IPR FWD invalidating Immunex’s “human antibody” claims invalidated (“nothing in the claim’s language restricts ‘human antibodies’ to those that are fully human”)

Immunex Corp. v. Sanofi-Aventis U.S. LLC et al. (USPTO as Intervenor)

Docket No. 2019-1749, -1777 (IPR2017-01879, -01884)

PROST, REYNA, TARANTO

October 13, 2020

Brief Summary:  Immunex appealed two IPR final written decisions (FWDs) invalidating the challenged claims of US 8,679,487 directed to human anti-IL4R antibodies (“”[a]n isolated human antibody…wherein the light chain…comprises the amino acid sequence of SEQ ID NO:10 and the heavy chain…comprises the amino acid sequence of SEQ ID NO:12”).  The FC panel opinion explains that “[t]his appeal concerns what ‘human antibody’ means in this patent…must a ‘human antibody’ be entirely human?  Or may it also be ‘partially human,’ including ‘humanized’?”  In the ‘884 FWD, the USPTO (“Board”) invalidated the ‘487 claims for obviousness in view of the Hart, Schering-Plough and Hoogenboom references disclosing “fully murine” antibodies, “‘grafting’…CDRs onto an otherwise fully human antibody”, and closing the “gap between ‘humanized’ and ‘fully human’”, respectively, concluding “that the ‘humanized’ antibody met its construction of ‘human antibody.’”  Immunex argued the Board’s construction was erroneous.  In the ‘879 IPR, the Board “concluded that Sanofi had not shown by a preponderance of the evidence that claims 1-14, 16, and 17 were anticipated by one of Immunex’s own publications”.  Sanofi’s appeal argued the Board erred in determining that “the disclosure was not § 102(e) prior art ‘by another.’”

Immunex filed a terminal disclaimer (TD) “[a]fter appellant briefing was complete” and the ‘487 patent “therefore expired on May 26, 2020, just over two months before oral argument.”  The Board applied the Broadest Reasonable Interpretation (BRI) standard to these IPRs, while “in all newly filed IPRs, the Board applies the Phillips district-court claim construction standard” (37 CFR 42.100(b), Phillips (FC 2005) (“ordinary meaning”)).  Immunex argued the Phillips standard should apply but the FC panel disagreed since “when Sanofi filed its IPRs, the Board applied” the ordinary meaning “standard only to expired patents” (In re CBS-Sys., FC 2016; Wasica, FC 2017; Andrea Elecs., FC 2020 (does not “mean that whenever a patent expires on appeal, at any time and for any reason, Phillips applies”)) and “the patentee shortened the term abruptly after the parties had already fully briefed claim construction under the BRI standard” (In re Thorington, CCPA 1969 (“Our predecessor court has refused to consider terminal disclaimers filed after the Board’s decision.”)) 

The FC panel reviewed the “Board’s evaluation of the intrinsic record de novo” (Kaken, FC 2020; Teva, FC 2015) and found it to support “the correctness of the Board’s construction” (e.g., “the language of the claim itself” (Allergan Sales, FC 2019), “nothing in the claim’s language restricts ‘human antibodies’ to those that are fully human”, no “express definition” of “human antibody” in the ‘487 specification (“makes clear that ‘human antibodies’ is a broad category encompassing both partially and completely human antibodies”), and the prosecution history shows the “two terms…are not interchangeable” (the claims of a related patent, “strong presumption against a claim construction that excludes a disclosed embodiment” (Nobel Biocare, FC 2018), claim amendments, “examiner expressly wrote that the amended ‘human’ antibodies encompassed ‘humanized’ antibodies”).  The FC panel was unpersuaded by Immunex’s proposed extrinsic evidence including expert testimony since “the intrinsic evidence here decides the issue” (Helmsderfer, FC 2008).  The FC panel also explained that the Board did not err in departing from a DC interpretation of “human antibody” from “litigation that prompted this IPR” (Power Integrations, FC 2015 (“the Board ‘is not generally bound by a previous judicial construction of a claim term”); Board required “to provide ‘reasoning in sufficient detail to permit meaningful appellate review”).  The Board decision was therefore affirmed.

Sanofi’s cross-appeal regarding the ‘879 IPR was dismissed since the Board’s ‘884 IPR FWD was affirmed.

This entry was posted in Claim Construction, Inter Parties Review (IPR), IPR, Terminal Disclaimers. Bookmark the permalink.

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