HR 3269
ETHIC Act
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Bill overview
The Eliminating Thickets to Increase Competition Act (ETHIC Act) aims to reduce patent litigation by limiting the number of patents that can be asserted in a single lawsuit. Specifically, it restricts patent holders from bringing multiple infringement actions against a party who is developing or selling a drug or biological product if those patents are part of a ‘Patent Group’ – a set of patents linked through disclaimers. This change is intended to promote competition and reduce legal uncertainty for pharmaceutical and biotechnology companies.
Key provisions
- Limits patent assertions to one patent per Patent Group in infringement lawsuits.
- Defines a Patent Group as two or more commonly owned patents or applications linked through disclaimers.
- Applies to actions against entities submitting drug approval applications or seeking biological product licensure.
- The amendment applies to applications submitted on or after the bill’s enactment date.
- The bill addresses ‘patent thickets,’ which are groups of patents that can create barriers to innovation.
- It clarifies the definition of a Patent Group based on disclaimers.
- It restricts a plaintiff from bringing multiple actions against the same defendant within a Patent Group.
- It targets patent litigation related to drugs and biological products.
Who is affected
- Pharmaceutical companies
- Biotechnology companies
- Drug developers
- Biological product manufacturers
- Patent holders
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Primary sponsor
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119th CONGRESS — 1st Session
H. R. 3269
IN THE HOUSE OF REPRESENTATIVES
A BILL
To address patent thickets.
This Act may be cited as the Eliminating Thickets to Increase Competition Act ETHIC Act
or the
.
Section 271(e) of title 35, United States Code, is amended by adding at the end the following:
A person who brings an action for infringement of a patent under this section against a party described in subparagraph (B) may assert in the action not more than one patent per Patent Group.
A party described in this subparagraph is—
a person who—
submits an application for approval of a drug under subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), or is a holder of such an approved application; or
submits an application for licensure of a biological product under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)), or is a holder of such a licensure; or
a person making, using, selling, offering for sale, introducing or delivering into interstate commerce, or importing—
a biological product licensed under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)).
A person who brings an action described in subparagraph (A) asserting a patent against a party may not bring any additional actions described in that subparagraph asserting a patent in the same Patent Group against that party.
For purposes of this paragraph, the term Patent Group means 2 or more commonly owned patents or applications that—
are identified on 1 or more disclaimers under section 253 to another commonly owned patent; or
are subject to 1 or more disclaimers under section 253 to another commonly owned patent.
For purposes of clause (i)(I)—
each patent or application that is identified on a disclaimer under section 253 is part of the same Patent Group as the patent or application subject to the disclaimer.
The amendment made by subsection (a) shall apply with respect to an application submitted under subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) on or after the date of enactment of this Act.