What conditions must be met for a patent to qualify for term extension?

According to 35 U.S.C. 156(a)(1)-(5) and 37 CFR 1.720, the following conditions must be met:

• The patent has not expired before the application for extension is filed
• The patent has never been previously extended under 35 U.S.C. 156(e)(1)
• The application is submitted by the patent owner or its agent within 60 days of regulatory approval
• The product has been subject to a regulatory review period before its commercial marketing or use
• The approval is the first permitted commercial marketing or use of the product (with some exceptions for animal drugs and veterinary biological products)

Additionally, no other patent term can have been extended for the same regulatory review period for the product.

To learn more:

• patent term extension
• eligibility conditions
• regulatory approval
• first commercial use