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

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.

To learn more:

• patent term extension
• covered date
• drug products
• Controlled Substances Act