Federal Circuit Holdings:
Inequitable conduct occurs when a patentee breaches the duty of "candor, good faith, and honesty" either by making affirmative misrepresentations or failing to disclose material information to the PTO.
An inquiry into inequitable conduct involves: 1) a determination whether the withheld information meets a threshold level of materiality and intent to mislead, and 2) a weighing of the materiality and intent in light of all the circumstances to determine whether the patent should be held unenforceable. The predicate facts must be proven by clear and convincing evidence.
The test for materiality is whether there is a substantial likelihood that a reasonable examiner would have considered the information important.
A declarant's relationship with the patent applicant or holder are material if: 1) the declarant's views on the underlying issue are material, and 2) the past relationship was a significant one.
Here, the declarations were highly material to the pivotal issue of whether a reference to "peroral" in prior art would be read by those in the art to suggest gastrointestinal absorption. Significant past relationships included having been a research director or paid consultant for the patentholder or having received research funding from the patentholder.
The applicants were on notice as to the materiality of the past relationships because the examiners were clearly concerned about the objectivity of those providing declarations.
Summary judgment on the issue of intent was appropriate because the record established that: 1) the applicant knew of the information, 2) the applicant knew or should have known of the materiality of the information, and 3) the applicant did not provide a credible explanation for the withholding.
In view of all the circumstances, the trial court did not abuse its discretion in finding inequitable conduct as a matter of law.
Inventors must diclose the known relationships between declarants and interested parties so that patent examiners can consider those interests in weighing the declarations.
According to the vigorous dissent, the majority incorrectly treated past affiliations as "per se" material, and wrongly adopted a "should have known" standard for deceptive intent.
