Each Issued Patent Claim Has A Presumption of Validity: “A patent shall be presumed valid. Each claim of a patent (whether in independent, dependent, or multiple dependent form) shall be presumed valid independently of the validity of other claims; dependent or multiple dependent claims shall be presumed valid even though dependent upon an invalid claim. The burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity.” 35 U.S.C. § 282. This presumption “is a ‘common core of thought and truth’ reflected in this Court’s precedents for a century. Radio Corp. of America v. Radio Engineering Laboratories, Inc., 293 U. S. 1, 8 (1934).” Commil USA (U.S. 05/26/2015). Presumption of validity extends to patent eligibility under Sec. 101. CellSpin (Fed. Cir. 06/26/19).
Standard Of Proof For Invalidity Is “Clear and Convincing Evidence”: Standard of proof for patent invalidity is “clear and convincing” evidence. S. Ct. rejected contentions that “a defendant in an infringement action need only persuade the jury of an invalidity defense by a preponderance of the evidence” and that “a preponderance standard must apply at least when an invalidity defense rests on evidence that was never considered by the PTO in the examination process.” i4i (U.S. 06/09/2011). AccordCommil USA (U.S. 05/26/2015) (referring to the clear and convincing standard as a “high bar.”). SeeCore Wireless (Fed. Cir. 01/25/18) (in view of clear and convincing evidence burden of proof, granting JMOL for challenger who lost jury verdict “is generally ‘reserved for extreme cases,’ such as when the opposing party’s witness makes a key admission.”)
But, If Invalidity Evidence Is New, Jury Most Often Should Be Told That And Instructed To Consider Whether It Is Materially New: “although we have no occasion to endorse any particular formulation, we note that a jury instruction on the effect of new evidence can, and when requested, most often should be given. When warranted, the jury may be instructed to consider that it has heard evidence that the PTO had no opportunity to evaluate before granting the patent. When it is disputed whether the evidence presented to the jury differs from that evaluated by the PTO, the jury may be instructed to consider that question. In either case, the jury may be instructed to evaluate whether the evidence before it is materially new, and if so, to consider that fact when determining whether an invalidity defense has been proved by clear and convincing evidence.” i4i (U.S. 06/09/2011) (dictum; such an instruction waived here); see alsoIn re NTP (Fed. Cir. 08/01/11) (“As Congress acknowledged, examiners have limited time to review each application and cannot be expected to fully address every possible issue before them.”); Stone Strong (Fed. Cir. 10/17/11) (non-precedential) (citing i4i in holding claims obvious as a matter of law); cf.Mintz (Fed. Cir. 05/30/12) (vacating Summ. J. of obviousness, noting that art applied by D. Ct. had been considered by PTO). Cf.Guangdong (Fed. Cir. 08/27/19) (Fed. Cir. 08/27/19) (aff’g ITC finding no inherency anticipation, in part because applicants distinguished the reference during original prosecution: “arguments and references already considered by the Patent Office may carry less weight with the fact finder.”); Shire (Fed. Cir. 09/24/15) (aff’g Summ. J. of non-obviousness; added burden of overcoming deference to examiner where asserted reference listed on face of patent); Blephex (Fed. Cir. 02/02/22) (aff’g preliminary injunction; Examiner presumed to have considered prior art listed on face of patent); Cadence Pharm. (Fed. Cir. 03/23/15) (citing Examiner’s initial rejection of claims on same combination now argued by challenger, as a factor contributing to challenger’s “difficult burden” on appeal to overturn non-obviousness judgment). Submitting evidence that a reference was not before the Patent Office in original examination does not necessarily open door to telling jury about a non-institution decision in an IPR. Tek Global (Fed. Cir. 03/29/19) (“Such evidence—properly limited to the context of pre-issuance examination—does not by itself necessarily suggest, warrant, or invite introduction of evidence concerning a related, non-institution decision.”)
“Enhanced Burden” To Show Invalidity With Prior Art Considered By The Patent Office, But Still Only “Clear And Convincing Evidence” Needed: A “‘party challenging validity shoulders an enhanced burden if the invalidity argument relies on the same prior art considered during examination,’” but this means only that “persuading a fact finder that an expert agency is incorrect on a proposition is likely to be a greater forensic challenge to the advocate than showing the proposition to be incorrect in the absence of a contrary expert-agency determination,” not that there is a higher burden than “clear and convincing evidence.” Intercontinental Great Brands (Fed. Cir. 09/07/17) (2-1) (aff’g Summ. J. obviousness).
Burden of Production May, Or May Not, Shift to Patentee: Although challenger always has burden of persuasion, if it meets its burden of production by making prima facie showing of invalidity, that shifts burden of production to patentee to rebut that showing. Novo Nordisk (Fed. Cir. 06/18/13) (aff’g bench trial judgment of obviousness) (2-1); Core Wireless (Fed. Cir. 01/25/18) (aff’g jury verdict of no anticipation despite patent owner having no expert witness rebutting anticipation evidence); seeValeant (Fed. Cir. 04/08/20) (rev’g Summ. J. of non-obviousness; that references disclosed ranges overlapping claimed range created “prima facie” case of obviousness sufficient to survive summary judgment, even though prior art solutions are merely “structurally and functionally similar compounds” as claimed compounds); but seeIn re Magnum Oil (Fed. Cir. 07/25/16) (“prima facie” case applies in prosecution context, not “adjudicatory context of an IPR”).
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