‘‘(AA) a certification
described 
in 
paragraph
(2)(A)(vii)(IV) with respect
to the patent to which the
new patent information re-
lates; or
‘‘(BB) a statement that
any method of use claim of
that patent does not claim a
use for which the applicant
is seeking approval under
this subsection in accord-
ance 
with 
paragraph
(2)(A)(viii).
‘‘(ff) 
UNLAWFUL
CON-
DUCT.—The Federal Trade Com-
mission determines that the ap-
plicant engaged in unlawful con-
duct with respect to the applica-
tion in violation of section 1 of
the Sherman Act (15 U.S.C. 1).
‘‘(IV) 
SUBSEQUENT
APPLICA-
TION.—The term ‘subsequent applica-
tion’ means an application for ap-
proval of a drug that is filed subse-
quent to the filing of a first applica-
tion for approval of that drug.
‘‘(ii) FORFEITURE
OF
180-DAY
PE-
RIOD.—
‘‘(I) IN
GENERAL.—Except as
provided in subclause (II), if a for-
feiture event occurs with respect to a
first application—
‘‘(aa) the 180-day period
under subparagraph (B)(v) shall
be forfeited by the first applicant;
and
‘‘(bb) any subsequent appli-
cation shall become effective as
provided under clause (i), (ii),
(iii), or (iv) of subparagraph (B),
and clause (v) of subparagraph
(B) shall not apply to the subse-
quent application.
‘‘(II) FORFEITURE
TO
FIRST
SUBSEQUENT APPLICANT.—If the sub-
sequent application that is the first to
be made effective under subclause (I)
was the first among a number of sub-
sequent applications to be filed—
‘‘(aa) that first subsequent
application shall be treated as
the first application under this
subparagraph 
(including 
sub-
clause (I)) and as the previous
application under subparagraph
(B)(v); and
‘‘(bb) any other subsequent
applications shall become effec-
tive as provided under clause (i),
(ii), (iii), or (iv) of subparagraph
(B), but clause (v) of subpara-
graph (B) shall apply to any such
subsequent application.
‘‘(iii) AVAILABILITY.—The 180-day
period under subparagraph (B)(v) shall be
available to a first applicant submitting an
application for a drug with respect to any
patent without regard to whether an appli-
cation has been submitted for the drug
under this subsection containing such a
certification with respect to a different pat-
ent.
‘‘(iv) APPLICABILITY.—The 180-day
period described in subparagraph (B)(v)
shall apply to an application only if a civil
action is brought against the applicant for
infringement of a patent that is the subject
of the certification.’’.
(b) APPLICABILITY.—The amendment made by sub-
section (a) shall be effective only with respect to an appli-
cation filed under section 505(j) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the date
of enactment of this Act for a listed drug for which no
certification under section 505(j)(2)(A)(vii)(IV) of that
Act was made before the date of enactment of this Act,
except that if a forfeiture event described in section
505(j)(5)(D)(i)(III)(ff) of that Act occurs in the case of
an applicant, the applicant shall forfeit the 180-day period
under section 505(j)(5)(B)(v) of that Act without regard
to when the applicant made a certification under section
505(j)(2)(A)(vii)(IV) of that Act.
SEC. 6. FAIR TREATMENT FOR INNOVATORS.
(a) BASIS FOR APPLICATION.—Section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)
is amended—
(1) in subsection (b)(3)(B), by striking the sec-
ond sentence and inserting ‘‘The notice shall include
a detailed statement of the factual and legal basis of
the applicant’s opinion that, as of the date of the no-
tice, the patent is not valid or is not infringed, and
shall include, as appropriate for the relevant patent,
a description of the applicant’s proposed drug sub-
stance, drug formulation, drug composition, or meth-
od of use. All information disclosed under this sub-
paragraph shall be treated as confidential and may
be used only for purposes relating to patent adju-
dication. Nothing in this subparagraph precludes the
applicant from amending the factual or legal basis
on which the applicant relies in patent litigation.’’;
and
(2) in subsection (j)(2)(B)(ii), by striking the
second sentence and inserting ‘‘The notice shall in-
clude a detailed statement of the factual and legal
basis of the opinion of the applicant that, as of the
date of the notice, the patent is not valid or is not
infringed, and shall include, as appropriate for the
relevant patent, a description of the applicant’s pro-
posed drug substance, drug formulation, drug com-
position, or method of use. All information disclosed
under this subparagraph shall be treated as con-
fidential and may be used only for purposes relating
to patent adjudication. Nothing in this subparagraph
precludes the applicant from amending the factual
or legal basis on which the applicant relies in patent
litigation.’’.
(b) INJUNCTIVE RELIEF.—Section 505(j)(5)(B) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(5)(B)) (as amended by section 4(a)(1)) is
amended—
(1) in clause (iii), by adding at the end the fol-
lowing: ‘‘A court shall not regard the extent of the
ability of an applicant to pay monetary damages as
a whole or partial basis on which to deny a prelimi-
nary or permanent injunction under this clause.’’;
and
(2) in clause (iv), by adding at the end the fol-
lowing:
‘‘(IV) INJUNCTIVE RELIEF.—A court shall
not regard the extent of the ability of an appli-
cant to pay monetary damages as a whole or
partial basis on which to deny a preliminary or
permanent injunction under this clause.’’.
SEC. 7. BIOEQUIVALENCE.
(a) IN GENERAL.—The amendments to part 320 of
title 21, Code of Federal Regulations, promulgated by the
Commissioner of Food and Drugs on July 17, 1991 (57
Fed. Reg. 17997 (April 28, 1992)), shall continue in effect
as an exercise of authorities under sections 501, 502, 505,
(III) by striking ‘‘application’’
and inserting ‘‘application—’’;
(ii) by striking the third through fifth
sentences; and
(iii) in the sixth sentence—
(I) by striking ‘‘The Secretary’’
and inserting the following:
‘‘(C) GUIDANCE.—The Secretary’’; and
(II) by striking ‘‘clause (A)’’ and
inserting ‘‘subparagraph (B)(i)’’; and
(C) in paragraph (2)—
(i) by striking ‘‘clause (A) of such
paragraph’’ 
and 
inserting 
‘‘paragraph
(1)(B)(i)’’;
(ii) in subparagraphs (A) and (B), by
striking ‘‘paragraph (1) or’’; and
(iii) in subparagraph (B)—
(I) 
by 
striking 
‘‘paragraph
(1)(A)’’ and inserting ‘‘paragraph
(1)(B)(i)’’; and
(II) by striking ‘‘patent’’ each
place 
it 
appears 
and 
inserting
‘‘claim’’; and
(3) in subsection (c)—
(A) in paragraph (3)—
(i) in subparagraph (A)—
(I) by striking ‘‘(A) If the appli-
cant’’ and inserting the following:
‘‘(A) CLAUSE (i) OR (ii) CERTIFICATION.—
If the applicant’’; and
(II) by striking ‘‘may’’ and in-
serting ‘‘shall’’;
(ii) in subparagraph (B)—
(I) by striking ‘‘(B) If the appli-
cant’’ and inserting the following:
‘‘(B) CLAUSE (iii) CERTIFICATION.—If the
applicant’’; and
(II) by striking ‘‘may’’ and in-
serting ‘‘shall’’;
(iii) by redesignating subparagraph
(D) as subparagraph (E); and
(iv) in subparagraph (E) (as redesig-
nated by clause (iii)), by striking ‘‘clause
(A) of subsection (b)(1)’’ each place it ap-
pears 
and 
inserting 
‘‘subsection
(b)(1)(B)(i)’’; and
(B) by redesignating paragraph (4) as
paragraph (5); and
(4) in subsection (j)—
(A) in paragraph (2)(A)—
(i) in clause (vi), by striking ‘‘clauses
(B) through ((F)’’ and inserting ‘‘sub-
clauses (ii) through (vi) of subsection
(b)(1)’’;
(ii) in clause (vii), by striking ‘‘(b)
or’’; and
(iii) in clause (viii)—
(I) by striking ‘‘(b) or’’; and
(II) by striking ‘‘patent’’ each
place 
it 
appears 
and 
inserting
‘‘claim’’; and
(B) in paragraph (5)—
(i) in subparagraph (B)—
(I) in clause (i)—
(aa) by striking ‘‘(i) If the
applicant’’ and inserting the fol-
lowing:
‘‘(i) SUBCLAUSE (i) OR (ii) CERTIFI-
CATION.—If the applicant’’; and
(bb) by striking ‘‘may’’ and
inserting ‘‘shall’’;
(II) in clause (ii)—
(aa) by striking ‘‘(ii) If the
applicant’’ and inserting the fol-
lowing:
‘‘(i) 
SUBCLAUSE
(iii) 
CERTIFI-
CATION.—If the applicant’’; and
(bb) by striking ‘‘may’’ and
inserting ‘‘shall’’;
(III) in clause (iii), by striking
‘‘(2)(B)(i)’’ each place it appears and
inserting ‘‘(2)(B)’’; and
(IV) in clause (v) (as redesig-
nated by section 4(a)(1)(B)), by strik-
ing ‘‘continuing’’ and inserting ‘‘con-
taining’’; and
(ii) by redesignating subparagraphs
(C) and (D) as subparagraphs (E) and
(F), respectively.
(b) SECTION 505A.—Section 505A of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is
amended—
(1) 
in 
subsections 
(b)(1)(A)(i) 
and
(c)(1)(A)(i)—
(A) by striking ‘‘(c)(3)(D)(ii)’’ each place
it appears and inserting ‘‘(c)(3)(E)(ii)’’; and
(B) by striking ‘‘(j)(5)(D)(ii)’’ each place
it appears and inserting ‘‘(j)(5)(F)(ii)’’;
(2) 
in 
subsections 
(b)(1)(A)(ii) 
and
(c)(1)(A)(ii)—
(A) by striking ‘‘(c)(3)(D)’’ each place it
appears and inserting ‘‘(c)(3)(E)’’; and
(B) by striking ‘‘(j)(5)(D)’’ each place it
appears and inserting ‘‘(j)(5)(F)’’;
(3) in subsections (e) and (l)—
(A) by striking ‘‘505(c)(3)(D)’’ each place
it appears and inserting ‘‘505(c)(3)(E)’’; and
(B) by striking ‘‘505(j)(5)(D)’’ each place
it appears and inserting ‘‘505(j)(5)(F)’’; and
(4) 
in 
subsection 
(k), 
by 
striking
‘‘505(j)(5)(B)(iv)’’ and inserting ‘‘505(j)(5)(B)(v)’’.
(c) SECTION 527.—Section 527(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360cc(a)) is
amended in the second sentence by striking ‘‘505(c)(2)’’
and inserting ‘‘505(c)(1)(B)’’.
Æ