new drug under section 505(j) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)). 
(4) ANDA FILER.—The term ‘‘ANDA filer’’ 
means a party that has filed an ANDA with the 
Food and Drug Administration. 
(5) PATENT INFRINGEMENT.—The term ‘‘pat-
ent infringement’’ means infringement of any patent 
or of any filed patent application, extension, reissu-
ance, renewal, division, continuation, continuation in 
part, reexamination, patent term restoration, patent 
of addition, or extension thereof. 
(6) PATENT INFRINGEMENT CLAIM.—The term 
‘‘patent infringement claim’’ means any allegation 
made to an ANDA filer, whether or not included in 
a complaint filed with a court of law, that its ANDA 
or drug to be manufactured under such ANDA may 
infringe any patent. 
SEC. 3. FTC RULEMAKING. 
The Federal Trade Commission may, by rule promul-
gated under section 553 of title 5, United States Code, 
exempt certain agreements described in section 2 if the 
Commission finds such agreements to be in furtherance 
of market competition and for the benefit of consumers. 
Consistent with the authority of the Commission, such 
rules may include interpretive rules and general state-
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ments of policy with respect to the practices prohibited 
under section 2. 
SEC. 4. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD 
UNDER THE FFDCA. 
Section 505(j)(5)(D)(i) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)) is amend-
ed— 
(1) in subclause (I)(bb)— 
(A) by redesignating subitem (CC) as 
subitem (EE); and 
(B) by inserting after subitem (BB) the 
following: 
‘‘(CC) In a declaratory 
judgment action described in 
subitem (AA), a court dis-
misses the action for lack of 
subject matter jurisdiction, 
either with or without preju-
dice. 
‘‘(DD) The applicant 
files with the Secretary a 
covenant 
by 
the 
patent 
owner that the patent owner 
will not sue the applicant for 
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infringement with respect to 
the patent.’’; and 
(2) in subclause (V), by inserting ‘‘section 2 of 
the Protecting Consumer Access to Generic Drugs 
Act of 2009 or’’ after ‘‘that the agreement has vio-
lated’’. 
SEC. 5. NOTICE AND CERTIFICATION OF AGREEMENTS. 
(a) 
NOTICE
OF
ALL
AGREEMENTS.—Section 
1112(c)(2) of the Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2003 (21 U.S.C. 3155 
note) is amended by— 
(1) striking ‘‘the Commission the’’ and insert-
ing ‘‘the Commission (1) the’’; and 
(2) inserting before the period at the end the 
following: ‘‘; and (2) a description of the subject 
matter of any other agreement the parties enter into 
within 30 days of an entering into an agreement 
covered by subsection (a) or (b)’’. 
(b) CERTIFICATION OF AGREEMENTS.—Section 1112 
of such Act is amended by adding at the end the following: 
‘‘(d) CERTIFICATION.—The Chief Executive Officer 
or the company official responsible for negotiating any 
agreement required to be filed under subsection (a), (b), 
or (c) shall execute and file with the Assistant Attorney 
General and the Commission a certification as follows: ‘I 
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declare under penalty of perjury that the following is true 
and correct: The materials filed with the Federal Trade 
Commission and the Department of Justice under section 
1112 of subtitle B of title XI of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003, with 
respect to the agreement referenced in this certification: 
(1) represent the complete, final, and exclusive agreement 
between the parties; (2) include any ancillary agreements 
that are contingent upon, provide a contingent condition 
for, or are otherwise related to, the referenced agreement; 
and (3) include written descriptions of any oral agree-
ments, representations, commitments, or promises be-
tween the parties that are responsive to subsection (a) or 
(b) of such section 1112 and have not been reduced to 
writing.’.’’. 
Æ 
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