATENT RIGHTS IN INVEN- TIONS MADE WITH FEDERAL ASSISTANCE Sec. 200. Policy and objective. 201. Definitions. 202. Disposition of rights. 203. March-in rights. 204. Preference for United States industry. 205. Confidentiality. 206. Uniform clauses and regulations. 207. Domestic and foreign protection of federally owned inventions. 208. Regulations governing Federal licensing. 209. Licensing federally owned inventions. 210. Precedence of chapter. 211. Relationship to antitrust laws. 212. Disposition of rights in educational awards. Editorial Notes AMENDMENTS 2000—Pub. L. 106–404, § 4(b), Nov. 1, 2000, 114 Stat. 1744, substituted ‘‘Licensing federally owned inventions’’ for ‘‘Restrictions on licensing of federally owned inven- tions’’ in item 209. 1984—Pub. L. 98–620, title V, § 501(15), Nov. 8, 1984, 98 Stat. 3368, added item 212. 1982—Pub. L. 97–256, title I, § 101(5), Sept. 8, 1982, 96 Stat. 816, redesignated chapter 38, as added by Pub. L. 96–517, § 6(a), Dec. 12, 1980, 94 Stat. 3018, comprising sec- tions 200 to 211, as chapter 18, and transferred chapter 18, as so redesignated, to end of this part from end of part IV. § 200. Policy and objective It is the policy and objective of the Congress to use the patent system to promote the utiliza- tion of inventions arising from federally sup- ported research or development; to encourage maximum participation of small business firms in federally supported research and development efforts; to promote collaboration between com- mercial concerns and nonprofit organizations, including universities; to ensure that inventions Page 88 TITLE 35—PATENTS § 201 1 See References in Text note below. made by nonprofit organizations and small busi- ness firms are used in a manner to promote free competition and enterprise without unduly en- cumbering future research and discovery; to pro- mote the commercialization and public avail- ability of inventions made in the United States by United States industry and labor; to ensure that the Government obtains sufficient rights in federally supported inventions to meet the needs of the Government and protect the public against nonuse or unreasonable use of inven- tions; and to minimize the costs of admin- istering policies in this area. (Added Pub. L. 96–517, § 6(a), Dec. 12, 1980, 94 Stat. 3018; amended Pub. L. 106–404, § 5, Nov. 1, 2000, 114 Stat. 1745.) Editorial Notes AMENDMENTS 2000—Pub. L. 106–404 substituted ‘‘enterprise without unduly encumbering future research and discovery;’’ for ‘‘enterprise;’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective July 1, 1981, but implementing regu- lations authorized to be issued earlier, see section 8(f) of Pub. L. 96–517, set out as an Effective Date of 1980 Amendment note under section 41 of this title. SHORT TITLE This chapter is popularly known as the Bayh-Dole Act. Section 6(a) of Pub. L. 96–517, Dec. 12, 1980, 94 Stat. 3018, which enacted this chapter, is also popularly known as the Bayh-Dole Act and also as the University and Small Business Patent Procedures Act of 1980. For complete classification of section 6(a) of Pub. L. 96–517 to the Code, see Tables. § 201. Definitions As used in this chapter— (a) The term ‘‘Federal agency’’ means any executive agency as defined in section 105 of title 5, and the military departments as de- fined by section 102 of title 5. (b) The term ‘‘funding agreement’’ means any contract, grant, or cooperative agreement entered into between any Federal agency, other than the Tennessee Valley Authority, and any contractor for the performance of ex- perimental, developmental, or research work funded in whole or in part by the Federal Gov- ernment. Such term includes any assignment, substitution of parties, or subcontract of any type entered into for the performance of ex- perimental, developmental, or research work under a funding agreement as herein defined. (c) The term ‘‘contractor’’ means any per- son, small business firm, or nonprofit organi- zation that is a party to a funding agreement. (d) The term ‘‘invention’’ means any inven- tion or discovery which is or may be patent- able or otherwise protectable under this title or any novel variety of plant which is or may be protectable under the Plant Variety Pro- tection Act (7 U.S.C. 2321 et seq.). (e) The term ‘‘subject invention’’ means any invention of the contractor conceived or first actually reduced to practice in the perform- ance of work under a funding agreement: Pro- vided, That in the case of a variety of plant, the date of determination (as defined in sec- tion 41(d) 1 of the Plant Variety Protection Act (7 U.S.C. 2401(d))) must also occur during the period of contract performance. (f) The term ‘‘practical application’’ means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such condi- tions as to establish that the invention is being utilized and that its benefits are to the extent permitted by law or Government regu- lations available to the public on reasonable terms. (g) The term ‘‘made’’ when used in relation to any invention means the conception or first actual reduction to practice of such invention. (h) The term ‘‘small business firm’’ means a small business concern as defined at section 2 of Public Law 85–536 (15 U.S.C. 632) and imple- menting regulations of the Administrator of the Small Business Administration. (i) The term ‘‘nonprofit organization’’ means universities and other institutions of higher education or an organization of the type de- scribed in section 501(c)(3) of the Internal Rev- enue Code of 1986 (26 U.S.C. 501(c)) and exempt from taxation under section 501(a) of the In- ternal Revenue Code (26 U.S.C. 501(a)) or any nonprofit scientific or educational organiza- tion qualified under a State nonprofit organi- zation statute. (Added Pub. L. 96–517, § 6(a), Dec. 12, 1980, 94 Stat. 3019; amended Pub. L. 98–620, title V, § 501(1), (2), Nov. 8, 1984, 98 Stat. 3364; Pub. L. 99–514, § 2, Oct. 22, 1986, 100 Stat. 2095; Pub. L. 107–273, div. C, title III, § 13206(a)(12), Nov. 2, 2002, 116 Stat. 1904.) Editorial Notes REFERENCES IN TEXT The Plant Variety Protection Act, referred to in sub- sec. (d), is Pub. L. 91–577, Dec. 24, 1970, 84 Stat. 1542, which is classified principally to chapter 57 (§ 2321 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 2321 of Title 7 and Tables. Section 41 of the Plant Variety Protection Act (7 U.S.C. 2401(d)), referred to in subsec. (e), was subse- quently amended, and no longer defines the term ‘‘date of determination’’. AMENDMENTS 2002—Subsec. (a). Pub. L. 107–273 struck out ‘‘United States Code,’’ after ‘‘section 105 of title 5,’’ and ‘‘, United States Code’’ after ‘‘section 102 of title 5’’. 1986—Subsec. (i). Pub. L. 99–514 substituted ‘‘Internal Revenue Code of 1986’’ for ‘‘Internal Revenue Code of 1954’’. 1984—Subsec. (d). Pub. L. 98–620, § 501(1), inserted ‘‘or any novel variety of plant which is or may be protectable under the Plant Variety Protection Act (7 U.S.C. 2321 et seq.)’’ after ‘‘title’’. Subsec. (e). Pub. L. 98–620, § 501(2), inserted ‘‘: Provided, That in the case of a variety of plant, the date of determination (as defined in section 41(d) of the Plant Variety Protection Act (7 U.S.C. 2401(d))) must also occur during the period of contract performance’’ after ‘‘agreement’’.

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Federal law — U.S. Code and appendices · legal_authorities

15 U.S.C. § 632 — Definitions

**(a) Small business concerns** (1) **In general** — For the purposes of this chapter, a small-business concern, including but not limited to enterprises that are engaged in the business of production of food and fiber, ranching and raising of livestock, aquaculture, and all other farming and agricultural related industries, shall be deemed to be one which is independently owned and operated and which is not dominant in its field of operation. (2) **Establishment of size standards** (A) *In general* — In addition to the criteria specified in paragraph (1) and subject to the requirements specified under subparagraph (C), the Administrator may specify detailed definitions or standards by which a business concern may be determined to be a small business concern for the purposes of this chapter or any other Act. (B) *Additional criteria* — The standards described in paragraph (1) may utilize number of employees, dollar volume of business, net worth, net income, a combination thereof, or other appropriate factors. (C) *Requirements* — Unless specifically authorized by statute, no Federal department (including the Administration when acting pursuant to subparagraph (A)) or agency may prescribe a size standard for categorizing a business concern as a small business concern, unless such proposed size standard— (i) is proposed after an opportunity for public notice and comment; (ii) provides for determining— (I) the size of a manufacturing concern as measured by the manufacturing concern’s average employment based upon employment during each of the manufacturing concern’s pay periods for the preceding 24 months; (II) the size of a business concern providing services on the basis of the annual average gross receipts of the business concern over

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Federal law — U.S. Code and appendices · legal_authorities

15 U.S.C. § 632 — Definitions

§ 632. Definitions (a) Small business concerns (1) In general For the purposes of this chapter, a small- business concern, including but not limited to enterprises that are engaged in the business of production of food and fiber, ranching and raising of livestock, aquaculture, and all other farming and agricultural related industries, shall be deemed to be one which is independ- ently owned and operated and which is not dominant in its field of operation. (2) Establishment of size standards (A) In general In addition to the criteria specified in paragraph (1) and subject to the require- ments specified under subparagraph (C), the Administrator may specify detailed defini- tions or standards by which a business con- cern may be determined to be a small busi- ness concern for the purposes of this chapter or any other Act. (B) Additional criteria The standards described in paragraph (1) may utilize number of employees, dollar vol- ume of business, net worth, net income, a combination thereof, or other appropriate factors. (C) Requirements Unless specifically authorized by statute, no Federal department (including the Ad- ministration when acting pursuant to sub- paragraph (A)) or agency may prescribe a size standard for categorizing a business concern as a small business concern, unless such proposed size standard— (i) is proposed after an opportunity for public notice and comment; (ii) provides for determining— (I) the size of a manufacturing concern as measured by the manufacturing con- cern’s average employment based upon employment during each of the manufac- turing concern’s pay periods for the pre- ceding 24 months; (II) the size of a business concern pro- viding services on the basis of the annual average gross receipts of the busine

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Federal law — U.S. Code and appendices · legal_authorities

26 U.S.C. § 501 — Exemption from tax on corporations, certain trusts, etc.

**(a) Exemption from taxation** An organization described in subsection (c) or (d) or section 401(a) shall be exempt from taxation under this subtitle unless such exemption is denied under section 502 or 503. **(b) Tax on unrelated business income and certain other activities** An organization exempt from taxation under subsection (a) shall be subject to tax to the extent provided in parts II, III, and VI of this subchapter, but (notwithstanding parts II, III, and VI of this subchapter) shall be considered an organization exempt from income taxes for the purpose of any law which refers to organizations exempt from income taxes. **(c) List of exempt organizations** The following organizations are referred to in subsection (a): (1) Any corporation organized under Act of Congress which is an instrumentality of the United States but only if such corporation— (A) is exempt from Federal income taxes— (i) under such Act as amended and supplemented before July 18, 1984, or (ii) under this title without regard to any provision of law which is not contained in this title and which is not contained in a revenue Act, or (B) is described in subsection (l). (2) Corporations organized for the exclusive purpose of holding title to property, collecting income therefrom, and turning over the entire amount thereof, less expenses, to an organization which itself is exempt under this section. Rules similar to the rules of subparagraph (G) of paragraph (25) shall apply for purposes of this paragraph. (3) Corporations, and any community chest, fund, or foundation, organized and operated exclusively for religious, charitable, scientific, testing for public safety, literary, or educational purposes, or to foster national or international amateur sports competition (but only

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Federal law — U.S. Code and appendices · legal_authorities

26 U.S.C. § 501 — Exemption from tax on corporations, cer-

§ 501. Exemption from tax on corporations, cer- tain trusts, etc. (a) Exemption from taxation An organization described in subsection (c) or (d) or section 401(a) shall be exempt from tax- ation under this subtitle unless such exemption is denied under section 502 or 503. (b) Tax on unrelated business income and cer- tain other activities An organization exempt from taxation under subsection (a) shall be subject to tax to the ex- tent provided in parts II, III, and VI of this sub- chapter, but (notwithstanding parts II, III, and VI of this subchapter) shall be considered an or- ganization exempt from income taxes for the purpose of any law which refers to organizations exempt from income taxes. (c) List of exempt organizations The following organizations are referred to in subsection (a): (1) Any corporation organized under Act of Congress which is an instrumentality of the United States but only if such corporation— (A) is exempt from Federal income taxes— (i) under such Act as amended and sup- plemented before July 18, 1984, or (ii) under this title without regard to any provision of law which is not con- tained in this title and which is not con- tained in a revenue Act, or (B) is described in subsection (l). (2) Corporations organized for the exclusive purpose of holding title to property, collecting income therefrom, and turning over the entire amount thereof, less expenses, to an organiza- tion which itself is exempt under this section. Rules similar to the rules of subparagraph (G) Page 1661 TITLE 26—INTERNAL REVENUE CODE § 501 1 See References in Text note below. of paragraph (25) shall apply for purposes of this paragraph. (3) Corporations, and any community chest, fund, or foundation, organized and operated exclusively for religiou

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Federal law — U.S. Code and appendices · legal_authorities

35 U.S.C. § 200 — Policy and objective

It is the policy and objective of the Congress to use the patent system to promote the utilization of inventions arising from federally supported research or development; to encourage maximum participation of small business firms in federally supported research and development efforts; to promote collaboration between commercial concerns and nonprofit organizations, including universities; to ensure that inventions made by nonprofit organizations and small business firms are used in a manner to promote free competition and enterprise without unduly encumbering future research and discovery; to promote the commercialization and public availability of inventions made in the United States by United States industry and labor; to ensure that the Government obtains sufficient rights in federally supported inventions to meet the needs of the Government and protect the public against nonuse or unreasonable use of inventions; and to minimize the costs of administering policies in this area.

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Federal law — U.S. Code and appendices · legal_authorities

7 U.S.C. § 2321 — Establishment

There is hereby established in the Department of Agriculture an office to be known as the Plant Variety Protection Office, which shall have the functions set forth in this chapter.

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Federal law — U.S. Code and appendices · legal_authorities

7 U.S.C. § 2321 — Establishment

§ 2321. Establishment There is hereby established in the Department of Agriculture an office to be known as the Plant Variety Protection Office, which shall have the functions set forth in this chapter. (Pub. L. 91–577, title I, § 1, Dec. 24, 1970, 84 Stat. 1542; Pub. L. 96–574, § 1, Dec. 22, 1980, 94 Stat. 3350.) Editorial Notes AMENDMENTS 1980—Pub. L. 96–574 substituted ‘‘an office’’ for ‘‘a bu- reau’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Pub. L. 91–577, title III, § 141, Dec. 24, 1970, 84 Stat. 1558, provided that: ‘‘This Act [this chapter] shall take effect upon enactment [Dec. 24, 1970]. Applications may be filed with the Secretary and held by him until the Office of Plant Variety Protection is organized and in operation’’. SHORT TITLE OF 1994 AMENDMENT Pub. L. 103–349, § 1(a), Oct. 6, 1994, 108 Stat. 3136, pro- vided that: ‘‘This Act [amending sections 2327, 2330, 2353, 2354, 2357, 2401, 2402, 2404, 2422, 2423, 2424, 2425, 2442, 2461, 2462, 2463, 2482, 2483, 2486, 2501, 2504, 2532, 2541, 2542, 2543, 2561, 2566, 2567, 2568, and 2570 of this title, repealing sections 2463, 2502 and 2503 of this title, and enacting provisions set out as notes under section 2401 of this title] may be cited as the ‘Plant Variety Protection Act Amendments of 1994’.’’ SHORT TITLE OF 1992 AMENDMENT Pub. L. 102–560, § 1, Oct. 28, 1992, 106 Stat. 4230, pro- vided that: ‘‘This Act [enacting section 2570 of this title and section 296 of Title 35, Patents, amending section 2541 of this title and section 271 of Title 35, and enact- ing provisions set out as a note under section 2541 of this title] may be cited as the ‘Patent and Plant Vari- ety Protection Remedy Clarification Act’.’’ SHORT TITLE Pub. L. 91–577, title III, § 145, Dec. 24, 1970,

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Federal law — U.S. Code and appendices · legal_authorities

7 U.S.C. § 2401 — Definitions and rules of construction

**(a) Definitions** As used in this chapter: (1) **Asexually reproduced** — The term “asexually reproduced” means produced by a method of plant propagation using vegetative material (other than seed) from a single parent, including cuttings, grafting, tissue culture, and propagation by root division. (2) **Basic seed** — The term “basic seed” means the seed planted to produce certified or commercial seed. (3) **Breeder** — The term “breeder” means the person who directs the final breeding creating a variety or who discovers and develops a variety. If the actions are conducted by an agent on behalf of a principal, the principal, rather than the agent, shall be considered the breeder. The term does not include a person who redevelops or rediscovers a variety the existence of which is publicly known or a matter of common knowledge. (4) **Essentially derived variety** (A) *In general* — The term “essentially derived variety” means a variety that— (i) is predominantly derived from another variety (referred to in this paragraph as the “initial variety”) or from a variety that is predominantly derived from the initial variety, while retaining the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety; (ii) is clearly distinguishable from the initial variety; and (iii) except for differences that result from the act of derivation, conforms to the initial variety in the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety. (B) *Methods* — An essentially derived variety may be obtained by the selection of a natural or induced mutant or of a somaclonal variant, the selection of a variant individual from plants of the

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Federal law — U.S. Code and appendices · legal_authorities

7 U.S.C. § 2401 — Definitions and rules of construction

§ 2401. Definitions and rules of construction (a) Definitions As used in this chapter: (1) Asexually reproduced The term ‘‘asexually reproduced’’ means produced by a method of plant propagation using vegetative material (other than seed) from a single parent, including cuttings, graft- ing, tissue culture, and propagation by root di- vision. (2) Basic seed The term ‘‘basic seed’’ means the seed plant- ed to produce certified or commercial seed. (3) Breeder The term ‘‘breeder’’ means the person who directs the final breeding creating a variety or who discovers and develops a variety. If the actions are conducted by an agent on behalf of a principal, the principal, rather than the agent, shall be considered the breeder. The term does not include a person who redevelops or rediscovers a variety the existence of which is publicly known or a matter of common knowledge. (4) Essentially derived variety (A) In general The term ‘‘essentially derived variety’’ means a variety that— (i) is predominantly derived from an- other variety (referred to in this paragraph as the ‘‘initial variety’’) or from a variety that is predominantly derived from the initial variety, while retaining the expres- sion of the essential characteristics that result from the genotype or combination of genotypes of the initial variety; (ii) is clearly distinguishable from the initial variety; and (iii) except for differences that result from the act of derivation, conforms to the initial variety in the expression of the es- sential characteristics that result from the genotype or combination of genotypes of the initial variety. (B) Methods An essentially derived variety may be ob- tained by the selection of a natural or in- duced mutant or of a somaclonal variant, the

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