How is the approval date determined for drug products in patent term extension applications?

For drug products, the approval date used in patent term extension applications is determined based on the Food and Drug Administration’s (FDA) communication. According to MPEP 2754.01:

“For drug products the approval date is the date of a letter by the Food and Drug Administration indicating that the application has been approved, even if the letter requires further action before the drug can be marketed.”

This interpretation is supported by case law, as the MPEP cites:

“Mead Johnson Pharmaceutical Group v. Bowen, 838 F.2d 1332, 1336; 6 USPQ2d 1565, 1568 (D.C. Cir. 1988).”

It’s important to note that the approval date is based on the FDA’s letter indicating approval, even if additional steps are required before the drug can be marketed. This distinction is crucial for accurately calculating the 60-day filing period for patent term extension applications related to drug products.

To learn more:

• drug products
• FDA approval
• patent term extension
• approval date
• Mead Johnson Pharmaceutical Group v. Bowen