What types of products are eligible for patent term extension?

Source: FAQ (MPEP-Based)BlueIron Update: 2024-09-29

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

According to MPEP 2750, the following types of products are eligible for patent term extension under 35 U.S.C. 156:

  • Human drugs
  • Food or color additives
  • Medical devices
  • Animal drugs
  • Veterinary biological products

It’s important to note that “Animal drug products which are primarily manufactured through biotechnology are excluded from the provisions of patent term extension.”

Topics: Adjustments And Extensions MPEP 2700 - Patent Terms MPEP 2750 - Patent Term Extension For Delays At Other Agencies Under 35 U.S.C. 156 Patent Law Patent Procedure
Tags: Eligible Products, patent term extension, Premarket Approval, Regulatory Review