35 U.S.C. § 156 : US Code - Section 156: Extension of patent term

Search 35 U.S.C. § 156 : US Code - Section 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.
(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.
(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.