Case 2:15-cv-00285-MCA-JBC Document 1 Filed 01/14/15 Page 1 of 9 PageID: 1
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`
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`OF COUNSEL:
`
`Lisa Pensabene
`John Kappos
`Filko Prugo
`Daniel O’Boyle
`O’MELVENY & MYERS LLP
`7 Times Square
`New York, New York 10036
`(212) 326-2000
`
`John E. Flaherty
`Ravin R. Patel
`McCARTER & ENGLISH LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, New Jersey 07102
`(973) 622-4444
`
`
`
`Attorneys for Plaintiffs Alcon Laboratories,
`Inc.; Alcon Pharmaceuticals Ltd.; Senju
`Pharmaceutical Co., Ltd.; and Mitsubishi
`Chemical Corporation
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`Filed Electronically
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`CIVIL ACTION NO. _______________
`
`COMPLAINT FOR PATENT
`INFRINGEMENT
`
`
`
`ALCON LABORATORIES, INC.; ALCON
`PHARMACEUTICALS LTD.; SENJU
`PHARMACEUTICAL CO., LTD.; and
`MITSUBISHI CHEMICAL CORPORATION,
`
`v.
`
`AKORN, INC.,
`
`Plaintiffs,
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`Defendant.
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`COMPLAINT
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`Plaintiffs Alcon Laboratories, Inc.; Alcon Pharmaceuticals Ltd.; Senju Pharmaceutical
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`Co., Ltd.; and Mitsubishi Chemical Corporation (collectively, “Plaintiffs”) by way of this
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`Complaint against Defendant Akorn, Inc. (“Akorn”) allege as follows:
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`1.
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`Plaintiff Alcon Laboratories, Inc. (“Alcon Laboratories”) is a corporation
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`THE PARTIES
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`organized and existing under the laws of the State of Delaware, with a principal place of business
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`at 6201 South Freeway, Fort Worth, Texas 76134.
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`2.
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`Plaintiff Alcon Pharmaceuticals Ltd. (“Alcon Pharmaceuticals,” collectively with
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`Alcon Laboratories, “Alcon”) is a corporation organized and existing under the laws of
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`1
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`SENJU-MITSUBISHI 2002
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`

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`Case 2:15-cv-00285-MCA-JBC Document 1 Filed 01/14/15 Page 2 of 9 PageID: 2
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`Switzerland, having a principal place of business at Rue Louis d’Affry 6, Case postale, 1701
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`Fribourg, Switzerland.
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`3.
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`Plaintiff Senju Pharmaceutical Co., Ltd. (“Senju”) is a corporation organized and
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`existing under the laws of Japan, with a principal place of business at 2-5-8, Hirano-machi,
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`Chuo-ku, Osaka 541-0046, Japan.
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`4.
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`Plaintiff Mitsubishi Chemical Corporation (“Mitsubishi Chemical”) is a
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`corporation organized and existing under the laws of Japan with a principal place of business at
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`1-1-1 Marunouchi, Chiyoda-ku, Tokyo 100-8251, Japan.
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`5.
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`Upon information and belief, Defendant Akorn is a corporation organized and
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`existing under the laws of the State of Louisiana with a principal place of business at 1925 West
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`Field Court, Suite 300, Lake Forest, Illinois 60045.
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`6.
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`This is an action for infringement of United States Patent No. 6,114,319 (“the
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`NATURE OF THE ACTION
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`’319 patent”) under 35 U.S.C. § 271(e)(2) and for declaratory judgment of infringement under 28
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`U.S.C. §§ 2201-02 and 35 U.S.C. § 271(a), (b), and (c). The action arises out of the submission
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`by Akorn of Abbreviated New Drug Application (“ANDA”) No. 207284 to the U.S. Food and
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`Drug Administration (“FDA”) seeking approval to manufacture and sell a generic version
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`(“Akorn’s ANDA product”) of Alcon Laboratories’ DUREZOL® (difluprednate ophthalmic
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`emulsion) 0.05% product prior to the expiration of the ’319 patent.
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`JURISDICTION AND VENUE
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`7.
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`This action arises under the patent laws of the United States of America, United
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`States Code, Title 35, Section 1, et seq. and the Declaratory Judgment Act. This Court has
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`subject matter jurisdiction over the action under 28 U.S.C. §§ 1331, 1338, 2201, and 2202.
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`8.
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`Upon information and belief, this Court has personal jurisdiction over Akorn.
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`Upon information and belief, Akorn is in the business of manufacturing, marketing, importing,
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`and selling pharmaceutical drug products, including generic drug products. Upon information
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`and belief, Akorn directly manufactures, markets, and sells generic drug products throughout the
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`
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`2
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`

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`Case 2:15-cv-00285-MCA-JBC Document 1 Filed 01/14/15 Page 3 of 9 PageID: 3
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`United States and in this judicial district, and this judicial district is a likely destination for
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`Akorn’s ANDA Product. Upon information and belief, Akorn purposefully has conducted and
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`continues to conduct business in this judicial district.
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`9.
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`According to its website, Akorn employs 100 people and maintains an ophthalmic
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`product manufacturing facility in Somerset, New Jersey, located at 72 Veronica Avenue.
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`Akorn’s ANDA product is an ophthalmic product.
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`10.
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`Akorn is currently registered to do business in New Jersey, appointed an agent for
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`service of process in New Jersey, and filed an annual report in New Jersey on September 25,
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`2013. Additionally, the status report for Akorn from the New Jersey Business Gateway lists
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`Akorn’s principal business address as 72 Veronica Ave Ste 6, Somerset, NJ, 08873.
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`11.
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`Akorn obtained a Drug and Medical Device Certificate of Registration in New
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`Jersey, issued on January 10, 2014 and expiring January 31, 2015, and is currently registered in
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`New Jersey as “Manufacturer and Wholesale.”
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`12.
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`Akorn has previously been sued in this district, did not challenge this Court’s
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`assertion of personal jurisdiction over it, and asserted counterclaims for the purpose of litigating
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`a patent infringement dispute in this district. See, e.g., Novartis Pharms. Corp. v. Akorn, Inc.,
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`Case No. 2:13-cv-06835-SDW-MCA (D.N.J. filed Nov. 8, 2013); Bausch & Lomb Inc. et al. v.
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`Akorn, Inc. et al., Case No. 1:14-cv-01866-NLH-JS (D.N.J. filed Mar. 23, 2014).
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`13.
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`Through Akorn’s outside counsel, Akorn agreed not to contest jurisdiction in this
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`district for this matter.
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`14.
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`Upon information and belief, venue is proper in this Court under 28 U.S.C.
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`§§ 1391, and 1400(b).
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`BACKGROUND
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`The Patent-in-Suit
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`The U.S. Patent and Trademark Office (“USPTO”) duly and legally issued the
`
`A.
`15.
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`’319 patent, entitled “Compositions Containing Difluprednate,” on September 5, 2000. The
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`USPTO issued an ex parte reexamination certificate for the ’319 patent on May 18, 2004. Senju
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`
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`3
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`

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`Case 2:15-cv-00285-MCA-JBC Document 1 Filed 01/14/15 Page 4 of 9 PageID: 4
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`
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`and Mitsubishi Chemical are the assignees of the ’319 patent. Plaintiffs hold all substantial
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`rights in the ’319 patent and have the right to sue for infringement thereof. A copy of the ’319
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`patent is attached as Exhibit A.
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`16.
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`Alcon Pharmaceuticals is the exclusive licensee of the ’319 patent in the
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`ophthalmic field throughout the United States.
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`B.
`17.
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`Alcon’s NDA
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`Alcon Pharmaceuticals is the holder of New Drug Application (“NDA”) No.
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`022212 for difluprednate ophthalmic emulsion 0.05%, sold in the United States by Alcon
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`Laboratories under the trademark DUREZOL®. The FDA approved NDA No. 022212 on June
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`23, 2008.
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`18.
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`DUREZOL® (difluprednate ophthalmic emulsion) 0.05% is covered by one or
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`more claims of the ’319 patent, which has been listed in connection with DUREZOL® in the
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`FDA’s publication, Approved Drug Products with Therapeutic Equivalence Evaluations,
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`commonly known as the “Orange Book.”
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`C.
`19.
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`Akorn’s ANDA
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`By no earlier than December 3, 2014, Alcon Pharmaceuticals received a letter
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`from Akorn dated December 2, 2014 (“Notice Letter”), purporting to be a Notice of Certification
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`for ANDA No. 207284 pursuant to § 505(j)(2)(B)(iv) of the Federal Food, Drug, and Cosmetic
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`Act, 21 U.S.C. § 355(j)(2)(B)(iv) and 21 C.F.R. § 314.95 (“Paragraph IV Certification”).
`
`20.
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`By no earlier than December 4, 2014, Senju received Akorn’s Notice Letter dated
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`December 2, 2014.
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`21.
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`By no earlier than December 4, 2014, Mitsubishi Chemical received Akorn’s
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`Notice Letter dated December 2, 2014.
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`22.
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`Akorn’s Notice Letter states that Akorn has submitted ANDA No. 207284 to the
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`FDA seeking approval from the FDA to engage in the commercial manufacture, use, and/or sale
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`of Akorn’s ANDA Product before the expiration of the ’319 patent.
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`4
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`23.
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`Upon information and belief, the purpose of Akorn’s Paragraph IV Certification
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`submitted with Akorn’s ANDA is to obtain approval to engage in the commercial manufacture,
`
`use, import, offer for sale and/or sale of Akorn’s ANDA Product before the expiration of the
`
`’319 patent.
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`24.
`
`Upon information and belief, Akorn was aware of the ’319 patent when Akorn
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`filed ANDA No. 207284 with a Paragraph IV Certification.
`
`25.
`
`Upon information and belief, Akorn’s ANDA product is the same, or substantially
`
`the same, as DUREZOL® (difluprednate ophthalmic emulsion) 0.05%.
`
`26.
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`Upon information and belief, Akorn’s ANDA No. 207284 refers to and relies
`
`upon NDA No. 022212 and contains data that, according to Akorn, demonstrate the
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`bioequivalence of Akorn’s ANDA Product and DUREZOL® (difluprednate ophthalmic
`
`emulsion) 0.05%.
`
`27.
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`Akorn’s Notice Letter lacks any legal or factual basis for non-infringement of any
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`claim of the ’319 patent.
`
`COUNT I
`
`28.
`
`herein.
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`patent.
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`29.
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`30.
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`(INFRINGEMENT OF THE ’319 PATENT BY AKORN)
`
`Plaintiffs incorporate each of the preceding paragraphs 1-27 as if fully set forth
`
`Defendant Akorn’s ANDA Product is covered by one or more claims of the ’319
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`Defendant Akorn’s submission of ANDA No. 207284 for the purposes of
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`obtaining approval to engage in the commercial manufacture, use, import, offer for sale and/or
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`sale of Akorn’s ANDA Product before the expiration of the ’319 patent is an act of infringement
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`under 35 U.S.C. § 271(e)(2)(A) of the ’319 patent.
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`5
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`Case 2:15-cv-00285-MCA-JBC Document 1 Filed 01/14/15 Page 6 of 9 PageID: 6
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`
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`(DECLARATORY JUDGMENT OF INFRINGEMENT OF THE ’319 PATENT BY
`AKORN)
`
`COUNT II
`
`31.
`
`herein.
`
`32.
`
`Plaintiffs incorporate each of the preceding paragraphs 1-30 as if fully set forth
`
`Upon information and belief, Akorn intends to engage in the commercial
`
`manufacture, use, import, offer for sale and/or sale of Akorn’s ANDA Product immediately and
`
`imminently upon approval of Akorn’s ANDA No. 207284.
`
`33.
`
`The commercial manufacture, use, import, offer for sale and/or sale of Akorn’s
`
`ANDA Product would infringe one or more claims of the ’319 patent.
`
`34.
`
`Upon information and belief, Akorn has knowledge of the claims of the ’319
`
`patent. Notwithstanding this knowledge, Akorn has continued to assert its intent to engage in the
`
`manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of Akorn's
`
`ANDA Product immediately and imminently upon approval of ANDA No. 207284.
`
`35.
`
`Upon information and belief, Akorn plans and intends to, and will, contribute to
`
`the infringement of the ’319 patent when ANDA No. 207284 is approved, and plans and intends
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`to, and will, do so immediately and imminently upon such approval.
`
`36.
`
`Upon information and belief, Akorn plans and intends to, and will, actively
`
`induce infringement of the ’319 patent when ANDA No. 207284 is approved, and plans and
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`intends to, and will, do so immediately and imminently upon such approval.
`
`37.
`
`The commercial manufacture, use, import, offer for sale and/or sale of Akorn’s
`
`ANDA Product will constitute direct infringement of one or more claims of the ’319 patent
`
`under 35 U.S.C. § 271(a), inducement of infringement of one or more claims of the ’319 patent
`
`under 35 U.S.C. § 271(b), and contributory infringement of one or more claims of the ’319
`
`patent under 35 U.S.C. § 271(c).
`
`38.
`
`Upon information and belief, Akorn has acted, and will continue to act, with full
`
`knowledge of the ’319 patent and without a reasonable basis for believing that it would not be
`
`
`
`
`
`6
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`

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`Case 2:15-cv-00285-MCA-JBC Document 1 Filed 01/14/15 Page 7 of 9 PageID: 7
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`
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`liable for infringing the ’319 patent, contributing to the infringement of the ’319 patent, and
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`actively inducing infringement of the ’319 patent.
`
`39.
`
`There is an actual and justiciable case or controversy between Plaintiffs and
`
`Defendant Akorn concerning the infringement of the ’319 patent. Plaintiffs are entitled to a
`
`declaration that Defendant Akorn’s commercial manufacture, use, import, offer for sale and/or
`
`sale of Akorn’s ANDA Product will infringe one or more claims of the ’319 patent.
`
`40.
`
`Unless Defendant Akorn is enjoined from infringing the ’319 patent, Plaintiffs
`
`will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
`
`41.
`
`Akorn’s actions have created in Plaintiffs a reasonable apprehension of
`
`irreparable harm and loss resulting from Akorn’s threatened imminent actions.
`
`42.
`
`’319 patent.
`
`Upon information and belief, Akorn will knowingly and willfully infringe the
`
`WHEREFORE, Plaintiffs pray for judgment as follows:
`
`PRAYER FOR RELIEF
`
`A.
`
`Declaring that under 35 U.S.C. § 271(e)(2), Akorn has infringed at least one claim
`
`of the ’319 patent through Akorn’s submission of ANDA No. 207284 to the FDA to obtain
`
`approval for the commercial manufacture, use, import, offer for sale, and/or sale in the United
`
`States of Akorn’s ANDA Product prior to the expiration date of the ’319 patent;
`
`B.
`
`Declaring that the making, using, offering to sell, selling, marketing, distributing
`
`or importing of Akorn’s ANDA Product prior to the expiration of the ’319 patent will infringe,
`
`actively induce infringement, and/or contribute to the infringement of one or more claims of the
`
`’319 patent;
`
`C.
`
`Ordering that under 35 U.S.C. § 271(e)(4)(A) the effective date of any approval
`
`by the FDA of Akorn’s ANDA Product be a date that is not earlier than the expiration of the
`
`’319 patent and any related regulatory exclusivities, or such later date as the Court may
`
`determine;
`
`D.
`
`
`
`
`
`Enjoining under 35 U.S.C. § 271(e)(4)(D) Akorn and its affiliates, subsidiaries,
`
`7
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`

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`Case 2:15-cv-00285-MCA-JBC Document 1 Filed 01/14/15 Page 8 of 9 PageID: 8
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`
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`officers, agents, servants, attorneys, and employees, and those acting in privity or in concert with
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`them, from making, using, importing into the United States, offering to sell and/or selling in the
`
`United States Akorn’s ANDA Product until after the expiration date of the ’319 patent and any
`
`related regulatory exclusivities, or such later date as the Court may determine;
`
`E.
`
`Enjoining Akorn and its affiliates, subsidiaries, officers, agents, servants,
`
`attorneys, and employees, and those acting in privity or in concert with them from seeking,
`
`obtaining or maintaining approval of Akorn’s ANDA No. 207284 until expiration of the ’319
`
`patent and any related regulatory exclusivities;
`
`F.
`
`Declaring this to be an exceptional case under 35 U.S.C. §§ 285 and 271(e)(4)
`
`and awarding Plaintiffs costs, expenses and disbursements in this action, including reasonable
`
`attorneys’ fees; and
`
`Awarding Plaintiffs such further and additional relief as this Court deems proper
`
`G.
`
`and just.
`
`
`
`
`Dated: January 14, 2015
`
`
`OF COUNSEL:
`
`Lisa Pensabene
`John Kappos
`Filko Prugo
`Daniel O’Boyle
`O’MELVENY & MYERS LLP
`7 Times Square
`New York, New York 10036
`(212) 326-2000
`
`
`
`
`
`
`By: /s/ John E Flaherty
`John E. Flaherty
`Ravin R. Patel
`McCARTER & ENGLISH LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, New Jersey 07102
`(973) 622-4444
`
`Attorneys for Plaintiffs Alcon Laboratories,
`Inc.; Alcon Pharmaceuticals Ltd.; Senju
`Pharmaceutical Co., Ltd.; and Mitsubishi
`Chemical Corporation
`
`
`8
`
`
`
`

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`Case 2:15-cv-00285-MCA-JBC Document 1 Filed 01/14/15 Page 9 of 9 PageID: 9
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`CERTIFICATION PURSUANT TO L. CIV. R. 11.2
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`Plaintiffs, by their undersigned counsel, hereby certify pursuant to L. Civ. R. 11.2 that the
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`
`
`
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`matter in controversy is not the subject of any other action pending in any court, or of any
`
`pending arbitration or administrative proceeding.
`
`
`
`
`By: /s/ John E Flaherty
`John E. Flaherty
`Ravin R. Patel
`McCARTER & ENGLISH LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, New Jersey 07102
`(973) 622-4444
`
`Attorneys for Plaintiffs Alcon Laboratories,
`Inc.; Alcon Pharmaceuticals Ltd.; Senju
`Pharmaceutical Co., Ltd.; and Mitsubishi
`Chemical Corporation
`
`
`9
`
`
`
`
`
`
`Dated: January 14, 2015
`
`
`
`OF COUNSEL:
`
`Lisa Pensabene
`John Kappos
`Filko Prugo
`Daniel O’Boyle
`O’MELVENY & MYERS LLP
`7 Times Square
`New York, New York 10036
`(212) 326-2000
`
`
`
`
`
`
`
`
`

`
`-6  5HY 

`
`Case 2:15-cv-00285-MCA-JBC Document 1-1 Filed 01/14/15 Page 1 of 2 PageID: 10
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`I. (a) PLAINTIFFS
`ALCON LABORATORIES, INC.; ALCON PHARMACEUTICALS LTD.;
`SENJU PHARMACEUTICAL CO., LTD.; and MITSUBISHI CHEMICAL
`CORPORATION,
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`John E. Flaherty, Esq.
`McCarter & English, LLP, Four Gateway Center, 100 Mulberry Street,
`Newark, NJ, 07102. Tel: 973-622-4444 Email: jflaherty@mccarter.com
`
`DEFENDANTS
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`VI. CAUSE OF ACTION
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`VII. REQUESTED IN
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`VIII. RELATED CASE(S)
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`Case 2:15-cv-00285-MCA-JBC Document 1-1 Filed 01/14/15 Page 2 of 2 PageID: 11
`
`INSTRUCTIONS FOR ATTORNEYS COMPLETING CIVIL COVER SHEET FORM JS 44
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`

`
`Case 2:15-cv-00285-MCA-JBC Document 1-2 Filed 01/14/15 Page 1 of 10 PageID: 12
`Case 2:15—cv—OO285—MCA—JBC Document 1-2 Filed 01/14/15 Page 1 of 10 Page|D: 12
`
`EXHIBIT A
`EXHIBIT A
`
`
`
`

`
`Case 2:15-cv-00285-MCA-JBC Document 1-2 Filed 01/14/15 Page 2 of 10 PageID: 13
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`Case 2:15-cv-00285-MCA-JBC Document 1-2 Filed 01/14/15 Page 3 of 10 PageID: 14
`Case 2:15—cv—OO285—MCA—JBC Document 1-2 Filed 01/14/15 Page 3 of 10 Page|D: 14
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`6,114,319
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`2
`It is therefore an object of the present invention to provide
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`a composition containing difluprednate, which shows supe-
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`rior transfer of the drug to the lesion, uniform drug distri-
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`bution upon administration, less uncomfortable feeling and
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`foreign sensation upon administration, and less side effects.
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`According to the present invention, it has now been found
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`that a dosage form of a liquid composition containing
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`difluprednate, oil, water and an emulsifier results in quick
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`transfer of a large amount of difluprednate, uniform drug
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`distribution and extremely reduced levels of uncomfortable
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`feeling and foreign sensation upon local administration to
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`the eye, nose, ear and the like. Inasmuch as difluprednate can
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`be transferred smoothly, administration of a small dose
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`thereof is sufficient to bring about efficacy, whereby side
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`effects can be suppressed.
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`That is, the present invention provides the following.
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`(1) A difluprednate liquid composition comprising
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`difluprednate, oil, water and an emulsifier.
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`(2) The composition of (1) above, comprising 10—100,000
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`parts by weight of oil, 100—100,000 parts by weight of
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`water and 10—100,000 parts by weight of the emulsifier,
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`per part by weight of difluprednate.
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`(3) The composition of (1) above, comprising 10—10,000
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`parts by weight of oil, 100—50,000 parts by weight of
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`water and 10—10,000 parts by weight of the emulsifier, per
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`part by weight of difluprednate.
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`(4) The composition of (1) above, comprising 10—5,000
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`parts by weight of oil, 500—50,000 parts by weight of
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`water and 10—5,000 parts by weight of the emulsifier, per
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`part by weight of difluprednate.
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`(5) The composition of (1) above, wherein the oil comprises
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`a fatty acid ester of glycerol.
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`(6) The composition of (5) above, wherein the fatty acid
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`ester of glycerol is a member selected from the group
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`consisting of castor oil, peanut oil, cotton seed oil, soy-
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`bean oil, olive oil and a medium chain fatty acid triglyc-
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`eride.
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`(7) The composition of (1) above, wherein the emulsifier
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`comprises a surfactant.
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`(8) The composition of (7) above, wherein the surfactant is
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`a nonionic surfactant.
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`(9) The composition of (8) above, wherein the nonionic
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`surfactant is a member selected from the group consisting
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`of polyoxyethylene hydrogenated castor oil and a poly-
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`oxyethylenesorbitan fatty acid ester.
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`(10) The composition of (9) above, wherein the polyoxy-
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`ethylenesorbitan fatty acid ester is a member selected
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`from the group consisting of polyoxyethylene-sorbitan
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`monooleate, polyoxyethylenesorbitan monolaurate,
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`polyoxyethylene-sorbitan monopalmitate and polyoxy-
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`ethylenesorbitan monostearate.
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`(11) The composition of any one of (1) to (4) above, which
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`is an oil-in-water type emulsion.
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`(12) The composition of any one of (1) to (4) above, which
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`is in the form of an eye drop, a nasal drop or an ear drop.
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`DETAILED DESCRIPTION OF THE
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`INVENTION
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`invention contains
`The composition of the present
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