II 

Calendar No. 132 

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, Mr. BLUMENTHAL, Mrs. CAPITO, Mrs. MURRAY, 

Mr. SCOTT of Florida, Mr. KENNEDY, Mr. HAWLEY, and Mr. DURBIN) 

introduced the following bill; which was read twice and referred to the 

Committee on the Judiciary 

JUNE 28 (legislative day, JUNE 27), 2019 

Reported by Mr. GRAHAM, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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’’. 


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1 SEC. 2. PRODUCT HOPPING; PATENT THICKETING. 

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

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

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

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

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

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

8 The term ‘abbreviated new drug application’ means 

9 an application under subsection (b)(2) or (j) of sec10 tion 505 of the Federal Food, Drug, and Cosmetic 

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

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

13 term ‘biosimilar biological product’ means a biologi14 cal product licensed under section 351(k) of the 

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

16 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT LI17 CENSE APPLICATION.—The term ‘biosimilar biologi18 cal product license application’ means an application 

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

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

21 ‘‘(4) COMPETITION WINDOW.—The term ‘com22 petition window’ means— 

23 ‘‘(A) with respect to a listed drug, the pe24 riod between— 

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


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1 ‘‘(I) 8 years before any patent or 

2 marketing exclusivity granted under 

3 chapter V of the Federal Food, Drug, 

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

5 seq.) with respect to such listed drug 

6 expires; and 

7 ‘‘(II) the date on which the first 

8 abbreviated new drug application that 

9 references such listed drug is filed; 

10 and 

11 ‘‘(ii) the later of— 

12 ‘‘(I) the date that is 180 days 

13 after the first abbreviated new drug 

14 application that references such listed 

15 drug is filed; and 

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

17 the date on which the generic drug 

18 that is the subject of the abbreviated 

19 new drug application described in sub20 clause (I) enters the marketplace; or 

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

22 the period between— 

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

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

25 marketing exclusivity (including any 


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1 extension of such exclusivity) granted 

2 under section 351 of the Public 

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

4 or section 527 of the Federal Food, 

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

6 360cc) with respect to such reference 

7 product expires; and 

8 ‘‘(II) the date on which the first 

9 biosimilar biological product license 

10 application that references such ref11 erence product is filed; and 

12 ‘‘(ii) the later of— 

13 ‘‘(I) the date that is 180 days 

14 after the date on which the first bio15 similar biological product license ap16 plication that references such ref17 erence product enters the market18 place; and 

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

20 the date on which the biosimilar bio21 logical product that is the subject of 

22 the biosimilar biological product li23 cense application described in sub24 clause (I) enters the marketplace. 


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1 ‘‘(5) EXPECTED REVENUE.—The term ‘ex2 pected revenue’, with respect to a follow-on product, 

3 means the financial value represented by the number 

4 of individuals in the target population multiplied by 

5 the financial revenue generated by each member of 

6 the target population over the 3-year period begin7 ning— 

8 ‘‘(A) on the day that 3 generic drugs ref9 erencing the same listed drug or 2 or more bio10 similar biological products referencing the same 

11 reference product would have been widely avail12 able in the market; or 

13 ‘‘(B) if 3 or more generic drugs ref14 erencing the same listed drug or 2 or more bio15 similar biological products referencing the same 

16 reference product are already widely available in 

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

18 enters the market. 

19 ‘‘(6) FOLLOW-ON PRODUCT.—The term ‘follow20 on product’ means a drug approved through an ap21 plication or supplement to an application submitted 

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

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

24 product licensed through an application or supple25 ment to an application submitted under section 


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1 351(a) of the Public Health Service Act (42 U.S.C. 

2 262(a)) for a change, modification, or reformulation 

3 to the same manufacturer’s previously approved 

4 drug or biological product. 

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

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

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

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

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

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

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

12 355(j)(7)). 

13 ‘‘(9) PATENT FAMILY.—The term ‘patent fam14 ily’ means a group of related patents that continue 

15 the priority date of the underlying composition of 

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

17 biological product or a use of the same drug or bio18 logical product. 

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

20 portfolio’ means a group of related patents covering 

21 the same or similar technical content. 

22 ‘‘(11) PATENT THICKETING.— 

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

24 thicketing’ means an action taken to limit com25 petition by a patentee with respect to a drug 


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1 approved under section 505(c) of the Federal 

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

3 355(c)) or a biological product licensed under 

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

5 (42 U.S.C. 262(a)) in which— 

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

7 the same patent family or patent port8 folio— 

9 ‘‘(aa) that claim the drug or bio10 logical product or a use of the drug or 

11 biological product, a form of the drug 

12 or biological product, a method of use 

13 of the drug or biological product, or a 

14 method of manufacture of a drug or 

15 biological product; and 

16 ‘‘(bb) whose effective filing date 

17 does not precede the date of filing the 

18 application under section 505(b) of 

19 the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 355(b)) or sec21 tion 351(a) of the Public Health Serv22 ice Act (42 U.S.C. 262(a)); or 

23 ‘‘(II) the underlying composition of 

24 matter patent is found invalid and the pat25 entee obtains patents in the same patent 


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1 family or patent portfolio that claim the 

2 drug or biological product or a use of the 

3 drug or biological product, a form of the 

4 drug or biological product, a method of use 

5 of the drug or biological product, or a 

6 method of manufacture of the drug or bio7 logical product; 

8 ‘‘(ii) an abbreviated new drug applica9 tion referencing such approved drug or a 

10 biosimilar biological product license appli11 cation referencing such licensed biological 

12 product could not be marketed without 

13 practicing one or more of the inventions 

14 claimed in the additional patents described 

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

16 ‘‘(iii) the Commission determines that 

17 the patentee improperly limited competi18 tion by obtaining patents described in sub19 clause (I) or (II) of clause (i). 

20 ‘‘(B) FACTORS TO CONSIDER.—The Com21 mission may establish that an action described 

22 in subparagraph (A) improperly limits competi23 tion if the Commission establishes a reasonable 

24 number of the following factors in a manner 


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1 that is sufficient to demonstrate anticompetitive 

2 intent: 

3 ‘‘(i) The additional patents described 

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

5 subparagraph as the ‘additional patents’) 

6 stem from few patent families. 

7 ‘‘(ii) The additional patents have com8 mon specifications. 

9 ‘‘(iii) The additional patents did not 

10 issue on an application with respect to 

11 which a requirement for restriction under 

12 section 121 of title 35, United States 

13 Code, has been made, or on an application 

14 filed as a result of such a requirement. 

15 ‘‘(iv) The additional patents have 

16 overlapping or identical claims. 

17 ‘‘(v) The additional patents have been 

18 granted to the patentee on formulations or 

19 compositions of the product and not used. 

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

21 patents have been invalidated in an inter 

22 partes review conducted under chapter 31 

23 of title 35, United States Code, or a post24 grant proceeding conducted under chapter 

25 32 of that title. 


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1 ‘‘(vii) Litigation with applicants under 

2 section 351(k) of the Public Health Service 

3 Act has been extended based on the addi4 tional patents. 

5 ‘‘(viii) The applications with respect 

6 to the additional patents described in sub7 clause (I) or (II) of subparagraph (A)(i) 

8 are submitted not more than 36 months 

9 before the expiration of the underlying 

10 composition of matter patent. 

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

12 shareholder call, or another demonstration 

13 of purpose that the patentee intended to 

14 use the number of patents or length of ex15 tended patent protection in order to unduly 

16 limit competition. 

17 ‘‘(12) REFERENCE PRODUCT.—The term ‘ref18 erence product’ has the meaning given the term in 

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

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

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

22 population’, with respect to a drug, means the popu23 lation of individuals that— 

24 ‘‘(A) would experience a significant health 

25 improvement from a follow-on product; and 


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

2 product solely because of the significant health 

3 improvement that those individuals would expe4 rience. 

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

6 ‘ultimate parent entity’ has the meaning given the 

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

8 Regulations, or any successor regulation. 

9 ‘‘(15) UNDERLYING COMPOSITION OF MATTER

10 PATENT.—The term ‘underlying composition of mat11 ter patent’ means a patent with respect to the mol12 ecules, compounds, or new formulations of the active 

13 ingredient of a drug or biological product. 

14 ‘‘(b) PROHIBITIONS.— 

15 ‘‘(1) PATENT THICKETING.— 

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

17 subparagraph (B), an action by a drug manu18 facturer that constitutes patent thicketing shall 

19 be considered to be an unfair method of com20 petition in or affecting commerce in violation of 

21 section 5(a). 

22 ‘‘(B) REBUTTAL.— 

23 ‘‘(i) IN GENERAL.—Subject to sub24 paragraph (C), an action that constitutes 

25 patent thicketing shall not be considered to 


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1 be an unfair method of competition in or 

2 affecting commerce in violation of section 

3 5(a) if the manufacturer described in that 

4 paragraph demonstrates to the Commis5 sion or a district court of the United 

6 States, as applicable, by a preponderance 

7 of the evidence in a proceeding initiated by 

8 the Commission under subsection 

9 (c)(1)(A), or in a suit brought under sub10 paragraph (B) or (C) of subsection (c)(1), 

11 that the anticompetitive effects of the ac12 tion do not outweigh the pro-competitive 

13 effects of the action. 

14 ‘‘(ii) EVIDENCE.—In making a dem15 onstration under clause (i) that the anti16 competitive effects of patent thicketing do 

17 not outweigh the pro-competitive effects of 

18 that behavior, a manufacturer described in 

19 subparagraph (A)— 

20 ‘‘(I) may present evidence that— 

21 ‘‘(aa) the inventions claimed 

22 in the additional patents de23 scribed in subclauses (I) and (II) 

24 of subsection (a)(11)(A)(i) re25 sulted in— 


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1 ‘‘(AA) clinically mean2 ingful and significant thera3 peutic or safety benefits; 

4 ‘‘(BB) significantly im5 proved product purity or po6 tency; 

7 ‘‘(CC) significant 

8 gained efficiencies in manu9 facturing; or 

10 ‘‘(DD) other improved 

11 product attributes having 

12 substantial benefits for con13 sumers or patients; 

14 ‘‘(bb) a generic drug or bio15 similar biological product could 

16 be marketed commercially with17 out incorporating the improve18 ments claimed in the additional 

19 patents described in item (aa); or 

20 ‘‘(cc) for each of the later 

21 filed patents, the manufacturer 

22 had substantial financial reason, 

23 apart from the financial effects 

24 of reduced competition, to file 

25 each of the patents; and 


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1 ‘‘(II) in making a demonstration 

2 under subclause (I), shall submit to 

3 the Commission or the court, as appli4 cable, all research and development, 

5 manufacturing, marketing, and other 

6 costs associated with approval of the 

7 original drug under section 505(c) of 

8 the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 355(c)) or licen10 sure of the original biological product 

11 under section 351(a) of the Public 

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

13 262(a)), which— 

14 ‘‘(aa) shall include— 

15 ‘‘(AA) any documents 

16 relating to the costs and 

17 benefits of the later filed 

18 patents with respect to pa19 tients who use the drug; and 

20 ‘‘(BB) any applications 

21 for patents that were filed 

22 and rejected; and 

23 ‘‘(bb) shall not be construed 

24 to limit the information that the 

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1 plicable, may otherwise obtain in 

2 any proceeding or action insti3 tuted with respect to a violation 

4 of this section. 

5 ‘‘(C) RESPONSE.—The Commission may 

6 rebut any evidence presented by a drug manu7 facturer under subparagraph (B) by estab8 lishing by a preponderance of the evidence that 

9 the harm to consumers from the action that is 

10 the subject of that presentation is greater than 

11 the benefits to consumers from that action. 

12 ‘‘(2) PRODUCT HOPPING.— 

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

14 subparagraph (B), any of the following actions 

15 by a manufacturer of a reference product or 

16 listed drug shall be considered to be an unfair 

17 method of competition in or affecting commerce 

18 in violation of section 5(a): 

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

20 the date on which the manufacturer of the 

21 reference drug receives notice that an ap22 plicant has submitted to the Commissioner 

23 of Food and Drugs an abbreviated new 

24 drug application or biosimilar biological 

25 product license application and ending on 


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1 the date that is 180 days after the date on 

2 which that generic drug or biosimilar bio3 logical product first enters, or could enter, 

4 the market, or is denied— 

5 ‘‘(I) upon the request of the 

6 manufacturer of the listed drug or 

7 reference product, the Commissioner 

8 of Food and Drugs— 

9 ‘‘(aa) withdraws the ap10 proval of the application for the 

11 listed drug or reference product; 

12 or 

13 ‘‘(bb) places the listed drug 

14 or reference product on the dis15 continued products list; or 

16 ‘‘(II) the manufacturer of the 

17 listed drug or reference product an18 nounces discontinuance of, or intent 

19 to withdraw, the application for the 

20 reference product. 

21 ‘‘(ii) The manufacturer of a previously 

22 approved drug or biological product mar23 kets or sells a follow-on product during the 

24 competition window. 

25 ‘‘(B) REBUTTAL.— 


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1 ‘‘(i) IN GENERAL.—Subject to sub2 paragraph (C), an action described in sub3 paragraph (A) shall not be considered to 

4 be an unfair method of competition in or 

5 affecting commerce if— 

6 ‘‘(I) with respect to an action de7 scribed in subparagraph (A)(i), the 

8 manufacturer of the listed drug or 

9 reference product demonstrates to the 

10 Commission or a district court of the 

11 United States, as applicable, by a pre12 ponderance of the evidence in a pro13 ceeding initiated by the Commission 

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

15 suit brought under subparagraph (B) 

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

17 manufacturer removed such drug 

18 from the market for significant and 

19 documented safety reasons; or 

20 ‘‘(II) with respect to an action 

21 described in subparagraph (A)(ii)— 

22 ‘‘(aa) the manufacturer 

23 demonstrates to the Commission 

24 or a district court of the United 

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1 ponderance of the evidence in a 

2 proceeding initiated by the Com3 mission under subsection 

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

5 under subparagraph (B) or (C) 

6 of subsection (c)(1), that— 

7 ‘‘(AA) the follow-on 

8 product described in such 

9 subparagraph (A)(ii) (re10 ferred to in this subclause as 

11 the ‘follow-on product’) pro12 vides a clinically meaningful 

13 and significant additional 

14 health benefit to the target 

15 population beyond that pro16 vided by the previously ap17 proved drug or biological 

18 product; 

19 ‘‘(BB) the follow-on 

20 product was the available 

21 means that was least likely 

22 to reduce competition; and 

23 ‘‘(CC) the manufac24 turer had substantive finan25 cial reasons, apart from the 


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1 financial effects of reduced 

2 competition, to introduce the 

3 follow-on product to the 

4 market; and 

5 ‘‘(bb) in making the dem6 onstration required under item 

7 (aa), the manufacturer provides 

8 to the Commission— 

9 ‘‘(AA) all research and 

10 development, manufacturing, 

11 marketing, and other related 

12 costs associated with the 

13 drug or biological product 

14 previously approved under 

15 section 505(c) of the Fed16 eral Food, Drug, and Cos17 metic Act (21 U.S.C. 

18 355(c)) or section 351(a) of 

19 the Public Health Service 

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

21 the follow-on product, in22 cluding all documents, 

23 memos, or other business 

24 documents that explain, 

25 mention, or otherwise justify 


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1 the decision of the manufac2 turer to develop and manu3 facture the follow-on prod4 uct; and 

5 ‘‘(BB) the revenue ob6 tained by the manufacturer 

7 with respect to the drug or 

8 biological product previously 

9 approved under section 

10 505(c) of the Federal Food, 

11 Drug, and Cosmetic Act (21 

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

13 351(a) of the Public Health 

14 Service Act (42 U.S.C. 

15 262(a)) and the expected 

16 revenue of the manufacturer 

17 with respect to the pre18 viously approved drug or bi19 ological product and the fol20 low-on product. 

21 ‘‘(ii) RULE OF CONSTRUCTION.— 

22 Nothing in clause (i) may be construed to 

23 limit the information that the Commission 

24 may otherwise obtain in any proceeding or 


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1 action instituted 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 

7 that— 

8 ‘‘(i) the harm to consumers of the 

9 drug or biological product that is the sub10 ject of the product from the action that is 

11 the subject of that presentation is greater 

12 than the benefits to consumers of the drug 

13 or biological product that is the subject of 

14 challenged action; or 

15 ‘‘(ii) a primary purpose of the manu16 facturer in pursuing the challenged action 

17 was to block or otherwise hinder the entry 

18 into the market of a generic drug or bio19 similar biological product. 

20 ‘‘(c) ENFORCEMENT.— 

21 ‘‘(1) IN GENERAL.—If the Commission has rea22 son to believe that any drug manufacturer has vio23 lated, is violating, or is about to violate this section, 

24 the Commission may take any of the following ac25 tions: 


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1 ‘‘(A) Institute a proceeding— 

2 ‘‘(i) that, except as provided in para3 graph (2), complies with the requirements 

4 under section 5(b); and 

5 ‘‘(ii) in which the Commission may 

6 impose on the manufacturer any penalty 

7 that the Commission may impose for a vio8 lation of section 5. 

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

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

11 in a district court of the United States to tem12 porarily enjoin the action of the drug manufac13 turer. 

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

15 United States to permanently enjoin the action 

16 of the drug manufacturer. 

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

18 Commission may seek— 

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

20 paragraph (3); and 

21 ‘‘(II) any other equitable remedy, in22 cluding ancillary equitable relief. 

23 ‘‘(2) JUDICIAL REVIEW.— 

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

25 provision of section 5, any drug manufacturer 


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1 that is subject to a final order of the Commis2 sion that is issued in a proceeding initiated 

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

4 days after the date on which the Commission 

5 issues the order, petition for review of the order 

6 in— 

7 ‘‘(i) the United States Court of Ap8 peals for the District of Columbia Circuit; 

9 or 

10 ‘‘(ii) the court of appeals of the 

11 United States for the circuit in which the 

12 ultimate parent entity of the manufacturer 

13 is incorporated, as of the date on which the 

14 manufacturer obtains the underlying com15 position of matter patent with respect to 

16 the proceeding or files a new drug applica17 tion under section 505(b) of the Federal 

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

19 355(b)) or biological product license appli20 cation under section 351(a) of the Public 

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

22 that is the subject of the proceeding, as 

23 applicable. 

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1 ducted by a court of appeals of the United 

2 States under subparagraph (A), the factual 

3 findings of the Commission shall be conclusive 

4 if those facts are supported by the evidence. 

5 ‘‘(3) EQUITABLE REMEDIES.— 

6 ‘‘(A) DISGORGEMENT.— 

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

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

9 may seek, and the court may order, 

10 disgorgement of any unjust enrichment 

11 that a person obtained as a result of the 

12 violation that gives rise to the suit in 

13 which the Commission seeks the claim. 

14 ‘‘(ii) CALCULATION.—Any disgorge15 ment that is ordered with respect to a per16 son under clause (i) shall be offset by any 

17 amount of restitution that the person is or18 dered to pay under subparagraph (B). 

19 ‘‘(iii) LIMITATIONS PERIOD.—The 

20 Commission may bring a claim for 

21 disgorgement under this subparagraph not 

22 later than 5 years after the latest date on 

23 which the person against which the claim 

24 is brought receives any unjust enrichment 

25 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. 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Affordable Prescriptions 

3 for Patients Act of 2019’’. 

4 SEC. 2. PRODUCT HOPPING. 

5 (a) IN GENERAL.—The Federal Trade Commission Act 

6 (15 U.S.C. 41 et seq.) is amended by inserting after section 

7 26 (15 U.S.C. 57c–2) the following: 

8 ‘‘SEC. 27. PRODUCT HOPPING. 

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

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

11 The term ‘abbreviated new drug application’ means 

12 an application under subsection (b)(2) or (j) of sec13 tion 505 of the Federal Food, Drug, and Cosmetic Act 

14 (21 U.S.C. 355). 

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

16 term ‘biosimilar biological product’ means a biologi17 cal product licensed under section 351(k) of the Public 

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

19 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT LICENSE

20 APPLICATION.—The term ‘biosimilar biological prod21 uct license application’ means an application sub22 mitted under section 351(k) of the Public Health 

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

24 ‘‘(4) FOLLOW-ON PRODUCT.—The term ‘follow-on 

25 product’— 


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1 ‘‘(A) means a drug approved through an 

2 application or supplement to an application sub3 mitted under section 505(b) of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 355(b)) or a 

5 biological product licensed through an applica6 tion or supplement to an application submitted 

7 under section 351(a) of the Public Health Service 

8 Act (42 U.S.C. 262(a)) for a change, modifica9 tion, or reformulation to the same manufactur10 er’s previously approved drug or biological prod11 uct that treats the same medical condition; and 

12 ‘‘(B) excludes such an application or sup13 plement to an application for a change, modi14 fication, or reformulation of a drug or biological 

15 product that is requested by the Secretary or nec16 essary to comply with law, including sections 

17 505A and 505B of the Federal Food, Drug, and 

18 Cosmetic Act (21 U.S.C. 355a, 355c). 

19 ‘‘(5) GENERIC DRUG.—The term ‘generic drug’ 

20 means a drug approved under an application sub21 mitted under subsection (b)(2) or (j) of section 505 of 

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

23 355). 

24 ‘‘(6) LISTED DRUG.—The term ‘listed drug’ 

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


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

2 355(j)(7)). 

3 ‘‘(7) MANUFACTURER.—The term ‘manufacturer’ 

4 means the holder, licensee, or assignee of— 

5 ‘‘(A) an approved application for a drug 

6 under section 505(c) of the Federal Food, Drug, 

7 and Cosmetic Act (21 U.S.C. 355(c)); or 

8 ‘‘(B) a biological product license under sec9 tion 351(a) of the Public Health Service Act (42 

10 U.S.C. 262(a)). 

11 ‘‘(8) REFERENCE PRODUCT.—The term ‘reference 

12 product’ has the meaning given the term in section 

13 351(i) of the Public Health Service Act (42 U.S.C. 

14 262(i)). 

15 ‘‘(9) ULTIMATE PARENT ENTITY.—The term ‘ul16 timate parent entity’ has the meaning given the term 

17 in section 801.1 of title 16, Code of Federal Regula18 tions, or any successor regulation. 

19 ‘‘(b) PROHIBITION ON PRODUCT HOPPING.— 

20 ‘‘(1) PRIMA FACIE.—Except as provided in para21 graph (2), a manufacturer of a reference product or 

22 listed drug shall be considered to have engaged in an 

23 unfair method of competition in or affecting com24 merce in violation of section 5(a) if the Commission 

25 demonstrates by a preponderance of the evidence in a 


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1 proceeding initiated by the Commission under sub2 section (c)(1)(A), or in a suit brought under subpara3 graph (B) or (C) of subsection (c)(1), that, during the 

4 period beginning on the date on which the manufac5 turer of the reference product or listed drug first re6 ceives notice that an applicant has submitted to the 

7 Commissioner of Food and Drugs an abbreviated new 

8 drug application or biosimilar biological product li9 cense application and ending on the date that is 180 

10 days after the date on which that generic drug or bio11 similar biological product is first marketed, the man12 ufacturer engaged in either of the following actions: 

13 ‘‘(A) The manufacturer engaged in a hard 

14 switch, which shall be established by dem15 onstrating that the manufacturer engaged in ei16 ther of the following actions: 

17 ‘‘(i) Upon the request of the manufac18 turer of the listed drug or reference product, 

19 the Commissioner of Food and Drugs with20 drew the approval of the application for the 

21 listed drug or reference product or placed 

22 the listed drug or reference product on the 

23 discontinued products list and the manufac24 turer marketed or sold a follow-on product. 


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1 ‘‘(ii) The manufacturer of the listed 

2 drug or reference product— 

3 ‘‘(I)(aa) announced withdrawal 

4 of, discontinuance of the manufacture 

5 of, or intent to withdraw the applica6 tion with respect to the drug or ref7 erence product in a manner that im8 pedes competition from a generic drug 

9 or a biosimilar biological product, as 

10 established by objective circumstances; 

11 or 

12 ‘‘(bb) destroyed the inventory of 

13 the listed drug or reference product in 

14 a manner that impedes competition 

15 from a generic drug or a biosimilar bi16 ological product, which may be estab17 lished by objective circumstances; and 

18 ‘‘(II) marketed or sold a follow-on 

19 product. 

20 ‘‘(B) The manufacturer engaged in a soft 

21 switch, which shall be established by dem22 onstrating that the manufacturer engaged in 

23 both of the following actions: 

24 ‘‘(i) The manufacturer took actions 

25 with respect to the listed drug or reference 


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1 product other than those described in sub2 paragraph (A) that unfairly disadvantage 

3 the listed drug or reference product relative 

4 to the follow-on product described in clause 

5 (ii) in a manner that impedes competition 

6 from a generic drug or a biosimilar biologi7 cal product that is highly similar to, and 

8 has no clinically meaningful difference with 

9 respect to safety, purity, and potency from, 

10 the reference product, which may be estab11 lished by objective circumstances. 

12 ‘‘(ii) The manufacturer marketed or 

13 sold a follow-on product. 

14 ‘‘(2) JUSTIFICATION.— 

15 ‘‘(A) IN GENERAL.—Subject to paragraph 

16 (3), the actions described in paragraph (1) by a 

17 manufacturer of a listed drug or reference prod18 uct shall not be considered to be an unfair meth19 od of competition in or affecting commerce if— 

20 ‘‘(i) the manufacturer demonstrates to 

21 the Commission or a district court of the 

22 United States, as applicable, by a prepon23 derance of the evidence in a proceeding ini24 tiated by the Commission under subsection 

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1 paragraph (B) or (C) of subsection (c)(1), 

2 that— 

3 ‘‘(I) the manufacturer would have 

4 taken the actions regardless of whether 

5 a generic drug that references the listed 

6 drug or biosimilar biological product 

7 that references the reference product 

8 had already entered the market; and 

9 ‘‘(II)(aa) with respect to a hard 

10 switch under paragraph (1)(A), the 

11 manufacturer took the action for rea12 sons relating to the safety risk to pa13 tients of the listed drug or reference 

14 product; 

15 ‘‘(bb) with respect to an action de16 scribed in item (aa) or (bb) of para17 graph (1)(A)(ii)(I), there is a supply 

18 disruption that— 

19 ‘‘(AA) is outside of the con20 trol of the manufacturer; 

21 ‘‘(BB) prevents the produc22 tion or distribution of the appli23 cable listed drug or reference 

24 product; and 


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1 ‘‘(CC) cannot be remedied by 

2 reasonable efforts; or 

3 ‘‘(cc) with respect to a soft switch 

4 under paragraph (1)(B), the manufac5 turer had legitimate pro-competitive 

6 reasons, apart from the financial ef7 fects of reduced competition, to take the 

8 action. 

9 ‘‘(B) RULE OF CONSTRUCTION.—Nothing in 

10 subparagraph (A) may be construed to limit the 

11 information that the Commission may otherwise 

12 obtain in any proceeding or action instituted 

13 with respect to a violation of this section. 

14 ‘‘(3) RESPONSE.—With respect to a justification 

15 offered by a manufacturer under paragraph (2), the 

16 Commission may— 

17 ‘‘(A) rebut any evidence presented by a 

18 manufacturer during that justification; or 

19 ‘‘(B) establish by a preponderance of the 

20 evidence that, on balance, the pro-competitive 

21 benefits from the conduct described in subpara22 graph (A) or (B) of paragraph (1), as applica23 ble, do not outweigh any anticompetitive effects 

24 of the conduct, even in consideration of the jus25 tification so offered. 


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1 ‘‘(c) ENFORCEMENT.— 

2 ‘‘(1) IN GENERAL.—If the Commission has rea3 son to believe that any manufacturer has violated, is 

4 violating, or is about to violate this section, the Com5 mission may take any of the following actions: 

6 ‘‘(A) Institute a proceeding— 

7 ‘‘(i) that, except as provided in para8 graph (2), complies with the requirements 

9 under section 5(b); and 

10 ‘‘(ii) in which the Commission may 

11 impose on the manufacturer any penalty 

12 that the Commission may impose for a vio13 lation of section 5. 

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

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

16 a district court of the United States to tempo17 rarily enjoin the action of the manufacturer. 

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

19 United States, in which the Commission may 

20 seek— 

21 ‘‘(i) to permanently enjoin the action 

22 of the manufacturer; 

23 ‘‘(ii) any of the remedies described in 

24 paragraph (3); and 


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1 ‘‘(iii) any other equitable remedy, in2 cluding ancillary equitable relief. 

3 ‘‘(2) JUDICIAL REVIEW.— 

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

5 provision of section 5, any manufacturer that is 

6 subject to a final order of the Commission that 

7 is issued in a proceeding instituted under para8 graph (1)(A) may, not later than 30 days after 

9 the date on which the Commission issues the 

10 order, petition for review of the order in— 

11 ‘‘(i) the United States Court of Appeals 

12 for the District of Columbia Circuit; or 

13 ‘‘(ii) the court of appeals of the United 

14 States for the circuit in which the ultimate 

15 parent entity of the manufacturer is incor16 porated. 

17 ‘‘(B) TREATMENT OF FINDINGS.—In a re18 view of an order issued by the Commission con19 ducted by a court of appeals of the United States 

20 under subparagraph (A), the factual findings of 

21 the Commission shall be conclusive if those facts 

22 are supported by the evidence. 

23 ‘‘(3) EQUITABLE REMEDIES.— 

24 ‘‘(A) DISGORGEMENT.— 


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

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

3 may seek, and the court may order, 

4 disgorgement of any unjust enrichment that 

5 a person obtained as a result of the viola6 tion that gives rise to the suit. 

7 ‘‘(ii) CALCULATION.—Any 

8 disgorgement that is ordered with respect to 

9 a person under clause (i) shall be offset by 

10 any amount of restitution ordered under 

11 subparagraph (B). 

12 ‘‘(iii) LIMITATIONS PERIOD.—The 

13 Commission may seek disgorgement under 

14 this subparagraph not later than 5 years 

15 after the latest date on which the person 

16 from which the disgorgement is sought re17 ceives any unjust enrichment from the ef18 fects of the violation that gives rise to the 

19 suit in which the Commission seeks the 

20 disgorgement. 

21 ‘‘(B) RESTITUTION.— 

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

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

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1 tion with respect to the violation that gives 

2 rise to the suit. 

3 ‘‘(ii) LIMITATIONS PERIOD.—The Com4 mission may seek restitution under this sub5 paragraph not later than 5 years after the 

6 latest date on which the person from which 

7 the restitution is sought receives any unjust 

8 enrichment from the effects of the violation 

9 that gives rise to the suit in which the Com10 mission seeks the restitution. 

11 ‘‘(4) RULES OF CONSTRUCTION.—Nothing in this 

12 subsection may be construed as— 

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

14 suit seeking a temporary injunction under para15 graph (1)(B) before bringing a suit seeking a 

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

17 or 

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

19 Commission under this Act to seek relief or ob20 tain a remedy with respect to a violation of this 

21 Act.’’. 

22 (b) APPLICABILITY.—Section 27 of the Federal Trade 

23 Commission Act, as added by subsection (a), shall apply 

24 with respect to any— 


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1 (1) conduct that occurs on or after the date of en2 actment of this Act; and 

3 (2) action or proceeding that is commenced on or 

4 after the date of enactment of this Act. 

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

6 amendments made by this section, shall modify, impair, 

7 limit, or supersede the applicability of the antitrust laws 

8 as defined in subsection (a) of the first section of the Clay9 ton Act (15 U.S.C. 12(a)), and of section 5 of the Federal 

10 Trade Commission Act (15 U.S.C. 45) to the extent that 

11 it applies to unfair methods of competition. 

12 (d) RULEMAKING.—The Federal Trade Commission 

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

14 Code, to carry out section 27 of the Federal Trade Commis15 sion Act, as added by subsection (a), including by defining 

16 any terms used in such section 27 (other than terms that 

17 are defined in subsection (a) of such section 27). 

18 SEC. 3. TITLE 35 AMENDMENTS. 

19 (a) IN GENERAL.—Section 271(e) of title 35, United 

20 States Code, is amended— 

21 (1) in paragraph (2)(C), in the flush text fol22 lowing clause (ii), by adding at the end the following: 

23 ‘‘With respect to a submission described in clause (ii), 

24 the act of infringement shall extend to any patent 

25 that claims the biological product, a method of using 


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1 the biological product, or a method or product used 

2 to manufacture the biological product.’’; and 

3 (2) by adding at the end the following: 

4 ‘‘(7)(A) Subject to subparagraphs (C), (D), and (E), 

5 if the sponsor of an approved application for a reference 

6 product, as defined in section 351(i) of the Public Health 

7 Service Act (42 U.S.C. 262(i)) (referred to in this para8 graph as the ‘reference product sponsor’), brings an action 

9 for infringement under this section against an applicant 

10 for approval of a biological product under section 351(k) 

11 of such Act that references that reference product (referred 

12 to in this paragraph as the ‘subsection (k) applicant’), the 

13 reference product sponsor may assert in the action a total 

14 of not more than 20 patents of the type described in sub15 paragraph (B), not more than 10 of which shall have issued 

16 after the date specified in section 351(l)(7)(A) of such Act. 

17 ‘‘(B) The patents described in this subparagraph are 

18 patents that satisfy each of the following requirements: 

19 ‘‘(i) Patents that claim the biological product 

20 that is the subject of an application under section 

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

22 262(k)) (or a use of that product) or a method or 

23 product used in the manufacture of such biological 

24 product. 


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1 ‘‘(ii) Patents that are included on the list of pat2 ents described in section 351(l)(3)(A) of the Public 

3 Health Service Act (42 U.S.C. 262(l)(3)(A)), includ4 ing as provided under section 351(l)(7) of such Act. 

5 ‘‘(iii) Patents that— 

6 ‘‘(I) have an actual filing date of more than 

7 4 years after the date on which the reference 

8 product is approved; or 

9 ‘‘(II) include a claim to a method in a 

10 manufacturing process that is not used by the 

11 reference product sponsor. 

12 ‘‘(C) The court in which an action described in sub13 paragraph (A) is brought may increase the number of pat14 ents limited under that subparagraph— 

15 ‘‘(i) if the request to increase that number is 

16 made without undue delay; and 

17 ‘‘(ii)(I) if the interest of justice so requires; or 

18 ‘‘(II) for good cause shown, which— 

19 ‘‘(aa) shall be established if the subsection 

20 (k) applicant fails to provide information re21 quired under section 351(l)(2)(A) of the Public 

22 Health Service Act (42 U.S.C. 262(l)(2)(A)) that 

23 would enable the reference product sponsor to 

24 form a reasonable belief with respect to whether 


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1 a claim of infringement under this section could 

2 reasonably be asserted; and 

3 ‘‘(bb) may be established— 

4 ‘‘(AA) if there is a material change to 

5 the biological product (or process with re6 spect to the biological product) of the sub7 section (k) applicant that is the subject of 

8 the application; 

9 ‘‘(BB) if, with respect to a patent on 

10 the supplemental list described in section 

11 351(l)(7)(A) of Public Health Service Act 

12 (42 U.S.C. 262(l)(7)(A)), the patent would 

13 have issued before the date specified in such 

14 section 351(l)(7)(A) but for the failure of the 

15 Office to issue the patent or a delay in the 

16 issuance of the patent, as described in para17 graph (1) of section 154(b) and subject to 

18 the limitations under paragraph (2) of such 

19 section 154(b); or 

20 ‘‘(CC) for another reason that shows 

21 good cause, as determined appropriate by 

22 the court. 

23 ‘‘(D) In determining whether good cause has been 

24 shown for the purposes of subparagraph (C)(ii)(II), a court 

25 may consider whether the reference product sponsor has proVerDate Sep 11 2014 20:45 Jun 28, 2019 Jkt 034408 PO 00000 Frm 00042 Fmt 6652 Sfmt 6203 E:\BILLS\S1416.RS S1416

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1 vided a reasonable description of the identity and relevance 

2 of any information beyond the subsection (k) application 

3 that the court believes is necessary to enable the court to 

4 form a belief with respect to whether a claim of infringe5 ment under this section could reasonably be asserted. 

6 ‘‘(E) The limitation imposed under subparagraph 

7 (A)— 

8 ‘‘(i) shall apply only if the subsection (k) appli9 cant completes all actions required under paragraphs 

10 (2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of 

11 section 351(l) of the Public Health Service Act (42 

12 U.S.C. 262(l)); and 

13 ‘‘(ii) shall not apply with respect to any patent 

14 that claims, with respect to a biological product, a 

15 method for using that product in therapy, diagnosis, 

16 or prophylaxis, such as an indication or method of 

17 treatment or other condition of use.’’. 

18 (b) APPLICABILITY.—The amendments made by sub19 section (a) shall apply with respect to an application sub20 mitted under section 351(k) of the Public Health Service 

21 Act (42 U.S.C. 262(k)) on or after the date of enactment 

22 of this Act. 


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Calendar No. 132 

116TH CONGRESS 

1ST SESSION S. 1416 

A BILL 

To amend the Federal Trade Commission Act to 

uct manufacturers, and for other purposes. prohibit anticompetitive behaviors by drug prodJUNE 28 (legislative day, JUNE 27), 2019 

Reported with an amendment 


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