Effective patent term is frequently less than 20 years due to the time lost for clinical trails, FDA approval and patent prosecution. In order to stimulate product development and innovation, Congress in 1984 enacted Title II of the Drug Price Competition and Patent Term Restoration Act (Public Law 98-417) to extend patent life to compensate patent holders for marketing time lost while developing the product and awaiting government approval. The products eligible for patent extension includes:human drug products, medical devices, food additives, or color additives, and animal drug products.A maximum of 5 years can be restored to the patent. In all cases, the total patent life for the product with the patent extension cannot exceed 14 years from the product’s approval date, or in other words, 14 years of potential marketing time. If the patent life of the product after approval has 14 or more years, the product would not be eligible for patent extension.Application for patent extension must be filed within 60 days of FDA approval of the drug product even if the product cannot be commercially marketed at that time.
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Filed under: Patent term
Before June 8, 1995(Uruguay Rounds Agreements Act), US patents typically had 17 years of patent life from the date the patent was issued. Patents granted after the June 8, 1995 date now have a 20-year patent life from the date of the first filing of the patent application.
