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2750    Patent Term Extension for Delays at other Agencies under 35 U.S.C. 156

MPEP SECTION SUMMARY The right to a patent term extension based upon regulatory review is the result of the Drug Price Competition and Patent Term Restoration Act of 1984. The statute enables the owners of patents on certain human drugs, food or color additives, medical devices, animal drugs, and veterinary biological products to restore to the terms of those patents some of the time lost while awaiting premarket government approval from a regulatory agency. This section provides further details on these term extensions.

35 U.S.C. 156 was designed to create new incentives for the research and development of certain products subject to pre-market government approval by a regulatory agency

• the statute enables owners of patents to add to the patent term if they lost time awaiting pre-market government approval from a regulatory agency

An application for the extension of the term of a patent must be submitted by the owner of record of the patent or its agent within the sixty-day period beginning on the date the product received permission for commercial marketing or use under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use.

 

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