A sample complaint that an accused infringer may use as a starting point to seek a declaratory judgment of non-infringement or invalidity under the Hatch-Waxman Act of a patent listed in the Food and Drug Administration's (FDA)'s Orange Book. This Standard Document contains integrated drafting notes with important explanations and tips for drafting the complaint's caption, preliminary statement, jurisdiction and venue sections, facts section, legal claims, prayer for relief, and signature block.