Therasense Nonsense

Sam S. Han Ph.D., University of Dayton

Abstract

In Therasense v. Becton, Dickinson & Co., a sharply divided en banc Court of Appeals for the Federal Circuit pronounced a new standard for inequitable conduct. Despite the reasons set forth by the concurring and dissenting judges, the majority elevated the requirements for inequitable conduct. Specifically, the Therasense majority required two elements to be shown: (a) specific intent to deceive; and (b) but-for materiality. Specific intent would be established if one could show proof of: (a) knowledge of the information; (b) knowledge of the materiality of the information; and (c) deliberate decision to withhold the information from the United States Patent and Trademark Office ("USPTO" or "PTO"). But for materiality would require one to show that the patent would not have issued but for the withheld information. This comment analyzes the Therasense majority's heightened requirement for inequitable conduct, and shows why the heightened requirement is not only impractical, but also logically impossible to meet.