Therasense Makes No Sense–Federal Circuit Grants En Banc Review of Inequitable Conduct

The Federal Circuit issued an order granting en banc review of its decision in Therasense v. Becton Dickinson to revisit the standard for proving inequitable conduct.  Inequitable conduct is used by defendants to invalidate a patent.  To prove inequitable conduct, a defendant must prove that the patentee (1)  made an affirmative misrepresentation of a material fact, or (2) failed to disclose material information, or (3) submitted false material information.  In the past, inequitable conduct has generally focused on a failure to disclose pertinent prior art known by the applicant.  However, the recent panel decision by the Federal Circuit in Therasense held that an applicant has a duty to disclose to the USPTO any contradictory attorney argument made in any related application anywhere in the world.

The decision has received much criticism because of the draconian effects of such a rule.  The en banc review will focus on the standard for proving materiality and intent to deceive by the applicant.  One of the questions is whether causation should be required.  In other words, should the test be whether the claim would have issued had the applicant disclosed the inconsistent attorney argument in a related foreign application to the U.S. examiner.  The answer should be obvious unless our goal is to simply reduce the number of valid patents.

In practice, requiring patent attorneys to disclose any contradictory arguments made in any related patent application is unduly burdensome on applicants.  While we certainly do not want to invite applicants to make contradictory arguments, invalidating a patent due to a contradictory attorney argument is a harsh result, particularly if there is no direct evidence of intent to deceive or if the failure to disclose would have made no difference in the examiner’s decision to allow the application.  Thus, the Federal Circuit’s decision in Therasense makes no sense and should be brought in line with the realities of everyday patent prosecution by requiring proof of causation.


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