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Authors

Lawrence Pope

Abstract

The doctrine of inequitable conduct is in need of clarification. The Court of Appeals for the Federal Circuit has recently granted en banc review in Therasense, Inc. v. Becton, Dickinson, & Co. to determine the appropriate standards for each prong of inequitable conduct doctrine: materiality and intent. While the parties and the amici have almost unanimously proposed that the standard of materiality should be less inclusive than “what a reasonable examiner would want to know in deciding upon patentability,” there is much debate regarding how the standard for materiality should be articulated. One proposal is that the courts should look to 37 C.F.R. § 1.56 (“Rule 56”) in formulating an appropriate standard of materiality. But Rule 56 has two key and distinct subparts,(b)(1) and (b)(2), that provide different definitions of materiality. This paper is an exploration of both the clarity and policy flaws of subpart (b)(2). It is far from clear what “information” is encompassed by subpart (b)(2); how strictly should “inconsistent” be interpreted; and what level of reliability, if any, should be required of “inconsistent” information before it is considered material. This paper suggests that the en banc court in Therasense should adopt Rule 56(b)(1) as the sole measure of materiality in judicial inequitable conduct analyses.

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