United States HR 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act

Bill Text

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117TH CONGRESS
1ST SESSION H. R. 2884
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
APRIL 28, 2021
Mr. JOHNSON of Georgia (for himself and Mr. ISSA) 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 im-
prove the process for subsection (k) applicants to resolve
patent infringement claims for biological products (com-
monly known as the ‘‘patent dance’’), and for other
purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Affordable Prescrip-4
tions for Patients Through Improvements to Patent Liti-5
gation Act’’. 6
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SEC. 2. TITLE 35 AMENDMENTS. 1
(a) IN GENERAL.—Section 271(e) of title 35, United 2
States Code, is amended— 3
(1) in paragraph (2)(C), in the flush text fol-4
lowing clause (ii), by adding at the end the fol-5
lowing: ‘‘With respect to a submission described in 6
clause (ii), the act of infringement shall extend to 7
any patent that claims the biological product, a 8
method of using the biological product, or a method 9
or product used to manufacture the biological prod-10
uct.’’; and 11
(2) by adding at the end the following: 12
‘‘(7)(A) Subject to subparagraphs (C), (D), and (E), 13
if the sponsor of an approved application for a reference 14
product, as defined in section 351(i) of the Public Health 15
Service Act (42 U.S.C. 262(i)) (referred to in this para-16
graph as the ‘reference product sponsor’), brings an action 17
for infringement under this section against an applicant 18
for approval of a biological product under section 351(k) 19
of such Act that references that reference product (re-20
ferred to in this paragraph as the ‘subsection (k) appli-21
cant’), the reference product sponsor may assert in the 22
action a total of not more than 20 patents of the type 23
described in subparagraph (B), not more than 10 of which 24
shall have issued after the date specified in section 25
351(l)(7)(A) of such Act. 26
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‘‘(B) The patents described in this subparagraph are 1
patents that satisfy each of the following requirements: 2
‘‘(i) Patents that claim the biological product 3
that is the subject of an application under section 4
351(k) of the Public Health Service Act (42 U.S.C. 5
262(k)) (or a use of that product) or a method or 6
product used in the manufacture of such biological 7
product. 8
‘‘(ii) Patents that are included on the list of 9
patents described in section 351(l)(3)(A) of the Pub-10
lic Health Service Act (42 U.S.C. 262(l)(3)(A)), in-11
cluding as provided under section 351(l)(7) of such 12
Act. 13
‘‘(iii) Patents that— 14
‘‘(I) have an actual filing date of more 15
than 4 years after the date on which the ref-16
erence product is approved; or 17
‘‘(II) include a claim to a method in a 18
manufacturing process that is not used by the 19
reference product sponsor. 20
‘‘(C) The court in which an action described in sub-21
paragraph (A) is brought may increase the number of pat-22
ents limited under that subparagraph— 23
‘‘(i) if the request to increase that number is 24
made without undue delay; and 25
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‘‘(ii)(I) if the interest of justice so requires; or 1
‘‘(II) for good cause shown, which— 2
‘‘(aa) shall be established if the subsection 3
(k) applicant fails to provide information re-4
quired under section 351(k)(2)(A) of the Public 5
Health Service Act (42 U.S.C. 262(k)(2)(A)) 6
that would enable the reference product sponsor 7
to form a reasonable belief with respect to 8
whether a claim of infringement under this sec-9
tion could 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 re-13
spect to the biological product) of the sub-14
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 fail-22
ure of the Office to issue the patent or a 23
delay in the issuance of the patent, as de-24
scribed in p