May 14, 2021
Fish & Richardson Attorneys Contribute Chapter to New Biosimilars Book
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.
"Our chapter is the only one that deals specifically with patent issues in detail, including the significant role of inter partes review in litigation strategy. We also discuss the Hatch-Waxman safe harbor, which is important to the biologics industry," said Coggio. "In addition, we discuss the ramifications of Supreme Court, Federal Circuit and district court rulings on the information exchange and patent dance provisions, using leading cases as illustrations."
The U.S. biologics and biosimilars markets have rapidly evolved over the past few years, with Fish on the cutting edge of the field.
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