The bill amends 35 U.S.C. 271(e) to extend infringement liability to patents that claim a biological product, a use of that product, or a method or product used in manufacturing the biological product. It also creates a new framework under which a reference product sponsor can assert a prescribed number of patents against a biosimilar applicant seeking FDA approval under section 351(k).
The sponsor may bring no more than 20 patents, with a cap of 10 that have issued after a specified date, and only if those patents meet specific criteria. The court may increase the number for good cause, subject to conditions and evidence-based standards.
The applicability is limited to applications submitted under 351(k) on or after enactment.
Taken together, the provisions aim to harden patent-based defenses for biologics while imposing guardrails to prevent patent assertion from delaying biosimilar entry. The bill creates a structured, though potentially complex, landscape for biosimilar litigation, with a focus on patents tied to the product, its manufacturing, or its uses, and tied to patents listed under the Public Health Service Act.”
At a Glance
What It Does
It broadens infringement to include patents that claim the biological product, its use, or its manufacturing methods. It also introduces a cap-based mechanism for patent assertions by reference product sponsors against biosimilar applicants, plus criteria for which patents count toward the cap.
Who It Affects
Reference product sponsors (brand biologics) holding listed biosimilar-relevant patents and biosimilar applicants seeking FDA approval under 351(k); courts handling patent disputes in biosimilar cases.
Why It Matters
It reshapes the strategic calculus of biosimilar litigation by enabling broader patent claims while introducing caps and good-cause standards to manage litigation volume and delay risk.
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What This Bill Actually Does
The bill rewrites how patent infringement is treated in the biosimilars space. It updates the infringement standard in 271(e) so that the act of infringing can extend to patents that claim the biological product itself, a method of using that product, or a manufacturing method used to produce it.
This broadens the universe of patents that could be asserted in a biosimilar dispute, potentially widening the scope of what a sponsor can target to protect a reference product.
A new subsection creates a structured cap on how many patents a reference product sponsor can bring against a biosimilar applicant. The sponsor may assert up to 20 patents, with no more than 10 of those patents issued after a date tied to the reference product’s approval.
To be counted, patents must satisfy three criteria: they claim the biological product or an associated manufacturing or use method; they are listed on the patent list described in the biosimilar framework; and they either have more than four years between the reference product approval and patent filing or claim a manufacturing method not used by the reference sponsor.The bill also allows a court to increase the cap for good cause, under conditions designed to ensure timely and relevant disclosure of information and to prevent abuse. Good cause can be shown if the sponsor provides a reasonable description of additional necessary information and if certain factual changes or listing gaps are shown.
The limitation on the cap applies only when the subsection (k) applicant completes required approvals and filings under the biosimilars statute, and it does not apply to patents that claim a method of using the product in therapy or other indications. The amendments apply to applications submitted on or after enactment.Overall, SB1041 introduces a more expansive, but more tightly regulated, patent- assertion regime for biosimilars—balancing stronger patent defenses for reference products with procedural guardrails to avoid undue delays in biosimilar entry.
The Five Things You Need to Know
Up to 20 patents may be asserted by a reference product sponsor against a biosimilar applicant, with a cap of 10 authoring patents issued after a specified date.
Patents counted must claim the biological product, a manufacturing method, or a use, and must be listed under the biosimilar framework.
The court may increase the number of patents for good cause, subject to defined criteria and evidence requirements.
The cap does not apply to patents that claim a method of using the product for therapy, diagnosis, or prophylaxis.
The amendments apply only to biosimilar applications submitted under 351(k) on or after enactment.
Section-by-Section Breakdown
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Expanded patent infringement scope
Section 2 amends 271(e) to extend infringement liability to patents that claim the biological product itself, its uses, or manufacturing methods. This broadens the set of patents a reference product sponsor can leverage in actions against biosimilar applicants, aligning patent scope with the realities of biosimilar development and production.
Patent assertion cap and patent eligibility
The sponsor may assert up to 20 patents against a subsection (k) applicant, with no more than 10 issued after the date specified in 351(l)(7)(A). Eligible patents must claim the biological product, a manufacturing method, or a use related to the product, and must be listed under the relevant 351(l) framework, including as extended by paragraph (7).
Good cause and court discretion
The court may increase the number of patents if the request is made without undue delay and the interest of justice requires it, or for other good cause shown. Good cause can be demonstrated if the reference sponsor provides necessary information to enable the court to assess infringement potential, including situations where there are manufacturing changes or gaps in patent listing. The court may also consider additional factors, such as patent issuance delays caused by the patent office.
Applicability
The amendments apply to applications submitted under 351(k) on or after the date of enactment. This ensures that only post-enactment biosimilar filings are subject to the new cap-and-criteria framework, preventing retroactive application.
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Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- Reference product sponsors (brand biologics) gain a clearer, capped framework to assert biomedical patents and defend market share in the biosimilar space.
- Patent law practitioners representing reference product sponsors gain clearer guidelines and leverage for biosimilar disputes.
- Courts handling patent cases in the biosimilar context benefit from defined criteria and procedures that streamline decision-making and reduce dispute volatility.
Who Bears the Cost
- Biosimilar applicants face potentially broader patent challenges and longer, more complex litigations as sponsors bring more patents under the cap.
- Small biotech firms developing biosimilars may bear higher entry costs and longer timelines due to expanded patent strategies and potential disputes over eligibility.
- The public may experience higher drug-approval timelines and uncertainty if patent disputes delay biosimilar market entry.
Key Issues
The Core Tension
Balancing the need to protect biologic innovations with the goal of enabling biosimilar competition—between broad patent protection and timely patient access.
The bill’s new framework creates a tension between preserving strong patent protections for reference biologics and enabling timely biosimilar competition. While the cap structure aims to prevent litigation from ballooning, the eligibility criteria (e.g., patents that claim manufacturing processes not used by the sponsor or those filed more than four years after approval) may still permit strategic patent placement that extends protection or delays entry.
The reliance on court-determined “good cause” introduces a degree of subjectivity and potential inconsistency across cases. There is also a risk that broader patent claims could chill legitimate biosimilar development if sponsors pursue aggressive litigation whenever post-approval changes occur in manufacturing techniques.
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