persons or organizations to file this peti-
tion: llllllll. I verify under 
penalty of perjury that the foregoing is 
true and correct.’. 
‘‘(B) EXHAUSTION
OF
ADMINISTRATIVE 
REMEDIES.— 
‘‘(i) FINAL AGENCY ACTION WITHIN 
180 DAYS.—The Secretary shall be consid-
ered to have taken final agency action on 
a petition referred to in subparagraph (A) 
if— 
‘‘(I) during the 180-day period 
referred to in clause (iii) of such sub-
paragraph, the Secretary makes a 
final decision within the meaning of 
section 10.45(d) of title 21, Code of 
Federal Regulations; or 
‘‘(II) such period expires without 
the Secretary having made such a 
final decision. 
‘‘(ii) DISMISSAL
OF
CERTAIN
CIVIL 
ACTIONS.—If a civil action is filed with re-
spect to a petition referred to in subpara-
graph (A) before final agency action within 
the meaning of clause (i) has occurred, the 
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court shall dismiss the action for failure to 
exhaust administrative remedies. 
‘‘(C) APPLICABILITY OF CERTAIN REGULA-
TIONS.—The provisions of this section are in 
addition to the requirements for the submission 
of a petition to the Secretary that apply under 
section 10.30 or 10.35 of title 21, Code of Fed-
eral Regulations. 
‘‘(D) ANNUAL REPORT ON DELAYS IN AP-
PROVALS PER PETITIONS.—The Secretary shall 
annually submit to the Congress a report that 
specifies— 
‘‘(i) the number of applications under 
this subsection that were approved during 
the preceding 12-month period; 
‘‘(ii) the number of such applications 
whose effective dates were delayed by peti-
tions referred to in subparagraph (A) dur-
ing such period; and 
‘‘(iii) the number of days by which the 
applications were so delayed. 
‘‘(E) EXCEPTION.—This paragraph does 
not apply to a petition that is made by the 
sponsor of an application under this subsection 
and that seeks only to have the Secretary take 
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or refrain from taking any form of action with 
respect to that application. 
‘‘(F) DEFINITION.—For purposes of this 
paragraph, the term ‘petition’ includes any re-
quest to the Secretary, without regard to 
whether the request is characterized as a peti-
tion.’’. 
(b) ADDITIONAL AMENDMENTS.— 
(1) PATENTS.—Section 271(e) of title 35, 
United States Code, is amended— 
(A) in paragraph (2)— 
(i) by striking ‘‘or’’ at the end of sub-
paragraph (A); 
(ii) by adding ‘‘or’’ at the end of sub-
paragraph (B); 
(iii) by inserting after subparagraph 
(B) the following: 
‘‘(C) 
a 
notice 
described 
in 
section 
351(k)(16)(B) of the Public Health Service Act, but 
only with respect to a patent identified in such a no-
tice,’’; and 
(iv) in the matter after and below sub-
paragraph (C) (as inserted by clause (iii) 
of this subparagraph), by inserting before 
the period the following: ‘‘, or if the notice 
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described in subparagraph (C) is provided 
in connection with an application to obtain 
a license to engage in the commercial man-
ufacture, use, or sale of a biological prod-
uct claimed in a patent or the use of which 
is claimed in a patent before the expiration 
of such patent’’; and 
(B) by adding at the end the following 
paragraph: 
‘‘(5) Notwithstanding the preceding subsection: 
‘‘(A) A patent that is disclosed in a response to 
a request for patent information pursuant to sub-
paragraph (A) of section 351(k)(16) of the Public 
Health Service Act with respect to which a notice 
was provided pursuant to subparagraph (B) of such 
section, and for which an action for infringement of 
the patent was (I) brought after the expiration of 
the 45-day period described in such subparagraph, 
or (II) brought before the expiration of the 45-day 
period described in such section 351, but not main-
tained through a final court decision or a dismissal 
with prejudice regarding the validity, enforceability, 
and/or infringement, the sole and exclusive remedy 
which may be granted by a court upon a finding of 
infringement of such patent by the person who sub-
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mitted the notice described in subclause (A), or any 
person found to have induced or contributed to such 
infringement, shall be a reasonable royalty. 
‘‘(B) No action for infringement can be brought 
under this section against an applicant that sent a 
request for patent information pursuant to subpara-
graph (A)(i) of section 351(k)(16) of the Public 
Health Service Act by the owner of a patent that 
should have been disclosed in response to such a re-
quest, but was not timely disclosed under that sub-
paragraph.’’. 
(2) TAX
CREDIT
TESTING
TO
DEMONSTRATE 
INTERCHANGEABLITY.—Subpart A of part IV of 
subchapter A of chapter 1 of the Internal Revenue 
Code of 1954 (relating to credits allowable) is 
amended by inserting after section 45C the following 
new section: 
‘‘SEC. 45C–1. CLINICAL TESTING EXPENSES FOR CERTAIN 
DRUGS TO DEMONSTRATE INTERCHANGE-
ABILITY. 
‘‘(a) GENERAL RULE.—There shall be allowed as a 
credit against the tax imposed by this chapter for the tax-
able year an amount equal to 50 percent of the qualified 
clinical testing expenses for the taxable year. 
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‘‘(b) QUALIFIED CLINICAL TESTING EXPENSES.— 
For purposes of this section— 
‘‘(1) 
QUALIFIED
CLINICAL
TESTING
EX-
PENSES.— 
‘‘(A) IN GENERAL.—Except as otherwise 
provided in this paragraph, the term ‘qualified 
clinical testing expenses’ means the amounts 
which are paid or incurred by the taxpayer dur-
ing the taxable year which would be described 
in subsection (b) of section 41 if such sub-
section were applied with the modifications set 
forth in subparagraph (B). 
‘‘(B) MODIFICATIONS.—For purposes of 
subparagraph (A), subsection (b) of section 41 
shall be applied— 
‘‘(i) by substituting ‘clinical testing’ 
for ‘qualified research’ each place it ap-
pears in paragraphs (2) and (3) of such 
subsection, and 
‘‘(ii) by substituting ‘100 percent’ for 
‘65 percent’ in paragraph (3)(A) of such 
subsection. 
‘‘(D) SPECIAL
RULE.—For purposes of 
this paragraph, section 41 shall be deemed to 
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remain in effect for periods after December 31, 
2006. 
‘‘(2) CLINICAL
TESTING.—The term ‘clinical 
testing’ means any human clinical testing which is 
carried out under an exemption for a drug being 
tested for interchangeability under section 351(k) of 
the Public Health Service Act. 
‘‘(3) SPECIAL LIMITATIONS ON FOREIGN TEST-
ING.— 
‘‘(A) IN GENERAL.—No credit shall be al-
lowed under this section with respect to any 
clinical testing conducted outside the United 
States unless— 
‘‘(i) such testing is conducted outside 
the United States because there is an in-
sufficient testing population in the United 
States, and 
‘‘(ii) such testing is conducted by a 
United States person or by any other per-
son who is not related to the taxpayer 
seeking the interchangeable designation 
under section 351(k) of the Public Health 
Service Act. 
‘‘(B) SPECIAL LIMITATION FOR CORPORA-
TIONS TO WHICH SECTION 936 APPLIES.—No 
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credit shall be allowed under this section with 
respect to any clinical testing conducted by a 
corporation to which section 934(b) applies or 
to which an election under section 936 applies. 
‘‘(4) CERTAIN
RULES
MADE
APPLICABLE.— 
Rules similar to the rules of paragraphs (1) and (2) 
of section 41(f) shall apply for purposes of this sec-
tion. 
‘‘(5) ELECTION.—This section shall apply to 
any taxpayer for any taxable year only if such tax-
payer elects (at such time and in such manner as 
the Secretary may by regulations prescribe) to have 
this section apply for such taxable year.’’. 
(3) 
CONFORMING
AMENDMENT.—Section 
2201(b) of title 28, United States Code, is amended 
by inserting before the period the following: ‘‘, or 
section 351 of the Public Health Service Act’’. 
Æ 
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