What happens if a product receives approval after business hours or on a non-business day?
When a product receives approval for commercial marketing or use outside of normal business hours or on a non-business day, special rules apply for determining the official approval date. According to MPEP 2754.01:
“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.”
This rule ensures a consistent approach to calculating the 60-day filing period for patent term extension applications, regardless of when the approval is actually transmitted. It’s crucial for patent holders and their representatives to understand this rule to accurately determine the start of the filing period and avoid missing the deadline.
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