How does the “first permitted marketing or use” requirement affect patent term extension eligibility?

The “first permitted marketing or use” requirement is a crucial factor in determining eligibility for patent term extension. According to 35 U.S.C. 156(a)(5) and 37 CFR 1.720(e), the approval for commercial marketing or use must generally be the first permitted under the provision of law under which the regulatory review occurred.

For human drug products:

• The approval must be the first permitted commercial marketing or use of the active ingredient as a single entity or in combination with another active ingredient.
• If a product contains multiple active ingredients, it can form the basis of an extension if any one active ingredient has not been previously approved.

For animal drugs or veterinary biological products, there’s an exception:

• A patent may be eligible for extension based on a second or subsequent approval if it’s the first approval for use in food-producing animals, even if there was a prior approval for use in non-food producing animals.

This requirement ensures that patent term extensions are granted for truly novel products entering the market for the first time.

To learn more:

• first permitted marketing
• commercial use
• patent term extension
• regulatory approval