What is the “covered date” for certain drug products in patent term extension applications?

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

The “covered date” is a specific term used in patent term extension applications for certain drug products. According to 35 U.S.C. 156(i)(2), the covered date is defined as the later of:

• The date an application is approved under specific sections of the Public Health Service Act or Federal Food, Drug, and Cosmetic Act
• The date an application is conditionally approved under the Federal Food, Drug, and Cosmetic Act
• The date a request for indexing is granted under the Federal Food, Drug, and Cosmetic Act
• The date of issuance of an interim final rule controlling the drug under the Controlled Substances Act

This date is crucial for determining the 60-day filing period for patent term extension applications for certain drug products subject to control under the Controlled Substances Act.