I 
118TH CONGRESS 
1ST SESSION H. R. 6436 
To amend title 35, United States Code, to prevent double patenting, and 
for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 15, 2023 
Mr. RYAN introduced the following bill; which was referred to the Committee 
on the Judiciary 
A BILL 
To amend title 35, United States Code, to prevent double 
patenting, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Stopping Pharma’s 
Ripoffs and Drug Savings For All Act’’. 
SEC. 2. PREVENTION OF DOUBLE PATENTING. 
(a) IN GENERAL.—Section 253 of title 35, United 
States Code, is amended by adding at the end the fol-
lowing: 
‘‘(c) DISCLAIMERS OF DRUG PATENT TERM.— 
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‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), in a proceeding challenging the validity of 
patents under section 505(c) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(c)) with re-
spect to a drug, under section 351(l) of the Public 
Health Service Act (42 U.S.C. 262(l)) with respect 
to a biological product, or a Federal district court 
proceeding involving patents that are the subject of 
an action under section 271(e)(2), the patentee shall 
be presumed to have disclaimed the patent term for 
each of the listed patents after the date on which the 
term of the first patent expires, subject to the excep-
tions provided for in subsection (2). 
‘‘(2) DEMONSTRATION
OF
DISTINCT
INVEN-
TIONS.—If a patentee demonstrates by a preponder-
ance of the evidence that certain patents described 
in paragraph (1) cover patentably distinct inventions 
from the invention claimed in the first such patent 
to expire, no part of the term of any such patent 
shall be presumed to have been disclaimed, and all 
patent term extensions granted by the United States 
Patent and Trademark Office shall be respected, un-
less and to the extent the patentee expressly dis-
claims, in writing, the patent term for each such 
patent.’’. 
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(b) USPTO REVIEW.— 
(1) DEFINITIONS.—In this subsection— 
(A) the term ‘‘Office’’ means the United 
States Patent and Trademark Office; and 
(B) the term ‘‘Director’’ means the Under 
Secretary of Commerce for Intellectual Property 
and Director of the Office. 
(2) REVIEW.—The Director shall conduct a 
comprehensive review of the patent examination pro-
cedures of the Office to determine whether the Of-
fice— 
(A) is using best examination practices, 
guidance, and procedures to avoid the issuance 
of patents relating to the same drug, or biologi-
cal product, that are not patentably distinct 
from one another, and not subject to an appro-
priate disclaimer of patent term; and 
(B) should develop and implement new 
practices, guidance, or procedures to— 
(i) improve examination of patent ap-
plications relating to the same drug or bio-
logical product; and 
(ii) reduce the improper issuance of 
patents that improperly extend the term of 
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exclusivity afforded a new drug or biologi-
cal product. 
(3) REPORT.—Not later than 1 year after the 
date of enactment of this Act, the Director shall 
submit to the Committee on the Judiciary of the 
House of Representatives a report that contains— 
(A) the findings from the review conducted 
under paragraph (2); and 
(B) any recommendations of the Director 
with respect to the review conducted under 
paragraph (2). 
Æ 
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