USPTO Allows Filing of Certain Initial Patent Term Extension Applications via Electronic Filing in Response to the COVID-19 Outbreak

Sheldon L. Wolfe | 06.02.20

Time spent on securing Food and Drug Administration (FDA) approval for regulated products (such as pharmaceuticals, medical devices, and agrochemicals) effectively shortens the term of patent protection for the underlying invention of those products. Even a few months of additional patent term can dramatically affect the value of the resulting patent. The patent owners of these inventions may receive patent term extension (PTE) under the US patent statute for some patent term lost while developing a product and obtaining (FDA) approval.

The United States Patent and Trademark Office (USPTO) considers the effects of the COVID-19 outbreak to be an ​“extraordinary situation” within the meaning of its rules. Accordingly, on May 29, 2020, the USPTO began receiving electronic filings of potentially eligible initial PTE applications resulting from delay due to obtaining FDA approval of the regulated inventions. The filings of these initial PTE applications were previously prohibited from electronic filing with the USPTO.

Please contact one of Boardman Clark’s Intellectual Property (IP) attorneys for further information regarding potential PTE resulting from delay due to obtaining FDA approval on an inventive product. The USPTO’s May 29, 2020 Notice can be found here.

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