How 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 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…
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