Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 1 of 26 PageID #: 607
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`BAXTER HEALTHCARE CORPORATION,
`
` Plaintiff,
`
`v.
`
`HOSPIRA, INC. and ORION CORP.,
`
` Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. 18-303-RGA
`
`OPENING BRIEF IN SUPPORT OF BAXTER’S
`MOTION FOR JUDGMENT ON THE PLEADINGS
`
`OF COUNSEL:
`
`Neal Seth
`Lawrence M. Sung
`Bethany A. Corbin
`WILEY REIN LLP
`1776 K Street N.W.
`Washington, DC 20006
`(202) 719-7000
`
`Date: April 24, 2018
`
`POTTER ANDERSON & CORROON LLP
`
`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
`
`Attorneys for Plaintiff
`Baxter Healthcare Corporation
`
`PUBLIC VERSION
`
`Public version dated: May 1, 2018
`
`

`

`Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 2 of 26 PageID #: 608
`
`TABLE OF CONTENTS
`
`Pages
`
`I.
`II.
`III.
`IV.
`V.
`VI.
`
`VII.
`
`INTRODUCTION ...............................................................................................................1
`NATURE AND STAGE OF THE PROCEEDINGS ..........................................................2
`LEGAL STANDARDS .......................................................................................................2
`SUMMARY OF THE ARGUMENT ..................................................................................3
`STATEMENT OF FACTS ..................................................................................................4
`ARGUMENT .......................................................................................................................7
`A.
`Baxter is Entitled to a Declaration of Noninfringement for the ’158 Patent, ’470
`Patent, and ’527 Patent as a Matter of Law. ............................................................7
`1.
`The Baxter ANDA Product Is Not “Disposed Within a Sealed Glass
`Container,” which is A Necessary Element of the Claims of the Glass
`Patents. .........................................................................................................8
`Prosecution History Estoppel Prevents Defendants from Asserting
`Infringement under the Doctrine of Equivalents. ........................................9
`Baxter is Entitled to a Declaration of Noninfringement for the ’867 Patent. ........11
`1.
`Baxter Does Not Directly Infringe the ’867 Patent. ..................................11
`2.
`Baxter Does Not Induce Infringement of the ’867 Patent. ........................12
`i
`Baxter Carved Out the Infringing ICU Sedation Indication. .........13
`ii
`Procedural Sedation Does Not Infringe the ’867 Patent. ...............14
`iii
`Knowledge of Downstream Infringement is Insufficient to Create
`Intent for Inducement. ....................................................................17
`Baxter Has No Intent to Market the Baxter ANDA Product for Use
`in the ICU. ......................................................................................18
`The Baxter ANDA Product Does Not Contributorily Infringe the ’867
`Patent..........................................................................................................19
`Baxter Did Not Infringe the ’867 Patent By Filing an ANDA Application. .........19
`C.
`CONCLUSION ..................................................................................................................20
`
`2.
`
`3.
`
`B.
`
`iv
`
`i
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`

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`Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 3 of 26 PageID #: 609
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Abbott Labs. v. Novopharm Ltd.,
`323 F.3d 1324 (Fed. Cir. 2003)..................................................................................................9
`
`Alza Corp. v. Andrx Pharm., LLC,
`607 F. Supp. 2d 614 (D. Del. 2009) .........................................................................................12
`
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) .................................................................................................................12
`
`AstraZeneca LP v. Apotex, Inc.,
`633 F.3d 1042 (Fed. Cir. 2010) (AstraZeneca 2010) ...................................................12, 17, 18
`
`AstraZeneca Pharm., LP v. Apotex Corp.,
`669 F.3d 1370 (Fed. Cir. 2012) (AstraZeneca 2012) .....................................................3, 19, 20
`
`Bayer AG v. Elan Pharm. Research Corp.,
`212 F.3d 1241 (Fed. Cir. 2000)........................................................................................8, 9, 10
`
`Centrak, Inc. v. Sonitor Techs., Inc.,
`No. 14-183, 2017 WL 3730617 (D. Del. Aug. 30, 2017) ..........................................................3
`
`DiCarlo v. St. Mary Hosp.,
`530 F.3d 255 (3d Cir. 2008).......................................................................................................3
`
`DSU Med. Corp. v. JMS Co.,
`471 F.3d 1293 (Fed. Cir. 2006)................................................................................................12
`
`Eli Lilly & Co. v. Teva Parenteral Medicines, Inc.,
`845 F.3d 1357 (Fed. Cir. 2017)..........................................................................................11, 17
`
`Eli Lilly Co. v. Medtronic, Inc.,
`496 U.S. 661 (1990) .................................................................................................................19
`
`Exergen Corp. v. Wal-Mart Stores, Inc.,
`575 F.3d 1312 (Fed. Cir. 2009)................................................................................................11
`
`Ferring B.V. v. Watson Labs., Inc.-Fla.,
`764 F.3d 1401 (Fed. Cir. 2014)................................................................................................13
`
`Genetic Techs. Ltd. v. Bristol-Myers Squibb Co.,
`72 F. Supp. 3d 521 (D. Del. 2014) .............................................................................................3
`
`ii
`
`

`

`Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 4 of 26 PageID #: 610
`
`GlaxoSmithKline LLC v. Teva Pharm. USA, Inc.,
`No. 14-878, 2016 WL 3946770 (D. Del. July 20, 2016) .........................................................14
`
`Hockerson-Halberstadt, Inc. v. Avia Grp. Int’l, Inc.,
`222 F.3d 951 (Fed. Cir. 2000)....................................................................................................3
`
`Hospira Inc. v. Burwell,
`No. 14-02662, 2014 WL 4406901 (D. Md. Sept. 5, 2014) ..................................................7, 16
`
`Hospira, Inc. v. Amneal Pharm., LLC,
`Nos. 18-1522, 18-1688 (Fed. Cir. Feb. 6, 2018) ........................................................................9
`
`Hospira, Inc. v. Fresenius Kabi USA, LLC,
`No. 16C651, 2017 WL 5891058 (N.D. Ill. Nov. 27, 2017) .....................................................10
`
`Johnson & Johnston Assocs. Inc. v. R.E. Serv. Co.,
`285 F.3d 1046, 1051 (Fed. Cir. 2002) (en banc)......................................................................11
`
`Mas-Hamilton Grp. v. LaGard, Inc.,
`156 F.3d 1206 (Fed. Cir. 1998)..................................................................................................8
`
`Otsuka Pharm. Co., Ltd. v. Torrent Pharm. Ltd., Inc.,
`99 F. Supp. 3d 461 (D.N.J. 2015) ............................................................................................14
`
`Rosenau v. Unifund Corp.,
`539 F.3d 218 (3d Cir. 2008).......................................................................................................3
`
`Sanofi v. Glenmark Pharm. Inc., USA,
`204 F. Supp. 3d 665 (D. Del. 2016) .........................................................................................12
`
`Takeda Pharm. USA, Inc. v. West-Warn Pharm. Corp.,
`785 F.3d 625 (Fed. Cir. 2015)......................................................................................13, 14, 17
`
`Vehicle Operation Techs. LLC v. Am. Honda Motor Co. Inc.,
`67 F. Supp. 3d 637 (D. Del. 2014) .............................................................................................8
`
`Warner-Lambert Co. v. Apotex Corp.,
`316 F.3d 1348 (Fed. Cir. 2003)..............................................................................12, 13, 17, 18
`
`Statutes
`
`21 U.S.C. § 331(a) .........................................................................................................................18
`
`21 U.S.C. § 355(j)(2)(A)(vii)(IV) ....................................................................................................6
`
`21 U.S.C. § 355(j)(2)(A)(viii) ..........................................................................................................6
`
`35 U.S.C. § 112(d) ...........................................................................................................................8
`
`iii
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`

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`Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 5 of 26 PageID #: 611
`
`35 U.S.C. § 271 ...................................................................................................................... passim
`
`Other Authorities
`
`FDA Decision Letter (Aug. 18, 2014), Docket No. FDA-2014-N-0087 ............................... passim
`
`Fed. R. Civ. P. 12(c) ....................................................................................................................2, 3
`
`Fed. R. Civ. P. 12(d) ........................................................................................................................3
`
`Fed. R. Civ. P. 56(a) ........................................................................................................................3
`
`Hospira, Inc. v. Sandoz Int’l GmbH, No. 3:09-cv-04591, ECF No. 397 (D.N.J.) .........................16
`
`Hospira Submission (Jan. 24, 2014), Docket No. FDA-2014-N-0087 ..........................................15
`
`U.S. Patent No. 5,344,840........................................................................................................15, 16
`
`U.S. Patent No. 6,716,867...................................................................................................... passim
`
`U.S. Patent No. 8,242,158...................................................................................................... passim
`
`U.S. Patent No. 8,338,470...................................................................................................... passim
`
`U.S. Patent No. 8,455,527...................................................................................................... passim
`
`Zachary Brennan, Trump FY 2019 Budget Calls for 180-Day Exclusivity Changes
`for Generic Drugs, Regulatory Affairs Professionals Soc. (Feb. 12, 2018),
`https://bit.ly/2o2rkj3...................................................................................................................1
`
`iv
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`

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`Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 6 of 26 PageID #: 612
`
`I.
`
`INTRODUCTION
`
`This case arises from a regulatory conundrum plaguing generic drug manufacturers in
`
`which first-to-file generic applicants may indefinitely block subsequent generics from entering
`
`the market.1 Baxter Healthcare Corporation (“Baxter”) is the current holder of Abbreviated New
`
`Drug Application (“ANDA”) No. 208532 for a proposed drug product containing
`
`dexmedetomidine hydrochloride in 0.9% sodium chloride injection 200 mcg/50 mL and 400
`
`mcg/100 mL (the “Baxter ANDA Product”). The Food and Drug Administration (“FDA”)
`
`tentatively approved ANDA No. 208532, but withheld final approval because of a first
`
`applicant’s continued eligibility for 180-day exclusivity. Unless a first applicant triggers the
`
`running of the 180-day exclusivity period by obtaining approval and initiating marketing, the
`
`FDA is statutorily prohibited from finally approving Baxter’s ANDA Product until 2032, when
`
`the relevant patents owned by Hospira, Inc. (“Hospira”) and Orion Corp. (“Orion”) (collectively,
`
`“Defendants”) and any applicable pediatric exclusivity expire.
`
`This unnecessary delay can be prevented if a court enters a final decision from which no
`
`appeal (other than a petition to the Supreme Court for a writ of certiorari) is or can be taken that
`
`the relevant patents are invalid or not infringed. The applicable patents in this case are U.S.
`
`Patent Nos. 6,716,867 (the “’867 Patent”), 8,242,158 (the “’158 Patent”), 8,338,470 (the “’470
`
`Patent”), and 8,455,527 (the “’527 Patent”) (collectively, “the Patents-in-Suit”). Baxter does not
`
`infringe the Patents-in-Suit because the Baxter ANDA Product is not disposed in a sealed glass
`
`container, as required by the claims of the ’158 Patent, ’470 Patent, and ’527 Patent.
`
`Furthermore, Baxter carved out all infringing uses in the ’867 Patent, thus demonstrating its
`
`1 The Administration issued a call to change the way generic drugs come to market to ensure that
`first-to-file generic applicants do not indefinitely block subsequent generics. See Zachary
`Brennan, Trump FY 2019 Budget Calls for 180-Day Exclusivity Changes for Generic Drugs,
`Regulatory Affairs Professionals Soc. (Feb. 12, 2018), https://bit.ly/2o2rkj3.
`
`

`

`Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 7 of 26 PageID #: 613
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`intent not to market the Baxter ANDA Product for use in an intensive care unit (“ICU”). While
`
`judgment at this stage is unusual in patent cases, Baxter submits that this case warrants early
`
`disposition to avoid the wasteful use of the Court’s and the parties’ resources. No material issues
`
`of fact exist, and judgment can be granted as a matter of law based upon the papers, records, and
`
`pleadings on file with the Court, and matters of public record.
`
`II.
`
`NATURE AND STAGE OF THE PROCEEDINGS
`
`This is a declaratory judgment action seeking a declaration of non-infringement of the
`
`Patents-in-Suit to enable Baxter to bring the Baxter ANDA Product to market at the earliest date
`
`under the applicable statutes and FDA regulations. Although the FDA has tentatively approved
`
`ANDA No. 208532, Baxter cannot obtain final approval to market the Baxter ANDA Product
`
`because of a first applicant’s continued eligibility for 180-day exclusivity. Without a final
`
`judgment that the Patents-in-Suit are invalid or not infringed, Baxter may be precluded from
`
`obtaining final approval for the Baxter ANDA Product until 2032. Accordingly, Baxter filed this
`
`lawsuit on February 22, 2018 requesting a declaration of non-infringement. (D.I. 1.)
`
`Defendants answered the complaint on March 20, 2018, and asserted a counterclaim
`
`against Baxter for infringement of the ’867 Patent. (D.I. 10.) Defendants did not assert any
`
`affirmative defenses. Baxter filed its sealed answer to the counterclaim on April 10, 2018 (D.I.
`
`14), and a redacted version on April 17, 2018 (D.I. 15). Baxter’s Motion for Judgment on the
`
`Pleadings (“Motion”) is presented to the Court at the close of the pleadings.2
`
`III.
`
`LEGAL STANDARDS
`
`The Federal Rules of Civil Procedure provide that “[a]fter pleadings are closed—but
`
`early enough not to delay trial—a party may move for judgment on the pleadings.” Fed. R. Civ.
`
`2 To the extent the Court considers matters outside the pleadings, the Court must convert this
`Motion into one for summary judgment pursuant to Federal Rule of Civil Procedure 12(d).
`
`2
`
`

`

`Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 8 of 26 PageID #: 614
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`P. 12(c). Judgment should be granted if no material issue of fact remains to be resolved and the
`
`movant is entitled to judgment as a matter of law. Rosenau v. Unifund Corp., 539 F.3d 218, 221
`
`(3d Cir. 2008). The court may consider the pleadings, exhibits thereto, documents incorporated
`
`by reference, and matters of public record, including patent prosecution history, without
`
`converting the motion into one for summary judgment. Hockerson-Halberstadt, Inc. v. Avia Grp.
`
`Int’l, Inc., 222 F.3d 951, 957 (Fed. Cir. 2000); Genetic Techs. Ltd. v. Bristol-Myers Squibb Co.,
`
`72 F. Supp. 3d 521, 526 (D. Del. 2014). In deciding a Rule 12(c) motion, the court should accept
`
`well-pleaded allegations as true, but need not accept unsupported conclusory statements.
`
`DiCarlo v. St. Mary Hosp., 530 F.3d 255, 263 (3d Cir. 2008).
`
`If, on a Rule 12(c) motion, matters outside the pleadings are presented to the court, “the
`
`motion must be treated as one for summary judgment under Rule 56.” Fed. R. Civ. P. 12(d).
`
`Summary judgment is appropriate if there is no dispute as to any material fact, and judgment can
`
`be entered as a matter of law. Fed. R. Civ. P. 56(a). The moving party satisfies its burden by
`
`highlighting the absence of evidence supporting the non-moving party’s case. Centrak, Inc. v.
`
`Sonitor Techs., Inc., No. 14-183, 2017 WL 3730617, at *2 (D. Del. Aug. 30, 2017) (Andrews,
`
`J.). Speculation that an ANDA may infringe is not evidence of infringement. See AstraZeneca
`
`Pharm., LP v. Apotex Corp., 669 F.3d 1370, 1381 (Fed. Cir. 2012) (AstraZeneca 2012).
`
`IV.
`
`SUMMARY OF THE ARGUMENT
`
`The Court should grant judgment of noninfringement on the Patents-in-Suit in favor of
`
`Baxter for the following reasons.
`
`1.
`
`Defendants admit that the Baxter ANDA Product does not infringe the ’158
`
`Patent, ’470 Patent, and ’527 Patent because it is not disposed in a sealed glass container. The
`
`patent claims require dexmedetomidine to be disposed in a “sealed glass container.” The Baxter
`
`3
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`

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`Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 9 of 26 PageID #: 615
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`ANDA Product, however, is packaged in a plastic GALAXY container. Defendants admit that
`
`“Baxter does not infringe any claim” of these patents “that requires a ‘sealed glass container.’”
`
`(D.I. 10, ¶¶ 87-89, 95-96, 102-103.) Moreover, any allegation of infringement under the doctrine
`
`of equivalents is barred by prosecution history estoppel and the disclosure-dedication doctrine.
`
`2.
`
`The Baxter ANDA Product does not infringe the ’867 Patent. There is no
`
`infringement as a matter of law under 35 U.S.C. § 271(a), (b), or (c). First, Baxter does not
`
`directly practice any of the methods claimed in the ’867 Patent, precluding direct infringement.
`
`Second, Baxter has not knowingly induced infringement and has no specific intent to encourage
`
`another’s infringement under § 271(b). The label for the Baxter ANDA Product purposefully
`
`omits (“carves out”) the infringing method-of-use for the ’867 Patent and does not promote use
`
`of the product in an ICU. Further, Baxter has no intent to encourage infringement, and mere
`
`knowledge of potential downstream infringement is legally insufficient to establish intent. Third,
`
`there is no contributory infringement because the Baxter ANDA Product is not made or adapted
`
`for infringing use, and instead has substantial noninfringing uses.
`
`3.
`
`Baxter did not commit an act of artificial infringement under § 271(e)(2) with
`
`respect to the ’867 Patent because Baxter carved out the infringing use. Baxter’s decision to
`
`carve out the infringing use of the ’867 Patent precludes a finding of infringement under
`
`§ 271(e)(2) because Baxter did not submit an ANDA with a Paragraph IV Certification for the
`
`’867 Patent. The Federal Circuit has held that ANDA applicants may forego both Paragraph IV
`
`Certification and a § 271(e)(2) infringement suit by excluding patented indications from their
`
`ANDAs. Baxter did precisely this through its use of a Section viii Carve-Out.
`
`V.
`
`STATEMENT OF FACTS
`
`The material facts of this case are not in dispute.
`
`4
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`

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`Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 10 of 26 PageID #: 616
`
`1.
`
`Defendants are co-assignees of the ’867 Patent, which recites “[a] method of
`
`sedating a patient in an intensive care unit . . . wherein the patient remains orientated and
`
`arousable.” (D.I. 1, ¶¶ 15, 19-20 & Ex. A; D.I. 10, ¶¶ 15, 19-20, Counterclaim ¶¶ 10, 17.)
`
`2.
`
`Hospira is the assignee of three United States patents at issue in this case: the ’158
`
`Patent,’470 Patent, and ’527 Patent (collectively, the “Glass Patents”). (D.I. 1, ¶¶ 23, 37, 50; D.I.
`
`10, ¶¶ 23, 37, 50.) The claims of the Glass Patents require “a ready to use liquid pharmaceutical
`
`composition . . . disposed within a sealed glass container.” (D.I. 1, ¶¶ 26-27, 40-41, 53-54 & Exs.
`
`B-D; D.I. 10, ¶¶ 26-27, 40-41, 53-54, 86, 94, 101.)
`
`3.
`
`When the applications for the Glass Patents were initially filed with the Patent
`
`and Trademark Office (“PTO”), the claims did not require that the sealed container be made of
`
`glass. (D.I. 1, ¶ 28; D.I. 10, ¶ 28.) The PTO rejected the originally filed claims. (D.I. 1, ¶ 42; D.I.
`
`10, ¶ 42.) In response, Hospira amended the independent claims of the Glass Patents to include
`
`the present requirement that the sealed container be “a sealed glass container.” (D.I. 1, ¶ 29; D.I.
`
`10, ¶¶ 29, 43.) Hospira explained that using glass containers resulted in superior stability
`
`compared to using plastic containers. (D.I. 1, ¶¶ 30-31, 43-44, 55; D.I. 10, ¶¶ 30-31, 43-44, 55.)
`
`4.
`
`Defendants admit that Baxter does not infringe any claim of the Glass Patents that
`
`requires a “sealed glass container.” (D.I. 10, ¶¶ 33, 46, 58, 87-89, 95-96, 102-103.)
`
`5.
`
`Hospira is the current holder of approved New Drug Application No. 21-038 for
`
`Precedex® Injection (dexmedetomidine HCl), 200 mcg base/50 mL and 400 mcg base/100mL.
`
`(D.I. 1, ¶ 62; D.I. 10, ¶ 62, Counterclaim ¶ 11.) Precedex is currently approved for two uses: (1)
`
`Sedation of initially intubated and mechanically ventilated patients during treatment in an
`
`intensive care setting (“ICU Sedation”); and (2) Sedation of non-intubated patients prior to
`
`and/or during surgical and other procedures (“Procedural Sedation”). Ex. 1, FDA Decision
`
`5
`
`

`

`Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 11 of 26 PageID #: 617
`
`Letter, at 1 (Aug. 18, 2014), Docket No. FDA-2014-N-0087.3 When Precedex was first approved
`
`in 1999, the only approved indication was ICU Sedation. Id. at 1-2.
`
`6.
`
`Hospira identified the Patents-in-Suit to the FDA for listing in the Orange Book
`
`with respect to Precedex. (D.I. 1, ¶¶ 63-65; D.I. 10, ¶¶ 63-65, Counterclaim ¶ 12.)
`
`7.
`
`Celerity Pharmaceuticals, LLC submitted and later transferred to Baxter ANDA
`
`No. 208532 for the Baxter ANDA Product. (D.I. 1, ¶ 66; D.I. 10, Counterclaim ¶¶ 14, 16.)
`
`Baxter’s ANDA seeks FDA approval for the commercial manufacture, use, importation, offer for
`
`sale, and sale of generic dexmedetomidine HCl, 200 mcg base/50 mL and 400 mcg base/100 mL
`
`prior to the expiry of the ’867 Patent. (D.I. 1, ¶ 66; D.I. 10, Counterclaim ¶ 14.)
`
`8.
`
`On June 6, 2016, Baxter served Hospira with a Notice Letter informing Hospira
`
`of Baxter’s ANDA seeking approval to manufacture, use, import, offer for sale, or sell the Baxter
`
`ANDA Product before expiration of the Patents-in-Suit. (D.I. 1, ¶ 69; D.I. 10, ¶ 69.) The Notice
`
`Letter had a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”)
`
`that the Glass Patents will not be infringed by the Baxter ANDA Product because the Baxter
`
`ANDA Product is provided in a plastic container rather than a “sealed glass container.” (D.I. 1, ¶
`
`69; D.I. 10, ¶ 69.) The Notice Letter further advised that Baxter’s ANDA contained a statement
`
`pursuant to 21 U.S.C. § 355(j)(2)(A)(viii) (“Section viii Carve-out”) that the ’867 Patent does not
`
`claim any indication for which Baxter’s ANDA seeks approval. (D.I. 1, ¶ 70.)
`
`9.
`
`The label for the Baxter ANDA Product carves out ICU Sedation and omits all
`
`references to use of the product in an ICU. (D.I. 14, Attachs. C & D; see D.I. 10, Counterclaim
`
`¶¶ 18, 19.)
`
`3 The FDA Decision Letter is a matter of public record. Baxter attached a copy of this letter as
`Exhibit 2 to Attachment A in support of its Answer to Defendants’ Counterclaim (D.I. 14 & 15).
`A copy of the letter is also attached to this Brief as Exhibit 1. The letter is available for public
`download at https://www.regulations.gov/document?D=FDA-2014-N-0087-0025.
`
`6
`
`

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`Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 12 of 26 PageID #: 618
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`VI.
`
`ARGUMENT
`
`A judgment of noninfringement in favor of Baxter is warranted as a matter of law for
`
`three primary reasons. First, Defendants admit that the Baxter ANDA Product does not infringe
`
`the ’158 Patent, ’470 Patent, and ’527 Patent because it is not disposed in a sealed glass
`
`container. Second, Baxter does not infringe the ’867 Patent because it does not directly treat
`
`patients with an infringing method of use, purposefully carved out all infringing uses of the
`
`patent to avoid inducement, and developed the Baxter ANDA Product to have substantial
`
`noninfringing uses. Third, there is no artificial infringement under § 271(e)(2) because, with
`
`respect to the ’867 Patent, Baxter did not submit a Paragraph IV Certification. Accordingly, this
`
`case may be resolved on a Rule 12(c) motion due to the absence of genuine factual disputes.4
`
`A.
`
`Baxter is Entitled to a Declaration of Noninfringement for the ’158 Patent,
`’470 Patent, and ’527 Patent as a Matter of Law.
`
`The Court should grant judgment in favor of Baxter on the Glass Patents for at least two
`
`reasons. First, it is undisputed that the Baxter ANDA Product is not disposed in a sealed glass
`
`container. Defendants even expressly acknowledge that the Baxter ANDA Product does not
`
`infringe any claim of the Glass Patents that requires a sealed glass container. (D.I. 10, ¶¶ 33, 46,
`
`58, 87-89, 95-96, 102-103.) Second, prosecution history estoppel precludes Defendants from
`
`asserting infringement of the Glass Patents under the doctrine of equivalents. Accordingly, a
`
`judgment of noninfringement is warranted as a matter of law.
`
`4 In fact, a strong argument exists that Defendants’ failure to take action against Baxter and other
`generic manufacturers for creation of generic dexmedetomidine products suggests that
`Defendants do not believe the Patents-in-Suit are infringed. If Defendants believed that a generic
`dexmedetomidine product (concentrate or premix) with a carved-out label could still infringe the
`’867 Patent, it is curious that they did not sue a single filer whose label carved out the ICU
`indication, either at the ANDA stage or at launch. See, e.g., Hospira v. Burwell, No. 14-02662,
`2014 WL 4406901, at *6-8 (D. Md. Sept. 5, 2014). Further, Hospira did not sue Baxter upon
`receipt of Baxter’s Notice Letter with the Paragraph IV Certifications for the Glass Patents.
`
`7
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`

`

`Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 13 of 26 PageID #: 619
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`1.
`
`The Baxter ANDA Product Is Not “Disposed Within a Sealed Glass
`Container,” which is A Necessary Element of the Claims of the Glass
`Patents.
`
`To prove infringement, the patentee must demonstrate that the accused product “contains
`
`every limitation in the asserted claims.” Mas-Hamilton Grp. v. LaGard, Inc., 156 F.3d 1206,
`
`1211 (Fed. Cir. 1998). The absence of any claim limitation from the accused product means
`
`“there is no literal infringement as a matter of law.” Bayer AG v. Elan Pharm. Research Corp.,
`
`212 F.3d 1241, 1247 (Fed. Cir. 2000); see, e.g., Vehicle Operation Techs. LLC v. Am. Honda
`
`Motor Co. Inc., 67 F. Supp. 3d 637, 644 (D. Del. 2014).
`
`Here, the claims of the Glass Patents require dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof to be disposed within a sealed glass container. (D.I. 1, Exs. B-D.) The
`
`independent claims of the Glass Patents each recite “[a] ready to use liquid pharmaceutical
`
`composition . . . disposed within a sealed glass container.” (Id.) Each of the Glass Patents’
`
`dependent claims incorporate the limitations of the independent claims from which they depend,
`
`meaning all claims of the Glass Patents require disposition within a sealed glass container. (D.I.
`
`1, ¶¶ 27, 41, 54 & Exs. B-D; D.I. 10, ¶¶ 27, 41, 54); see 35 U.S.C. § 112(d).
`
`The Baxter ANDA Product is not disposed in a sealed glass container. (D.I. 1, ¶¶ 86, 89,
`
`94, 96, 101, 103; D.I. 14, Attach. C, at 1, 4-5; id., Attach. D, at 3; see also id., Attach. B ¶¶ 16-
`
`17.) Rather, the label for the Baxter ANDA Product indicates that it will be packaged in a
`
`“GALAXY container,” which is a plastic container. (D.I. 14, Attach. C, at 1, 4-5; id., Attach. D,
`
`at 3; see also id., Attach. B ¶¶ 16-17.) Defendants acknowledge this and expressly “admit[] that
`
`Baxter does not infringe any claim” of the Glass Patents “that requires a ‘sealed glass
`
`container.’” (D.I. 10, ¶¶ 33, 58, 87-89, 95-96, 102-103.) Indeed, Defendants did not counterclaim
`
`for infringement of the Glass Patents, and indicated that no controversy exists between the
`
`8
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`

`

`Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 14 of 26 PageID #: 620
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`parties on these patents.5 (D.I. 10, ¶¶ 90, 97, 104.) Therefore, Baxter is entitled to judgment as a
`
`matter of law that it does not infringe the ’158 Patent, ’470 Patent, and ’527 Patent.
`
`2.
`
`Prosecution History Estoppel Prevents Defendants from Asserting
`Infringement under the Doctrine of Equivalents.
`
`The Baxter ANDA Product also cannot infringe the Glass Patents under the doctrine of
`
`equivalents. The doctrine of equivalents permits a finding of infringement if there is an
`
`insubstantial difference between the limitations of the claim and the accused product. Abbott
`
`Labs. v. Novopharm Ltd., 323 F.3d 1324, 1329 (Fed. Cir. 2003). Prosecution history estoppel,
`
`however, “is one limitation on the scope of equivalents that a patentee can claim.” Bayer AG,
`
`212 F.3d at 1251. This estoppel may occur as a result of “(i) amendments made to overcome
`
`patentability rejections or (ii) arguments made during prosecution that show ‘a clear and
`
`unmistakable surrender of subject matter.’” Id. Assertions made to the PTO may preclude a
`
`patentee from asserting equivalency. Id. at 1252.
`
`The prosecution history for the Glass Patents demonstrates an unambiguous intent by
`
`Hospira to limit the patents’ scope to disposition of dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof in sealed glass containers. The word “glass” is a critical component of the
`
`patents, and its inclusion was necessary for Hospira to secure allowance of the claims.
`
`Specifically, when the applications for the Glass Patents were originally filed, the claims did not
`
`require that the sealed container be made of glass. (D.I. 1, ¶ 28; D.I. 10, ¶ 28.) Rather, the
`
`independent claims of the Glass Patents originally required disposition only within a “sealed
`
`container.” The PTO rejected all claims of the Glass Patents as anticipated or made obvious by
`
`5 In Hospira, Inc. v. Amneal Pharmaceuticals, LLC, Nos. 18-1522, 18-1688 (Fed. Cir. Feb. 6,
`2018), which concerns the validity of the Glass Patents, counsel for Hospira filed a Motion for
`Extension of Time to File Principal and Response Brief (D.I. 22). Although counsel cited this
`case in support of the extension, he did not list this case in the Certificate of Interest as a case
`that would be directly affected by the Federal Circuit’s decision in the pending appeal. It thus
`appears that Defendants have conceded that the Glass Patents are no longer an issue in this case.
`
`9
`
`

`

`Case 1:18-cv-00303-RGA Document 23 Filed 05/01/18 Page 15 of 26 PageID #: 621
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`the prior art. (D.I. 1, ¶¶ 29, 42; D.I. 10, ¶¶ 29, 42); Ex. 2, ’158 Patent Prosecution History
`
`Excerpts, § 1, Non-Final Rejection (Feb. 13, 2012); Ex. 3, ’470 Patent Prosecution History
`
`Excerpts, § 1, Non-Final Rejection (Aug. 17, 2012).
`
`In response, Hospira made narrowing amendments to its independent claims by including
`
`the requirement that the sealed container be a “glass” container. (D.I. 1, ¶ 29; D.I. 10, ¶ 29); Ex.
`
`2, § 2, Amendments to the Claims (Mar. 13, 2012). In its filings with the PTO, Hospira argued
`
`that using glass containers resulted in unexpectedly superior stability compared to using plastic
`
`containers. (D.I. 1, ¶¶ 30-31, 43-44, 55; D.I. 10, ¶¶ 30-31, 43-44, 55); Ex. 2, § 3, Response to
`
`Office Action, at 7-8 (Mar. 13, 2012); Ex. 3, § 2, Response to Office Action, at 6 (Sept. 17,
`
`2012); id. § 3, Decl. of Huailiang Wu, Ph.D., ¶ 13 (Sept. 17, 2012); Ex. 4, ’527 Patent
`
`Prosecution History Excerpts, § 1, Accelerated Examination Support Document, at 46 (Nov. 15,
`
`2012).6
`
`The PTO accepted Hospira’s disclaimers and issued notices of allowance for the Glass
`
`Patents. The examiners stated that “requiring the composition to be disposed within a sealed
`
`glass container[] was effective to overcome the previous rejection under 35 U.S.C[. §] 102(b),”
`
`Ex. 2, § 4, Notice of Allowan