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Biosimilars Litigation and Client Counseling
American Bar Association
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In biosimilars litigation, the Biologics Price Competition and Innovation Act’s “patent dance” is only the beginning. Chapter 8 of Biosimilars Litigation and Client Counseling, co-authored by Principal Louis Fogel, explores the high-stakes world of “second wave” infringement actions.
This chapter explains how the biosimilar applicant’s notice of commercial marketing triggers a new phase of litigation, which is often faster-paced and less predictable than the first. As exclusivity periods expire, sponsors and applicants may face dual-track disputes, preliminary injunctions, and declaratory judgment actions over remaining patents. Strategic timing and regulatory insight are critical as parties navigate overlapping litigation and market entry.
Learn more about the full edition: Biosimilars Litigation and Client Counseling
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