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…
Read MoreHow is the application date determined for patent term extension purposes?
The determination of the application date for patent term extension purposes is specifically addressed in 35 U.S.C. 156(d)(1): “For purposes of determining the date on which a product receives permission under the second sentence of this paragraph, if such permission is transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on…
Read MoreCan the 60-day filing period for patent term extension applications be extended or waived?
No, the 60-day filing period for patent term extension applications cannot be extended or waived. The MPEP 2754.01 is very clear on this point: “The statutory time period is not extendable and cannot be waived or excused.” This strict adherence to the 60-day filing period is exemplified by a case cited in the MPEP: “See…
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