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Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, ANDA Litigation focuses both on the current and developing law as well as the strategies and tactics employed by the litigants. This is a ready roadmap to practice in the area – an especially valuable resource as the Hatch-Waxman Act with it amendments is a hybrid of two already complex areas of the law – U. S. patent law and FDA regulatory law –makes patent litigation in this area especially complicated and hotly contested. This book focuses on the “price competition” side of the act that specifically authorizes and streamlines the process of generic entry through the establishment of the Abbreviated New Drug Application (ANDA).
This updated edition of ANDA Litigation begins with an explanation of the act, its implementation, and litigation under the act, including responses to the complaint, discovery, the work of experts, and patent claim construction and summary judgment. Additional practice-focused information examines issues such as preparing the case for trial, the work of trial, managing the litigation process, post-trial issues and appeals, remedies, settlement, antitrust implications, and regulation and litigation of pharmaceuticals outside the U.S. Fifty appendices taken from successful ANDA litigation practices include many necessary sample complaints, forms, motions, and other legal resources.
Written by a team of experienced ANDA and patent litigators sharing a wide base of knowledge in this specialized practice area, this is an essential resource for novice litigators in the field, while the book’s more detailed material, analysis, and strategy are designed to assist the more experienced ANDA litigator.
