Under U.S. patent law, applicants have a duty to inform the U.S. Patent and Trademark Office (USPTO) of all known information that is material to patentability. The USPTO’s standard for materiality can be found in USPTO regulations at 37 C.F.R. 1.56. When a patent applicant breaches the duty of disclosure with an intent to deceive the USPTO, a court may find that the applicant engaged in inequitable conduct. A finding of inequitable conduct can render the patent unenforceable.
Earlier this year, in Therasense, Inc. v. Becton-Dickinson & Co., the U.S. Court of Appeals for the Federal Circuit revised the standard of materiality, and in the process raised the bar for finding that an applicant engaged in inequitable conduct. Prior to Therasense, courts often used the USPTO regulation’s “reasonable examiner” standard for materiality – asking whether a reasonable examiner would have considered the withheld information to be material. Therasense revised this standard by requiring the following conditions for most cases of inequitable conduct: (1) the accused infringer must show that the applicant has a specific intent to deceive the USPTO; and (2) the court must find that the withheld prior art is “but-for” material. In other words, the court must determine whether the USPTO would have rejected the claim if it had received the prior art.
In response to Therasense, the USPTO recently published a proposal to revise the materiality standard of 37 C.F.R 1.56(b ) to align it with that of the Therasense decision. Under the proposed rule change, information is material to patentability if:
(1) The Office would not allow a claim if it were aware of the information, applying the preponderance of the evidence standard and giving the claim its broadest reasonable construction; or
(2) The applicant engages in affirmative egregious misconduct before the Office as to the information.
For applicants who may be concerned about whether disclosure under the new standard amounts to an admission of unpatentability, the USPTO’s notice encourages applicants to err on the side of disclosure by stating that “the Office will not regard information disclosures as admissions of unpatentability for any claims in the application.” The notice also acknowledges that the USPTO may need to revise the rulemaking if the United States Supreme Court modifies the Therasense standard on appeal.
The USPTO will accept comments on the proposed rule through September 19, 2011.