§ 156. — Extension of patent term.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 35USC156]
TITLE 35--PATENTS
PART II--PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS
CHAPTER 14--ISSUE OF PATENT
Sec. 156. Extension of patent term
(a) The term of a patent which claims a product, a method of using a
product, or a method of manufacturing a product shall be extended in
accordance with this section from the original expiration date of the
patent, which shall include any patent term adjustment granted under
section 154(b), if--
(1) the term of the patent has not expired before an application
is submitted under subsection (d)(1) for its extension;
(2) the term of the patent has never been extended under
subsection (e)(1) of this section;
(3) an application for extension is submitted by the owner of
record of the patent or its agent and in accordance with the
requirements of paragraphs (1) through (4) of subsection (d);
(4) the product has been subject to a regulatory review period
before its commercial marketing or use;
(5)(A) except as provided in subparagraph (B) or (C), the
permission for the commercial marketing or use of the product after
such regulatory review period is the first permitted commercial
marketing or use of the product under the provision of law under
which such regulatory review period occurred;
(B) in the case of a patent which claims a method of
manufacturing the product which primarily uses recombinant DNA
technology in the manufacture of the product, the permission for the
commercial marketing or use of the product after such regulatory
review period is the first permitted commercial marketing or use of
a product manufactured under the process claimed in the patent; or
(C) for purposes of subparagraph (A), in the case of a patent
which--
(i) claims a new animal drug or a veterinary biological
product which (I) is not covered by the claims in any other
patent which has been extended, and (II) has received permission
for the commercial marketing or use in non-food-producing
animals and in food-producing animals, and
(ii) was not extended on the basis of the regulatory review
period for use in non-food-producing animals,
the permission for the commercial marketing or use of the drug or
product after the regulatory review period for use in food-producing
animals is the first permitted commercial marketing or use of the
drug or product for administration to a food-producing animal.
The product referred to in paragraphs (4) and (5) is hereinafter in this
section referred to as the ``approved product''.
(b) Except as provided in subsection (d)(5)(F), the rights derived
from any patent the term of which is extended under this section shall
during the period during which the term of the patent is extended--
(1) in the case of a patent which claims a product, be limited
to any use approved for the product--
(A) before the expiration of the term of the patent--
(i) under the provision of law under which the
applicable regulatory review occurred, or
(ii) under the provision of law under which any
regulatory review described in paragraph (1), (4), or (5) of
subsection (g) occurred, and
(B) on or after the expiration of the regulatory review
period upon which the extension of the patent was based;
(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 product--
(A) before the expiration of the term of the patent--
(i) under any provision of law under which an applicable
regulatory review occurred, and
(ii) under the provision of law under which any
regulatory review described in paragraph (1), (4), or (5) of
subsection (g) occurred, and
(B) on or after the expiration of the regulatory review
period upon which the extension of the patent was based; 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--
(A) the approved product, or
(B) the product if it has been subject to a regulatory
review period described in paragraph (1), (4), or (5) of
subsection (g).
As used in this subsection, the term ``product'' includes an approved
product.
(c) The term of a patent eligible for extension under subsection (a)
shall be extended by the time equal to the regulatory review period for
the approved product which period occurs after the date the patent is
issued, except that--
(1) each period of the regulatory review period shall be reduced
by any period determined under subsection (d)(2)(B) during which the
applicant for the patent extension did not act with due diligence
during such period of the regulatory review period;
(2) after any reduction required by paragraph (1), the period of
extension shall include only one-half of the time remaining in the
periods described in paragraphs (1)(B)(i), (2)(B)(i), (3)(B)(i),
(4)(B)(i), and (5)(B)(i) of subsection (g);
(3) if the period remaining in the term of a patent after the
date of the approval of the approved product under the provision of
law under which such regulatory review occurred when added to the
regulatory review period as revised under paragraphs (1) and (2)
exceeds fourteen years, the period of extension shall be reduced so
that the total of both such periods does not exceed fourteen years;
and
(4) in no event shall more than one patent be extended under
subsection (e)(1) for the same regulatory review period for any
product.
(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. The application shall
contain--
(A) the identity of the approved product and the Federal statute
under which regulatory review occurred;
(B) the identity of the patent for which an extension is being
sought and the identity of each claim of such patent which claims
the approved product or a method of using or manufacturing the
approved product;
(C) information to enable the Director to determine under
subsections (a) and (b) the eligibility of a patent for extension
and the rights that will be derived from the extension and
information to enable the Director and the Secretary of Health and
Human Services or the Secretary of Agriculture to determine the
period of the extension under subsection (g);
(D) a brief description of the activities undertaken by the
applicant during the applicable regulatory review period with
respect to the approved product and the significant dates applicable
to such activities; and
(E) such patent or other information as the Director may
require.
(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--
(i) the Secretary of Agriculture if the patent claims a drug
product or a method of using or manufacturing a drug product and the
drug product is subject to the Virus-Serum-Toxin Act, and
(ii) the Secretary of Health and Human Services if the patent
claims any other 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 who is so
notified a copy of the application. Not later than 30 days after the
receipt of an application from the Director, the Secretary receiving the
application shall review the dates contained in the application pursuant
to paragraph (1)(C) and determine the applicable regulatory review
period, shall notify the Director of the determination, and shall
publish in the Federal Register a notice of such determination.
(B)(i) If a petition is submitted to the Secretary making the
determination under subparagraph (A), not later than 180 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
making the determination shall, in accordance with regulations
promulgated by such Secretary, determine if the applicant acted with due
diligence during the applicable regulatory review period. The Secretary
making the determination shall make such determination not later than 90
days after the receipt of such a petition. For a drug product, device,
or additive subject to the Federal Food, Drug, and Cosmetic Act or the
Public Health Service Act, the Secretary may not delegate the authority
to make the determination prescribed by this clause to an office below
the Office of the Director \1\ of Food and Drugs. For a product subject
to the Virus-Serum-Toxin Act, the Secretary of Agriculture may not
delegate the authority to make the determination prescribed by this
clause to an office below the Office of the Assistant Secretary for
Marketing and Inspection Services.
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\1\ So in original. Probably should be ``Commissioner''.
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(ii) The Secretary making a determination under clause (i) shall
notify the Director 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 60-day period beginning on the publication of a
determination, the Secretary making the determination to hold an
informal hearing on the determination. If such a request is made within
such period, such Secretary shall hold such hearing not later than 30
days after the date of the request, or at the request of the person
making the request, not later than 60 days after such date. The
Secretary who is holding the hearing 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 30 days after the completion of the
hearing, such Secretary shall affirm or revise the determination which
was the subject of the hearing and shall notify the Director of any
revision of the determination and shall publish any such revision in the
Federal Register.
(3) For the purposes of paragraph (2)(B), the term ``due diligence''
means that degree of attention, continuous directed effort, and
timeliness as may reasonably be expected from, and are ordinarily
exercised by, a person during a regulatory review period.
(4) An application for the extension of the term of a patent is
subject to the disclosure requirements prescribed by the Director.
(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) the identity of the product subject to regulatory review and
the Federal statute under which such review is occurring;
(ii) the identity of the patent for which interim extension is
being sought and the identity of each claim of such patent which
claims the product under regulatory review or a method of using or
manufacturing the product;
(iii) information to enable the Director to determine under
subsection (a)(1), (2), and (3) the eligibility of a patent for
extension;
(iv) a brief description of the activities undertaken by the
applicant during the applicable regulatory review period to date
with respect to the product under review and the significant dates
applicable to such activities; and
(v) such patent or other information as the Director may
require.
(B) If the Director determines that, except for permission to market
or use the product commercially, the patent would be eligible for an
extension of the patent term under this section, the Director shall
publish in the Federal Register a notice of such determination,
including the identity of the product under regulatory review, and shall
issue to the applicant a certificate of interim extension for a period
of not more than 1 year.
(C) The owner of record of a patent, or its agent, for which an
interim extension has been granted under subparagraph (B), may apply for
not more than 4 subsequent interim extensions under this paragraph,
except that, in the case of a patent subject to subsection (g)(6)(C),
the owner of record of the patent, or its agent, may apply for only 1
subsequent interim extension under this paragraph. Each such subsequent
application shall be made during the period beginning 60 days before,
and ending 30 days before, the expiration of the preceding interim
extension.
(D) Each certificate of interim extension under this paragraph shall
be recorded in the official file of the patent and shall be considered
part of the original patent.
(E) Any interim extension granted under this paragraph shall
terminate at the end of the 60-day period beginning on the date on which
the product involved receives permission for commercial marketing or
use, except that, if within that 60-day period the applicant notifies
the Director of such permission and submits any additional information
under paragraph (1) of this subsection not previously contained in the
application for interim extension, the patent shall be further extended,
in accordance with the provisions of this section--
(i) for not to exceed 5 years from the date of expiration of the
original patent term; or
(ii) if the patent is subject to subsection (g)(6)(C), from the
date on which the product involved receives approval for commercial
marketing or use.
(F) The rights derived from any patent the term of which is extended
under this paragraph shall, during the period of interim extension--
(i) in the case of a patent which claims a product, be limited
to any use then under regulatory review;
(ii) in the case of a patent which claims a method of using a
product, be limited to any use claimed by the patent then under
regulatory review; and
(iii) 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 product then under regulatory review.
(e)(1) A determination that a patent is eligible for extension may
be made by the Director solely on the basis of the representations
contained in the application for the extension. If the Director
determines that a patent is eligible for extension under subsection (a)
and that the requirements of paragraphs (1) through (4) of subsection
(d) have been complied with, the Director shall issue to the applicant
for the extension of the term of the patent a certificate of extension,
under seal, for the period prescribed by subsection (c). Such
certificate shall be recorded in the official file of the patent and
shall be considered as part of the original patent.
(2) If the term of a patent for which an application has been
submitted under subsection (d)(1) would expire before a certificate of
extension is issued or denied under paragraph (1) respecting the
application, the Director shall extend, until such determination is
made, the term of the patent for periods of up to one year if he
determines that the patent is eligible for extension.
(f) For purposes of this section:
(1) The term ``product'' means:
(A) A drug product.
(B) Any medical device, food additive, or color additive
subject to regulation under the Federal Food, Drug, and Cosmetic
Act.
(2) The term ``drug product'' means the active ingredient of--
(A) 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), or
(B) a new animal drug or veterinary biological product (as
those terms are used in the Federal Food, Drug, and Cosmetic Act
and the Virus-Serum-Toxin Act) which is not primarily
manufactured using recombinant DNA, recombinant RNA, hybridoma
technology, or other processes involving site specific genetic
manipulation techniques,
including any salt or ester of the active ingredient, as a single
entity or in combination with another active ingredient.
(3) The term ``major health or environmental effects test''
means a test which is reasonably related to the evaluation of the
health or environmental effects of a product, which requires at
least six months to conduct, and the data from which is submitted to
receive permission for commercial marketing or use. Periods of
analysis or evaluation of test results are not to be included in
determining if the conduct of a test required at least six months.
(4)(A) Any reference to section 351 is a reference to section
351 of the Public Health Service Act.
(B) Any reference to section 503, 505, 512, or 515 is a
reference to section 503, 505, 512, or 515 of the Federal Food,
Drug, and Cosmetic Act.
(C) Any reference to the Virus-Serum-Toxin Act is a reference to
the Act of March 4, 1913 (21 U.S.C. 151-158).
(5) The term ``informal hearing'' has the meaning prescribed for
such term by section 201(y) \2\ of the Federal Food, Drug, and
Cosmetic Act.
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\2\ See References in Text note below.
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(6) The term ``patent'' means a patent issued by the United
States Patent and Trademark Office.
(7) The term ``date of enactment'' as used in this section means
September 24, 1984, for a human drug product, a medical device, food
additive, or color additive.
(8) The term ``date of enactment'' as used in this section means
the date of enactment of the Generic Animal Drug and Patent Term
Restoration Act for an animal drug or a veterinary biological
product.
(g) For purposes of this section, the term ``regulatory review
period'' has the following meanings:
(1)(A) In the case of a product which is a new drug, antibiotic
drug, or human biological product, the term means the period
described in subparagraph (B) to which the limitation described in
paragraph (6) applies.
(B) The regulatory review period for a new drug, antibiotic
drug, or human biological product is the sum of--
(i) the period beginning on the date an exemption under
subsection (i) of section 505 or subsection (d) of section 507
\2\ became effective for the approved product and ending on the
date an application was initially submitted for such drug
product under section 351, 505, or 507,\2\ and
(ii) the period beginning on the date the application was
initially submitted for the approved product under section 351,
subsection (b) of section 505, or section 507 \2\ and ending on
the date such application was approved under such section.
(2)(A) In the case of a product which is a food additive or
color additive, the term means the period described in subparagraph
(B) to which the limitation described in paragraph (6) applies.
(B) The regulatory review period for a food or color additive is
the sum of--
(i) the period beginning on the date a major health or
environmental effects test on the additive was initiated and
ending on the date a petition was initially submitted with
respect to the product under the Federal Food, Drug, and
Cosmetic Act requesting the issuance of a regulation for use of
the product, and
(ii) the period beginning on the date a petition was
initially submitted with respect to the product under the
Federal Food, Drug, and Cosmetic Act requesting the issuance of
a regulation for use of the product, and ending on the date such
regulation became effective or, if objections were filed to such
regulation, ending on the date such objections were resolved and
commercial marketing was permitted or, if commercial marketing
was permitted and later revoked pending further proceedings as a
result of such objections, ending on the date such proceedings
were finally resolved and commercial marketing was permitted.
(3)(A) In the case of a product which is a medical device, the
term means the period described in subparagraph (B) to which the
limitation described in paragraph (6) applies.
(B) The regulatory review period for a medical device is the sum
of--
(i) the period beginning on the date a clinical
investigation on humans involving the device was begun and
ending on the date an application was initially submitted with
respect to the device under section 515, and
(ii) the period beginning on the date an application was
initially submitted with respect to the device under section 515
and ending on the date such application was approved under such
Act or the period beginning on the date a notice of completion
of a product development protocol was initially submitted under
section 515(f)(5) and ending on the date the protocol was
declared completed under section 515(f)(6).
(4)(A) In the case of a product which is a new animal drug, the
term means the period described in subparagraph (B) to which the
limitation described in paragraph (6) applies.
(B) The regulatory review period for a new animal drug product
is the sum of--
(i) the period beginning on the earlier of the date a major
health or environmental effects test on the drug was initiated
or the date an exemption under subsection (j) of section 512
became effective for the approved new animal drug product and
ending on the date an application was initially submitted for
such animal drug product under section 512, and
(ii) the period beginning on the date the application was
initially submitted for the approved animal drug product under
subsection (b) of section 512 and ending on the date such
application was approved under such section.
(5)(A) In the case of a product which is a veterinary biological
product, the term means the period described in subparagraph (B) to
which the limitation described in paragraph (6) applies.
(B) The regulatory period for a veterinary biological product is
the sum of--
(i) the period beginning on the date the authority to
prepare an experimental biological product under the Virus-
Serum-Toxin Act became effective and ending on the date an
application for a license was submitted under the Virus-Serum-
Toxin Act, and
(ii) the period beginning on the date an application for a
license was initially submitted for approval under the Virus-
Serum-Toxin Act and ending on the date such license was issued.
(6) A period determined under any of the preceding paragraphs is
subject to the following limitations:
(A) If the patent involved was issued after the date of the
enactment of this section, the period of extension determined on
the basis of the regulatory review period determined under any
such paragraph may not exceed five years.
(B) If the patent involved was issued before the date of the
enactment of this section and--
(i) no request for an exemption described in paragraph
(1)(B) or (4)(B) was submitted and no request for the
authority described in paragraph (5)(B) was submitted,
(ii) no major health or environmental effects test
described in paragraph (2)(B) or (4)(B) was initiated and no
petition for a regulation or application for registration
described in such paragraph was submitted, or
(iii) no clinical investigation described in paragraph
(3) was begun or product development protocol described in
such paragraph was submitted,
before such date for the approved product the period of
extension determined on the basis of the regulatory review
period determined under any such paragraph may not exceed five
years.
(C) If the patent involved was issued before the date of the
enactment of this section and if an action described in
subparagraph (B) was taken before the date of the enactment of
this section with respect to the approved product and the
commercial marketing or use of the product has not been approved
before such date, the period of extension determined on the
basis of the regulatory review period determined under such
paragraph may not exceed two years 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.
(h) The Director may establish such fees as the Director determines
appropriate to cover the costs to the Office of receiving and acting
upon applications under this section.
(Added Pub. L. 98-417, title II, Sec. 201(a), Sept. 24, 1984, 98 Stat.
1598; amended Pub. L. 100-670, title II, Sec. 201(a)-(h), Nov. 16, 1988,
102 Stat. 3984-3987; Pub. L. 103-179, Secs. 5, 6, Dec. 3, 1993, 107
Stat. 2040, 2042; Pub. L. 103-465, title V, Sec. 532(c)(1), Dec. 8,
1994, 108 Stat. 4987; Pub. L. 105-115, title I, Sec. 125(b)(2)(P), Nov.
21, 1997, 111 Stat. 2326; Pub. L. 106-113, div. B, Sec. 1000(a)(9)
[title IV, Secs. 4404, 4732(a)(10)(A)], Nov. 29, 1999, 113 Stat. 1536,
1501A-560, 1501A-582; Pub. L. 107-273, div. C, title III,
Sec. 13206(a)(9), (b)(1)(B), Nov. 2, 2002, 116 Stat. 1904, 1906.)
References in Text
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 (Sec. 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), and (g)(2)(B), (3)(B)(ii), (6)(C), is act
June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified
generally to chapter 9 (Sec. 301 et seq.) of Title 21. 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)
and (f)(2)(A), is act July 1, 1944, ch. 373, 58 Stat. 682, as amended,
which is classified generally to chapter 6A (Sec. 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, and 515 of the Federal Food, Drug, and
Cosmetic Act, referred to in subsecs. (f)(4)(B) and (g)(1)(B), (3)(B),
are classified, respectively, to sections 353, 355, 360b, and 360e 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, Sec. 125(b)(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) and (g)(1)(B)(i), (ii), 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 Pub. 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 Pub. L. 98-417, which was
approved Sept. 24, 1984.
Amendments
2002--Subsec. (b)(3)(B). Pub. L. 107-273, Sec. 13206(a)(9)(A),
substituted ``paragraph'' for ``paragraphs''.
Subsec. (d). Pub. L. 107-273, Sec. 13206(b)(1)(B), made technical
correction to directory language of Pub. L. 106-113, Sec. 1000(a)(9)
[title IV, Sec. 4732(a)(10)(A)]. See 1999 Amendment note below.
Subsec. (d)(2)(B)(i). Pub. L. 107-273, Sec. 13206(a)(9)(B),
substituted ``below the Office'' for ``below the office''.
Subsec. (e). Pub. L. 107-273, Sec. 13206(b)(1)(B), made technical
correction to directory language of Pub. L. 106-113, Sec. 1000(a)(9)
[title IV, Sec. 4732(a)(10)(A)]. See 1999 Amendment note below.
Subsec. (g)(6)(B)(iii). Pub. L. 107-273, Sec. 13206(a)(9)(C),
substituted ``submitted'' for ``submittted''.
Subsec. (h). Pub. L. 107-273, Sec. 13206(b)(1)(B), made technical
correction to directory language of Pub. L. 106-113, Sec. 1000(a)(9)
[title IV, Sec. 4732(a)(10)(A)]. See 1999 Amendment note below.
1999--Subsec. (a). Pub. L. 106-113, Sec. 1000(a)(9) [title IV,
Sec. 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''.
Subsecs. (d), (e), (h). Pub. L. 106-113, Sec. 1000(a)(9) [title IV,
Sec. 4732(a)(10)(A)], as amended by Pub. L. 107-273,
Sec. 13206(b)(1)(B), substituted ``Director'' for ``Commissioner''
wherever appearing.
1997--Subsec. (f)(4)(B). Pub. L. 105-115, Sec. 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, Sec. 6(1)(A), substituted
``subsection (d)(1)'' for ``subsection (d)''.
Subsec. (a)(3). Pub. L. 103-179, Sec. 6(1)(B), substituted
``paragraphs (1) through (4) of subsection (d)'' for ``subsection (d)''.
Subsec. (b). Pub. L. 103-179, Sec. 6(2), substituted ``Except as
provided in subsection (d)(5)(F), the rights'' for ``The rights'' in
introductory provisions.
Subsec. (c)(4). Pub. L. 103-179, Sec. 5(1), substituted ``extended
under subsection (e)(1)'' for ``extended''.
Subsec. (d)(1). Pub. L. 103-179, Sec. 5(2), substituted ``Except as
provided in paragraph (5), such'' for ``Such'' in second sentence.
Subsec. (d)(5). Pub. L. 103-179, Sec. 5(3), added par. (5).
Subsec. (e)(1). Pub. L. 103-179, Sec. 6(3)(A), substituted
``paragraphs (1) through (4) of subsection (d)'' for ``subsection (d)''.
Subsec. (e)(2). Pub. L. 103-179, Sec. 6(3)(B), substituted
``subsection (d)(1)'' for ``subsection (d)''.
1988--Subsec. (a)(5)(A). Pub. L. 100-670, Sec. 201(a)(1), inserted
``or (C)'' after ``in subparagraph (B)''.
Subsec. (a)(5)(C). Pub. L. 100-670, Sec. 201(a)(2), (3), added
subpar. (C).
Subsec. (b). Pub. L. 100-670, Sec. 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--
``(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). Pub. L. 100-670, Sec. 201(c), substituted
``(3)(B)(i), (4)(B)(i), and (5)(B)(i)'' for ``and (3)(B)(i)''.
Subsec. (d)(1)(C). Pub. L. 100-670, Sec. 201(d), inserted ``or the
Secretary of Agriculture'' after ``and Human Services''.
Subsec. (d)(2)(A). Pub. L. 100-670, Sec. 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). Pub. L. 100-670, Sec. 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). Pub. L. 100-670, Sec. 201(g)(1), struck out
``human'' before ``drug product''.
Subsec. (f)(2). Pub. L. 100-670, Sec. 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). Pub. L. 100-670, Sec. 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). Pub. L. 100-670, Sec. 201(g)(3), added pars.
(7) and (8).
Subsec. (g)(1)(A). Pub. L. 100-670, Sec. 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). Pub. L. 100-670, Sec. 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). Pub. L. 100-670, Sec. 201(h)(3),
substituted ``paragraph (6)'' for ``paragraph (4)''.
Subsec. (g)(4), (5). Pub. L. 100-670, Sec. 201(h)(4), added pars.
(4) and (5). Former par. (4) redesignated (6).
Subsec. (g)(6). Pub. L. 100-670, Sec. 201(h)(4), redesignated former
par. (4) as (6).
Subsec. (g)(6)(B)(i). Pub. L. 100-670, Sec. 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). Pub. L. 100-670, Sec. 201(h)(5)(B),
substituted ``paragraph (2)(B) or (4)(B)'' for ``paragraph (2)''.
Subsec. (g)(6)(C). Pub. L. 100-670, Sec. 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''.
Effective Date of 1999 Amendment
Amendment by section 1000(a)(9) [title IV, Sec. 4404] of Pub. 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, Sec. 4405(a)] of Pub. L. 106-113, set out
as a note under section 154 of this title.
Amendment by section 1000(a)(9) [title IV, Sec. 4732(a)(10)(A)] of
Pub. L. 106-113 effective 4 months after Nov. 29, 1999, see section
1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-113, set out as a note
under section 1 of this title.
Effective Date of 1994 Amendment
Amendment by Pub. 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(b)(1), (3) of Pub. L. 103-465, set
out as a note under section 154 of this title.
Section Referred to in Other Sections
This section is referred to in sections 273, 282 of this title.
