How is the date of product approval determined for patent term extension purposes?

The date of product approval for patent term extension purposes varies depending on the type of product. According to MPEP 2754.01:

• For drug products: The approval date is the date of the FDA letter indicating application approval, even if further action is required before marketing.
• For food or color additives: The relevant date is the effective date of the regulation or order, typically the publication date in the Federal Register.
• For drug products requiring Controlled Substances Act controls: The approval date is the “covered date” as defined in 35 U.S.C. 156(i)(2), which is the later of several possible dates related to approval and control measures.

The MPEP also states: “For purposes of determining the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use, if such permission is transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on a day that is not a business day, the product shall be deemed to have received such permission on the next business day.”

To learn more:

• product approval date
• patent term extension
• regulatory review
• FDA approval