How is the approval date determined for food or color additives 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.

For food or color additives, the approval date used in patent term extension applications is determined differently from drug products. According to MPEP 2754.01:

“For food or color additives, the relevant date is the effective date of the regulation or order, which is set forth in the regulation or order, and generally is the date that the regulation or order is published, e.g., in the Federal Register.”

The MPEP further clarifies:

“This date will generally be later than the date the approval is communicated to the marketing applicant.”

This distinction is important for patent holders and attorneys to note when calculating the 60-day filing period for patent term extension applications related to food or color additives. The effective date of the regulation, typically the publication date in the Federal Register, serves as the starting point for the filing period, not the date when the approval is initially communicated to the applicant.