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.
“Despite a slowdown in biosimilars litigation activity in 2020 and an active Supreme Court case that could nullify the Biologics Price Competition and Innovation Act, biosimilars will remain a critical component of U.S. healthcare landscape moving forward,” said Alexandra Valenti, Goodwin partner and senior editor of the guide.
“As we look ahead at several critical biosimilars cases in play and one-party control in Washington, we anticipate significant change for the biosimilars market in the year ahead,” added Rob Cerwinski, Goodwin partner and senior editor of the guide. “Our updated Guide tackles the most pressing issues affecting this market and serves as a critical resource for companies looking to succeed in this space.”
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:
- Litigation over antitrust claims challenging as anticompetitive AbbVie’s activities with regard to patent protection on its Humira product
- The important role of the preliminary injunction proceedings in BPCIA litigation, and recent decisions in that context
- The extent to which biosimilar manufacturers may be protected from patent infringement judgments by the safe harbor statute
The publication continues to serve as a leading resource for biosimilars companies 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 Rob Cerwinski, Michael Cottler and Alexandra Valenti as senior editors, and contributors Christine Armellino, Beth Ashbridge, Naomi Birbach, Elaine Herrmann Blais, Jacqueline Genovese Bova, James Breen, Brian Burgess, Cindy Chang, Linnea Cipriano, Jane Cullis, Natasha Daughtrey, Kevin DeJong, Brian Drummond, Sarah Fischer, Christopher Holding, Zachariah Holmes, Nilda Isidro, William James, William Jay, Julius Jefferson, Glenn Kerner, Alexandra Lu, Daniel Margolis, Nicholas Mitrokostas, Elizabeth Mulkey, Emily Rapalino, Alison Siedor, Julie Tibbets, Steven Tjoe, Josh Weinger, Daryl Wiesen, Huiya Wu and Keith Zullow. Scott Lassman and Joshua Whitehill were guest contributors.
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