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35 U.S.C. § 257 — Supplemental examinations to consider, re-

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

35 U.S.C. § 257 — Supplemental examinations to consider, re-

Page 103 TITLE 35—PATENTS § 257 1982—Pub. L. 97–247 substituted ‘‘Correction of named inventor’’ for ‘‘Misjoinder of inventor’’ as section catchline and, in text, substituted ‘‘Whenever through error a person is named in an issued patent as the in- ventor, or through error an inventor is not named in an issued patent and such error arose without any decep- tive intention on his part, the Commissioner may, on application of all the parties and assignees, with proof of the facts and such other requirements as may be im- posed, issue a certificate correcting such error’’ for ‘‘Whenever a patent is issued on the application of per- sons as joint inventors and it appears that one of such persons was not in fact a joint inventor, and that he was included as a joint inventor by error and without any deceptive intention, the Commissioner may, on ap- plication of all the parties and assignees, with proof of the facts and such other requirements as may be im- posed, issue a certificate deleting the name of the erro- neously joined person from the patent’’, substituted ‘‘The error of omitting inventors or naming persons who are not inventors shall not invalidate the patent in which such error occurred if it can be corrected as pro- vided in this section’’ for ‘‘Whenever a patent is issued and it appears that a person was a joint inventor, but was omitted by error and without deceptive intention on his part, the Commissioner may, on application of all the parties and assignees, with proof of the facts and such other requirements as may be imposed, issue a certificate adding his name to the patent as a joint inventor’’, and struck out provision that the misjoinder or nonjoinder of joint inventors not invalidate a pat- ent, if such error could be corrected as pr

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Page 103 TITLE 35—PATENTS § 257 1982—Pub. L. 97–247 substituted ‘‘Correction of named inventor’’ for ‘‘Misjoinder of inventor’’ as section catchline and, in text, substituted ‘‘Whenever through error a person is named in an issued patent as the in- ventor, or through error an inventor is not named in an issued patent and such error arose without any decep- tive intention on his part, the Commissioner may, on application of all the parties and assignees, with proof of the facts and such other requirements as may be im- posed, issue a certificate correcting such error’’ for ‘‘Whenever a patent is issued on the application of per- sons as joint inventors and it appears that one of such persons was not in fact a joint inventor, and that he was included as a joint inventor by error and without any deceptive intention, the Commissioner may, on ap- plication of all the parties and assignees, with proof of the facts and such other requirements as may be im- posed, issue a certificate deleting the name of the erro- neously joined person from the patent’’, substituted ‘‘The error of omitting inventors or naming persons who are not inventors shall not invalidate the patent in which such error occurred if it can be corrected as pro- vided in this section’’ for ‘‘Whenever a patent is issued and it appears that a person was a joint inventor, but was omitted by error and without deceptive intention on his part, the Commissioner may, on application of all the parties and assignees, with proof of the facts and such other requirements as may be imposed, issue a certificate adding his name to the patent as a joint inventor’’, and struck out provision that the misjoinder or nonjoinder of joint inventors not invalidate a pat- ent, if such error could be corrected as provided in this section. 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 1999 AMENDMENT Amendment by Pub. L. 106–113 effective 4 months after Nov. 29, 1999, see section 1000(a)(9) [title IV, § 4731] of Pub. L. 106–113, set out as a note under section 1 of this title. EFFECTIVE DATE OF 1982 AMENDMENT Amendment by Pub. L. 97–247 effective six months after Aug. 27, 1982, see section 17(c) of Pub. L. 97–247, set out as an Effective Date note under section 294 of this title. § 257. Supplemental examinations to consider, re- consider, or correct information (a) REQUEST FOR SUPPLEMENTAL EXAMINA- TION.—A patent owner may request supple- mental examination of a patent in the Office to consider, reconsider, or correct information be- lieved to be relevant to the patent, in accord- ance with such requirements as the Director may establish. Within 3 months after the date a request for supplemental examination meeting the requirements of this section is received, the Director shall conduct the supplemental exam- ination and shall conclude such examination by issuing a certificate indicating whether the in- formation presented in the request raises a sub- stantial new question of patentability. (b) REEXAMINATION ORDERED.—If the certifi- cate issued under subsection (a) indicates that a substantial new question of patentability is raised by 1 or more items of information in the request, the Director shall order reexamination of the patent. The reexamination shall be con- ducted according to procedures established by chapter 30, except that the patent owner shall not have the right to file a statement pursuant to section 304. During the reexamination, the Director shall address each substantial new question of patentability identified during the supplemental examination, notwithstanding the limitations in chapter 30 relating to patents and printed publication or any other provision of such chapter. (c) EFFECT.— (1) IN GENERAL.—A patent shall not be held unenforceable on the basis of conduct relating to information that had not been considered, was inadequately considered, or was incorrect in a prior examination of the patent if the in- formation was considered, reconsidered, or corrected during a supplemental examination of the patent. The making of a request under subsection (a), or the absence thereof, shall not be relevant to enforceability of the patent under section 282. (2) EXCEPTIONS.— (A) PRIOR ALLEGATIONS.—Paragraph (1) shall not apply to an allegation pled with particularity in a civil action, or set forth with particularity in a notice received by the patent owner under section 505(j)(2)(B)(iv)(II) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(B)(iv)(II)), before the date of a sup- plemental examination request under sub- section (a) to consider, reconsider, or correct information forming the basis for the allega- tion. (B) PATENT ENFORCEMENT ACTIONS.—In an action brought under section 337(a) of the Tariff Act of 1930 (19 U.S.C. 1337(a)), or sec- tion 281, paragraph (1) shall not apply to any defense raised in the action that is based upon information that was considered, re- considered, or corrected pursuant to a sup- plemental examination request under sub- section (a), unless the supplemental exam- ination, and any reexamination ordered pur- suant to the request, are concluded before the date on which the action is brought. (d) FEES AND REGULATIONS.— (1) FEES.—The Director shall, by regulation, establish fees for the submission of a request for supplemental examination of a patent, and to consider each item of information sub- mitted in the request. If reexamination is or- dered under subsection (b), fees established and applicable to ex parte reexamination pro- ceedings under chapter 30 shall be paid, in ad- dition to fees applicable to supplemental ex- amination. (2) REGULATIONS.—The Director shall issue regulations governing the form, content, and other requirements of requests for supple- mental examination, and establishing proce- dures for reviewing information submitted in such requests. (e) FRAUD.—If the Director becomes aware, during the course of a supplemental examina- tion or reexamination proceeding ordered under this section, that a material fraud on the Office may have been committed in connection with Page 104 TITLE 35—PATENTS § 261 the patent that is the subject of the supple- mental examination, then in addition to any other actions the Director is authorized to take, including the cancellation of any claims found to be invalid under section 307 as a result of a re- examination ordered under this section, the Di- rector shall also refer the matter to the Attor- ney General for such further action as the At- torney General may deem appropriate. Any such referral shall be treated as confidential, shall not be included in the file of the patent, and shall not be disclosed to the public unless the United States charges a person with a criminal offense in connection with such referral. (f) RULE OF CONSTRUCTION.—Nothing in this section shall be construed— (1) to preclude the imposition of sanctions based upon criminal or antitrust laws (includ- ing section 1001(a) of title 18, the first section of the Clayton Act, and section 5 of the Fed- eral Trade Commission Act to the extent that section relates to unfair methods of competi- tion); (2) to limit the authority of the Director to investigate issues of possible misconduct and impose sanctions for misconduct in connection with matters or proceedings before the Office; or (3) to limit the authority of the Director to issue regulations under chapter 3 relating to sanctions for misconduct by representatives practicing before the Office. (Added and amended Pub. L. 112–29, §§ 12(a), 20(j), Sept. 16, 2011, 125 Stat. 325, 335.) Editorial Notes REFERENCES IN TEXT The first section of the Clayton Act, referred to in subsec. (f)(1), is classified to section 12 of Title 15, Com- merce and Trade, and section 53 of Title 29, Labor. Section 5 of the Federal Trade Commission Act, re- ferred to in subsec. (f)(1), is classified to section 45 of Title 15, Commerce and Trade. AMENDMENTS 2011—Subsec. (c)(2)(B). Pub. L. 112–29, § 20(j), struck out ‘‘of this title’’ after ‘‘281’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2011 AMENDMENT Amendment by section 20(j) of Pub. L. 112–29 effective upon the expiration 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 Pub. L. 112–29, § 12(c), Sept. 16, 2011, 125 Stat. 327, pro- vided that: ‘‘The amendments made by this section [en- acting this section] shall take effect upon the expira- tion of the 1-year period beginning on the date of the enactment of this Act [Sept. 16, 2011] and shall apply to any patent issued before, on, or after that effective date.’’ CHAPTER 26—OWNERSHIP AND ASSIGNMENT Sec. 261. Ownership; assignment. 262. Joint owners. § 261. Ownership; assignment Subject to the provisions of this title, patents shall have the attributes of personal property. The Patent and Trademark Office shall main- tain a register of interests in patents and appli- cations for patents and shall record any docu- ment related thereto upon request, and may re- quire a fee therefor. Applications for patent, patents, or any inter- est therein, shall be assignable in law by an in- strument in writing. The applicant, patentee, or his assigns or legal representatives may in like manner grant and convey an exclusive right under his application for patent, or patents, to the whole or any specified part of the United States. A certificate of acknowledgment under the hand and official seal of a person authorized to administer oaths within the United States, or, in a foreign country, of a diplomatic or consular officer of the United States or an officer author- ized to administer oaths whose authority is proved by a certificate of a diplomatic or con- sular officer of the United States, or apostille of an official designated by a foreign country which, by treaty or convention, accords like ef- fect to apostilles of designated officials in the United States, shall be prima facie evidence of the execution of an assignment, grant or con- veyance of a patent or application for patent. An interest that constitutes an assignment, grant or conveyance shall be void as against any subsequent purchaser or mortgagee for a valu- able consideration, without notice, unless it is recorded in the Patent and Trademark Office within three months from its date or prior to the date of such subsequent purchase or mort- gage. (July 19, 1952, ch. 950, 66 Stat. 810; Pub. L. 93–596, § 1, Jan. 2, 1975, 88 Stat. 1949; Pub. L. 97–247, § 14(b), Aug. 27, 1982, 96 Stat. 321; Pub. L. 112–211, title II, § 201(d), Dec. 18, 2012, 126 Stat. 1535.) HISTORICAL AND REVISION NOTES Based on Title 35, U.S.C., 1946 ed., § 47 (R.S. 4898, amended (1) Mar. 3, 1897, ch. 391, § 5, 29 Stat. 93 [29 Stat. 693], (2) Feb. 18, 1922, ch. 58, § 6, 42 Stat. 391, (3) Aug. 18, 1941, ch. 370, 55 Stat. 634). The first paragraph is new but is declaratory only. The second paragraph is the same as in the cor- responding section of existing statute. The third para- graph is from the existing statute, a specific reference to another statute is omitted. The fourth paragraph is the same as the existing statute but language has been changed. Editorial Notes AMENDMENTS 2012—Pub. L. 112–211 inserted ‘‘The Patent and Trade- mark Office shall maintain a register of interests in patents and applications for patents and shall record any document related thereto upon request, and may require a fee therefor.’’ at end of first par. and sub- stituted ‘‘An interest that constitutes an assignment’’ for ‘‘An assignment’’ in fourth par. 1982—Pub. L. 97–247 inserted ‘‘, or apostille of an offi- cial designated by a foreign country which, by treaty or convention, accords like effect to apostilles of des- ignated officials in the United States’’. 1975—Pub. L. 93–596 substituted ‘‘Patent and Trade- mark Office’’ for ‘‘Patent Office’’.

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

19 U.S.C. § 1337 — Unfair practices in import trade

**(a) Unlawful activities; covered industries; definitions** (1) Subject to paragraph (2), the following are unlawful, and when found by the Commission to exist shall be dealt with, in addition to any other provision of law, as provided in this section: (A) Unfair methods of competition and unfair acts in the importation of articles (other than articles provided for in subparagraphs (B), (C), (D), and (E)) into the United States, or in the sale of such articles by the owner, importer, or consignee, the threat or effect of which is— (i) to destroy or substantially injure an industry in the United States; (ii) to prevent the establishment of such an industry; or (iii) to restrain or monopolize trade and commerce in the United States. (B) The importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, importer, or consignee, of articles that— (i) infringe a valid and enforceable United States patent or a valid and enforceable United States copyright registered under title 17; or (ii) are made, produced, processed, or mined under, or by means of, a process covered by the claims of a valid and enforceable United States patent. (C) The importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, importer, or consignee, of articles that infringe a valid and enforceable United States trademark registered under the Trademark Act of 1946 [[15 U.S.C. 1051](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1051&num=0&edition=prelim) et seq.]. (D) The importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, i

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

19 U.S.C. § 1337 — Unfair practices in import trade

Page 117 TITLE 19—CUSTOMS DUTIES § 1337 1 See References in Text note below. act, that the duty or duties shall not exceed a specified ad valorem rate upon the articles pro- vided for in such paragraph, no rate determined under the provisions of this section upon such articles shall exceed the maximum ad valorem rate so specified. (h) Definitions For the purpose of this section— (1) The term ‘‘domestic article’’ means an article wholly or in part the growth or product of the United States; and the term ‘‘foreign ar- ticle’’ means an article wholly or in part the growth or product of a foreign country. (2) The term ‘‘United States’’ includes the several States and Territories and the District of Columbia. (3) The term ‘‘foreign country’’ means any empire, country, dominion, colony, or protec- torate, or any subdivision or subdivisions thereof (other than the United States and its possessions). (4) The term ‘‘cost of production’’, when ap- plied with respect to either a domestic article or a foreign article, includes, for a period which is representative of conditions in pro- duction of the article: (A) The price or cost of materials, labor costs, and other direct charges incurred in the production of the arti- cle and in the processes or methods employed in its production; (B) the usual general ex- penses, including charges for depreciation or depletion which are representative of the equipment and property employed in the pro- duction of the article and charges for rent or interest which are representative of the cost of obtaining capital or instruments of produc- tion; and (C) the cost of containers and cov- erings of whatever nature, and other costs, charges, and expenses incident to placing the article in condition packed ready for d

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

21 U.S.C. § 355 — New drugs

**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug. **(b) Filing application; contents** (1) (A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as components of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the articles used as components thereof as the Secretary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and (viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approv

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

21 U.S.C. § 355 — New drugs

Page 186 TITLE 21—FOOD AND DRUGS § 355 § 355. New drugs (a) Necessity of effective approval of application No person shall introduce or deliver for intro- duction into interstate commerce any new drug, unless an approval of an application filed pursu- ant to subsection (b) or (j) is effective with re- spect to such drug. (b) Filing application; contents (1)(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the ap- plication— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as compo- nents of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the arti- cles used as components thereof as the Sec- retary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under section 355c of this title; and (viii) the patent number and expiration date of each patent for which a claim of patent in- fringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug sub- stance (active ingredient) patent or a drug product (formulation or composition) pat- ent; or (II) claims a method of using such drug for which approval is sought or has been granted in the application. (B) If an a

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

35 U.S.C. § 257 — Supplemental examinations to consider, reconsider, or correct information

**(a) Request for Supplemental Examination.—** A patent owner may request supplemental examination of a patent in the Office to consider, reconsider, or correct information believed to be relevant to the patent, in accordance with such requirements as the Director may establish. Within 3 months after the date a request for supplemental examination meeting the requirements of this section is received, the Director shall conduct the supplemental examination and shall conclude such examination by issuing a certificate indicating whether the information presented in the request raises a substantial new question of patentability. **(b) Reexamination Ordered.—** If the certificate issued under subsection (a) indicates that a substantial new question of patentability is raised by 1 or more items of information in the request, the Director shall order reexamination of the patent. The reexamination shall be conducted according to procedures established by chapter 30, except that the patent owner shall not have the right to file a statement pursuant to section 304. During the reexamination, the Director shall address each substantial new question of patentability identified during the supplemental examination, notwithstanding the limitations in chapter 30 relating to patents and printed publication or any other provision of such chapter. **(c) Effect.—** (1) **In general.—** — A patent shall not be held unenforceable on the basis of conduct relating to information that had not been considered, was inadequately considered, or was incorrect in a prior examination of the patent if the information was considered, reconsidered, or corrected during a supplemental examination of the patent. The making of a request under subsection (a), or the absence thereof, shall not be relevant to

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