`
`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.
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`
`
`
`
`
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`
`
`SAGENT PHARMACEUTICALS
`INC.,
`
`
`
`Defendant.
`
`COMPLAINT
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`Plaintiffs Baxter Healthcare Corporation (“Baxter Healthcare”), Baxter International Inc.
`
`
`
`
`
`(“Baxter International”), and Baxter Healthcare S.A. (“Baxter HAS”) (collectively, “Baxter” or
`
`“Plaintiffs”), for their Complaint against defendant Sagent Pharmaceuticals Inc. (“Sagent” or
`
`“Defendant”) allege as follows:
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`PARTIES
`
`1.
`
`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.
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`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.
`
`3.
`
`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.
`
`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.
`
`Upon information and belief, Sagent is a corporation incorporated in Delaware,
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`having its principal place of business at 1901 N. Roselle Road, Suite 700, Schaumburg, Illinois
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`60195.
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`6.
`
`Upon information and belief, Sagent is a specialty pharmaceutical company
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`focused on developing, manufacturing, sourcing and marketing injectable pharmaceutical
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`products for sale primarily in the United States of America.
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`NATURE OF ACTION
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`7.
`
`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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`8.
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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).
`
`9.
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`This Court has personal jurisdiction over Sagent because, inter alia, they have
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`committed – or aided, abetted, planned, contributed to, or participated in the commission of –
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`tortious conduct which will lead to foreseeable harm and injury to Baxter in the State of New
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`Jersey, and in doing so, Sagent has purposefully directed its activities at the residents of this
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`forum.
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`10.
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`This Court also has personal jurisdiction over Sagent 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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`11.
`
`Upon information and belief, Sagent develops, manufactures, sources, and
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`markets injectable pharmaceutical products that it sells throughout the United States, including in
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`the State of New Jersey, including by making and shipping into this judicial district, or by
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`offering to sell or selling, or causing others to offer to sell or sell, generic pharmaceutical
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`products in this judicial district. Upon information and belief, Sagent derives substantial revenue
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`from goods used or consumed or services rendered in this judicial district.
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`12.
`
`Sagent’s 10-K claims, for instance, that Sagent is a specialty pharmaceutical
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`company focused on developing, manufacturing, sourcing and marketing injectable
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`pharmaceutical products, which Sagent sells primarily in the United States of America. Upon
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`information and belief, Sagent derives revenue from its sales in New Jersey and is registered
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`with the New Jersey Department of Health Food & Drug Safety as a wholesale drug
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`manufacturer (Registration # 5004419).
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`13.
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`Sagent’s 10-K additionally claims that Sagent launched 12 products in 2013, and
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`had 62 ANDA’s under FDA review at the end of the period. According to Sagent’s 10-K,
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`Sagent’s FDA approved products include “key” products Cefepime, Levofloxacin, Docetaxel,
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`Leucovorin Calcium, Zoledronic acid, and Heparin.
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`14.
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`Upon information and belief, Sagent intends, upon FDA approval to do so, to
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`manufacture, distribute and sell the generic equivalents of Baxter’s BREVIBLOC® products in
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`10 mg/mL 250 mL infusion bags and 20 mg/mL 100 mL infusion bags (see description below of
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`Sagent’s ANDA relating to these products) that Baxter accuses of infringement in this matter
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`throughout the United States and in this judicial district.
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`15.
`
`Upon information and belief, Sagent has previously submitted to and availed itself
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`of the jurisdiction of this Court for patent infringement suits. See, e.g., Astrazeneca et al. v.
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`Sagent Pharma Inc., 1:14-cv-05539-RMB-KMW, Novartis v. Actavis et al., 2:13-civ-1028-
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`SDW-MCA (admitting that it sells generic versions of branded drugs in the United States,
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`including in New Jersey).
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`THE DRUG APPROVAL PROCESS
`
`16.
`
`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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`17.
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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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`18.
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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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`19.
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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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`20.
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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).
`
`FACTUAL BACKGROUND
`
`21.
`
`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.
`
`22.
`
`On March 4, 2003, the PTO duly and legally issued the ‘540 Patent, entitled
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`“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.
`
`23.
`
`Baxter International and Baxter HSA are the owners of the ‘094 Patent and the
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`‘540 Patent.
`
`24.
`
`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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`25.
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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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`26.
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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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`27.
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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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`28.
`
`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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`29.
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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).
`
`30.
`
`Upon information and belief, prior to January 23, 2015, Sagent submitted to the
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`FDA Abbreviated New Drug Application Number 207107 (the “ANDA”) pursuant to 35 U.S.C.
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`§ 355(j), seeking approval to engage in the commercial manufacture, use, and sale of proposed
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`Esmolol Hydrochloride in Sodium Chloride Solution products in dosages of 10 mg/ML 250 mL
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`infusion bags and 20 mg/mL 100 mL infusion bags (collectively, the “Proposed ANDA
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`Products”), referencing versions of Baxter’s BREVIBLOC® in plastic container and
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`BREVIBLOC® double strength in plastic container products.
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`31.
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`On or about January 23, 2015, Sagent sent Baxter International a notice stating
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`that Sagent had submitted ANDA No. 207107 seeking approval to manufacture, use, or sell the
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`Proposed ANDA products prior to the expiration of the ‘094 Patent and the ‘540 Patent (the
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`“Paragraph IV Notice”).
`
`32.
`
`33.
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`Baxter first received Sagent’s Paragraph IV Notice on January 26, 2015.
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`The Paragraph IV Notice advised Baxter that Sagent’s ANDA included a
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`Paragraph IV Certification stating that it was Sagent’s opinion that the ‘094 Patent is not valid.
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`The Notice did not include any assertion that Sagent’s Proposed ANDA Products would not
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`infringe the claims of the ‘094 Patent. The Notice also stated that it was Sagent’s opinion that
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`claims 1-6, 8-10, and 12-16 of the ‘540 Patent are invalid, and that Sagent’s manufacture, use,
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`importation, sale and offer for sale of its Proposed ANDA Products would not infringe claims 7
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`and 11 of the ‘540 Patent. The Notice did not include any assertion that claims 7-8 and 11 are
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`invalid, or that claims 1-6 and 9-16 of the ‘540 Patent would not be infringed by Sagent’s
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`manufacture, use, importation, sale and offer for sale of its Proposed ANDA Products.
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`COUNT I
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`INFRINGEMENT OF THE ‘094 PATENT
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`34.
`
`Baxter incorporates each of the preceding paragraphs 1-33 as if fully set forth
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`herein.
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`35.
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`Sagent’s submission of ANDA No. 207107 to the FDA including the Paragraph
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`IV Certification submitted therewith, which seeks FDA approval to engage in the commercial
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`manufacture, use, and sale of its 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).
`
`36.
`
`Upon FDA approval of ANDA No. 207107, Sagent 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
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`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
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`such activities, unless this Court orders that the effective date of any FDA approval of Sagent’s
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`ANDA is no earlier than the expiration date of the ‘094 Patent and any additional periods of
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`exclusivity.
`
`37.
`
`Baxter has no adequate remedy at law for Sagent’s infringement of the ‘094
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`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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`38.
`
`Upon information and belief, Sagent was aware of the existence of the ‘094 Patent
`
`as demonstrated by its reference to that patent in its ANDA, and were aware that the filing of its
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`Paragraph IV Certification with respect to the ‘094 Patent constitutes infringement of that patent.
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`This is an exceptional case within the meaning of 35 U.S.C. § 285.
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`COUNT II
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`INFRINGEMENT OF THE ‘540 PATENT
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`39.
`
`Baxter incorporates each of the preceding paragraphs 1-38 as if fully set forth
`
`herein.
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`40.
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`Sagent’s submission of ANDA No. 207107 to the FDA including the Paragraph
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`IV Certification submitted therewith, which seeks FDA approval to engage in the commercial
`
`manufacture, use, and sale of its Proposed ANDA Products prior to the expiration of the ‘540
`
`Patent, constitutes infringement of the ‘540 Patent under 35 U.S.C. § 271(e)(2)(A).
`
`41.
`
`Upon FDA approval of ANDA No. 207107, Sagent will directly or indirectly
`
`infringe the ‘540 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
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`such activities, unless this Court orders that the effective date of any FDA approval of Sagent’s
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`ANDA is no earlier than the expiration date of the ‘540 Patent and any additional periods of
`
`exclusivity.
`
`42.
`
`Baxter has no adequate remedy at law for Sagent’s 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.
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`43.
`
`Upon information and belief, Sagent was aware of the existence of the ‘540 Patent
`
`as demonstrated by its reference to that patent in its ANDA, and were aware that the filing of its
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`Paragraph IV Certification with respect to the ‘540 Patent constitutes infringement of that patent.
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`This is an exceptional case within the meaning of 35 U.S.C. § 285.
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`WHEREFORE, Baxter respectfully requests the following relief:
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`PRAYER FOR RELIEF
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`A. A judgment that, pursuant to 35 U.S.C. § 271(e)(2)(A), Sagent has infringed the
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`‘094 Patent;
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`B. A judgment that, pursuant to 35 U.S.C. § 271(e)(2)(A), Sagent has infringed the
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`‘540 Patent;
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`C. A declaration that Sagent’s commercial manufacture, use, offer for sale, sale in or
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`importation into the United States of the Proposed ANDA Products would infringe the ‘094
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`Patent;
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`D. A declaration that Sagent’s commercial manufacture, use, offer for sale, sale in or
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`importation into the United States of its Proposed ANDA Products would infringe the ‘540
`
`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 Sagent’s ANDA No. 207107 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 Sagent, its 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 Sagent, its
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`officers, agents, servants and employees, and those persons in active concert or participation with
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`any of them, commercially make, use, sell, offer for sale in, or import into, the United States, any
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`of the ANDA Products prior to the expiration of the ‘094 and ‘540 Patents for the full terms
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`thereof (including any extensions), and that any such monetary relief be awarded with
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`prejudgment interest;
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`H. A permanent injunction restraining and enjoining Sagent, its officers, agents,
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`servants and employees, and those persons in active concert or participations with any of them,
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`from seeking, obtaining or maintaining final approval of Sagent’s ANDA No. 207107 until
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`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
`
`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.
`
`DECHERT LLP
`
`
`
` /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
`
`ATTORNEYS FOR PLAINTIFFS BAXTER
`HEALTHCARE CORPORATION, BAXTER
`INTERNATIONAL INC., and BAXTER
`HEALTHCARE S.A.
`
`
`
`
`
`Dated: March 6, 2015
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`LOCAL CIVIL RULE 11.2 CERTIFICATION
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`
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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-
`
`suit are the subject of other patent infringement actions pending in this district, encaptioned
`
`Baxter Healthcare Corp. et al., v. HQ Specialty Pharma Corp., C.A. No. 2:13-cv-6228-FSH-
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`MAH, and Baxter Healthcare Corp. et al., v. Agila Specialties Private Limited, C.A. No. 2:14-
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`cv-07094-FSH-MAH.
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`By /s/ Robert D. Rhoad
` ROBERT D. RHOAD
`
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`Dated: March 6, 2015
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