In the life sciences industry, which encompasses pharmaceuticals and biopharmaceuticals, patent protection and exclusivity rights are of critical importance. For industry innovators, patents and exclusivity rights are essential for companies and academic institutions to protect and recoup the very substantial research and development investments that are made to discover and develop medicines that can treat and cure ailments, diseases, and other medical conditions. For generic and biosimilar manufacturers, challenging those patents?and the financial incentives to do so?allows them to manufacture and market affordable medicines with relatively small investments. The Federal Courts, U.S. Congress, and U.S. Food and Drug Administration (FDA) have created a body of case law, statutes, and regulations that are tailored to this industry.