Can 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 MoreWhat are “B delays” in patent term adjustment?
“B delays” are another category of delays in the patent examination process that can lead to patent term adjustments. According to MPEP 2731, B delays occur when: The USPTO fails to issue a patent within three years of the actual filing date of the application The application is involved in an interference proceeding The application…
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 MoreWhat are applicant delays in patent term adjustment?
Applicant delays are periods during patent prosecution that reduce the overall patent term adjustment. According to MPEP 2731, applicant delays include: Failing to reply to a notice or action within three months Filing a supplemental reply or other paper that was not expressly requested by the examiner Submitting a preliminary amendment or other preliminary paper…
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 MoreWhat actions can reduce patent term adjustment?
Several actions by the applicant can reduce patent term adjustment, including: Suspension of action at the applicant’s request Deferral of issuance of a patent Abandonment of the application or late payment of the issue fee Failure to file a petition to withdraw holding of abandonment or revive an application within 2 months Conversion of a…
Read MoreHow does abandonment of an application affect patent term adjustment?
Abandonment of an application can significantly impact patent term adjustment. According to 37 CFR 1.704(c)(3): “Abandonment of the application or late payment of the issue fee as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.” For applications where a notice of…
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