119-hr890

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 890 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 890

To amend title 35, United States Code, to prevent double patenting, and 
 for other purposes.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 January 31, 2025

 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 Representatives 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 following:
 ``
            (c) Disclaimers of Drug Patent Term.--
 ``

    (1) In general.--Except as provided in paragraph

    (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 respect 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 exceptions provided for in subsection

    (2) .
 ``

    (2) Demonstration of distinct inventions.--If a patentee 
 demonstrates by a preponderance 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, unless and to the extent the 
 patentee expressly disclaims, in writing, the patent term for 
 each such patent.''.

    (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 procedures of the Office to 
 determine whether the Office--
        (A) is using best examination practices, guidance, 
 and procedures to avoid the issuance of patents 
 relating to the same drug, or biological product, that 
 are not patentably distinct from one another, and not 
 subject to an appropriate disclaimer of patent term; 
 and
        (B) should develop and implement new practices, 
 guidance, or procedures to--
            (i) improve examination of patent 
 applications relating to the same drug or 
 biological product; and
            (ii) reduce the improper issuance of 
 patents that improperly extend the term of 
 exclusivity afforded a new drug or biological 
 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) .
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