What is the role of examiners in patent term extensions?
According to MPEP 2720, examiners do not make decisions regarding patent term extensions. The MPEP states: “Examiners make no decisions regarding patent term extensions.“ This means that the determination and calculation of patent term extensions are not part of the examiner’s duties during the patent examination process. Instead, these decisions are made by other entities…
Read MoreWhat types of products are eligible for patent term extension?
According to MPEP 2750, the following types of products are eligible for patent term extension under 35 U.S.C. 156: Human drugs Food or color additives Medical devices Animal drugs Veterinary biological products It’s important to note that “Animal drug products which are primarily manufactured through biotechnology are excluded from the provisions of patent term extension.”…
Read MoreWhen does a withdrawal of a patent term extension application become effective?
A withdrawal of a patent term extension application becomes effective when it is acknowledged in writing by the USPTO. According to MPEP 2764: “An express withdrawal pursuant to this section is effective when acknowledged in writing by the Office.” This means that simply submitting a withdrawal request is not sufficient. The withdrawal only takes effect…
Read MoreWhat is the duty of disclosure in patent term extension proceedings?
The duty of disclosure in patent term extension proceedings refers to the obligation of candor and good faith towards the USPTO, the Secretary of Health and Human Services, and the Secretary of Agriculture. This duty applies to the patent owner, their agent, attorneys, and anyone substantially involved in the patent term extension process. According to…
Read MoreHow long can a stay be granted for a patent term extension application?
According to MPEP 2765, a stay of processing for a patent term extension application can be granted for a limited period: “Any petition for stay can only be granted for a period of up to six months.” This six-month limitation ensures that the patent term extension process is not indefinitely delayed while also providing sufficient…
Read MoreWhat is the “due care” standard for reinstating reduced patent term adjustment?
The “due care” standard for reinstating reduced patent term adjustment is higher than the ordinary due care standard. According to the MPEP, “the phrases ‘all due care’ and ‘unable to respond’ invoke a higher degree of care than the ordinary due care standard of 35 U.S.C. 133, as well as the ‘reasonable efforts to conclude…
Read MoreHow is the approval date determined for drug products in patent term extension applications?
For drug products, the approval date used in patent term extension applications is determined based on the Food and Drug Administration’s (FDA) communication. According to MPEP 2754.01: “For drug products the approval date is the date of a letter by the Food and Drug Administration indicating that the application has been approved, even if the…
Read MoreWhat should an applicant do if they disagree with the patent term extension information printed on the patent?
If an applicant disagrees with the patent term extension information printed on the front page of the patent, they can request a review. According to MPEP 2720: “If applicant disagrees with the patent term extension information printed on the front page of the patent, applicant may request review by way of a petition under 37…
Read MoreWhat is the difference between patent term extension and patent term adjustment?
Patent term extension and patent term adjustment are two distinct concepts in U.S. patent law, each applying to different time periods and situations: Patent Term Extension: Applies to utility and plant patents filed between June 8, 1995, and May 28, 2000 Governed by former 35 U.S.C. 154(b) and 37 CFR 1.701 Detailed in MPEP §…
Read MoreHow is the application date determined for patent term extension purposes?
The determination of the application date for patent term extension purposes is specifically addressed in 35 U.S.C. 156(d)(1): “For purposes of determining the date on which a product receives permission under the second sentence of this paragraph, if such permission is transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on…
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