To prevail on the defense of inequitable conduct, the accused infringer must prove that the applicant misrepresented or omitted material information with the specific intent to deceive the PTO. Therasense v. Becton, Dickinson and Co. (en banc). The accused infringer must prove both elements — intent and materiality — by clear and convincing evidence. Id. A district court should not use a sliding scale, where a weak showing of intent may be found sufficient based on a strong showing of materiality, and vice versa. Id. If the accused infringer meets its burden, then the district court must weigh the equities to determine whether finding inequitable conduct is warranted. Id. A finding of inequitable conduct as to “any single claim renders the entire patent unenforceable” and may “render unenforceable other related patents and applications in the same technology family.” Id.
Standard at the district court and on appeal. “Inequitable conduct is equitable in nature, with no right to a jury, and the trial court has the obligation to resolve the underlying facts of materiality and intent. Where a court submits the question to a jury, and both parties agree that the jury findings will be advisory, the court shall treat them as such.” Am. Calcar v. Am. Honda Motor (2011). A district court’s findings of fact on materiality and intent are reviewed for clear error. Ohio Willow Wood v. Alps South (2016). The “ultimate finding of inequitable conduct based on those underlying facts” is reviewed for abuse of discretion. Id.
But-for materiality. The materiality required to establish inequitable conduct is but-for materiality. Therasense. To meet this element, the accused infringer must “show that the patentee withheld or misrepresented information that, in the absence of the withholding or misrepresentation, would have prevented a patent claim from issuing.” Ohio Willow Wood II.
Withheld reference. In assessing the materiality of a withheld reference, “the court must determine whether the PTO would have allowed the claim if it had been aware of the undisclosed reference.” Therasense. “[T]he court must first determine the broadest reasonable construction of the claims that the PTO would have applied during prosecution.” Regeneron v. Merus N.V. Next, based on the broadest reasonable construction, the court must determine, applying a preponderance of the evidence standard, whether a reasonable patent examiner would have allowed the claims had he or she known of the withheld references. Id. (affirming district court’s finding that the withheld references were but-for material); see also Am. Calcar v. Am. Honda Motor (2014) (affirming finding of materiality where the only difference between the withheld reference and the claim “would have been obvious to a person of ordinary skill in the art”); August Tech. v. Camtek (finding the withheld reference was not material because it “[did] not supply the missing element for purposes of the obviousness analysis”).
Prior examiner rejection. A reference is material if the examiner made a rejection based on the misrepresented prior art. TransWeb v. 3M Innovative Properties (finding reference but-for material where the examiner “rejected all claims as obvious over that disclosure” and only allowed the claims after a dubious assertion by the applicant); Apotex v. UCB (finding misrepresentations but-for material where the “Examiner’s rejections were based on the very same prior art that is the subject of [the] misrepresentations).
Cumulative reference. A reference is not but-for material if it is “merely cumulative.” Regeneron. A reference is cumulative when it “teaches no more than what a reasonable examiner would consider to be taught by the prior art already before the PTO.” Id. (finding withheld references but-for material and rejecting argument that they are cumulative of references the examiner considered); see also U.S. Water v. Novozymes A/S (finding alleged omissions were not material where the examiner “was aware of” the omitted information from the party’s declaration and from a third party’s submission).
Issue secondary to patentability. A finding of materiality may be based on an issue secondary to patentability if that issue was dispositive at the PTO. Ohio Willow Wood II (affirming finding of materiality “[g]iven the Board’s determination that corroboration was the dispositive issue, and in light of … assertions before the PTO that there was no corroborating evidence”).
Relation to district court invalidity. “When a claim is properly invalidated in district court based on the deliberately withheld reference, then that reference is necessarily material” because a finding of invalidity in a district court requires clear and convincing evidence, a higher evidentiary burden than that used in prosecution at the PTO. Aventis Pharma S.A. v. Hospira (finding withheld references “necessarily material” after affirming district court’s invalidity decision based on the references); see also Am. Calcar I. However, “even if a district court does not invalidate a claim based on a deliberately withheld reference, the reference may be material if it would have blocked patent issuance” under the PTO’s preponderance of the evidence standard. Therasense; see also Am. Am. Calcar II (“The jury’s verdict finding the patents at issue non-obvious thus does not weigh on the determination of materiality for inequitable conduct”).
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Affirmative egregious misconduct. Although inequitable conduct generally requires but-for materiality, there is “an exception in cases of affirmative egregious misconduct.” Therasense. This exception deals with “deliberately planned and carefully executed schemes to defraud the PTO and the courts.” Id. “When the patentee has engaged in affirmative acts of egregious misconduct, such as the filing of an unmistakably false affidavit, the misconduct is material.” Intellect Wireless v. HTC (affirming materiality finding where the applicant’s “original declaration was unmistakably false” and the “revised declaration failed to correct the falsehoods in the original declaration”). “Neither [the] mere nondisclosure of prior art references to the PTO nor [the] failure to mention prior art references in an affidavit constitutes affirmative egregious misconduct.” Therasense. Certain misrepresentations, however, may be “tantamount to the filing of an unmistakably false affidavit,” and thus sufficient to satisfy the materiality prong. Ohio Willow Wood v. Alps South (2014) (finding summary judgment of no inequitable conduct inappropriate because of the “existence of genuine issues of material fact regarding materiality”).
Interpreting the prior art. “There is nothing wrong with advocating, in good faith, a reasonable interpretation of the teachings of the prior art.” TransWeb. Moreover, undisclosed information is non-material if the information can “be rendered irrelevant in light of subsequent argument or explanation by the patentee.” Novo Nordisk v. Caraco (finding omissions not material where “even after taking the omitted test protocol into account, the court specifically found that [the expert’s] conclusions … had not been shown to be false”). It is improper, however, to “affirmatively and knowingly misrepresented material facts regarding the prior art.” TransWeb.
Relation to future prosecutions. In AstraZeneca v. Aurobindo, the Federal Circuit affirmed a finding of materiality because “the reference compounds [were] sufficiently similar in structure to warrant citation,” despite that “the references were held by the PTO not to negate patentability of [the reissue].” In Energy Heating v. Heat On-The-Fly, the Federal Circuit affirmed a finding of materiality despite that a continuation application later issued and the patentee made a full disclosure. “The district court did not abuse its discretion in not considering the PTO’s issuance of the continuation patent because (1) the continuation patent was issued after the district court’s judgment; and (2) the claims of the continuation patent materially differ from the [claims of the patent at issue.]” Id.
Compliance with USPTO Procedural rules. “[W]here the PTO’s procedural rules are unambiguous, deciding what it would have done in a particular circumstance does not require us to second-guess the agency.” Rembrandt v. Comcast of Fla./Pa. (finding misrepresentation material where, from the PTO issued guidance and regulations, it was “clear… that the PTO would not have revived the patents if it had known that [the applicant] consciously allowed them to expire”). Conduct in compliance with the standard PTO procedure may support a finding of no materiality. Network Signatures v. State Farm (finding no materiality because “compliance with the standard PTO procedure for delayed payment, using the PTO form for delayed payment, does not provide clear and convincing evidence of withholding of material information”).
Rule 56. Materiality is not governed by the standard in PTO Rule 56. Therasense.
Related litigation. Information from a related litigation may be material to patentability depending on the theories asserted and the materials available in the case. In Outside the Box Innovations, LLC v. Travel Caddy, a related litigation was not material to a patent application, and thus need not have been disclosed, because “there was no citation of prior art, nor any pleading of invalidity or unpatentability in the [related litigation] complaint as it existed during pendency of the [patent] application.”