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Bayer Healthcare LLC v. Baxalta Inc.

United States District Court, D. Delaware

June 29, 2018


          Rodger D. Smith II, Michael J. Flynn, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE; Bradford J. Badke (argued), Sona De (argued), Caroline Bercier, SIDLEY AUSTIN LLP, New York NY; Sue Wang, Kevin O'Brien, SIDLEY AUSTIN LLP, San Francisco, CA; Grace L.W. St. Vincent, SIDLEY AUSTIN LLP, Chicago, IL. Attorneys for Plaintiff.

          Frederick L. Cottrell, III, Kelly E. Farnan, Jason J. Rawnsley, RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE; Edgar H. Haug (argued), Angus Chen (argued), Porter F. Fleming, Sandra Kuzmich, Richard F. Kurz, Erika Selli, Michelle E. Irwin, HAUG PARTNERS LLP, New York, NY. Attorneys for Defendants.



         Presently before the Court is the issue of claim construction of multiple terms in U.S. Patent No. 9, 364, 520 ("the '520 patent"). The Court has considered the Parties' Joint Claim Construction Brief. (D.I. 99). The Court heard oral argument on February 28, 2018. (D.I. 108 ("Tr.")). The parties submitted supplemental briefing at the Court's request. (D.I. 109, 111).

         I. BACKGROUND

         The patent-in-suit is directed to forms of factor VIII, "a protein necessary for normal blood clotting in response to injury." (D.I. 99 at 1). The '520 patent claims factor VIII conjugates not found in nature, made up of recombinant factor VIII and one or more biocompatible polymers chemically bonded to factor VIII at the protein region known as the "B-domain." (Id. at 1, 3). The claimed factor VIII conjugates are formed through a process called PEGylation, which is the conjugation of recombinant factor VIII with polyethylene glycol ("PEG"), a biocompatible polymer. (Id. at 5). PEGylation occurs at "one of numerous amino acid sites across" factor VIII. (Id. at 6).


         "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. AWHCorp., 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 (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., 135 S.Ct. 831, 841 (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. 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 omitted).


         Independent claims 1 and 9 of the '520 patent contain all disputed limitations, and are representative. (Id. at 1, 3-4). They read as follows:

1. An isolated polypeptide conjugate comprising
a functional factor VIII polypeptide and one or more biocompatible polymers,
wherein the functional factor VIII polypeptide comprises the amino acid sequence of SEQ ID NO: 4 or an allelic variant thereof and has a B-domain, and
further wherein the biocompatible polymer comprises polyalkylene oxide and is covalently attached to the functional factor VIII polypeptide at the B-domain.
9. A pharmaceutical composition comprising
(1) a therapeutically effective amount of a monopegylatedpolypeptide conjugate,
wherein the monopegylated polypeptide conjugate comprises a functional factor VIII polypeptide and one polyethylene glycol polymer,
the functional factor VIII polypeptide comprises the amino acid sequence of SEQ ID NO: 4 or an allelic variant thereof and has a B-domain, and
the polyethylene glycol is covalently attached to the functional factor VIII polypeptide at the B-domain; and
(2) a pharmaceutically acceptable adjuvant.

         ('520 patent, claims 1, 9) (disputed terms italicized).

         A. "an isolated polypeptide conjugate" (claim 1)

         1. Plaintiff s proposed construction:

         The preamble is not limiting.

         To the extent the preamble is limiting, plain and ordinary meaning: "recombinant polypeptide conjugate"

         2. Defendants 'proposed construction:

         "a polypeptide conjugate that is not heterogeneous and in which essentially all the molecules have polyalkylene oxide attached at the B-domain"

         3. Court's construction:

         "a polypeptide conjugate where conjugation was not random" "[A]n isolated polypeptide conjugate" appears in the preamble of claim 1. The parties dispute whether the preamble is limiting. (D.I. 99 at 12).

         "In general, a preamble limits the invention if it recites essential structure or steps, or if it is 'necessary to give life, meaning, and vitality' to the claim." Catalina Marketing Int'l, Inc. v., Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (citing Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)). "No litmus test defines when a preamble limits claim scope." Catalina, 289 F.3d at 808. However, the Federal Circuit has identified "[s]ome guideposts" for determining when a preamble does limit claim scope. Id. For example, a preamble might limit claim scope when "Jepson claiming" is used; when there is "dependence on a particular disputed preamble phase for antecedent basis"; "when the preamble is essential to understand limitations or terms in the claim body"; "when reciting additional structure or steps underscored as important by the specification"; and when the preamble contains "statements of intended use or asserted benefits . . ., but only if the applicant clearly and unmistakably relied on those uses or benefits to distinguish prior art." Id. at 808-09.

         Defendants make two arguments that the preamble is limiting. First, Defendants argue that Plaintiff made "an isolated polypeptide conjugate" an "essential element" of the claims by amending the preamble during prosecution, and by disparaging "heterogeneous" conjugates in the specification. (D.I. 99 at 16-17). Second, Defendants argue that Plaintiff made a disclaimer by relying on the preamble to distinguish the claimed conjugate over the prior art during prosecution. (Mat 18, 32).

         As to Defendants' first argument, Plaintiff added the term "an isolated conjugate" in a claim amendment during prosecution, and relied on three paragraphs from the specification as support. (D.I. 63-1 at p. 515-16). Defendants argue that the paragraphs show "that the claimed conjugate was 'isolated' by having one amino acid available for conjugation, applying the three-step site-directed conjugation method, and yielding a conjugate that was not heterogeneous." (D.I. 99 at 17). However, as Plaintiff notes, this amendment occurred not in response to an art rejection, but during a claim election to proceed with product claims, rather than method claims. (Id. at 24 (citing D.I. 62-6 at p. 38)). Furthermore, I agree with Plaintiff that the cited "enabling passages do not invoke the preamble term 'isolated polypeptide conjugate' to distinguish the prior art, much ...

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