II 

109TH CONGRESS 

2D SESSION S. 3582 

To prohibit brand name drug companies from compensating generic drug 

companies to delay the entry of a generic drug into the market. 

IN THE SENATE OF THE UNITED STATES 

JUNE 27, 2006 

Mr. KOHL (for himself, Mr. LEAHY, Mr. GRASSLEY, and Mr. SCHUMER) introduced the following bill; which was read twice and referred to the Committee on Commerce, Science, and Transportation 

A BILL 

To prohibit brand name drug companies from compensating 

generic drug companies to delay the entry of a generic 

drug into the market. 

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 ‘‘Preserve Access to Af5 fordable Generics Act’’. 

6 SEC. 2. UNFAIR COMPETITION. 

7 Section 5 of the Federal Trade Commission Act (15 

8 U.S.C. 45) is amended by adding at the end the following: 


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1 ‘‘(o)(1) It shall be considered an unfair method of 

2 competition affecting commerce under subsection (a)(1) 

3 for a person, in connection with the sale of a drug product, 

4 to directly or indirectly be a party to any agreement re5 solving or settling a patent infringement claim in which— 

6 ‘‘(A) an ANDA filer receives anything of value; 

7 and 

8 ‘‘(B) the ANDA filer agrees not to research, de9 velop, manufacture, market, or sell the ANDA prod10 uct for any period of time. 

11 ‘‘(2) CONSTRUCTION.—Nothing in this subsection 

12 shall prohibit a resolution or settlement of patent infringe13 ment claim in which the value paid by the NDA holder 

14 to the ANDA filer as a part of the resolution or settlement 

15 of the patent infringement claim includes no more than 

16 the right to market the ANDA product prior to the expira17 tion of the patent that is the basis for the patent infringe18 ment claim. 

19 ‘‘(3) In this subsection: 

20 ‘‘(A) The term ‘ANDA’ means an abbreviated 

21 new drug application, as defined under section 

22 505(j) of the Federal Food, Drug, and Cosmetic Act 

23 (21 U.S.C. 355(j)). 


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1 ‘‘(B) The term ‘ANDA filer’ means a party who 

2 has filed an ANDA with the Federal Drug Adminis3 tration. 

4 ‘‘(C) The term ‘ANDA product’ means the 

5 product to be manufactured under the ANDA that 

6 is the subject of the patent infringement claim. 

7 ‘‘(D) The term ‘drug product’ means a finished 

8 dosage form (e.g., tablet, capsule, or solution) that 

9 contains a drug substance, generally, but not nec10 essarily, in association with 1 or more other ingredi11 ents, as defined in section 314.3(b) of title 21, Code 

12 of Federal Regulations. 

13 ‘‘(E) The term ‘NDA’ means a new drug appli14 cation, as defined under section 505(b) of the Fed15 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

16 355(b)). 

17 ‘‘(F) The term ‘NDA holder’ means— 

18 ‘‘(i) the party that received FDA approval 

19 to market a drug product pursuant to an NDA; 

20 ‘‘(ii) a party owning or controlling enforce21 ment of the patent listed in the Approved Drug 

22 Products With Therapeutic Equivalence Eval23 uations (commonly known as the ‘FDA Orange 

24 Book’) in connection with the NDA; or 


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1 ‘‘(iii) the predecessors, subsidiaries, divi2 sions, groups, and affiliates controlled by, con3 trolling, or under common control with any of 

4 the entities described in subclauses (i) and (ii) 

5 (such control to be presumed by direct or indi6 rect share ownership of 50 percent or greater), 

7 as well as the licensees, licensors, successors, 

8 and assigns of each of the entities. 

9 ‘‘(G) The term ‘patent infringement’ means in10 fringement of any patent or of any filed patent ap11 plication, extension, reissue, renewal, division, con12 tinuation, continuation in part, reexamination, pat13 ent term restoration, patents of addition and exten14 sions thereof. 

15 ‘‘(H) The term ‘patent infringement claim’ 

16 means any allegation made to an ANDA filer, 

17 whether or not included in a complaint filed with a 

18 court of law, that its ANDA or ANDA product may 

19 infringe any patent held by, or exclusively licensed 

20 to, the NDA holder of the drug product.’’. 

Æ 


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