How is the public notified about patent term extensions?

The public is notified about patent term extensions through official publications: Regular extensions are published in the Official Gazette of the USPTO. Interim extensions under 35 U.S.C. 156(d)(5) are published in both the Official Gazette and the Federal Register. MPEP 2759 states: “Notification of the issuance of the certificate or order of extension will be…

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What is considered a “product” for patent term extension purposes?

For patent term extension purposes, the term “product” is defined in 35 U.S.C. 156(f) as: The active ingredient of a new human drug, antibiotic drug, or human biological product The active ingredient of a new animal drug or veterinary biological product (with certain limitations on manufacturing processes) Any medical device, food additive, or color additive…

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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…

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What are patent term extensions and adjustments?

Patent term extensions and adjustments are mechanisms to extend the term of a patent beyond the standard 20-year period. There are two main types: Patent term adjustments under 35 U.S.C. 154 for delays within the USPTO. These apply to utility and plant patents issuing from applications filed on or after June 8, 1995. Patent term…

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What’s the difference between withdrawing a patent term extension application and responding to an election requirement?

There’s a significant difference between withdrawing a patent term extension application and responding to an election requirement. The MPEP 2764 notes: “This is a different situation as compared to MPEP § 2761 where the withdrawal is in response to a requirement for election and not an express withdrawal under 37 CFR 1.770.” Key differences include:…

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