But-For Materiality and Tightened Inequitable Conduct Standards: The Therasense v. Becton, Dickinson En Banc Federal Circuit Decision
Haynes and Boone, LLP Press
On May 25, 2011, the en banc Federal Circuit announced its decision in Therasense, Inc. v. Becton, Dickinson & Company regarding the appropriate standards for succeeding with an inequitable conduct defense. The majority decision by Chief Judge Rader requires separate findings of materiality and intent, but modifies these so that (1) “but-for” materiality is required to find inequitable conduct unless there is affirmative egregious misconduct, and (2) the intent to deceive the United States Patent Office (“Patent Office”) must be “the single most reasonable inference able to be drawn from the evidence.” The “but-for” materiality requires a court to consider whether the Patent Office would not have allowed a particular claim if the reference or information had been provided during examination. The analysis, however, is not the same as that applied by a court in determining invalidity because the legal standard applied in the “but-for” materiality determination is the preponderance of the evidence standard used in the Patent Office, and the claim construction applied is also the Patent Office standard of the broadest reasonable construction.
1 Judge O’Malley joined in the intent portion of the majority opinion (Section V) but did not join the portion of the majority or dissenting opinions relating to the requirements for materiality. Judge O’Malley stated that the test of materiality should encompass any of the following: (1) “but-for” materiality, (2) conduct constituting a false or misleading representation of fact, and/or (3) when “the district court finds that the behavior is so offensive that the court is left with a firm conviction that the integrity of the PTO process as to the application at issue was wholly undermined.” (Opinion Concurring-in-part and Dissenting-in-part at 9) (O’Malley, J.).
2 If, however, the Supreme Court revises the standard for invalidity in the presently pending i4i v. Microsoft case, this distinction would disappear and the reasons to raise inequitable conduct as a separate defense would appear to diminish.
3 See http://www.uspto.gov/news/pr/2011/11-36.jsp.
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