‘‘(19) STATUTORY
EXCLUSIVITY.—The term 
‘statutory exclusivity’ means those prohibitions on 
the approval of drug applications under clauses (ii) 
through (iv) of section 505(c)(3)(E) (5- and 3-year 
data exclusivity), section 527 (orphan drug exclu-
sivity), or section 505A (pediatric exclusivity) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(c)(3)(E), 360cc, 355a), or on the licensing of 
biological 
product 
applications 
under 
section 
351(k)(7) (12-year exclusivity) or paragraph (2) or 
(3) of section 351(m) (pediatric exclusivity) of the 
Public Health Service Act (42 U.S.C. 262) or under 
section 527 of the Federal Food, Drug, and Cos-
metic Act (orphan drug exclusivity).’’. 
(b) EFFECTIVE DATE.—Section 27 of the Federal 
Trade Commission Act, as added by this section, shall 
apply to all agreements described in section 27(a)(1) of 
that Act entered into on or after the date of enactment 
of this Act. 
SEC. 4. NOTICE AND CERTIFICATION OF AGREEMENTS. 
(a) NOTICE OF ALL AGREEMENTS.—Section 1111(7) 
of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (21 U.S.C. 355 note) is 
amended by inserting ‘‘or the owner of a patent for which 
a claim of infringement could reasonably be asserted 
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against any person for making, using, offering to sell, sell-
ing, or importing into the United States a biological prod-
uct that is the subject of a biosimilar biological product 
application’’ before the period at the end. 
(b) CERTIFICATION OF AGREEMENTS.—Section 1112 
of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (21 U.S.C. 355 note) is 
amended by adding at the end the following: 
‘‘(d) CERTIFICATION.—The Chief Executive Officer 
or the company official responsible for negotiating any 
agreement under subsection (a) or (b) that is required to 
be filed under subsection (c), within 30 days after such 
filing, shall execute and file with the Assistant Attorney 
General and the Commission a certification as follows: ‘I 
declare that the following is true, correct, and complete 
to the best of my knowledge: The materials filed with the 
Federal Trade Commission and the Department of Justice 
under section 1112 of subtitle B of title XI of the Medi-
care Prescription Drug, Improvement, and Modernization 
Act of 2003, with respect to the agreement referenced in 
this certification— 
‘‘ ‘(1) represent the complete, final, and exclu-
sive agreement between the parties; 
‘‘ ‘(2) include any ancillary agreements that are 
contingent upon, provide a contingent condition for, 
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or are otherwise related to, the referenced agree-
ment; and 
‘‘ ‘(3) include written descriptions of any oral 
agreements, representations, commitments, or prom-
ises between the parties that are responsive to sub-
section (a) or (b) of such section 1112 and have not 
been reduced to writing.’.’’. 
SEC. 5. NOTIFICATION OF AGREEMENTS. 
Section 1112 of the Medicare Prescription Drug, Im-
provement, and Modernization Act of 2003 (21 U.S.C. 
355 note) is amended by adding at the end the following: 
‘‘(4) RULE OF CONSTRUCTION.— 
‘‘(A) An agreement that is required in sub-
section (a) or (b) shall include agreements re-
solving any outstanding disputes, including 
agreements resolving or settling a Patent Trial 
and Appeal Board proceeding. 
‘‘(B) For purposes of subparagraph (A), 
the term ‘Patent Trial and Appeal Board pro-
ceeding’ means a proceeding conducted by the 
United States Patent and Trademark Office 
Patent Trial and Appeal Board, including but 
not limited to inter parties review, post-grant 
review, the transitional program for covered 
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business method patents, and derivation pro-
ceedings.’’. 
SEC. 6. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 
Section 505(j)(5)(D)(i)(V) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) 
is amended by inserting ‘‘section 27 of the Federal Trade 
Commission Act or’’ after ‘‘that the agreement has vio-
lated’’. 
SEC. 7. COMMISSION LITIGATION AUTHORITY. 
Section 16(a)(2) of the Federal Trade Commission 
Act (15 U.S.C. 56(a)(2)) is amended— 
(1) in subparagraph (D), by striking ‘‘or’’ after 
the semicolon; 
(2) in subparagraph (E), by inserting ‘‘or’’ 
after the semicolon; and 
(3) inserting after subparagraph (E) the fol-
lowing: 
‘‘(F) under section 27;’’. 
SEC. 8. REPORT ON ADDITIONAL EXCLUSION. 
Within 1 year of enactment, the Federal Trade Com-
mission shall provide a recommendation, and the Commis-
sion’s basis for it, to the Committee on the Judiciary of 
the House of Representatives and the Committee on the 
Judiciary of the Senate regarding a potential amendment 
to include in section 27(c) of the Federal Trade Commis-
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sion Act, an additional exclusion for consideration granted 
by an NDA holder or biological product license holder to 
the ANDA filer or biosimilar biological product application 
filer, respectively, as part of the resolution or settlement, 
a release, waiver, or limitation of a claim for damages or 
other monetary relief. 
SEC. 9. STATUTE OF LIMITATIONS. 
The Federal Trade Commission shall commence any 
enforcement proceeding described in section 27 of the 
Federal Trade Commission Act, as added by section 3, ex-
cept for an action described in section 27(f)(2) of the Fed-
eral Trade Commission Act, not later than 6 years after 
the date on which the parties to the agreement file the 
certification under section 1112(d) of the Medicare Pre-
scription Drug, Improvement, and Modernization Act of 
2003 (21 U.S.C. 355 note). 
SEC. 10. SEVERABILITY. 
If any provision of this Act, an amendment made by 
this Act, or the application of such provision or amend-
ment to any person or circumstance is held to be unconsti-
tutional, the remainder of this Act, the amendments made 
by this Act, and the application of the provisions of such 
Act or amendments to any person or circumstance shall 
not be affected. 
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