Disclosure Requirements Under The BPCIA

The Biologics Price Competition and Innovation Act (BPCIA) provides for a series of disclosures between a biosimilar applicant and the innovator company, commonly referred to as the "patent dance." 42 U.S.C. §262(l). While the Federal Circuit is about to address whether the disclosure requirements of the BPCIA are mandatory (after one district court found them optional), a question for parties engaging in the patent dance is how much detail is contemplated by the BPCIA disclosure requirements. Specifically, the BPCIA provides that, no later than 60 days after the innovator company identifies the list of patents that may be asserted against the biosimilar applicant, the biosimilar applicant shall provide to the innovator company, with respect to each patent listed, "a detailed statement that describes, on a claim by claim basis, the factual and legal basis of the opinion of the [biosimilar] applicant that such patent is invalid, unenforceable, or will not be infringed by the commercial marketing of the biological product that is the subject of the...application." 42 USC § 262(l)(3)(B)(ii)(I).

In determining the standard and appropriate level of detail required by the disclosures pursuant to the patent dance, looking to analogous disclosure requirements in the Hatch-Waxman context provides helpful guidance. The Hatch Waxman Act sets forth a mechanism for a generic drug company to file an abbreviated new drug application ("ANDA"), which allows the generic company to piggyback off the research and development work and regulatory submissions of the innovator company for a small-molecule drug. In doing so, a generic drug maker that seeks to obtain regulatory approval prior to the expiration of applicable patents must certify pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) ("Paragraph IV") that the patents covering the innovator company's approved drug (or use thereof) - published in the FDA's "Orange Book" - are either invalid, not infringed, or unenforceable. Using language similar to the BPCIA, the Hatch Waxman Act requires that the generic drug maker provide the innovator company with a Paragraph IV notification letter that includes "a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed." 21 USC § 355(j)(2)(B)(iv)(II).

Gleaning from the Hatch-Waxman context, "detailed statement" disclosures under the BPCIA should have a reasonable basis and establish a prima facie...