Patents are ideal protection for marketable products and can be a valuable business asset. They not only keep competitors at bay but have the potential to create revenue streams through licensing. These benefits end when the patent expires, which is generally 20 years after its filing date. For some industries, such as medical device and pharmaceuticals, patent-term issues arise when pre-market regulatory approval is required by agencies such as the Food and Drug Administration. The approval process is notoriously time-consuming and keeps products off the market until the approval is granted, sometimes many years after the patent has been issued. However, U.S. patent law includes provisions for extending the patent term in such instances to compensate for lost time.

For example, let's say a surgeon invents a new surgical stapler and files a patent application on February 20, 1997. The patent is issued three years later, on June 6, 2000. Because he has not yet received FDA approval, he can't put the stapler on the market, even though his patent term is running. Under this scenario, the patent would normally expire on February 20, 2017, 20 years after the filing date. Four years later he finally receives FDA approval, on June 6, 2004. The surgeon is now four years into his patent term, but is just now able to begin marketing the stapler. He has essentially lost four years of patent protection. By getting a patent term extension beyond February 20, 2017, the surgeon is able to recapture some of this time.

Because of the complexity, you may want to consult an attorney before starting the extension process. A patent is eligible for a term extension if the patent claims a product subject to a regulatory review period before its commercial marketing or use. Patents covering a method of using or manufacturing such a product are also eligible. Other conditions of eligibility for extension include:

1. The application for extension must be submitted to the Patent Office before the original patent term expires.

2. The patent has not previously received a similar patent term extension.

3. The claimed product has received permission for commercial marketing and use.

In some cases, an interim extension can be obtained where the patent owner reasonably expects the regulatory review period to extend beyond the original expiration date of the patent.

The process begins when a patent owner submits an application for a patent term extension. The Patent Office initially determines whether the application is formally complete and whether the patent is eligible for extension. If the application meets its requirements, the Patent Office notifies the appropriate regulatory agency of the application and provides a copy. The regulatory agency then determines the length of the applicable regulatory review period and informs the Patent Office. The Patent Office subsequently calculates the length of extension for which the patent is eligible and issues an appropriate Certificate of Extension.

The application for an extension must be filed by the patent owner within 60 days of regulatory approval. The application must clearly identify:

1. the approved product

2. the Federal statute including the applicable provision of law under which the regulatory review occurred

3. the date when the product received permission for commercial marketing or use

4. the patent for which an extension is being sought.

Patrick R. Scanlon is a partner practicing patent law with the firm Preti Flaherty, headquartered in Portland, Maine. He may be reached at pscanlon@preti.com. For more information visit www.preti.com.