Changes To The Inequitable Conduct Defense

On May 25, 2011, the
Court of Appeals for the Federal Circuit (CAFC) issued a long-awaited en banc decision
in Therasense, Inc. v. Becton, Dickinson
& Co
., 2011
U.S. App. LEXIS 10590 (Fed. Cir. 2011). 
The decision raises the standard for proving inequitable conduct
and presumably will make it much more difficult for defendants to succeed on the
inequitable conduct defense, which has often been referred to as the “atomic
bomb” of patent defenses due to its immensely destructive effects on patent

In a 6-1-4
decision, the court held: (1) the sliding scale test for materiality and intent
no longer applies, (2) materiality and intent must be separately proven by
clear and convincing evidence, (3) specific intent to deceive the United States
Patent & Trademark Office (hereinafter PTO) cannot be inferred unless such
inference is the only reasonable inference that can be drawn from the evidence,
(4) materiality requires a finding that, but for the information not being
disclosed to the PTO, the claim at issue would not have been allowed, and (5)
even if materiality and intent are proven by clear and convincing evidence, the
patent will only be held to be unenforceable if the patentee’s misconduct resulted
in the unfair benefit of receiving an unwarranted claim.  The court carved out an exception to the
but-for materiality requirement for cases where egregious affirmative
misconduct on the part of the patentee is proven.

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