What 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…

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What 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…

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