Case: 1:16-cv-00651 Document #: 84 Filed: 01/17/18 Page 1 of 15 PageID #:2503
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF
`ILLINOIS EASTERN DIVISION
`
`
`
`
`
`
`
`C.A. Nos. 1:16-cv-00651
` 1:17-cv-07903
`
`Hon. Rebecca R. Pallmeyer
`
`
`
`Plaintiff,
`
`Defendants.
`
`v.
`
`FRESENIUS KABI USA, LLC,
`
`
`
`
`HOSPIRA, INC.
`
`
`
`
`
`
`
`
`
`
`
`
`FRESENIUS KABI’S OPPOSITION TO
`HOSPIRA’S MOTION TO STRIKE INVALIDITY THEORIES
`
`
`
`
`
`

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`Case: 1:16-cv-00651 Document #: 84 Filed: 01/17/18 Page 2 of 15 PageID #:2504
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`TABLE OF CONTENTS
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`I.
`
`II.
`
`INTRODUCTION .............................................................................................................. 1
`
`BACKGROUND ................................................................................................................ 2
`
`A.
`
`B.
`
`C.
`
`Hospira Agreed to Supplementation, Without Restrictions .................................... 2
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`New Intervening Law Also Affects the Invalidity Contentions ............................. 4
`
`Claim Construction Issued November 27, 2017 ..................................................... 5
`
`III.
`
`ARGUMENTS .................................................................................................................... 5
`
`A.
`
`B.
`
`Hospira Argues the Wrong Standard and Cannot Meet the
`Requirements for a Motion to Strike ...................................................................... 5
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`Fresenius Kabi Did Not Unreasonably Delay in Seeking to Amend
`Its Contentions ........................................................................................................ 6
`
`1.
`
`2.
`
`Fresenius Kabi’s Amended Contentions Are Based on
`Changes in Law and Fact Not Available in July 2016. ............................... 7
`
`Hospira’s Own Amended Contentions Confirm the Parties’
`Agreement ................................................................................................... 7
`
`C.
`
`Hospira Has Not Shown Any Prejudice from Fresenius Kabi’s
`Amended Contentions ............................................................................................. 9
`
`1.
`
`2.
`
`No burdensome factual discovery would be required ............................... 10
`
`Hospira’s Speculative Assertion of Additional Expert and
`Claim Construction Issues Do Not Show Prejudice ................................. 11
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`IV.
`
`CONCLUSION ................................................................................................................. 11
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`
`
`
`
`

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`
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`I.
`
`INTRODUCTION
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`Hospira moves to strike even though Hospira and the Court already agreed that
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`supplemental contentions could be made, and Fresenius Kabi did so on January 5, consistent
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`with the parties’ agreement and the Court’s January 4 Order. Hospira has not attempted to meet
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`the high bar of a motion to strike under Rule 12(f), but instead relies upon the wrong standard:
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`cases where there was no prior agreement or court authorization for amended contentions.
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`While Hospira now asserts that it assumed restrictions on what supplementation should
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`be allowed, (a) its assumptions were never shared nor are they reflected in the Court’s January 4
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`Order and (b) even Hospira’s supplemental contentions were not limited by its own newly-
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`asserted assumptions. Moreover, Fresenius Kabi’s supplemental invalidity contentions are based
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`on intervening events—not on Hospira’s document production date—so they are not late and
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`cause no prejudice to Hospira.
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`Hospira knew that Fresenius Kabi intended to supplement contentions, but said nothing
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`about any assumed limitation. Indeed, in September 2017—even before the claim construction
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`ruling issued—Fresenius Kabi approached Hospira about amending its contentions. In telephone
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`calls, Hospira agreed that both sides could amend, and that the amendment should happen after
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`the claim construction ruling, to avoid multiple rounds of supplementation. That made sense
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`also because the first fact discovery period had ended earlier in 2017, and the second was not due
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`to begin until after the Court’s claim construction ruling issued.
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`Based on these events, there is actually only one disputed contention: the prior purchases
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`of the dexmedetomidine IND anticipate the claimed invention under various provisions of § 102.
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`It should not be stricken.
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`

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`
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`II.
`
`BACKGROUND
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`Hospira’s timeline in its brief omits major events that occurred between the filing of Final
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`Contentions in July 2016 and the Court’s claim construction ruling in November 2017. Hospira
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`omits that, by Local Patent Rule, fact discovery was closed until the claim construction ruling.
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`Hospira also omits that, in the same time period, Hospira had a trial last summer in Delaware on
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`the same patents asserted here, Hospira did not produce expert reports from that trial until
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`September 2017, and the Federal Circuit in another case issued a ruling in May 2017 that
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`materially influenced Fresenius Kabi’s invalidity position.
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`A.
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`Hospira Agreed to Supplementation, Without Restrictions
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`In August 2017, Hospira was in trial against another party, involving the same patents-in-
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`suit. The parties concluded post-trial briefing in October 2017. Hospira took unanticipated
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`positions in that trial, which affected the validity contentions that Fresenius Kabi previously
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`submitted. For example, in that trial, Hospira addressed its own prior purchase of
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`dexmedetomidine in a glass vial, and argued it was not prior art. But when evaluating that
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`argument, it became clear Hospira was wrong, particularly in view of new case law (as discussed
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`further below). As another example, Hospira argued that patent claims related to the short-term
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`stability of dexmedetomidine in glass really meant “under room temperature conditions” rather
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`than the typical accelerated aging conditions using high temperature and humidity.
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`Fresenius Kabi, and indeed both parties, consistently maintained that they would
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`supplement contentions, including in view of arguments made in the Delaware Trial. Hospira’s
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`time line leaves out that Fresenius Kabi approached Hospira about amending its contentions in
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`September 2017—immediately after the Delaware Trial and even before post-trial briefing was
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`complete. Ex. A, Wallace Email (Sep. 14, 2017).
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`2
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`The Court held a status conference in September 2017 where the parties stated the need
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`to amend contentions based on the events that had occurred since Final Contentions were filed in
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`July 2016. D.I. 65 at 1-2 (Jt. Mtn to Set Status Conference); Ex. B, Hearing Tr. 2:13-3:22 (Sep.
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`19, 2017). At that time, since discovery was halted until after the Court’s claim construction
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`ruling issued, there was no reason to insist upon piecemeal supplementations before and after the
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`ruling. Hospira’s position, too, was that contentions could and should be amended after the
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`Court issued the claim construction order.
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`In November 2017, the parties again discussed and agreed that contentions should be
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`amended to incorporate developments that had occurred since July 2016, including the Delaware
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`trial and two newly asserted patents. Hospira’s supplementation had no limitations. Ex. C, Esat
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`Email & Attachment at 6 (Dec. 8, 2017). Again, at the December 2017 status conference before
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`the Court, both parties openly requested leave to freely amend contentions and Hospira still
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`raised no question or limitation. Hospira in fact confirmed the agreement to supplement on the
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`record:
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`MR. WALLACE: [. . .] Basically at the beginning of January, Fresenius Kabi
`would send its -- we would simultaneously exchange their infringement
`contentions on the new patents, and we would propose our invalidity contentions,
`amending the old contentions and adding in the new patents as well.
`
`And then that would put us at the end of January for -- or the beginning of
`February for the responsive contentions. And then at that point, all that would
`really be left is expert discovery.
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`MS. HORTON: That's actually not at all inconsistent with what Hospira has
`agreed with Fresenius Kabi.
`
`Pls.’ Ex. 1 (Hearing Tr.) at 8:9–23 (emphasis added).1 Hospira did not object until after
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`receiving Fresenius Kabi’s contentions on January 5. There may have been an internal
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`1 Hospira mischaracterizes the December 2017 status conference. Fresenius Kabi did not
`demand a faster schedule, but informed the Court that following the Local Patent Rules would
`3
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`

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`
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`disagreement at counsel’s law firm, because Mr. Lyerla was not involved in any prior discussion
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`or agreement about supplementation, but suddenly he was the one calling to object about the
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`supplemental contentions.
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`On January 4, 2018, the Court entered the joint schedule, which, again, both parties
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`submitted. It allowed supplemental contentions to be submitted on January 5. Fresenius Kabi
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`timely submitted its supplemental contentions on that day. While Hospira now complains about
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`the time remaining until trial, this is not Fresenius Kabi’s fault; the 30-month stay expiration is
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`statutory and trial in April is necessary to avoid TRO or preliminary injunction proceedings.
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`B.
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`New Intervening Law Also Affects the Invalidity Contentions
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`Hospira’s argument in the Delaware trial, that its prior purchase of dexmedetomidine in
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`glass was not prior art, used to be a legitimate argument because the details of what was
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`purchased may not have been public. But that law changed in May 2017. Hospira’s argument is
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`no longer legitimate, and its own prior purchase of dexmedetomidine in glass is prior art; that is
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`the argument Hospira seeks to strike.
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`In May 2017, the Federal Circuit decided Helsinn Healthcare S.A. v. Teva
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`Pharmaceuticals USA, Inc., 855 F.3d 1356 (Fed. Cir. 2017). In Helsinn, the Federal Circuit
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`found that a public sale may be invalidating prior art, even where the details about what was sold
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`were confidential. Id. at 1366-67. Fresenius Kabi’s IND anticipation argument in the
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`supplemental contentions is based directly on that intervening law, which was not available by
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`the July 2016 Final Contentions or the November 2016 deposition of a Hospira representative.
`
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`likely cause an interruption for preliminary injunction proceedings because of the timing of
`Fresenius Kabi’s anticipated FDA approval. The Court ruled it prefers an accelerated schedule
`over the Local Patent Rules to hold trial before injunction proceedings would be necessary. Pls.’
`Ex. 1 at 5:6–6:4.
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`
`
`4
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`

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`After Helsinn, the law supported Fresenius Kabi’s invalidity argument: even though Hospira
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`argued that the details of what it previously bought may have been confidential, that is now
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`irrelevant to the question of invalidity.
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`C.
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`Claim Construction Issued November 27, 2017
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`As discussed above, the parties waited by agreement until after November 27, 2017 to
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`include all supplemental contentions. At the December 11 status hearing, the parties agreed to
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`supplement contentions. The Court entered the parties’ joint proposed order to that effect on
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`January 4. The claim construction order also affected the invalidity contentions. Fresenius Kabi
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`voluntarily withdrew its prior anticipation contentions, in view of the Court’s claim construction
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`about the terms “sealed” and “ready to use.” At the same time, however—and in view of the
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`developments above—the claim construction ruling warranted anticipation based on Hospira’s
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`prior purchase of the dexmedetomidine-in-glass product described in an IND that had already
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`been submitted to the FDA.
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`III. ARGUMENTS
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`Hospira’s Motion to Strike should be denied. First, Hospira cannot meet the strict
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`standard for a motion to strike, nor does it attempt to do so in its brief. Second, Fresenius Kabi
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`did not unreasonably delay in seeking to amend its contentions. Third, Hospira is not prejudiced
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`by Fresenius Kabi’s contentions.
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`A.
`
`Hospira Argues the Wrong Standard and Cannot Meet the Requirements for
`a Motion to Strike
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`While styled a motion to strike, Hospira never actually articulates the standard for a
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`motion to strike and makes an argument that does not apply here. Hospira argues that Fresenius
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`Kabi should not be allowed to amend its invalidity contentions, but that argument does not apply
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`here because the parties already agreed—and the Court already granted—leave to amend.
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`5
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`

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`Federal Rule of Civil Procedure 12(f) governs motions to strike amended contentions.
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`Sloan Valve Co. v. Zurn Indus., Inc., No. 1:10-cv-00204, 2012 WL 6214608, at *2 (N.D. Ill.
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`Dec. 13, 2012) (applying Fed. R. Civ. P. 12(f) to strike amended final infringement
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`contentions). In general, “motions to strike are ‘strongly disfavored.’” Labriola v. Clinton
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`Entm’t Mgmt., LLC, No. 15-C-4123, 2017 WL 1150989, at *6 n.15 (N.D. Ill. Mar. 28, 2017)
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`(citation omitted). Under Rule 12(f), the movant may strike any “insufficient defense or any
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`redundant, immaterial, impertinent or scandalous matter.” Fed. R. Civ. P. 12(f). Courts
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`“routinely deny motions to strike unless the challenged allegations have no possible relation or
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`logical connection to the subject matter of the controversy and may cause some form of
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`significant prejudice to one or more of the parties to the action.” Republic Techs. (NA), LLC v.
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`BBK Tobacco & Foods, LLC, 262 F. Supp. 3d 605, 610-11 (N.D. Ill. 2017) (citation and internal
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`quotations omitted). Hospira’s motion does not even try to meet this standard, and for this
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`reason should be denied.
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`B.
`
`Fresenius Kabi Did Not Unreasonably Delay in Seeking to Amend Its
`Contentions
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`Even under Hospira’s view, Fresenius Kabi did not unreasonably delay in amending, and
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`kept Hospira apprised that it would be amending invalidity contentions. Fresenius Kabi had
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`consistently informed Hospira that it sought to supplement its invalidity contentions to
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`incorporate the developments since Final Contentions were served in July 2016, including
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`intervening case law, the Delaware Trial, and the claim construction order in this case. Hospira
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`agreed and never objected to Fresenius Kabi’s proposals, and even jointly submitted a proposed
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`order that was entered on January 4.
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`6
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`

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`1.
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`Fresenius Kabi’s Amended Contentions Are Based on Changes in Law
`and Fact Not Available in July 2016.
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`Fresenius Kabi’s anticipation theory is this: Hospira previously bought an “IND” where
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`another company had a dexmedetomidine-in-glass product that was so developed, it was already
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`in an FDA submission. The details of that product may have been secret, but the sale itself was
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`very public. Fresenius Kabi’s invalidity contentions rely upon the change in law under Helsinn
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`and Hospira’s argument and testimony at the Delaware trial. The IND was subject to testimony
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`at the Delaware Trial.
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`2.
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`Hospira’s Own Amended Contentions Confirm the Parties’ Agreement
`
`Hospira now argues that it assumed all along Fresenius Kabi’s contentions could only be
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`supplemented based on the claim construction ruling and no other intervening events. It is
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`unclear where that assumption came from, since it was never before asserted, and there were no
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`such limitations requested at the December 11 hearing or in the parties’ proposed joint order that
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`the Court entered on January 4. More telling, and despite what it says in its footnote 2 (D.I. 81 at
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`6), Hospira itself also took the same approach in amending its infringement contentions
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`submitted on January 5, not limited to the claim construction ruling.
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`Hospira’s old and new infringement contentions for one limitation of claim 1 of the ’106
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`patent are restated below,2 followed by a discussion showing that the changes go far beyond the
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`claim construction ruling, just as the parties agreed:
`
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`2 Claims 1 of the ’106 recites: “A ready to use liquid pharmaceutical composition for parenteral
`administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt
`thereof disposed within a sealed glass container, wherein the liquid pharmaceutical
`composition when stored in the glass container for at least five months exhibits no more
`than about 2% decrease in the concentration of dexmedetomidine.” The terms construed by
`the Court are underlined, the claim limitation at issue in the contention is bolded.
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`
`
`7
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`

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`
`
`Hospira’s Final Contentions, Ex. A
`(July 26, 2016)
`The Fresenius Proposed Products
`exhibited less than a 2% decrease in
`the concentration of
`dexmedetomidine over a 3 month
`accelerated study. See e.g., FK-
`DEXMED 0000350, 0682-84, 1856-
`57.
`
`
`
`Hospira’s Amended Contentions (Jan. 5, 2018)
`
`The Fresenius Proposed Products exhibited less than
`a 2% decrease in the concentration of
`dexmedetomidine over at least five months,
`regardless of which storage conditions Fresenius
`asserts apply to this claim. See e.g., FKDEXMED
`0000350, 0682-84, 1856-57, 0194960, 62, 64, 66,
`68, 70, 72, 74, 76, 78, 80, 82, 84, 87.
`
`Additionally, the Fresenius Proposed Products’
`specification at least includes infringing products.
`This constitutes infringement as a matter of law
`under Sunovion Pharm. v. Teva Pharm., 731 F.3d
`1271 (Fed. Cir. 2013). Where, as here, “an ANDA
`specification defines a compound such that it meets
`the limitations of an asserted claim, then there is
`almost never a genuine issue of material fact that the
`claim is infringed.” Sunovion, 731 F.3d at 1280.
`
`The Fresenius Proposed Products’ specification
`provides that the Products will stay within 90%-
`110% dexmedetomidine potency—i.e., no more than
`10% dexmedetomidine loss—over their proposed
`two-year shelf life. See e.g., FKDEXMED 0000350,
`0682-84, 1856-57, 0194960, 62, 64, 66, 68, 70, 72,
`74, 76, 78, 80, 82, 84, 87. In other words, Fresenius
`seeks approval to market products losing as little as
`0% over two years, and losing no more than 10%
`over twenty-four months. This constitutes
`infringement under Sunovion.
`
`Moreover, the Fresenius Proposed Products’
`specification specifies loss of no more than 10%
`over 24 months mathematically equates to no more
`than 2.08% over 5 months (5/24 x 10% = 2.08%).
`(Id.) Therefore, Fresenius’ specification matches the
`claimed loss of ‘no more than about 2%’.
`
`Each of these paragraphs contains new contentions that are not limited to claim
`
`construction. The first paragraph in Hospira’s new contentions adds “regardless of which
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`8
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`

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`storage conditions” are used, whereas the old paragraph was limited to “a 3 month accelerated
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`study” for the storage conditions. Hospira’s new contentions do not rely upon the claim
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`construction hearing: the storage conditions were not even briefed. This change directly stems
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`from arguments made at the Delaware Trial. These changes confirm that Hospira had the same
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`view that Fresenius Kabi did: supplements were allowed by agreement and Court permission on
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`January 5, 2017, and they did not have to be limited to the claim construction ruling.
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`The second and third paragraphs in Hospira’s new contentions rely upon 2013 case law
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`(Sunovian) applied to Fresenius Kabi’s specification in its ANDA—a document Hospira had
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`when the litigation began in 2016. There was no reason Hospira could not have made this
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`contention in July 2016, and this does not depend on any claim construction argument. This
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`again confirms that Hospira had the same broad view that Fresenius Kabi did about supplemental
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`contentions.
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`The fourth paragraph in Hospira’s contentions refers to a new “mathematically equates”
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`argument to argue that data for time periods other than 5 months (as claimed) can still be
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`calculated. Again, the stability calculation was not part of claim construction, and Hospira could
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`have made this math argument in July 2016. But it did not and used the January 5 opportunity to
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`supplement contentions—without limiting changes to claim construction—just as both parties
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`had already agreed to do and the Court permitted. Indeed, this new contention specifically
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`relates to a similar argument Hospira made in the Delaware Trial, confirming both parties
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`intended to incorporate new arguments and positions that had developed since July 2016.
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`C.
`
`Hospira Has Not Shown Any Prejudice from Fresenius Kabi’s Amended
`Contentions
`
`Fresenius Kabi’s Amended Contentions put no new burdens on Hospira, and Fresenius
`
`Kabi had already proposed limitations to make sure that Hospira did not have to undertake any
`
`
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`9
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`

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`new fact discovery. Hospira acts as if no discussions occurred, and suggests it would have to go
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`to Finland to acquire additional facts. Not so. The question is what Hospira itself knows about
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`its own prior transaction. If it has no information at this time, it can say so, and Fresenius Kabi
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`offered that opportunity to Hospira during a recent telephone call.
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`1.
`
`No burdensome factual discovery would be required
`
`The question to be resolved for the IND anticipation issue is a legal one, and one that
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`Fresenius Kabi was prepared to move for summary judgment to obtain. The legal question is
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`whether the prior purchase by Hospira of dexmedetomidine-in-glass constitutes an invalidating
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`“sale” under § 102. There is no serious dispute about what that product is, since it was already
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`disclosed in an IND.
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`Because it is uniquely in Hospira’s hands, Fresenius Kabi did seek discovery from
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`Hospira about its views on whether legally a sale occurred. Like the supplemental contentions,
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`the parties also discussed supplemental discovery to be held after the claim construction decision
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`issued. And the parties jointly proposed that discovery could be issued and that the second fact
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`discovery period will close February 2, 2018. If it does not want to respond, Hospira’s relief is
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`to object to those requests as burdensome—not to strike defenses or postpone trial dates.
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`The public sale issue was not a surprise, because in its recent first counterclaims to a
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`newly-asserted patent (No. 17-cv-7903, D.I. 18), Fresenius Kabi told Hospira about the public
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`sale facts at issue. In response to the counterclaims, Hospira admitted that there was a sale and
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`that the sale was public. No. 17-cv-7903, D.I. 22. Fresenius Kabi’s discovery requests do not
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`require Hospira to dive back into the depths of history. For Interrogatory No. 14 Hospira need
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`only describe (1) how it acquired the dexmedetomidine product; (2) whether that acquisition
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`included the paper or electronic IND files; and (3) agree that of course Hospira provided
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`consideration to Abbott for the acquisition. Pls.’ Ex. 5 at 2-3. Interrogatory No. 15 is limited to
`10
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`

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`Hospira’s own knowledge of clinical trials using dexmedetomidine, not Orion or Abbott’s
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`knowledge. Id. at 3.
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`2.
`
`Hospira’s Speculative Assertion of Additional Expert and Claim
`Construction Issues Do Not Show Prejudice
`
`Fresenius Kabi’s amended contentions do not raise new claim construction or expert
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`discovery issues. See D.I. 81 at 9. Expert discovery has not begun so the Amended Contentions
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`cannot adversely affect the schedule. Moreover, Hospira need only respond to Fresenius Kabi’s
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`report on invalidity, it does not file the opening report on these issues. Hospira has time to
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`address the contentions in its responsive report.
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`Similarly, Hospira argues that it may have raised different claim construction issues in
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`view of the IND argument. But what argument would it have made? Hospira is silent apart from
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`identifying a claim terms “ready to use” and “pharmaceutical compositions for parenteral
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`administration to a subject,” and leaving it to the readers to guess how that could affect the
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`contentions. “Ready to use” was a construed term. And if Hospira were consistent with its own
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`proposal, it would never have added new contentions that implicate the meaning of “storage”
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`conditions for the ’106 patent. Any remaining issues are resolvable during expert discovery, and
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`Hospira’s experts can apply the claim terms to the IND.
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`If there is delay, Fresenius Kabi and the Court will be prejudiced. Any delay would
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`require injunction proceedings which the Court already ruled ought to be avoided. Fresenius
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`Kabi agrees.
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`IV. CONCLUSION
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`Fresenius Kabi respectfully requests that the Court deny Hospira’s motion to strike and
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`request to further amend the scheduling order.
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`
`
`
`
`11
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`

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`Case: 1:16-cv-00651 Document #: 84 Filed: 01/17/18 Page 14 of 15 PageID #:2516
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`
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`Dated: January 17, 2018
`
`
`
`
`
`SCHIFF HARDIN LLP
`
`__/s/ Imron T. Aly_____________________
`Imron T. Aly (IL Bar No. 6269322)
`Joel M. Wallace (IL Bar No. 6304223)
`Emily Peña (IL Bar No. 6321281)
`Tara L. Kurtis (IL Bar No. 6323880)
`233 South Wacker Drive, Suite 7100
`Chicago, Illinois 60606
`(312) 258-5500
`
`Ahmed M.T. Riaz (pro hac vice)
`666 Fifth Avenue, 17th Floor
`New York, New York 10103
`(212) 753-5000
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`Attorneys for Defendant/Counterclaimant
`Fresenius Kabi USA, LLC
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`Case: 1:16-cv-00651 Document #: 84 Filed: 01/17/18 Page 15 of 15 PageID #:2517
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`CERTIFICATE OF SERVICE
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`I hereby certify pursuant to Fed. R. Civ. P. 5 and LR 5.5 that on January 17, 2018, I
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`served the foregoing FRESENIUS KABI’S OPPOSITION TO HOSPIRA’S MOTION TO
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`STRIKE INVALIDITY THEORIES upon counsel of record via the Court’s ECF system.
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`Date: January 17, 2018
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`__/s/ Joel M. Wallace________
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` Joel M. Wallace
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