What is considered a “product” for patent term extension purposes?

For patent term extension purposes, the term “product” is defined in 35 U.S.C. 156(f) as:

• The active ingredient of a new human drug, antibiotic drug, or human biological product
• The active ingredient of a new animal drug or veterinary biological product (with certain limitations on manufacturing processes)
• Any medical device, food additive, or color additive subject to regulation under the Federal Food, Drug, and Cosmetic Act

Importantly, a “product” refers to the active ingredient found in the final dosage form prior to administration, not the resultant form after administration. The MPEP clarifies:

“A ‘drug product’ means the active ingredient found in the final dosage form prior to administration of the product to the patient, not the resultant form the drug may take after administration.”

Different forms of the same chemical moiety (e.g., salt vs. ester) may be considered different products for extension purposes, even if used to treat the same condition.

To learn more:

• product definition
• active ingredient
• drug product
• patent term extension