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How Amending ANDA Specifications Can Win or Lose Pharmaceutical Patent Litigation

Published in Intellectual Property Westlaw Journal
Article | April 1, 2015

In this article, Katten attorneys Martin S. Masar III and Thomas J. Maas analyze a strategy for certain patent infringement litigation involving generic drugs. Since the enactment of the Hatch-Waxman Act in 1984, patent litigation has been an integral component of the pharmaceutical industry. Marty and Thomas provide tips and potential pitfalls for Hatch-Waxman litigation involving amendments to Abbreviated New Drug Applications (ANDAs) to avoid infringement. For example, they discuss best practices for amending the specification in these cases, including: (1) directly addressing the infringement inquiry; (2) ensuring that specifications are wholly inconsistent with one or more claim elements; and (3) accounting for the timing of the amendment.

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