aaiPharma Inc. v. Thompson

Pioneer (i.e., brand name) drug manufacturers are required to submit a New Drug Application (NDA) to the FDA for approval. NDA applicants are required to provide the FDA a listing of all patents that claim the approved drug or method to use that drug. Once it approves the NDA, the FDA then publishes the list in the "Approved Drug Products with Therapeutic Equivalence Evaluations" also known as the "Orange Book." The Hatch-Waxman Act created the opportunity for manufacturers of generic drugs to enter the market without spending a lot of money on clinical studies to demonstrate the generic drug's safety and efficacy. The generic manufacturer is able to submit an Abbreviated New Drug Application (ANDA), which relies on clinical studies by the pioneer drug manufacturer. The NDA applicant must supplement its Orange Book list about new patents that issue while approval is pending or within 30 days of new patents issued after approval. An ANDA applicant reviews the Orange Book patents and makes one of four certifications with its ANDA: (I) no pioneer drug patent information submitted to FDA; (II) the patent has expired; (III) patent will expire on a certain date; or (IV) patent is invalid or will not be infringed. A paragraph IV certification requires notice to the patentee and the NDA holder, which triggers a 45-day review period in which the patentee could file suit for infringement. If suit is filed, the ANDA is automatically stayed for 30 months. If the patent is not listed in the Orange Book, the ANDA applicant is not required to file a paragraph IV certification. Plaintiff received a patent on a variant of the active drug in Prozac. It tried to have its patent included in the Orange Book because the patent of Eli Lilly & Co., the patentee of Prozac and the holder of the NDA, was about to expire and several generic manufacturers planned to launch generic versions immediately. By including the Plaintiff's patent, generic manufacturers would be required to give notice to Plaintiff and trigger the review and potential stay periods. Only the NDA holders can submit patents for listing in the Orange Book, therefore Plaintiff asked Lilly to submit. The patentee refused and Plaintiff asked the FDA (Defendant) to intervene. Following procedure, the FDA requested Lilly confirm whether its Orange Book listing was correct. When Plaintiff did not get its patent listed, it sued Defendant under the Administrative Procedure Act hours before Defendant was to approve the generic manufacturer's ANDAs. The district court denied relief and Plaintiff appealed.