S 2276
ETHIC Act
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Bill overview
This bill, the Eliminating Thickets to Increase Competition Act (ETHIC Act), aims to reduce what are known as "patent thickets" in the pharmaceutical industry. It limits the number of patents a single party can assert in an infringement lawsuit to one per Patent Group, which is defined as two or more commonly owned patents or applications linked by double patenting disclaimers. The changes apply to applications submitted after the bill’s enactment, focusing on drug and biological product approvals and licensure.
Key provisions
- Limits patent assertions to one per Patent Group in infringement lawsuits.
- Defines a Patent Group as two or more commonly owned patents or applications linked by double patenting disclaimers.
- Applies to applications for drug approval and biological product licensure.
- Specifically targets patents identified on disclaimers under section 253.
- Addresses obviousness-type double patenting.
- The amendment applies to applications submitted on or after the bill’s enactment.
Who is affected
- Pharmaceutical companies
- Drug manufacturers
- Biological product manufacturers
- Patent holders
- Individuals seeking drug approval or licensure
Notable changes
- Restricts the number of patents that can be asserted in a single infringement lawsuit.
- Introduces a new definition of ‘Patent Group’ based on double patenting disclaimers.
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119th CONGRESS — 1st Session
S. 2276
IN THE SENATE OF THE UNITED STATES
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 obviate obviousness-type double patenting of another commonly owned patent; or
are subject to 1 or more disclaimers under section 253 to obviate obviousness-type double patenting of 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.