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Additional affidavits determined to lead to inequitable conductFebruary 16, 2006

In a split decision, The United States Court of Appeals for the Federal Circuit affirmed a District Court’s grant of summary judgment regarding United States patent number 5,047,398 (the ‘398 patent’) owned by Ferring B.V. and Aventis Pharmaceuticals, Inc. The decision was that the ‘398 patent was unenforceable due to inequitable conduct on the part of one of the inventors during the prosecution of the application.The Federal Circuit stated: Inequitable conduct occurs when a patentee breaches his or her duty to the PTO of ‘candor, good faith, and honesty. While inequitable conduct includes affirmative misrepresentations of material facts, it also arises when the patentee fails to disclose material information to the PTO. The inequitable conduct analysis is performed in two steps comprising ‘first, a determination of whether the withheld reference meets a threshold level of materiality and intent to mislead, and second, a weighing of the materiality and intent in light of all the circumstances to determine whether the applicant’s conduct is so culpable that the patent should be unenforceable.The court continued to state: The predicate facts must be proven by clear and convincing evidence. While [the Court’s] precedent urges caution in the grant of summary judgment respecting a defense of inequitable conduct, summary judgment is not foreclosed.Barr Laboratories raised the defense of inequitable conduct when Ferring B.V. and Aventis Pharmaceuticals, Inc. brought suit alleging Barr infringed the ‘398 patent. The ‘398 patent discloses a salt form of 1-deamino-*-D-arginine vasopressin, DDAVP. DDVAP is a medicinal compound that prevents diuretic symptoms associated with diabetes. The ‘398 patent allowed for DDVAP to be taken in a solid oral form that would then be absorbed through the gastrointestinal tract. Prior versions of the compound had to be dissolved in a patient’s mouth or sprayed up a patient’s nose and absorbed through the surrounding tissue.The Federal Circuit found that one of the inventor’s efforts in gathering additional affidavits from non-inventors amounted to inequitable conduct. The inventor gathered multiple affidavits from multiple sources over the extended period of time that the application was being prosecuted before the USPTO. What the inventor failed to disclose, and hence the crux of the case, was that the scientists that had submitted affidavits had significant contacts with the assignee of the patent rights. The District Court and Federal Circuit courts found this failure to disclose the connection of the third parties to the assignee as inequitable conduct when the Examiner asked the inventor to have non-inventor third parties submit affidavits regarding a material fact.The Federal Circuit then went on to state: ‘

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