Case 1:14-cv-07094-JBS-JS Document 1 Filed 11/12/14 Page 1 of 16 PageID: 1
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`LAW OFFICES
`DECHERT LLP
`A PENNSYLVANIA LIMITED LIABILITY PARTNERSHIP
`902 CARNEGIE CENTER, SUITE 500
`PRINCETON, NEW JERSEY 08540-6531
`(609) 955-3200
`ATTORNEYS FOR PLAINTIFFS BAXTER HEALTHCARE CORPORATION,
`BAXTER INTERNATIONAL INC., AND BAXTER HEALTHCARE S.A.
`
`
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`BAXTER HEALTHCARE
`CORPORATION, BAXTER
`INTERNATIONAL INC., and
`BAXTER HEALTHCARE S.A.,
`
`Plaintiffs,
`
`v.
`
`C.A. No.
`
`
`
`
`
`
`
`
`
`
`AGILA SPECIALTIES PRIVATE
`LIMITED, AGILA SPECIALTY INC.,
`AGILA SPECIALTIES INC. F/K/A/
`STRIDES INC., MYLAN INC.,
`MYLAN PHARMACEUTICALS INC.,
`MYLAN INSTITUTIONAL INC., and
`MYLAN INSTITUTIONAL LLC.,
`
`
`
`Defendants.
`
`
`
`COMPLAINT
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`Plaintiffs Baxter Healthcare Corporation (“Baxter Healthcare”), Baxter International Inc.
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`(“Baxter International”), and Baxter Healthcare S.A. (“Baxter HSA”) (collectively, “Baxter” or
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`“Plaintiffs”), for their Complaint against defendants Agila Specialties Private Limited, Agila
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`Specialty Inc., and Agila Specialties Inc. (collectively “Agila” or the “Agila Defendants”), and
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`Mylan Inc., Mylan Pharmaceuticals Inc., Mylan Institutional Inc., and Mylan Institutional LLC
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`
`
`MYLAN ET AL. - EXHIBIT 1027
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`Case 1:14-cv-07094-JBS-JS Document 1 Filed 11/12/14 Page 2 of 16 PageID: 2
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`(collectively “Mylan” or the “Mylan Defendants”) (collectively with Agila, the “Defendants”),
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`allege as follows:
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`PARTIES
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`1.
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`Plaintiff Baxter International is a corporation incorporated in Delaware, having its
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`principal place of business at One Baxter Parkway, Deerfield, IL 60015.
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`2.
`
`Plaintiff Baxter Healthcare is a corporation incorporated in Delaware, having its
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`principal place of business at One Baxter Parkway, Deerfield, IL 60015. Baxter Healthcare is a
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`wholly owned subsidiary of Baxter International.
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`3.
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`Plaintiff Baxter HSA is a corporation incorporated in Switzerland, having its
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`principal place of business at Hertistrasse 2, Wallisellen, CH-8304, Switzerland. Baxter HSA is
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`a wholly owned subsidiary of Baxter International.
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`4.
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`Baxter is a global healthcare company that develops, manufactures and markets
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`products for people with hemophilia, immune disorders, infectious diseases, kidney disease,
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`trauma, and other chronic and acute medical conditions.
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`5.
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`Upon information and belief, defendant Mylan Inc. is a corporation incorporated
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`in Pennsylvania, having its principal place of business at 1000 Mylan Blvd. Canonsburg, PA
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`15317. Mylan touts itself as one of the world’s leading generics and specialty pharmaceutical
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`companies, with sales in approximately 140 countries and territories and providing medicine to
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`7 billion people worldwide.
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`6.
`
`Upon information and belief, defendant Agila Specialties Private Limited is a
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`wholly owned subsidiary of Mylan Inc., and is a corporation organized and operating under the
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`laws of India with its principal place of business at Strides House, Bilekahalli, Bannerghatta
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`Road, Bangalore—560076, Karnataka, India, or elsewhere in India.
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`7.
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`Upon information and belief, to the extent it exists (see ¶ 47 below), defendant
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`Agila Specialty Inc. is a wholly owned subsidiary of Mylan Inc., having offices at 781 Chestnut
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`Ridge Road, Morgantown, WV 26505 and is designated by Agila Specialties Private Limited as
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`its U.S. agent. Upon information and belief, Agila Specialty Inc. is not a West Virginia
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`corporation or registered to do business in West Virginia.
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`8.
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`Upon information and belief, defendant Agila Specialties Inc. (formerly known as
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`Strides Inc.) is a wholly owned subsidiary of Mylan Inc., and is a corporation incorporated in
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`New Jersey with its principal place of business at 201, South Main Street, Suite 3, Lambertville,
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`NJ 08530. Agila Specialties Inc. is registered with the State of New Jersey Division of Revenue
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`and Enterprise Services (Entity ID 0100791546).
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`9.
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`The Agila Defendants are pharmaceutical companies engaged in the world-wide
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`development, manufacture, and marketing of generic injectable products.
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`10.
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`Upon information and belief, defendant Mylan Pharmaceuticals Inc. is a wholly
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`owned subsidiary of Mylan Inc., and is a corporation incorporated in West Virginia, having its
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`principal place of business at 781 Chestnut Ridge Road, Morgantown, WV 26505.
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`11.
`
`Upon information and belief, defendant Mylan Pharmaceuticals Inc. is primarily
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`responsible for the marketing, distribution and sales of Mylan Inc.’s products.
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`12.
`
`Upon information and belief, Mylan Institutional Inc. is a corporation
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`incorporated in Illinois and whose registered office is at 1718 Northrock Court, Rockford, IL
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`61103.
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`13.
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`Upon information and belief, defendant Mylan Institutional LLC is a limited
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`liability corporation incorporated in Delaware with a principal place of business at 4901
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`Hiawatha Dr., Rockford, IL 61103.
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`14.
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`Upon information and belief, defendants Mylan Institutional Inc. and Mylan
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`Institutional LLC are primarily responsible for the marketing, distribution, sales and packaging
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`of Mylan Inc.’s products to Mylan’s institutional customers, such as hospitals.
`
`NATURE OF ACTION
`
`15.
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`This is an action for infringement of United States Patent Nos. 6,310,094 (“the
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`‘094 Patent”) and 6,528,540 (“the ‘540 Patent”) (collectively, “the Patents-in-Suit”). This action
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`is based upon the Patent Laws of the United States, 35 U.S.C. § 100, et seq.
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`JURISDICTION AND VENUE
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`16.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. §§ 1331 and 1338(a) (patent infringement). Venue is proper in this district pursuant to 28
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`U.S.C. §§ 1391(b), 1391(c) and 1400(b).
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`17.
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`This Court has personal jurisdiction over Defendants because, inter alia, they
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`have committed – or aided, abetted, planned, contributed to, or participated in the commission
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`of – tortious conduct which will lead to foreseeable harm and injury to Baxter in the State of
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`New Jersey, and in doing so, Defendants have purposefully directed their activities at the
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`residents of this forum.
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`18.
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`This Court also has personal jurisdiction over Defendants because, inter alia, they
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`have maintained continuous and systematic contacts with the State of New Jersey and this
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`District.
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`19.
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`Upon information and belief, Defendants collaborate to market and sell generic
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`pharmaceutical products, pursuant to the abbreviated new drug application process, throughout
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`the United States, including in the State of New Jersey, at least by making and shipping into this
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`judicial district, or by offering to sell or selling, or causing others to offer to sell or sell, generic
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`pharmaceutical products. Defendants derive substantial revenue from goods used or consumed
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`or services rendered in this judicial district.
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`20. Mylan is in the business of making and selling pharmaceutical drug products,
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`including generic drug products. Upon information and belief, Mylan Inc., directly or through its
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`subsidiaries including through Agila and the other Mylan Defendants, manufactures, imports,
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`markets and sells generic drugs throughout the United States and in this judicial district.
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`21. Mylan Inc.’s 10-K claims, for instance, that Mylan holds the number one ranking
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`in the U.S. generics prescription market in terms of sales, and number two ranking in terms of
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`prescriptions dispensed. The10-K further states that approximately one in every 12 prescriptions
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`dispensed in the U.S. is a Mylan product. Upon information and belief, Mylan Inc. derives
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`revenue from its operations in New Jersey and is registered with the State of New Jersey
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`Division of Revenue and Enterprise Services (Entity ID 0100971292).
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`22. Mylan acquired Agila from Strides Arcolabes Limited in December 2013. In its
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`promotional materials, Mylan claims that as a result of its acquisition of Agila, Mylan now
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`commands one of the largest portfolios of injectable medications in the pharmaceutical industry,
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`and that Mylan now has an expanded focus on essential therapies including cardiovascular
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`treatments, as well as expanded manufacturing infrastructure and capabilities.
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`23. Mylan, Inc.’s 10-K similarly states that the acquisition of Agila doubles Mylan’s
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`injectables portfolio, including in the U.S. market and this judicial district.
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`24.
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`Upon information and belief, Agila has over 80 abbreviated new drug applications
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`approved by the FDA and more than 100 filed applications pending FDA approval. The FDA
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`approved products for which Agila Specialties Private Limited is listed as the applicant holder
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`and manufacturer include Adenosine, Ampicillin Sodium, Ampicillin Sodium/Sulbactam
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`Sodium, Haloperidol Decanoate, Ketorolac Tromethamine, Lidocaine Hydrochloride, MESNA,
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`Oxacillin Sodium, Piperacillin Sodium/Tazobactam Sodium, Sumatriptan Succinate,
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`Vancomycin Hydrochloride, and Zoledronic Acid. See, e.g.,
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`http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. Upon information and belief, these
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`products are sold throughout the United States, including in this judicial district.
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`25.
`
`Upon information and belief, Defendants operate as a single vertically integrated
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`business with respect to the regulatory approval, manufacturing, marketing, sale and distribution
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`of generic pharmaceutical products throughout the U.S. including in this judicial district. See
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`e.g., www.mylan.com/company/about-us.
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`26.
`
`For example, Mylan, through its subsidiary Mylan Pharmaceuticals Inc.,
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`manufactures, markets, sells and distributes generic pharmaceutical products approved by the
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`FDA including the products Rabeprazol Sodium and Voriconazole. Upon information and
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`belief, Mylan Pharmaceuticals Inc., derives revenue from its operations in New Jersey and is
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`registered with the State of New Jersey Division of Revenue and Enterprise Services (Entity ID
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`4302546711).
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`27.
`
`Similarly, upon information and belief, Mylan, through its subsidiary Mylan
`
`Institutional LLC, manufactures, markets, sells, packages and distributes generic pharmaceutical
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`products approved by the FDA (including, for example, Esmolol Hydrochloride Injection;
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`Cidofovir Injection, solution; Cosyntropin Injection, powder, for solution; Dexrazoxane
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`Hydrochloride; and Fomepizole Injection, solution) to Mylan’s institutional customers. Upon
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`information and belief, Mylan Institutional LLC derives revenue from its operations in New
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`Jersey.
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`28.
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`In addition, upon information and belief, Mylan, through its subsidiary Mylan
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`Institutional Inc., manufactures, markets, sells, packages, and distributes institutional generic
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`pharmaceutical products. Mylan Institutional Inc. is registered with the State of New Jersey
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`Division of Revenue and Enterprise Services (Entity ID 4302546711).
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`29.
`
`Upon information and belief, Defendants intend to manufacture for distribution
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`and distribute and sell generic equivalents of Baxter’s BREVIBLOC® products in 10 mg/ml (250
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`mg) and 20 mg/ml (100 mg/ml) infusion bags (see description below of Defendants’ ANDA
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`relating to these products) throughout the United States and in this judicial district.
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`30.
`
`Upon information and belief, Defendants have previously submitted to and
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`availed themselves of the jurisdiction of this Court for patent infringement suits. See, e.g.,
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`Warner Chilcott Laboratories Ireland Limited et al. v. Mylan Pharmaceuticals Inc. et al., 2:09-
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`cv-02073-WJM-MF; Pfizer Inc. et al. v. Mylan Inc. et al., 2:10-cv-03246-DMC-JAD; Janssen
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`Pharmaceuticals Inc. v. Mylan Inc. et al., 2:10-cv-06018-SRC-CLW, Novartis Pharma et al. v.
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`Akorn, Inc., et. al., 2:13-cv-05125-SDW-MCA.
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`THE DRUG APPROVAL PROCESS
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`31.
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`A company seeking to market a new pharmaceutical drug in the United States
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`must first obtain approval from FDA, typically through the filing of a New Drug Application
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`(“NDA”). See 21 U.S.C. §355(a). The sponsor of the NDA is required to submit information on
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`all patents claiming the drug that is the subject of the NDA, or a method of using that drug, to
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`FDA, and FDA then lists such patent information in its publication, the Approved Drug Products
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`with Therapeutic Equivalence Evaluations, which is referred to as the “Orange Book.” See 21
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`U.S.C. §355(b)(1) and (c)(2).
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`32.
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`On the other hand, a company seeking to market a generic version of a previously
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`approved drug is not required to submit a full NDA. Instead, it may file an Abbreviated New
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`Drug Application (“ANDA”). See 21 U.S.C. §355(j). The generic drug approval process is
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`considered “abbreviated” because the generic manufacturer may piggyback on the innovator
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`company’s data and FDA’s prior finding of safety and efficacy by demonstrating, among other
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`things, that the generic product is bioequivalent to the previously approved drug (the “listed
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`drug” or “branded drug”).
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`33.
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`In conjunction with this “abbreviated” application process, Congress has put in
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`place a process for resolving patent disputes relating to generic drugs, pursuant to which an
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`ANDA filer must provide certifications addressing each of the patents listed in the Orange Book
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`for the branded drug. See 21 U.S.C. § 355(j)(2)(A)(vii); 21 C.F.R. § 314.94(a)(12). An ANDA
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`filer may certify, for instance, that it believes a patent is invalid or will not be infringed by the
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`manufacture, use, or sale of the generic drug for which the ANDA is submitted. See 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV); 21 C.F.R. § 314.94(a)(12)(i)(A)(4). This is known as a “Paragraph IV
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`Certification.”
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`34.
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`The filer of an ANDA with a Paragraph IV Certification must also provide notice
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`to both the owners of the listed patents and the holder of the NDA for the referenced listed drug.
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`This “Paragraph IV Notice” must include a detailed statement of the factual and legal bases for
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`the applicant’s belief that the challenged patent is invalid or not infringed by the proposed
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`generic product. 21 U.S.C. § 355(j)(2)(B); 21 C.F.R. §314.95.
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`35.
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`If the patentee or NDA holder files a patent infringement action within 45 days of
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`receiving a Paragraph IV Notice from an ANDA filer, final approval of the ANDA is generally
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`subject to a 30-month stay. See 21 U.S.C. § 355(j)(5)(B)(iii); 21 C.F.R. § 314.107(b)(3). The
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`30-month stay is important to the innovator companies because it protects them from the severe
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`financial harm that could otherwise ensue from the FDA granting approval to a potentially
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`infringing product without first providing an opportunity for the infringement case to be
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`resolved. Put another way, the innovator company is assured of a 30-month period during which
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`in may try to enforce its intellectual property rights and resolve any patent dispute before the
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`generic product enters the market. See 21 U.S.C. § 355(j)(5)(B)(iii).
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`FACTUAL BACKGROUND
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`36.
`
`On October 30, 2001, the United States Patent and Trademark Office (“PTO”)
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`duly and legally issued the ‘094 Patent, entitled “Ready-to-Use Esmolol Solution,” to Baxter
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`International as assignee. A true and correct copy of the ‘094 Patent is attached as Exhibit A.
`
`37.
`
`On March 4, 2003, the PTO duly and legally issued the ‘540 Patent, entitled
`
`“Esmolol Formulation,” to Baxter International as assignee. A true and correct copy of the ‘540
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`Patent is attached as Exhibit B.
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`38.
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`Baxter International and Baxter HSA are the owners of the ‘094 Patent and the
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`‘540 Patent.
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`39.
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`On February 16, 2001, the FDA approved Baxter Healthcare’s supplemental NDA
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`No. 19-386/S-018 for BREVIBLOC® Premixed Injection (esmolol HCl in sodium chloride) in
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`2500mg/250mL IntraVia Containers, under § 505(b) of the Federal Food, Drug and Cosmetic
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`Act, 21 U.S.C. § 355(b).
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`40.
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`On January 27, 2003, the FDA approved Baxter Healthcare’s supplemental NDA
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`No. 19-386/S-020 for BREVIBLOC® Double Strength Premixed Injection (esmolol
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`hydrochloride) 20 mg/mL in 100 mL Containers, under § 505(b) of the Federal Food, Drug and
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`Cosmetic Act, 21 U.S.C. § 355(b) (collectively with the above BREVIBLOC® Premixed
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`Injection (2500mg/250mL IntraVia Containers), “BREVIBLOC® Premixed Injection Products”).
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`41.
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`The BREVIBLOC® Premixed Injection Products are indicated, among other
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`things, for the rapid control of the heart rate in patients with atrial fibrillation or atrial flutter in
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`perioperative, postoperative, or other emergent circumstances where short term control of the
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`heart rate with a short-acting agent is desirable.
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`42.
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`Baxter Healthcare is the holder of the NDAs for each of the BREVIBLOC®
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`Premixed Injection Products. It makes and sells the BREVIBLOC® Premixed Injection
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`Products to hospitals and other healthcare providers, by exclusive license under the Patents-in-
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`Suit, throughout the United States.
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`43.
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`Plaintiffs jointly own all rights, title and interest in the Patents-in-Suit, including
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`all rights needed to bring this action in Plaintiffs’ names.
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`44.
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`Baxter Healthcare submitted information regarding the ‘094 and ‘540 Patents to
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`the FDA for listing in the “Orange Book” with respect to the BREVIBLOC® Premixed Injection
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`Products. The FDA thereafter listed the ‘094 and ‘540 Patents in the Orange Book with respect
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`to those products, pursuant to 21 C.F.R. § 314.53(e).
`
`45.
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`Upon information and belief, prior to September 30, 2014, Defendants submitted
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`to the FDA Abbreviated New Drug Application Number 206608 (the “ANDA”) pursuant to 35
`
`U.S.C. § 355(j), seeking approval to engage in the commercial manufacture, use, and sale of
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`proposed Esmolol Hydrochloride in Sodium Chloride Solution products in dosages of 10mg/ml
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`(250 mg) and 20 mg/ml (100 mg/ml) (collectively, the “Proposed ANDA Products”), referencing
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`versions of Baxter’s BREVIBLOC® in plastic container and BREVIBLOC® double strength in
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`plastic container products.
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`46.
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`On or about September 30, 2014, Defendants sent Baxter Healthcare and Baxter
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`International a notice stating that Agila Specialties Private Limited had submitted ANDA No.
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`206608 seeking approval to manufacture, use, or sell the Proposed ANDA Products prior to the
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`expiration of the ‘094 Patent and the ‘540 Patent (the “Paragraph IV Notice”). The Paragraph IV
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`Notice was written on Mylan letterhead, identified Agila Specialties Private Limited as a “Mylan
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`Company”, and was signed by Samir Patel, VP Global IP Operations of Mylan.
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`47.
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`The Paragraph IV Notice also specifically identified Agila Specialty Inc. as U.S.
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`agent for Agila Specialties Private Limited. Baxter has investigated the corporate status of Agila
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`Specialty Inc., but has been unable to locate any records regarding the place of incorporation,
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`locations of any offices, or corporate existence of Agila Specialty Inc. Upon information and
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`belief, Agila Specialty Inc. may not exist, and the reference in the Paragraph IV Notice may have
`
`been intended to refer instead to Agila Specialties Inc., which as noted above is a New Jersey
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`corporation with its principal place of business in New Jersey.
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`48.
`
`The Paragraph IV Notice advised Baxter that Defendants’ ANDA included a
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`Paragraph IV Certification stating that it was Defendants’ opinion that the ‘094 and ‘540 patents
`
`are not valid. That Notice did not include any assertion that Defendants’ proposed products
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`would not infringe the claims of those patents.
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`49.
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`On October 29, 2014, Baxter sent Defendants’ a letter seeking confirmation that
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`their products, if approved by the FDA and sold by Defendants in the U.S., would infringe the
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`‘094 and ‘540 patents, or alternatively requesting Defendants provide Baxter with a detailed
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`statement for the basis of any non-infringement contentions, along with confidential access to the
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`ANDA. To date, however, Defendants have not responded to that letter and have not provided
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`access to any portion of the ANDA.
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`COUNT I
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`INFRINGEMENT OF THE ‘094 PATENT
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`50.
`
`Baxter incorporates each of the preceding paragraphs 1 to 49 as if fully set forth
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`herein.
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`51.
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`Defendants’ submission of ANDA No. 206608 to the FDA, including the
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`Paragraph IV Certification submitted therewith, which seeks FDA approval to engage in the
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`commercial manufacture, use, and sale of Proposed ANDA Products prior to the expiration of
`
`the ‘094 Patent, constitutes infringement of the ‘094 Patent under 35 U.S.C. § 271(e)(2)(A).
`
`52.
`
`Upon FDA approval of ANDA No. 206608, Defendants will directly or indirectly
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`infringe the ‘094 Patent under 35 U.S.C. § 271(a), (b) and/or (c) by engaging in the commercial
`
`manufacture, use, offer for sale, sale in and/or importation into the United States of the ANDA
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`Products, and/or by actively inducing and contributing to infringement of others engaging in
`
`such activities, unless this Court orders that the effective date of any FDA approval of
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`Defendants’ ANDA is no earlier than the expiration date of the ‘094 Patent and any additional
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`periods of exclusivity.
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`53.
`
`Baxter has no adequate remedy at law for Defendants’ infringement of the ‘094
`
`Patent, and will be substantially and irreparably harmed by any such infringing activities unless
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`those activities are enjoined by this Court.
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`54.
`
`Upon information and belief, Defendants were aware of the existence of the ‘094
`
`Patent as demonstrated by their reference to that patent in their ANDA, and were aware that the
`
`filing of their Paragraph IV Certification with respect to the ‘094 Patent constitutes infringement
`
`of that patent. This is an exceptional case within the meaning of 35 U.S.C. § 285.
`
`COUNT II
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`INFRINGEMENT OF THE ‘540 PATENT
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`55.
`
`Baxter incorporates each of the preceding paragraphs 1 to 49 as if fully set forth
`
`herein.
`
`56.
`
`Defendants’ submission of ANDA No. 206608 to the FDA, including the
`
`Paragraph IV Certification submitted therewith, which seeks FDA approval to engage in the
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`commercial manufacture, use, and sale of Proposed ANDA Products prior to the expiration of
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`the ‘540 Patent, constitutes infringement of the ‘540 Patent under 35 U.S.C. § 271(e)(2)(A).
`
`57.
`
`Upon FDA approval of Defendants’ ANDA No. 206608, Defendants will directly
`
`or indirectly infringe the ‘540 Patent under 35 U.S.C. § 271(a), (b) and/or (c) by engaging in the
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`commercial manufacture, use, offer for sale, sale in and/or importation into the United States of
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`the Proposed ANDA Products, and/or by actively inducing and contributing to infringement of
`
`others engaging in such activities, unless this Court orders that the effective date of any FDA
`
`approval of Defendants’ ANDA is no earlier than the expiration date of the ‘540 Patent and any
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`additional periods of exclusivity.
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`58.
`
`Baxter has no adequate remedy at law for Defendants’ infringement of the ‘540
`
`Patent, and will be substantially and irreparably harmed by any such infringing activities unless
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`those activities are enjoined by this Court.
`
`59.
`
`Upon information and belief, Defendants were aware of the existence of the ‘540
`
`Patent as demonstrated by their reference to that patent in its ANDA, and were aware that the
`
`filing of their Paragraph IV Certification with respect to the ‘540 Patent constitutes infringement
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`of that patent. This is an exceptional case within the meaning of 35 U.S.C. § 285.
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`PRAYER FOR RELIEF
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`WHEREFORE, Baxter respectfully requests the following relief:
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`A. A judgment that, pursuant to 35 U.S.C. § 271(e)(2)(A), Defendants have infringed
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`the ‘094 Patent;
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`B. A judgment that, pursuant to 35 U.S.C. § 271(e)(2)(A), Defendants have infringed
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`the ‘540 Patent;
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`C. A declaration that Defendants’ commercial manufacture, use, offer for sale, sale
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`in or importation into the United States of the Proposed ANDA Products would infringe the ‘094
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`Case 1:14-cv-07094-JBS-JS Document 1 Filed 11/12/14 Page 14 of 16 PageID: 14
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`Patent;
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`D. A declaration that Defendants’ commercial manufacture, use, offer for sale, sale
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`in or importation into the United States of its Proposed ANDA Products would infringe the ‘540
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`Patent;
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`E. An order, pursuant to 35 U.S.C. § 271(e)(4)(A), that the effective date of any
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`approval of Defendants’ ANDA No. 206608 and/or of the Proposed ANDA Products shall not be
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`earlier than the expiration date of the ‘094 and ‘540 Patents, including any extensions;
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`F. A permanent injunction, pursuant to 35 U.S.C. § 271(e)(4)(B), restraining and
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`enjoining Defendants, their officers, agents, servants and employees, and those persons in active
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`concert or participation with any of them, from infringement of the ‘094 and ‘540 Patents for the
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`full terms thereof (including any extensions), including without limitation, enjoining such
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`persons from commercially making, using, selling, or offering to sell any of the Proposed ANDA
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`Products within the United States, or importing any such products into the United States, during
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`the terms of those patents;
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`G. An order that judgment be entered awarding Baxter monetary relief if Defendants,
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`their officers, agents, servants and employees, and those persons in active concert or
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`participation with any of them, commercially make, use, sell, offer for sale in, or import into, the
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`United States, any of the ANDA Products prior to the expiration of the ‘094 and ‘540 Patents for
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`the full terms thereof (including any extensions), and that any such monetary relief be awarded
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`with prejudgment interest;
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`H. A permanent injunction restraining and enjoining Defendants, their officers,
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`agents, servants and employees, and those persons in active concert or participations with any of
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`Case 1:14-cv-07094-JBS-JS Document 1 Filed 11/12/14 Page 15 of 16 PageID: 15
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`them, from seeking, obtaining or maintaining final approval of Defendants’ ANDA No. 206608
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`until expiration of the ‘094 and ‘540 Patents;
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`I. A declaration that this is an exceptional case and an award of reasonable
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`attorneys’ fees pursuant to 35 U.S.C. § 285;
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`J. Costs and expenses in this action; and
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`K. Such other and further relief as the Court may deem just and proper.
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`DECHERT LLP
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` /s/ Robert D. Rhoad
`Robert D. Rhoad
`Brian M. Goldberg
`902 Carnegie Center, Suite 500
`Princeton, NJ 08540-6531
`(609) 955-3200
`robert.rhoad@dechert.com
`brian.goldberg@dechert.com
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`ATTORNEYS FOR PLAINTIFFS BAXTER
`HEALTHCARE CORPORATION,, BAXTER
`INTERNATIONAL INC., and BAXTER
`HEALTHCARE S.A.
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`Dated: November 12, 2014
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`Of Counsel:
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`Kevin M. Flannery
`Vincent A. Gallo
`Teri A. Evans
`DECHERT LLP
`Cira Centre
`2929 Arch Street
`Philadelphia, PA 19104
`(215) 994-4000
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`ATTORNEYS FOR PLAINTIFFS BAXTER
`HEALTHCARE CORPORATION, BAXTER
`INTERNATIONAL INC., and
`BAXTER HEALTHCARE S.A.
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`Case 1:14-cv-07094-JBS-JS Document 1 Filed 11/12/14 Page 16 of 16 PageID: 16
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`CERTIFICATION OF NON-ARBITRABILITY
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`Pursuant to Local Civil Rule 201.1 (d)(2), the undersigned attorney for plaintiffs Baxter
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`Healthcare Corporation and Baxter International Inc. certifies that this action is not eligible for
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`compulsory arbitration under Local Civil Rule 201.1 because the relief sought in the Complaint
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`primarily consists of a demand for preliminary and permanent injunctive relief, and because if
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`Defendants were to commercially make, use, sell, offer for sale in, or import into the United
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`States any of the Proposed ANDA Products prior to the expiration of the ‘094 and ‘540 Patents,
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`Baxter’s monetary damages would exceed $150,000.
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`LOCAL CIVIL RULE 11.2 CERTIFICATION
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`Pursuant to Local Civil Rule 11.2, the undersigned attorney for plaintiffs Baxter
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`Healthcare Corporation and Baxter International Inc. certifies that to the best of his knowledge,
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`the matter in controversy is not the subject of another action pending in any court or of any
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`pending arbitration or administrative proceeding. Plaintiffs do note, however, that the patents-in-
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`suit are the subject of another patent infringement action pending in this district, encaptioned
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`Baxter Healthcare Corp. et al., v. HQ Specialty Pharma Corp., C.A. No. 2:13-cv-6228-FSH-
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`MAH.
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`DECHERT LLP
`Attorneys for Plaintiffs
`Baxter Healthcare Corporation,
`Baxter International Inc., and
`Baxter Healthcare S.A.
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`By /s/ Robert D. Rhoad
` ROBERT D. RHOAD
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`Dated: November 12, 2014
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