Who is subject to the duty of disclosure in patent term extension proceedings?
The duty of disclosure in patent term extension proceedings applies to a wide range of individuals involved in the process. According to MPEP 2762: “A duty of candor and good faith toward the USPTO, the Secretary of Health and Human Services, and the Secretary of Agriculture rests on the patent owner or its agent, on…
Read MoreWho can apply for a patent term extension?
According to MPEP 2752, the patent term extension application must be submitted by the owner of record of the patent or its agent. Specifically, 35 U.S.C. 156(d)(1) states: “To obtain an extension of the term of a patent under this section, the owner of record of the patent or its agent shall submit an application…
Read MoreWhen should material information be disclosed in patent term extension proceedings?
Material information should be disclosed promptly in patent term extension proceedings. The MPEP 2762 provides clear guidance on the timing: “All such individuals who are aware, or become aware, of material information adverse to a determination of entitlement to the extension sought, which has not been previously made of record in the patent term extension…
Read MoreWhat is the purpose of correspondence between the USPTO and regulatory agencies in patent term extension?
The correspondence between the USPTO and regulatory agencies serves multiple purposes in the patent term extension process: To facilitate eligibility decisions for patent term extension To allow both entities to carry out their responsibilities under 35 U.S.C. 156 To exchange information regarding regulatory review period determinations, due diligence petitions, and informal regulatory agency hearings As…
Read MoreHow 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 MoreHow does the USPTO make a preliminary eligibility decision for patent term extension?
The USPTO makes a preliminary eligibility decision for patent term extension through the following process: The USPTO sends an initial letter to the relevant regulatory agency requesting information on eligibility. Upon receiving a reply from the regulatory agency, the USPTO reviews the information provided. The USPTO compares the regulatory agency’s information with the details in…
Read MoreWhat information does the USPTO request from regulatory agencies to determine patent term extension eligibility?
The USPTO requests specific information from regulatory agencies to help determine patent term extension eligibility. According to the MPEP, this information typically includes: Verification of whether the product underwent a regulatory review period within the meaning of 35 U.S.C. 156(g) prior to commercial marketing or use Confirmation that the marketing permission was for the first…
Read MoreWhen can the USPTO make a final determination on a patent term extension application?
The USPTO can make a final determination on a patent term extension application at various points in the process. According to MPEP 2755: “A final determination may be made at any time after an application is filed.“ This means that once an applicant submits their patent term extension application, the USPTO has the authority to…
Read MoreHow does the USPTO evaluate petitions for stay in patent term extension applications?
The USPTO evaluates petitions for stay in patent term extension applications based on the standard of “good and sufficient cause.” According to MPEP 2765: “The standard for granting requests under both 37 CFR 1.103 and 37 CFR 1.314 is good and sufficient cause.” The USPTO considers several factors when evaluating these petitions: The nature and…
Read MoreWhat additional information might the USPTO require for patent term extension applications?
The USPTO may require additional information from applicants for patent term extension applications. According to MPEP 2755: “The Director or other appropriate officials may require from applicant further information or make such independent inquiries as desired before a final determination is made on whether a patent is eligible for extension.“ If further information is required,…
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