BOSTON, Jan. 24, 2019 /PRNewswire/ -- 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.
Fish & Richardson, a premier global intellectual property law firm, is sought-after and trusted by the world's most innovative brands and influential technology leaders. Fish offers patent prosecution, counseling and litigation; trademark and copyright prosecution, counseling and litigation; and commercial litigation services. Our deep bench of attorneys with first-chair trial experience in every technology makes us the go-to firm for the most technically complex cases. We have an established reputation as a top-tier firm for patent portfolio planning, strategy and prosecution, as well as post-grant proceedings at the PTAB. Fish was established in 1878, and now has more than 400 attorneys and technology specialists in the U.S., Europe and China. Our success is rooted in our creative and inclusive culture, which values the diversity of people, experiences and perspectives. For more information, visit fr.com or follow us at @FishRichardson.
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