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…
Read MoreWhat 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…
Read MoreHow is the date of product approval determined for patent term extension purposes?
The date of product approval for patent term extension purposes varies depending on the type of product. According to MPEP 2754.01: For drug products: The approval date is the date of the FDA letter indicating application approval, even if further action is required before marketing. For food or color additives: The relevant date is the…
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…
Read MoreWhat is a petition for stay in processing of a patent term extension application?
A petition for stay in processing of a patent term extension application is a request made by a patent owner to temporarily halt the processing of their patent term extension application. This is typically done when there are unresolved issues relating to the patent, such as involvement in an interference, an appeal of a trial…
Read MoreWhat types of patents are eligible for patent term extension?
Patents eligible for extension under 35 U.S.C. 156 include those that: Claim a product as defined in 35 U.S.C. 156(f)(1) Claim a method of using such a product Claim a method of manufacturing such a product The product must be one of the following: A human drug product A medical device A food additive A…
Read MoreWhat 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…
Read MoreWhat’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:…
Read MoreWhat happens to a patent term extension application when a reissue patent is filed?
When a reissue patent is filed during the processing of a patent term extension application, several steps need to be taken: The Office should receive notice of the reissue filing (see MPEP § 2762). If necessary, the applicant should request a stay of action on the term extension application (see MPEP § 2765). If the…
Read MoreShould a new patent term extension application be filed for a reissue patent?
No, a new patent term extension application should not be filed for a reissue patent. Instead, a specific procedure should be followed: According to MPEP § 2766: “A whole new application for patent term extension should not be filed since any such filing would be outside the 60-day time frame within which an application must…
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