To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
This bill limits brand biologic manufacturers to asserting no more than 20 patents (maximum 10 issued after a key date) in litigation against biosimilar competitors. This addresses "patent thickets" - strategies where brand companies pile up patents to block generic competition.
Who Benefits and How
Biosimilar manufacturers face reduced patent litigation barriers to market entry. Patients and health systems may see faster biosimilar competition and lower prices. Generic drug competition is enhanced.
Who Bears the Burden and How
Brand biologic manufacturers (reference product sponsors) lose ability to assert unlimited patents against biosimilar applicants.
Key Provisions
- Limits patent assertions to 20 total, with maximum 10 post-BLA patents
- Court may increase limit for good cause or interest of justice
- Applies to patents claiming the biologic, its use, or manufacturing methods
- Includes exceptions for biosimilar applicant failures to provide required information
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers.
At a Glance
What This Bill Does
Limits the number of patents that reference biologic sponsors can assert in litigation against biosimilar applicants, addressing "patent thickets" that delay generic/biosimilar competition.
Who Benefits
- Biosimilar manufacturers
- Patients
- Health systems
Who Bears Costs
- Brand biologic manufacturers
Key Policy Areas
Pharmaceuticals, Intellectual Property, Antitrust, Drug Pricing
Primary Purpose
Limits the number of patents that reference biologic sponsors can assert in litigation against biosimilar applicants, addressing "patent thickets" that delay generic/biosimilar competition.
Policy Domains
Legislative Strategy
"Limit patent thicket strategies to enable biosimilar competition"
Sponsors
Legislative Progress
Passed SenateMr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, Mr. Durbin, …
Passed Senate (inferred from es version)
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Brand-name pharmaceutical manufacturers, Generic drug manufacturers
Positive-direction: Generic drug manufacturers
Negative-direction: Brand-name pharmaceutical manufacturers
Biosimilar manufacturers, Brand-name biologic manufacturers
Positive-direction: Biosimilar manufacturers
Negative-direction: Brand-name biologic manufacturers
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology