Press Release November 17, 2021

Goodwin Releases Update to its Comprehensive Guide to Biosimilars Litigation and Regulation in the U.S.

Global law firm Goodwin today announced the release of the 2020-2021 annual update to its definitive biosimilars treatise Guide to Biosimilars Litigation and Regulation in the U.S. The guide, first launched in 2019, is the industry’s first and leading compendium of the laws and regulations governing biosimilars in the U.S., and is authored by a multidisciplinary team of experts drawn from Goodwin’s Intellectual Property, Life Sciences, FDA, Products Litigation + Counseling, Antitrust + Competition, and Appellate Litigation practices. It is published by Thomson Reuters.

“The expected second-wave of BPCIA litigation is upon us, and courts are getting busy grappling with patent and antitrust issues pertaining to biosimilar products,” said Alexandra Valenti, Goodwin partner and senior editor of the guide. “At the same time, the market is maturing, with almost 20 biosimilars now on the market in the U.S., including the first two interchangeable products. This edition of the guide provides a great resource for practitioners and non-lawyers alike as the industry gears up for the next phase of biosimilar litigation and market competition.”

The guide takes a deep dive into each section of the Biologics Price Competition and Innovation Act (BPCIA) and examines how the provisions of the statute and related regulations work in practice — at the FDA, in the courtroom, and before the U.S. Patent & Trademark Office. The guide also provides an overview of the latest legal and regulatory issues unique to biosimilar products, including new developments from the past year such as new FDA guidance on interchangeable product and the Federal Circuit’s recent decision interpreting the notice of commercial marketing statute.

The publication continues to serve as a leading resource for those seeking guidance on topics such as:

  • The “patent dance” pre-litigation mechanism for exchanging patent information and contentions
  • Issues of patent infringement, validity, and enforceability, and how they have been litigated in the biosimilars context
  • Antitrust claims regarding tactics used to allegedly halt or delay biosimilar competition
  • Potential product liability issues related to biosimilar products
  • Regulations and frequently-evolving FDA guidance applicable to applications to market biosimilar products

The Goodwin authors include Alexandra Valenti as senior editor, and contributors Christine Armellino, Beth Ashbridge, Naomi Birbach, Elaine Herrmann Blais, Jacqueline Genovese Bova, James Breen, Brian Burgess, Linnea Cipriano, Jane Cullis, Natasha Daughtrey, Kevin DeJong, Brian Drummond, Christopher Holding, Zachariah Holmes, William James, William JayAlexandra Lu, Daniel Margolis, Nicholas Mitrokostas, Elizabeth Mulkey, Emily Rapalino, Alison Siedor, Julie Tibbets, Steven Tjoe, Josh Weinger, Daryl Wiesen, Huiya Wu and Keith Zullow. Robert Cerwinski was a guest contributor.

To purchase from Thomson Reuters, click here.

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