Patent Infringement by ANDA Filing

Courts are in general designed to adjudicate past events (e.g., crimes and torts which have already occurred). Thus, for example, proving patent infringement merely requires showing the court the on-market product, and comparing it to the patent at issue. United States law, however, provides for a fundamentally-different kind of infringement: potential future infringement by a future generic pharmaceutical product which does not yet exist because it has not yet been approved for marketing. This type of infringement requires US courts to adjudicate future events, predicting the likely characteristics of the future generic pharmaceutical. In requiring a court to adjudicate a potential future event, this type of infringement can pose a unique evidentiary challenge to judges. This article discusses how US judges evaluate potential future infringement by generic pharmaceuticals in case of a ‘Paragraph (iv)’ challenge of the Orange Book listed patents or a potential challenge to the patents envisaged on the Paragraph (iv) declaration.