By: Patrick Scanlon

Patents are the ideal protection of marketable products and can be a very valuable business asset. They not only keep competitors from producing the patented invention but also create potential 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 by agencies like the Food and Drug Administration is required. The approval process is notoriously time-consuming and keeps these 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, this hypothetical situation is one that would benefit from a patent term extension: a surgeon who invented a new surgical stapler filed a patent application on February 20, 1997. The patent was issued over three years later, on June 6, 2000. Because he had not yet received FDA approval, he could not put the stapler on the market, even though his patent term was running. Under this scenario, the patent would normally expire on February 20, 2017, 20 years after the filing date. The clock ticked for another four years until he finally received 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 obtaining a patent term extension beyond February 20, 2017, the surgeon would be able to recapture some of this time.

Patent term extensions are granted based on the length of time consumed by the regulatory approval process after the patent issues (i.e., the surgeon mentioned above would be awarded some portion of the four years consumed by the FDA approval process). Generally, the longer the regulatory review process, the longer the patent term extension will be. However, each case is unique and is determined by the U.S. Patent Office.

Eligibility for Patent Term Extensions

A patent is eligible for a patent 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. Applicable products include medical devices, human drugs, food or color additives, animal drugs, and veterinary biological products. 

Other conditions of eligibility for patent term extension are that:

• an application for extension is submitted to the Patent Office before the original patent term has expired
• the patent has not previously received a similar patent term extension
• 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 that the regulatory review period will extend beyond the original expiration date of the patent.

The Patent Term Extension Process

A brief overview of the process for obtaining a patent term extension is provided below.  Because of the complexity involved, an attorney should be consulted before embarking on this process.

The process begins with a patent owner submitting 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 a patent term extension must be filed by the owner of record of the patent within 60 days of obtaining regulatory approval for commercial marketing and use.  The application must clearly identify:

• the approved product
• the Federal statute including the applicable provision of law under which the regulatory review occurred
• the date on which the product received permission for commercial marketing or use
• the patent for which an extension is being sought. 

The application must also provide information to enable the eligibility of the patent for a term extension and the applicable regulatory review period to be determined.

Conclusion

Patent owners have the opportunity to regain a significant amount of patent term that would otherwise be lost to the regulatory process.  The patent term extension process can be a very valuable tool for pharmaceutical companies and medical device developers, particularly in light of the aggressive enforcement of patents typically seen in these industries.

About the author: 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.