Patent Infringement Complaint
(Hatch-Waxman Act)

Summary

This template is a Patent Infringement Complaint for use by a brand-name drug company suing a generic drug manufacturer for infringement of an Orange Book listed patent under The Drug Price Competition and Patent Term Restoration Act of 1984, 21 U.S.C. § 355(j), known as the Hatch-Waxman Act (the Act). This template includes practical guidance and drafting notes. The Act established a streamlined FDA approval process for bioequivalent generic versions of FDA-approved brand-name drugs, via the filing of an Abbreviated New Drug Application (ANDA). The ANDA scheme allows a brand-name drug company to sue an ANDA applicant for patent infringement based on the ANDA filing, before the generic drug is approved for sale. This template can be used as a starting point in drafting a complaint and should be adapted as necessary to your case. Be aware that the following documents typically have to be served along with a complaint: a summons, a civil cover sheet, and a corporate disclosure statement. An ADR compliance or notification certificate and notice of related cases also may be required. Check the court's local rules and local patent rules for special requirements and see generally TWG Practice Guide: Fed. Civ. Proc. Before Trial § 17-XVI. Also check local rules and local patent rules for any additional requirements for filing Hatch-Waxman complaints, such as the supplemental information sheet to be filed with Hatch-Waxman complaints in the District of Delaware. Following the abrogation of Form 18 of the Federal Rules of Civil Procedure that took effect on December 1, 2015, the Federal Rules no longer include a template for a patent infringement complaint. A complaint for patent infringement, like other federal court complaints, must comply with the notice pleading standards established by the Supreme Court in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) and Ashcroft v. Iqbal, 556 U.S. 662 (2009). District courts applying the Iqbal/Twombly pleading standard have differed significantly on the level of detail that is required for patent infringement complaints. Therefore, be sure to research the district court case law on this issue. Also conduct an adequate factual investigation and legal analysis before filing a complaint. For the types of inquiries that you should make, see Pre-litigation Opinion on Patent Infringement and Validity. For a general discussion of how to draft a complaint in federal court, see Commencing a Lawsuit: Drafting and Filing the Complaint (Federal). For additional resources related to patent enforcement, see Patent Enforcement Resource Kit. For a full listing of resources for Hatch-Waxman litigation, see Hatch-Waxman Litigation Resource Kit. For a full listing of key content covering life sciences patents and licensing, see Life Sciences Patents and Licensing Resource Kit.