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, 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, 360span, 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 Puspan. L. 105–115, title I, § 125(span)(1), Nov. 21, 1997, 111 Stat. 2325.

Section 201 of the Federal Food, Drug, and Cosmetic Act, referred to in subsec. (f)(5), which is classified to section 321 of Title 21, was subsequently amended, and section 201(y) no longer defines the term “informal hearing”. However, such term is defined elsewhere in that section.

Section 351 of the Public Health Service Act, referred to in subsecs. (f)(4)(A), (g)(1)(B)(i), (ii), and (i)(2)(A)(i), is classified to section 262 of Title 42, The Public Health and Welfare.

The date of enactment of the Generic Animal Drug and Patent Term Restoration Act, referred to in subsec. (f)(8), is the date of enactment of Puspan. L. 100–670, which was approved Nov. 16, 1988.

The date of the enactment of this section, referred to in subsec. (g)(6), is the date of the enactment of Puspan. L. 98–417, which was approved Sept. 24, 1984.

The Controlled Substances Act, referred to in subsec. (i)(1), is title II of Puspan. 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.

Section 201 of the Controlled Substances Act, referred to in subsec. (i)(2)(D), is classified to section 811 of Title 21, Food and Drugs.

2015—Subsec. (d)(1). Puspan. 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”.

Subsec. (i). Puspan. L. 114–89, § 2(c)(2), added subsec. (i).

2011—Subsec. (d)(1). Puspan. L. 112–29 inserted concluding provisions.

2002—Subsec. (span)(3)(B). Puspan. L. 107–273, § 13206(a)(9)(A), substituted “paragraph” for “paragraphs”.

Subsec. (d). Puspan. L. 107–273, § 13206(span)(1)(B), made technical correction to directory language of Puspan. L. 106–113, § 1000(a)(9) [title IV, § 4732(a)(10)(A)]. See 1999 Amendment note below.

Subsec. (d)(2)(B)(i). Puspan. L. 107–273, § 13206(a)(9)(B), substituted “below the Office” for “below the office”.

Subsec. (e). Puspan. L. 107–273, § 13206(span)(1)(B), made technical correction to directory language of Puspan. L. 106–113, § 1000(a)(9) [title IV, § 4732(a)(10)(A)]. See 1999 Amendment note below.

Subsec. (g)(6)(B)(iii). Puspan. L. 107–273, § 13206(a)(9)(C), substituted “submitted” for “submittted”.

Subsec. (h). Puspan. L. 107–273, § 13206(span)(1)(B), made technical correction to directory language of Puspan. L. 106–113, § 1000(a)(9) [title IV, § 4732(a)(10)(A)]. See 1999 Amendment note below.

1999—Subsec. (a). Puspan. L. 106–113, § 1000(a)(9) [title IV, § 4404], in introductory provisions, inserted “, which shall include any patent term adjustment granted under section 154(span),” after “the original expiration date of the patent”.

Subsecs. (d), (e), (h). Puspan. L. 106–113, § 1000(a)(9) [title IV, § 4732(a)(10)(A)], as amended by Puspan. L. 107–273, § 13206(span)(1)(B), substituted “Director” for “Commissioner” wherever appearing.

1997—Subsec. (f)(4)(B). Puspan. L. 105–115, § 125(span)(2)(P), struck out “507,” after “505,” in two places.

1994—Subsec. (a)(2). Puspan. L. 103–465 inserted “under subsection (e)(1) of this section” after “extended”.

1993—Subsec. (a)(1). Puspan. L. 103–179, § 6(1)(A), substituted “subsection (d)(1)” for “subsection (d)”.

Subsec. (a)(3). Puspan. L. 103–179, § 6(1)(B), substituted “paragraphs (1) through (4) of subsection (d)” for “subsection (d)”.

Subsec. (span). Puspan. L. 103–179, § 6(2), substituted “Except as provided in subsection (d)(5)(F), the rights” for “The rights” in introductory provisions.

Subsec. (c)(4). Puspan. L. 103–179, § 5(1), substituted “extended under subsection (e)(1)” for “extended”.

Subsec. (d)(1). Puspan. L. 103–179, § 5(2), substituted “Except as provided in paragraph (5), such” for “Such” in second sentence.

Subsec. (d)(5). Puspan. L. 103–179, § 5(3), added par. (5).

Subsec. (e)(1). Puspan. L. 103–179, § 6(3)(A), substituted “paragraphs (1) through (4) of subsection (d)” for “subsection (d)”.

Subsec. (e)(2). Puspan. L. 103–179, § 6(3)(B), substituted “subsection (d)(1)” for “subsection (d)”.

1988—Subsec. (a)(5)(A). Puspan. L. 100–670, § 201(a)(1), inserted “or (C)” after “in subparagraph (B)”.

Subsec. (a)(5)(C). Puspan. L. 100–670, § 201(a)(2), (3), added subpar. (C).

Subsec. (span). Puspan. L. 100–670, § 201(span), amended subsec. (span) generally. Prior to amendment, subsec. (span) 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—

“(1) in the case of a patent which claims a product, be limited to any use approved for the approved product before the expiration of the term of the patent under the provision of law under which the applicable regulatory review occurred;

“(2) in the case of a patent which claims a method of using a product, be limited to any use claimed by the patent and approved for the approved product before the expiration of the term of the patent under the provision of law under which the applicable regulatory review occurred; and

“(3) in the case of a patent which claims a method of manufacturing a product, be limited to the method of manufacturing as used to make the approved product.”

Subsec. (c)(2). Puspan. L. 100–670, § 201(c), substituted “(3)(B)(i), (4)(B)(i), and (5)(B)(i)” for “and (3)(B)(i)”.

Subsec. (d)(1)(C). Puspan. L. 100–670, § 201(d), inserted “or the Secretary of Agriculture” after “and Human Services”.

Subsec. (d)(2)(A). Puspan. L. 100–670, § 201(e), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: “Within sixty days of the submittal of an application for extension of the term of a patent under paragraph (1), the Commissioner shall notify the Secretary of Health and Human Services if the patent claims any human drug product, a medical device, or a food additive or color additive or a method of using or manufacturing such a product, device, or additive and if the product, device, and additive are subject to the Federal Food, Drug, and Cosmetic Act, of the extension application and shall submit to the Secretary a copy of the application. Not later than thirty days after the receipt of an application from the Commissioner, the Secretary shall review the dates contained in the application pursuant to paragraph (1)(C) and determine the applicable regulatory review period, shall notify the Commissioner of the determination, and shall publish in the Federal Register a notice of such determination.”

Subsec. (d)(2)(B). Puspan. L. 100–670, § 201(f), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows:

“(i) If a petition is submitted to the Secretary under subparagraph (A), not later than one hundred and eighty days after the publication of the determination under subparagraph (A), upon which it may reasonably be determined that the applicant did not act with due diligence during the applicable regulatory review period, the Secretary shall, in accordance with regulations promulgated by the Secretary determine if the applicant acted with due diligence during the applicable regulatory review period. The Secretary shall make such determination not later than ninety days after the receipt of such a petition. The Secretary may not delegate the authority to make the determination prescribed by this subparagraph to an office below the Office of the Commissioner of Food and Drugs.

“(ii) The Secretary shall notify the Commissioner of the determination and shall publish in the Federal Register a notice of such determination together with the factual and legal basis for such determination. Any interested person may request, within the sixty-day period beginning on the publication of a determination, the Secretary to hold an informal hearing on the determination. If such a request is made within such period, the Secretary shall hold such hearing not later than thirty days after the date of the request, or at the request of the person making the request, not later than sixty days after such date. The Secretary shall provide notice of the hearing to the owner of the patent involved and to any interested person and provide the owner and any interested person an opportunity to participate in the hearing. Within thirty days after the completion of the hearing, the Secretary shall affirm or revise the determination which was the subject of the hearing and notify the Commissioner of any revision of the determination and shall publish any such revision in the Federal Register.”

Subsec. (f)(1)(A). Puspan. L. 100–670, § 201(g)(1), struck out “human” before “drug product”.

Subsec. (f)(2). Puspan. L. 100–670, § 201(g)(1), amended par. (2) generally. Prior to amendment, par. (2) read as follows: “The term ‘human drug product’ means the active ingredient of a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act) including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.”

Subsec. (f)(4)(B), (C). Puspan. L. 100–670, § 201(g)(2), which directed general amendment of subpars. (B) and (C) of par. (4), was executed by amending subpar. (B) generally, and adding subpar. (C) as probable intent of Congress in light of absence of subpar. (C) in par. (4). Prior to amendment, subpar. (B) read as follows: “Any reference to section 503, 505, 507, or 515 is a reference to section 503, 505, 507, or 515 of the Federal Food, Drug, and Cosmetic Act.”

Subsec. (f)(7), (8). Puspan. L. 100–670, § 201(g)(3), added pars. (7) and (8).

Subsec. (g)(1)(A). Puspan. L. 100–670, § 201(h)(1)(A), (2), substituted “new drug, antibiotic drug, or human biological product” for “human drug product” and “paragraph (6)” for “paragraph (4)”.

Subsec. (g)(1)(B). Puspan. L. 100–670, § 201(h)(1)(B), substituted “new drug, antibiotic drug, or human biological product” for “human drug product” in introductory provisions and “product” for “human drug product” in cls. (i) and (ii).

Subsec. (g)(2)(A), (3)(A). Puspan. L. 100–670, § 201(h)(3), substituted “paragraph (6)” for “paragraph (4)”.

Subsec. (g)(4), (5). Puspan. L. 100–670, § 201(h)(4), added pars. (4) and (5). Former par. (4) redesignated (6).

Subsec. (g)(6). Puspan. L. 100–670, § 201(h)(4), redesignated former par. (4) as (6).

Subsec. (g)(6)(B)(i). Puspan. L. 100–670, § 201(h)(5)(A), substituted “paragraph (1)(B) or (4)(B) was submitted and no request for the authority described in paragraph (5)(B) was submitted” for “paragraph (1)(B) was submitted”.

Subsec. (g)(6)(B)(ii). Puspan. L. 100–670, § 201(h)(5)(B), substituted “paragraph (2)(B) or (4)(B)” for “paragraph (2)”.

Subsec. (g)(6)(C). Puspan. L. 100–670, § 201(h)(5)(C), inserted “or in the case of an approved product which is a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act or the Virus-Serum-Toxin Act), three years” after “exceed two years”.

Puspan. L. 112–29, § 37(span), Sept. 16, 2011, 125 Stat. 341, provided that:

Amendment by section 1000(a)(9) [title IV, § 4404] of Puspan. L. 106–113 effective on date that is 6 months after Nov. 29, 1999, and, except for design patent application filed under chapter 16 of this title, applicable to any application filed on or after such date, see section 1000(a)(9) [title IV, § 4405(a)] of Puspan. L. 106–113, set out as a note under section 154 of this title.

Amendment by section 1000(a)(9) [title IV, § 4732(a)(10)(A)] of Puspan. L. 106–113 effective 4 months after Nov. 29, 1999, see section 1000(a)(9) [title IV, § 4731] of Puspan. L. 106–113, set out as a note under section 1 of this title.

Amendment by Puspan. L. 103–465 effective 6 months after Dec. 8, 1994, and applicable to all patent applications filed in the United States on or after that effective date, with provisions relating to earliest filed patent application, see section 534(span)(1), (3) of Puspan. L. 103–465, set out as a note under section 154 of this title.