Affordable Prescriptions for Patients Act
The Affordable Prescriptions for Patients Act would reform how patent infringement is handled in the biosimilars space by amending 35 U.S.C. 271(e). The bill expands the types of patents that can be considered when a biosimilar sponsor seeks FDA approval (under the 351(k) pathway) and is facing an infringement action brought by the sponsor of the original biologic (the reference product sponsor). Specifically, it adds that infringement can extend to patents covering the biological product, its uses, or manufacturing methods, for certain regulatory submissions. It also introduces a cap on how many patents the reference product sponsor may assert in such actions against a biosimilar applicant, with detailed criteria for which patents count and when the cap can be increased for “good cause.” The adjustments are limited to applications submitted under 351(k) on or after enactment, and several exclusions apply, notably excluding patents that claim therapeutic indications or methods of using the product. The overall aim is to balance patent rights with faster access to affordable biologics.
Key Points
- 1Expands infringement scope: For submissions described in 271(e)(2)(C)(ii), infringement extends to patents that claim the biological product, its use, or a manufacturing method used to produce the product.
- 2New patent cap for reference product sponsors: In an infringement action against a subsection (k) applicant (biosimilar), the sponsor may assert no more than 20 patents total, with no more than 10 issued after the date specified in 351(l)(7)(A).
- 3Criteria for counted patents: Patents must (a) claim the biological product or its use, or a manufacturing method for the product; (b) be on the list described in 351(l)(3)(A) (including as modified by 351(l)(7)(A)); and (c) either have a filing date more than 4 years after the reference product’s approval or claim a manufacturing method not used by the reference sponsor.
- 4Potential cap increases for good cause: The court may increase the number of patents allowed if there is no undue delay and good cause is shown, including if the reference sponsor lacks necessary information to form a reasonable belief about infringement or if there are material changes to the product/process, or if certain patents would have issued but for Office delay.
- 5Good-cause standards and disclosure: The court may consider reasonable descriptions of information beyond the subsection (k) application that are needed to assess infringement potential.
- 6Exclusion for use patents from the cap: Patents that claim a method of using the product in therapy or other indications are not subject to the cap.
- 7Actionability conditions: Any increase in the cap requires the subsection (k) applicant to complete specific actions under 351(l) (and related sections) and does not apply to patents claiming only therapeutic indications.
- 8Effective date: These amendments apply to applications submitted under 351(k) on or after enactment.
- 9Context and scope: The change targets the regulation of patent disputes in the biosimilar approval process, attempting to curb broad or “patent-thicket” assertions while preserving protections for genuine product/method patents.