Description

Biosimilars Litigation and Client Counseling Kenneth Laurence Dorsney ISBN 9781639054657

Biosimilars Litigation and Client Counseling is an essential guide to the rapidly evolving field of biologic products and biosimilars, with a particular focus on the Biologics Price Competition and Innovation Act (BPCIA). This resource is designed for patent attorneys, judges, and pharmaceutical executives navigating the complex legal and regulatory landscape surrounding biologics and biosimilars.

The book explains the statutory and regulatory framework for obtaining biologic and biosimilar approvals and offers an in-depth analysis of the legal challenges that can arise. It provides actionable guidance for legal counsel, including strategies for managing litigation, anticipating common pitfalls, and effectively advising clients involved in biologics or biosimilars.

For judges, this guide serves as a concise reference to the BPCIA and related statutes, walking through typical litigation scenarios, common disputes, and how courts have historically resolved these cases.

Pharmaceutical managers and executives will benefit from the insights on patent portfolio strategy, biosimilar development considerations, and a practical understanding of the legal processes that impact business decisions in this competitive market.

Whether for practitioners, the bench, or corporate decision-makers, Biosimilars Litigation and Client Counseling provides expert analysis, practical strategies, and a comprehensive roadmap to navigating this specialized and high-stakes area of law.

Biosimilars Litigation and Client Counseling Kenneth Laurence Dorsney ISBN 9781639054657, 978-1639054657 & 9781639054664

Author
Kenneth Laurence Dorsney