What is the deadline for filing a patent term extension application?
The deadline for filing a patent term extension application is specified in 35 U.S.C. 156(d)(1):
“Except as provided in paragraph (5), such an application may only be submitted within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use, or in the case of a drug product described in subsection (i), within the sixty-day period beginning on the covered date (as defined in subsection (i)).”
This means that generally, the application must be filed within 60 days of receiving marketing approval from the relevant regulatory agency. For certain drug products, the deadline is based on the “covered date” as defined in the statute.
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