What conditions must be met for a patent to qualify for term extension?
According to 35 U.S.C. 156(a)(1)-(5) and 37 CFR 1.720, the following conditions must be met: The patent has not expired before the application for extension is filed The patent has never been previously extended under 35 U.S.C. 156(e)(1) The application is submitted by the patent owner or its agent within 60 days of regulatory approval…
Read MoreWhat constitutes a “complete application” for patent term extension?
A “complete application” for patent term extension is defined in 37 CFR 1.741(a) and must meet the requirements set forth in 35 U.S.C. 156(d)(1). The MPEP states: “The Office will consider each of these statutory requirements to be satisfied in an application which provides sufficient information, directed to each requirement, to act on the application,…
Read MoreWhat is a Certificate of Extension of Patent Term?
A Certificate of Extension of Patent Term is an official document issued by the Director of the USPTO to extend the term of a patent that has been determined eligible for extension under 35 U.S.C. 156. According to MPEP 2759, “Such certificate shall be recorded in the official file of the patent and shall be…
Read MoreCan a Certificate of Extension be issued if the patent term cannot be extended?
No, a Certificate of Extension cannot be issued if the patent term cannot be extended, even if the patent is otherwise eligible for extension. According to MPEP 2759, which cites 37 CFR 1.780: “No certificate of, or order granting, an extension will be issued if the term of the patent cannot be extended, even though…
Read MoreWhat is considered a “business day” for patent term extension applications?
For patent term extension applications, the definition of a “business day” is specific and important for calculating deadlines. According to MPEP 2754.01: “The term ‘business day’ in this context means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under 5 U.S.C. 6103.” This definition is crucial when determining the exact date a…
Read MoreHow is the approval date determined for food or color additives in patent term extension applications?
For food or color additives, the approval date used in patent term extension applications is determined differently from drug products. According to MPEP 2754.01: “For food or color additives, the relevant date is the effective date of the regulation or order, which is set forth in the regulation or order, and generally is the date…
Read MoreHow is the approval date determined for drug products under the Controlled Substances Act?
For drug products that the Secretary of Health and Human Services intends to recommend controls under the Controlled Substances Act, the approval date is determined differently. According to MPEP 2754.01: “Where the regulatory review is of a drug product for which the Secretary of Health and Human Services intends to recommend controls under the Controlled…
Read MoreHow is the regulatory review period for an animal drug determined?
For animal drugs where the New Animal Drug Application (NADA) components were submitted to FDA in a phased review, the approval phase begins on the date of the submission of the administrative NADA. As stated in MPEP 2757: “To determine the regulatory review period for an animal drug where the New Animal Drug Application (NADA)…
Read MoreWhat additional information is required when submitting an application for patent term extension under 35 U.S.C. 156(d)(1) after an interim extension?
When submitting an application for patent term extension under 35 U.S.C. 156(d)(1) following an interim extension, specific additional information is required. According to MPEP 2754.02, this includes: The fee for an application for patent term extension under 35 U.S.C. 156(d)(1) Identification of the date the product received permission for commercial marketing or use A statement…
Read MoreCan the 60-day filing period for patent term extension applications be extended or waived?
No, the 60-day filing period for patent term extension applications cannot be extended or waived. The MPEP 2754.01 is very clear on this point: “The statutory time period is not extendable and cannot be waived or excused.” This strict adherence to the 60-day filing period is exemplified by a case cited in the MPEP: “See…
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