Fish & Richardson attorneys Brian D. Coggio, Dr. Tasha Francis and Ron Vogel have written a chapter in the recently-released book, “Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development,” which provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars.
Coggio, Francis and Vogel, who are highly-regarded thought leaders in intellectual property (IP) considerations for biosimilars, wrote the chapter on “Litigation-Related Issues Under the Biologics Price Competition and Innovation Act (BPCIA).” The chapter covers the pertinent provisions of the BPCIA that relate to patent issues, including the so-called patent dance, the two waves of litigation, the 180-day notice of commercialization that is triggered by the second wave, and inter partes review, which plays a significant role in biosimilars’ attempts to avoid district court litigation for their proposed products. The chapter also contains a useful comparison of the key provisions of the BPCIA with corresponding provisions of the Hatch-Waxman Act.