What information must be included in a patent term extension application?
According to 35 U.S.C. 156(d)(1), a patent term extension application must contain the following information: The identity of the approved product and the Federal statute under which regulatory review occurred The identity of the patent for which an extension is being sought and the relevant claims Information to determine eligibility for extension and the rights…
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 MoreCan a registered practitioner sign a patent term extension application on behalf of the patent owner?
Yes, a registered practitioner can sign a patent term extension application on behalf of the patent owner. According to 37 CFR 1.730(b)(2): “If the application is submitted by the patent owner, the application must be signed either by: … (2) A registered practitioner on behalf of the patent owner.” However, the USPTO may require proof…
Read MoreWhat are the reasons for filing a petition for stay in a patent term extension application?
Patent owners may file a petition for stay in a patent term extension application when there are unresolved issues relating to the patent that need to be addressed before the extension can be granted. MPEP 2765 states: “Such issues could include, but are not limited to, involvement in an interference, an appeal of a trial…
Read MoreWhat are the reasons for patent term extension under former 35 U.S.C. 154(b)?
Under former 35 U.S.C. 154(b), as referenced in MPEP 2720, there are three main reasons for patent term extension: Interference or derivation proceedings under 35 U.S.C. 135(a) The application being placed under a secrecy order under 35 U.S.C. 181 Appellate review by the Patent Trial and Appeal Board or by a Federal court under 35…
Read MoreWhy are third-party submissions not allowed in patent term extension proceedings?
The exclusion of third-party submissions in patent term extension proceedings is based on several factors outlined in MPEP 2763: The statute provides for public input into the regulatory review period determination, but not for proceedings before the USPTO. The patent applicant already has a duty of disclosure to both the USPTO and the regulatory agency.…
Read MoreWhat is the purpose of patent term extension under 35 U.S.C. 156?
The purpose of patent term extension under 35 U.S.C. 156 is to compensate patent owners for time lost during the premarket regulatory review process. As stated in the MPEP: “The statute enables the owners of patents on certain human drugs, food or color additives, medical devices, animal drugs, and veterinary biological products to restore to…
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