An act to amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new drug applications, to amend title 35, United States Code, to authorize the extension of the patents for certain regulated products, and for other purposes.
PL 98-417 (S.1538), enacted 09/24/1984

PUBLIC LAW 98-417—SEPT. 24, 1984 
98 STAT. 1585 
Public Law 98-417 
98th Congress 
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 Restora-
tion 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 subsec-
tion (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 ingredi-
ent 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 ingre-
dients 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, informa-
tion 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 re-
specting 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 infor-
mation 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 
PUBLIC LAW 98-417—SEPT. 24, 1984 
Claims. 
Prohibition. 
Claims. 
Marketing. 
"(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 therapeu-
tic 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 be-
cause of differences approved under a petition filed under sub-
paragraph (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 subsec-
tion (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 sub-
paragraph (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 applica-
tion, 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 de-
scribed 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, infor-
mation 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 ingredi-
ent 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), 
21 USC 321. 
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 adminis-
tration, 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 adminis-
tration, 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 administra-
tion, dosage form, or strength of the drug is different from that 
of the listed drug referred to in the application, no petition to 
98 STAT. 1588 
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 submit-
ted 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 admin-
istered to patients for a condition of use referred to in such 
paragraph; 
Labeling. 
"(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 be-
cause 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 inac-
tive ingredients of the drug are unsafe for use under the 
conditions prescribed, recommended, or suggested in the label-
ing 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 inac-
tive ingredients are included; 
"(I) the approval under subsection (c) of the listed drug re-
ferred 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 subsec-
tion 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. 
Effective dates. 
"(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 sub-
clause (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 sub-
clause (IV) of paragraph (2)(A)(vii), the approval shall be made 
effective immediately unless an action is brought for infringe-
ment of a patent which is the subject of the certification before 
the expiration of forty-five days from the date the notice pro-
vided 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 pro-
vided 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 appli-
cant 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 de-
scribed 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 
PUBLIC LAW 98-417—SEPT. 24, 1984 
Prohibitions. 
Claims. 
hearing before the Secretary on the question of whether such appli-
cation 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 appli-
cant otherwise agree. Any such hearing shall thereafter be con-
ducted 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 subsec-
tion (b). 
"(ii) If an application submitted under subsection (b) for a drug, no 
active ingredient (including any ester or salt of the active ingredi-
ent) 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 expira-
tion 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 be-
ginning 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 enact-
ment of this subsection and if such application contains reports of 
new clinical investigations (other than bioavailability studies) essen-
tial 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 supple-
ment 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 applica-
tion 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 enact-
ment 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 subsec-
tion (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 subpara-
graph (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 
PUBLIC LAW 98-417—SEPT. 24, 1984 
Federal 
Register, 
publication. 
Claims. 
21 u s e 355. 
Public 
information. 
Claims. 
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 simi-
lar experimental conditions in either a single dose or multi-
ple 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 con-
ditions 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 informa-
tion 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 applica-
tion could not file patent information under subsection (b) because 
no patent had been issued when an application was filed or ap-
proved, 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 sub-
section, 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 amend-
ed 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 
PUBLIC LAW 98-417—SEPT. 24, 1984 
Claims. 
Marketing. 
Ante, p. 1592. 
Effective dates. 
Claims. 
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 para-
graph (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 de-
scribed 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 deter-
mined 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 expira-
tion 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 
Post, p. 1603. 
"(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 re-
ceived, no action may be brought under section 2201 of title 28, 
Post, p. 1597. 
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 
Prohibitions. 
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 Janu-
ary 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 investi-
gations 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) 
98 STAT. 1596 
PUBLIC LAW 98-417—SEPT. 24, 1984 
ClEiims. 
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 submit-
ted 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 de-
scribed 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 investi-
gations were conducted. 
"(iv) If a supplement to an application approved under subsec-
tion (b) is approved after the date of enactment of this clause 
and the supplement contains reports of new clinical investiga-
tions (other than bioavailabilty studies) essential to the ap-
proval 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 investiga-
tions were conducted. 
"(v) If an application (or supplement to an application) sub-
mitted 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 submit-
ted 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 ob-
tained 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 
Ante, p. 1585. 
the following: 
"(1) Safety and effectiveness data and information which has been 
Public 
submitted in an application under subsection (b) for a drug and 
availability. 
which has not previously been disclosed to the public shall be made 
available to the public, upon request, unless extraordinary circum-
stances 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 applica-
tion under subsection (j) which refers to such drug or upon the 
date upon which the approval of an application under subsec-
tion (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 require-
ments 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 promul-
gated under subsection (a) take effect, abbreviated new drug applica-
tions 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 re-
quirements 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. 
Regulations. 
21 u s e 355 note. 
Ante, pp. 
1592-1594. 
Ante, p. 1592. 
Ante, p. 1594. 
98 STAT. 1598 
PUBLIC LAW 98-417—SEPT. 24, 1984 
35 use 156. 
Claims. 
Marketing. 
Claims. 
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: 
"§ 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 expira-
tion date of the patent if— 
"(1) the term of the patent has not expired before an applica-
tion 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 mar-
keting 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 manu-
facturing 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 mar-
keting 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 expira-
tion 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 manufac-
turing 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 provi-
sion of law under which such regulatory review occurred when 
added to the regulatory review period as revised under para-
graphs (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 manufac-
turing 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 appli-
cable 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 Commis-
sioner 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 manufactur-
ing 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 subpara-
graph (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 
PUBLIC LAW 98-417—SEPT. 24, 1984 
Prohibition. 
Federal 
Register, 
publication. 
Hearing. 
Federal 
Register, 
publication. 
Records. 
21 u s e 301. 
period, the Secretary shall, in accordance with regulations promul-
gated by the Secretary determine if the applicant acted with due 
diligence during the applicable regulatory review period. The Secre-
tary 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 subpara-
graph to an office below the Office of the Commissioner of Food and 
Drugs. 
"(ii) The Secretary shall notify the Commissioner of the determi-
nation 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 opportu-
nity 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 representa-
tions contained in the application for the extension. If the Commis-
sioner 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 determina-
tion 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 ingredi-
ent 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 
21 use 301; 42 
salt or ester of the active ingredient, as a single entity or in 
USC 201 note. 
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. 
42 use 262. 
"(B) Any reference to section 503, 505, 507, or 515 is a refer-
ence to section 503, 505, 507, or 515 of the Federal Food, Drug, 
and Cosmetic Act. 
21 use 353, 355, 
"(5) The term 'informal hearing' has the meaning prescribed 
^57,360e. 
for such term by section 201(y) of the Federal Food, Drug, and 
Cosmetic Act. 
21 use 321. 
"(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 
21 use 355, 357. 
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 
Ante, pp. 1592, 
507 and ending on the date such application was approved 
i^^^. 
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 subpara-
graph (B) to which the limitation described in paragraph (4) 
applies. 
"(B) The regulatory review period for a food or color additive 
is the sum o
f
—
-
"(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 issu- 
> 
ance 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 
98 STAT. 1602 
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 investiga-
tion on humans involving the device was begun and ending 
on the date an application was initially submitted with 
21 use 360e. 
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 ini-
tially 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 para-
graphs 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 deter-
mined on the basis of the regulatory review period deter-
mined 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 para-
graph (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 enact-
ment 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. 
Fees. 
"(h) The Commissioner may establish such fees as the Commis-
sioner 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 infor-
mation 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 manu-
facture, 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. 
21 u s e 301, 151 
note. 
Ante, p. 1585. 
Ante, p. 1593. 
35 u s e 285. 
Ante, p. 1598. 
TITLE III—AMENDMENTS TO THE TEXTILE FIBER PROD- 
Labeling. 
UCTS IDENTIFICATION ACT AND THE WOOL PRODUCTS 
Hosiery. 
LABELING ACT OF 1939 
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: 
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: 
"<e) For purposes of this Act, in addition to the textile fiber 
products contained therein, a package of textile fiber products in-
tended for sale to the ultimate consumer shall be misbranded unless 
such package has affixed to it a stamp, tag, label, or other means of 
identification bearing the information required by subsection (b), 
with respect to such contained textile fiber products, or is transpar-
ent to the extent it allows for the clear reading of the stamp, tag, 
label, or other means of identification on the textile fiber product, or 
in the case of hosiery items, this section shall not be construed as 
requiring the affixing of a stamp, tag, label, or other means of 
identification to each hosiery product contained in a package if (1) 
such hosiery products are intended for sale to the ultimate con-
sumer in such package, (2) such package has affixed to it a stamp, 
tag, label, or other means of identification bearing, with respect to 
the hosiery products contained therein, the information required by 
subsection (b), and (3) the information on the stamp, tag, label, or 
other means of identification affixed to such package is equally 
applicable with respect to each textile fiber product contained 
therein.". 
SEC. 303. Section 4 of the Textile Fiber Products Identification Act 
(15 U.S.C. 70b) is amended by adding at the end thereof the follow-
ing new subsections: 
"(i) For the purposes of this Act, a textile fiber product shall be 
considered to be falsely or deceptively advertised in any mail order 
catalog or mail order promotional material which is used in the 
direct sale or direct offering for sale of such textile fiber product, 
unless such textile fiber product description states in a clear and 
conspicuous manner that such textile fiber product is processed or 
manufactured in the United States of America, or imported, or both. 
"(j) For purposes of this Act, any textile fiber product shall be 
misbranded if a stamp, tag, label, or other identification conforming 
to the requirements of this section is not on or affixed to the inside 
center of the neck midway between the shoulder seams or, if such 
product does not contain a neck, in the most conspicuous place on 
the inner side of such product, unless it is on or affixed on the outer 
side of such product, or in the case of hosiery items on the outer side 
of such product or package.". 
SEC. 304. Paragraph (2) of section 4(a) of the Wool Products 
Labeling Act of 1939 (15 U.S.C. 68b(aX2)) is amended by adding at 
the end thereof the following new subparagraph: 
"(D) the name of the country where processed or manu-
SEC. 305. Section 4 of the Wool Products Labeling Act of 1939 (15 
U.S.C. 68b) is amended by adding at the end thereof the following 
new subsections: 
"(e) For the purposes of this Act, a wool product shall be consid-
ered to be falsely or deceptively advertised in any mail order 
promotional material which is used in the direct sale or direct 
offering for sale of such wool product, unless such wool product 
description states in a clear and conspicuous manner that such wool 
product is processed or manufactured in the United States of Amer-
ica, or imported, or both. 
PUBLIC LAW 98-417—SEPT. 24, 1984 
98 STAT. 1605 
"(f) For purposes of this Act, any wool product shall be mis-
branded if a stamp, tag, label, or other identification conforming to 
the requirements of this section is not on or affixed to the inside 
center of the neck midway between the shoulder seams or, if such 
product does not contain a neck, in the most conspicuous place on 
the inner side of such product, unless it is on or affixed on the outer 
side of such product or in the case of hosiery items, on the outer side 
of such product or package.". 
SEC. 306. Section 5 of the Wool Products Labeling Act of 1939 (15 
U.S.C. 68c) is amended— 
(1) by striking out "Any person" in the first paragraph and 
inserting in lieu thereof "(a) Any person", 
(2) by striking out "Any person" in the second paragraph and 
inserting in lieu thereof "(b) Any person", and 
(3) by inserting after subsection Ot)) (as designated by this 
section) the following new subsection: 
"(c) For the purposes of subsections (a) and Ot)) of this section, any 
package of wool products intended for sale to the ultimate consumer 
shall also be considered a wool product and shall have affixed to it a 
stamp, tag, label, or other means of identification bearing the 
information required by section 4, with respect to the wool products 
contained therein, unless such package of wool products is transpar-
ent to the extent that it allows for the clear reading of the stamp, 
tag, label, or other means of identification affixed to the wool 
product, or in the case of hosiery items this section shall not be 
construed as requiring the affixing of a stamp, tag, label, or other 
means of identification to each hosiery product contained in a 
package if (1) such hosiery products are intended for sale to the 
ultimate consumer in such package, (2) such package has affixed to 
it a stamp, tag, label, or other means of identification bearing, with 
respect to the hosiery products contained therein, the information 
required by subsection (4), and (3) the information on the stamp, tag, 
label, or other means of identification affixed to such package is 
equally applicable with respect to each hosiery product contained 
therein.". 
SEC. 307. The amendments made by this title shall be effective 
Effective date, 
ninety days after the date of enactment of this Act. 
15 USC 68b note. 
Approved September 24, 1984. 
LEGISLATIVE HISTORY—S. 1538 (H.R. 3605): 
HOUSE REPORT No. 98-857 accompanying H.R. 3605, Pt. 1 (Comm. on Energy and 
Commerce) and Pt. 2 (Comm. on the Judiciary). 
SENATE REPORT No. 98-547 (Comm. on the Judiciary). 
CONGRESSIONAL RECORD, Vol. 130 (1984): 
June 29, considered and passed Senate. 
Sept. 6, considered and passed House, amended, in lieu of H.R. 3605. 
Sept. 12, Senate concurred in House amendments. 
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 20, No. 39 (1984): 
Sept. 24, Presidential statement.