I 

118TH CONGRESS 

2D SESSION H. R. 9070 

To amend title 35, United States Code, to prohibit product hopping, and 

for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 18, 2024 

Mr. ISSA (for himself and Mr. JOHNSON of Georgia) introduced the following 

bill; which was referred to the Committee on the Judiciary, and in addition to the Committees on Ways and Means, and Energy and Commerce, 

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 amend title 35, United States Code, to prohibit product 

hopping, 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 2024’’. 

6 SEC. 2. TITLE 35 AMENDMENTS. 

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

8 States Code, is amended— 


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1 (1) in paragraph (2)(C), in the flush text fol2 lowing clause (ii), by adding at the end the fol3 lowing: ‘‘With respect to a submission described in 

4 clause (ii), the act of infringement shall extend to 

5 any patent that claims the biological product, a 

6 method of using the biological product, or a method 

7 or product used to manufacture the biological prod8 uct.’’; and 

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

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

11 if the sponsor of an approved application for a reference 

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

13 Service Act (42 U.S.C. 262(i)) (referred to in this para14 graph as the ‘reference product sponsor’), brings an action 

15 for infringement under this section against an applicant 

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

17 of such Act that references that reference product (re18 ferred to in this paragraph as the ‘subsection (k) appli19 cant’), the reference product sponsor may assert in the 

20 action a total of not more than 20 patents of the type 

21 described in subparagraph (B), not more than 10 of which 

22 shall have issued after the date specified in section 

23 351(l)(7)(A) of such Act. 

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

25 patents that satisfy each of the following requirements: 


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

2 that is the subject of an application under section 

3 351(k) of the Public Health Service Act (42 U.S.C. 

4 262(k)) (or a use of that product) or a method or 

5 product used in the manufacture of such biological 

6 product. 

7 ‘‘(ii) Patents that are included on the list of 

8 patents described in paragraph (3)(A) of section 

9 351(l) of the Public Health Service Act (42 U.S.C. 

10 262(l)), including as provided under paragraph (7) 

11 of such section 351(l). 

12 ‘‘(iii) Patents that— 

13 ‘‘(I) have an actual filing date of more 

14 than 4 years after the date on which the ref15 erence product is approved; or 

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

17 manufacturing process that is not used by the 

18 reference product sponsor. 

19 ‘‘(C) The court in which an action described in sub20 paragraph (A) is brought may increase the number of pat21 ents limited under that subparagraph— 

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

23 made without undue delay; and 

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

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


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

2 (k) applicant fails to provide information re3 quired section 351(k)(2)(A) of the Public 

4 Health Service Act (42 U.S.C. 262(k)(2)(A)) 

5 that would enable the reference product sponsor 

6 to form a reasonable belief with respect to 

7 whether a claim of infringement under this sec8 tion could reasonably be asserted; and 

9 ‘‘(bb) may be established— 

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

11 the biological product (or process with re12 spect to the biological product) of the sub13 section (k) applicant that is the subject of 

14 the application; 

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

16 the supplemental list described in section 

17 351(l)(7)(A) of Public Health Service Act 

18 (42 U.S.C. 262(l)(7)(A)), the patent would 

19 have issued before the date specified in 

20 such section 351(l)(7)(A) but for the fail21 ure of the Office to issue the patent or a 

22 delay in the issuance of the patent, as de23 scribed in paragraph (1) of section 154(b) 

24 and subject to the limitations under para25 graph (2) of such section 154(b); or 


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1 ‘‘(CC) for another reason that shows 

2 good cause, as determined appropriate by 

3 the court. 

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

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

6 court may consider whether the reference product sponsor 

7 has provided a reasonable description of the identity and 

8 relevance of any information beyond the subsection (k) ap9 plication that the court believes is necessary to enable the 

10 court to form a belief with respect to whether a claim of 

11 infringement under this section could reasonably be as12 serted. 

13 ‘‘(E) The limitation imposed under subparagraph 

14 (A)— 

15 ‘‘(i) shall apply only if the subsection (k) appli16 cant completes all actions required under paragraphs 

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

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

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

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

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

22 method for using that product in therapy, diagnosis, 

23 or prophylaxis, such as an indication or method of 

24 treatment or other condition of use.’’. 


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1 (b) APPLICABILITY.—The amendments made by sub2 section (a) shall apply with respect to an application sub3 mitted under section 351(k) of the Public Health Service 

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

5 of this Act. 

6 (c) MEDICARE IMPROVEMENT FUND.—Section 

7 1898(b)(1) of the Social Security Act (42 U.S.C. 

8 1395iii(b)(1)) is amended by striking ‘‘$0’’ and inserting 

9 ‘‘$1,800,000,000’’. 

Æ 


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