Case 1:18-cv-00303-RGA Document 8 Filed 03/16/18 Page 1 of 8 PageID #: 103
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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 Fourteen (14) Day Extension of Time to Answer, Move or Otherwise Respond to
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`Complaint (“Extension Motion”) filed by Hospira, Inc. (“Hospira”). While normally Baxter
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`would readily consent to reasonable extensions of time, the circumstances of this case are
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`unique, and a denial of Hospira’s Extension Motion is warranted for three reasons. First, Hospira
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`has been aware of the facts and legal principles surrounding this dispute for nearly two years.
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`Second, Hospira has litigated similar disputes against other parties in numerous courts. Third,
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`Baxter’s case for noninfringement is exceptionally strong, and this case implicates a failure of
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`the Hatch-Waxman regime that only prompt judicial relief can correct. Accordingly, Baxter
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`respectfully requests that the Court deny Hospira’s Extension Motion.
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`NATURE OF THE CASE & PROCEDURAL HISTORY
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`This case raises a unique and time-sensitive issue, the resolution of which is crucial for
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`mitigating harm to both Baxter and the public. Hospira is the assignee or co-assignee of four
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`United States patents at issue in this case: Nos. 6,716,867 (the “’867 Patent”), 8,242,158 (the
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`“’158 Patent”), 8,338,470 (the “’470 Patent”), and 8,455,527 (the “’527 Patent”) (collectively,
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`“the Patents-in-Suit”). The ’867 Patent requires “[a] method of sedating a patient in an intensive
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`care unit . . . wherein the patient remains orientated and arousable,” while the ’158 Patent, ’470
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`Patent, and ’527 Patent each require “[a] ready to use liquid pharmaceutical composition . . .
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`disposed within a sealed glass container.”
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`Hospira identified the Patents-in-Suit to the Food and Drug Administration (“FDA”) for
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`listing in the Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange
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`Book”). By doing so, Hospira stated that the Patents-in-Suit were ones in which “a claim of
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`patent infringement could reasonably be asserted if a person not licensed by the owner engaged
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`in the manufacture, use, or sale of the drug” products containing dexmedetomidine HCl, 200
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`mcg base/50 mL and 400 mcg base/100 mL. The Patents-in-Suit remain listed in the Orange
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`Book with respect to Hospira’s New Drug Application (“NDA”) No. 21-038 for Precedex®
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`Injection (dexmedetomidine HCl), 200 mcg base/50 mL and 400 mcg base/100 mL.
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`In April 2016, Celerity Pharmaceuticals, LLC submitted and later transferred to Baxter
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`Abbreviated New Drug Application (“ANDA”) No. 208532 for a proposed drug product
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`containing dexmedetomidine HCl, 200 mcg base/50 mL and 400 mcg base/100 mL (the “Baxter
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`ANDA Product”). Baxter’s ANDA seeks FDA approval for the commercial manufacture, use,
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`importation, offer for sale and sale of the Baxter ANDA Product. Baxter seeks to bring its
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`product to market at the earliest possible date under the applicable statutes and FDA regulations
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`to allow the public to enjoy the benefits of generic competition for these products.1
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`In accordance with Title XI of the Medicare Modernization Act of 2003, Baxter filed a
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`certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”) certifying
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`that the ’158 Patent, the ’470 Patent, and the ’527 Patent (collectively, the “Paragraph IV
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`1 In addition, the Baxter ANDA Product provides greatly improved convenience of use for
`clinicians because it is packaged in a flexible plastic IV container rather than a glass vial.
`2
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`Patents”) will not be infringed by the manufacture, use, or sale of the Baxter’s ANDA Product.
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`In particular, Baxter’s ANDA Product does not use a sealed glass container. Similarly, Baxter
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`included a statement pursuant to 21 U.S.C. § 505(j)(2)(A)(viii) and 21 C.F.R. §
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`314.94(a)(12)(iii)(A) (“Section viii Carve-out”) that the method of use recited in the ’867 patent
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`does not claim any indication for which Baxter’s ANDA seeks approval. Baxter’s ANDA does
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`not seek approval of a label including a method of sedating a patient in an intensive care unit
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`wherein the patient remains orientated and arousable.
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`On June 6, 2016, Baxter served Hospira with a Notice Letter informing Hospira of
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`Baxter’s ANDA seeking approval to manufacture and market Baxter’s ANDA Product before the
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`expiration of the Patents-in-Suit. As required by statute, this letter explained the basis for
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`Baxter’s Paragraph IV Certification and Section viii Carve-out. Hospira had 45 days to sue
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`Baxter for infringement upon receipt of the letter, but elected not to file suit.2
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`On January 25, 2018, the FDA tentatively approved Baxter’s ANDA No. 208532. As
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`stated in the FDA’s tentative approval letter, the approval of ANDA No. 208532 was tentative
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`rather than final because of a first applicant’s continued eligibility for 180-day exclusivity. But
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`for that eligibility, the FDA would have finally approved Baxter’s ANDA, permitting the
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`immediate marketing of the Baxter ANDA Product. Unless a first applicant triggers the running
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`of the 180-day exclusivity period by obtaining approval and initiating marketing, the FDA will
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`be statutorily prohibited from finally approving Baxter’s ANDA Product until 2032, when the
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`Patents-in-Suit and any applicable pediatric exclusivity expire. This delay can be prevented if a
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`court enters a final decision from which no appeal (other than a petition to the Supreme Court for
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`2 Baxter has also timely amended its ANDA and provided notice to Hospira as additional, newly
`issued patents were added to the Orange Book while the ANDA has been pending.
`3
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`a writ of certiorari) has been or can be taken that the Patents-in-Suit are invalid or not infringed.
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`21 U.S.C. § 355(j)(5)(D)(i)(I)(bb)(AA). No court has yet entered final judgment that includes a
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`finding that the Patents-in-Suit are invalid or not infringed.
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`On February 22, 2018, Baxter filed its Complaint for Declaratory Judgment seeking a
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`declaration of noninfringement of the Patents-in-Suit. (D.I. 1.) Hospira was served with the
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`Complaint on February 23, 2018. (D.I. 5.) Accordingly, Hospira’s responsive pleading is
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`currently due on or before March 16, 2018. Fed. R. Civ. P. 12(a)(i).
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`On March 16, 2018, Hospira filed a Motion for Extension of Time (D.I. 7.), requesting
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`this Court to extend Hospira’s time for filing a responsive pleading to the Complaint by 14 days,
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`until April 2, 2018.
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`ARGUMENT
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`Baxter opposes the extension of time for three primary reasons: (1) Hospira has been on
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`notice of the issues in this case since it received multiple notice letters from Baxter beginning in
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`June 2016; (2) Hospira has engaged in extensive litigation with similar plaintiffs regarding
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`infringement of the Patents-in-Suit; and (3) Baxter and the public are suffering irreparable harm
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`from Baxter’s inability to bring the Baxter ANDA Product to market. Therefore, there is no good
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`cause under Federal Rule of Civil Procedure 6(b)(1)(A) to delay the responsive pleading
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`deadline.
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`First, this lawsuit should come as no surprise to Hospira, which has been on notice of
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`Baxter’s position regarding noninfringement since June 2016. In accordance with Title XI of the
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`Medicare Modernization Act of 2003, Baxter, as an ANDA applicant, is permitted to bring a
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`declaratory judgment action for noninfringement of a patent listed in the Orange Book if the
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`NDA holder does not sue within 45 days of receiving notice of a Paragraph IV certification. 21
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`4
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`U.S.C. § 355(j)(5)(C). Baxter provided Hospira with its Paragraph IV Certification and Section
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`viii Carve-out notice on June 6, 2016. Hospira had 45 days to file suit and challenge Baxter’s
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`ANDA for infringement. During this time period, Hospira had an opportunity to examine the
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`Patents-in-Suit and Baxter’s ANDA Product in-depth. Hospira gained familiarity with the
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`underlying law and facts of this suit and, following its review, elected not to sue Baxter.
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`Accordingly, Hospira has been on notice of the core facts and legal arguments in this case since
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`June 2016, and should not require any additional time to respond.
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`Second, none of Baxter’s noninfringement positions are novel or surprising in view of
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`Hospira’s prior litigation experience involving alleged infringement of the ’867 Patent and
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`dexmedetomidine premix products packaged in plastic containers. See, e.g., Hospira, Inc. et al.
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`v. Eurohealth S.A.R.L. et al., C.A. No. 14-1008 (D. Del.); Hospira Inc. & Orion Corp. v. Sandoz
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`Int’l GmbH, et al., Civ. No. 09-00665 (D. Del.); Hospira, Inc. & Orion Corp. v. Aurobindo
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`Pharma Ltd., et al., Civ. No. 14-00486 (D. Del.); Hospira, Inc. & Orion Corp. v. Ben Venue
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`Labs, Inc., Civ. No. 14-00487 (D. Del.); Hospira & Orion Corp. v. Actavis LLC et al., Civ. No.
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`14-00488 (D. Del.); Hospira, Inc. & Orion Corp. v. Ben Venue Labs, Inc., et al., Civ. No. 14-
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`1008 (D. Del.); Hospira, Inc. & Orion Corp. v. Sandoz Int’l GmbH & Sandoz, Inc., C.A. No. 09-
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`4591-MLC (D.N.J.). Hospira is extremely familiar with the Patents-in-Suit – more so than
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`Baxter – and should be able to timely respond to a lawsuit that is substantively similar to its past
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`and current litigation.
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`Third, Baxter has a strong case for noninfringement, and will suffer irreparable harm
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`unless the Court provides prompt judicial relief. Specifically, with respect to the ’158 Patent,
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`’470 Patent, and ’527 Patent, the Baxter ANDA Product does not infringe because these Patents
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`each require “[a] ready to use liquid pharmaceutical composition . . . disposed within a sealed
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`5
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`glass container.” The Baxter ANDA Product does not use a sealed glass container. Additionally,
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`the ’867 patent does not claim any indication for which Baxter’s ANDA seeks approval. Baxter’s
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`ANDA does not seek approval for a method of sedating a patient in an intensive care unit
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`wherein the patient remains orientated and arousable. Rather, Baxter’s ANDA seeks approval
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`only for a method of “sedation of non-intubated patients prior to and/or during surgical and other
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`procedures.”3 Therefore, this is a relatively straightforward noninfringement case that can and
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`should be resolved expeditiously to enable Baxter and the public to benefit from the Baxter
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`ANDA Product. The claims asserted in the Complaint are not sufficiently complex or novel to
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`warrant an extension.
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`Moreover, any delay in this case will harm both Baxter and the public. The Baxter
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`ANDA Product is a generic dexmedetomidine hydrochloride in a flexible plastic container,
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`which presents a more affordable and cost-effective drug option for hospitals and their patients.
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`Savings generated from generic drugs continue to soar in the United States, with the U.S. health
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`care system saving $1.67 trillion in the last decade and $253 billion in 2016 alone.4 Baxter seeks
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`to contribute to this health care cost savings – both for insurers, hospitals, and patients – through
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`its generic product. However, Hospira’s inclusion of the Patents-in-Suit in the Orange Book and
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`the presence of a first applicant that has not yet marketed its product have precluded Baxter from
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`bringing its product to market, potentially until 2032. The Court can remedy this harmful result
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`through a judgment of noninfringement.
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`Further, any delay in this case will contribute to Baxter losing some of its already
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`3 This method was purportedly covered by Orion’s US Patent No. 5,344,840, which expired in
`2011.
`4 See Ass’n for Accessible Medicines, Generic Drug Access & Savings in the U.S. (2017),
`available at https://accessiblemeds.org/resources/blog/2017-generic-drug-access-and-savings-us-
`report.
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`6
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`developed product due to expiration. The Baxter ANDA Product that has already been developed
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`and is waiting to come to market is beginning to expire in Baxter’s warehouse due to this
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`regulatory quandary. In fact, President Trump has issued a call to change the way generic drugs
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`come to market to ensure that first-to-file generic applicants do not unreasonably and indefinitely
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`block subsequent generics from entering the marketplace, as is occurring in this case.5 Therefore,
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`Baxter submits that expeditious resolution of this case is crucial to prevent further harm to
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`Baxter and the public.
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`CONCLUSION
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`Baxter recognizes that it is unusual to oppose a routine motion for extension of time at
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`the pleading stage. However, Baxter submits that this is a unique case in which the parties have
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`been aware of the facts for almost two years, and expeditious resolution of this case is crucial to
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`prevent further harm to Baxter and the public. For these reasons, Baxter respectfully requests that
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`the Court deny Hospira’s Extension Motion.
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`5 See Zachary Brennan, Trump FY 2019 Budget Calls for 180-Day Exclusivity Changes for
`Generic Drugs, Regulatory Affairs
`Professionals
`Society
`(Feb.
`12,
`2018),
`https://www.raps.org/news-and-articles/news-articles/2018/2/trump-fy-2019-budget-calls-for-
`180-day-exclusivity.
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`7
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`Case 1:18-cv-00303-RGA Document 8 Filed 03/16/18 Page 8 of 8 PageID #: 110
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`OF COUNSEL:
`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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`
`
`
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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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`Dated: March 16, 2018
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`Attorneys for Plaintiff
`Baxter Healthcare Corporation
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`8
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