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Therasense, Inc. v. Becton, Dickinson and Co.

Posted in Opinion Commentary by Jake Ward on May 25, 2011

CAFC Endorses a “But-for” Standard for Materiality, and a “Knowing and Deliberate” Standard for Intent to Deceive, in Establishing Inequitable Conduct as a Defense to Patent Infringement.

(CAFC 2011, Appeal 2008-1511)

The en banc CAFC decision in Therasense v. Becton was rendered today. The 6-1-4 opinion appears to severely limit the activities that rise to the level of “inequitable conduct” for the purpose of invalidating a patent. Specifically, the court endorsed a “but-for” standard for materiality, and a “knowing and deliberate” standard for intent to deceive. The court appears to be moving away from the former “sliding scale” test for inequitable conduct, which provided that a greater showing of materiality permitted a lesser showing of intent to deceive.

The full opinion may be read by clicking the above link.  The holding is reproduced below for the convenience of our readers.

In this case, the district court held the ’551 patent un-enforceable for inequitable conduct because Abbott did not disclose briefs it submitted to the EPO regarding the European counterpart of the ’382 patent. Trial Opinion at 1127. Because the district court found statements made in the EPO briefs material under the PTO’s Rule 56 materiality standard, not under the but-for materiality standard set forth in this opinion, this court vacates the district court’s findings of materiality. Id. at 1113, 1115. On remand, the district court should determine whether the PTO would not have granted the patent but for Ab-bott’s failure to disclose the EPO briefs. In particular, the district court must determine whether the PTO would have found Sanghera’s declaration and Pope’s accompany-ing submission unpersuasive in overcoming the obvious-ness rejection over the ’382 patent if Abbott had disclosed the EPO briefs.

The district court found intent to deceive based on the absence of a good faith explanation for failing to disclose the EPO briefs. Id. at 1113-16. However, a “patentee need not offer any good faith explanation unless the accused infringer first . . . prove[s] a threshold level of intent to deceive by clear and convincing evidence.” Star, 537 F.3d at 1368. The district court also relied upon the “should have known” negligence standard in reaching its finding of intent. See Trial Opinion at 1113 (“Attorney Pope knew or should have known that the withheld information would have been highly material to the examiner”). Because the district court did not find intent to deceive under the knowing and deliberate standard set forth in this opinion, this court vacates the district court’s findings of intent. Id. at 1113-16. On remand, the dis-trict court should determine whether there is clear and convincing evidence demonstrating that Sanghera or Pope knew of the EPO briefs, knew of their materiality, and made the conscious decision not to disclose them in order to deceive the PTO.

For the foregoing reasons, this court vacates the dis-trict court’s finding of inequitable conduct and remands for further proceedings consistent with this opinion. This court also reinstates Parts I, III, and IV of the panel decision reported at 593 F.3d 1289, affirming the district court’s judgment of obviousness, noninfringement, and anticipation, respectively. The judgment below is


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  1. patent litigation said, on May 30, 2011 at 7:20 pm

    What good news that the CAFC is finally making a concrete effort to, as Dennis Crouch put it, “cure the ‘plague’ of inequitable conduct pleadings” in patent litigation. It’s pretty major that a finding of inequitable conduct no longer automatically serves to invalidate a patent. That part of the ruling should itself prove quite effective in immediately reducing the number of IC pleadings. It’s about time. Bravo.

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