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Hatch-Waxman Litigation

Our life sciences practitioners have literally written the book on Abbreviated New Drug Application (ANDA) patent litigation. As authors of Pharmaceutical and Biotech Patent Law (Practising Law Institute) and the ABA's Patent Litigation Strategies Handbook chapter on Hatch-Waxman litigation, our patent lawyers are at the cutting edge when it comes to litigating Hatch-Waxman suits against generic infringers and counseling on life cycle management. We have litigated some of the most significant Hatch-Waxman cases and have extensive experience in the complex interaction between patent and FDA regulatory issues. Our clients have entrusted us with the defending against generic challenges to products such as Viagra®, Celebrex®, Allegra®, Gleevec®, Diflucan®, Ampyra®, and Treanda®. In addition to trying ANDA patent cases, our team has been involved in the negotiation and drafting of many tactical settlements, and routinely advises on the antitrust issues arising from settling ANDA patent litigation between pioneer pharmaceutical manufacturers and generics.