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35 U.S.C. § 257 — Supplemental examinations to consider, reconsider, or correct information
Federal law — U.S. Code and appendices · legal_authorities
**(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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Source location: Title 35, Chapter 25, § 257; chapter-025-amendment-and-correction-of-patents.md
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**(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 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)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j/2/B/iv/II&num=0&edition=prelim)), before the date of a supplemental examination request under subsection (a) to consider, reconsider, or correct information forming the basis for the allegation.
(B) *Patent enforcement actions.—* — In an action brought under section 337(a) of the Tariff Act of 1930 ([19 U.S.C. 1337(a)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title19-section1337/a&num=0&edition=prelim)), or section 281, paragraph (1) shall not apply to any defense raised in the action that is based upon information that was considered, reconsidered, or corrected pursuant to a supplemental examination request under subsection (a), unless the supplemental examination, and any reexamination ordered pursuant 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 submitted in the request. If reexamination is ordered under subsection (b), fees established and applicable to ex parte reexamination proceedings under chapter 30 shall be paid, in addition to fees applicable to supplemental examination.
(2) **Regulations.—** — The Director shall issue regulations governing the form, content, and other requirements of requests for supplemental examination, and establishing procedures for reviewing information submitted in such requests.
**(e) Fraud.—** If the Director becomes aware, during the course of a supplemental examination or reexamination proceeding ordered under this section, that a material fraud on the Office may have been committed in connection with the patent that is the subject of the supplemental 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 reexamination ordered under this section, the Director shall also refer the matter to the Attorney General for such further action as the Attorney 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 (including [section 1001(a) of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1001/a&num=0&edition=prelim), the first section of the Clayton Act, and section 5 of the Federal Trade Commission Act to the extent that section relates to unfair methods of competition);
(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.
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Federal law — U.S. Code and appendices · legal_authorities
**(a)** “Antitrust laws,” as used herein, includes the Act entitled “An Act to protect trade and commerce against unlawful restraints and monopolies,” approved July second, eighteen hundred and ninety; sections seventy-three to seventy-six, inclusive, of an Act entitled “An Act to reduce taxation, to provide revenue for the Government, and for other purposes,” of August twenty-seventh, eighteen hundred and ninety-four; an Act entitled “An Act to amend sections seventy-three and seventy-six of the Act of August twenty-seventh, eighteen hundred and ninety-four, entitled ‘An Act to reduce taxation, to provide revenue for the Government, and for other purposes,’ ” approved February twelfth, nineteen hundred and thirteen; and also this Act.“Commerce,” as used herein, means trade or commerce among the several States and with foreign nations, or between the District of Columbia or any Territory of the United States and any State, Territory, or foreign nation, or between any insular possessions or other places under the jurisdiction of the United States, or between any such possession or place and any State or Territory of the United States or the District of Columbia or any foreign nation, or within the District of Columbia or any Territory or any insular possession or other place under the jurisdiction of the United States: Provided, That nothing in this Act contained shall apply to the Philippine Islands. The word “person” or “persons” wherever used in this Act shall be deemed to include corporations and associations existing under or authorized by the laws of either the United States, the laws of any of the Territories, the laws of any State, or the laws of any foreign country.
**(b)** This Act may be cited as the “Clayton Act”.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Declaration of unlawfulness; power to prohibit unfair practices; inapplicability to foreign trade**
(1) Unfair methods of competition in or affecting commerce, and unfair or deceptive acts or practices in or affecting commerce, are hereby declared unlawful.
(2) The Commission is hereby empowered and directed to prevent persons, partnerships, or corporations, except banks, savings and loan institutions described in [section 57a(f)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section57a/f/3&num=0&edition=prelim), Federal credit unions described in [section 57a(f)(4) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section57a/f/4&num=0&edition=prelim), common carriers subject to the Acts to regulate commerce, air carriers and foreign air carriers subject to part A of subtitle VII of title 49, and persons, partnerships, or corporations insofar as they are subject to the Packers and Stockyards Act, 1921, as amended [[7 U.S.C. 181](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section181&num=0&edition=prelim) et seq.], except as provided in section 406(b) of said Act [[7 U.S.C. 227(b)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section227/b&num=0&edition=prelim)], from using unfair methods of competition in or affecting commerce and unfair or deceptive acts or practices in or affecting commerce.
(3) This subsection shall not apply to unfair methods of competition involving commerce with foreign nations (other than import commerce) unless—
(A) such methods of competition have a direct, substantial, and reasonably foreseeable effect—
(i) on commerce which is not commerce with foreign nations, or on import commerce with foreign nations; or
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In General.—** The United States Patent and Trademark Office, subject to the policy direction of the Secretary of Commerce—
(1) shall be responsible for the granting and issuing of patents and the registration of trademarks; and
(2) shall be responsible for disseminating to the public information with respect to patents and trademarks.
**(b) Specific Powers.—** The Office—
(1) shall adopt and use a seal of the Office, which shall be judicially noticed and with which letters patent, certificates of trademark registrations, and papers issued by the Office shall be authenticated;
(2) may establish regulations, not inconsistent with law, which—
(A) shall govern the conduct of proceedings in the Office;
(B) shall be made in accordance with [section 553 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section553&num=0&edition=prelim);
(C) shall facilitate and expedite the processing of patent applications, particularly those which can be filed, stored, processed, searched, and retrieved electronically, subject to the provisions of section 122 relating to the confidential status of applications;
(D) may govern the recognition and conduct of agents, attorneys, or other persons representing applicants or other parties before the Office, and may require them, before being recognized as representatives of applicants or other persons, to show that they are of good moral character and reputation and are possessed of the necessary qualifications to render to applicants or other persons valuable service, advice, and assistance in the presentation or prosecution of their applications or other business before the Office;
(E) shall recognize the public interest in continuing to safeguard broad access to the United States patent sys
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Federal law — U.S. Code and appendices · legal_authorities
The word “person” or “persons” wherever used in [section 52 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section52&num=0&edition=prelim) shall be deemed to include corporations and associations existing under or authorized by the laws of either the United States, the laws of any of the Territories, the laws of any State, or the laws of any foreign country.
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Federal law — U.S. Code and appendices · legal_authorities
**(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
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
Source: Supplied 2024 U.S. Code historical extraction · 19 U.S.C. § 1337
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Federal law — U.S. Code and appendices · legal_authorities
**(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355
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Federal law — U.S. Code and appendices · legal_authorities
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
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 355
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Federal law — U.S. Code and appendices · legal_authorities
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
Source: Supplied 2024 U.S. Code historical extraction · 35 U.S.C. § 257
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