Drug Price Competition and Patent Term Restoration Act of 1984

PUBLIC LAW 98-417—SEPT. 24, 1984
Public Law 98-417
98th Congress

98 STAT. 1585

An Act

To amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new
drug appHcations, to amend title 35, United States Code, to authorize the extension
of the patents for certain regulated products, and for other purposes.

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That this Act may
be cited as the "Drug Price Competition and Patent Term Restoration Act of 1984".
TITLE I—ABBREVIATED NEW DRUG APPLICATIONS
SEC. 101. Section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) is amended by redesignating subsection (j) as subsection (k) and inserting after subsection (i) the following:
"(jXD Any person may file with the Secretary an abbreviated
application for the approval of a new drug.
"(2)(A) An abbreviated application for a new drug shall contain—
"(i) information to show that the conditions of use prescribed,
recommended, or suggested in the labeling proposed for the new
drug have been previously approved for a drug listed under
paragraph (6) (hereinafter in this subsection referred to as a
'listed drug');
"(ii)(I) if the listed drug referred to in clause (i) has only one
active ingredient, information to show that the active ingredient of the new drug is the same as that of the listed drug;
"(II) if the listed drug referred to in clause (i) has more than
one active ingredient, information to show that the active ingredients of the new drug are the same as those of the listed drug,
or
"(III) if the listed drug referred to in clause (i) has more than
one active ingredient and if one of the active ingredients of the
new drug is different and the application is filed pursuant to the
approval of a petition filed under subparagraph (C), information
to show that the other active ingredients of the new drug are
the same as the active ingredients of the listed drug, information to show that the different active ingredient is an active
ingredient of a listed drug or of a drug which does not meet the
requirements of section 201(p), and such other information respecting the different active ingredient with respect to which
the petition was filed as the Secretary may require;
"(iii) information to show that the route of administration,
the dosage form, and the strength of the new drug are the same
as those of the listed drug referred to in clause (i) or, if the route
of administration, the dosage form, or the strength of the new
drug is different and the application is filed pursuant to the
approval of a petition filed under subparagraph (C), such information respecting the route of administration, dosage form, or
strength with respect to which the petition was filed as the
Secretary may require;

Sept. 24, 1984
[S. 1538]

Drug Price
Competition and
Patent Term
Restoration Act
of 1984.
21 u s e 301 note.

Labeling.

21 u s e 321.

98 STAT. 1586

Claims.

Prohibition.

Claims.

Marketing.

PUBLIC LAW 98-417—SEPT. 24, 1984

"(iv) information to show that the new drug is bioequivalent
to the listed drug referred to in clause (i), except that if the
application is filed pursuant to the approval of a petition filed
under subparagraph (C), information to show that the active
ingredients of the new drug are of the same pharmacological or
therapeutic class as those of the listed drug referred to in clause
(i) and the new drug can be expected to have the same therapeutic effect as the listed drug when administered to patients for a
condition of use referred to in clause (i);
"(v) information to show that the labeling proposed for the
new drug is the same as the labeling approved for the listed
drug referred to in clause (i) except for changes required because of differences approved under a petition filed under subparagraph (C) or because the new drug and the listed drug are
produced or distributed by different manufacturers;
"(vi) the items specified in clauses (B) through (F) of subsection (b)(1);
"(vii) a certification, in the opinion of the applicant and to the
best of his knowledge, with respect to each patent which claims
the listed drug referred to in clause (i) or which claims a use for
such listed drug for which the applicant is seeking approval
under this subsection and for which information is required to
be filed under subsection (b) or (c)—
"(I) that such patent information has not been filed,
"(11) that such patent has expired,
"(III) of the date on which such patent will expire, or
"(IV) that such patent is invalid or will not be infringed
by the manufacture, use, or sale of the new drug for which
the application is submitted; and
"(viii) if with respect to the listed drug referred to in clause (i)
information was filed under subsection (b) or (c) for a method of
use patent which does not claim a use for which the applicant is
seeking approval under this subsection, a statement that the
method of use patent does not claim such a use.
The Secretary may not require that an abbreviated application
contain information in addition to that required by clauses (i)
through (viii).
"(BXi) An applicant who makes a certification described in subparagraph (A)(viiXIV) shall include in the application a statement
that the applicant will give the notice required by clause (ii) to—
"(I) each owner of the patent which is the subject of the
certification or the representative of such owner designated to
receive such notice, and
"(II) the holder of the approved application under subsection
(b) for the drug which is claimed by the patent or a use of which
is claimed by the patent or the representative of such holder
designated to receive such notice,
"(ii) The notice referred to in clause (i) shall state that an application, which contains data from bioavailability or bioequivalence
studies, has been submitted under this subsection for the drug with
respect to which the certification is made to obtain approval to
engage in the commercial manufacture, use, or sale of such drug
before the expiration of the patent referred to in the certification.
Such notice shall include a detailed statement of the factual and
legal basis of the applicant's opinion that the patent is not valid or
will not be infringed.

PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1587

"(iii) If an application is amended to include a certification described in subparagraph (A)(vii)(IV), the notice required by clause (ii)
shall be given when the amended application is submitted.
"(C) If a person wants to submit an abbreviated application for a
new drug which has a different active ingredient or whose route of
administration, dosage form, or strength differ from that of a listed
drug, such person shall submit a petition to the Secretary seeking
permission to file such an application. The Secretary shall approve
or disapprove a petition submitted under this subparagraph within
ninety days of the date the petition is submitted. The Secretary shall
approve such a petition unless the Secretary finds—
"(i) that investigations must be conducted to show the safety
and effectiveness of the drug or of any of its active ingredients,
the route of administration, the dosage form, or strength which
differ from the listed drug; or
"(ii) that any drug with a different active ingredient may not
be adequately evaluated for approval as safe and effective on
the bsisis of the information required to be submitted in an
abbreviated application.
"(3) Subject to paragraph (4), the Secretary shall approve an
application for a drug unless the Secretary finds—
"(A) the methods used in, or the facilities and controls used
for, the manufacture, processing, and packing of the drug are
inadequate to assure and preserve its identity, strength, quality,
and purity;
"(B) information submitted with the application is insufficient
to show that each of the proposed conditions of use have been
previously approved for the listed drug referred to in the
application;
"(C)(i) if the listed drug has only one active ingredient, information submitted with the application is insufficient to show
that the active ingredient is the same as that of the listed drug;
"(ii) if the listed drug has more than one active ingredient,
information submitted with the application is insufficient to
show that the active ingredients are the same as the active
ingredients of the listed drug, or
"(iii) if the listed drug has more than one active ingredient
and if the application is for a drug which has an active ingredient different from the listed drug, information submitted with
the application is insufficient to show—
"(I) that the other active ingredients are the same as the
active ingredients of the listed drug, or
"(II) that the different active ingredient is an active
ingredient of a listed drug or a drug which does not meet
the requirements of section 201(p),
or no petition to file an application for the drug with the
different ingredient was approved under paragraph (2XC);
"(D)(i) if the application is for a drug whose route of administration, dosage form, or strength of the drug is the same as the
route of administration, dosage form, or strength of the listed
drug referred to in the application, information submitted in
the application is insufficient to show that the route of administration, dosage form, or strength is the same as that of the listed
drug, or
"(ii) if the application is for a drug whose route of administration, dosage form, or strength of the drug is different from that
of the listed drug referred to in the application, no petition to

21 USC 321.

98 STAT. 1588

Labeling.

Effective dates.

PUBLIC LAW 98-417—SEPT. 24, 1984

file an application for the drug with the different route of
administration, dosage form, or strength was approved under
paragraph (2XC);
"(E) if the application was filed pursuant to the approval of a
petition under paragraph (2XC), the application did not contain
the information required by the Secretary respecting the active
ingredient, route of administration, dosage form, or strength
which is not the same;
"(F) information submitted in the application is insufficient to
show that the drug is bioequivalent to the listed drug referred to
in the application or, if the application was filed pursuant to a
petition approved under paragraph (2)(C), information submitted in the application is insufficient to show that the active
ingredients of the new drug are of the same pharmacological or
therapeutic class as those of the listed drug referred to in
paragraph (2)(A)(i) and that the new drug can be expected to
have the same therapeutic effect as the listed drug when administered to patients for a condition of use referred to in such
paragraph;
"(G) information submitted in the application is insufficient
to show that the labeling proposed for the drug is the same as
the labeling approved for the listed drug referred to in the
application except for changes required because of differences
approved under a petition filed under paragraph (2)(C) or because the drug and the listed drug are produced or distributed
by different manufacturers;
"(H) information submitted in the application or any other
information available to the Secretary shows that (i) the inactive ingredients of the drug are unsafe for use under the
conditions prescribed, recommended, or suggested in the labeling proposed for the drug, or (ii) the composition of the drug is
unsafe under such conditions because of the tjrpe or quantity of
inactive ingredients included or the manner in which the inactive ingredients are included;
"(I) the approval under subsection (c) of the listed drug referred to in the application under this subsection has been
withdrawn or suspended for grounds described in the first
sentence of subsection (e), the Secretary has published a notice
of opportunity for hearing to withdraw approval of the listed
drug under subsection (c) for grounds described in the first
sentence of subsection (e), the approval under this subsection of
the listed drug referred to in the application under this subsection has been withdrawn or suspended under paragraph (5), or
the Secretary has determined that the listed drug has been
withdrawn from sale for safety or effectiveness reasons;
"(J) the application does not meet any other requirement of
paragraph (2)(A); or
"(K) the application contains an untrue statement of material
fact.
"(4XA) Within one hundred and eighty days of the initial receipt
of an application under paragraph (2) or within such additional
period as may be agreed upon by the Secretary and the applicant,
the Secretary shall approve or disapprove the application.
"(B) The approval of an application submitted under paragraph (2)
shall be made effective on the last applicable date determined under
the following:

PUBLIC LAW 98-417—SEPT. "2l, 1984

98 STAT. 1589

"(i) If the applicant only made a certification described in
subclause (I) or (II) of paragraph (2)(A)(vii) or in both such
subclauses, the approval may be made effective immediately,
"(ii) If the applicant made a certification described in subclause (III) of paragraph (2)(A)(vii), the approval may be made
effective on the date certified under subclause (III).
"(iii) If the applicant made a certification described in subclause (IV) of paragraph (2)(A)(vii), the approval shall be made
effective immediately unless an action is brought for infringement of a patent which is the subject of the certification before
the expiration of forty-five days from the date the notice provided under paragraph (2)(B)(i) is received. If such an action is
brought before the expiration of such days, the approval shall
be made effective upon the expiration of the thirty-month
period beginning on the date of the receipt of the notice provided under paragraph (2)(B)(i) or such shorter or longer period
as the court may order because either party to the action failed
to reasonably cooperate in expediting the action, except that—
"(I) if before the expiration of such period the court
decides that such patent is invalid or not infringed, the
approval shall be made effective on the date of the court
decision,
"(II) if before the expiration of such period the court
decides that such patent has been infringed, the approval
shall be made effective on such date as the court orders
under section 271(e)(4)(A) of title 35, United States Code, or
"(III) if before the expiration of such period the court
grants a preliminary injunction prohibiting the applicant
from engaging in the commercial manufacture or sale of
the drug until the court decides the issues of patent validity
and infringement and if the court decides that such patent
is invalid or not infringed, the approval shall be made
effective on the date of such court decision.
In such an action, each of the parties shall reasonably cooperate
in expediting the action. Until the expiration of forty-five days
from the date the notice made under paragraph (2)(B)(i) is
received, no action may be brought under section 2201 of title
28, United States Code, for a declaratory judgment with respect
to the patent. Any action brought under section 2201 shall be
brought in the judicial district where the defendant has its
principal place of business or a regular and established place of
business.
"(iv) If the application contains a certification described in
subclause (IV) of paragraph (2)(AXvii) and is for a drug for
which a previous application has been submitted under this
subsection continuing such a certification, the application shall
be made effective not earlier than one hundred and eighty days
after—
"(I) the date the Secretary receives notice from the applicant under the previous application of the first commercial
marketing of the drug under the previous application, or
"(II) the date of a decision of a court in an action described in clause (iii) holding the patent which is the subject
of the certification to be invalid or not infringed,
whichever is earlier.
"(C) If the Secretary decides to disapprove an application, the
Secretary shall give the applicant notice of an opportunity for a

Claims.

Post, p. 1603.

Post, p. 1597.

Hearing
opportunity.

98 STAT. 1590

Prohibitions.

Claims.

PUBLIC LAW 98-417—SEPT. 24, 1984

hearing before the Secretary on the question of whether such application is approvable. If the applicant elects to accept the opportunity
for hearing by written request within thirty days after such notice,
such hearing shall commence not more than ninety days after the
expiration of such thirty days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary's order thereon shall
be issued within ninety days after the date fixed by the Secretary for
filing final briefs.
"(D)(i) If an application (other than an abbreviated new drug
application) submitted under subsection (b) for a drug, no active
ingredient (including any ester or salt of the active ingredient) of
which has been approved in any other application under subsection
(b), was approved during the period beginning January 1, 1982, and
ending on the date of the enactment of this subsection, the Secretary
may not make the approval of an application submitted under this
subsection which refers to the drug for which the subsection (b)
application was submitted effective before the expiration of ten
years from the date of the approval of the application under subsection (b).
"(ii) If an application submitted under subsection (b) for a drug, no
active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under
subsection (b), is approved after the date of the enactment of this
subsection, no application may be submitted under this subsection
which refers to the drug for which the subsection (b) application was
submitted before the expiration of five years from the date of the
approval of the application under subsection (b), except that such an
application may be submitted under this subsection after the expiration of four years from the date of the approval of the subsection (b)
application if it contains a certification of patent invalidity or
noninfringement described in subclause (IV) of paragraph (2)(A)(vii).
The approval of such an application shall be made effective in
accordance with subparagraph (B) except that, if an action for
patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of the
subsection (b) application, the thirty-month period referred to in
subparagraph (B)(iii) shall be extended by such amount of time (if
any) which is required for seven and one-half years to have elapsed
from the date of approval of the subsection (b) application.
"(iii) If an application submitted under subsection (b) for a drug,
which includes an active ingredient (including any ester or salt of
the active ingredient) that has been approved in another application
approved under subsection (b), is approved after the date of enactment of this subsection and if such application contains reports of
new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by
the applicant, the Secretary may not make the approval of an
application submitted under this subsection for the conditions of
approval of such drug in the subsection (b) application effective
before the expiration of three years from the date of the approval of
the application under subsection (b) for such drug.
"(iv) If a supplement to an application approved under subsection
(b) is approved after the date of enactment of this subsection and the
supplement contains reports of new clinical investigations (other
than bioavailability studies) essential to the approval of the supplement and conducted or sponsored by the person submitting the

PUBLIC LAW 98-417—SfiPf. 24, 1984

98 STAT. 1591

supplement, the Secretary may not make the approval of an application submitted under this subsection for a change approved in the
supplement effective before the expiration of three years from the
date of the approval of the supplement under subsection (b).
"(v) If an application (or supplement to an application) submitted
under subsection (b) for a drug, which includes an active ingredient
(including any ester or salt of the active ingredient) that has been
approved in another application under subsection (b), was approved
during the period beginning January 1,1982, and ending on the date
of the enactment of this subsection, the Secretary may not make the
approval of an application submitted under this subsection which
refers to the drug for which the subsection (b) application was
submitted or which refers to a change approved in a supplement to
the subsection (b) application effective before the expiration of two
years from the date of enactment of this subsection.
"(5) If a drug approved under this subsection refers in its approved
application to a drug the approval of which was withdrawn or
"suspended for grounds described in the first sentence of subsection
(e) or was withdrawn or suspended under this paragraph or which,
as determined by the Secretary, has been withdrawn from sale for
safety or effectiveness reasons, the approval of the drug under this
subsection shall be withdrawn or suspended—
"(A) for the same period as the withdrawal or suspension
under subsection (e) or this paragraph, or
"(B) if the listed drug has been withdrawn from sale, for the
period of withdrawal from sale or, if earlier, the period ending
on the date the Secretary determines that the withdrawal from
sale is not for safety or effectiveness reasons.
"(6)(A)(i) Within sixty days of the date of the enactment of this
subsection, the Secretary shall publish and make available to the
public—
"(I) a list in alphabetical order of the official and proprietary
name of each drug which has been approved for safety and
effectiveness under subsection (c) before the date of the enactment of this subsection;
"(II) the date of approval if the drug is approved after 1981
and the number of the application which was approved; and
"(III) whether in vitro or in vivo bioequivalence studies, or
both such studies, are required for applications filed under this
subsection which will refer to the drug published.
"(ii) Every thirty days after the publication of the first list under
clause (i) the Secretry shall revise the list to include each drug
which has been approved for safety and effectiveness under subsection (c) or approved under this subsection during the thirty-day
period.
"(iii) When patent information submitted under subsection (b) or
(c) respecting a drug included on the list is to be published by the
Secretary the Secretary shall, in revisions made under clause (ii),
include such information for such drug.
"(B) A drug approved for safety and effectiveness under subsection
(c) or approved under this subsection shall, for purposes of this
subsection, be considered to have been published under subparagraph (A) on the date of its approval or the date of enactment,
whichever is later.
"(C) If the approval of a drug was withdrawn or suspended for
grounds described in the first sentence of subsection (e) or was
withdrawn or suspended under paragraph (5) or if the Secretary

Approved-drug
list.
Public
availability.

98 STAT. 1592

Federal
Register,
publication.

Claims.
21 u s e 355.

Public
information.

Claims.

PUBLIC LAW 98-417—SEPT. 24, 1984

determines that a drug has been withdrawn from sale for safety or
effectiveness reasons, it may not be published in the list under
subparagraph (A) or, if the withdrawal or suspension occurred after
its publication in such list, it shall be immediately removed from
such list—
"(i) for the same period as the withdrawal or suspension
under subsection (e) or paragraph (5), or
"(ii) if the listed drug has been withdrawn from sale, for the
period of withdrawal from sale or, if earlier, the period ending
on the date the Secretary determines that the withdrawal from
sale is not for safety or effectiveness reasons.
A notice of the removal shall be published in the Federal Register.
"(7) For purposes of this subsection:
"(A) The term 'bioavailability' means the rate and extent to
which the active ingredient or therapeutic ingredient is
absorbed from a drug and becomes available at the site of drug
action.
"(B) A drug shall be considered to be bioequivalent to a listed
drug if—
"(i) the rate and extent of absorption of the drug do not
show a significant difference from the rate and extent of
absorption of the listed drug when administered at the
same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses; or
"(ii) the extent of absorption of the drug does not show a
significant difference from the extent of absorption of the
listed drug when administered at the same molar dose of
the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses and the
difference from the listed drug in the rate of absorption of
the drug is intentional, is reflected in its proposed labeling,
is not essential to the attainment of effective body drug
concentrations on chronic use, and is considered medically
insignificant for the drug.".
SEC. 102. (a)(1) Section 505(b) of such Act if amended by adding at
the end the following: "The applicant shall file with the application
the patent number and the expiration date of any patent which
claims the drug for which the applicant submitted the application or
which claims a method of using such drug and with respect to which
a claim of patent infringement could reasonably be asserted if a
person not licensed by the owner engaged in the manufacture, use,
or sale of the drug. If an application is filed under this subsection for
a drug and a patent which claims such drug or a method of using
such drug is issued after the filing date but before approval of the
application, the applicant shall amend the application to include the
information required by the preceding sentence. Upon approval of
the application, the Secretary shall publish information submitted
under the two preceding sentences.".
(2) Section 505(c) of such Act is amended by inserting "(1)" after
"(c)", by redesignating paragraphs (1) and (2) as subparagraphs (A)
and (B), respectively, and by adding at the end the following:
"(2) If the patent information described in subsection (b) could not
be filed with the submission of an application under subsection (b)
because the application was filed before the patent information was
required under subsection (b) or a patent was issued after the
application was approved under such subsection, the holder of an

PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1593

approved application shall file with the Secretary the patent
number and the expiration date of any patent which claims the drug
for which the application was submitted or which claims a method
of using such drug and with respect to which a claim of patent
infringement could reasonably be asserted if a person not licensed
by the owner engaged in the manufacture, use, or sale of the drug. If
the holder of an approved application could not file patent information under subsection (b) because it was not required at the time the
application was approved, the holder shall file such information
under this subsection not later than thirty days after the date of the
enactment of this sentence, and if the holder of an approved application could not file patent information under subsection (b) because
no patent had been issued when an application was filed or approved, the holder shall file such information under this subsection
not later than thirty days after the date the patent involved is
issued. Upon the submission of patent information under this subsection, the Secretary shall publish it.".
(3)(A) The first sentence of section 505(d) of such Act is amended
by redesignating clause (6) as clause (7) and inserting after clause (5)
the following: "(6) the application failed to contain the patent
information prescribed by subsection (b); or".
(B) The first sentence of section 505(e) of such Act is amended by
redesignating clause (4) as clause (5) and inserting after clause (3)
the following: "(4) the patent information prescribed by subsection
(c) was not filed within thirty days after the receipt of written notice
from the Secretary specifying the failure to file such information;
or".
(b)(1) Section 505(a) of such Act is amended by inserting "or (j)"
after "subsection (b)".
(2) Section 505(c) of such Act is amended by striking out "this
subsection" and inserting in lieu thereof "subsection Ot))".
(3) The second sentence of section 505(e) of such Act is amended by inserting "submitted under subsection (b) or (j)" after "an
application".
(4) The second sentence of section 505(e) is amended by striking
out "(j)" each place it occurs in clause (1) and inserting in lieu
thereof "(k)".
(5) Section 505(k)(l) of such Act (as so redesignated) is amended by
striking out "pursuant to this section" and inserting in lieu thereof
"under subsection (b) or (j)".
(6) Subsections (a) and (b) of section 527 of such Act are each
amended by striking out "505(b)" each place it occurs and inserting
in lieu thereof "505".
SEC. 103. (a) Section 505(b) of such Act is amended by inserting
"(1)" after "(b)", by redesignating clauses (1) through (6) as clauses
(A) through (F), respectively, and by adding at the end the following:
"(2) An application submitted under paragraph (1) for a drug for
which the investigations described in clause (A) of such paragraph
and relied upon by the applicant for approval of the application
were not conducted by or for the applicant and for which the
applicant has not obtained a right of reference or use from the
person by or for whom the investigations were conducted shall also
include—
"(A) a certification, in the opinion of the applicant and to the
best of his knowledge, with respect to each patent which claims
the drug for which such investigations were conducted or which
claims a use for such drug for which the applicant is seeking

Public
information.
21 u s e 355.

Ante, p. 1592.

Supra.

Ante, p. 1585.

21 u s e 360cc.

Ante, p. 1592.

eiaims.

98 STAT. 1594

Claims.

Marketing.

Ante, p. 1592.
Effective dates.

Claims.

PUBLIC LAW 98-417—SEPT. 24, 1984

approval under this subsection and for which information is
required to be filed under paragraph (1) or subsection (c)—
"(i) that such patent information has not been filed,
"(ii) that such patent has expired,
"(iii) of the date on which such patent will expire, or
"(iv) that such patent is invalid or will not be infringed by
the manufacture, use, or sale of the new drug for which the
application is submitted; and
"(B) if with respect to the drug for which investigations
described in paragraph (1)(A) were conducted information was
filed under paragraph (1) or subsection (c) for a method of use
patent which does not claim a use for which the applicant is
seeking approval under this subsection, a statement that the
method of use patent does not claim such a use.
"(3)(A) An applicant who makes a certification described in paragraph (2)(A)(iv) shall include in the application a statement that the
applicant will give the notice required by subparagraph (B) to—
"(i) each owner of the patent which is the subject of the
certification or the representative of such owner designated to
receive such notice, and
"(ii) the holder of the approved application under subsection
(b) for the drug which is claimed by the patent or a use of which
is claimed by the patent or the representative of such holder
designated to receive such notice.
"(B) The notice referred to in subparagraph (A) shall state that an
application has been submitted under this subsection for the drug
with respect to which the certification is made to obtain approval to
engage in the commercial manufacture, use, or sale of the drug
before the expiration of the patent referred to in the certification.
Such notice shall include a detailed statement of the factual and
legal basis of the applicant's opinion that the patent is not valid or
will not be infringed.
"(C) If an application is amended to include a certification described in paragraph (2)(A)(iv), the notice required by subparagraph
(B) shall be given when the amended application is submitted.",
(b) Section 505(c) of such Act (as amended by section 102(a)(2)) is
amended by adding at the end the following:
"(3) The approval of an application filed under subsection 0>)
which contains a certification required by paragraph (2) of such
subsection shall be made effective on the last applicable date determined under the following:
"(A) If the applicant only made a certification described in
clause (i) or (ii) of subsection (b)(2)(A) or in both such clauses, the
approval may be made effective immediately.
(B) If the applicant made a certification described in clause
(iii) of subsection (b)(2)(A), the approval may be made effective
on the date certified under clause (iii).
"(C) If the applicant made a certification described in clause
(iv) of subsection (b)(2)(A), the approval shall be made effective
immediately unless an action is brought for infringement of a
patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under
paragraph (3XB) is received. If such an action is brought before
the expiration of such days, the approval may be made effective
upon the expiration of the thirty-month period beginning on the
date of the receipt of the notice provided under paragraph (3XB)
or such shorter or longer period as the court may order because

PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1595

either party to the action failed to reasonably cooperate in
expediting the action, except that—
"(i) if before the expiration of such period the court
decides that such patent is invalid or not infringed, the
approval may be made effective on the date of the court
decision,
"(ii) if before the expiration of such period the court
decides that such patent has been infringed, the approval
may be made effective on such date as the court orders
under section 271(eX4)(A) of title 35, United States Code, or
"(iii) if before the expiration of such period the court
grants a preliminary injunction prohibiting the applicant
from engaging in the commercial manufacture or sale of
the drug until the court decides the issues of patent validity
and infringement and if the court decides that such patent
is invalid or not infringed, the approval shall be made
effective on the date of such court decision.
In such an action, each of the parties shall reasonably cooperate
in expediting the action. Until the expiration of forty-five days
from the date the notice made under paragraph (3)(B) is received, no action may be brought under section 2201 of title 28,
United States Code, for a declaratory judgment with respect to
the patent. Any action brought under such section 2201 shall be
brought in the judicial district where the defendant has its
principal place of business or a regular and established place of
business.
"(D)(i) If an application (other than an abbreviated new drug
application) submitted under subsection (b) for a drug, no active
ingredient (including any ester or salt of the active ingredient)
of which has been approved in any other application under
subsection (b), was approved during the period beginning January 1, 1982, and ending on the date of the enactment of this
subsection, the Secretary may not make the approval of another
application for a drug for which the investigations described in
clause (A) of subsection (b)(1) and relied upon by the applicant
for approval of the application were not conducted by or for the
applicant and for which the applicant has not obtained a right
of reference or use from the person by or for whom the investigations were conducted effective before the expiration of ten
years from the date of the approval of the application previously
approved under subsection (b).
"(ii) If an application submitted under subsection (b) for a
drug, no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other
application under subsection (b), is approved after the date of
the enactment of this clause, no application which refers to the
drug for which the subsection (b) application was submitted and
for which the investigations described in clause (A) of subsection
(b)(1) and relied upon by the applicant for approval of the
application were not conducted by or for the applicant and for
which the applicant has not obtained a right of reference or use
from the person by or for whom the investigations were
conducted may be submitted under subsection (b) before the
expiration of five years from the date of the approval of the
application under subsection (b), except that such an application
may be submitted under subsection (b) after the expiration of
four years from the date of the approval of the subsection (b)

Post, p. 1603.

Post, p. 1597.

Prohibitions.

98 STAT. 1596

ClEiims.

PUBLIC LAW 98-417—SEPT. 24, 1984
application if it contains a certification of patent invalidity or
noninfringement described in clause (iv) of subsection (b)(2)(A).
The approval of such an application shall be made effective in
accordance with this paragraph except that, if an action for
patent infringement is commenced during the one-year period
beginning forty-eight months after the date of the approval of
the subsection (b) application, the thirty-month period referred
to in subparagraph (C) shall be extended by such amount of time
(if any) which is required for seven and one-half years to have
elapsed from the date of approval of the subsection (b)
application.
"(iii) If an application submitted under subsection (b) for a
drug, which includes an active ingredient (including any ester
or salt of the active ingredient) that has been approved in
another application approved under subsection (b), is approved
after the date of the enactment of this clause and if such
application contains reports of new clinical investigations (other
than bioavailability studies) essential to the approval of the
application and conducted or sponsored by the applicant, the
Secretary may not make the approval of an application submitted under subsection (b) for the conditions of approval of such
drug in the approved subsection (b) application effective before
the expiration of three years from the date of the approval of
the application under subsection (b) if the investigations described in clause (A) of subsection (b)(1) and relied upon by the
applicant for approval of the application were not conducted by
or for the applicant and if the applicant has not obtained a right
of reference or use from the person by or for whom the investigations were conducted.
"(iv) If a supplement to an application approved under subsection (b) is approved after the date of enactment of this clause
and the supplement contains reports of new clinical investigations (other than bioavailabilty studies) essential to the approval of the supplement and conducted or sponsored by the
person submitting the supplement, the Secretary may not make
the approval of an application submitted under subsection (b)
for a change approved in the supplement effective before the
expiration of three years from the date of the approval of the
supplement under subsection (b) if the investigations described
in clause (A) of subsection (b)(1) and relied upon by the applicant
for approval of the application were not conducted by or for the
applicant and if the applicant has not obtained a right of
reference or use from the person by or for whom the investigations were conducted.
"(v) If an application (or supplement to an application) submitted under subsection (b) for a drug, which includes an active
ingredient (including any ester or salt of the active ingredient)
that has been approved in another application under subsection
(b), was approved during the period beginning January 1, 1982,
and ending on the date of the enactment of this clause, the
Secretary may not make the approval of an application submitted under this subsection and for which the investigations
described in clause (A) of subsection (b)(1) and relied upon by the
applicant for approval of the application were not conducted by
or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for
whom the investigations were conducted and which refers to the

PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1597

drug for which the subsection (b) application was submitted
effective before the expiration of two years from the date of
enactment of this clause.".
SEC. 104. Section 505 of such Act is amended by adding at the end
the following:
"(1) Safety and effectiveness data and information which has been
submitted in an application under subsection (b) for a drug and
which has not previously been disclosed to the public shall be made
available to the public, upon request, unless extraordinary circumstances are shown—
"(1) if no work is being or will be undertaken to have the
application approved,
"(2) if the Secretary has determined that the application is
not approvable and all legal appeals have been exhausted,
"(3) if approval of the application under subsection (c) is
withdrawn and all legal appeals have been exhausted,
"(4) if the Secretary has determined that such drug is not a
new drug, or
"(5) upon the effective date of the approval of the first application under subsection (j) which refers to such drug or upon the
date upon which the approval of an application under subsection (j) which refers to such drug could be made effective if such
an application had been submitted.
"(m) For purposes of this section, the term 'patent' means a patent
issued by the Patent and Trademark Office of the Department of
Commerce.".
SEC. 105. (a) The Secretary of Health and Human Services shall
promulgate, in accordance with the notice and comment requirements of section 553 of title 5, United States Code, such regulations
as may be necessary for the administration of section 505 of the
Federal Food, Drug, and Cosmetic Act, as amended by sections 101,
102, and 103 of this Act, within one year of the date of enactment of
this Act.
(b) During the period beginning sixty days after the date of the
enactment of this Act and ending on the date regulations promulgated under subsection (a) take effect, abbreviated new drug applications may be submitted in accordance with the provisions of section
314.2 of title 21 of the Code of Federal Regulations and shall be
considered as suitable for any drug which has been approved for
safety and effectiveness under section 505(c) of the Federal Food,
Drug, and Cosmetic Act before the date of the enactment of this Act.
If any such provision is inconsistent with the requirements of
section 505(j) of the Federal Food, Drug, and Cosmetic Act, the
Secretary shall consider the application under the applicable requirements of such section. The Secretary of Health and Human
Services may not approve such an abbreviated new drug application
which is filed for a drug which is described in sections 505(cX3XD)
and 505(jX4XD) of the Federal Food, Drug, and Cosmetic Act except
in accordance with such section.
SEC. 106. Section 2201 of title 28, United States Code, is amended
by inserting "(a)" before "In a case" and by adding at the end the
following:
"(b) For limitations on actions brought with respect to drug
patents see section 505 of the Federal Food, Drug, and Cosmetic
Act.".

Ante, p. 1585.
Public
availability.

Regulations.
21 u s e 355 note.

Ante, pp.
1592-1594.
Ante, p. 1592.

Ante, p. 1594.

Ante, p. 1585.

98 STAT. 1598

PUBLIC LAW 98-417—SEPT. 24, 1984
TITLE II—PATENT EXTENSION

SEC. 201. (a) Title 35 of the United States Code is amended by
adding the following new section immediately after section 155A:
35 u s e 156.
Claims.

Marketing.

Claims.

"§ 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 if—
"(1) the term of the patent has not expired before an application is submitted under subsection (d) for its extension;
"(2) the term of the patent has never been extended;
"(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 subsection (d);
"(4) the product has been subject to a regulatory review
period before its commercial marketing or use;
"(5XA) except as provided in subparagraph (B), 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; or
"(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.
The product referred to in paragraphs (4) and (5) is hereinafter in
this section referred to as the 'approved product*.
"(b) 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.
"(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 (dX2XB)
during which the applicant for the patent extension did not act
with due diligence during such period of the regulatory review
period;

PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1599

"(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 (l)(B)(i), (2)(B)(i), and (3)(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 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 Commissioner. 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 Commissioner 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 Commissioner and the Secretary
of Health and Human Services 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 Commissioner
may require.
"(2)(A) 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.
"(B)(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

Prohibition.

21 u s e 301.
Federal
Register,
publication.

Regulations.

98 STAT. 1600

Prohibition.

Federal
Register,
publication.
Hearing.

Federal
Register,
publication.

Records.

21 u s e 301.

PUBLIC LAW 98-417—SEPT. 24, 1984

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 sixtyday 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.
"(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
Commissioner.
"(e)(1) A determination that a patent is eligible for extension may
be made by the Commissioner solely on the basis of the representations contained in the application for the extension. If the Commissioner determines that a patent is eligible for extension under
subsection (a) and that the requirements of subsection (d) have been
complied with, the Commissioner 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) would expire before a certificate of
extension is issued or denied under paragraph (1) respecting the
application, the Commissioner 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 human 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 '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

PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1601

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.
"(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.
"(4XA) Any reference to section 351 is a reference to section
351 ofthe Public Health Service Act.
"(B) 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.
"(5) The term 'informal hearing' has the meaning prescribed
for such term by section 201(y) of the Federal Food, Drug, and
Cosmetic Act.
"(6) The term 'patent' means a patent issued by the United
States Patent and Trademark Office.
"(g) For purposes of this section, the term 'regulatory review
period' has the following meanings:
"(IXA) In the case of a product which is a human drug
product, the term means the period described in subparagraph
(B) to which the limitation described in paragraph (4) applies.
"(B) The regulatory review period for a human drug 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
became effective for the approved humsin drug product and
ending on the date an application was initially submitted
for such drug product under section 351, 505, or 507, and
"(ii) the period beginning on the date the application was
initially submitted for the approved human drug product
under section 351, subsection (b) of section 505, or section
507 and ending on the date such application was approved
under such section.
"(2XA) 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 (4)
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 Fodd, 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

21 use 301; 42
USC 201 note.

42 use 262.
21 use 353, 355,
^57,360e.
21 use 321.

21 use 355, 357.

Ante, pp. 1592,
i^^^.

>

98 STAT. 1602

21 use 360e.

Fees.

PUBLIC LAW 98-417—SEPT. 24, 1984

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 (4) 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 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) was submitted,
"(ii) no major health or environmental effects test
described in paragraph (2) 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 submittted,
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.
"(h) The Commissioner may establish such fees as the Commissioner determines appropriate to cover the costs to the Office of
receiving and acting upon applications under this section.".
(b) The analysis for chapter 14 of title 35 of the United States Code
is amended by adding at the end thereof the following:

PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1603

"156. Extension of patent term.".

SEC. 202. Section 271 of title 35, United States Code, is amended by
adding at the end the following:
"(e)(1) It shall not be an act of infringement to make, use, or sell a
patented invention (other than a new animal drug or veterinary
biological product (as those terms are used in the Federal Food,
Drug, and Cosmetic Act and the Act of March 4, 1913)) solely for
uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use,
or sale of drugs.
"(2) It shall be an act of infringement to submit an application
under section 505(j) of the Federal Food, Drug, and Cosmetic Act or
described in section 505(b)(2) of such Act for a drug claimed in a
patent or the use of which is claimed in a patent, if the purpose of
such submission is to obtain approval under such Act to engage in
the commercial manufacture, use, or sale of a drug claimed in a
patent or the use of which is claimed in a patent before the
expiration of such patent.
"(3) In any action for patent infringement brought under this
section, no injunctive or other relief may be granted which would
prohibit the making, using, or selling of a patented invention under
paragraph (1).
"(4) For an act of infringement described in paragraph (2)—
"(A) the court shall order the effective date of any approval of
the drug involved in the infringement to be a date which is not
earlier than the date of the expiration of the patent which has
been infringed,
"(B) injunctive relief may be granted against an infringer to
prevent the commercial manufacture, use, or sale of an
approved drug, and
"(C) damages or other monetary relief may be awarded
against an infringer only if there has been commercial manufacture, use, or sale of an approved drug.
The remedies prescribed by subparagraphs (A), (B), and (C) are the
only remedies which may be granted by a court for an act of
infringement described in paragraph (2), except that a court may
award attorney fees under section 285.".
SEC. 203. Section 282 of title 35, United States Code, is amended by
adding at the end the following: "Invalidity of the extension of a
patent term or any portion thereof under section 156 of this title
because of the material failure—
"(1) by the applicant for the extension, or
"(2) by the Commissioner,
to comply with the requirements of such section shall be a defense
in any action involving the infringement of a patent during the
period of the extension of its term and shall be pleaded. A due
diligence determination under section 156(dX2) is not subject to
review in such an action.".

Marketing.

TITLE III—AMENDMENTS TO THE TEXTILE FIBER PRODUCTS IDENTIFICATION ACT AND THE WOOL PRODUCTS
LABELING ACT OF 1939

Labeling.
Hosiery.

SEC. 301. Subsection (b) of section 4 of the Textile Fiber Products
Identification Act (15 U.S.C. 70b) is amended by adding at the end
thereof the following new paragraph:

21 u s e 301, 151
note.

Ante, p. 1585.
Ante, p. 1593.

35 u s e 285.
Ante, p. 1598.

98 STAT. 1604

PUBLIC LAW 98-417—SEPT. 24, 1984

"(5) If it is a textile fiber product processed or manufactured
in the United States, it be so identified.".
SEC. 302. Subsection (e) of section 4 of the Textile Fiber Products
Identification Act (15 U.S.C. 70b) is amended to read as follows:
"File Typeapplication/pdfFile Modified2022-06-15File Created2011-11-11