sion of the new patent information either a certifi-
cation described in paragraph (2)(A)(vii)(IV) or a 
statement that the method of use patent does not 
claim a use for which the applicant is seeking ap-
proval under this subsection in accordance with 
paragraph (2)(A)(viii); except, however, that such 
date may be extended due to extraordinary or un-
usual circumstances, as determined by the Secretary; 
or 
‘‘(VI) the previous applicant is determined by 
the Secretary, after a fair and sufficient hearing and 
in consultation with the Federal Trade Commission, 
to have engaged in anticompetitive or collusive con-
duct, or any other conduct intended to unfairly mo-
nopolize the commercial manufacturing of the drug 
of the application. 
‘‘(ii) If under clause (i) the previous applicant re-
ferred to in subparagraph (B)(iv) forfeits the 180-day pe-
riod described in such subparagraph, such period shall be-
come available to the next applicant submitting an appli-
cation containing a certification under paragraph 
(2)(A)(vii)(IV) if—
‘‘(I) no action described in subparagraph 
(B)(iii)(II) was brought against or by the previous 
applicant, or such an action was brought but did not
result in a final judgment that included a finding 
that the patent involved is invalid; and 
‘‘(II) an action described in subparagraph 
(B)(iii)(II) is brought against or by the next appli-
cant, and such action results in a final judgment 
that includes a finding that the patent involved is in-
valid. 
‘‘(iii) The 180-day period described in subparagraph 
(B)(iv) shall be available only to—
‘‘(I) the previous applicant submitting an appli-
cation for a drug under this subsection containing a 
certification described in paragraph (2)(A)(vii)(IV) 
with respect to any patent; or 
‘‘(II) under clause (ii), the next applicant sub-
mitting an application for a drug under this sub-
section containing such a certification with respect 
to any patent; 
even if an application has been submitted for the drug 
under this subsection containing such a certification with 
respect to a different patent. 
‘‘(iv) The 180-day period described in subparagraph 
(B)(iv) for an application containing a certification de-
scribed in paragraph (2)(A)(vii)(IV) shall apply only if an 
action is brought for infringement of a patent that is the 
subject of the certification or the applicant brings an ac-
tion (not later than 60 days after the date on which the 
notice provided under paragraph (2)(B)(ii) was received) 
against the holder of the approved application for the list-
ed drug.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
this section 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)) 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 the enactment of this Act. 
SEC. 202. PATENT CERTIFICATION. 
(a) ABBREVIATED NEW DRUG APPLICATIONS.—Sec-
tion 505(j)(5) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)(5)) is amended—
(1) in subparagraph (B), by striking clause (iii) 
and inserting the following: 
‘‘(iii)(I) If the applicant made a certification de-
scribed in paragraph (2)(A)(vii)(IV) and—
‘‘(aa) no action is brought for infringement 
of a patent that is the subject of the certifi-
cation before the expiration of the 45-day pe-
riod beginning on the date on which the notice 
provided under paragraph (2)(B)(ii) was re-
ceived; and
‘‘(bb) the applicant does not bring an ac-
tion for declaratory judgment authorized in 
subclause (II) before the expiration of the 60-
day period beginning on the date on which the 
notice provided under paragraph (2)(B)(ii) was 
received; 
the approval shall be made effective on the expira-
tion of 60 days after the date on which the notice 
provided under paragraph (2)(B)(ii) was received, 
provided none of the conditions for denial of ap-
proval in paragraph (4) apply. 
‘‘(II) With respect to an applicant who made a 
certification described in paragraph (2)(A)(vii)(IV), 
if an action referred to in item (aa) of subclause (I) 
is brought before the expiration of the period de-
scribed in such item, or if the applicant brings an 
action for declaratory judgment of invalidity or non-
infringement of such patent (which action is hereby 
authorized) before the expiration of the period de-
scribed in item (bb) of such subclause, the approval 
shall, provided none of the conditions for denial of 
approval in paragraph (4) apply, be made effective 
in accordance with the following: 
‘‘(aa) If the action is an action referred to 
in subclause (I)(aa), and neither the holder of