On July 11, 2024, the United States Senate unanimously passed S.B. 150, a significant piece of legislation that aims to amend 35 U.S.C. § 271(e) by introducing a new provision (subsection (7)) to address biosimilar-related litigation. This bill, known as the Affordable Prescriptions for Patients Act of 2023, seeks to bring about changes that could impact the way patents are asserted in infringement actions against biosimilar applicants. The implications of this bill are far-reaching and could have significant effects on the pharmaceutical industry.
According to the proposed legislation, infringement under 35 U.S.C. § 271(e)(2)(C)(ii) would 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. This expansion of the definition of infringement highlights the Senate’s focus on addressing issues related to biosimilar products and ensuring fair competition in the market.
One of the key aspects of the bill is the limitation on the number of patents that a sponsor of an originator biological product (RPS) can assert against a biosimilar applicant in an infringement action. Under the proposed legislation, the RPS may assert a total of no more than 20 patents that meet specific requirements. These requirements include the patents claiming the biological product that is the subject of the aBLA or the use of the product, being included on the list of patents provided to the biosimilar applicant, and having certain filing dates or claims related to manufacturing processes.
Moreover, the bill stipulates that no more than 10 of the 20 patents may have been issued or exclusively licensed after the RPS provided its initial list of patents to the biosimilar applicant during the patent dance. This limitation aims to ensure that the number of patents asserted by the RPS is reasonable and relevant to the biosimilar product in question.
To trigger this limitation on the number of patents, the biosimilar applicant must comply with certain provisions, including providing the RPS with the aBLA and relevant manufacturing process information, engaging in the patent dance, and exchanging patent lists. These requirements are designed to streamline the process of patent assertion and ensure transparency between the RPS and the biosimilar applicant.
The bill also outlines circumstances under which the court may increase the number of patents that can be asserted by the RPS. Factors such as the interest of justice, good cause, and delays in patent issuance by the PTO are taken into consideration when determining whether to allow additional patents to be asserted in an infringement action.
Furthermore, the bill specifies that the limitation on the number of patents would only apply to aBLAs submitted after the enactment of the legislation. This provision is intended to ensure that the new rules apply to future biosimilar applications and do not retroactively impact existing cases.
If enacted, the proposed legislation could have several implications for the pharmaceutical industry. It may incentivize biosimilar applicants to engage in the patent dance and provide relevant information to the RPS in order to limit the number of patents that can be asserted against them. This could lead to more efficient resolution of patent disputes and promote competition in the biosimilar market.
However, the proposed changes could also give rise to new challenges and disputes, particularly around the adequacy of information provided by biosimilar applicants and the scope of patents that can be asserted by the RPS. These issues are likely to be the subject of ongoing debate and litigation as the industry adapts to the new regulatory landscape.
In conclusion, the passage of S.B. 150 by the Senate represents a significant development in the regulation of biosimilar products and patent litigation in the pharmaceutical industry. The proposed changes outlined in the bill have the potential to impact the way patents are asserted and litigated in infringement actions involving biosimilar applicants. As the bill moves to the House of Representatives for further consideration, stakeholders in the pharmaceutical industry will be closely monitoring its progress and assessing the potential implications for their businesses.
