1. What is Patent Term Restoration?

Patents issued by the Patent Trademark Office (PTO) grant patent holders the right to exclude others from making, using, or selling an invention. The granting of this exclusive right is designed to encourage innovation. The patent holder is likely to reap greater profits if protected from direct competition. These profits are intended to serve as incentives for creating innovative products that benefit the public.

The Uruguay Rounds Agreements Act (Public Law 103-465), which became effective on June 8, 1995, changed the patent term in the United States. Before June 8, 1995, 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. However, the effective patent term is frequently less than 20 years because patents are often obtained before products are actually marketed. Many factors influence the length of the effective patent term, including the requirements in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act that certain products receive FDA approval before marketing. New human drug products generally must undergo extensive testing in animals and humans to show that the drugs are both safe and effective before FDA will approve the product for marketing. Consequently, 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. Title II of the Act created a program whereby patent holders whose patents claim a human drug product, medical device, food additive or color additive could recoup some of the lost patent time. In 1988, Congress enacted the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) which contained provisions for patent restoration to animal drug products. The regulations governing the Patent Term Restoration program are located in the Code of Federal Regulations, 21 CFR Part 60.

2. What products are included?

As stated above human drug products, medical devices, food additives, or color additives, and animal drug products are eligible for patent extension. This Q&A pertains only to human drug products. Human drug product means the active ingredient of a new drug or human biologic product (as those terms are used in the Food, Drug and Cosmetic Act and the Public Health Service Act).

3. What is the maximum amount of time that the patent can be extended?

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.

4.What is FDA’s role in the Patent Term Restoration Program?

FDA’s primary responsibility is to assist the Patent Trademark Office (PTO) in determining a product’s eligibility for patent term restoration and to provide information to PTO regarding a product’s regulatory review period. As described below, FDA also has the responsibility for due diligence petitions and due diligence hearings. PTO is responsible for determining the period of patent extension. FDA defers to PTO on all matters involving the construction and validity of patent claims.