How is eligibility for patent term extension determined?

The eligibility for patent term extension is primarily determined based on the information provided in the application. According to MPEP 2755, “A determination as to whether a patent is eligible for extension may be made by the Director solely on the basis of the representations contained in the application for extension filed in compliance with…

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What is the role of the FDA in the patent term extension process?

The Food and Drug Administration (FDA) plays a crucial role in the patent term extension process for certain products. Specifically: The FDA assists the USPTO in determining the eligibility of patents for term extension for products requiring regulatory review (excluding veterinary biological products). It is responsible for determining the regulatory review period for these products.…

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