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Limiting Patent Assertions in Generic and Biosimilar Drug Litigation.

This bill limits brand-name drug companies to asserting only one patent per 'Patent Group' in infringement lawsuits against generic and biosimilar drug manufacturers. The goal is to dismantle 'patent thickets' that delay market entry of cheaper alternatives. Citizens should benefit from faster access to affordable medications, potentially lowering healthcare costs.
Key points
Patent Litigation Limit: In lawsuits against generic or biosimilar drug applicants, the plaintiff can assert no more than one patent from a related 'Patent Group' in a single action.
Promoting Competition: This change aims to prevent pharmaceutical companies from using multiple related patents to block competition, thus speeding up the availability of cheaper drugs.
Applicability: The rule applies to applications for generic drugs (under section 505(j)) and biosimilar products (under section 351(k)) submitted on or after the enactment date.
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Additional Information
Print number: 118_S_3583
Sponsor: Sen. Welch, Peter [D-VT]
Process start date: 2024-01-11
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OFFICIAL LEGAL TITLE

A bill to address patent thickets.

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 118_S_3583.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2024-01-11.

What are the main provisions?

Key points include:

  • Patent Litigation Limit: In lawsuits against generic or biosimilar drug applicants, the plaintiff can assert no more than one patent from a related 'Patent Group' in a single action.
  • Promoting Competition: This change aims to prevent pharmaceutical companies from using multiple related patents to block competition, thus speeding up the availability of cheaper drugs.
  • Applicability: The rule applies to applications for generic drugs (under section 505(j)) and biosimilar products (under section 351(k)) submitted on or after the enactment date.
What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Sen. Welch, Peter [D-VT].

What is the latest detailed status?

The latest detailed status is: Introduced in Senate

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-26.

CATEGORIES

Health Courts and Law Economy