The patent statute (35 U.S.C. § 282) indicates that an issued patent is “presumed valid” and that the “burden of establising invalidity” rests with the party asserting invalidity. The Federal Circuit has held that the presumption of validity is properly realized by a clear and convincing standard. The Supreme Court has not directly ruled on the issue. However, in KSR v. Teleflex, the Supreme Court did note that the “the rationale underlying the presumption — that the PTO, in its expertise, has approved the claim — seems much diminished” in cases where the patentee “fail[ed] to disclose” the key prior art to the PTO.
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