Term Act of 2019

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. 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 ‘‘Terminating the Ex- 4 tension of Rights Misappropriated Act of 2019’’ or the 5 ‘‘Term Act of 2019’’. 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 fol- 9 lowing: 10 VerDate Sep 11 2014 04:24 Jun 14, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3199.IH H3199 kjohnson on DSK79L0C42 with BILLS 2 •HR 3199 IH ‘‘(c) DISCLAIMERS OF DRUG PATENT TERM.— 1 ‘‘(1) IN GENERAL.—Except as provided in para- 2 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 re- 5 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 excep- 13 tions provided for in subsection (2). 14 ‘‘(2) DEMONSTRATION OF DISTINCT INVEN- 15 TIONS.—If a patentee demonstrates by a preponder- 16 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, un- 23 less and to the extent the patentee expressly dis- 24 VerDate Sep 11 2014 04:24 Jun 14, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3199.IH H3199 kjohnson on DSK79L0C42 with BILLS 3 •HR 3199 IH claims, in writing, the patent term for each such 1 patent.’’. 2 (b) USPTO REVIEW.— 3 (1) DEFINITIONS.—In this subsection— 4 (A) the term ‘‘Office’’ means the United 5 States Patent and Trademark Office; and 6 (B) the term ‘‘Director’’ means the Under 7 Secretary of Commerce for Intellectual Property 8 and Director of the Office. 9 (2) REVIEW.—The Director shall conduct a 10 comprehensive review of the patent examination pro- 11 cedures of the Office to determine whether the Of- 12 fice— 13 (A) is using best examination practices, 14 guidance, and procedures to avoid the issuance 15 of patents relating to the same drug, or biologi- 16 cal product, that are not patentably distinct 17 from one another, and not subject to an appro- 18 priate disclaimer of patent term; and 19 (B) should develop and implement new 20 practices, guidance, or procedures to— 21 (i) improve examination of patent ap- 22 plications relating to the same drug or bio- 23 logical product; and 24 VerDate Sep 11 2014 04:24 Jun 14, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3199.IH H3199 kjohnson on DSK79L0C42 with BILLS 4 •HR 3199 IH (ii) reduce the improper issuance of 1 patents that improperly extend the term of 2 exclusivity afforded a new drug or biologi- 3 cal product. 4 (3) REPORT.—Not later than 1 year after the 5 date of enactment of this Act, the Director shall 6 submit to the Committee on the Judiciary of the 7 House of Representatives a report that contains— 8 (A) the findings from the review conducted 9 under paragraph (2); and 10 (B) any recommendations of the Director 11 with respect to the review conducted under 12 paragraph (2). 13 Æ VerDate Sep 11 2014 04:24 Jun 14, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H3199.IH H3199 kjohnson on DSK79L0C42 with BILLS