Hatch-Waxman Presuit Considerations For Generics: Part 1

Law360 (May 29, 2019, 3:43 PM EDT) -- This is the first part of a two-part article addressing how counsel for a generic drug company should prepare for patent litigation under the Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act.

The first part includes a brief recap of the Hatch-Waxman litigation scheme and discusses the early steps that counsel should take, including defining the objective and choosing the best procedural path. Careful presuit preparation increases the likelihood of a favorable result, whether through litigation or settlement, and minimizes the small, but real, risk of a fees award against your client that...

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