S1041-119

What This Bill Does

This bill amends title 35 section 271(e) for biologic patent litigation. For biosimilar submissions, the act of infringement extends to patents that claim the biological product, a method of using the product, or a method or product used to manufacture it. At the same time, if a reference-product sponsor sues a biosimilar applicant under the Biologics Price Competition and Innovation Act pathway, the sponsor may generally assert no more than 20 qualifying patents, and no more than 10 of those may have issued after the statutory supplemental-list date.

The cap applies to patents claiming the biosimilar product, its use, or manufacturing methods or products; listed under the Public Health Service Act patent exchange; and either filed more than four years after reference-product approval or claiming a manufacturing process not used by the sponsor. Courts may raise the cap if the request is timely and justice or good cause requires it, including when the biosimilar applicant fails to provide required information, materially changes the biological product or process, or patent office delay affected issuance. The cap applies only if the biosimilar applicant completes specified patent-dance steps and does not apply to therapy, diagnosis, prophylaxis, indication, method-of-treatment, or other condition-of-use patents.

Who Benefits and How

Biosimilar applicants benefit from a presumptive cap on the number of late-issued or unused-process patents a reference-product sponsor can assert. Patients using biologics may benefit if patent-thicket limits speed biosimilar competition. Health plan payers benefit if biosimilar entry reduces biologic drug spending. Federal courts benefit from statutory criteria for increasing the patent cap. Biologics patent litigators benefit from clearer categories of patents inside and outside the cap.

Who Bears the Burden and How

Reference product sponsors lose some ability to assert large numbers of qualifying biologic patents in a single biosimilar infringement action. Biosimilar applicants must complete specified patent-dance steps to receive the cap. Federal district courts must decide good-cause requests and evaluate information gaps, material changes, and patent office delays. Patent portfolio managers must sort patents by filing date, manufacturing use, supplemental-list timing, and treatment-method exclusions.

Key Provisions

• Expands biologic infringement coverage to biological-product, use, and manufacturing patents tied to biosimilar submissions.
• Limits reference-product sponsors to 20 qualifying patents in covered biosimilar litigation.
• Limits late-issued patents within that group to 10.
• Allows courts to increase the cap for justice or good cause.
• Excludes treatment, diagnosis, prophylaxis, indication, and other condition-of-use patents from the cap.