What happens if a product is not approved within the period of interim extension under 35 U.S.C. 156(d)(5)?
If a product does not receive approval within the period of interim extension granted under 35 U.S.C. 156(d)(5), further action is required to maintain the patent’s extended term. According to MPEP 2754.02: “If the product is not approved within the period of interim extension under 35 U.S.C. 156(d)(5), a new request for interim extension must…
Read MoreWhat 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…
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