In Short

The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents that a sponsor of an originator biological product, or RPS, may assert in an infringement action against a biosimilar applicant.

The Result: S.B. 150 has been sent to the United States House of Representatives.

Looking Forward: The Affordable Prescriptions for Patients Act of 2023 will likely be referred to a House Committee for further public hearings and deliberation. If the proposed legislation becomes law as drafted, it may create additional incentives for biosimilar applicants to engage in the "patent dance," so that the RPS may be limited in the number of patents it may assert in an infringement action under 35 U.S.C. § 271(e).

On July 11, 2024, the United States Senate unanimously passed S.B. 150. This pending legislation seeks to amend 35 U.S.C. § 271(e) by adding a new provision (subsection (7)) to address litigation relating to biosimilars. It additionally clarifies that infringement under 35 U.S.C. § 271(e)(2)(C)(ii), which applies when the biosimilar applicant does not provide its FDA application under 42 U.S.C. § 262(k) ("aBLA") or associated manufacturing information, "shall extend to any patent that claims the biological product, a method of using the biological product, or a method or product used to manufacture the biological product."

Specifically, subject to the biosimilar applicant complying with certain provisions under 42 U.S.C. § 262(l) and subject to certain exceptions, new subsection (7) of 35 U.S.C. § 271(e) would limit the number of patents asserted by the RPS in Biologics Price Competition and Innovation Act ("BPCIA") litigation as follows:

The RPS may assert a total of no more than 20 patents against a biosimilar applicant in an infringement action, and those patents must satisfy each of the following requirements:

• Claim a "biological product that is the subject of the" aBLA or use of the product, "or a method or product used in the manufacture of such a biological product";
• Are included on the list of patents provided by the RPS to the biosimilar applicant pursuant to 42 U.S.C. § 262(l)(3)(A); and
• Either (i) "have an actual filing date of more than 4 years after the date on which reference product is approved" or (ii) "include a claim to a method in a manufacturing process that is not used by the" RPS.

Moreover, no more than 10 of those 20 patents may have issued or have been exclusively licensed after the RPS provided its initial list of patents to the biosimilar applicant in the patent dance.

For the patent number limitation to apply to an infringement action by the RPS, the biosimilar applicant needs to provide the RPS with the aBLA and other manufacturing process relevant to the biosimilar not later than 20 days after acceptance of the aBLA by the FDA, and the biosimilar applicant needs to engage in certain aspects of the patent dance, including:

• The biosimilar applicant providing a detailed statement describing the basis for non-infringement, invalidity, or unenforceability of each patent claim pursuant to 42 U.S.C. §§ 262(l)(3)(B)(ii) and (7);
• The exchange of patent lists pursuant to 42 U.S.C. § 262(l)(5);
• The biosimilar applicant supplying the Secretary with a copy of the complaint not later than 30 days after its service pursuant to 42 U.S.C. § 262(l)(6)(C)(i); and
• The biosimilar applicant providing notice to the RPS not later than 180 days before the date of the first commercial marketing of the biosimilar pursuant to 42 U.S.C. § 262(l)(8)(A).

Further, the limitation on the number of patents does not apply to any patent that claims a method for using the biological "product in therapy, diagnosis, or prophylaxis, such as an indication or method of treatment or other condition of use."

Moreover, the court may increase the number of patents:

• If the request to increase that number is made without undue delay, and
• Either (i) the interest of justice so requires it, or (ii) for good cause.

The bill articulates the circumstances under which good cause "shall" be established (i.e., where the aBLA applicant does not provide information to the sponsor to allow for an assessment of infringement) and "may" be established (i.e., material change to the biologic product or process, delay by the PTO in issuing a patent, or court discretion for "another reason that shows good cause").

The amendment would only apply to aBLAs submitted on or after the bill's enactment.

If enacted, the amendment may provide an additional incentive for a biosimilar applicant to provide its aBLA and other manufacturing process information to the RPS and to engage in the required aspects of patent dance—namely, to limit the total number of patents the RPS may assert in an infringement action. Whether the aBLA applicant provides adequate "other information that describes the process or processes used to manufacture the biological product" is already the subject of considerable debate in many BPCIA litigations, and the proposed legislation would likely further heighten these disputes. Further, if the amendment is enacted, the RPS may be incentivized to prioritize and narrow the set of patents it asserts, perhaps eliminating patents where infringement may be less certain.

Three Key Takeaways

1. If enacted, the proposed amendment to 35 U.S.C. § 271(e) may incentivize a biosimilar applicant to provide its aBLA and other manufacturing process information and to engage in the required aspects of the patent dance to limit the total number of patents the RPS may assert in a BPCIA "patent dance" infringement action.
2. If the proposed amendment to 35 U.S.C. § 271(e) is enacted, an RPS may want to consider reviewing and prioritizing the patents it would potentially assert in an infringement action.
3. If enacted, a biosimilar applicant's compliance with the steps of the "patent dance" will likely become an even more contentious issue in BPCIA litigations.