Baxalta Inc. v. Bayer Healthcare LLC, Civil Action No. 17-1316-RGA

Citation513 F.Supp.3d 426
Decision Date19 January 2021
Docket NumberCivil Action No. 17-1316-RGA
Parties BAXALTA INCORPORATED, Baxalta US Inc. and Nektar Therapeutics, Plaintiffs; v. BAYER HEALTHCARE LLC, Defendant.
CourtU.S. District Court — District of Delaware

Frederick L. Cottrell, III, Kelly E. Farnan, Nicole K. Pedi, RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE; Edgar H. Haug, Sandra Kuzmich, Richard F. Kurz, Erika V. Selli, Kaitlin Abrams, HAUG PARTNERS LLP, New York, NY; Attorneys for Plaintiffs.

Rodger D. Smith II, Michael J. Flynn, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE; Bradford J. Badke, Sona De, Ching-Lee Fukuda, Julie L. Hsia, Timothy Q. Li, SIDLEY AUSTIN LLP, New York, NY; Grace L.W. St. Vincent, SIDLEY AUSTIN LLP, Chicago, IL; Sue Wang, Saurabh Prabhakar, SIDLEY AUSTIN LLP, San Francisco, CA; Paul J. Zegger, Lauren Cranford Katzeff, SIDLEY AUSTIN LLP, Washington, D.C. Attorneys for Defendant.



Before me are Plaintiffsmotion for Partial Summary Judgment and to Exclude Certain Expert Opinions (D.I. 447) and Defendant's motion for Summary Judgment. (D.I. 450). Oral argument was held on November 12, 2020 (D.I. 601), and I have considered the parties’ briefs and supplemental materials. (D.I. 448, 451, 462, 463, 468, 469, 602, 603, 613, 614). For the reasons set forth below, Plaintiffs’ motion is GRANTED in part and DENIED in part. Defendant's motion is GRANTED in part and DENIED in part.


Plaintiffs Baxalta Incorporated, Baxalta US Inc., and Nektar Therapeutics (collectively "Baxalta"1 ) filed this action for patent infringement against Bayer Healthcare LLC on September 15, 2017. (D.I. 1). The parties provide competing treatments for hemophilia A

: Bayer's Jivi and Baxalta's Adynovate. (D.I. 281 ¶¶ 64, 66, 77).

Baxalta asserts two patent families against Bayer, the Bossard Patents and the Bentley Patents. (See D.I. 281 ¶ 1; D.I. 1 ¶ 1 in 18-cv-01355). The Bossard Patents are directed to PEGylated Factor VIII conjugates. (D.I. 448 at 5; see also ’223 Patent ). Following claim narrowing, the seven remaining Bossard Patents are: U.S. Patent No. 7,199,223 ("the ’223 Patent"), U.S. Patent No. 7,863,421 ("the ’421 Patent"), U.S. Patent No. 8,247,536 ("the ’536 Patent") ; U.S. Patent No. 8,519,102 ("the ’102 Patent"), U.S. Patent No. 8,618,259 ("the ’259 Patent"), U.S. Patent No. 8,889,831 ("the ’831 Patent"), and U.S. Patent No. 9,999,657 ("the ’657 Patent"). (D.I. 533). These patents share a common specification and claim priority to a 2003 provisional application. (D.I. 448 at 5 (citing U.S. Patent Application No. 60/450,578)).

The Bentley Patents are not specific to Factor VIII

but claim "branched reactive polymers that may be conjugated with biologically active molecules to form a biologically active conjugate." (D.I. 448 at 5). The three remaining Bentley Patents are U.S. Patent No. 8,809,453 ("the ’453 Patent"), U.S. Patent No. 8,273,833 ("the ’833 Patent"), and U.S. Patent No. 9,187,569 ("the ’569 Patent"). (D.I. 533). These patents share a common specification and claim priority to a 2002 non-provisional application. (D.I. 448 at 5 (citing U.S. Patent Application No. 10/290,892 )).

Baxalta moves for partial summary judgment of no-invalidity for lack of utility under § 101, prior invention under § 102(g), derivation under § 102(f), and obviousness under § 103 based on §§ 102(f) & 102(g) prior art. (D.I. 447). Baxalta also moves to exclude certain opinions of Bayer's expert, Dr. Russell. (Id. ).

On both the Bossard and Bentley Patents, Bayer moves for summary judgment of lack of enablement, lack of utility under § 101, lack of adequate written description, anticipation, no willful infringement, and no induced infringement. (D.I. 450). Bayer's anticipation argument rests on U.S. Patent No. 5,643,575 (the "Martinez Patent"). (D.I. 451 at 2). Bayer also moves for summary judgment of non-infringement of the ’569 Patent as matter of law, and non-infringement of the Bentley Patents under the doctrine of equivalents. (D.I. 450).

A. Summary Judgment

"The court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." FED. R. CIV. P. 56(a). Material facts are those "that could affect the outcome" of the proceeding. Lamont v. New Jersey , 637 F.3d 177, 181 (3d Cir. 2011) (quoting Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) ). "[A] dispute about a material fact is ‘genuine’ if the evidence is sufficient to permit a reasonable jury to return a verdict for the nonmoving party." Id. The burden on the moving party may be discharged by pointing out to the district court that there is an absence of evidence supporting the non-moving party's case. Celotex Corp. v. Catrett , 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).

The burden then shifts to the non-movant to demonstrate the existence of a genuine issue for trial. Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp. , 475 U.S. 574, 586–87, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) ; Williams v. Borough of West Chester, Pa. , 891 F.2d 458, 460–61 (3d Cir. 1989). A non-moving party asserting that a fact is genuinely disputed must support such an assertion by: "(A) citing to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations ..., admissions, interrogatory answers, or other materials; or (B) showing that the materials cited [by the opposing party] do not establish the absence ... of a genuine dispute ...." FED. R. CIV. P. 56(c)(1). The non-moving party's evidence "must amount to more than a scintilla, but may amount to less (in the evaluation of the court) than a preponderance." Williams , 891 F.2d at 461.

When determining whether a genuine issue of material fact exists, the court must view the evidence in the light most favorable to the non-moving party and draw all reasonable inferences in that party's favor. Wishkin v. Potter , 476 F.3d 180, 184 (3d Cir. 2007). If the non-moving party fails to make a sufficient showing on an essential element of its case with respect to which it has the burden of proof, the moving party is entitled to judgment as a matter of law. See Celotex Corp. , 477 U.S. at 322, 106 S.Ct. 2548.

B. Claim Construction

"It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude." Phillips v. AWH Corp. , 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (internal quotation marks omitted). " [T]here is no magic formula or catechism for conducting claim construction.’ Instead, the court is free to attach the appropriate weight to appropriate sources ‘in light of the statutes and policies that inform patent law.’ " SoftView LLC v. Apple Inc. , 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips , 415 F.3d at 1324 ) (alteration in original). When construing patent claims, a court considers the literal language of the claim, the patent specification, and the prosecution history. Markman v. Westview Instruments, Inc. , 52 F.3d 967, 977–80 (Fed. Cir. 1995) (en banc), aff'd , 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). Of these sources, "the specification is always highly relevant to the claim construction analysis.

Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Phillips , 415 F.3d at 1315 (internal quotation marks omitted).

"[T]he words of a claim are generally given their ordinary and customary meaning.... [Which is] the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Id. at 1312–13 (citations and internal quotation marks omitted). "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321 (internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words." Id. at 1314.

When a court relies solely upon the intrinsic evidence—the patent claims, the specification, and the prosecution history—the court's construction is a determination of law. See Teva Pharm. USA, Inc. v. Sandoz, Inc. , 574 U.S. 318, 135 S. Ct. 831, 841, 190 L.Ed.2d 719 (2015). The court may also make factual findings based upon consideration of extrinsic evidence, which "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Phillips , 415 F.3d at 1317–19 (internal quotation marks omitted). Extrinsic evidence may assist the court in understanding the underlying technology, the meaning of terms to one skilled in the art, and how the invention works. Id. Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent and its prosecution history. Id.

"A claim construction is persuasive, not because it follows a certain rule, but because it defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa’ per Azioni , 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would exclude the inventor's device is rarely the correct interpretation." Osram GMBH v. Int'l Trade Comm'n , 505 F.3d 1351, 1358 (Fed. Cir. 2007) (citation and internal quotation marks omitted).

C. Daubert

Federal Rule of Evidence 702 sets out the requirements for expert witness testimony and states:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise

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