What is the maximum period of patent term extension?

The maximum period of patent term extension depends on several factors, including the date of patent issuance and the regulatory review period. According to MPEP 2758:

  • For patents issued after September 24, 1984, the extension cannot exceed five years.
  • For patents issued before September 24, 1984, with regulatory review starting after this date, the extension cannot exceed five years.
  • For patents issued before September 24, 1984, with regulatory review starting before this date but approval after, the extension cannot exceed two years (or three years for animal drugs and veterinary biological products).

Additionally, the total patent term after extension cannot exceed 14 years from the product’s approval date.

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Topics: Adjustments, And Extensions, MPEP 2700 - Patent Terms, MPEP 2758 - Notice Of Final Determination - Calculation Of Patent Term Extension, Patent Law, Patent Procedure
Tags: Maximum Extension Period, patent term extension, Regulatory Review Period