By Jeffrey Lewis and Niki Ikahihifo-Bender ( September 10, 2018, 12:35 PM EDT) -- Under the Drug Price Competition and Patent Restoration Act of 1984,[1] commonly known as the "Hatch-Waxman Act," a new pharmaceutical sponsor identifies patents of certain types that would be infringed by a generic, and the U.S. Food and Drug Administration publishes those patents in its List of Approved Drug Products with Therapeutic Equivalence Evaluations (the so-called "Orange Book").[2] Anyone wishing to market a generic must file an abbreviated new drug application certifying (1) that there is no patent information in the Orange Book; (2) that each listed patent has expired; (3) the date that each patent expires delaying approval until expiration; or (4) that it does not infringe those patent(s).[3] A generic applicant that files a paragraph IV certification must give notice to the sponsor and any other patent holders of the certification as well as inter alia provide reasons for believing that it will not infringe the patents.[4]...