Case 1:18-cv-00303-RGA Document 20 Filed 04/30/18 Page 1 of 8 PageID #: 586
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`BAXTER HEALTHCARE CORPORATION,
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` Plaintiff,
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`v.
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`HOSPIRA, INC. and ORION CORP.,
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` Defendants.
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`C.A. No. 18-303-RGA
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`OPPOSITION TO MOTION FOR EXTENSION OF TIME
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`Plaintiff Baxter Healthcare Corporation (“Baxter”), by counsel, submits this Opposition
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`to Motion for a 14-Day Extension of Time to File Response to Plaintiff’s Motion for Judgment
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`on the Pleadings (“Extension Motion”) filed by Hospira, Inc. and Orion Corp. (collectively,
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`“Hospira”). The Court should deny Hospira’s Extension Motion for two reasons. First, Baxter
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`would be prejudiced by any extension because time is of the essence due to the expiry of United
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`States Patent No. 6,716,867 on March 31, 2019. Second, Baxter’s Motion for Judgment on the
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`Pleadings does not raise complex issues of fact or law that require extensive analysis, and
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`Hospira is already familiar with the applicable legal standards given its extensive litigation of
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`this patent in other cases. Accordingly, Baxter respectfully requests that the Court deny
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`Hospira’s Extension Motion.
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`NATURE OF THE CASE & PROCEDURAL POSTURE
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`This case raises a time-sensitive issue, the resolution of which is crucial for mitigating
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`harm to Baxter. Baxter is the current holder of Abbreviated New Drug Application (“ANDA”)
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`No. 208532 for a proposed drug product containing dexmedetomidine hydrochloride in 0.9%
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`sodium chloride injection, 200 mcg/50 mL and 400 mcg/100 mL (the “Baxter ANDA Product”).
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`The Food and Drug Administration (“FDA”) tentatively approved ANDA No. 208532 on
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`January 25, 2018, but withheld final approval because of a first applicant’s continued eligibility
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`for 180-day exclusivity. Unless the first applicant either forfeits its exclusivity or makes use of
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`the 180-day exclusivity period by obtaining approval and initiating marketing, the FDA will be
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`prohibited from finally approving Baxter’s ANDA Product until 2032, when the last of the
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`relevant patents owned by Hospira and applicable pediatric exclusivity expire. This delay can be
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`prevented if a court enters final judgment of noninfringement from which no appeal, other than a
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`petition for writ of certiorari to the Supreme Court, is or can be taken on all four of the patents at
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`issue in this case: United States Patent Nos. 6,716,867 (the “’867 Patent”), 8,242,158 (the “’158
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`Patent”), 8,338,470 (the “’470 Patent), and 8,455,527 (the “’527 Patent”) (collectively, “the
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`Patents-in-Suit”).
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`Baxter filed this declaratory judgment lawsuit on February 22, 2018, less than a month
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`after the FDA tentatively approved ANDA No. 208532. (D.I. 1.) After requesting a 14-day
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`extension of time to answer the complaint (D.I. 7), only four days of which this Court granted
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`(D.I. 9), Hospira filed its answer on March 20, 2018 (D.I. 10). In its answer, Hospira admitted
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`that Baxter did not infringe any claim of the ’158 Patent, ’470 Patent, and ’527 Patent that
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`requires a “sealed glass container” because the Baxter ANDA Product is disposed in a plastic
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`container. (D.I. 10, ¶¶ 33, 46, 58, 87-89, 95-96, 102-103.) Hospira further represented to the
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`Court in the jointly filed Proposed Scheduling Order (D.I. 18) and its Extension Motion (D.I. 19,
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`¶ 6) that it is not asserting the ’158 Patent, ’470 Patent, and ’527 Patent. As such, three of the
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`four patents are not at issue, and the Court can easily—and should—grant judgment as a matter
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`of law with respect to those patents.
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`2
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`In conjunction with its answer, Hospira filed a counterclaim against Baxter for
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`infringement of the ’867 Patent.1 (D.I. 10.) Baxter answered the counterclaim on April 10, 2018.
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`(D.I. 14.) On April 24, 2018, Baxter filed its Motion for Judgment on the Pleadings. (D.I. 16.)
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`Hospira’s answering brief is currently due on May 8, 2018. See Local Rule 7.1.2(b).
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`On April 30, 2018, Hospira filed a Motion for Extension for Time (D.I. 19), requesting
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`that this Court extend its time for filing the answering brief by 14 days, until May 22, 2018.
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`ARGUMENT
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`Baxter opposes the requested extension of time for two primary reasons: (1) an extension
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`of time prejudices Baxter because time is of the essence due to expiry of the ’867 Patent on
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`March 31, 2019; and (2) Baxter’s Motion for Judgment on the Pleadings does not raise novel or
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`complex issues of fact or law, and Hospira is familiar with the relevant legal standards given its
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`litigation of this patent in other cases. Therefore, good cause under Federal Rule of Civil
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`Procedure 6(b)(1)(A) does not exist in this case.
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`A.
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`Time is of the Essence because the ’867 Patent Expires on March 31, 2019.
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`First, granting an extension of time would prejudice Baxter because Baxter must obtain a
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`final non-appealable judgment of non-infringement of the ’867 Patent before January 11, 2019.
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`Otherwise, even with a favorable decision on the other three patents, FDA may be precluded
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`from approving Baxter’s ANDA until 2020.
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`After the ’867 Patent expires on March 31, 2019, a six-month pediatric exclusivity period
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`extends until October 1, 2019, during which FDA may not approve ANDAs for generic
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`dexmedetomidine hydrochloride without a waiver from Hospira. Upon patent expiry, this Court
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`1 The ’867 Patent expires on March 31, 2019, with a pediatric exclusivity period starting upon
`patent expiry and extending until October 1, 2019.
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`3
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`will no longer be able to issue a judgment of noninfringement, while at the same time, the
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`pediatric exclusivity period starts. Thus, absent a final non-appealable judgment before the ’867
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`patent expires, Baxter must endure the six-month pediatric exclusivity period without means for
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`judicial relief. Moreover, to the extent the first applicant finally markets its product, possibly
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`starting at the very end of the pediatric exclusivity period, Baxter will be subject to an additional
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`180-day delay while the first applicant exercises its exclusive marketing right.
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`To avoid this delay, Baxter must obtain a judgment of noninfringement not only from this
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`Court but also from the U.S. Court of Appeals for the Federal Circuit before expiry of the ’867
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`Patent. Only a final judgment from which no appeal (other than a petition to the Supreme Court
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`for a writ of certiorari) is or can be taken will enable FDA to grant final approval of Baxter’s
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`ANDA. As a practical matter, such judgment must be rendered no later than January 11, 2019,
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`because a first applicant has 75 days after final judgment to launch or forfeit its exclusivity, and
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`Baxter must still obtain final approval from FDA. Thus, Baxter has less than eight months to
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`obtain a final judgment of noninfringement. This underscores why Baxter submitted expedited
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`dates in its Proposed Scheduling Order.
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`Indeed, Baxter has litigated this case expeditiously from its inception. Contrary to
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`Hospira’s assertion (D.I. 19, ¶ 3), Baxter did not delay in bringing its declaratory judgment
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`action. Baxter’s ANDA was not tentatively approved by FDA until January 25, 2018. On that
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`date Baxter expected to receive full FDA approval of its ANDA, because of the first applicant’s
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`apparent forfeiture of exclusivity for failure to obtain tentative approval within 30 months after
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`submitting its ANDA. As such, there was no apparent need for this suit until January 25, 2018.
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`Moreover, filing suit against Hospira before receiving tentative approval would likely have
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`raised ripeness concerns (or at least a protest from Hospira). Baxter filed this declaratory
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`judgment lawsuit on February 22, 2018, less than one month after it received tentative approval.
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`(D.I. 1.) On April 24, 2018, Baxter moved for judgment on the pleadings.2 Thus, Baxter’s actions
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`have not been dilatory, and indeed Baxter has prosecuted this case with a sense of urgency while
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`Hospira has now sought extensions for both of its responsive filings. (See D.I. 7 (requesting a 14-
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`day extension of time to answer the complaint); D.I. 19 (requesting a 14-day extension of time to
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`file a responsive brief to Baxter’s Motion for Judgment on the Pleadings).)
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`Therefore, the Court should deny Hospira’s Extension Motion because any delay would
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`prejudice Baxter and thwart the purposes of the Hatch-Waxman provisions of the Food, Drug,
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`and Cosmetic Act, one of which is that a section viii statement regarding a method-of-use patent
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`should not delay approval of a generic drug because a section viii statement, with corresponding
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`carved-out labeling, is plain and satisfactory evidence that there is no intent to infringe that
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`patent. While Hospira asserts that the ’867 Patent does not affect whether Baxter can receive
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`final FDA approval to launch its product (D.I. 19, ¶ 6), this argument misses the point. FDA
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`cannot finally approve Baxter’s ANDA because a first applicant included a Paragraph IV
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`certification as to the ’867 Patent in its application. Therefore, without a final judgment that
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`Baxter does not infringe the ’867 Patent, FDA cannot approve Baxter’s ANDA because a first
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`filer has not triggered its period of exclusivity. Only after a final judgment of noninfringement on
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`all the Patents-in-Suit forces the first applicant to either market its product or forfeit its
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`exclusivity can FDA approve Baxter’s ANDA.
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`2 Hospira asserts that Baxter took over five weeks to respond to the counterclaim and file its
`motion. (D.I. 19, ¶ 4.) This wording is deceptive. Hospira filed its answer and counterclaim on
`March 20, 2018, and Baxter filed its answer to the counterclaim on April 10, 2018—within the
`prescribed 21-day response time. Baxter then filed its Motion for Judgment on the Pleadings on
`April 24, 2018—14 days later. Thus, Baxter filed its actual motion only two weeks after the
`pleadings closed.
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`B.
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`Baxter’s Motion for Judgment on the Pleadings Does Not Raise Complex Issues of
`Law.
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`Second, Baxter’s Motion for Judgment on the Pleadings does not raise complex issues of
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`fact or law that warrant an extension of time. In its answer and representations to this Court,
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`Hospira admitted that Baxter does not infringe any claim of the ’158 Patent, ’470 Patent, and
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`’527 Patent that requires a “sealed glass container” (D.I. 10, ¶¶ 33, 46, 58, 87-89, 95-96, 102-
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`103), and that these patents are not being asserted against Baxter (D.I. 18; D.I. 19, ¶ 6). Thus,
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`Hospira should have no difficulty responding to (and indeed acceding to) Baxter’s Motion for
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`Judgment on the Pleadings with respect to these three patents. Although Baxter sent Hospira a
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`proposed consent judgment on these three patents over a month ago, Hospira has not responded.
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`This means the only legal dispute between the parties concerns infringement of the ’867
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`Patent. Resolution of this issue, however, turns on questions of law. Hospira is intimately
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`familiar with the legal principles at issue in this case and their application to the ’867 patent
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`based on its prior litigation experience involving the ’867 Patent. See, e.g., Hospira, Inc. et al. v.
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`Eurohealth S.A.R.L. et al., C.A. No. 14-1008-GMS (D. Del.); Hospira Inc. & Orion Corp. v.
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`Sandoz Int’l GmbH, et al., Civ. No. 09-00665 (D. Del.); Hospira, Inc. & Orion Corp. v.
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`Aurobindo Pharma Ltd., et al., Civ. No. 14-00486 (D. Del.); Hospira, Inc. & Orion Corp. v. Ben
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`Venue Labs, Inc., Civ. No. 14-00487 (D. Del.); Hospira & Orion Corp. v. Actavis LLC et al.,
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`Civ. No. 14-00488 (D. Del.); Hospira, Inc. & Orion Corp. v. Ben Venue Labs, Inc., et al., Civ.
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`No. 14-1008 (D. Del.); Hospira, Inc. & Orion Corp. v. Sandoz Int’l GmbH & Sandoz, Inc., C.A.
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`No. 09-4591-MLC (D.N.J.). Hospira is knowledgeable about the Patents-in-Suit—more so than
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`Baxter—and should be able to timely submit an answering brief in a lawsuit that is substantively
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`similar to its past and current litigation.
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` Moreover, this Court’s local rules already grant Hospira 14 days to draft its answering
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`brief. See Local Rule 7.1.2(b). Hospira seeks to double this timeframe despite contesting only
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`one of the four patents. While Hospira claims that it needs additional time to review the
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`attachments submitted as part of Baxter’s answer to the counterclaim (D.I. 19, ¶ 4), Hospira has
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`had since April 10, 2018 to review these documents. Additionally, two of the attachments are
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`simply versions of labels for the Baxter ANDA Product, and Baxter does not rely in its Motion
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`for Judgment on the Pleadings on one of the declarations filed. Accordingly, Baxter submits that
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`Hospira has failed to show good cause for an extension.
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`CONCLUSION
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`Baxter recognizes that it is unusual to oppose routine motions for extension of time.
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`However, Baxter submits that this is a unique case in which expeditious resolution is critical to
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`prevent further harm to Baxter. Moreover, Hospira has admitted in its pleadings that Baxter does
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`not infringe three of the four Patents-in-Suit, and has failed to establish good cause for doubling
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`the time to submit an answering brief that addresses primarily the ’867 Patent. The lack of good
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`cause is further highlighted by the fact that Hospira has extensive experience with the legal
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`principles surrounding the Patents-in-Suit based on its prior litigation. For these reasons, Baxter
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`respectfully requests that the Court deny Hospira’s Extension Motion.
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`Case 1:18-cv-00303-RGA Document 20 Filed 04/30/18 Page 8 of 8 PageID #: 593
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`OF COUNSEL:
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`Neal Seth
`Lawrence M. Sung
`Bethany A. Corbin
`WILEY REIN, LLP
`1776 K St. NW
`Washington, DC 20006
`(202) 719-7000
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`Dated: April 30, 2018
`5760511
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`POTTER ANDERSON & CORROON LLP
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`By: /s/ Philip A. Rovner
`Philip A. Rovner (#3215)
`Jonathan A. Choa (#5319)
`Alan R. Silverstein (#5066)
`Hercules Plaza
`P.O. Box 951
`Wilmington, DE 19899
`(302) 984-6000
`provner@potteranderson.com
`jchoa@potteranderson.com
`asilverstein@potteranderson.com
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`Attorneys for Plaintiff
`Baxter Healthcare Corporation
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`8
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