Determining Infringement by Reference to ANDA Specification and the Physical Product Likely to be Sold

In Hatch-Waxman litigation, the filing of an ANDA seeking approval to market a pharmaceutical product before the expiration of patents covering that product is a technical act of infringement sufficient to establish jurisdiction to resolve the issues of patent infringement and validity in litigation. This article examines the litigation that follows the ANDA filing by considering whether the product that is likely to be sold would infringe the patent.