II 

116TH CONGRESS 

1ST SESSION S. 1416 

To amend the Federal Trade Commission Act to prohibit anticompetitive 

behaviors by drug product manufacturers, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 9, 2019 

Mr. CORNYN (for himself and Mr. BLUMENTHAL) introduced the following bill; 

which was read twice and referred to the Committee on the Judiciary 

A BILL 

To amend the Federal Trade Commission Act to prohibit 

anticompetitive behaviors by drug product manufacturers, 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 ‘‘Affordable Prescrip5 tions for Patients Act of 2019’’. 

6 SEC. 2. PRODUCT HOPPING; PATENT THICKETING. 

7 (a) IN GENERAL.—The Federal Trade Commission 

8 Act (15 U.S.C. 41 et seq.) is amended by inserting after 

9 section 26 (15 U.S.C. 57c–2) the following: 


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1 ‘‘SEC. 27. PRODUCT HOPPING; PATENT THICKETING. 

2 ‘‘(a) DEFINITIONS.—In this section: 

3 ‘‘(1) ABBREVIATED NEW DRUG APPLICATION.— 

4 The term ‘abbreviated new drug application’ means 

5 an application under subsection (b)(2) or (j) of sec6 tion 505 of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 355). 

8 ‘‘(2) BIOSIMILAR BIOLOGICAL PRODUCT.—The 

9 term ‘biosimilar biological product’ means a biologi10 cal product licensed under section 351(k) of the 

11 Public Health Service Act (42 U.S.C. 262(k)). 

12 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT LI13 CENSE APPLICATION.—The term ‘biosimilar biologi14 cal product license application’ means an application 

15 submitted under section 351(k) of the Public Health 

16 Service Act (42 U.S.C. 262(k)). 

17 ‘‘(4) COMPETITION WINDOW.—The term ‘com18 petition window’ means— 

19 ‘‘(A) with respect to a listed drug, the pe20 riod between— 

21 ‘‘(i) the date that is the earlier of— 

22 ‘‘(I) 8 years before any patent or 

23 marketing exclusivity granted under 

24 chapter V of the Federal Food, Drug, 

25 and Cosmetic Act (21 U.S.C. 351 et 


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1 seq.) with respect to such listed drug 

2 expires; and 

3 ‘‘(II) the date on which the first 

4 abbreviated new drug application that 

5 references such listed drug is filed; 

6 and 

7 ‘‘(ii) the later of— 

8 ‘‘(I) the date that is 180 days 

9 after the first abbreviated new drug 

10 application that references such listed 

11 drug is filed; and 

12 ‘‘(II) the date that is 1 year after 

13 the date on which the generic drug 

14 that is the subject of the abbreviated 

15 new drug application described in sub16 clause (I) enters the marketplace; or 

17 ‘‘(B) with respect to a reference product, 

18 the period between— 

19 ‘‘(i) the date that is the earlier of— 

20 ‘‘(I) 6 years before any patent or 

21 marketing exclusivity (including any 

22 extension of such exclusivity) granted 

23 under section 351 of the Public 

24 Health Service Act (42 U.S.C. 262) 

25 or section 527 of the Federal Food, 


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1 Drug, and Cosmetic Act (21 U.S.C. 

2 360cc) with respect to such reference 

3 product expires; and 

4 ‘‘(II) the date on which the first 

5 biosimilar biological product license 

6 application that references such ref7 erence product is filed; and 

8 ‘‘(ii) the later of— 

9 ‘‘(I) the date that is 180 days 

10 after the date on which the first bio11 similar biological product license ap12 plication that references such ref13 erence product enters the market14 place; and 

15 ‘‘(II) the date that is 1 year after 

16 the date on which the biosimilar bio17 logical product that is the subject of 

18 the biosimilar biological product li19 cense application described in sub20 clause (I) enters the marketplace. 

21 ‘‘(5) EXPECTED REVENUE.—The term ‘ex22 pected revenue’, with respect to a follow-on product, 

23 means the financial value represented by the number 

24 of individuals in the target population multiplied by 

25 the financial revenue generated by each member of 


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1 the target population over the 3-year period begin2 ning— 

3 ‘‘(A) on the day that 3 generic drugs ref4 erencing the same listed drug or 2 or more bio5 similar biological products referencing the same 

6 reference product would have been widely avail7 able in the market; or 

8 ‘‘(B) if 3 or more generic drugs ref9 erencing the same listed drug or 2 or more bio10 similar biological products referencing the same 

11 reference product are already widely available in 

12 the market, the day that the follow-on product 

13 enters the market. 

14 ‘‘(6) FOLLOW-ON PRODUCT.—The term ‘follow15 on product’ means a drug approved through an ap16 plication or supplement to an application submitted 

17 under section 505(b) of the Federal Food, Drug, 

18 and Cosmetic Act (21 U.S.C. 355(c)) or a biological 

19 product licensed through an application or supple20 ment to an application submitted under section 

21 351(a) of the Public Health Service Act (42 U.S.C. 

22 262(a)) for a change, modification, or reformulation 

23 to the same manufacturer’s previously approved 

24 drug or biological product. 


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1 ‘‘(7) GENERIC DRUG.—The term ‘generic drug’ 

2 means a drug approved under subsection (b)(2) or 

3 (j) of section 505 of the Federal Food, Drug, and 

4 Cosmetic Act (21 U.S.C. 355). 

5 ‘‘(8) LISTED DRUG.—The term ‘listed drug’ 

6 means a drug listed under section 505(j)(7) of the 

7 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

8 355(j)(7)). 

9 ‘‘(9) PATENT FAMILY.—The term ‘patent fam10 ily’ means a group of related patents that continue 

11 the priority date of the underlying composition of 

12 matter patent, all of which claim the same drug or 

13 biological product or a use of the same drug or bio14 logical product. 

15 ‘‘(10) PATENT PORTFOLIO.—The term ‘patent 

16 portfolio’ means a group of related patents covering 

17 the same or similar technical content. 

18 ‘‘(11) PATENT THICKETING.— 

19 ‘‘(A) IN GENERAL.—The term ‘patent 

20 thicketing’ means an action taken to limit com21 petition by a patentee with respect to a drug 

22 approved under section 505(c) of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 

24 355(c)) or a biological product licensed under 


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1 section 351(a) of the Public Health Service Act 

2 (42 U.S.C. 262(a)) in which— 

3 ‘‘(i)(I) the patentee obtains patents in 

4 the same patent family or patent port5 folio— 

6 ‘‘(aa) that claim the drug or bio7 logical product or a use of the drug or 

8 biological product, a form of the drug 

9 or biological product, a method of use 

10 of the drug or biological product, or a 

11 method of manufacture of a drug or 

12 biological product; and 

13 ‘‘(bb) whose effective filing date 

14 does not precede the date of filing the 

15 application under section 505(b) of 

16 the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 355(b)) or sec18 tion 351(a) of the Public Health Serv19 ice Act (42 U.S.C. 262(a)); or 

20 ‘‘(II) the underlying composition of 

21 matter patent is found invalid and the pat22 entee obtains patents in the same patent 

23 family or patent portfolio that claim the 

24 drug or biological product or a use of the 

25 drug or biological product, a form of the 


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1 drug or biological product, a method of use 

2 of the drug or biological product, or a 

3 method of manufacture of the drug or bio4 logical product; 

5 ‘‘(ii) an abbreviated new drug applica6 tion referencing such approved drug or a 

7 biosimilar biological product license appli8 cation referencing such licensed biological 

9 product could not be marketed without 

10 practicing one or more of the inventions 

11 claimed in the additional patents described 

12 in subclause (I) or (II) of clause (i); and 

13 ‘‘(iii) the Commission determines that 

14 the patentee improperly limited competi15 tion by obtaining patents described in sub16 clause (I) or (II) of clause (i). 

17 ‘‘(B) FACTORS TO CONSIDER.—The Com18 mission may establish that an action described 

19 in subparagraph (A) improperly limits competi20 tion if the Commission establishes a reasonable 

21 number of the following factors in a manner 

22 that is sufficient to demonstrate anticompetitive 

23 intent: 

24 ‘‘(i) The additional patents described 

25 in subparagraph (A)(i) (referred to in this 


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1 subparagraph as the ‘additional patents’) 

2 stem from few patent families. 

3 ‘‘(ii) The additional patents have com4 mon specifications. 

5 ‘‘(iii) The additional patents did not 

6 issue on an application with respect to 

7 which a requirement for restriction under 

8 section 121 of title 35, United States 

9 Code, has been made, or on an application 

10 filed as a result of such a requirement. 

11 ‘‘(iv) The additional patents have 

12 overlapping or identical claims. 

13 ‘‘(v) The additional patents have been 

14 granted to the patentee on formulations or 

15 compositions of the product and not used. 

16 ‘‘(vi) One or more of the additional 

17 patents have been invalidated in an inter 

18 partes review conducted under chapter 31 

19 of title 35, United States Code, or a post20 grant proceeding conducted under chapter 

21 32 of that title. 

22 ‘‘(vii) Litigation with applicants under 

23 section 351(k) of the Public Health Service 

24 Act has been extended based on the addi25 tional patents. 


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1 ‘‘(viii) The applications with respect 

2 to the additional patents described in sub3 clause (I) or (II) of subparagraph (A)(i) 

4 are submitted not more than 36 months 

5 before the expiration of the underlying 

6 composition of matter patent. 

7 ‘‘(ix) A public or internal statement, a 

8 shareholder call, or another demonstration 

9 of purpose that the patentee intended to 

10 use the number of patents or length of ex11 tended patent protection in order to unduly 

12 limit competition. 

13 ‘‘(12) REFERENCE PRODUCT.—The term ‘ref14 erence product’ has the meaning given the term in 

15 section 351(i) of the Public Health Service Act (42 

16 U.S.C. 262(i)). 

17 ‘‘(13) TARGET POPULATION.—The term ‘target 

18 population’, with respect to a drug, means the popu19 lation of individuals that— 

20 ‘‘(A) would experience a significant health 

21 improvement from a follow-on product; and 

22 ‘‘(B) would have bought the follow-on 

23 product solely because of the significant health 

24 improvement that those individuals would expe25 rience. 


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1 ‘‘(14) ULTIMATE PARENT ENTITY.—The term 

2 ‘ultimate parent entity’ has the meaning given the 

3 term in section 801.1 of title 16, Code of Federal 

4 Regulations, or any successor regulation. 

5 ‘‘(15) UNDERLYING COMPOSITION OF MATTER

6 PATENT.—The term ‘underlying composition of mat7 ter patent’ means a patent with respect to the mol8 ecules, compounds, or new formulations of the active 

9 ingredient of a drug or biological product. 

10 ‘‘(b) PROHIBITIONS.— 

11 ‘‘(1) PATENT THICKETING.— 

12 ‘‘(A) PRIMA FACIE.—Except as provided in 

13 subparagraph (B), an action by a drug manu14 facturer that constitutes patent thicketing shall 

15 be considered to be an unfair method of com16 petition in or affecting commerce in violation of 

17 section 5(a). 

18 ‘‘(B) REBUTTAL.— 

19 ‘‘(i) IN GENERAL.—Subject to sub20 paragraph (C), an action that constitutes 

21 patent thicketing shall not be considered to 

22 be an unfair method of competition in or 

23 affecting commerce in violation of section 

24 5(a) if the manufacturer described in that 

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1 sion or a district court of the United 

2 States, as applicable, by a preponderance 

3 of the evidence in a proceeding initiated by 

4 the Commission under subsection 

5 (c)(1)(A), or in a suit brought under sub6 paragraph (B) or (C) of subsection (c)(1), 

7 that the anticompetitive effects of the ac8 tion do not outweigh the pro-competitive 

9 effects of the action. 

10 ‘‘(ii) EVIDENCE.—In making a dem11 onstration under clause (i) that the anti12 competitive effects of patent thicketing do 

13 not outweigh the pro-competitive effects of 

14 that behavior, a manufacturer described in 

15 subparagraph (A)— 

16 ‘‘(I) may present evidence that— 

17 ‘‘(aa) the inventions claimed 

18 in the additional patents de19 scribed in subclauses (I) and (II) 

20 of subsection (a)(11)(A)(i) re21 sulted in— 

22 ‘‘(AA) clinically mean23 ingful and significant thera24 peutic or safety benefits; 


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1 ‘‘(BB) significantly im2 proved product purity or po3 tency; 

4 ‘‘(CC) significant 

5 gained efficiencies in manu6 facturing; or 

7 ‘‘(DD) other improved 

8 product attributes having 

9 substantial benefits for con10 sumers or patients; 

11 ‘‘(bb) a generic drug or bio12 similar biological product could 

13 be marketed commercially with14 out incorporating the improve15 ments claimed in the additional 

16 patents described in item (aa); or 

17 ‘‘(cc) for each of the later 

18 filed patents, the manufacturer 

19 had substantial financial reason, 

20 apart from the financial effects 

21 of reduced competition, to file 

22 each of the patents; and 

23 ‘‘(II) in making a demonstration 

24 under subclause (I), shall submit to 

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1 cable, all research and development, 

2 manufacturing, marketing, and other 

3 costs associated with approval of the 

4 original drug under section 505(c) of 

5 the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 355(c)) or licen7 sure of the original biological product 

8 under section 351(a) of the Public 

9 Health Service Act (42 U.S.C. 

10 262(a)), which— 

11 ‘‘(aa) shall include— 

12 ‘‘(AA) any documents 

13 relating to the costs and 

14 benefits of the later filed 

15 patents with respect to pa16 tients who use the drug; and 

17 ‘‘(BB) any applications 

18 for patents that were filed 

19 and rejected; and 

20 ‘‘(bb) shall not be construed 

21 to limit the information that the 

22 Commission or the court, as ap23 plicable, may otherwise obtain in 

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1 tuted with respect to a violation 

2 of this section. 

3 ‘‘(C) RESPONSE.—The Commission may 

4 rebut any evidence presented by a drug manu5 facturer under subparagraph (B) by estab6 lishing by a preponderance of the evidence that 

7 the harm to consumers from the action that is 

8 the subject of that presentation is greater than 

9 the benefits to consumers from that action. 

10 ‘‘(2) PRODUCT HOPPING.— 

11 ‘‘(A) PRIMA FACIE.—Except as provided in 

12 subparagraph (B), any of the following actions 

13 by a manufacturer of a reference product or 

14 listed drug shall be considered to be an unfair 

15 method of competition in or affecting commerce 

16 in violation of section 5(a): 

17 ‘‘(i) If, during the period beginning on 

18 the date on which the manufacturer of the 

19 reference drug receives notice that an ap20 plicant has submitted to the Commissioner 

21 of Food and Drugs an abbreviated new 

22 drug application or biosimilar biological 

23 product license application and ending on 

24 the date that is 180 days after the date on 

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1 logical product first enters, or could enter, 

2 the market, or is denied— 

3 ‘‘(I) upon the request of the 

4 manufacturer of the listed drug or 

5 reference product, the Commissioner 

6 of Food and Drugs— 

7 ‘‘(aa) withdraws the ap8 proval of the application for the 

9 listed drug or reference product; 

10 or 

11 ‘‘(bb) places the listed drug 

12 or reference product on the dis13 continued products list; or 

14 ‘‘(II) the manufacturer of the 

15 listed drug or reference product an16 nounces discontinuance of, or intent 

17 to withdraw, the application for the 

18 reference product. 

19 ‘‘(ii) The manufacturer of a previously 

20 approved drug or biological product mar21 kets or sells a follow-on product during the 

22 competition window. 

23 ‘‘(B) REBUTTAL.— 

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1 paragraph (A) shall not be considered to 

2 be an unfair method of competition in or 

3 affecting commerce if— 

4 ‘‘(I) with respect to an action de5 scribed in subparagraph (A)(i), the 

6 manufacturer of the listed drug or 

7 reference product demonstrates to the 

8 Commission or a district court of the 

9 United States, as applicable, by a pre10 ponderance of the evidence in a pro11 ceeding initiated by the Commission 

12 under subsection (c)(1)(A), or in a 

13 suit brought under subparagraph (B) 

14 or (C) of subsection (c)(1), that the 

15 manufacturer removed such drug 

16 from the market for significant and 

17 documented safety reasons; or 

18 ‘‘(II) with respect to an action 

19 described in subparagraph (A)(ii)— 

20 ‘‘(aa) the manufacturer 

21 demonstrates to the Commission 

22 or a district court of the United 

23 States, as applicable, by a pre24 ponderance of the evidence in a 

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1 mission under subsection 

2 (c)(1)(A), or in a suit brought 

3 under subparagraph (B) or (C) 

4 of subsection (c)(1), that— 

5 ‘‘(AA) the follow-on 

6 product described in such 

7 subparagraph (A)(ii) (re8 ferred to in this subclause as 

9 the ‘follow-on product’) pro10 vides a clinically meaningful 

11 and significant additional 

12 health benefit to the target 

13 population beyond that pro14 vided by the previously ap15 proved drug or biological 

16 product; 

17 ‘‘(BB) the follow-on 

18 product was the available 

19 means that was least likely 

20 to reduce competition; and 

21 ‘‘(CC) the manufac22 turer had substantive finan23 cial reasons, apart from the 

24 financial effects of reduced 

25 competition, to introduce the 


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1 follow-on product to the 

2 market; and 

3 ‘‘(bb) in making the dem4 onstration required under item 

5 (aa), the manufacturer provides 

6 to the Commission— 

7 ‘‘(AA) all research and 

8 development, manufacturing, 

9 marketing, and other related 

10 costs associated with the 

11 drug or biological product 

12 previously approved under 

13 section 505(c) of the Fed14 eral Food, Drug, and Cos15 metic Act (21 U.S.C. 

16 355(c)) or section 351(a) of 

17 the Public Health Service 

18 Act (42 U.S.C. 262(a)) and 

19 the follow-on product, in20 cluding all documents, 

21 memos, or other business 

22 documents that explain, 

23 mention, or otherwise justify 

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1 facture the follow-on prod2 uct; and 

3 ‘‘(BB) the revenue ob4 tained by the manufacturer 

5 with respect to the drug or 

6 biological product previously 

7 approved under section 

8 505(c) of the Federal Food, 

9 Drug, and Cosmetic Act (21 

10 U.S.C. 355(c)) or section 

11 351(a) of the Public Health 

12 Service Act (42 U.S.C. 

13 262(a)) and the expected 

14 revenue of the manufacturer 

15 with respect to the pre16 viously approved drug or bi17 ological product and the fol18 low-on product. 

19 ‘‘(ii) RULE OF CONSTRUCTION.— 

20 Nothing in clause (i) may be construed to 

21 limit the information that the Commission 

22 may otherwise obtain in any proceeding or 

23 action instituted with respect to a violation 

24 of this section. 


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1 ‘‘(C) RESPONSE.—The Commission may 

2 rebut any evidence presented by a drug manu3 facturer under subparagraph (B) by estab4 lishing by a preponderance of the evidence 

5 that— 

6 ‘‘(i) the harm to consumers of the 

7 drug or biological product that is the sub8 ject of the product from the action that is 

9 the subject of that presentation is greater 

10 than the benefits to consumers of the drug 

11 or biological product that is the subject of 

12 challenged action; or 

13 ‘‘(ii) a primary purpose of the manu14 facturer in pursuing the challenged action 

15 was to block or otherwise hinder the entry 

16 into the market of a generic drug or bio17 similar biological product. 

18 ‘‘(c) ENFORCEMENT.— 

19 ‘‘(1) IN GENERAL.—If the Commission has rea20 son to believe that any drug manufacturer has vio21 lated, is violating, or is about to violate this section, 

22 the Commission may take any of the following ac23 tions: 

24 ‘‘(A) Institute a proceeding— 


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1 ‘‘(i) that, except as provided in para2 graph (2), complies with the requirements 

3 under section 5(b); and 

4 ‘‘(ii) in which the Commission may 

5 impose on the manufacturer any penalty 

6 that the Commission may impose for a vio7 lation of section 5. 

8 ‘‘(B) In the same manner and to the same 

9 extent as provided in section 13(b), bring suit 

10 in a district court of the United States to tem11 porarily enjoin the action of the drug manufac12 turer. 

13 ‘‘(C)(i) Bring suit in a district court of the 

14 United States to permanently enjoin the action 

15 of the drug manufacturer. 

16 ‘‘(ii) In a suit brought under clause (i), the 

17 Commission may seek— 

18 ‘‘(I) any of the remedies described in 

19 paragraph (3); and 

20 ‘‘(II) any other equitable remedy, in21 cluding ancillary equitable relief. 

22 ‘‘(2) JUDICIAL REVIEW.— 

23 ‘‘(A) IN GENERAL.—Notwithstanding any 

24 provision of section 5, any drug manufacturer 

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1 sion that is issued in a proceeding initiated 

2 under paragraph (1)(A) may, not later than 30 

3 days after the date on which the Commission 

4 issues the order, petition for review of the order 

5 in— 

6 ‘‘(i) the United States Court of Ap7 peals for the District of Columbia Circuit; 

8 or 

9 ‘‘(ii) the court of appeals of the 

10 United States for the circuit in which the 

11 ultimate parent entity of the manufacturer 

12 is incorporated, as of the date on which the 

13 manufacturer obtains the underlying com14 position of matter patent with respect to 

15 the proceeding or files a new drug applica16 tion under section 505(b) of the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 

18 355(b)) or biological product license appli19 cation under section 351(a) of the Public 

20 Health Service Act (42 U.S.C. 262(a)) 

21 that is the subject of the proceeding, as 

22 applicable. 

23 ‘‘(B) TREATMENT OF FINDINGS.—In a re24 view of an order issued by the Commission con25 ducted by a court of appeals of the United 


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1 States under subparagraph (A), the factual 

2 findings of the Commission shall be conclusive 

3 if those facts are supported by the evidence. 

4 ‘‘(3) EQUITABLE REMEDIES.— 

5 ‘‘(A) DISGORGEMENT.— 

6 ‘‘(i) IN GENERAL.—In a suit brought 

7 under paragraph (1)(C), the Commission 

8 may seek, and the court may order, 

9 disgorgement of any unjust enrichment 

10 that a person obtained as a result of the 

11 violation that gives rise to the suit in 

12 which the Commission seeks the claim. 

13 ‘‘(ii) CALCULATION.—Any disgorge14 ment that is ordered with respect to a per15 son under clause (i) shall be offset by any 

16 amount of restitution that the person is or17 dered to pay under subparagraph (B). 

18 ‘‘(iii) LIMITATIONS PERIOD.—The 

19 Commission may bring a claim for 

20 disgorgement under this subparagraph not 

21 later than 5 years after the latest date on 

22 which the person against which the claim 

23 is brought receives any unjust enrichment 

24 from the effects of the violation that gives 


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1 rise to the suit in which the Commission 

2 seeks the claim. 

3 ‘‘(B) RESTITUTION.— 

4 ‘‘(i) IN GENERAL.—In a suit brought 

5 under paragraph (1)(C), the Commission 

6 may seek, and the court may order, res7 titution with respect to the violation that 

8 gives rise to the suit in which the Commis9 sion seeks the claim. 

10 ‘‘(ii) LIMITATIONS PERIOD.—The 

11 Commission may bring a claim for restitu12 tion under this subparagraph not later 

13 than 5 years after the latest date on which 

14 the person against which the claim is 

15 brought receives any unjust enrichment 

16 from the effects of the violation that gives 

17 rise to the suit in which the Commission 

18 seeks the claim. 

19 ‘‘(4) RULES OF CONSTRUCTION.—Nothing in 

20 this subsection may be construed as— 

21 ‘‘(A) requiring the Commission to bring a 

22 suit seeking a temporary injunction under para23 graph (1)(B) before bringing a suit seeking a 

24 permanent injunction under paragraph (1)(C); 

25 or 


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1 ‘‘(B) affecting any other authority of the 

2 Commission under this Act to seek relief or ob3 tain a remedy with respect to a violation of this 

4 Act.’’. 

5 (b) APPLICABILITY.—Section 27 of the Federal 

6 Trade Commission Act, as added by subsection (a), shall 

7 apply with respect to any— 

8 (1) conduct that occurs on or after the date of 

9 enactment of this Act; and 

10 (2) action or proceeding that is commenced on 

11 or after the date of enactment of this Act. 

12 (c) ANTITRUST LAWS.—Nothing in this section, or 

13 the amendments made by this section, shall modify, im14 pair, limit, or supersede the applicability of the antitrust 

15 laws as defined in subsection (a) of the first section of 

16 the Clayton Act (15 U.S.C. 12(a)), and of section 5 of 

17 the Federal Trade Commission Act (15 U.S.C. 45) to the 

18 extent that it applies to unfair methods of competition. 

19 (d) RULEMAKING.—The Federal Trade Commission 

20 may issue rules under section 553 of title 5, United States 

21 Code, to carry out section 27 of the Federal Trade Com22 mission Act, as added by subsection (a), including by de23 fining any terms used in such section 27. 

Æ 


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