FDA: Patent Term Restoration, Frequently Asked Questions

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.

 

Click here for answers to frequently asked questions about patent term restoration program from the U.S. Food and Drug Administration's Center for Drug Evaluation and Research.

 

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