I 

112TH CONGRESS 

2D SESSION H. R. 3995 

To prohibit brand name drug companies from compensating generic drug 

companies to delay the entry of a generic drug into the market, and 

for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 9, 2012 

Mr. RUSH (for himself and Mr. WAXMAN) introduced the following bill; which 

was referred to the Committee on Energy and Commerce, and in addition 

to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions 

as fall within the jurisdiction of the committee concerned 

A BILL 

To prohibit brand name drug companies from compensating 

generic drug companies to delay the entry of a generic 

drug into the market, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protecting Consumer 

5 Access to Generic Drugs Act of 2012’’. 


pwalker on DSK7TPTVN1PROD with BILLS
2 

•HR 3995 IH

1 SEC. 2. UNFAIR AND DECEPTIVE ACTS AND PRACTICES RE2 LATED TO NEW DRUG APPLICATIONS. 

3 (a) CONDUCT PROHIBITED.—It shall be unlawful for 

4 any person to directly or indirectly be a party to any 

5 agreement resolving or settling a patent infringement 

6 claim in which— 

7 (1) an ANDA filer receives anything of value; 

8 and 

9 (2) the ANDA filer agrees not to research, de10 velop, manufacture, market, or sell, for any period 

11 of time, the drug that is to be manufactured under 

12 the ANDA involved and is the subject of the patent 

13 infringement claim. 

14 (b) EXCEPTIONS.—Notwithstanding subsection 

15 (a)(1), subsection (a) does not prohibit a resolution or set16 tlement of a patent infringement claim in which the value 

17 received by the ANDA filer includes no more than— 

18 (1) the right to market the drug that is to be 

19 manufactured under the ANDA involved and is the 

20 subject of the patent infringement claim, before the 

21 expiration of— 

22 (A) the patent that is the basis for the pat23 ent infringement claim; or 

24 (B) any other statutory exclusivity that 

25 would prevent the marketing of such drug; and 


pwalker on DSK7TPTVN1PROD with BILLS
3 

•HR 3995 IH

1 (2) the waiver of a patent infringement claim 

2 for damages based on prior marketing of such drug. 

3 (c) ENFORCEMENT.—A violation of subsection (a) 

4 shall be treated as an unfair and deceptive act or practice 

5 and an unfair method of competition in or affecting inter6 state commerce prohibited under section 5 of the Federal 

7 Trade Commission Act (15 U.S.C. 45). The Federal Trade 

8 Commission shall enforce this Act in the same manner, 

9 by the same means, and with the same jurisdiction as 

10 though all applicable terms and provisions of the Federal 

11 Trade Commission Act were incorporated into and made 

12 a part of this Act. 

13 (d) DEFINITIONS.—In this section: 

14 (1) AGREEMENT.—The term ‘‘agreement’’ 

15 means anything that would constitute an agreement 

16 for purposes of section 5 of the Federal Trade Com17 mission Act (15 U.S.C. 45). 

18 (2) AGREEMENT RESOLVING OR SETTLING.— 

19 The term ‘‘agreement resolving or settling’’, in ref20 erence to a patent infringement claim, includes any 

21 agreement that is contingent upon, provides a con22 tingent condition for, or is otherwise related to the 

23 resolution or settlement of the claim. 

24 (3) ANDA.—The term ‘‘ANDA’’ means an ab25 breviated new drug application for the approval of a 


pwalker on DSK7TPTVN1PROD with BILLS
4 

•HR 3995 IH

1 new drug under section 505(j) of the Federal Food, 

2 Drug, and Cosmetic Act (21 U.S.C. 355(j)). 

3 (4) ANDA FILER.—The term ‘‘ANDA filer’’ 

4 means a party that has filed an ANDA with the 

5 Food and Drug Administration. 

6 (5) PATENT INFRINGEMENT.—The term ‘‘pat7 ent infringement’’ means infringement of any patent 

8 or of any filed patent application, extension, 

9 reissuance, renewal, division, continuation, continu10 ation in part, reexamination, patent term restora11 tion, patent of addition, or extension thereof. 

12 (6) PATENT INFRINGEMENT CLAIM.—The term 

13 ‘‘patent infringement claim’’ means any allegation 

14 made to an ANDA filer, whether or not included in 

15 a complaint filed with a court of law, that its ANDA 

16 or drug to be manufactured under such ANDA may 

17 infringe any patent. 

18 SEC. 3. FTC RULEMAKING. 

19 The Federal Trade Commission may, by rule promul20 gated under section 553 of title 5, United States Code, 

21 exempt certain agreements described in section 2 if the 

22 Commission finds such agreements to be in furtherance 

23 of market competition and for the benefit of consumers. 

24 Consistent with the authority of the Commission, such 

25 rules may include interpretive rules and general stateVerDate Mar 15 2010 06:41 Feb 10, 2012 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3995.IH H3995

pwalker on DSK7TPTVN1PROD with BILLS
5 

•HR 3995 IH

1 ments of policy with respect to the practices prohibited 

2 under section 2. 

3 SEC. 4. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD 

4 UNDER THE FFDCA. 

5 Section 505(j)(5)(D)(i) of the Federal Food, Drug, 

6 and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)) is amended 

7 in subclause (V) by inserting ‘‘section 2 of the Protecting 

8 Consumer Access to Generic Drugs Act of 2012 or’’ after 

9 ‘‘that the agreement has violated’’. 

10 SEC. 5. NOTICE AND CERTIFICATION OF AGREEMENTS. 

11 (a) NOTICE OF ALL AGREEMENTS.—Section 

12 1112(c)(2) of the Medicare Prescription Drug, Improve13 ment, and Modernization Act of 2003 (21 U.S.C. 3155 

14 note) is amended by— 

15 (1) striking ‘‘the Commission the’’ and insert16 ing ‘‘the Commission (1) the’’; and 

17 (2) inserting before the period at the end the 

18 following: ‘‘; and (2) a description of the subject 

19 matter of any other agreement the parties enter into 

20 within 30 days of an entering into an agreement 

21 covered by subsection (a) or (b)’’. 

22 (b) CERTIFICATION OF AGREEMENTS.—Section 1112 

23 of such Act is amended by adding at the end the following: 

24 ‘‘(d) CERTIFICATION.—The Chief Executive Officer 

25 or the company official responsible for negotiating any 


pwalker on DSK7TPTVN1PROD with BILLS
6 

•HR 3995 IH

1 agreement required to be filed under subsection (a), (b), 

2 or (c) shall execute and file with the Assistant Attorney 

3 General and the Commission a certification as follows: ‘I 

4 declare under penalty of perjury that the following is true 

5 and correct: The materials filed with the Federal Trade 

6 Commission and the Department of Justice under section 

7 1112 of subtitle B of title XI of the Medicare Prescription 

8 Drug, Improvement, and Modernization Act of 2003, with 

9 respect to the agreement referenced in this certification: 

10 (1) represent the complete, final, and exclusive agreement 

11 between the parties; (2) include any ancillary agreements 

12 that are contingent upon, provide a contingent condition 

13 for, or are otherwise related to, the referenced agreement; 

14 and (3) include written descriptions of any oral agree15 ments, representations, commitments, or promises be16 tween the parties that are responsive to subsection (a) or 

17 (b) of such section 1112 and have not been reduced to 

18 writing.’.’’. 

Æ 


pwalker on DSK7TPTVN1PROD with BILLS