FC panel affirms DC claim construction, enablement, damages, and no willfulness findings

Bayer Healthcare LLC v. Baxalta Inc. et al. and Nektar Therapeutics

Docket No. 2019-2418, 2020-1017 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-2418.OPINION.3-1-2021_1740684.pdf)

NEWMAN, LINN, STOLL

March 1, 2021

Brief Summary:  DC claim construction, enablement, damages, and no willfulness findings affirmed.

Summary:  Baxalta/Nektar (“B/N”) appealed DC denial of its motions for judgment as a matter of law (JMOL) or a new trial on infringement, enablement, damages ($155+ million), and its award of pre-verdict supplemental damages, regarding Bayer’s US 9,364,520 directed to recombinant “polypeptide conjugate[s]” of human factor VIII (FVIII) “covalently attached” through its B domain (one of six domains) to “one or more biocompatible polymers” comprising polyalkylene oxide (“‘site-directed’ PEGylation”).  Bayer cross-appealed regarding the DC’s denial of its motion for a new trial on willfulness.   B/N’s infringing product is Adynovate, “a recombinant PEGylated FVIII product” made by “‘amine/lysine’ PEGylation”.  The DC construed “an isolated polypeptide conjugate” to mean “a polypeptide conjugate where conjugation was not random” since “Bayer…clearly and unmistakably disclaimed” randomly conjugated products.  The DC also concluded that Bayer did not disclaim “PEGylation at amine or carboxy sites”.  The FC panel found no error in these constructions based on “[t]he plain claim language” that “requires PEGylation at the B-domain as a region”, “[s]tatements in the specification support this view” and “discloses embodiments of site-directed PEGylation at cysteine amino acids within the B-domain” without stating “that this it the only embodiment or otherwise indicate that the invention is limited to site-directed PEGylation at cysteine amino acids”, and the prosecution history (no “clear and unmistakable surrender of claims directed to non-random amine/lysine PEGylation”).  Regarding the specification, B/N “present[ed] a close question as to disparagement” of “[r]andom modification of FVIII by targeting primary amines” in the Background section, citing Invidior (FC 2019 (“the specification repeatedly disparages conventional top air drying”)) and SciMed (FC 2011 (“the specification unequivocally limited ‘all embodiments’”) but the FC panel disagreed (also pointing to Gaus, FC 2004 (disavowel due to specification statements regarding what is “essential to [the] invention” and criticism of prior art); Bayer’s specification “nowhere disparages non-random” conjugation).  The FC panel also found B/N’s arguments that Bayer’s statement against the prior art that “[a]ny conjugation with these reactive groups is random” to “have some merit” but disagreed based on, e.g., “how a person of ordinary skill in the art would have understood the prosecution history as a whole”.  The FC panel also concluded the DC did not err in denying Baxalta’s motion for JMOL of noninfringement (e.g., “the jury was in the best position to determine whether it found” which of the “experts more persuasive”).  Baxalta also argued that the claims are not enabled “because it does not enable non-random lysine PEGylation” but the FC panel disagreed, finding substantial evidence (e.g., expert testimony) supported the jury’s verdict (e.g., “the specificiation need not include a working example of every possible embodiment”, DC can consider “the knowledge of an ordinary skilled artisan” (Alcon, FC 2014; Amgen, FC 2003; Falko-Gunter, FC 2006; McRO, FC 2020; Spectra-Physics, FC 1987 (“patent need not teach, and preferably omits, what is well known in the art”)).  The FC panel also found no error with the DC’s denial of Baxalta’s motion for JMOL or a new trial on damages (e.g., based on expert testimony on damages and royalties, including pre-verdict supplemental damages).  The FC panel also found no error in the DC’s grant of JMOL of no willful infringement by Baxalta since, e.g., “the record is insufficient to establish that Baxalta’s ‘conduct rose to the level of wanton, malicious, and bad-faith behavior required for willful infringement’” (SRI Int’l, FC 2019; “The evidence adduced at trial merely demonstrates Baxalta’s knowledge of the ‘520 patent and Baxalta’s direct infringement of the asserted claims.  Knowledge of the asserted patent and evidence of infringement is necessary, but not sufficient, for a finding of willfulness.  Rather, willfulness requires deliberate or intentional infringement.”  Eko Brands, FC 2020).  The DC decision was therefore affirmed.

This entry was posted in Claim Construction, Damages, Enablement, Royalties, Willfullness. Bookmark the permalink.

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