I 

116TH CONGRESS 

1ST SESSION H. R. 3991 

To amend title 35, United States Code, to clarify and improve the process 

for subsection (k) applicants to resolve patent infringement claims for 

biological products (commonly known as the ‘‘patent dance’’), and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 25, 2019 

Mr. JOHNSON of Georgia (for himself and Mrs. ROBY) introduced the 

following bill; which was referred to the Committee on the Judiciary 

A BILL 

To amend title 35, United States Code, to clarify and improve the process for subsection (k) applicants to resolve 

patent infringement claims for biological products (commonly known as the ‘‘patent dance’’), 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 Through Improvements to Patent Liti6 gation Act of 2019’’. 


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1 SEC. 2. TITLE 35 AMENDMENTS. 

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

3 States Code, is amended— 

4 (1) in paragraph (2)(C), in the flush text fol5 lowing clause (ii), by adding at the end the fol6 lowing: ‘‘With respect to a submission described in 

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

8 any patent that claims the biological product, a 

9 method of using the biological product, or a method 

10 or product used to manufacture the biological prod11 uct.’’; and 

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

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

14 if the sponsor of an approved application for a reference 

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

16 Service Act (42 U.S.C. 262(i)) (referred to in this para17 graph as the ‘reference product sponsor’), brings an action 

18 for infringement under this section against an applicant 

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

20 of such Act that references that reference product (re21 ferred to in this paragraph as the ‘subsection (k) appli22 cant’), the reference product sponsor may assert in the 

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

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

25 shall have issued after the date specified in section 

26 351(l)(7)(A) of such Act. 


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

2 patents that satisfy each of the following requirements: 

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

4 that is the subject of an application under section 

5 351(k) of the Public Health Service Act (42 U.S.C. 

6 262(k)) (or a use of that product) or a method or 

7 product used in the manufacture of such biological 

8 product. 

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

10 patents described in section 351(l)(3)(A) of the Pub11 lic Health Service Act (42 U.S.C. 262(l)(3)(A)), in12 cluding as provided under section 351(l)(7) of such 

13 Act. 

14 ‘‘(iii) Patents that— 

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

16 than 4 years after the date on which the ref17 erence product is approved; or 

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

19 manufacturing process that is not used by the 

20 reference product sponsor. 

21 ‘‘(C) The court in which an action described in sub22 paragraph (A) is brought may increase the number of pat23 ents limited under that subparagraph— 

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

25 made without undue delay; and 


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

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

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

4 (k) applicant fails to provide information re5 quired under paragraph (2)(A) that would en6 able the reference product sponsor to form a 

7 reasonable belief with respect to whether a 

8 claim of infringement under this section could 

9 reasonably be asserted; and 

10 ‘‘(bb) may be established— 

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

12 the biological product (or process with re13 spect to the biological product) of the sub14 section (k) applicant that is the subject of 

15 the application; 

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

17 the supplemental list described in section 

18 351(l)(7)(A) of Public Health Service Act 

19 (42 U.S.C. 262(l)(7)(A)), the patent would 

20 have issued before the date specified in 

21 such section 351(l)(7)(A) but for the fail22 ure of the Office to issue the patent or a 

23 delay in the issuance of the patent, as de24 scribed in paragraph (1) of section 154(b) 


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1 and subject to the limitations under para2 graph (2) of such section 154(b); or 

3 ‘‘(CC) for another reason that shows 

4 good cause, as determined appropriate by 

5 the court. 

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

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

8 court may consider whether the reference product sponsor 

9 has provided a reasonable description of the identity and 

10 relevance of any information beyond the subsection (k) ap11 plication that the court believes is necessary to enable the 

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

13 infringement under this section could reasonably be as14 serted. 

15 ‘‘(E) The limitation imposed under subparagraph 

16 (A)— 

17 ‘‘(i) shall apply only if the subsection (k) appli18 cant completes all actions required under paragraphs 

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

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

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

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

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

24 method for using that product in therapy, diagnosis, 


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1 or prophylaxis, such as an indication or method of 

2 treatment or other condition of use.’’. 

3 (b) APPLICABILITY.—The amendments made by sub4 section (a) shall apply with respect to an application sub5 mitted under section 351(k) of the Public Health Service 

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

7 of this Act. 

Æ 


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