Pioneer Hi-Bred International, Inc. v. Inari Agriculture, Inc.

Pioneer Hi-Bred International, Inc. v. Inari Agriculture, Inc. The Federal Circuit affirmed the Board's determination that the challenged claims were not enabled. The court held that the Board did not err in relying on post-priority experimental data submitted by Pioneer, where the tested variants could have been made at the priority date, and substantial evidence supported the Board's finding that the specification did not enable the full claimed genus. The decision reinforces that post-priority testing can be used to test whether a patent enables the full scope of a claimed genus, particularly where the claims cover a vast functional genus with limited disclosed examples. Affirmed. The claims covered enzymes defined by an 85% sequence-identity limitation, an AAD-12 motif, and a dual herbicide-degrading function. The Board found lack of enablement for a claimed genus estimated at 2.14 x 10^106 species, with the specification disclosing only two example species. Pioneer argued that the Board legally erred by relying on post-priority experimental data, but the Federal Circuit held that such evidence may be relevant when it concerns variants that could have been made as of the priority date. Pioneer's own later testing showed only two of eight structurally qualifying enzymes had the claimed dual function, undermining its asserted structure-function correlation. The court also found no abuse of discretion in the Board's reliance on Inari's expert testimony. § 112(a) waiver / forfeiture non-precedential § 112(a) waiver / forfeiture non-precedential § 112(a) waiver / forfeiture non-precedential