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Understanding Patent Term Extensions: An Overview

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Copyright © DrugPatentWatch. Originally published at
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In the world of patents, the right to exclude others from using or selling an invention is granted only during the patent’s validity. Once a patent expires, this exclusivity vanishes. However, there is a way to extend a patent’s term, and it’s known as “Patent Term Extension” or “PTE.”

PTE is specifically available for certain types of patents, with drug products and medical devices being the most common. For these industries, where lengthy reviews are conducted by the Federal Drug Administration (FDA) before commercial launch, patents are often filed well before FDA approval, leading to a significant loss of the patent term. PTE seeks to address this issue by restoring some of the lost time during the FDA’s review process.

The concept of Patent Term Extension was introduced as part of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the “Hatch-Waxman Act.” Congress aimed to incentivize innovation while promoting market competition for drugs, ultimately benefiting the public’s access to important new medications and medical advancements.

Eligibility for PTE is limited to patents claiming the product, a method of using the product, or a method of manufacturing the product. Several requirements must be met, such as the patent term not having expired, the product undergoing regulatory review before commercial marketing, and the product obtaining FDA permission for commercial use.

The process of obtaining PTE is complex and involves both the United States Patent and Trademark Office (USPTO) and the FDA. The USPTO determines if the application meets formal requirements and eligibility criteria, and then forwards it to the FDA for verification. Upon receiving the FDA’s confirmation, the USPTO calculates the length of PTE based on a specific formula.

The maximum extension granted by PTE is five years, and the total patent term with the extension cannot exceed fourteen years from the FDA’s product approval date. The USPTO issues a final determination, and if eligible, a certificate of patent term extension is granted without issuing a new patent.

It is important to note that Patent Term Extensions have limitations, and the specific rules and regulations governing them are intricate. For a deeper understanding and in-depth information on the requirements and process, interested parties should refer to the original article by Fish & Richardson on JDSupra.


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