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

Recording of a 90-minute premium CLE video webinar with Q&A


Conducted on Tuesday, May 11, 2021

Recorded event now available

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Course Materials

This CLE course will guide patent counsel on the Biologics Price Competition and Innovation Act (BPCIA). The panel will discuss the new Purple Book and issues related to exclusivities and the retroactivity of the BPCIA. The panel will address the potential unavailability of IPR and PGR proceedings for biosimilar manufacturers and what it means for biosimilars. The panel will also address the ongoing debate over whether the BPCIA's patent dispute resolution procedures are allowed or required and the litigation that has followed as a result. The panel will look back at the 10 years of the BPCIA and discuss where things are going.

Description

The BPCIA, signed into law on March 23, 2010, is now just over 10 years old and has seen almost 100 drugs approved as biosimilar to or interchangeable with a 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 recent Federal Circuit decision raises questions about limiting venue in Hatch-Waxman, which may in turn 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 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 now are required to 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 biosimilars court decisions and regulatory actions in order to make well 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 deciding 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 notice. In addition, reference product sponsors need to consider how to prepare for infringement suits and declaratory judgment actions in case 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 potential design-around options.

Listen as our authoritative panel of patent attorneys examines the BPCIA and its impact. The panel will discuss the new Purple Book requirements, as well as issues related to exclusivities and the disputed retroactivity of the BPCIA. The panel will review the case law coming out of 10 years of the BPCIA and discuss where things are going.

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Outline

  1. BPCIA framework
  2. Purple Book
  3. Exclusivities
  4. Disputed retroactivity of the BPCIA
  5. BPCIA litigation
    1. Court decisions
    2. PTAB decisions
  6. Future of BPCIA
  7. Best practices

Benefits

The panel will review these and other key issues:

  • What the Purple Book and the new transparency requirements mean for biologics companies
  • How the courts are treating BPCIA issues
  • Implications of the potential unavailability of IPR and PGR for biosimilars

Faculty

Feldstein, Mark
Mark J. Feldstein, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and...  |  Read More

Lipton, Alissa
Alissa K. Lipton

Partner
Finnegan Henderson Farabow Garrett & Dunner

Ms. Lipton represents clients in patent proceedings in district courts, before the U.S. Court of Appeals for the...  |  Read More

Murphy, Amanda
Amanda K. Murphy, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new...  |  Read More

Yang, Yieyie
Yieyie Yang, Ph.D.

Attorney
Finnegan Henderson Farabow Garrett & Dunner

Dr. Yang focuses on complex patent litigation before U.S. district courts and inter partes review (IPR) proceedings in...  |  Read More

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