Therasense requires but-for materiality and specific intent to deceive, both proven by clear and convincing evidence. The defense renders the entire patent unenforceable and may extend to related patents.
The standard was tightened substantially in 2011.
Alternative Names:
Inequitable Conduct Defense|Patent Fraud Defense
Why it Matters?
Therasense sharply reduced viable claims by requiring but-for materiality, meaning the Office would not have allowed the claim had it known, and by eliminating the sliding scale that permitted inferring intent from high materiality. Both elements now require independent proof. The defense retains value where established because it renders the entire patent unenforceable and supports an exceptional case fee award.
Frequently Confused with
Related terms
Frequently asked questions
What did Therasense require?
Why does the defense retain value?





