Why are third-party submissions not allowed in patent term extension proceedings?
The exclusion of third-party submissions in patent term extension proceedings is based on several factors outlined in MPEP 2763: The statute provides for public input into the regulatory review period determination, but not for proceedings before the USPTO. The patent applicant already has a duty of disclosure to both the USPTO and the regulatory agency.…
Read MoreHow do RCE filings affect patent term adjustment?
Request for Continued Examination (RCE) filings can significantly impact patent term adjustment calculations. According to MPEP 2731: Time consumed by continued examination of the application requested by the applicant under 35 U.S.C. 132(b) is not included in the “B delay” three-year period The filing of an RCE within three years of the application’s actual filing…
Read MoreWhat is the impact of filing a Request for Continued Examination (RCE) on patent term adjustment?
Filing a Request for Continued Examination (RCE) after a notice of allowance has been mailed can result in a reduction of patent term adjustment. According to 37 CFR 1.704(c)(12): “Submission of a request for continued examination under 35 U.S.C. 132(b) after any notice of allowance under 35 U.S.C. 151 has been mailed as constituting a…
Read MoreWhat is the purpose of patent term extension under 35 U.S.C. 156?
The purpose of patent term extension under 35 U.S.C. 156 is to compensate patent owners for time lost during the premarket regulatory review process. As stated in the MPEP: “The statute enables the owners of patents on certain human drugs, food or color additives, medical devices, animal drugs, and veterinary biological products to restore to…
Read MoreHow 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 MoreAre provisional applications considered in calculating patent term?
No, provisional applications are not considered in calculating the patent term. The MPEP clearly states, Domestic benefit under 35 U.S.C. 119(e) to one or more U.S. provisional applications is not considered in the calculation of the twenty-year term. This means that the filing date of a provisional application does not affect the 20-year term of…
Read MoreWhat 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…
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…
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