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. 

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 ‘‘Stopping Pharma’s 

5 Ripoffs and Drug Savings For All Act’’. 

6 SEC. 2. PREVENTION OF DOUBLE PATENTING. 

7 (a) IN GENERAL.—Section 253 of title 35, United 

8 States Code, is amended by adding at the end the fol9 lowing: 

10 ‘‘(c) DISCLAIMERS OF DRUG PATENT TERM.— 


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1 ‘‘(1) IN GENERAL.—Except as provided in para2 graph (2), in a proceeding challenging the validity of 

3 patents under section 505(c) of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 355(c)) with re5 spect to a drug, under section 351(l) of the Public 

6 Health Service Act (42 U.S.C. 262(l)) with respect 

7 to a biological product, or a Federal district court 

8 proceeding involving patents that are the subject of 

9 an action under section 271(e)(2), the patentee shall 

10 be presumed to have disclaimed the patent term for 

11 each of the listed patents after the date on which the 

12 term of the first patent expires, subject to the excep13 tions provided for in subsection (2). 

14 ‘‘(2) DEMONSTRATION OF DISTINCT INVEN15 TIONS.—If a patentee demonstrates by a preponder16 ance of the evidence that certain patents described 

17 in paragraph (1) cover patentably distinct inventions 

18 from the invention claimed in the first such patent 

19 to expire, no part of the term of any such patent 

20 shall be presumed to have been disclaimed, and all 

21 patent term extensions granted by the United States 

22 Patent and Trademark Office shall be respected, un23 less and to the extent the patentee expressly dis24 claims, in writing, the patent term for each such 

25 patent.’’. 


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1 (b) USPTO REVIEW.— 

2 (1) DEFINITIONS.—In this subsection— 

3 (A) the term ‘‘Office’’ means the United 

4 States Patent and Trademark Office; and 

5 (B) the term ‘‘Director’’ means the Under 

6 Secretary of Commerce for Intellectual Property 

7 and Director of the Office. 

8 (2) REVIEW.—The Director shall conduct a 

9 comprehensive review of the patent examination pro10 cedures of the Office to determine whether the Of11 fice— 

12 (A) is using best examination practices, 

13 guidance, and procedures to avoid the issuance 

14 of patents relating to the same drug, or biologi15 cal product, that are not patentably distinct 

16 from one another, and not subject to an appro17 priate disclaimer of patent term; and 

18 (B) should develop and implement new 

19 practices, guidance, or procedures to— 

20 (i) improve examination of patent ap21 plications relating to the same drug or bio22 logical product; and 

23 (ii) reduce the improper issuance of 

24 patents that improperly extend the term of 


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1 exclusivity afforded a new drug or biologi2 cal product. 

3 (3) REPORT.—Not later than 1 year after the 

4 date of enactment of this Act, the Director shall 

5 submit to the Committee on the Judiciary of the 

6 House of Representatives a report that contains— 

7 (A) the findings from the review conducted 

8 under paragraph (2); and 

9 (B) any recommendations of the Director 

10 with respect to the review conducted under 

11 paragraph (2). 

Æ 


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