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 stated in the MPEP: “Consequently, to facilitate eligibility decisions and permit the regulatory agency and the Office to carry out their responsibilities under 35 U.S.C. 156, both the Food and Drug Administration and the Department of Agriculture have entered into an ‘agreement’ of cooperation with the Office.”
To learn more:
Topics:
Adjustments,
And Extensions,
MPEP 2700 - Patent Terms,
MPEP 2756 - Correspondence Between The Uspto And The Regulatory Agency,
Patent Law,
Patent Procedure