United States District Court, D. Delaware
AMGEN INC. and AMGEN MANUFACTURING, LIMITED, Plaintiffs,
HOSPIRA, INC., Defendant.
W. Whetzel and Jason J. Rawnsley, RICHARDS, LAYTON &
FINGER, P.A., Wilmington, DE; Kevin M. Flowers, Mark H.
Izraelewicz, John R. Labbe, Julianne M. Hartzell, Benjamin T.
Horton, Tiffany D. Gehrke, and Douglas G. Bolesch, MARSHALL,
GERSTEIN & BORUN LLP, Chicago, IL; Nicholas Groombridge,
Eric Alan Stone, Jennifer H. Wu, and Stephen A Maniscalco,
PAUL, WEISS, RIFKIND, WHARTON & GARRISON LLP, New York,
NY. Attorneys for Plaintiffs.
Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLP,
Wilmington, DE; Thomas J. Meloro, Michael W. Johnson, Heather
M. Schneider, Dan Constantinescu, M. Diana Danca, Tara L.
Thieme, and Philip F. DiSanto, WILKIE FARR & GALLAGHER
LLP, New York, NY. Attorneys for Defendant.
ANDREWS U.S. DISTRICT JUDGE.
September 18, 2015, Amgen, Inc. and Amgen Manufacturing,
Limited (collectively, "Amgen") sued Hospira, Inc.
for infringement of U.S. Patent No. 5, 856, 298 under 35
U.S.C. §§ 271(a) and 271(e)(2)(C) and for
infringement of U.S. Pat. No. 5, 756, 349 under §
271(a). (D.I. 1). The '298 patent and the '349 patent
cover erythropoietin ("epoetin" or "EPO")
isoforms and aspects of their production. Hospira submitted
Biologic License Application ("BLA") No. 125-545 to
the FDA in December 2014, seeking FDA approval for
Hospira's epoetin biosimilar product. (D.I. 290-1 at 1).
Amgen asserts that Hospira's manufacture of drug
substance for its epoetin biosimilar drug product infringes
claims 24 and 27 of the '298 patent and claims 1-7 of the
'349 patent. (D.I. 290 at 1).
a jury trial from September 18-22, 2017. (D.I. 328-332
("Trial Tr.")). The jury found each of the asserted
claims not proved invalid, decided that the asserted claims
of the '349 patent were not infringed, and returned a
verdict of infringement of all asserted claims of the
'298 patent. (D.I. 325 at 2). Of Hospira's twenty-one
accused drug substance batches, the jury found seven batches
entitled to the safe harbor defense. (Id. at 3). The
jury awarded Amgen $70 million in damages for Hospira's
infringement. (Id. at 4).
before the Court are Hospira's Rule 50(a) Motion for
Judgment as a Matter of Law on the Issues of Safe Harbor,
Noninfringement, Invalidity, and Damages and related briefing
(D.I. 336, 337, 348, 351), Hospira's Motion for Judgment
as a Matter of Law Under Rule 50(b) and, in the Alternative,
For Remittitur or New Trial Under Rule 59 and related
briefing (D.I. 355, 357, 374, 381), Hospira's Motion to
Seal Confidential Exhibits Admitted at Trial and related
briefing (D.I. 361, 369, 370), Amgen's Renewed Motion for
Judgment as a Matter of Law of Infringement of the '349
Patent or, in the Alternative, for a New Trial and related
briefing (D.I. 356, 358, 373, 380), and Amgen's Motion
for Prejudgment and Post-judgment Interest and related
briefing (D.I. 352, 376, 382).
Judgment as a Matter of Law
as a matter of law is appropriate if "the court finds
that a reasonable jury would not have a legally sufficient
evidentiary basis to find for [a] party" on an issue.
Fed.R.Civ.P. 50(a)(1). "Entry of judgment as a matter of
law is a 'sparingly' invoked remedy, granted only if,
viewing the evidence in the light most favorable to the
nonmovant and giving it the advantage of every fair and
reasonable inference, there is insufficient evidence from
which a jury reasonably could find liability." Marra
v. Phila. Hous. Auth, 497 F.3d 286, 300 (3d Cir. 2007)
assessing the sufficiency of the evidence, the Court must
give the nonmovant, "as [the] verdict winner, the
benefit of all logical inferences that could be drawn from
the evidence presented, resolve all conflicts in the evidence
in his favor and, in general, view the record in the light
most favorable to him." Williamson v. Consol. Rail
Corp., 926 F.2d 1344, 1348 (3d Cir. 1991). The Court may
"not determine the credibility of the witnesses [nor]
substitute its choice for that of the jury between
conflicting elements in the evidence." Perkin-Elmer
Corp. v. Computervision Corp., 732 F.2d 888, 893 (Fed.
Cir. 1984). Rather, the Court must determine whether the
evidence reasonably supports the jury's verdict. See
Gomez v. Allegheny Health Servs. Inc., 71 F.3d 1079,
1083 (3d Cir. 1995); 9B Charles Alan Wright & Arthur
R. Miller, Federal Practice and Procedure § 2524
(3d ed. 2008) ("The question is not whether there is
literally no evidence supporting the party against whom the
motion is directed but whether there is evidence upon which
the jury might reasonably find a verdict for that
the movant bears the burden of proof, the Third Circuit
applies a stricter standard. Fireman's Fund Ins. Co.
v. Videfreeze Corp., 540 F.2d 1171, 1177 (3d Cir. 1976).
To grant judgment as a matter of law in favor of a party that
bears the burden of proof on an issue, the Court "must
be able to say not only that there is sufficient evidence to
support the [movant's proposed] finding, even though
other evidence could support as well a contrary finding, but
additionally that there is insufficient evidence for
permitting any different finding." Id.
Rule of Civil Procedure 59(a)(1)(A) provides, in pertinent
part: "The court may, on motion, grant a new trial on
all or some of the issues-and to any party- . . . after a
jury trial, for any reason for which a new trial has
heretofore been granted in an action at law in federal court.
. . ." Among the most common reasons for granting a new
trial are: "(1) when the jury's verdict is against
the clear weight of the evidence, and a new trial must be
granted to prevent a miscarriage of justice; (2) when newly
discovered evidence exists that would likely alter the
outcome of the trial; (3) when improper conduct by an
attorney or the court unfairly influenced the verdict; or (4)
when the jury's verdict was facially inconsistent."
See Zarow-Smith v. N.J. Transit Rail Operations,
Inc., 953 F.Supp. 581, 584-85 (D.N.J. 1997) (citations
decision to grant or deny a new trial is committed to the
sound discretion of the district court. Allied Chem.
Corp. v. Daiflon, Inc., 449 U.S. 33, 36 (1980);
Olefins Trading, Inc. v. Han Yang Chem Corp., 9 F.3d
282, 289 (3d Cir. 1993). Although the standard for granting a
new trial is less rigorous than the standard for granting
judgment as a matter of law-in that the Court need not view
the evidence in the light most favorable to the verdict
winner-a new trial should only be granted where "a
miscarriage of justice would result if the verdict were to
stand" or where the verdict "cries out to be
overturned" or "shocks [the] conscience."
Williamson, 926 F.2d at 1352-53.
HOSPIRA'S 50(a) AND 50(b) MOTIONS
Rule 50(a) motion raises the same issues as its Rule 50(b)
motion. Having considered and decided the issues
in ruling on Hospira's Rule 50(b) motion, I will dismiss
Hospira's Rule 50(a) motion as moot.
seeks judgment as a matter of law on the issues of the
applicability of its safe harbor defense, noninfringement and
invalidity of the '298 patent, and damages. (D.I. 357,
pp. 1-22). Alternatively, Hospira seeks a new trial based on
what it characterizes as improper jury instructions on the
safe harbor defense and third party liability, improper claim
construction, and contradictory infringement and validity
verdicts. (Id. pp. 22-30). Finally, Hospira argues
that it is entitled to a remittitur of the damages award.
(Id. p. 28).
parties dispute whether any reasonable jury could have found
some, but not all, of Hospira's drug substance batches
protected by the "safe harbor" defense.
(Id. p. 1; D.I. 374, p. 2).
Biologies Price Competition and Innovation Act of 2009
("BPCIA") "create[s] an artificial 'act of
infringement,' similar to that of 35 U.S.C. §
271(e)(2)(A), and [allows] infringement suits to begin based
on the filing of a biosimilar application prior to FDA
approval and prior to marketing of the biological
product." Amgen Inc. v. Sandoz Inc., 877 F.3d
1315, 1321 (Fed. Cir. 2017) (citing 35 U.S.C. §
271(e)(2)(C), (e)(4), (e)(6)). Section 271(e)(1) carves out
an exception to this rule, creating a "safe harbor"
defense for defendants when their otherwise-infringing
activities are "solely for uses reasonably related"
to obtaining FDA approval. 35 U.S.C. § 271(e)(1)
("It shall not be an act of infringement to make, use,
offer to sell, or sell within the United States or import
into the United States a patented invention . .. solely for
uses reasonably related to the development and submission of
information under a Federal law which regulates the
manufacture, use, or sale of drugs or veterinary biological
products."); Abtox, Inc. v. Exitron Corp., 122
F.3d 1019, 1027 (Fed. Cir. 1997) ("By its terms, this
shield from infringement permits use of 'patented
invention[s]' to acquire information for regulatory
approval of 'drugs or veterinary biological
products.'") (brackets in original). "As long
as the activity is reasonably related to FDA approval, [a
party's] intent or alternative uses are irrelevant to its
qualification to invoke the section 271(e)(1) shield."
Abtox, 122 F.3d at 1030.
asserts that no reasonable jury could find that the safe
harbor defense did not protect each of its twenty-one drug
substance batches. (D.I. 357, p. 1). Additionally, Hospira
contends that Amgen's arguments improperly limited the
applicability of the safe harbor defense to batches required
for FDA approval. (Id. p. 5). Since each batch was
used for one or more of biosimilarity testing, updating product
specifications, process validation, stability testing, or
continued process verification, Hospira insists that no
reasonable jury could have found that each of the batches was
not reasonably related to obtaining FDA approval.
(Id. pp. 4-8). According to Hospira, the jury
improperly second-guessed the number of batches that Hospira
manufactured, when "the subjective reason why any batch
was made is not relevant" to whether the safe harbor
applies. (D.I. 381, pp. 3-4). Essentially, Hospira argues
that since Hospira generated test data for each batch prior
to FDA approval, each batch could conceivably have been used
to respond to inquiries from the FDA, and each batch was
reasonably related to FDA approval.
disagrees and maintains that substantial evidence supports
the jury's reasonable conclusion that Hospira failed to
prove that the safe harbor defense applies to each of
Hospira's drug substance batches. (D.I. 374, p. 2).
According to Amgen, the evidence presented at trial gave the
jury ample reason to reject Hospira's arguments about
biosimilarity, product specifications, process validation,
stability, and continued process verification; credit
Amgen's witnesses; and conclude that the safe harbor
applied to only seven of Hospira's twenty-one drug
substance batches. (Id. pp. 2-4).
biosimilarity, even accepting as true that ten reference
product lots are required to establish biosimilarity, Amgen
points out that Hospira performed biosimilarity testing on
drug product batches, not drug substance batches, and that
Hospira had previously manufactured twenty-six drug product
batches from four drug substance batches. (Id. p. 12
(citing Trial Tr. 811:24-812:8; DTX-266 at 3-4)). Therefore,
Amgen argues, though Hospira performed biosimilarity testing
on nine drug substance batches, "the jury reasonably
concluded that the final two of those batches were not made
for uses reasonably related to seeking FDA approval where
Hospira had made 26 drug product batches from just 4 of those
drug substance batches for biosimilarity testing."
(Id. pp. 12-13).
also argues, "Hospira's witnesses admitted, and its
submissions to the FDA confirmed, that the FDA never required
Hospira to manufacture any additional batches of its drug
substance to support its narrowed release
specifications." (Id. p. 10 (citing Trial Tr.
823:4-824:1)). Regardless, Hospira would be required to
perform release testing on all batches manufactured before or
after FDA approval to ensure that the batches complied with
the release specifications in place at the time of
manufacture. (Trial Tr. 819:11-22). Each of the batches at
issue in this case "were released against specifications
that were in place at the time of manufacture, not against
revised specifications," and they remain available to
Hospira for future use, since they comply with the release
specifications at the time of their manufacture (D.I. 374, p.
10 (citing Trial Tr. 820:24-822:1)). Therefore, Amgen
asserts, Hospira's revised product specifications do not
justify the conclusion that product specification testing on
each of the batches at issue was reasonably related to
obtaining FDA approval.
process validation, Amgen submits that the "Process
Validation and/or Evaluation" section of Hospira's
BLA does not refer to batches other than those admitted by
Amgen or found by the jury to fall within the safe harbor.
(Id. p. 11 (citing DTX-250)). Amgen points out that
even Hospira's updated BLA does not list any of the
fourteen batches that the jury found to fall outside the safe
harbor defense. (Id.). Additionally, Amgen notes,
cleaning validation is "the only specific process
validation that Hospira raises in its motion," and
"Hospira's FDA expert, Dr. Levine, admitted that
cleaning validation need not be completed before FDA
approval." (Id. (citing Trial Tr.
1102:14-24, 1153:16-18); see also Trial Tr. 878:5-18
(Dr. Billingham acknowledging same)).
testing would not have required a reasonable jury to conclude
that each of Hospira's batches was protected by the safe
harbor, Amgen argues, because FDA guidance requires only
three batches to demonstrate stability before obtaining FDA
approval. (D.I. 374, p. 9 (citing PTX-492, p. 3)). Amgen
argues that the jury was therefore free to credit Dr.
Martin-Moe's testimony that Hospira's five batches
from 2009 to 2012 would have provided sufficient stability
data. (Id. (citing Trial Tr. 1329:6-1331:9)).
Additionally, stability testing was required each time a new
drug substance batch was made, regardless of the future uses
for the batch. (Trial Tr. 1338:2-1339:5). As further support,
Amgen cites an internal Hospira Risk Authorization document
confirming Hospira's belief that material from drug
substance batches manufactured in 2009 and 2012 was
sufficient to "support [the drug substance] 'shelf
life and commercial saleability of material produced in
subsequent campaigns.'" (D.I. 374, pp. 9-10 (quoting
PTX-342 at 1)). The Risk Authorization further states,
"The balance of the material from the 2013 campaign
(approximately 50%) and most of the material from the 2014
and 2015 campaigns will serve as commercial inventory to
support single dose vial launch stock." (PTX-342 at 1).
stability testing, Amgen's witnesses testified that
continued process verification is "an ongoing program .
.. during routine commercial production" that sometimes
"can take many years to complete." (D.I. 374, p. 8
(citing Trial Tr. 1336:21-1337:9)). Though the FDA requires
that applicants have committed to a continued process
verification program before approval, completing continued
process verification is not required to obtain FDA approval.
(Trial Tr. 1337:10-13; see also PTX-435, p. 14).
Hospira's witnesses confirmed that continued process
verification need not be completed before FDA approval, and
Hospira made no commitment to manufacture the thirty batches
tested for continued process verification prior to FDA
approval. (Trial Tr. 752:7-11 (Ms. Dianis), 747:17-748:3 (Ms.
Dianis), 883:3-6 (Dr. Billingham), 1095:8-24 (Dr. Levine)).
further argues that the jury was free to credit Amgen's
witnesses over Hospira's witnesses given the evidence
presented. (D.I. 374, pp. 4-5). First, though Hospira argues
that it manufactured each of the 2013, 2014, and 2015 drug
substance batches for use in obtaining FDA approval, Amgen
notes that Ms. Dianis, the regulatory lead for Hospira's
EPO product, "admitted that she did not know why Hospira
made its 2015 batches, or why Hospira made as many batches as
it did, and that she assumed Hospira's supply team (not
the regulatory team) made those decisions."
(Id. (citing Trial Tr. 738:22-740:2)). Second,
though Hospira informed the FDA in 2014 that its 2013 and
2014 batches were for "commercial inventory,"
Hospira's 2015 resubmission (after litigation began)
designated these batches for use for continued process
verification. (Id. at 5 (citing PTX-250 at 4-6;
DTX-255 at 5-8); see also Trial Tr. 748:9-751:23).
Third, Dr. Levine admitted that he did not consider whether
Hospira made any batches for commercial inventory, and that
"simply submitting data [to the FDA] isn't a
justification" for manufacturing a batch of drug
substance. (Trial Tr. 1075:18-1076:1, 1098:1-10).
with Amgen and conclude that substantial evidence supports
the jury's verdict that not all of Hospira's drug
substance batches are protected by the safe harbor. To
demonstrate entitlement to judgment as a matter of law on its
safe harbor defense, Hospira must demonstrate that
"there is insufficient evidence for permitting any other
finding." Fireman's Fund Ins. Co., 54OF.2d
at 1177. Hospira has not met that burden.
reasonable jury could have concluded that fewer than all of
the batches were protected by the safe harbor defense.
Testimony by Ms. Dianis and Dr. Levine either called into
question or contradicted Hospira's argument that each of
the batches at issue fell within the safe harbor defense.
Amgen's presentation of FDA guidance documents,
admissions in Hospira's internal documents, and
post-litigation changes to Hospira's representations to
the FDA also challenged Hospira's assertion that each
batch at issue was covered by the safe harbor. Finally,
Hospira's argument that the jury impermissibly focused on
Hospira's intent in manufacturing the batches does not
stand up to further scrutiny. Though all of the 2015 batches
were designated for use as "commercial inventory"
in Hospira's Risk Authorization, the jury nonetheless
found that some of those batches were protected by the safe
harbor. (D.I. 325 at 3). This suggests that the jury did not
improperly base its verdict on Hospira's intent. I
therefore conclude that substantial evidence supports the
jury's verdict that only some batches at issue are
covered by the safe harbor defense. I will deny Hospira's
motion for JMOL on this ground.
Noninfringement of the '298 Patent
submits that I should grant its motion for JMOL that it does
not infringe claims 24 or 27 of the '298 patent.
contends that it is entitled to JMOL of noninfringement of
claim 24 of the 298 patent because "Amgen failed to
prove that Hospira's process 'selectively elutes'
isoforms as required by claim 24 and as construed by the
Court." (D.I. 357, p. 12). According to Hospira, elution
of all biologically active isoforms does not qualify as
selective elution. (Id.). Specifically,
"Hospira's process does not achieve a precise set of
isoforms;" instead, it "results in a variable
number of different isoforms [i.e., five to eight], and a
variable amount of each isoform in the drug substance."
(Id. (citing Trial Tr. 984:5-989:17 (Dr. Levine))).
Dr. Levine opined that such variability is not consistent
with selective elution, because one would expect consistent
levels of each isoform across batches in a selective elution
process. (Trial Tr. 989:3-9, 1580:4-23). Finally, Hospira
argues that Amgen failed to prove infringement of the
'298 patent because it did not provide any analysis of
the starting material that Hospira puts into the
chromatography column. (D.I. 381, p. 9).
maintains that substantial evidence supports the jury's
conclusion that Hospira's process "selectively
elutes" isoforms as required by claim 24 of the '298
patent. Dr. Cummings testified that Hospira's process
"selectively elutes" isoforms because it
"first elute[s] more basic isoforms from the
chromatography column, then elute[s] the remaining desired
isoforms." (D.I. 374, p. 13 (citing Trial Tr.
468:11-469:4)). During trial, Amgen argued that Dr. Levine
ignored the first step in the elution process, and that Dr.
Levine admitted that he "was intentionally not showing
those [more basic isoform elution] steps because [he] had
already discussed this" the day before. (Trial Tr.
1156:22-1157:13). Amgen also notes that contrary to
Hospira's argument, the Court's claim construction
for claim 24 does not "require a 'precise set of
predetermined isoforms.'" (D.I. 374, p. 14; see
also D.I. 180 at 2). Further, Dr. Strickland, the
inventor on the '298 patent, testified that the process
he invented "select[s] isoforms by-well, specific
mixtures of isoforms[, ] by selective elution of an ion
exchange chromatography column." (Trial Tr. 373:14-20).
As further evidence that Hospira's process met the
"selectively elute" limitation, Amgen offered
Hospira's lot release specifications, which specified
five isoforms that must be present, and three additional
isoforms that may be present, with specific ranges for each
isoform. (DTX-141, p. 7; Trial Tr. 470:13-472:19). Finally,
Amgen asserts that Hospira's "starting
material" argument is frivolous because "Hospira
admitted in its BLA that its ion-exchange chromatography
process first removed the 'more basic' isoforms .. .
from the column (DTX-116 at 58), a step that would not be
necessary if the starting material did not contain isoforms
that were 'more basic' than the isoforms required by
Hospira's release specification." (D.I. 374, p. 15).
Similarly, Hospira's BLA test results reveal that the
only isoforms present in the material leaving the column in
Hospira's process are the same isoforms present in
Hospira's drug substance. (Id. (citing DTX-139,
p. 102; DTX-141, p. 7; Trial Tr. 474:19-476:11)).
with Amgen that substantial evidence supports the jury's
verdict that Hospira infringes claim 24 of the '298
patent. Dr. Strickland's testimony, Hospira's release
specifications, and Dr. Cummings' testimony provided the
jury substantial evidence to conclude that Hospira's
process met the "selectively elute" limitation and
infringed claim 24 of the '298 patent. Additionally, I
think Dr. Levine's admission that he did not include all
steps of the process in his demonstratives for the jury
provided a basis for the jury to question the reliability of
his conclusions and discount his testimony.
27 of the '298 patent requires "preparing a mixture
of two or more erythropoietin isoforms of claim 1."
Though I construed claim 27 as an independent claim, Hospira
argues that it is entitled to JMOL because Amgen did not
mention claim 1 during trial, nor did it present evidence
that "isoforms are isolated during Hospira's
manufacturing process." (D.I. 357, p. 13). Amgen
responds that since claim 27 is an independent claim, Amgen
was not required to present evidence that each of the
limitations of claim 1 was met in order to prove infringement
of claim 27. (Id. p. 15). As to the isolation of
isoforms, Amgen notes that the Court's construction of
claim 27 "does not require the isoforms of Claim 1 to be
separately prepared prior to making the mixture." (D.I.
374, p. 15 (citing D.I. 308 at 2)). Regardless, Amgen urges,
"the evidence at trial showed that the limitations of
claim 1 were satisfied, that is, that Hospira's product
contains 'biologically active' EPO."
(Id. (citing DTX-270, p. 17; Trial Tr. 394:1-4
(admission by Dr. Strickland that "all EPO isoforms have
with Amgen. Though Hospira may be correct that Amgen never
explicitly mentioned claim 1 at trial, Hospira does not
discuss substantively how Amgen failed to prove that the
limitations of claim 1 were met. Amgen has also offered
citations to Hospira's BLA and to the trial transcript to
support the conclusion that the limitations of claim 1 were
27 also has a limitation requiring the creation of an EPO
composition with a "predetermined in vivo specific
activity." Hospira argues that Amgen failed to prove
that Hospira infringed this limitation because "Dr.
Cummings did not provide any evidence of the actual in vivo
specific activity of Hospira's product," and
Hospira's product targets a range of in vivo specific
activities, rather than targeting a specific activity. (D.I.
357, p. 14). Hospira also contends, "Dr. Strickland
testified that in order to achieve a predetermined specific
in vivo activity, one selects individual isoforms and
prepares them in such a way to know what biological activity
they are going to get." (D.I. 381, pp. 9-10 (citing Trial
Tr. 375:12-376:2)). Since there is no evidence that Hospira
separates and selects individual isoforms, Hospira argues,
there was insufficient evidence for the jury to conclude that
Hospira infringed claim 27. (Id. p. 10). Amgen
responds that Dr. Cummings relied on Hospira's BLA, which
stated that 100% of lots fell within an in vivo specific
activity of 93-147 U/µg. (D.I. 374, p. 16 (citing DTX-270,
with Amgen. I do not find Dr. Strickland's testimony,
cited by Hospira, inconsistent with Hospira's BLA, which
identifies a predetermined in vivo specific activity-93-147
U/µg. (DTX-270, p. 17; see Trial Tr.
375:12-376:2). Hospira's BLA provided the jury with
substantial evidence to conclude that Hospira's process
achieved an EPO composition having a predetermined in vivo
therefore conclude that substantial evidence supports the
jury's verdict that Hospira infringes claims 24 and 27 of
the '298 patent. I will deny Hospira's JMOL on this
Invalidity of the '298 Patent
argues that it is entitled to JMOL that the '298 patent
is invalid because no reasonable jury could have found that
claims 24 and 27 were not anticipated or obvious over U.S.
Pat. No. 4, 667, 016 ("Lai"). (D.I. 357, p. 14).
Since it was Hospira's burden to prove invalidity, to
prevail on its JMOL, Hospira must demonstrate that
"there is insufficient evidence for permitting any
different finding" than that the disclosures in Lai
render invalid claims 24 and 27 of the '298 patent.
See Fireman's Fund Ins. Co., 54OF.2d at 1177.
parties dispute whether Hospira adequately proved that the
Lai process inherently anticipates claim 24 of the '298
patent. Specifically, they dispute whether Hospira proved
that Lai meets the "selectively eluting" and
"predetermined number of sialic acids" limitations
of claim 24.
asserts that Dr. Levine's testimony, Dr. Strickland's
testimony, and Dr. Cummings' testimony conclusively
established that Lai includes a "selective elution"
step. (Id. pp. 15-16). Dr. Levine did not dispute
that Lai does not refer to the removal of biologically active
EPO in ion exchange chromatography. (Trial Tr. 1010:10-16).
Based on "the fundamental principles on which ion
exchange chromatography works, and the difference in
between high sialic and low sialic acid containing
isoforms," however, Dr. Levine opined that Lai's
step 2 example 2 "low pH, low salt wash will remove
proteins that have a pKa greater than the biologically active
EPO . . . [which] will include the isoforms of EPO that have
a small number of sialic acid[s] and are therefore not
biologically active, or less biologically active."
(Id. 1010:1-16). As further support, Hospira points
to Dr. Levine's and Dr. Strickland's discussions of
the '298 patent's disclosure that the starting
material for the fourth isoform of EPO is the material
removed from the column in Example 2 of Lai, which contains
EPO isoforms with less than or equal to nine sialic acids.
(Id. 1034:5-14, 393:14-21). Dr. Cummings confirmed
that when Dr. Strickland replicated the experiment reported
in Example 2 of Lai, the result was that EPO isoforms
containing nine to fourteen sialic acids were retained on the
chromatography column after the first acid wash step.
(Id. 1508:15-1509:9). Therefore, Hospira argues, Lai
inherently discloses selective elution of EPO with less than
nine sialic acids. (D.I. 357, p. 16).
responds that the jury declined to credit Hospira's
argument that "practicing Example 2 of Lai
'necessarily and inevitably' resulted in
'selectively eluting' EPO molecules with a
'predetermined' number of sialic acids." (D.I.
374, pp. 16-17). Amgen points to Dr. Cummings, who testified
that, contrary to Dr. Levine's assertion, "all EPO
is biologically active," and the purpose of Lai was to
purify EPO, not to separate EPO isoforms. (Trial Tr.
1494:12-1495:4). Amgen maintains that despite testimony that
"some isoforms may be removed in Example 2 of Lai, none
of the witnesses "testified that Example 2 in Lai
'necessarily and inevitably' results in"
selectively eluting EPO isoforms with a predetermined number
of sialic acids, as would be required to prove inherent
anticipation. (D.I. 374, p. 18). Amgen argues that Dr.
Levine's admission that several factors could affect
which isoforms are present in the starting material
(including cell culture conditions and the components of the
cell culture medium) further supports that the Lai process
does not "necessarily and inevitably" meet the