What is the role of the USDA in the patent term extension process?
The United States Department of Agriculture (USDA), specifically its Animal and Plant Health Inspection Service (APHIS), plays a crucial role in the patent term extension process for certain products. According to the MPEP:
“The Animal and Plant Health Inspection Service of the United States Department of Agriculture is responsible for assisting the Office in determining the eligibility of patent for term extension which claims a veterinary biological product that has been subject to review under the Virus-Serum-Toxin Act (21 U.S.C. 151-59) and for determining the regulatory review period of the veterinary biological product.”
Key responsibilities of the USDA in this process include:
- Assisting the USPTO in determining eligibility for patents claiming veterinary biological products
- Determining the regulatory review period for these products
- Collaborating with the USPTO through a Memorandum of Understanding to establish procedures for information exchange and cooperation
This specialized role ensures that patents related to veterinary biological products receive appropriate consideration in the term extension process.
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