applicant may provide a notice under this sub-
paragraph with respect to any one or more pat-
ents provided by the holder of the reference 
product provided in response to a request under 
this paragraph. An applicant may submit addi-
tional notices at any time, and each notice shall 
be subject to the provisions of this subpara-
graph. Each notice shall— 
‘‘(i) be sent to the holder of approved 
application for the reference product and 
to the owner of the patent identified pursu-
ant to subparagraph (A)(i); 
‘‘(ii) include a detailed statement of 
the factual and legal bases for the appli-
cant’s belief that the patents included in 
the notice are invalid, unenforceable, or 
will not be infringed by the commercial 
sale of the product for which approval is or 
has been sought; and 
‘‘(iii) identify the judicial district or 
districts in which the applicant consents to 
suit being brought in response to the no-
tice. 
‘‘(C) ACTION FOR INFRINGEMENT.— 
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‘‘(i) TIMEFRAME FOR BRINGING AC-
TION.—Within 45 days of receipt of notice 
described in subparagraph (B), the holder 
of the approved application for the ref-
erence product, or the owner of the patent, 
may bring an action infringement solely 
with respect to the patent or patents in-
cluded in such notice. 
‘‘(ii) APPROPRIATE
JUDICIAL
DIS-
TRICT.—Notwithstanding section 1391 of 
title 28, United States Code, an infringe-
ment action brought within the 45-day pe-
riod referenced in clause (i) may be 
brought only in the judicial district identi-
fied pursuant to subparagraph (B)(iii). 
‘‘(D) LIMITATION ON DECLARATORY JUDG-
MENT
ACTIONS.—No action may be brought 
under section 2201 of title 28, United States 
Code by the recipient of a notice under sub-
paragraph (B) for a declaration of infringe-
ment, validity, or enforceability with respect to 
any patent which was not identified in the no-
tice, and with respect to the application under 
which the notice was sent, or with respect to 
the product of that application, prior to the 
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commercial marketing of that product. With re-
spect to a patent identified in the notice, not-
withstanding section 1391 of title 28, any such 
action may be brought only in the judicial dis-
tricts identified in the notice. 
‘‘(E) DISCRETION
OF
APPLICANTS.—A 
comparable biological product applicant may 
not be compelled, by court order or otherwise, 
to initiate the procedures set forth in this para-
graph. The decision as to whether to invoke the 
procedures set forth in this paragraph is left 
entirely to the discretion of the applicant or 
prospective applicant. 
‘‘(17) PETITIONS AND CIVIL ACTIONS REGARD-
ING APPROVAL OF CERTAIN APPLICATIONS.— 
‘‘(A) IN
GENERAL.—With respect to a 
pending application submitted under paragraph 
(1) or (2), if a petition is submitted to the Sec-
retary that seeks to have the Secretary take, or 
refrain from taking, any form of action relating 
to the approval of the application, including a 
delay in the effective date of the application, 
the following applies, subject to subparagraph 
(E): 
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‘‘(i)(I) In the case of an application 
under paragraph (2), the Secretary may 
not, subject to subclause (III), consider the 
petition if it is submitted later than 180 
days prior to the date on which the ap-
proval of the application may first be made 
effective. 
‘‘(II) In the case of an application 
under paragraph (1), the Secretary may 
not, subject to subclause (III), consider the 
petition if it is submitted later than 180 
days prior to the date on which the ap-
proval of the application may first be made 
effective. 
‘‘(III) The restriction established in 
subclause (I) or (II) (as the case may be) 
does not apply to the petition if the Sec-
retary determines that the petitioner has 
shown good cause for the failure to submit 
the petition by the applicable date under 
such subclause. 
‘‘(ii)(I) The Secretary may not, on the 
basis of the petition, delay approval of the 
application unless the Secretary determines 
that a delay is necessary to protect the 
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public health. Consideration of a petition 
shall be separate and apart from the re-
view and approval of the application. 
‘‘(II) With respect to a determination 
by the Secretary under subclause (I) that 
a delay is necessary to protect the public 
health: 
‘‘(aa) The Secretary shall publish 
on the Internet site of the Food and 
Drug Administration a statement pro-
viding the reasons underlying the de-
termination. 
‘‘(bb) Not later than 10 days 
after making the determination, the 
Secretary shall provide notice to the 
sponsor of the application and an op-
portunity for a meeting with the Com-
missioner to discuss the determina-
tion. 
‘‘(iii) The Secretary shall take final 
agency action on the petition not later 
than 180 days after the date on which the 
petition is submitted. The Secretary shall 
not extend such period, even with the con-
sent of the petitioner, for any reason, in-
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cluding based upon the submission of com-
ments relating to the petition or supple-
mental information supplied by the peti-
tioner. 
‘‘(iv) The Secretary may not consider 
the petition for review unless it is signed 
and contains the following verification: ‘I 
certify that, to my best knowledge and be-
lief: (a) this petition includes all informa-
tion and views upon which the petition re-
lies; (b) this petition includes representa-
tive data and/or information known to the 
petitioner which are unfavorable to the pe-
tition; and (c) I have taken reasonable 
steps to ensure that any representative 
data and/or information which are unfavor-
able to the petition were disclosed to me. 
I further certify that the information upon 
which I have based the action requested 
herein first became known to the party on 
whose behalf this petition is submitted on 
or 
about 
the 
following 
date: 
lllllll. I received or expect to 
receive payments, including cash and other 
forms of consideration, from the following 
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