lieves in good faith relate to the reference 
product, including patents that claim the 
approved biological product, any method of 
using such product, any component of such 
product, or any method or process of man-
ufacturing such product or component. 
‘‘(ii) COSTS OF COMPLYING WITH RE-
QUEST.—The application holder may de-
mand payment of not more than $1,000 to 
offset the cost of responding to the request 
for information. 
‘‘(iii) UPDATES.—For a period of two 
years beginning on the date on which the 
holder of the approved application for the 
reference product receives the request for 
information, the holder shall send to the 
applicant or prospective applicant updates 
of its response to the request for informa-
tion by identifying all relevant patents 
issued or licensed to the holder after the 
initial response under clause (i). Any such 
update must be provided, in the case of a 
new patent, not later than 30 days after 
the date on which the patent is issued and, 
in the case of a license, not later than 30 
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days after the date on which the holder ob-
tains the license. 
‘‘(iv) ADDITIONAL
REQUESTS.—The 
applicant may submit additional requests 
for patent information, subject to the re-
quirements of this paragraph, at any time. 
‘‘(B) PATENT
NOTIFICATIONS.—At any 
time after submitting an application under this 
subsection, the applicant may provide a notice 
of the application with respect to any one or 
more patents identified by the holder of the ref-
erence product pursuant to subparagraph (A). 
An applicant may submit additional notices at 
any time, and each notice shall be subject to 
the provisions of this subparagraph. Each no-
tice shall— 
‘‘(i) be sent to the holder of the ap-
proved application for the reference prod-
uct and to the owner of any patent identi-
fied by the holder pursuant to subpara-
graph (A); 
‘‘(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, are unenforceable, or 
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will not be infringed by the commercial 
sale of the product for which approval is 
being sought under this subsection; and 
‘‘(iii) identify 1 or more judicial dis-
tricts in which the applicant consents to 
such suit being brought. 
‘‘(C) ACTION FOR INFRINGEMENT.—With-
in 45 days after the date on which the holder 
of the approved application for the reference 
product, or the owner of a patent, receives a no-
tice under subparagraph (B), the holder or pat-
ent owner may bring an action for infringement 
only with respect to the patent or patents in-
cluded in the notice, and only in a judicial dis-
trict 
identified 
pursuant 
to 
subparagraph 
(B)(iii). 
‘‘(D) LIMITATION ON DECLARATORY JUDG-
MENT ACTIONS.—With respect to any patent re-
lating to a product that is the subject of an ap-
plication under this subsection, the recipient of 
a notice under subparagraph (B) with respect 
to that application may not, prior to the com-
mercial marketing of the product, bring any ac-
tion under section 2201 of title 28, United 
States Code, for a declaration of infringement, 
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