Hatch-Waxman Patent Litigation Toolkit

Resources for counsel involved in litigation arising under the Hatch-Waxman Act based on a generic drug manufacturer's filing of an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA), including background information on the Hatch-Waxman Act, pre-suit considerations for a patent owner's counsel, litigation documents and settlement issues.

Practical Law Intellectual Property & Technology

Patent litigation arising under the Hatch-Waxman Act ( www.practicallaw.com/9-543-2565) based on the filing of an Abbreviated New Drug Application ( www.practicallaw.com/2-543-2465) (ANDA) with the Food and Drug Administration ( www.practicallaw.com/3-501-7065) (FDA) presents unique challenges for litigants and their counsel. Parties and their counsel should be aware of the differences between general patent litigation and Hatch-Waxman patent litigation, both before litigation starts and once a patent infringement complaint is filed.

This Toolkit provides several continuously maintained resources designed to help both patent owners' and ANDA filers' counsel prepare for and conduct patent litigation arising under the Hatch-Waxman Act, including resources relating to:

  • The Hatch-Waxman Act generally.

  • A patent owner's pre-suit preparations before and after an ANDA filing.

  • Infringement claims under 35 U.S.C. § 271(e)(2).

  • Preparing a patent infringement complaint.

  • Discovery.

  • Settlement and related antitrust considerations.


General Considerations


Litigation Documents


Settlement Considerations

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