Case 1:13-cv-05723-NLH-AMD Document 1 Filed 09/25/13 Page 1 of 15 PageID: 1
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`
`
`Michael R. Griffinger
`Lisa H. Wang
`GIBBONS P.C.
`One Gateway Center
`Newark, New Jersey 07102-5310
`Telephone No.: (973) 596-4500
`Facsimile No.: (973) 596-0545
`
`Of Counsel:
`Edgar H. Haug
`Jason A. Lief
`Angus Chen
`FROMMER LAWRENCE & HAUG LLP
`745 Fifth Avenue
`New York, New York 10151
`Telephone No.: (212) 588-0800
`Facsimile No.: (212) 599-0500
`
`Attorneys for Plaintiffs
`Cornerstone Therapeutics Inc., Cornerstone
`BioPharma, Inc., and EKR Therapeutics, LLC
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`CORNERSTONE THERAPEUTICS INC.,
`CORNERSTONE BIOPHARMA, INC., and
`EKR THERAPEUTICS, LLC,
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`SANDOZ INC.
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`Civil Action No. ____________
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`Document electronically filed.
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`COMPLAINT
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`Plaintiffs,
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`v.
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`Defendant.
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`Plaintiffs Cornerstone Therapeutics Inc., Cornerstone BioPharma, Inc., and EKR
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`Therapeutics, LLC (“EKR”) (collectively “Cornerstone”), by its undersigned attorneys, for its
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`Complaint against defendant Sandoz Inc. (“Sandoz”) herein, allege as follows:
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`Sandoz Exhibit 1007 Page 1
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`

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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement arising under the patent laws of the
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`United States, Title 35, United States Code, involving United States Patent No. 7,612,102 (“the
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`’102 patent”) (attached as Exhibit A hereto), United States Patent No. 7,659,291 (“the ’291
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`patent”) (attached as Exhibit B hereto), United States Patent No. 8,455,524 (“the ’524 patent”)
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`(attached as Exhibit C hereto), and United States Patent No. 7,659,290 (“the ’290 patent”)
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`(attached as Exhibit D hereto) (collectively “the Patents-in-Suit”).
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`THE PARTIES
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`2.
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`Plaintiff Cornerstone Therapeutics Inc. is a corporation organized and existing
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`under the laws of the State of Delaware, having a place of business at 1255 Crescent Green
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`Drive, Suite 250, Cary, North Carolina 27518.
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`3.
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`Plaintiff Cornerstone BioPharma, Inc. is a corporation organized and existing
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`under the laws of the State of Nevada, having a place of business at 1255 Crescent Green Drive,
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`Suite 250, Cary, North Carolina 27518.
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`4.
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`Plaintiff EKR (formerly known as EKR Therapeutics, Inc.) is a wholly-owned
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`subsidiary of Cornerstone Therapeutics Inc., organized and existing under the laws of the State
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`of Delaware, having a place of business at 1255 Crescent Green Drive, Suite 250, Cary, North
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`Carolina 27518.
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`5.
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`Upon information and belief, Sandoz is a corporation organized and existing
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`under the laws of the State of Colorado, having its principal place of business at 506 Carnegie
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`Center, Suite 400, Princeton, New Jersey 08540.
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`6.
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`Upon information and belief, Sandoz develops, manufactures, and distributes
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`generic drugs throughout the United States, including in New Jersey.
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`2
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`Sandoz Exhibit 1007 Page 2
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`JURISDICTION AND VENUE
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`7.
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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, 1338(a), 2201, 2202 and/or 35 U.S.C. § 271.
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`8.
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`This Court has personal jurisdiction over Sandoz because, inter alia: (i) Sandoz
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`maintains a principal place of business in this judicial district; (ii) Sandoz has committed,
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`induced, or contributed to acts of patent infringement in this judicial district; (iii) Sandoz resides
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`and is doing business in this judicial district and maintains continuous and systematic contacts
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`with this judicial district; (iv) Sandoz is registered as a drug manufacturer and wholesale drug
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`distributor in the State of New Jersey under the registration number 5003732; (v) Sandoz has
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`consented to the jurisdiction of this Court in numerous prior actions; and (vi) Sandoz has availed
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`itself of the rights, benefits, and privileges of this Court by asserting claims and counterclaims in
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`numerous prior actions in this judicial district.
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`9.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b).
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`FACTS AS TO ALL COUNTS
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`10.
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`EKR is the current owner of New Drug Application (“NDA”) No. 19-734,
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`approved by the U.S. Food and Drug Administration (“FDA”) for the manufacture and sale of
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`Cardene® I.V. Premixed Injection, 0.1 mg/mL and 0.2 mg/mL. Cardene® I.V. is a nicardipine
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`hydrochloride premixed injection for intravenous administration indicated for the short-term
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`treatment of hypertension when oral therapy is not feasible or not desirable.
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`11.
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`The ’102 patent, titled “Pre-mixed, Ready-to-Use Pharmaceutical Compositions”
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`was duly and legally issued on November 3, 2009. The ’102 patent is generally directed to
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`pharmaceutical compositions comprising nicardipine hydrochloride.
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`12.
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`The ’291 patent, titled “Methods of Treatment with Pre-Mixed, Ready-to-Use
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`Pharmaceutical Compositions” was duly and legally issued on February 9, 2010. The ’291
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`3
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`Sandoz Exhibit 1007 Page 3
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`patent is generally directed to methods of treatment with pharmaceutical compositions
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`comprising nicardipine hydrochloride.
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`13.
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`The ’524 patent, titled “Methods of Treatment with Pre-mixed, Ready-to-Use
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`Pharmaceutical Compositions” was duly and legally issued on June 4, 2013. The ’524 patent is
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`generally directed to methods of treatment with pharmaceutical compositions comprising
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`nicardipine hydrochloride.
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`14.
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`The ’290 patent, titled “Methods of Preparing Pre-Mixed, Ready-to-Use
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`Pharmaceutical Compositions” was duly and legally issued on February 9, 2010. The ’290
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`patent is generally directed to methods of preparing pharmaceutical compositions comprising
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`nicardipine hydrochloride. The ’290 patent issued from U.S. Patent Application No. 12/407,551,
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`a division of U.S. Patent Application No. 11/788,076 which issued as the ’102 patent.
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`15.
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`The Patents-in-Suit all claim priority to U.S. Provisional Application No.
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`60/793,074, filed on April 18, 2006. EKR has been assigned, and currently owns, all rights, title,
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`and interest in the Patents-in-Suit.
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`16.
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`Pursuant to 21 U.S.C. § 355(b)(1), the ’102 patent, the ’291 patent and the ’524
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`patent are listed in FDA’s publication titled “Approved Drug Products with Therapeutic
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`Equivalence Evaluations” (commonly known as the “Orange Book”) as covering Cardene® I.V.
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`Premixed Injection.
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`17.
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`Upon information and belief, Sandoz prepared, submitted, and filed Abbreviated
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`New Drug Application No. 203978 (“Sandoz’s ANDA”) to the FDA under § 505(j) of the
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`Federal Food, Drug, and Cosmetic Act (“FDCA”) (codified at 21 U.S.C. § 355(j)) seeking
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`approval to engage in the commercial manufacture, use, sale, offer for sale and/or importation of
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`4
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`Sandoz Exhibit 1007 Page 4
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`generic Nicardipine HCl Intravenous Injection 0.1 mg/ml in sodium chloride and 0.2 mg/ml in
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`sodium chloride (“Sandoz’s Generic Products”).
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`18.
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`Sandoz sent a letter to Cornerstone Therapeutics Inc., Cornerstone BioPharma,
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`Inc., and EKR Therapeutics, LLC purporting to provide notification that Sandoz’s ANDA
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`contains certifications under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a “paragraph IV certification”)
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`with regard to the ’102, ’291, and ’524 patents (“Sandoz’s Notice Letter”).
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`19.
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`Sandoz’s Notice Letter does not provide non-infringement contentions for any
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`claim of the ’102, ’291, or ’524 patents.
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`FIRST COUNT
`(Infringement of the ’102 Patent by Sandoz)
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`20.
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`Cornerstone repeats and realleges each of the foregoing paragraphs as if fully set
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`forth herein.
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`21.
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`Upon information and belief, Sandoz seeks FDA approval for the manufacture,
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`marketing, sale, and/or distribution of Sandoz’s Generic Products.
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`22.
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`Upon information and belief, Sandoz included a paragraph IV certification to the
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`’102 patent to obtain approval to engage in the commercial manufacture, use, sale, offer for sale
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`and/or importation of Sandoz’s Generic Products before the expiration of the ’102 patent.
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`23.
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`Upon information and belief, Sandoz will commercially manufacture, sell, offer
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`for sale, and/or import Sandoz’s Generic Products upon, or in anticipation of, FDA approval and
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`before the expiration of the ’102 patent.
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`24.
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`Upon information and belief, as of the date of Sandoz’s Notice Letter, Sandoz
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`was aware of the statutory provisions and regulations set forth in 21 U.S.C. § 355(j)(2)(B)(iv)(II)
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`and 21 C.F.R. § 314.95(c)(6).
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`5
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`Sandoz Exhibit 1007 Page 5
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`25.
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`The inclusion of a paragraph IV certification to the ’102 patent in ANDA No.
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`203978 for the purpose of obtaining approval to engage in the commercial manufacture, use,
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`sale, offer for sale and/or importation of Sandoz’s Generic Products before the expiration of the
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`’102 patent is an act of direct and/or indirect infringement (including induced and/or contributory
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`infringement) by Sandoz of one or more claims of the ’102 patent under 35 U.S.C. §
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`271(e)(2)(A).
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`26.
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`Upon information and belief, Sandoz’s commercial manufacture, use, sale, offer
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`for sale and/or importation into the United States of Sandoz’s Generic Products that are the
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`subject of ANDA No. 203978 will infringe one or more claims of the ’102 patent under 35
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`U.S.C. § 271 et seq., including § 271(a), § 271(b), and/or § 271(c).
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`27.
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`Upon information and belief, Sandoz was and is aware of the existence of the
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`’102 patent and acted without a reasonable basis for believing that it would not be liable for
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`infringement of the ’102 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
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`28.
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`Sandoz’s infringement of the ’102 patent has caused and will cause Cornerstone
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`to suffer irreparable harm. Sandoz’s infringement will continue unless enjoined by the Court.
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`Cornerstone has no adequate remedy at law and thus preliminary and permanent injunctions are
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`appropriate to prohibit Sandoz from infringing the ’102 patent.
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`SECOND COUNT
`(Infringement of the ’291 Patent by Sandoz)
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`29.
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`Cornerstone repeats and realleges each of the foregoing paragraphs as if fully set
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`forth herein.
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`30.
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`Upon information and belief, Sandoz seeks FDA approval for the manufacture,
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`marketing, sale, and/or distribution of Sandoz’s Generic Products.
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`6
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`Sandoz Exhibit 1007 Page 6
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`31.
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`Upon information and belief, Sandoz included a paragraph IV certification to the
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`’291 patent to obtain approval to engage in the commercial manufacture, use, sale, offer for sale
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`and/or importation of Sandoz’s Generic Products before the expiration of the ’291 patent.
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`32.
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`Upon information and belief, Sandoz will commercially manufacture, sell, offer
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`for sale, and/or import Sandoz’s Generic Products upon, or in anticipation of, FDA approval and
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`before the expiration of the ’291 patent.
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`33.
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`Upon information and belief, as of the date of Sandoz’s Notice Letter, Sandoz
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`was aware of the statutory provisions and regulations set forth in 21 U.S.C. § 355(j)(2)(B)(iv)(II)
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`and 21 C.F.R. § 314.95(c)(6).
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`34.
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`The inclusion of a paragraph IV certification to the ’291 patent in ANDA No.
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`203978 for the purpose of obtaining approval to engage in the commercial manufacture, use,
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`sale, offer for sale and/or importation of Sandoz’s Generic Products before the expiration of the
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`’291 patent is an act of direct and/or indirect infringement (including induced and/or contributory
`
`infringement) by Sandoz of one or more claims of the ’291 patent under 35 U.S.C. §
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`271(e)(2)(A).
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`35.
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`Upon information and belief, Sandoz’s commercial manufacture, use, sale, offer
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`for sale and/or importation into the United States of Sandoz’s Generic Products that are the
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`subject of ANDA No. 203978 will infringe one or more claims of the ’291 patent under 35
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`U.S.C. § 271 et seq., including § 271(b) and/or § 271(c).
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`36.
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`Upon information and belief, Sandoz was and is aware of the existence of the
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`’291 patent and acted without a reasonable basis for believing that it would not be liable for
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`infringement of the ’291 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
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`
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`7
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`Sandoz Exhibit 1007 Page 7
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`37.
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`Sandoz’s infringement of the ’291 patent has caused and will cause Cornerstone
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`to suffer irreparable harm. Sandoz’s infringement will continue unless enjoined by the Court.
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`Cornerstone has no adequate remedy at law and thus preliminary and permanent injunctions are
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`appropriate to prohibit Sandoz from infringing the ’291 patent.
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`THIRD COUNT
`(Infringement of the ’524 Patent by Sandoz)
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`38.
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`Cornerstone repeats and realleges each of the foregoing paragraphs as if fully set
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`forth herein.
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`39.
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`Upon information and belief, Sandoz seeks FDA approval for the manufacture,
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`marketing, sale, and/or distribution of Sandoz’s Generic Products.
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`40.
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`Upon information and belief, Sandoz included a paragraph IV certification to the
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`’524 patent to obtain approval to engage in the commercial manufacture, use, sale, offer for sale
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`and/or importation of Sandoz’s Generic Products before the expiration of the ’524 patent.
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`41.
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`Upon information and belief, Sandoz will commercially manufacture, sell, offer
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`for sale, and/or import Sandoz’s Generic Products upon, or in anticipation of, FDA approval and
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`before the expiration of the ’524 patent.
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`42.
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`Upon information and belief, as of the date of Sandoz’s Notice Letter, Sandoz
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`was aware of the statutory provisions and regulations set forth in 21 U.S.C. § 355(j)(2)(B)(iv)(II)
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`and 21 C.F.R. § 314.95(c)(6).
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`43.
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`The inclusion of a paragraph IV certification to the ’524 patent in ANDA No.
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`203978 for the purpose of obtaining approval to engage in the commercial manufacture, use,
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`sale, offer for sale and/or importation of Sandoz’s Generic Products before the expiration of the
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`’524 patent is an act of direct and/or indirect infringement (including induced and/or contributory
`
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`8
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`Sandoz Exhibit 1007 Page 8
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`infringement) by Sandoz of one or more claims of the ’524 patent under 35 U.S.C. §
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`271(e)(2)(A).
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`44.
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`Upon information and belief, Sandoz’s commercial manufacture, use, sale, offer
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`for sale and/or importation into the United States of Sandoz’s Generic Products that are the
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`subject of ANDA No. 203978 will infringe one or more claims of the ’524 patent under 35
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`U.S.C. § 271 et seq., including § 271(b) and/or § 271(c).
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`45.
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`Upon information and belief, Sandoz was and is aware of the existence of the
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`’524 patent and acted without a reasonable basis for believing that it would not be liable for
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`infringement of the ’524 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
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`46.
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`Sandoz’s infringement of the ’524 patent has caused and will cause Cornerstone
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`to suffer irreparable harm. Sandoz’s infringement will continue unless enjoined by the Court.
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`Cornerstone has no adequate remedy at law and thus preliminary and permanent injunctions are
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`appropriate to prohibit Sandoz from infringing the ’524 patent.
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`FOURTH COUNT
`(Infringement of the ’290 Patent by Sandoz)
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`47.
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`Cornerstone repeats and realleges each of the foregoing paragraphs as if fully set
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`forth herein.
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`48.
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`Upon information and belief, Sandoz seeks FDA approval for the manufacture,
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`marketing, sale, and/or distribution of Sandoz’s Generic Products.
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`49.
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`Upon information and belief, Sandoz seeks FDA approval to engage in the
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`commercial manufacture, use, sale, offer for sale and/or importation of Sandoz’s Generic
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`Products before the expiration of the ’290 patent.
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`9
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`Sandoz Exhibit 1007 Page 9
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`50.
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`Upon information and belief, Sandoz will commercially manufacture, sell, offer
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`for sale, and/or import Sandoz’s Generic Products upon, or in anticipation of, FDA approval and
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`before expiration of the ’290 patent.
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`51.
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`Upon information and belief, the submission and/or filing of ANDA No. 203978
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`for the purpose of obtaining approval to engage in the commercial manufacture, use, sale, offer
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`for sale and/or importation of Sandoz’s Generic Products before the expiration of the ’290 patent
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`is an act of direct and/or indirect infringement (including induced and/or contributory
`
`infringement) by Sandoz of one or more claims of the ’290 patent under 35 U.S.C. §
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`271(e)(2)(A).
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`52.
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`Upon information and belief, Sandoz’s commercial manufacture, use, sale, offer
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`for sale and/or importation into the United States of Sandoz’s Generic Products that are the
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`subject of ANDA No. 203978 before the expiration of the ’290 patent will infringe one or more
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`claims of the ’290 patent under 35 U.S.C. § 271 et seq., including § 271(a), § 271(b), § 271(c)
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`and/or § 271(g).
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`53.
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`Upon information and belief, Sandoz was and is aware of the existence of the
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`’290 patent and acted without a reasonable basis for believing that it would not be liable for
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`infringement of the ’290 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
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`54.
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`Sandoz’s infringement of the ’290 patent has caused and will cause Cornerstone
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`to suffer irreparable harm. Sandoz’s infringement will continue unless enjoined by the Court.
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`Cornerstone has no adequate remedy at law and thus preliminary and permanent injunctions are
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`appropriate to prohibit Sandoz from infringing the ’290 patent.
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`PRAYER FOR RELIEF
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`WHEREFORE, Cornerstone respectfully requests the following relief:
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`i.
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`A judgment declaring that the ’102 patent is valid and enforceable;
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`10
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`Sandoz Exhibit 1007 Page 10
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`ii.
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`A judgment declaring that, pursuant to 35 U.S.C. § 271(e)(2)(A), the submission
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`to the FDA and filing of ANDA No. 203978 with a paragraph IV certification to obtain approval
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`for the commercial manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of Sandoz’s Generic Products was an act of infringement of the ’102 patent by Sandoz;
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`iii.
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`A judgment declaring that, pursuant to 35 U.S.C. § 271 et seq., including §
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`271(e)(2)(A), § 271(a), § 271(b) and/or § 271(c), the commercial manufacture, use, sale, offer
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`for sale and/or importation into the United States of Sandoz’s Generic Products prior to the
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`expiration of the ’102 patent, including any regulatory extensions, will constitute an act of
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`infringement by Sandoz;
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`iv.
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`An order that, pursuant to 35 U.S.C. §§ 271(e)(4)(A), 281, and/or 283, the
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`effective date of any approval of Sandoz’s Generic Products shall be no earlier than the date on
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`which the ’102 patent expires including any regulatory extensions;
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`v.
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`A judgment pursuant to 35 U.S.C. §§ 271(e)(4)(B), 281, and/or 283, preliminarily
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`and permanently enjoining Sandoz and its officers, agents, servants, employees, and attorneys,
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`and those persons in active concert or participation or privity with them or any of them, from
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`engaging in the commercial manufacture, use, sale, offer for sale, and/or importation in the
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`United States of the product that is the subject of ANDA No. 203978 until the expiration of the
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`’102 patent including any regulatory extensions;
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`vi.
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`A judgment awarding Cornerstone damages or other monetary relief, pursuant to
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`35 U.S.C. §§ 271(e)(4)(C) and/or 284, if Sandoz commercially manufactures, uses, sells, offers
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`to sell, and/or imports any product that is the subject of ANDA No. 203978 that infringes the
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`’102 patent;
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`11
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`Sandoz Exhibit 1007 Page 11
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`vii.
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`A judgment declaring that infringement of the ’102 patent is willful if Sandoz
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`commercially manufactures, uses, sells, offers to sell, and/or imports any product that is the
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`subject of ANDA No. 203978 that infringes the ’102 patent;
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`viii.
`
`ix.
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`A judgment declaring that the ’291 patent is valid and enforceable;
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`A judgment declaring that, pursuant to 35 U.S.C. § 271(e)(2)(A), the submission
`
`to the FDA and filing of ANDA No. 203978 with a paragraph IV certification to obtain approval
`
`for the commercial manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of Sandoz’s Generic Products was an act of infringement of the ’291 patent by Sandoz;
`
`x.
`
`A judgment declaring that, pursuant to 35 U.S.C. § 271 et seq., including §
`
`271(e)(2)(A), § 271(b) and/or § 271(c), the commercial manufacture, use, sale, offer for sale,
`
`and/or importation into the United States of Sandoz’s Generic Products prior to the expiration of
`
`the ’291 patent, including any regulatory extensions, will constitute an act of infringement by
`
`Sandoz;
`
`xi.
`
`An order that, pursuant to 35 U.S.C. §§ 271(e)(4)(A), 281, and/or 283, the
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`effective date of any approval of Sandoz’s Generic Products shall be no earlier than the date on
`
`which the ’291 patent expires including any regulatory extensions;
`
`xii.
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`A judgment pursuant to 35 U.S.C. §§ 271(e)(4)(B), 281, and/or 283, preliminarily
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`and permanently enjoining Sandoz and its officers, agents, servants, employees, and attorneys,
`
`and those persons in active concert or participation or privity with them or any of them, from
`
`engaging in the commercial manufacture, use, sale, offer for sale, and/or importation into the
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`United States of the product that is the subject of ANDA No. 203978 until the expiration of the
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`’291 patent including any regulatory extensions;
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`
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`12
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`Sandoz Exhibit 1007 Page 12
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`xiii.
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`A judgment awarding Cornerstone damages or other monetary relief, pursuant to
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`35 U.S.C. §§ 271(e)(4)(C) and/or 284, if Sandoz commercially manufactures, uses, sells, offers
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`to sell, and/or imports any product that is the subject of ANDA No. 203978 that infringes the
`
`’291 patent;
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`xiv.
`
`A judgment declaring that infringement of the ’291 patent is willful if Sandoz
`
`commercially manufactures, uses, sells, offers to sell, and/or imports any product that is the
`
`subject of ANDA No. 203978 that infringes the ’291 patent;
`
`xv.
`
`xvi.
`
`A judgment declaring that the ’524 patent is valid and enforceable;
`
`A judgment declaring that, pursuant to 35 U.S.C. § 271(e)(2)(A), the submission
`
`to the FDA and filing of ANDA No. 203978 with a paragraph IV certification to obtain approval
`
`for the commercial manufacture, use, sale, offer for sale, and/or importation into the United
`
`States of Sandoz’s Generic Products was an act of infringement of the ’524 patent by Sandoz;
`
`xvii.
`
`A judgment declaring that, pursuant to 35 U.S.C. § 271 et seq., including §
`
`271(e)(2)(A), § 271(b) and/or § 271(c), the commercial manufacture, use, sale, offer for sale,
`
`and/or importation into the United States of Sandoz’s Generic Products prior to the expiration of
`
`the ’524 patent, including any regulatory extensions, will constitute an act of infringement by
`
`Sandoz;
`
`xviii.
`
`An order that, pursuant to 35 U.S.C. §§ 271(e)(4)(A), 281, and/or 283, the
`
`effective date of any approval of Sandoz’s Generic Products shall be no earlier than the date on
`
`which the ’524 patent expires including any regulatory extensions;
`
`xix.
`
`A judgment pursuant to 35 U.S.C. §§ 271(e)(4)(B), 281, and/or 283, preliminarily
`
`and permanently enjoining Sandoz and its officers, agents, servants, employees, and attorneys,
`
`and those persons in active concert or participation or privity with them or any of them, from
`
`
`
`13
`
`
`
`
`
`Sandoz Exhibit 1007 Page 13
`
`

`

`Case 1:13-cv-05723-NLH-AMD Document 1 Filed 09/25/13 Page 14 of 15 PageID: 14
`
`engaging in the commercial manufacture, use, sale, offer for sale, and/or importation into the
`
`United States of the product that is the subject of ANDA No. 203978 until the expiration of the
`
`’524 patent including any regulatory extensions;
`
`xx.
`
`A judgment awarding Cornerstone damages or other monetary relief, pursuant to
`
`35 U.S.C. §§ 271(e)(4)(C) and/or 284, if Sandoz commercially manufactures, uses, sells, offers
`
`to sell, and/or imports any product that is the subject of ANDA No. 203978 that infringes the
`
`’524 patent;
`
`xxi.
`
`A judgment declaring that infringement of the ’524 patent is willful if Sandoz
`
`commercially manufactures, uses, sells, offers to sell, and/or imports any product that is the
`
`subject of ANDA No. 203978 that infringes the ’524 patent;
`
`xxii.
`
`xxiii.
`
`A judgment declaring that the ’290 patent is valid and enforceable;
`
`A judgment declaring that, pursuant to 35 U.S.C. § 271 et seq., including §
`
`271(e)(2)(A), § 271(a), § 271(b), § 271(c) and/or § 271(g), the commercial manufacture, use,
`
`sale, offer for sale, and/or importation into the United States of Sandoz’s Generic Products prior
`
`to the expiration of the ’290 patent, including any regulatory extensions, will constitute an act of
`
`infringement by Sandoz;
`
`xxiv.
`
`An order that, pursuant to 35 U.S.C. §§ 271(e)(4)(B), 281 and/or 283, the
`
`effective date of any approval of Sandoz’s Generic Products shall be no earlier than the date on
`
`which the ’290 patent expires including any regulatory extensions;
`
`xxv.
`
`A judgment pursuant to 35 U.S.C. §§ 271(e)(4)(B), 281 and/or 283, preliminarily
`
`and permanently enjoining Sandoz and its officers, agents, servants, employees, and attorneys,
`
`and those persons in active concert or participation or privity with them or any of them, from
`
`engaging in the commercial manufacture, use, sale, offer for sale, and/or importation into the
`
`
`
`14
`
`
`
`
`
`Sandoz Exhibit 1007 Page 14
`
`

`

`Case 1:13-cv-05723-NLH-AMD Document 1 Filed 09/25/13 Page 15 of 15 PageID: 15
`
`United States of the product that is the subject of ANDA No. 203978 until the expiration of the
`
`’290 patent including any regulatory extensions;
`
`xxvi.
`
`A judgment awarding Cornerstone damages or other monetary relief, pursuant to
`
`35 U.S.C. §§ 271(e)(4)(C) and/or 284, if Sandoz commercially manufactures, uses, sells, offers
`
`to sell, and/or imports any product that is the subject of ANDA No. 203978 that infringes the
`
`’290 patent;
`
`xxvii.
`
`A judgment declaring that infringement of the ’290 patent is willful if Sandoz
`
`commercially manufactures, uses, sells, offers to sell, and/or imports any product that is the
`
`subject of ANDA No. 203978 that infringes the ’290 patent;
`
`xxviii.
`
`A judgment declaring that, pursuant to 35 U.S.C. § 285, this is an exceptional
`
`case and awarding Cornerstone its attorneys’ fees and costs;
`
`xxix.
`
`Such other and further relief as this Court may deem just and proper.
`
`
`
`
`
`
`
`
`
`
`
`
`Of Counsel:
`
`
`Edgar H. Haug
`Jason A. Lief
`Angus Chen
`FROMMER LAWRENCE & HAUG LLP
`745 Fifth Avenue
`New York, New York 10151
`Telephone No.: (212) 588-0800
`Facsimile No.: (212) 599-0500
`
`Dated: September 25, 2013
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`By: s/ Michael R. Griffinger
`Michael R. Griffinger
`Lisa H. Wang
`GIBBONS P.C.
`One Gateway Center
`Newark, New Jersey 07102-5310
`Telephone No.: (973) 596-4500
`Facsimile No.: (973) 596-0545
`
`Attorneys for Plaintiffs
`Cornerstone Therapeutics Inc.,
`Cornerstone BioPharma, Inc., and
`EKR Therapeutics, LLC
`
`
`
`
`
`
`
`15
`
`
`
`
`
`Sandoz Exhibit 1007 Page 15
`
`

`

`Case 1:13-cv-05723-NLH-AMD Document 1-1 Filed 09/25/13 Page 1 of 23 PageID: 16
`
`
`
`
`
`
`
`
`EXHIBIT A
`
`
`
`
`
`Sandoz Exhibit 1007 Page 16
`
`

`

`Case 1:13-cv-05723-NLH-AMD Document 1-1 Filed 09/25/13 Page 2 of 23 PageID: 17
`IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`US007612102B2
`
`112j United States Patent
`Duncan et al.
`
`110) Patent No. :
`145) Date of Patent:
`
`US 7, 612, 102 B2
`Nov. 3, 2009
`
`154) PRE-MIXED, READY-TO-USE
`PHARMACEUTICAL COMPOSITIONS
`
`175)
`
`Inventors: Michelle Renee Duncan, Glenview, IL
`1US); Supriya Gupta, Sunnyvale, CA
`1US); David Hartley Haas, Fremont,
`CA (US); Norma V. Stephens, Skokie,
`IL 1US); Camellia Zamiri, Fremont, CA
`1US)
`173) Assignee: EKR Therapeutics, Inc.
`* ) Notice:
`the term of this
`Subject to any disclaimer,
`is extended or adjusted under 35
`patent
`U. S. C. 1541b) by 252 days.
`121) Appl. Noz 11/7SS, 076
`Apr. 1S, 2007
`122) Filed:
`Prior Publication Data
`165)
`
`1
`
`US 2007/0249689 Al
`
`Oct. 25, 2007
`
`Related U. S. Application Data
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`18, 2006.
`
`151) Int. Cl.
`zl 61K 31/44
`12006. 01)
`152) U. S. Cl. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 514/354; 424/400
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`. . . . . . . . . . . . . . . . . . . . . . . None
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`file for complete search history.
`
`156)
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