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This bill would change patent rules for certain medicines and biological products to help stop companies from using closely related patents to extend exclusive rights beyond the first patent’s end date. In patent disputes over drugs and biologics, later patents tied to the same product would generally be treated as if their term after the first patent expires has been given up, unless the patent owner can show those later patents cover truly different inventions. The bill would also require the Patent Office to review how it examines these patent applications and to report its findings to Congress, with the goal of reducing patents that unfairly stretch out drug exclusivity and delay lower-cost alternatives.
- In many drug and biologic patent disputes, later patents would be presumed not to add extra time beyond the first patent that expires.
- A patent owner could avoid that presumption by showing, with enough evidence, that the later patents are actually for distinct inventions.
- Any patent term extensions already granted by the Patent Office would still be honored if the patents are found to be distinct.
- The Patent Office would have to review its patent examination methods and, within one year, send Congress a report with its findings and any recommended changes.
Official Summaries
Stopping Pharma’s Ripoffs and Drug Savings For All Act
This bill addresses double patenting with respect to drug-related patents. Specifically, the bill requires an owner of drug-related patents, if the owner lists more than one patent as covering a particular drug, to prove in certain proceedings that each patent covers a distinct invention. If the patent owner fails to do so, then the owner shall have disclaimed patent protection from all the listed patents after the first patent expires.
This requirement shall apply to various proceedings challenging the validity of drug-related patents, as well as to infringement lawsuits filed by the patent owner against companies seeking Food and Drug Administration approval for generic or biosimilar versions of patented drugs.
The bill also directs the U.S. Patent and Trademark Office (USPTO) to review its examination procedures to prevent granting multiple patents for the same drug or biological product, unless the patents cover distinct inventions. The USPTO shall report to Congress its findings and recommendations from the review.
Current Full Text
[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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