I 

116TH CONGRESS 

1ST SESSION H. R. 3199 

To amend title 35, United States Code, to prevent double patenting, and 

for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 11, 2019 

Mr. JEFFRIES (for himself, Mr. COLLINS of Georgia, Ms. MUCARSEL-POWELL, 

and Mr. CLINE) 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 ‘‘Terminating the Ex5 tension of Rights Misappropriated Act of 2019’’ or the 

6 ‘‘Term Act of 2019’’. 

7 SEC. 2. PREVENTION OF DOUBLE PATENTING. 

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

9 States Code, is amended by adding at the end the fol10 lowing: 


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

2 ‘‘(1) IN GENERAL.—Except as provided in para3 graph (2), in a proceeding challenging the validity of 

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

5 Drug, and Cosmetic Act (21 U.S.C. 355(c)) with re6 spect to a drug, under section 351(l) of the Public 

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

8 to a biological product, or a Federal district court 

9 proceeding involving patents that are the subject of 

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

11 be presumed to have disclaimed the patent term for 

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

13 term of the first patent expires, subject to the excep14 tions provided for in subsection (2). 

15 ‘‘(2) DEMONSTRATION OF DISTINCT INVEN16 TIONS.—If a patentee demonstrates by a preponder17 ance of the evidence that certain patents described 

18 in paragraph (1) cover patentably distinct inventions 

19 from the invention claimed in the first such patent 

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

21 shall be presumed to have been disclaimed, and all 

22 patent term extensions granted by the United States 

23 Patent and Trademark Office shall be respected, un24 less and to the extent the patentee expressly disVerDate Sep 11 2014 04:24 Jun 14, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3199.IH H3199

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1 claims, in writing, the patent term for each such 

2 patent.’’. 

3 (b) USPTO REVIEW.— 

4 (1) DEFINITIONS.—In this subsection— 

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

6 States Patent and Trademark Office; and 

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

8 Secretary of Commerce for Intellectual Property 

9 and Director of the Office. 

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

11 comprehensive review of the patent examination pro12 cedures of the Office to determine whether the Of13 fice— 

14 (A) is using best examination practices, 

15 guidance, and procedures to avoid the issuance 

16 of patents relating to the same drug, or biologi17 cal product, that are not patentably distinct 

18 from one another, and not subject to an appro19 priate disclaimer of patent term; and 

20 (B) should develop and implement new 

21 practices, guidance, or procedures to— 

22 (i) improve examination of patent ap23 plications relating to the same drug or bio24 logical product; and 


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1 (ii) reduce the improper issuance of 

2 patents that improperly extend the term of 

3 exclusivity afforded a new drug or biologi4 cal product. 

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

6 date of enactment of this Act, the Director shall 

7 submit to the Committee on the Judiciary of the 

8 House of Representatives a report that contains— 

9 (A) the findings from the review conducted 

10 under paragraph (2); and 

11 (B) any recommendations of the Director 

12 with respect to the review conducted under 

13 paragraph (2). 

Æ 


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