Placed on Senate Legislative Calendar under General Orders. Calendar No. 44.
This bill amends 35 U.S.C. §271(e) to explicitly treat certain regulatory submissions for biological products (biosimilars) as acts of patent infringement covering patents claiming the biologic, uses of the biologic, and products or methods used to manufacture it. It allows a reference product sponsor to assert up to 20 specified patents (with limits on how many issued after a statutory date) against a 351(k) applicant, creates procedures for courts to increase that limit for good cause, links the limitation to information disclosures by the applicant, exempts method-of-use patents from the numeric cap, and applies to 351(k) applications filed on or after enactment.
Left emphasizes affordability harms and delayed biosimilars.
Relative to its intended legislative type, this bill is a substantive statutory amendment that is precisely drafted to alter patent-assertion rules applicable to biologic reference products and subsection (k) applicants.
This bill amends 35 U.S.C. §271(e) to explicitly treat certain regulatory submissions for biological products (biosimilars) as acts of patent infringement covering patents claiming the biologic, uses of the biologic, and products or methods used to manufacture it.
It allows a reference product sponsor to assert up to 20 specified patents (with limits on how many issued after a statutory date) against a 351(k) applicant, creates procedures for courts to increase that limit for good cause, links the limitation to information disclosures by the applicant, exempts method-of-use patents from the numeric cap, and applies to 351(k) applications filed on or after enactment.
Narrow, non‑fiscal bill with bipartisan potential but strong industry stakes and litigation implications create resistance.
Relative to its intended legislative type, this bill is a substantive statutory amendment that is precisely drafted to alter patent-assertion rules applicable to biologic reference products and subsection (k) applicants. It integrates closely with existing PHSA provisions and specifies concrete limits, exceptions, and conditions for judicial modification.
Left emphasizes affordability harms and delayed biosimilars.
These are examples from the analysis, not a ranked list of the most-affected groups.
Left emphasizes affordability harms and delayed biosimilars.
Likely views the bill skeptically because it strengthens patent-enforcement pathways for brand biologic sponsors and may slow biosimilar entry.
Concern centers on potential higher drug prices and extended exclusivity through litigation.
Some might note administrative clarifications, but see overall tilt toward originator-company protections.
Sees both clarifying and problematic elements: clarification of infringement for biologics reduces uncertainty, but the arbitrary patent cap and the method-of-use exemption invite litigation.
Would weigh whether the bill meaningfully speeds resolution and preserves competition while protecting genuine innovation.
Likely supportive because the bill strengthens intellectual property enforcement for biologic innovators and clarifies that biosimilar filings can constitute acts of infringement.
It balances by capping patent assertions and allowing courts to increase limits for good cause, preserving patent-holder rights.
Reached or meaningfully advanced
Reached or meaningfully advanced
Still ahead
Still ahead
Still ahead
Narrow, non‑fiscal bill with bipartisan potential but strong industry stakes and litigation implications create resistance.
The bill has not accumulated any surfaced votes yet.
Left emphasizes affordability harms and delayed biosimilars.
Narrow, non‑fiscal bill with bipartisan potential but strong industry stakes and litigation implications create resistance.
Relative to its intended legislative type, this bill is a substantive statutory amendment that is precisely drafted to alter patent-assertion rules applicable to biologic reference products and subsection (k) applicants…
Go beyond the headline summary with full stakeholder mapping, legislative design analysis, passage barriers, and lens-by-lens tradeoff breakdowns.