What is the role of the FDA in the patent term extension process?
The Food and Drug Administration (FDA) plays a crucial role in the patent term extension process for certain products. Specifically: The FDA assists the USPTO in determining the eligibility of patents for term extension for products requiring regulatory review (excluding veterinary biological products). It is responsible for determining the regulatory review period for these products.…
Read MoreWhat factors determine a utility patent’s expiration date?
According to MPEP 2211, several factors determine a utility patent’s expiration date: The term of the patent Payment of maintenance fees Any disclaimer filed to shorten the patent term Patent term extensions or adjustments for delays within the Office under 35 U.S.C. 154 (see MPEP § 2710, et seq.) Patent term extensions available under 35…
Read MoreWhat is the process for expunging confidential information from patent term extension applications?
The process for expunging confidential information from patent term extension applications is outlined in MPEP 2760. The key points are: “Otherwise, if a suitable petition to expunge is filed before the issuance of the certificate, the trade secret or confidential information will be expunged from the file and returned to the patent term extension applicant.”…
Read MoreAre there any exceptions to the prohibition on third-party participation in patent term extension proceedings?
While MPEP 2763 generally prohibits third-party participation in patent term extension proceedings, there is one potential exception mentioned: “Absent an invitation from the Director, any such submission would be inappropriate.“ This suggests that the Director of the USPTO has the discretion to invite third-party submissions in exceptional circumstances. However, such invitations are likely to be…
Read MoreWhat 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 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…
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