USPTO unveils tool to access key FDA data

Web page reveals information concerning patent term extension applications | President Joe Biden urged collaboration between USPTO and FDA.

The US Patent and Trademark Office (USPTO) has launched a webpage offering the public a new way to access information relating to applications for patent term extensions filed at the Food and Drug Administration (FDA).

A patent term extension is available for pharmaceutical and medical devices under the Hatch-Waxman Act and allows additional time to be added to a patent to compensate for delays in the FDA approval process.

The website provides access to information on applications that have been filed within the past five years. It includes the application number, patent number, and trade name identified in the application, and provides a link to the electronic file containing the relevant papers.

The move has been driven by feedback from stakeholders requesting readily available information about patent term extension applications.

Kathi Vidal, director of the USPTO, also committed to exploring ways to facilitate public access to information on these applications and grants in her letter to the FDA earlier this year.

The USPTO and FDA have partnered to facilitate access to affordable drugs, after being called on by US President Biden to collaborate.

As part of the efforts, the office will provide new tools for patent examiners to search global databases of technical information—including publicly available sources maintained by the FDA—to determine whether similar innovations already exist.

The FDA will assist by providing patent examiners with training on the state of the art in the pharmaceutical and biologics fields.

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