Case 1:18-cv-00303-RGA Document 52 Filed 09/28/18 Page 1 of 11 PageID #: 1075
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`BAXTER HEALTHCARE
`CORPORATION,
`
`
`
`
`
`HOSPIRA, INC. and ORION CORP.,
`
`
`
`v.
`
`
`
`Plaintiff,
`
`Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. 18-303-RGA
`
`DEMAND FOR JURY TRIAL
`
`DEFENDANTS’ FIRST AMENDED COUNTERCLAIM
`
`Pursuant to the Court’s Scheduling Order (D.I. 21 ¶ 3), Defendants Hospira, Inc.
`
`(“Hospira”) and Orion Corp. (“Orion”) (collectively, “Defendants”), through counsel, hereby file
`
`this amended counterclaim against Plaintiff Baxter Healthcare Corporation (“Baxter”).
`
`Parties, Jurisdiction, and Venue
`
`1.
`
`Baxter has filed a Complaint against Defendants seeking, among other things, a
`
`judgment that Baxter does not infringe U.S. Patent No. 6,716,867 (“the ‘867 patent”). An
`
`immediate and justiciable controversy exists between Baxter and Defendants regarding the
`
`infringement of the ‘867 patent.
`
`2.
`
`This Counterclaim arises under the patent laws of the United States, 35 U.S.C. § 1
`
`et seq., and the Federal Food, Drug and Cosmetic Act.
`
`3.
`
`Subject matter jurisdiction in this Court is proper under, among other things, 28
`
`U.S.C. §§ 1331 and 1338.
`
`4.
`
`Hospira is a Delaware corporation with its principal place of business at 275 North
`
`Field Drive, Lake Forest, Illinois 60045.
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`BAXTER HEALTHCARE
`CORPORATION,
`
`
`
`
`
`HOSPIRA, INC. and ORION CORP.,
`
`
`
`v.
`
`
`
`Plaintiff,
`
`Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. 18-303-RGA
`
`DEMAND FOR JURY TRIAL
`
`DEFENDANTS’ FIRST AMENDED COUNTERCLAIM
`
`Pursuant to the Court’s Scheduling Order (D.I. 21 ¶ 3), Defendants Hospira, Inc.
`
`(“Hospira”) and Orion Corp. (“Orion”) (collectively, “Defendants”), through counsel, hereby file
`
`this amended counterclaim against Plaintiff Baxter Healthcare Corporation (“Baxter”).
`
`Parties, Jurisdiction, and Venue
`
`1.
`
`Baxter has filed a Complaint against Defendants seeking, among other things, a
`
`judgment that Baxter does not infringe U.S. Patent No. 6,716,867 (“the ‘867 patent”). An
`
`immediate and justiciable controversy exists between Baxter and Defendants regarding the
`
`infringement of the ‘867 patent.
`
`2.
`
`This Counterclaim arises under the patent laws of the United States, 35 U.S.C. § 1
`
`et seq., and the Federal Food, Drug and Cosmetic Act.
`
`3.
`
`Subject matter jurisdiction in this Court is proper under, among other things, 28
`
`U.S.C. §§ 1331 and 1338.
`
`4.
`
`Hospira is a Delaware corporation with its principal place of business at 275 North
`
`Field Drive, Lake Forest, Illinois 60045.
`
`
`
`Case 1:18-cv-00303-RGA Document 52 Filed 09/28/18 Page 2 of 11 PageID #: 1076
`
`5.
`
`Orion is a corporation organized under the laws of Finland, with its principal place
`
`of business at Orionintie IA, FI-02200 Espoo, Finland.
`
`6.
`
`On information and belief, Baxter Healthcare Corporation is a corporation
`
`incorporated in Delaware with its principal place of business at One Baxter Parkway, Deerfield,
`
`IL 60015.
`
`7.
`
`This Court has personal jurisdiction over Baxter because, among other things,
`
`Baxter is incorporated in this District and Baxter has submitted to the jurisdiction of this Court by
`
`filing its Complaint with this Court.
`
`8.
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400 because, among
`
`other things, Baxter is incorporated in this District and selected this venue by filing its Complaint
`
`with this Court.
`
`The ‘867 Patent
`
`9.
`
`The ‘867 patent, entitled “Use of Dexmedetomidine for ICU Sedation,” was duly
`
`and legally issued by the USPTO on April 6, 2004.
`
`10.
`
`Hospira and Orion are co-assignees of the ‘867 patent and share ownership of the
`
`patent.
`
`11.
`
`Hospira is the holder of New Drug Application (“NDA”) No. 21-038 for
`
`dexmedetomidine hydrochloride injection, sold in the United States under the trademark
`
`PRECEDEX®. The United States Food and Drug Administration (“FDA”) originally approved
`
`NDA No. 21-038 on December 17, 1999.
`
`12.
`
`The ‘867 patent is duly listed in the Orange Book as covering PRECEDEX®. The
`
`claims of the ‘867 patent cover various methods of using PRECEDEX®.
`
`Count I: Infringement Of The ‘867 Patent
`
`13.
`
`Defendants re-allege herein the foregoing paragraphs of their Counterclaim.
`
`
`
`2
`
`
`
`Case 1:18-cv-00303-RGA Document 52 Filed 09/28/18 Page 3 of 11 PageID #: 1077
`
`14.
`
`On information and belief, Celerity Pharmaceuticals, LLC (“Celerity”) submitted
`
`ANDA No. 208532 to the FDA to seek approval to engage in the commercial manufacture, use,
`
`offer for sale, sale, and/or importation into the United States of its generic dexmedetomidine
`
`hydrochloride in 0.9% sodium chloride injection, 200 mcg/50 mL and 400 mcg/100 mL (“Baxter
`
`ANDA Product”) prior to the expiry of the ‘867 patent.
`
`15.
`
`16.
`
`Celerity was aware of the ‘867 patent when it submitted its ANDA.
`
`On information and belief, Baxter has assumed all rights and responsibilities with
`
`respect to ANDA No. 208532.
`
`17.
`
`The ‘867 patent covers, among other things, a method of sedating a patient in an
`
`intensive care unit comprising administering
`
`to
`
`the patient an effective amount of
`
`dexmedetomidine or a pharmaceutically acceptable salt thereof, wherein the patient remains
`
`arousable and orientated.
`
`18.
`
`Celerity was not required by the FDA to maintain a Paragraph IV Certification as
`
`to the ‘867 patent because its ANDA did not seek approval for the Precedex® indication that
`
`covers “sedation of initially intubated and mechanically ventilated patients during treatment in an
`
`intensive care setting.”
`
`19.
`
`However, on information and belief, while Baxter’s ANDA omits this indication,
`
`Baxter knows that its product will be used for this indication, which keeps ICU patients arousable
`
`and orientated. Medical professionals use dexmedetomidine drug products for this indication even
`
`when the drug products are not approved by the FDA for the indication.
`
`20. Moreover, on information and belief, Baxter’s ANDA seeks approval to market the
`
`Baxter ANDA Product for the Precedex® indication of “sedation of non-intubated patients prior
`
`
`
`3
`
`
`
`Case 1:18-cv-00303-RGA Document 52 Filed 09/28/18 Page 4 of 11 PageID #: 1078
`
`to and/or during surgical and other procedures.” Such sedation often occurs in an intensive care
`
`unit, and allows the patient to remain arousable and orientated.
`
`21.
`
`Therefore, the Baxter ANDA seeks approval to market the Baxter ANDA Product
`
`for uses covered by the ‘867 patent.
`
`22.
`
`By submitting this ANDA, Baxter committed an act of infringement under 35
`
`U.S.C. § 271(e)(2).
`
`23. Moreover, on information and belief, at least as early as August 28, 2018, Baxter
`
`began to manufacture, sell, offer for sale, and/or import in to the United States its Baxter ANDA
`
`Product, which constitutes an act of infringement under 35 U.S.C. § 271(b) and/or (c). See e.g.,
`
`http://ecatalog.baxter.com/ecatalog/loadproduct.html?cid=20016&lid=10001&hid=20001&pid=
`
`982028;
`
`http://ecatalog.baxter.com/ecatalog/loadproduct.html?cid=20016&lid=10001&hid=20001&pid=
`
`982026, attached hereto as Exhibit A.
`
`24.
`
`Baxter’s actions and conduct will encourage direct infringement of the ‘867 patent
`
`by others.
`
`25.
`
`On information and belief, Baxter acted despite an objectively high likelihood that
`
`its actions constituted infringement of a valid patent. Further, on information and belief, Baxter
`
`actually knew or should have known that its actions constituted infringement of a valid patent.
`
`Baxter’s infringement is therefore willful.
`
`26.
`
`Defendants will be irreparably harmed if Baxter is not enjoined from infringing the
`
`‘867 patent.
`
`
`
`4
`
`
`
`Case 1:18-cv-00303-RGA Document 52 Filed 09/28/18 Page 5 of 11 PageID #: 1079
`
`27.
`
`Baxter’s commercial manufacture, use, sale, offer for sale, and/or importation in to
`
`the United States prior to the termination of the exclusivity period of the ‘867 patent will cause
`
`Defendants injury, entitling Defendants to damages, including lost profits.
`
`Defendants’ Prayer for Relief
`
`WHEREFORE, Defendants respectfully request that this Court enter a Judgment and Order:
`
`A. Decreeing that any commercial manufacture, use, sale, offer for sale, and/or
`
`importation into the United States of the Baxter ANDA Product prior to the expiration of the ‘867
`
`patent, including regulatory extensions, will infringe the ‘867 patent;
`
`B. Entering a preliminary and permanent injunction pursuant to 35 U.S.C. §§
`
`271(e)(4) and 283 restraining Baxter and any entity acting in privity therewith from engaging in
`
`the commercial manufacture, use, offer for sale, sale, and/or importation into the United States of
`
`the Baxter ANDA product, or any product not colorably different therefrom, until the expiration
`
`of the ‘867 patent, including regulatory extensions; and
`
`C. Award Defendants damages or other monetary relief adequate to compensate
`
`Baxter’s infringement, together with prejudgment and post-judgment interest and costs in
`
`accordance with 35 U.S.C. § 284;
`
`D. Find that Baxter’s infringement has been willful and treble the damages awarded
`
`to Defendants under 35 U.S.C. § 284;
`
`E. Perform an accounting of Baxter’s infringing activities through trial and judgment;
`
`and
`
`
`
`
`
`F. Such other relief as the Court deems proper.
`
`Demand for Jury Trial
`
`Defendants demand a jury trial on all issues so triable.
`
`5
`
`
`
`Case 1:18-cv-00303-RGA Document 52 Filed 09/28/18 Page 6 of 11 PageID #: 1080
`
`Dated: September 27, 2018
`
`CONNOLLY GALLAGHER LLP
`
`
`
`/s/ Arthur G. Connolly, III
`Arthur G. Connolly, III (#2667)
`Ryan P. Newell (#4744)
`The Brandywine Building
`1000 West Street, Suite 1400
`Wilmington, DE 19801
`302) 757-7300
`aconnolly@connollygallagher.com
`rnewell@connollygallagher.com
`
`Attorneys for Defendants
`Hospira, Inc. and Orion Corp.
`
`6
`
`
`
`
`
`
`
`Case 1:18-cv-00303-RGA Document 52 Filed 09/28/18 Page 7 of 11 PageID #: 1081
`Case 1:18—cv—00303-RGA Document 52 Filed 09/28/18 Page 7 of 11 PageID #: 1081
`
`EXHIBIT A
`
`EXHIBIT A
`
`
`
`Product Catalog
`Page 1 of 2
`Case 1:18-cv-00303-RGA Document 52 Filed 09/28/18 Page 8 of 11 PageID #: 1082
`
`United States
`
`Dexmedetomidine Hydrochloride 4 mcg/mL in 0.9% Sodium
`Chloride injection (200 mcg/50 mL). Liquid Premix.
`SKU: 2G3496
`
`Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride injection, 200
`mcg/50 mL (4 mcg/mL) in GALAXY Plastic Container. Liquid Premix. NDC
`0338-9555-24. Please refer to full Prescribing Information
`
`Product Characteristics
`Trademark:
`
`Container Type:
`Volume:
`Dosage Form:
`Diluent:
`Strength:
`Concentration:
`Shelf Life from manufacture:
`Contains Preservative:
`Storage Recommendations:
`
`Rx Only:
`Package Insert Link:
`
`Carton
`Length:
`Width:
`Height:
`Volume:
`Weight:
`Pack Factor:
`
`Galaxy is a trademark of Baxter International Inc., or
`its subsidiaries.
`GALAXY
`50 ML
`Liquid
`Sodium Chloride
`200 mcg/50 mL
`4 mcg/mL
`21 months
`No
`Store at 20° to 25°C (68° to 77°F)[See USP Controlled
`Room Temperature]. Discard unused portion.
`Yes
`baxterpi.com/pi-pdf/Dexme(..)
`
`11.94 IN
`5.88 IN
`2.5 IN
`0.1 FC
`3.33 LB
`24
`
`http://ecatalog.baxter.com/ecatalog/loadproduct.html?cid=20016&lid=10001&hid=20001...
`
`9/27/2018
`
`
`
`Product Catalog
`Page 2 of 2
`Case 1:18-cv-00303-RGA Document 52 Filed 09/28/18 Page 9 of 11 PageID #: 1083
`
`Reimbursement Information
`NDC Outer
`HCPCS Code
`J3490
`A4216
`
`0338955524
`HCPCS Descriptor
`Unclassified Drugs
`Sterile Water, Saline and/or Dextrose, Diluent/Flush,
`10mL
`888-338-0001
`
`Medication Delivery Reimbursement
`Hotline
`Information Source: CMS
`Disclaimer: The coverage, coding, and payment information included in this guide has been compiled from various
`resources for informational use as a tool to assist providers with reimbursement issues. This information is current as of
`3/31/2008; however this information is subject to change and should not be construed as legal advice. Providers should
`exercise independent clinical judgment when selecting codes and submitting claims to accurately reflect services
`rendered to individual patients. Baxter Healthcare Corporation does not guarantee success in obtaining insurance
`payments. Providers are encouraged to contact third-party payors for specific information on their coverage, coding, and
`payment policies.
`
`Ordering information
`Baxter Product Code:
`UPN/GTIN CS Unit:
`UPN/GTIN EA Unit:
`National Drug Code:
`Unit of Measure:
`
`2G3496
`50303389555242
`00303389555247
`0338955524
`CA
`
`© 2018 Baxter. All rights reserved.
`
`http://ecatalog.baxter.com/ecatalog/loadproduct.html?cid=20016&lid=10001&hid=20001...
`
`9/27/2018
`
`
`
`Product Catalog
`Page 1 of 2
`Case 1:18-cv-00303-RGA Document 52 Filed 09/28/18 Page 10 of 11 PageID #: 1084
`
`United States
`
`Dexmedetomidine Hydrochloride 4 mcg/mL in 0.9% Sodium
`Chloride injection (400 mcg/100 mL). Liquid Premix.
`SKU: 2G3497
`
`Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride injection, 400
`mcg/100 mL (4 mcg/mL) in GALAXY Plastic Container. Liquid Premix.
`NDC 0338-9557-12. Please refer to full Prescribing Information
`
`Product Characteristics
`Trademark:
`
`Container Type:
`Volume:
`Dosage Form:
`Diluent:
`Strength:
`Concentration:
`Shelf Life from manufacture:
`Contains Preservative:
`Storage Recommendations:
`
`Rx Only:
`Package Insert Link:
`
`Carton
`Length:
`Width:
`Height:
`Volume:
`Weight:
`Pack Factor:
`
`Galaxy is a trademark of Baxter International Inc., or
`its subsidiaries.
`GALAXY
`100 ML
`Liquid
`Sodium Chloride
`400 mcg/100 mL
`4 mcg/mL
`21 months
`No
`Store at 20° to 25°C (68° to 77°F)[See USP Controlled
`Room Temperature]. Discard unused portion.
`Yes
`baxterpi.com/pi-pdf/Dexme(..)
`
`11.94 IN
`5.88 IN
`2.5 IN
`0.1 FC
`3.33 LB
`12
`
`http://ecatalog.baxter.com/ecatalog/loadproduct.html?cid=20016&lid=10001&hid=20001...
`
`9/27/2018
`
`
`
`Product Catalog
`Page 2 of 2
`Case 1:18-cv-00303-RGA Document 52 Filed 09/28/18 Page 11 of 11 PageID #: 1085
`
`Reimbursement Information
`NDC Outer
`HCPCS Code
`J3490
`A4216
`
`0338955712
`HCPCS Descriptor
`Unclassified Drugs
`Sterile Water, 0.9% Sodium Chloride and/or Dextrose
`Diluent/Flush, 10mL
`888-338-0001
`
`Medication Delivery Reimbursement
`Hotline
`Information Source: CMS
`Disclaimer: The coverage, coding, and payment information included in this guide has been compiled from various
`resources for informational use as a tool to assist providers with reimbursement issues. This information is current as of
`3/31/2008; however this information is subject to change and should not be construed as legal advice. Providers should
`exercise independent clinical judgment when selecting codes and submitting claims to accurately reflect services
`rendered to individual patients. Baxter Healthcare Corporation does not guarantee success in obtaining insurance
`payments. Providers are encouraged to contact third-party payors for specific information on their coverage, coding, and
`payment policies.
`
`Ordering information
`Baxter Product Code:
`UPN/GTIN CS Unit:
`UPN/GTIN EA Unit:
`National Drug Code:
`Unit of Measure:
`
`2G3497
`50303389557123
`00303389557128
`0338955712
`CA
`
`© 2018 Baxter. All rights reserved.
`
`http://ecatalog.baxter.com/ecatalog/loadproduct.html?cid=20016&lid=10001&hid=20001...
`
`9/27/2018
`
`
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