ANDA Litigation: Strategies and Tactics for Pharmaceutical Patent Litigators

ISBN: 978-1-61438-478-6, 978-1-61438-479-3
Product Code: 5370199, 5370199EBK
2012, 840 pages

Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law, this single-source guide balances perspectives from name-brand drug patentees and generic drug manufacturers. With a focus on current and developing law as well as practical strategies and tactics for litigation, it covers all steps in the litigation process.

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Representing a compromise in the pharmaceutical industry in balancing patent exclusivity against market competition, the effect of the Drug Price Competition and Patent Term Restoration Act (commonly known as the Hatch-Waxman Act) on controlling the pharmaceutical market remains unsettled....

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