What are the formal requirements for a patent term extension application?

The formal requirements for a patent term extension application are outlined in 37 CFR 1.740. Some key requirements include: Complete identification of the approved product Identification of the federal statute under which regulatory review occurred Date of product approval for commercial marketing or use For drug products, identification of each active ingredient Statement that the…

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How long does an interim extension last?

How long does an interim extension last? According to MPEP 2755.01, the duration of an interim extension is limited: “An interim extension granted under 35 U.S.C. 156(e)(2) terminates at the earlier of the expiration of the 60-day period beginning on the date on which the product involved receives permission for commercial marketing or use, or…

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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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How is the approval date determined for drug products in patent term extension applications?

For drug products, the approval date used in patent term extension applications is determined based on the Food and Drug Administration’s (FDA) communication. According to MPEP 2754.01: “For drug products the approval date is the date of a letter by the Food and Drug Administration indicating that the application has been approved, even if the…

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