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Amgen Inc. v. Hospira Inc.

United States District Court, D. Delaware

January 12, 2017

AMGEN INC., AMGEN MANUFACTURING, LIMITED, Plaintiffs,
v.
HOSPIRA, INC., Defendant.

          Jeffrey L. Moyer, Esq., RICHARDS, LAYTON & FINGER, Wilmington, DE; Kevin M. Flowers, Esq. (argued), John R. Labbe, Esq., Amanda K. Antons, Esq., MARSHALL GERSTEIN & BORUN LLP, Chicago, IL. Attorneys for Plaintiffs.

          Dominick T. Gattuso, Esq., PROCTOR HEYMAN & ENERIO LLP, Wilmington, DE; Thomas J. Meloro, Esq. (argued), Michael W. Johnson, Esq., Tara L. Thieme, Esq., WILLKIE FARR & GALLAGHER, New York, NY. Attorneys for Defendant.

          MEMORANDUM OPINION

          ANDREWS, U.S. DISTRICT JUDGE.

         Presently before me is the issue of claim construction of multiple terms in U.S. Patent No. 5, 856, 298 ("the '298 patent"). The '298 patent generally relates to erythropoietin ("EPO") isoforms. I have considered the parties' Joint Claim Construction Brief. (D.I. 104). I held a Markman hearing on September 21, 2016. I have also considered the parties' supplemental letters submitted after the Markman. (D.I. 138; D.I. 144-45). On November 30, 2016, 1 resolved several threshold issues and invited the parties to submit additional letters if issues remained. (D.I. 162). On December 14, 2016, the parties submitted a lengthy joint letter detailing remaining issues with respect to claim construction. (D.I. 164).

         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) (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).

         II. BACKGROUND

         In my previous opinion (D.I. 162), I construed "an isolated ... isoform" and "isolated ... isoform." In particular, I construed "isolated . .. isoform" as "a group of molecules that has a single isoelectric focusing point and a specific number of sialic acids per molecule, and appears as a single band on an isoelectric focusing gel (an example of which is shown in Figure 1 of the '298 patent)." I implicitly construed "an isolated . .. isoform" as "one and only one isolated ... isoform." I did not separately construe "isoform." In rejecting Plaintiffs proposal, I commented, "Plaintiffs reading would equate the phrase 'an isolated ... isoform' with 'an isoform.'" The present disputes require that I clarify my earlier constructions.

         "An isoform" is "a group of molecules that has a single isoelectric focusing point and a specific number of sialic acids per molecule, and appears as a single band on an isoelectric focusing gel (an example of which is shown in Figure 1 of the '298 patent)."

         "An isolated ... isoform" is "one and only one isoform, " meaning that only erythropoietin isoforms, all with the same isoelectric focusing point and the same number of sialic acids per molecule and which appear as a single band on an isoelectric focusing gel, are claimed. Erythropoietin isoforms with different isoelectric focusing points and different numbers of sialic acids per molecule and which appear at other bands on an isoelectric focusing gel are excluded.

         Separately, I also found claim 8 invalid because it did not properly depend from claim 1. (D.I. 162 at 7-9). Claim 1 required one and only one isoform. Because claim 8 claimed compositions consisting essentially of two or three isoforms, it ...


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