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…

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Is there a limit to the number of interim extensions an applicant can receive?

Yes, there is a general limit to the number of interim extensions an applicant can receive under 35 U.S.C. 156(d)(5). According to MPEP 2754.02: “An applicant is generally limited to four one-year interim extensions.” This limitation means that patent holders typically have up to four years of interim extensions to obtain product approval before they…

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When does an interim extension granted under 35 U.S.C. 156(d)(5) terminate?

An interim extension granted under 35 U.S.C. 156(d)(5) has a specific termination timeline. According to MPEP 2754.02: “An interim extension granted under 35 U.S.C. 156(d)(5) terminates sixty days after permission for commercial marketing or use of the product is granted, except, if within the sixty-day period any additional information needed for an application for patent…

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When should subsequent applications for interim extension be filed?

For subsequent applications for interim extension, the filing window is different from the first application. According to MPEP 2754.02: “Each subsequent application for interim extension must be filed during the period beginning sixty days before and ending thirty days before the expiration of the preceding interim extension.” This means that for any interim extension after…

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What is the filing window for a first application for interim extension under 35 U.S.C. 156(d)(5)?

The filing window for a first application for interim extension under 35 U.S.C. 156(d)(5) is specified in the MPEP. According to MPEP 2754.02: “A first application for interim extension under 35 U.S.C. 156(d)(5) (to extend the patent term before product approval) must be filed within the period beginning six months and ending fifteen days before…

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