What This Bill Does
This bill allows companies seeking approval to sell generic medications to file lawsuits against companies that hold patents on how drugs are used. The lawsuits aim to force corrections or deletions of information that the original drug makers submitted about patents claiming specific uses of their drugs.
Who It Affects
- Companies applying for approval to sell generic or biosimilar drugs
- Companies that hold approved applications for brand-name drugs or biological products
- Federal district courts
- The Secretary of Health and Human Services
Key Provisions
- A generic or biosimilar drug applicant can sue the holder of a brand-name drug's approved application in federal district court if the applicant states that a patent does not actually claim a use for that drug (Sec. 2)
- The lawsuit can seek a court order requiring the brand-name drug holder to correct or delete information about a use code on three grounds: the code does not match the patent, does not match an approved use, or is overly broad, inaccurate or inappropriate (Sec. 2)
- "Use code" means information about a patent that claims how a drug is used, based on information the drug company submitted during the approval process (Sec. 2)
What Changes
Federal law gains a new legal right allowing generic and biosimilar applicants to challenge the accuracy of use code information submitted by brand-name drug companies through federal lawsuits.
Important Definitions
- Use code: Information about a patent claiming how a drug is used that is approved, based on information the drug sponsor submitted during the approval process
Effective Date
Not specified in bill text
II
118TH CONGRESS
1ST SESSION
S. 1128
To establish special rules relating to information provided with respect to
drug applications concerning method of use patents.
IN THE SENATE OF THE UNITED STATES
MARCH 30, 2023
Ms. HASSAN (for herself and Mr. BRAUN) introduced the following bill; which
was read twice and referred to the Committee on Health, Education,
Labor, and Pensions
A BILL
To establish special rules relating to information provided
with respect to drug applications concerning method of
use patents.
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 ‘‘Ensuring Access to
4
Generic Medications Act’’.
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•S 1128 IS
SEC. 2. SPECIAL RULES RELATING TO METHOD OF USE
1
PATENTS.
2
Section 505 of the Federal Food, Drug, and Cosmetic
3
Act (21 U.S.C. 355) is amended by adding at the end the
4
following:
5
‘‘(z) CAUSE OF ACTION RELATING TO DRUG USE
6
CODES.—
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‘‘(1) IN GENERAL.—In the case of an applica-
8
tion under subsection (b)(2) or (j) of this section or
9
section 351(k) of the Public Health Service Act with
10
respect to which the applicant seeking approval in-
11
cludes in the application a statement that a patent
12
claiming a method of use does not claim a use for
13
the drug that is the subject of such application, as
14
described in subsection (b)(2)(B) or (j)(2)(A)(viii),
15
or in the case of an application under such section
16
351(k), as otherwise required by the Secretary, the
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sponsor of the application under subsection (b)(2) or
18
(j) or such section 351(k) described in paragraph (2)
19
may file a civil action in an appropriate district
20
court of the United States against the holder of the
21
approved application for the applicable reference
22
drug or reference product seeking a court order re-
23
quiring the holder to correct or delete information
24
relating to a use code submitted by the holder of the
25
reference drug or reference product with respect to
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•S 1128 IS
such patent claiming a method of use, on the ground
1
that such use code—
2
‘‘(A) does not correspond to a patent that
3
claims the reference drug or reference product
4
for which the application was approved;
5
‘‘(B) does not correspond to a patent that
6
claims an approved method of using the ref-
7
erence drug or reference product; or
8
‘‘(C) is overly broad or otherwise inac-
9
curate or inappropriate.
10
‘‘(2) RULE
OF
CONSTRUCTION.—Nothing in
11
this subsection shall be construed to affect the appli-
12
cation of subsection (j)(5)(C)(ii).
13
‘‘(3) DEFINITION.—For purposes of paragraph
14
(1), the term ‘use code’ means the information relat-
15
ing to a patent claiming a method of using a drug
16
that is approved under section 505 of this Act or
17
under section 351 of the Public Health Service Act,
18
as applicable, based upon information submitted by
19
the drug sponsor or holder of the approved applica-
20
tion
or
licensure
pursuant
to
section
21
314.53(c)(2)(ii)(P)(3) of title 21, Code of Federal
22
Regulations (or any successor regulations).’’.
23
Æ
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