Bioethics Blogs

Battle Lines Drawn Over Biosimilar Application And Patent Disclosure Process

The Biosimilars Price Competition and Innovation Act of 2009 (BPCIA) introduced a long-awaited, and highly-supported, abbreviated route to market for “biosimilar” and “interchangeable” biologic products. The goal was to create incentives for development and reduce health care costs in the same way that previous legislation had accomplished in the generic arena over three decades ago.

However, widespread criticism of BPCIA provisions to facilitate interactions between biosimilar applicants and reference biologic sponsors regarding application submission and patent status was swift and unrelenting. Attorneys practicing in the realm of Hatch-Waxman litigation for generic drugs balked at the drastic differences between the familiar public process grounded in required patent disclosures, FDA Orange Book listings, and generic applicant certifications and the private, iterative process set forth in the BPCIA. Legal scholars, industry representatives, and practitioners alike projected that a courtroom battle regarding real-world operation of the provisions was imminent.

The Statute

The amended Public Health Service Act §351, also referenced as 42 U.S.C. §262, states:

Not later than 20 days after the Secretary notifies the…applicant that the application has been accepted for review, the…applicant— (A) shall provide to the reference product sponsor a copy of the application submitted to the Secretary…, and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application. §351(l)(2).

The statute subsequently provides a schedule for an elaborate informational back-and-forth between the biosimilar applicant and the reference biologic sponsor. Following receipt of notification from the applicant, and keeping the information confidential, the reference product sponsor must within 60 days provide the applicant with a list of all patents “reasonably believe[d] to be infringed” and identify which patents it would be prepared to license to the applicant.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.