A sample answer and counterclaims that a patent owner may use as a starting point to respond and assert an infringement counterclaim to a declaratory judgment complaint brought under the Hatch-Waxman Act. This Standard Document contains integrated drafting notes with important explanations and tips for drafting responses to the declaratory judgment plaintiff's non-infringement, invalidity, and unenforceability allegations, and asserting infringement counterclaims and a prayer for relief.