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Intra-Cellular Therapies, Inc. v. Iancu

Bona Fide, But Procedurally Improper, After-Final Submission Leads to Applicant Delay in PTA

Intra-Cellular Therapies, Inc. v. Iancu, __ F.3d __, 2019 WL 4458569 (Fed. Cir. Sept. 18, 2019) (Wallach, CHEN, Hughes) (E.D. Va.: Hilton) (2 of 5 stars)

Fed Cir affirms summary judgment approving PTO’s computation of Patent Term Adjustment (“PTA”) under § 154(b). The dispute was whether the PTO’s treatment of the period between two after-final submissions by Intra-Cellular as “applicant delay” was consistent with § 154(b)(2)(C)(i)’s provision for accruing applicant delay where an applicant “fails to engage in reasonable efforts to conclude prosecution.” Intra-Cellular’s first after-final submission did not comply with PTO regulations for submissions after a final action (19 C.F.R. §§ 1.113(c) and 1.114); the second after-final submission did comply. The opinion analyzes the issue under Chevron, 467 U.S. 837 (1984). At Chevron step one, § 154(b)(2)(C)(i) is ambiguous as to whether Intra-Cellular’s first submission (which, though formally non-compliant, addressed the examiner’s various objections in the final Office Action) comprised “reasonable efforts to conclude prosecution.” At Chevron step two, the PTO’s determination that Intra-Cellular’s non-compliant response did not comprise “reasonable efforts to conclude prosecution” was supported by a permissible construction of the statute. Gilead, 778 F.3d 1341 (Fed. Cir. 2015), is not contradictory; though in Gilead an applicant’s conduct led to accrual of applicant delay notwithstanding the absence of any actual delay, it did not mean that an applicant’s bona fide (though procedurally improper) attempt to overcome outstanding rejections could not lead to applicant delay. Pfizer, 811 F.3d 466 (Fed. Cir. 2016), is also not contradictory; Pfizer’s finding of no delay because conduct was part of the typical “back and forth” of prosecution was inapplicable because Intra-Cellular’s improper filing was not typical. Nor was there any unfair surprise in the PTO’s interpretation of the relevant regulations. The opinion rejects an argument that the PTO’s interpretation here conflicts with various after-final “pilot” programs as waived, inapplicable because none of those programs were used here, and lacking in evidence of how those programs would affect delay. In a final footnote, the opinion notes that its decision “does not rely on deference to the agency under Auer v. Robbins, 519 U.S. 452 (1997), because that doctrine is not necessary to understand the regulations and deciding this case.” Op. at 22 n.3.

KEYWORDS: PATENT TERM ADJUSTMENT; APPLICANT DELAY; AFTER-FINAL; CHEVRON