Q Corner | Paragraph IV

What is Para IV and how to file Para IV? --- Dr. Jitendra Koundinya, Mumbai

This is the first question asked by our reader in our new section Q Corner. Para IV (or paragraph IV) is a statutory concept related to the US drug regulatory and patent system brought by the Drug Price Competition and Patent Term Restoration Act, 1984 also referred as “Hatch-Waxman Act.” Hatch-Waxman Act amended the Food, Drug and Cosmetic Act remarkably balancing the business interests of pioneers and generic drug manufactures, and is primarily credited for the development of the US generic drug industry. Title I of the Hatch-Waxman Act contains the drug price competition part, specifically authorizing generic drug manufactures to file Abbreviated New Drug Applications (ANDAs) along with bioavailability studies. The Act also required one of four certifications to be made when someone files an ANDA: 1) that the drug has not been patented; 2) that the patent has already expired; 3) the date on which the patent will expire, and the generic drug will not go on the market until that date passes; and 4) that the patent is not infringed or is invalid. Those certifications are now referred to as the paragraphs I, II, III and IV certifications. Title II of the Hatch-Waxman Act contains the patent term restoration part, specifically authorizing pioneers to receive an extension in patent term lost during the FDA approval process.

As a part of Para IV process, a generic applicant must do two things: 1) certify in its ANDA that the patent in question is invalid or is not infringed by the generic product and 2) notify the patent holder of the submission of the ANDA. Once the patent holder receives the ANDA notification, they have statutory discretion to file a patent infringement suit against the applicant within 45 days. If an infringement suit is filed within the 45-day period, FDA approval to market generic version is automatically stayed for 30 months. Notably, a Para IV certification can be triggered by a generic applicant for a drug product that has unexpired Orange Book (OB) listed patents and the generic applicant is seeking to market its generic equivalent before the expiration of OB patent(s).