As a patent owner, it’s essential to understand the concept of patent term extension and adjustment. These mechanisms can potentially extend the life of your patent, allowing you to maximize the benefits of your intellectual property.
Typically, a utility patent has a term of 20 years from the filing date of the application. Under certain circumstances, the term can be extended or adjusted to compensate for delays in the patent process or to account for regulatory review periods, such as those required for pharmaceuticals.
Patent term extension for pharmaceuticals
If you own a patent covering a new drug, biologic or medical device, you may be eligible for a patent term extension due to the time it takes to obtain regulatory approval from the Food and Drug Administration (FDA). The extension aims to restore a portion of the patent term that was consumed during the FDA review process. The maximum extension period is five years, but the combined patent term and extension period cannot exceed 14 years from the date of FDA approval.
Patent term adjustment for patent office delays
If your patent application experienced delays during the examination process at the United States Patent and Trademark Office (USPTO), you might be eligible for a patent term adjustment. The USPTO calculates the adjustment based on specific criteria, such as the USPTO’s failure to issue a first office action within 14 months of filing or to issue a patent within three years of filing. However, the adjustment can be reduced if you, as the applicant, are found to have contributed to the delay.
By being aware of these provisions and taking advantage of them when applicable, you can ensure that you fully benefit from the protection and value that your patent provides.