Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title35-section156&num=0&edition=prelim
Timestamp: 2020-05-25 01:41:13
Document Index: 622549194

Matched Legal Cases: ['§ 156', '§201', '§201', '§5', '§532', '§125', '§1000', '§4404', '§13206', '§37', '§2', '§151', '§301', '§201', '§125', '§801', '§2', '§13206', '§1000', '§4404', '§125', '§6', '§201', '§201', '§37']

[USC02] 35 USC 156: Extension of patent term
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35 USC 156: Extension of patent term Text contains those laws in effect on May 23, 2020
(d)(1) To obtain an extension of the term of a patent under this section, the owner of record of the patent or its agent shall submit an application to the Director. Except as provided in paragraph (5), such an application may only be submitted within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use, or in the case of a drug product described in subsection (i), within the sixty-day period beginning on the covered date (as defined in subsection (i)). The application shall contain-
(2)(A) Within 60 days of the submittal of an application for extension of the term of a patent under paragraph (1), the Director shall notify-
(5)(A) If the owner of record of the patent or its agent reasonably expects that the applicable regulatory review period described in paragraph (1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii) of subsection (g) that began for a product that is the subject of such patent may extend beyond the expiration of the patent term in effect, the owner or its agent may submit an application to the Director for an interim extension during the period beginning 6 months, and ending 15 days, before such term is due to expire. The application shall contain-
(i)(1) For purposes of this section, if the Secretary of Health and Human Services provides notice to the sponsor of an application or request for approval, conditional approval, or indexing of a drug product for which the Secretary intends to recommend controls under the Controlled Substances Act, beginning on the covered date, the drug product shall be considered to-
(Added Pub. L. 98–417, title II, §201(a), Sept. 24, 1984, 98 Stat. 1598 ; amended Pub. L. 100–670, title II, §201(a)–(h), Nov. 16, 1988, 102 Stat. 3984–3987 ; Pub. L. 103–179, §§5, 6, Dec. 3, 1993, 107 Stat. 2040 , 2042; Pub. L. 103–465, title V, §532(c)(1), Dec. 8, 1994, 108 Stat. 4987 ; Pub. L. 105–115, title I, §125(b)(2)(P), Nov. 21, 1997, 111 Stat. 2326 ; Pub. L. 106–113, div. B, §1000(a)(9) [title IV, §§4404, 4732(a)(10)(A)], Nov. 29, 1999, 113 Stat. 1536 , 1501A-560, 1501A-582; Pub. L. 107–273, div. C, title III, §13206(a)(9), (b)(1)(B), Nov. 2, 2002, 116 Stat. 1904 , 1906; Pub. L. 112–29, §37(a), Sept. 16, 2011, 125 Stat. 341 ; Pub. L. 114–89, §2(c), Nov. 25, 2015, 129 Stat. 700 .)
The Virus-Serum-Toxin Act, referred to in subsecs. (d)(2)(A)(i), (B)(i), (f)(2)(B), (4)(C), and (g)(5)(B), (6)(C), is the eighth paragraph under the heading "Bureau of Animal Industry" of act Mar. 4, 1913, ch. 145, 37 Stat. 828 , as amended, which is classified generally to chapter 5 (§151 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Short Title note set out under section 151 of Title 21 and Tables.
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (d)(2)(A)(ii), (B)(ii), (f), (g)(2)(B), (3)(B)(ii), (6)(C), and (i)(1)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040 , which is classified generally to chapter 9 (§301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.
The Public Health Service Act, referred to in subsecs. (d)(2)(B)(i), (f)(2)(A), and (i)(1)(A), is act July 1, 1944, ch. 373, 58 Stat. 682 , which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.
Sections 503, 505, 512, 515, 571, and 572 of the Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (f)(4)(B), (g)(1)(B), (3)(B), and (i)(2)(A)(ii), (B), (C), are classified, respectively, to sections 353, 355, 360b, 360e, 360ccc, and 360ccc–1 of Title 21, Food and Drugs. Section 507 of the Act, referred to in subsec. (g)(1)(B), was classified to section 357 of Title 21, prior to repeal by Pub. L. 105–115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325 .
The Controlled Substances Act, referred to in subsec. (i)(1), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242 , which is classified principally to subchapter I (§801 et seq.) of chapter 13 of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Short Title note set out under section 801 of Title 21 and Tables.
2015-Subsec. (d)(1). Pub. L. 114–89, §2(c)(1), in introductory provisions, inserted ", or in the case of a drug product described in subsection (i), within the sixty-day period beginning on the covered date (as defined in subsection (i))" after "marketing or use".
2011-Subsec. (d)(1). Pub. L. 112–29 inserted concluding provisions.
2002-Subsec. (b)(3)(B). Pub. L. 107–273, §13206(a)(9)(A), substituted "paragraph" for "paragraphs".
1999-Subsec. (a). Pub. L. 106–113, §1000(a)(9) [title IV, §4404], in introductory provisions, inserted ", which shall include any patent term adjustment granted under section 154(b)," after "the original expiration date of the patent".
1997-Subsec. (f)(4)(B). Pub. L. 105–115, §125(b)(2)(P), struck out "507," after "505," in two places.
1994-Subsec. (a)(2). Pub. L. 103–465 inserted "under subsection (e)(1) of this section" after "extended".
1993-Subsec. (a)(1). Pub. L. 103–179, §6(1)(A), substituted "subsection (d)(1)" for "subsection (d)".
1988-Subsec. (a)(5)(A). Pub. L. 100–670, §201(a)(1), inserted "or (C)" after "in subparagraph (B)".
Subsec. (b). Pub. L. 100–670, §201(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) read as follows: "The rights derived from any patent the term of which is extended under this section shall during the period during which the patent is extended-
Pub. L. 112–29, §37(b), Sept. 16, 2011, 125 Stat. 341 , provided that: "The amendment made by subsection (a) [amending this section] shall apply to any application for extension of a patent term under section 156 of title 35, United States Code, that is pending on, that is filed after, or as to which a decision regarding the application is subject to judicial review on, the date of the enactment of this Act [Sept. 16, 2011]."