How does the USPTO process a patent term extension application?
The USPTO follows a specific process for handling patent term extension applications under 35 U.S.C. 156. According to the MPEP, the process includes the following steps: The USPTO initially determines whether the application is formally complete and whether the patent is eligible for extension. The Director of the USPTO notifies the Secretary of Agriculture or…
Read MoreWhat is the regulatory review period in patent term extension?
The regulatory review period is a crucial component in calculating patent term extension. According to 35 U.S.C. 156(g), the regulatory review period has specific meanings for different types of products. MPEP 2758 states: “The Office will rely on the Secretary’s determination of the length of the regulatory review period when calculating the length of the…
Read MoreWhat information about the regulatory review period must be included in a patent term extension application?
A patent term extension application must include specific information about the regulatory review period as outlined in 37 CFR 1.740(a)(10). The required information varies depending on the type of product: For human drugs, antibiotics, and biological products: Effective date and number of the investigational new drug (IND) application Date and number of the new drug…
Read MoreHow is the regulatory review period determination communicated and published?
Once the regulatory agency determines the length of the regulatory review period, it publishes the information in the Federal Register and sends a letter to the USPTO with the same information. Both the Federal Register Notice and the letter to the USPTO include: The total length of the regulatory review period The relevant dates on…
Read MoreWhat is the regulatory agency’s role in determining the length of the regulatory review period?
The regulatory agency is responsible for determining the length of the regulatory review period for the approved product on which a patent term extension application is based. This determination is made based on the application and official regulatory agency records for the approved product. According to MPEP 2757, “Under 35 U.S.C. 156, the regulatory agency…
Read MoreWhat information does the regulatory agency’s letter to the USPTO not take into account?
The letter sent by the regulatory agency to the USPTO regarding the regulatory review period determination does not take into account two important factors: The issue date of the patent The exclusion of one-half of the testing phase MPEP 2757 specifies: “The letter to the Office makes clear that the determination does not take into…
Read MoreHow is the patent term extension period calculated?
The calculation of the patent term extension period is based on the regulatory review period and several other factors. According to MPEP 2758, the basic formula is: Period of Extension = RRP – PGRRP – DD – ½ (TP – PGTP) Where: RRP: Total number of days in the regulatory review period PGRRP: Number of…
Read MoreCan multiple patents receive interim extensions based on a single regulatory review period?
Yes, multiple patents can receive interim extensions based on a single regulatory review period under certain circumstances. According to MPEP 2755.01: “In circumstances where extensions of multiple patents have been sought based on a single regulatory review period as per 37 CFR 1.785, where those patents expire on the same day, multiple interim extensions under…
Read MoreCan multiple patents be extended for the same regulatory review period?
No, only one patent can be extended for a single regulatory review period for any product. This is explicitly stated in 35 U.S.C. 156(c)(4): “in no event shall more than one patent be extended under subsection (e)(1) for the same regulatory review period for any product.” The MPEP 2761 further clarifies: “Only one patent may…
Read MoreWhat is the maximum period of patent term extension?
The maximum period of patent term extension depends on several factors, including the date of patent issuance and the regulatory review period. According to MPEP 2758: For patents issued after September 24, 1984, the extension cannot exceed five years. For patents issued before September 24, 1984, with regulatory review starting after this date, the extension…
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