What happens if FDA approval is received during an interim extension?
What happens if FDA approval is received during an interim extension?
If FDA approval is received during an interim extension period, the patent holder must notify the USPTO promptly. According to MPEP 2755.01: “The patent owner must immediately notify the Office of any determination by the regulatory agency regarding the application for regulatory approval. After receiving permission for commercial marketing or use, the patent holder must file a written notice thereof within 5 working days with the Office.” This notification triggers the start of the 60-day period after which the interim extension will terminate, as per 35 U.S.C. 156(e)(2).
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Topics:
Adjustments,
And Extensions,
MPEP 2700 - Patent Terms,
MPEP 2755.01 - Interim Extension Of Patent Term During The Processing Of The Application,
Patent Law,
Patent Procedure