Description

ANDA Litigation: Strategies and Tactics for Pharmaceutical Patent Litigators 4th Edition Kenneth Laurence Dorsney ISBN 9781639056637

The Drug Price Competition and Patent Term Restoration Act—commonly known as the Hatch-Waxman Act—was designed to strike a balance between patent exclusivity and market competition in the pharmaceutical industry. Yet its impact on regulating the pharmaceutical marketplace remains unsettled. Amendments to the Act introduced an abbreviated pathway for FDA approval of generic versions of patented drugs through the Abbreviated New Drug Application (ANDA) process, as well as the right of patent holders to initiate litigation against ANDA applicants. These provisions have fueled extensive ANDA litigation and an ongoing effort to shape the evolving patent and regulatory framework governing FDA-approved branded and generic drugs. By combining two already complex legal regimes—U.S. patent law and FDA regulatory law—the Hatch-Waxman Act has made pharmaceutical patent litigation uniquely intricate and fiercely contested.

Now fully updated and expanded, the Fourth Edition of ANDA Litigation: Strategies and Tactics for Pharmaceutical Patent Litigators offers a comprehensive, single-source guide to the statutory and regulatory framework governing generic drug approval and its intersection with U.S. patent law, with a particular focus on Paragraph IV ANDA litigation. Spanning 23 in-depth chapters, the book addresses both established and emerging legal developments, while providing practical insight into the strategies and tactics employed by litigants on all sides.

ANDA Litigation serves as a clear roadmap for attorneys new to this highly specialized field, while also delivering advanced analysis and strategic guidance for experienced practitioners. The opening chapters explain the Hatch-Waxman Act and its implementation, including an overview of the FDA drug approval process, notice requirements, pre-litigation considerations, and the timing and sequencing of ANDA litigation.

The guide then delves deeply into the litigation process itself, covering pleadings and responses, discovery, expert testimony, patent claim construction, and summary judgment. Subsequent chapters focus on trial preparation and execution, effective case management, and post-trial issues, including appeals to the U.S. Court of Appeals for the Federal Circuit.

The book concludes with a detailed discussion of remedies, settlements, and antitrust considerations, and includes additional chapters addressing the regulation and litigation of pharmaceuticals outside the United States. Together, these features make this Fourth Edition an indispensable resource for attorneys navigating the complex and constantly evolving world of ANDA litigation.

ANDA Litigation: Strategies and Tactics for Pharmaceutical Patent Litigators 4th Edition Kenneth Laurence Dorsney ISBN 9781639056637, 978-1639056637 & 9781639056644

Author
Kenneth Laurence Dorsney