able comparable applicant has not been 
sued under paragraph (16)(C). 
Notwithstanding the foregoing provision, the 
sponsor of a subsequent comparable biological 
product application that has demonstrated 
interchangeability with the reference product 
may elect, at its option, to have the product ap-
proved as a non-interchangeable comparable bi-
ological product whose approval will not be de-
layed by operation of this paragraph. For pur-
poses of this paragraph, the term ‘final court 
decision’ means a final decision of a court from 
which no appeal (other than a petition to the 
United States Supreme Court for a writ of cer-
tiorari) has been or can be taken. 
‘‘(B) 
REBRANDED
INTERCHANGEABLE 
BIOLOGIC.—For purposes of this subsection, the 
term ‘rebranded interchangeable biologic’— 
‘‘(i) means any rebranded inter-
changeable version of a reference product 
that the holder of the biological product li-
cense approved under subsection (a) for 
that reference product seeks to commence 
marketing, selling, or distributing, directly 
or indirectly; and 
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‘‘(ii) does not include any product to 
be marketed, sold, or distributed— 
‘‘(I) by an entity eligible for ex-
clusivity with respect to such product 
under this paragraph; or 
‘‘(II) after expiration of any ex-
clusivity with respect to such product 
under this paragraph. 
‘‘(10) HEARING.—If the Secretary decides to 
disapprove a comparable biological product applica-
tion, the Secretary shall give the applicant notice of 
an opportunity for a hearing before the Secretary on 
the question of whether such application is approv-
able. 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 applicant 
otherwise agree. Any such hearing shall thereafter 
be conducted on an expedited basis and the Sec-
retary’s order thereon shall be issued within ninety 
days after the date fixed by the Secretary for filing 
final briefs. 
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‘‘(11) FINAL
ACTION
DATE.—The Secretary 
shall take a final action on a comparable biological 
product application by the final action date. 
‘‘(12) REQUEST
FOR
DELAY
OF
FINAL
AC-
TION.—Notwithstanding any other provision of law, 
the Secretary shall not fail or refuse to take a final 
action on a comparable biological product application 
by the final action date on the basis that a person, 
other than the sponsor of the comparable biological 
product, has requested (in a petition or otherwise) 
that the Secretary refuse to take or otherwise defer 
such final action, and no court shall enjoin the Sec-
retary from taking final action or stay the effect of 
final action previously taken by the Secretary, except 
by issuance of a permanent injunction based upon 
an express finding of clear and convincing evidence 
that the person seeking to have the Secretary refuse 
to take or otherwise to deter final action by the final 
action date— 
‘‘(A) has prevailed on the merits of the 
person’s complaint against the Secretary; 
‘‘(B) will suffer imminent and actual irrep-
arable injury, constituting more than irrecover-
able economic loss, and that also will threaten 
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imminent destruction of such person’s business; 
and 
‘‘(C) has an interest that outweighs the 
overwhelming interest that the public has in ob-
taining prompt access to a comparable biologi-
cal product. 
‘‘(13) REPORT ON EXTENSIONS OF FINAL AC-
TION DATE.—The Secretary shall prepare and sub-
mit to the President, the Committee on Energy and 
Commerce of the House of Representatives, and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate a report regarding any jointly 
executed written agreement to extend the final ac-
tion date under this Act within 15 calendar days of 
the joint execution of any such written agreement. 
‘‘(14) REPORT ON FAILURE TO TAKE FINAL AC-
TION.—The Secretary shall prepare and submit an-
nually to the President, the Committee on Energy 
and Commerce of the House of Representatives, and 
the Committee on Health, Education, Labor, and 
Pensions of the Senate a report detailing the specific 
and particularized reasons enumerated by the Re-
viewing Division for each instance of the Secretary’s 
failure to take final action by the final action date 
in the previous year. 
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‘‘(15) REGULATIONS.—The Secretary shall es-
tablish, by regulation within 2 years after the date 
of the enactment of this subsection, requirements for 
the efficient review, approval, suspension, and rev-
ocation of comparable biological product applications 
under this subsection. 
‘‘(16) PATENTS.— 
‘‘(A) REQUEST
FOR
PATENT
INFORMA-
TION.— 
‘‘(i) IN GENERAL.—At any time, in-
cluding at the initial stages of develop-
ment, an applicant or a prospective appli-
cant may send a written request for patent 
information to the holder of the approved 
application for the reference product. 
Within 60 days of receipt of such request, 
the holder of the approved application for 
the reference product shall provide to the 
applicant or prospective applicant a list of 
all patents owned by, or licensed to, the 
holder of the approved application that the 
application holder in good faith believes re-
late to the reference product, including 
patents that claim the approved biologic 
product, any method of using such prod-
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uct, any component of such product, or 
any method or process of manufacturing 
such product or component. 
‘‘(ii) COSTS OF COMPLYING WITH RE-
QUEST.—The application holder may de-
mand payment not exceeding $1,000 to 
offset the cost of responding to the infor-
mation request. 
‘‘(iii) UPDATES.—For a period of two 
years from the date of the request for in-
formation, the holder of the approved ap-
plication for the reference product shall 
update its response to the request for in-
formation by identifying newly issued or li-
censed relevant patents. The updates must 
be provided within 30 days of patent 
issuance, for newly issued patents, and 
within 30 days of obtaining a license, for 
newly licensed patents. 
‘‘(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 the submission of the application, the 
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