To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes.
Sponsors
Legislative Progress
Passed SenateMr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, Mr. Durbin, …
Mr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, Mr. Durbin, …
Mr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, Mr. Durbin, …
Mr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, Mr. Durbin, …
Mr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, Mr. Durbin, …
Mr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, Mr. Durbin, …
Mr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, Mr. Durbin, …
Mr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, Mr. Durbin, …
Mr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, Mr. Durbin, …
Mr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, Mr. Durbin, …
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 derived from the structured analysis below. See "Detailed Analysis" for per-title beneficiaries/burden bearers with clause-level evidence links.
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"
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