Failure to Disclose FDA Approval Activities Leads to Award of Attorney Fees

In affirming an award of attorney fees predicated on inequitable conduct in Bruno Independent Living Aids, Inc. v. Acorn Mobility Services LTD, et al. (Fed. Cir., January 11, 2005), the court found no error in the district court’s treatment of the "Wecolator" as prior art that was subject to the duty of disclosure:

Bruno argues that its claim of "substantial equivalence" between the SSRE-1500 stairlift and the Wecolator was relevant only for the purpose of securing FDA approval, and that it had no bearing on whether Bruno knew the Wecolator to be material prior art for purposes of patentability. This distinction is disingenuous in light of what the record reflects: the FDA submission was prepared by William Belson, who was also involved in the prosecution of the ’405 patent and had asked Bruno’s patent attorney to conduct a prior art search in preparation for filing the patent application. (J.A. 2859-61). More importantly, Bruno’s distinction is not persuasive because "an applicant who knew of the art or information cannot intentionally avoid learning of its materiality . . . it may be found that the applicant ‘should have known’ of that materiality." FMC Corp. v. Manitowoc Co., 835 F.2d 1411, 1415 (Fed. Cir. 1987) (footnote omitted). Accordingly, we are not persuaded that the district court clearly erred in charging Bruno with knowledge of the Wecolator’s materiality.

With regard to intent, the court then went on to conclude "The fact that an official of Bruno, who was involved in both the FDA and PTO submissions, chose to disclose the Wecolator to the FDA, but not to the PTO, certainly supports a finding of deceptive intent to withhold the disclosure from the PTO."