Hatch-Waxman Pre-suit Considerations from the Generic Perspective

Summary

This practice note addresses 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. It examines strategies that you should review with your client and actions that you should take in advance of Hatch-Waxman litigation. Careful pre-suit 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 may result from insufficient attention to pre-suit issues.