Therasense Opinions And The Doctrine Of Inequitable Conduct



Each person associated with the prosecution of a patent application has a duty of candor and good faith in dealing with the Patent and Trademark Office (“PTO”). Under the doctrine of inequitable conduct, a patent may be rendered unenforceable where that duty is breached, and the person intended to deceive or mislead the PTO.

In particular, one must disclose all material, non-cumulative information. Under the PTO's current rules, information is “material” if it satisfies either Rule 56(b)(1) or 56(b)(2). Information is material under Rule 56(b)(1) if it “establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim.” Information is material under Rule 56(b)(2) if it: “refutes, or is inconsistent with, a position the applicant takes in: (i) Opposing an argument of unpatentability relied on by the Office, or (ii) Asserting an argument of patentability.”

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