On March 20, 2020 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that on March 17, 2020 the U.S. Patent and Trademark Office ("USPTO") issued a Certificate to extend the duration of U.S. patent 6,409,990 for an additional five years through May 12, 2025 (Press release, Navidea Biopharmaceuticals, MAR 20, 2020, View Source [SID1234555723]). This Certificate was based on the U.S. Food and Drug Administration’s ("FDA") recommendation for a five-year extension under the Hatch-Waxman Act for patent term lost in regulatory review.
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This patent claims and protects Lymphoseek (technetium [Tc 99m] tilmanocept) and has been exclusively licensed with varying geographical and medical indication coverages to Cardinal Health and Navidea. Allowance of this patent extension will permit Cardinal Health and Navidea to extend their exclusive rights to manufacture and commercialize Lymphoseek until the end of the extended patent term in 2025.
"I am pleased the USPTO has taken positive action and extended the Lymphoseek patent until May 12, 2025," said Jed Latkin, CEO of Navidea. "This is an exciting time for Navidea as this extension is just the first of several IP related announcements that we expect to have over the next several quarters."