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Bioverativ Inc. v. CSL Behring LLC

United States District Court, D. Delaware

March 20, 2019

BIOVERATIV INC., BIOVERATIV THERAPEUTICS INC., and BIOVERATIV U.S. LLC, Plaintiffs,
v.
CSL BEHRING LLC, CSL BEHRING GMBH, and CSL BEHRING RECOMBINANT FACILITY AG, Defendants.

          Thomas C. Grimm, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE; Paul H. Berghoff (argued), Paula Fritsch, James Lovsin, and Ana Palma, McDONNELL BOEHNEN HULBERT & BERGHOFF LLP, Chicago, IL. Attorneys for Plaintiffs.

          Frederick L. Cottrell, III, RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE; Lisa J. Pirozzolo (argued), Kevin S. Prussia (argued), Annaleigh E. Curtis, and Emily R. Whelan, WILMERHALE. Attorneys for Defendants.

          MEMORANDUM OPINION

          ANDREWS, U.S. DISTRICT JUDGE.

         Presently before me is the issue of claim construction of multiple terms in U.S. Patent Nos. 9, 670, 475 ("'475 Patent"), 9, 629, 903 ('"903 Patent") and 9, 623, 091 ('"091 Patent"). (D.I. 88). I have considered the Parties' Joint Claim Construction Brief. (Id.). I heard oral argument on February 27, 2019. (D.I. 109).

         I. LEGAL STANDARD

         "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) (citation 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, 979-80 (Fed. Cir. 1995) (en banc), affd, 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.

         "[T]he words of a claim are generally given their ordinary and customary meaning. . . . [This 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. "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321. "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 on 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 on 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.3dat 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).

         II. BACKGROUND

         The patents-in-suit relate generally "to the field of therapeutics for hemostatic disorders." ('475 Patent at 1:35-36).

         The Parties dispute terms that appear in the claims of the '475 Patent. Claim 1 is representative:

1. A method of controlling a bleeding episode in a human subject in need thereof, comprising administering to the subject multiple doses of about 25 IU/kg to about 50 IU/kg of a chimeric Factor IX ("FIX") polypeptide comprising FIX and an FcRn binding partner ("FcRn BP") at a dosing interval of about 7 days between two doses, wherein the FcRn BP comprises Fc or albumin and wherein the subject exhibits the plasma FIX activity above 1 IU/dL during the dosing interval.

('475 Patent, claim 1 (disputed terms italicized)).

         The Parties dispute terms that appear in the claims of the '903 Patent. Claim 1 of the '903 Patent is representative:

1. A method of treating hemophilia B in a human subject in need thereof, comprising intravenously administering to the subject multiple doses of about 50 IU/kg to about 100 IU/kg of a chimeric Factor IX ("FIX") polypeptide comprising FIX and an FcRn binding partner ("FcRn BP") at a dosing interval of about 10 days to about 14 days between two doses, wherein the FcRn BP comprises Fc or albumin, wherein the trough level of the plasma FIX activity after each administration is at least 3 IU/dL after six days, and wherein the administration treats the human subject by reducing the frequency of spontaneous bleeding.

('903 Patent, claim 1 (disputed terms italicized)).

         The Parties dispute terms that appear in the claims of the '091 Patent. Claim 1 is representative:

1. A method of treating hemophilia B in a human subject in need thereof comprising intravenously administering to the subject multiple doses of about 50 IU/kg to about 100 IU/kg of a chimeric factor IX ("FIX") polypeptide comprising FIX and an FcRn binding partner ("FcRn BP") at a dosing interval of about 10 days to about 14 days between two doses, wherein the FcRn BP comprises Fc or albumin, wherein the administration maintains the plasma FIX activity of the subject above 1 IU/dL between the dosing interval, and wherein the administration treats the human subject by reducing the frequency of spontaneous bleeding.

('091 Patent, claim 1 (disputed terms italicized)).

         The Parties agree on constructions for twelve additional terms. (D.I. 101 at 1-3). Of importance, the Parties agree that "trough" or "trough level" means: "the lowest plasma Factor IX activity level reached after administering a dose of chimeric Factor IX polypeptide and before the next dose is administered, if any. Baseline Factor IX levels are subtracted from measured Factor IX levels to calculate the trough level." (Id. at 2).

         III. CONSTRUCTION OF DISPUTED TERMS

         1. "controlling a bleeding episode"[1]

a. Plaintiffs' construction:
"controlling (including suppressing or decreasing the incidence of) a bleeding episode but not eliminating 100% of bleeding in all ...

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