[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6436 Introduced in House (IH)]

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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 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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