When should a request for interim extension be filed?

According to 37 CFR 1.760, as cited in MPEP 2755.01: “Any such request should be filed at least three months prior to the expiration date of the patent.“ However, the MPEP clarifies that this time frame is not mandatory: “While 37 CFR 1.760 provides that a request for an interim extension by the applicant ‘should’…

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What is an interim extension of patent term?

An interim extension of patent term is a temporary extension granted by the Director of the USPTO under 35 U.S.C. 156(e)(2) when a patent’s term would expire before a final decision on a patent term extension application can be made. As stated in the MPEP: “If the term of a patent for which an application…

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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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What happens if a patent is determined to be ineligible for extension after an interim extension has been granted?

If a patent is determined to be ineligible for extension after an interim extension has been granted, the interim extension may be revoked. According to MPEP 2755.01: “Where an interim extension has been granted and it is subsequently determined that the patent is not eligible for patent term extension, the interim extension may be vacated…

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Can multiple patents receive interim extensions based on a single regulatory review period?

Yes, multiple patents can receive interim extensions based on a single regulatory review period under certain circumstances. According to MPEP 2755.01: “In circumstances where extensions of multiple patents have been sought based on a single regulatory review period as per 37 CFR 1.785, where those patents expire on the same day, multiple interim extensions under…

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How long can an interim extension last?

According to MPEP 2755.01, interim extensions can be granted for periods of up to one year each. The MPEP states: “The length of any interim extension is discretionary with the Director so long as it is for one year or less. Its length should be set to provide time for completion of any outstanding requirements.“…

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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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What happens if FDA approval is received during an interim extension?

What happens if FDA approval is received during an interim extension? If FDA approval is received during an interim extension period, the patent holder must notify the USPTO promptly. According to MPEP 2755.01: “The patent owner must immediately notify the Office of any determination by the regulatory agency regarding the application for regulatory approval. After…

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