Biologics Price Competition and Innovation Act: Purple Book, Dispute Resolution, Exclusivities, and Court Treatment

Description

The BPCIA, signed into law in 2010, is over 12 years old and has seen almost 100 drugs approved as biosimilar to or interchangeable with an FDA-licensed reference biological product. However, growing pains still exist. There is an ongoing disagreement about patent dispute resolution procedures (the "patent dance") under the BPCIA. Further, a Federal Circuit decision raises questions about limiting the venue in Hatch-Waxman, which may impact venue in BPCIA cases.

Further, language from the Purple Book Continuity Act of 2019 (tucked into the Further Extension of Continuing Appropriations Act, 2021), signed into law in December 2020, impacts the biologics regulation landscape. The statute requires reference product sponsors to provide the FDA with copies of any patent lists within 30 days of when they were first provided to biosimilar applicants as part of the "patent dance."

The listings of biologic products in the Purple Book must include, e.g., the nonproprietary name, the patent information, licensure and marketing status, and exclusivity periods. The FDA must update the list every 30 days. Previously, the exchange of information under the BPCIA patent dance was undertaken confidentially between the reference product BLA holder and the biosimilar applicant and providing patent lists to the FDA was voluntary. While the enacting legislation indicates that the patent holder "shall" provide this information to FDA, no consequences are specified for failing to comply.

Counsel should stay abreast of the latest biosimilar court decisions and regulatory actions to make informed decisions regarding participation in the patent dance, dispute resolution, and more. For example, considerations for applicants include possible outcomes of deciding whether to initiate a patent dance and when to provide commercial marketing notice. Considerations for reference product sponsors include possible outcomes when deciding which patents to identify during the patent dance and how to respond to commercial marketing notices.

In addition, reference product sponsors must consider preparing for infringement suits and declaratory judgment actions if the applicant does not comply with the patent dance. While the new law advances transparency, it also may lead to more validity/unpatentability challenges of specific patents, affect the scope of potential license negotiations, or provide information for possible design-around options.

Listen as our authoritative panel of patent attorneys examines the BPCIA and its impact. The panel will discuss the Purple Book requirements, issues related to exclusivities, and the disputed retroactivity of the BPCIA. The panel will review the case law from 12 years of the BPCIA and discuss where things are going.