I 
111TH CONGRESS 
1ST SESSION H. R. 3777 
To amend the Federal Food, Drug, and Cosmetic Act to define the term 
‘‘first applicant’’ for purposes of filing an abbreviated application for 
a new drug. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 8, 2009 
Mr. HASTINGS of Florida (for himself and Mr. TAYLOR) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
define the term ‘‘first applicant’’ for purposes of filing 
an abbreviated application for a new drug. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Drug Price Competi-
tion Act of 2009’’. 
SEC. 2. EXCLUSIVITY PERIOD. 
(a) FIRST APPLICANT.—Section 505(j)(5) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(5)) is amended— 
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(1) in subparagraph (B)(iv)— 
(A) in subclause (II), by striking item (bb) 
and inserting the following: 
‘‘(bb) FIRST
APPLICANT.— 
As used in this subsection, the 
term ‘first applicant’ means— 
‘‘(AA) 
an 
applicant 
that, on the first day on 
which a substantially com-
plete application containing 
a certification described in 
paragraph (2)(A)(vii)(IV) is 
submitted for approval of a 
drug, submits a substan-
tially complete application 
that contains and lawfully 
maintains a certification de-
scribed 
in 
paragraph 
(2)(A)(vii)(IV) for the drug; 
or 
‘‘(BB) an applicant for 
the drug not described in 
item (AA) that satisfies the 
requirements of subclause 
(III).’’; and 
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(B) by adding at the end the following: 
‘‘(III) An applicant described in 
subclause (II)(bb)(BB) shall— 
‘‘(aa) submit and lawfully 
maintain a certification described 
in paragraph (2)(A)(vii)(IV) or a 
statement described in paragraph 
(2)(A)(viii) for each unexpired 
patent for which a first applicant 
described in item (AA) had sub-
mitted a certification described in 
paragraph (2)(A)(vii)(IV) on the 
first day on which a substantially 
complete application containing 
such a certification was sub-
mitted; 
‘‘(bb) with regard to each 
such unexpired patent for which 
the applicant submitted a certifi-
cation described in paragraph 
(2)(A)(vii)(IV), no action for pat-
ent infringement was brought 
against the applicant within the 
45-day period specified in para-
graph (5)(B)(iii), or if an action 
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was brought within such time pe-
riod, the applicant has obtained 
the decision of a court (including 
a district court) that the patent 
is invalid or not infringed (in-
cluding any substantive deter-
mination that there is no cause 
of action for patent infringement 
or invalidity, and including a set-
tlement order or consent decree 
signed and entered by the court 
stating that the patent is invalid 
or not infringed); and 
‘‘(cc) but for the effective 
date of approval provisions in 
subparagraphs (B) and (F) and 
sections 505A and 527, be eligi-
ble to receive immediately effec-
tive approval at a time before 
any other applicant has begun 
commercial marketing.’’; and 
(2) in subparagraph (D)— 
(A) in clause (i)(IV), by striking ‘‘The first 
applicant’’ and inserting ‘‘The first applicant, 
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