Overview

Biosimilars Litigation and Client Counseling is a guide to the field of biologic products and biosimilars, as well as the laws governing them - most notably the Biologics Price Competition and Innovation Act. This guide is instructive to patent attorneys practicing in this field, judges that are assigned cases involving these products and related patents, and managers of pharmaceutical companies that design biologic or biosimilar products or are considering entering this market. It describes the statutory and regulatory framework for applying for and receiving a biologic and biosimilar application, and it provides an in-depth analysis of the legal processes and challenges that come with it. Legal counsel will find practice strategies and tips from the country's top litigators that provide valuable insight into this developing area of law. This includes guidance on what the biosimilar application process looks like, how to navigate certain questions and pitfalls that are likely to arise during the litigation process, and how to best serve a client that is involved with biologics. Judges will appreciate this book as a quick reference to the Biologics Price Competition and Innovation Act which will likely be governing the lawsuit related to biologics that is before them. This includes a walkthrough of typical litigation and summary of the relevant statutes and regulations that will be involved. Judges will also have a guide to the common disputes that arise in these cases and an understanding of how they have been decided. Managers or other decision-making members of a pharmaceutical company will also enjoy this book as a reference when strategizing a patent portfolio or what to consider when designing a biosimilar product, as well as benefiting from the deeper understanding of the legal process that this book provides.

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9781639054657

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Kenneth L. Dorsney, a registered patent attorney, maintains an active practice representing corporate clients and the interests of outside counsel in a wide variety of complex commercial matters, including patent, trademark, trade secret, and copyright litigation, mediation, and dispute resolution in the District of Delaware. A frequent speaker on patent law, Ken has spoken at numerous seminars and law schools on the topic. He is also an active committee member in several associations across the country focused on the practice of intellectual property law and litigation and past Co-Chair of the Intellectual Property Section of the Delaware Chapter of the Federal Bar Association and Chair Emeritus of the Intellectual Property Section of the Delaware State Bar Association. Chief Judge Connolly appointed Ken to serve on the Lawyer Advisory Committee for the U.S.D.C. in Delaware. Mr. Dorsney has a B.A. and B.M.E. from the University of Delaware and a J.D. from the University of Pittsburgh School of Law. He clerked for The Honorable Mary Pat Thynge, U.S. Magistrate Judge for the District of Delaware. After his clerkship with Judge Thynge, Mr. Dorsney clerked for The Honorable Kent A. Jordan, U.S. District Judge for the District of Delaware (in December 2006, Judge Jordan was elevated to the U.S. Court of Appeals for the Third Circuit). Mr. Dorsney is admitted to practice in Delaware, the District of Columbia, and before the U.S. Patent and Trademark Office.

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