Case 1:14-cv-06893-JBS-KMW Document 1 Filed 11/03/14 Page 1 of 15 PageID: 1
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`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and BAUSCH &
`LOMB PHARMA HOLDINGS CORP.
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`Plaintiffs,
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` Civil Action No.:
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`
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`v.
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`INNOPHARMA LICENSING, INC.,
`INNOPHARMA LICENSING, LLC,
`INNOPHARMA, INC., AND
`INNOPHARMA, LLC,
`
`
`Defendants.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Senju Pharmaceutical Co., Ltd., Bausch & Lomb Incorporated and Bausch &
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`Lomb Pharma Holdings Corp. (collectively “Plaintiffs”) by way of Complaint against
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`Defendants Innopharma Licensing, Inc., InnoPharma Licensing, LLC, InnoPharma, Inc., and
`
`InnoPharma, LLC (collectively, “Defendants”) allege as follows:
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`THE PARTIES
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`1.
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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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`2.
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`Plaintiff Bausch & Lomb Incorporated (“B+L”) is a corporation organized and
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`existing under the laws of New York, with a place of business at 1400 North Goodman St.,
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`Page 1 of 59
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`SENJU EXHIBIT 2009
`INNOPHARMA v. SENJU
`IPR2015-00903
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`

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`Case 1:14-cv-06893-JBS-KMW Document 1 Filed 11/03/14 Page 2 of 15 PageID: 2
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`Rochester, New York 14609. B+L is the registered holder of approved New Drug Application
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`No. 203168, which covers Prolensa®.
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`3.
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`Plaintiff Bausch & Lomb Pharma Holdings Corp. (“B+L Pharma Holdings”) is a
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`corporation organized and existing under the laws of Delaware, with a place of business at 700
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`Route 202/206, Bridgewater, New Jersey 08807. B+L Pharma Holdings is a wholly-owned
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`subsidiary of B+L.
`
`4.
`
`Upon information and belief, defendant Innopharma Licensing, Inc. is a
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`corporation organized and existing under the laws of Delaware, having a principal place of
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`business at 10 Knightsbridge Road, Picastaway, New Jersey 08854.
`
`5.
`
`Upon information and belief, defendant InnoPharma Licensing, LLC is a limited
`
`liability company organized and existing under the laws of Delaware, having a principal place of
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`business at 10 Knightsbridge Road, Picastaway, New Jersey 08854.
`
`6.
`
`Upon information and belief, defendant InnoPharma Inc. is a corporation
`
`organized and existing under the laws of Delaware, having a principal place of business at 10
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`Knightsbridge Road, Picastaway, New Jersey 08854.
`
`7.
`
` Upon information and belief, defendant InnoPharma, LLC is a limited liability
`
`company organized and existing under the laws of Delaware, having a principal place of
`
`business at 10 Knightsbridge Road, Picastaway, New Jersey 08854.
`
`NATURE OF THE ACTION
`
`8.
`
`This is an action for infringement of United States Patent Nos. 8,129,431 (“the
`
`’431 patent”), 8,669,290 (“the ’290 patent”), 8,754,131 (“the ’131 patent”), and 8,871,813 (“the
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`813 patent”) arising under the United States patent laws, Title 35, United States Code, § 100 et
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`seq., including 35 U.S.C. §§ 271 and 281. This action relates to Innopharma Licensing, Inc.’s
`
`filing of an Abbreviated New Drug Application (“ANDA”) under Section 505(j) of the Federal
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`Page 2 of 59
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`Case 1:14-cv-06893-JBS-KMW Document 1 Filed 11/03/14 Page 3 of 15 PageID: 3
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`Food, Drug, and Cosmetic Act (“the Act”), 21 U.S.C. § 355(j), seeking U.S. Food and Drug
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`Administration (“FDA”) approval to market generic Bromfenac Ophthalmic Solution 0.07%
`
`(“Innopharma Licensing, Inc.’s generic bromfenac ophthalmic solution”).
`
`JURISDICTION AND VENUE
`
`9.
`
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
`
`10.
`
`Upon information and belief, this Court has jurisdiction over Innopharma
`
`Licensing, Inc. Upon information and belief, Innopharma Licensing, Inc. is in the business of
`
`licensing, manufacturing, distributing and selling pharmaceutical products, including generic
`
`drug products. Upon information and belief, Innopharma Licensing, Inc. directly licenses,
`
`manufactures, markets and sells generic drug products throughout the United States and in this
`
`judicial district, and this judicial district is a likely destination for Innopharma Licensing, Inc.’s
`
`generic bromfenac ophthalmic solution. Upon information and belief, Innopharma Licensing,
`
`Inc. operates as a patent owner or lessor for InnoPharma, Inc., whose principal place of business
`
`is, on information and belief, at 10 Knightsbridge Road, Picastaway, New Jersey 08854, and has
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`thereby purposefully and systematically conducted and continues to conduct business in this
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`judicial district.
`
`11.
`
`Upon information and belief, this Court has jurisdiction over InnoPharma
`
`Licensing, LLC. Upon information and belief, InnoPharma Licensing, LLC is in the business of
`
`licensing, manufacturing, distributing and selling pharmaceutical products, including generic
`
`drug products. Upon information and belief, InnoPharma Licensing, LLC directly licenses,
`
`manufactures, markets and sells generic drug products throughout the United States and in this
`
`judicial district, and this judicial district is a likely destination for InnoPharma Licensing, LLC’s
`
`generic bromfenac ophthalmic solution. Upon information and belief, InnoPharma Licensing,
`
`LLC operates as a patent owner or lessor for InnoPharma, LLC, whose principal place of
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`Page 3 of 59
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`business is, on information and belief, at 10 Knightsbridge Road, Picastaway, New Jersey 08854,
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`and has thereby purposefully and systematically conducted and continues to conduct business in
`
`this judicial district.
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`12.
`
`Upon information and belief, this court has jurisdiction over InnoPharma, Inc.
`
`Upon information and belief, InnoPharma, Inc. directly, or indirectly, manufactures, markets and
`
`sells generic drug products, including generic drug products manufactured by Innopharma
`
`Licensing, Inc. and InnoPharma Licensing, LLC, throughout the United States and in this
`
`judicial district. Upon information and belief, InnoPharma, Inc. purposefully has conducted and
`
`continues to conduct business in this judicial district.
`
`13.
`
`Upon information and belief, this court has jurisdiction over InnoPharma, LLC.
`
`Upon information and belief, InnoPharma, LLC directly, or indirectly, manufactures, markets
`
`and sells generic drug products, including generic drug products manufactured by Innopharma
`
`Licensing, Inc. and InnoPharma Licensing, LLC, throughout the United States and in this
`
`judicial district. Upon information and belief, InnoPharma, LLC purposefully has conducted and
`
`continues to conduct business in this judicial district.
`
`14.
`
`Upon information and belief, venue is proper in this judicial district under 28
`
`U.S.C. §§ 1391(c) and (d), and § 1400(b).
`
`THE PATENTS IN SUIT
`
`15.
`
`The U.S. Patent and Trademark Office (“PTO”) issued the ’431 patent on March
`
`6, 2012. The ’431 patent claims, inter alia, formulations of bromfenac for ophthalmic
`
`administration. Plaintiffs hold all substantial rights in the ’431 patent and have the right to sue
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`for infringement thereof. Senju is the assignee of the ’431 patent. A copy of the ’431 patent is
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`attached hereto as Exhibit A.
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`Page 4 of 59
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`Case 1:14-cv-06893-JBS-KMW Document 1 Filed 11/03/14 Page 5 of 15 PageID: 5
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`16.
`
`The U.S. Patent and Trademark Office (“PTO”) issued the ’290 patent on March
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`11, 2014. The ’290 patent claims, inter alia, formulations of bromfenac for ophthalmic
`
`administration. Plaintiffs hold all substantial rights in the ’290 patent and have the right to sue
`
`for infringement thereof. Senju is the assignee of the ’290 patent. A copy of the ’290 patent is
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`attached hereto as Exhibit B.
`
`17.
`
`The U.S. Patent and Trademark Office (“PTO”) issued the ’131 patent on June 17,
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`2014. The ’131 patent claims, inter alia, formulations of bromfenac for ophthalmic
`
`administration. Plaintiffs hold all substantial rights in the ’131 patent and have the right to sue
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`for infringement thereof. Senju is the assignee of the ’131 patent. A copy of the ’131 patent is
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`attached hereto as Exhibit C.
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`18.
`
`The U.S. Patent and Trademark Office (“PTO”) issued the ’813 patent on October
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`28, 2014. The ’813 patent claims, inter alia, formulations of bromfenac for ophthalmic
`
`administration. Plaintiffs hold all substantial rights in the ’813 patent and have the right to sue
`
`for infringement thereof. Senju is the assignee of the ’813 patent. A copy of the ’813 patent is
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`attached hereto as Exhibit D.
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`19.
`
`B+L is the holder of New Drug Application (“NDA”) No. 203168 for Prolensa®,
`
`which the FDA approved on April 5, 2013. In conjunction with NDA No. 203168, the ’431, the
`
`’290, the ’131, and the ’813 patents are listed in the FDA’s Approved Drug Products with
`
`Therapeutic Equivalence Evaluations (“the Orange Book”).1
`
`20.
`
`Bromfenac Ophthalmic Solution 0.07% is sold in the United States under the
`
`trademark Prolensa®.
`
`1 Due to an error by the FDA, the information in the Orange Book for the ʼ813 patent
`incorrectly identifies the patent’s expiration date as January 16, 2016. Plaintiffs are in the
`process of notifying the FDA of this error and requesting that the FDA correct it.
`
`Page 5 of 59
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`INNOPHARMA LICENSING, INC.’S INFRINGING ANDA SUBMISSION
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`21.
`
`Upon information and belief, Innopharma Licensing, Inc. filed with the FDA
`
`ANDA No. 206326, under Section 505(j) of the Act and 21 U.S.C. § 355(j).
`
`22.
`
`Upon information and belief, Innopharma Licensing, Inc.’s ANDA No. 206326
`
`seeks FDA approval to sell in the United States Innopharma Licensing, Inc.’s generic bromfenac
`
`ophthalmic solution, intended to be a generic version of Prolensa®.
`
`23.
`
`Bausch & Lomb received a letter from Innopharma Licensing, Inc. dated
`
`September 19, 2014, purporting to be a Notice of Certification for ANDA No. 206326
`
`(“Innopharma Licensing, Inc.’s notice letter”) under Section 505(j)(2)(B)(ii) of the Act, 21
`
`U.S.C. § 355(j)(2)(B)(ii), and 21 § C.F.R. 314.95(c).
`
`24.
`
`Innopharma Licensing, Inc.’s notice letter alleges that Innopharma Licensing, Inc.
`
`has submitted to the FDA ANDA No. 206326 seeking FDA approval to sell generic bromfenac
`
`ophthalmic solution, intended to be a generic version of Prolensa®.
`
`25.
`
`Upon information and belief, ANDA No. 206326 seeks approval of Innopharma
`
`Licensing, Inc.’s generic bromfenac ophthalmic solution that is the same, or substantially the
`
`same, as Prolensa®.
`
`26.
`
`Upon information and belief, Innopharma Licensing, Inc.’s actions relating to
`
`ANDA No. 206326 complained of herein were done with the cooperation, the participation, the
`
`assistance of, and at least in part for the benefit of InnoPharma Licensing, LLC, InnoPharma,
`
`Inc., and InnoPharma, LLC.
`
`COUNT I
`
`Infringement of the ’431 Patent under § 271(e)(2)
`
`27.
`
`Paragraphs 1-26 are incorporated herein as set forth above.
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`28.
`
`Under 35 U.S.C. § 271(e)(2), Innopharma Licensing, Inc. has infringed at least
`
`one claim of the ’431 patent by submitting, or causing to be submitted to the FDA, ANDA No.
`
`206326 seeking approval for the commercial marketing of Innopharma Licensing, Inc.’s generic
`
`bromfenac ophthalmic solution before the expiration date of the ’431 patent.
`
`29.
`
`Upon information and belief, Innopharma Licensing, Inc.’s generic bromfenac
`
`ophthalmic solution will, if approved and marketed, infringe at least one claim of the ’431 patent.
`
`30.
`
`Upon information and belief, Innopharma Licensing, Inc. will, through the
`
`manufacture, use import, offer for sale and/or sale of Innopharma Licensing, Inc.’s generic
`
`bromfenac ophthalmic solution, directly infringe, contributorily infringe and/or induce
`
`infringement of at least one claim of the ’431 patent.
`
`COUNT II
`
`Declaratory Judgment of Infringement of the ’431 Patent
`
`Paragraphs 1-30 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`31.
`
`32.
`
`2202.
`
`33.
`
`There is an actual case or controversy such that the Court may entertain Plaintiffs’
`
`request for declaratory relief consistent with Article III of the United States Constitution, and this
`
`actual case or controversy requires a declaration of rights by this Court.
`
`34.
`
`Innopharma Licensing, Inc. has made, and will continue to make, substantial
`
`preparation in the United States to manufacture, use, offer to sell, sell and/or import Innopharma
`
`Licensing, Inc.’s generic bromfenac ophthalmic solution before the expiration date of the ’431
`
`patent, including Innopharma Licensing, Inc.’s filing of ANDA No. 206326.
`
`Page 7 of 59
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`35.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Innopharma Licensing, Inc.’s generic bromfenac ophthalmic solution
`
`will directly infringe, contributorily infringe and/or induce infringement of at least one claim of
`
`the ’431 patent.
`
`
`
`36.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Innopharma Licensing, Inc.’s generic
`
`bromfenac ophthalmic solution will constitute infringement of at least one claim of the ’431
`
`patent.
`
`37.
`
`38.
`
`COUNT III
`
`Infringement of the ’290 patent under § 271(e)(2)
`
`Paragraphs 1-36 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Innopharma Licensing, Inc. has infringed at least
`
`one claim of the ’290 patent by submitting, or causing to be submitted to the FDA, ANDA No.
`
`206326 seeking approval for the commercial marketing of Innopharma Licensing, Inc.’s generic
`
`bromfenac ophthalmic solution before the expiration date of the ’290 patent.
`
`39.
`
`Upon information and belief, Innopharma Licensing, Inc.’s generic bromfenac
`
`ophthalmic solution will, if approved and marketed, infringe at least one claim of the ’290 patent.
`
`40.
`
`Upon information and belief, Innopharma Licensing, Inc. will, through the
`
`manufacture, use import, offer for sale and/or sale of Innopharma Licensing, Inc.’s generic
`
`bromfenac ophthalmic solution, directly infringe, contributorily infringe and/or induce
`
`infringement of at least one claim of the ’290 patent.
`
`COUNT IV
`
`Declaratory Judgment of Infringement of the ’290 Patent
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`Page 8 of 59
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`Paragraphs 1-40 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`41.
`
`42.
`
`2202.
`
`43.
`
`There is an actual case or controversy such that the Court may entertain Plaintiffs’
`
`request for declaratory relief consistent with Article III of the United States Constitution, and this
`
`actual case or controversy requires a declaration of rights by this Court.
`
`44.
`
`Innopharma Licensing, Inc. has made, and will continue to make, substantial
`
`preparation in the United States to manufacture, use, offer to sell, sell and/or import Innopharma
`
`Licensing, Inc.’s generic bromfenac ophthalmic solution before the expiration date of the ’290
`
`patent, including Innopharma Licensing, Inc.’s filing of ANDA No. 206326.
`
`45.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Innopharma Licensing, Inc.’s generic bromfenac ophthalmic solution
`
`will directly infringe, contributorily infringe and/or induce infringement of at least one claim of
`
`the ’290 patent.
`
`
`
`46.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Innopharma Licensing, Inc.’s generic
`
`bromfenac ophthalmic solution will constitute infringement of at least one claim of the ’290
`
`patent.
`
`47.
`
`48.
`
`COUNT V
`
`Infringement of the ’131 patent under § 271(e)(2)
`
`Paragraphs 1-46 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Innopharma Licensing, Inc. has infringed at least
`
`one claim of the ’131 patent by submitting, or causing to be submitted to the FDA, ANDA No.
`
`Page 9 of 59
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`Case 1:14-cv-06893-JBS-KMW Document 1 Filed 11/03/14 Page 10 of 15 PageID: 10
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`206326 seeking approval for the commercial marketing of Innopharma Licensing, Inc.’s generic
`
`bromfenac ophthalmic solution before the expiration date of the ’131 patent.
`
`49.
`
`Upon information and belief, Innopharma Licensing, Inc.’s generic bromfenac
`
`ophthalmic solution will, if approved and marketed, infringe at least one claim of the ’131 patent.
`
`50.
`
`Upon information and belief, Innopharma Licensing, Inc. will, through the
`
`manufacture, use import, offer for sale and/or sale of Innopharma Licensing, Inc.’s generic
`
`bromfenac ophthalmic solution, directly infringe, contributorily infringe and/or induce
`
`infringement of at least one claim of the ’131 patent.
`
`COUNT VI
`
`Declaratory Judgment of Infringement of the ’131 Patent
`
`Paragraphs 1-50 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`51.
`
`52.
`
`2202.
`
`53.
`
`There is an actual case or controversy such that the Court may entertain Plaintiffs’
`
`request for declaratory relief consistent with Article III of the United States Constitution, and this
`
`actual case or controversy requires a declaration of rights by this Court.
`
`54.
`
`Innopharma Licensing, Inc. has made, and will continue to make, substantial
`
`preparation in the United States to manufacture, use, offer to sell, sell and/or import Innopharma
`
`Licensing, Inc.’s generic bromfenac ophthalmic solution before the expiration date of the ’131
`
`patent, including Innopharma Licensing, Inc.’s filing of ANDA No. 206326.
`
`55.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Innopharma Licensing, Inc.’s generic bromfenac ophthalmic solution
`
`Page 10 of 59
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`will directly infringe, contributorily infringe and/or induce infringement of at least one claim of
`
`the ’131 patent.
`
`
`
`56.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Innopharma Licensing, Inc.’s generic
`
`bromfenac ophthalmic solution will constitute infringement of at least one claim of the ’131
`
`patent.
`
`57.
`
`58.
`
`COUNT VII
`
`Infringement of the ’813 patent under § 271(e)(2)
`
`Paragraphs 1-56 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Innopharma Licensing, Inc. has infringed at least
`
`one claim of the ’131 patent by submitting, or causing to be submitted to the FDA, ANDA No.
`
`206326 seeking approval for the commercial marketing of Innopharma Licensing, Inc.’s generic
`
`bromfenac ophthalmic solution before the expiration date of the ’813 patent.
`
`59.
`
`Upon information and belief, Innopharma Licensing, Inc.’s generic bromfenac
`
`ophthalmic solution will, if approved and marketed, infringe at least one claim of the ’813 patent.
`
`60.
`
`Upon information and belief, Innopharma Licensing, Inc. will, through the
`
`manufacture, use import, offer for sale and/or sale of Innopharma Licensing, Inc.’s generic
`
`bromfenac ophthalmic solution, directly infringe, contributorily infringe and/or induce
`
`infringement of at least one claim of the ’813 patent.
`
`COUNT VI
`
`Declaratory Judgment of Infringement of the ’813 Patent
`
`61.
`
`Paragraphs 1-60 are incorporated herein as set forth above.
`
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`62.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`2202.
`
`63.
`
`There is an actual case or controversy such that the Court may entertain Plaintiffs’
`
`request for declaratory relief consistent with Article III of the United States Constitution, and this
`
`actual case or controversy requires a declaration of rights by this Court.
`
`64.
`
`Innopharma Licensing, Inc. has made, and will continue to make, substantial
`
`preparation in the United States to manufacture, use, offer to sell, sell and/or import Innopharma
`
`Licensing, Inc.’s generic bromfenac ophthalmic solution before the expiration date of the ’813
`
`patent, including Innopharma Licensing, Inc.’s filing of ANDA No. 206326.
`
`65.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Innopharma Licensing, Inc.’s generic bromfenac ophthalmic solution
`
`will directly infringe, contributorily infringe and/or induce infringement of at least one claim of
`
`the ’813 patent.
`
`
`
`66.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Innopharma Licensing, Inc.’s generic
`
`bromfenac ophthalmic solution will constitute infringement of at least one claim of the ’813
`
`patent.
`
`
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request that the Court enter judgment in their
`
`favor and against Defendants on the patent infringement claim set forth above and respectfully
`
`request that this Court:
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`Case 1:14-cv-06893-JBS-KMW Document 1 Filed 11/03/14 Page 13 of 15 PageID: 13
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`1.
`
`enter judgment that, under 35 U.S.C. § 271(e)(2), has infringed at least one claim
`
`of the ’431 patent through Innopharma Licensing, Inc.’s submission of ANDA No. 206326 to the
`
`FDA to obtain approval for the commercial manufacture, use, import, offer for sale and/or sale in
`
`the United States of Innopharma Licensing, Inc.’s generic bromfenac ophthalmic solution before
`
`the expiration of the ’431 patent;
`
`2.
`
`enter judgment that, under 35 U.S.C. § 271(e)(2), has infringed at least one claim
`
`of the ’290 patent through Innopharma Licensing, Inc.’s submission of ANDA No. 206326 to the
`
`FDA to obtain approval for the commercial manufacture, use, import, offer for sale and/or sale in
`
`the United States of Innopharma Licensing, Inc.’s generic bromfenac ophthalmic solution before
`
`the expiration of the ’290 patent;
`
`3.
`
`enter judgment that, under 35 U.S.C. § 271(e)(2), has infringed at least one claim
`
`of the ’131 patent through Innopharma Licensing, Inc.’s submission of ANDA No. 206326 to the
`
`FDA to obtain approval for the commercial manufacture, use, import, offer for sale and/or sale in
`
`the United States of Innopharma Licensing, Inc.’s generic bromfenac ophthalmic solution before
`
`the expiration of the ’131 patent;
`
`4.
`
`enter judgment that, under 35 U.S.C. § 271(e)(2), has infringed at least one claim
`
`of the ’813 patent through Innopharma Licensing, Inc.’s submission of ANDA No. 206326 to the
`
`FDA to obtain approval for the commercial manufacture, use, import, offer for sale and/or sale in
`
`the United States of Innopharma Licensing, Inc.’s generic bromfenac ophthalmic solution before
`
`the expiration of the ’813 patent;
`
`5.
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`order that the effective date of any approval by the FDA of Innopharma
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`Licensing, Inc.’s generic bromfenac ophthalmic solution be a date that is not earlier than the
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`expiration of the ’431 patent, the ’290 patent, the ’131 patent, and the ’813 patent, or such later
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`date as the Court may determine;
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`6.
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`enjoin Defendants from the commercial manufacture, use, import, offer for sale
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`and/or sale of Innopharma Licensing, Inc.’s generic bromfenac ophthalmic solution until
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`expiration of the ’431 patent, the ’290 patent, the ’131 patent, and the ’813 patent, or such later
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`date as the Court may determine;
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`7.
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`enjoin Defendants and all persons acting in concert with Defendants from
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`seeking, obtaining or maintaining approval of Innopharma Licensing, Inc.’s ANDA No. 206326
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`until expiration of the ’431 patent, the ’290 patent, the ’131 patent, and the ’813 patent;
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`8.
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`declare this to be an exceptional case under 35 U.S.C. §§ 285 and 271(e)(4) and
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`award Plaintiffs costs, expenses and disbursements in this action, including reasonable attorneys
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`fees;
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`9.
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`award Plaintiff such further and additional relief as this Court deems just and
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`proper.
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`Dated: November 3, 2014
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`Respectfully submitted,
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`s/ Melissa A. Chuderewicz
`Melissa A. Chuderewicz
`PEPPER HAMILTON, LLP
`(A Pennsylvania Limited Liability Partnership)
`301 Carnegie Center
`Suite 400
`Princeton, New Jersey, 08543-5276
`Tel: (609) 951-4118
`Fax: (609) 452-1147
`chuderem@pepperlaw.com
`
`Attorneys for Plaintiffs
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and BAUSCH & LOMB
`PHARMA HOLDINGS CORP.
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`Page 14 of 59
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`Case 1:14-cv-06893-JBS-KMW Document 1 Filed 11/03/14 Page 15 of 15 PageID: 15
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`Of Counsel:
`Bryan C. Diner
`Justin J. Hasford
`FINNEGAN, HENDERSON,
`FARABOW, GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
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`EXHIBIT A
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`Page 16 of 59
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`Case 1:14-cv-06893-JBS-KMW Document 1-1 Filed 11/03/14 Page 2 of 9 PageID: 17
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`Case 1:14-cv-06893-JBS-KMW Document 1-1 Filed 11/03/14 Page 8 of 9 PageID: 23
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`Case 1:14-cv-06893-JBS-KMW Document 1-1 Filed 11/03/14 Page 9 of 9 PageID: 24
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`Case 1:14-cv-06893-JBS-KMW Document 1-2 Filed 11/03/14 Page 1 of 11 PageID: 25
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`EXHIBIT B
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`Page 25 of 59
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`Case 1:14-cv-06893-JBS-KMW Document 1-2 Filed 11/03/14 Page 2 of 11 PageID: 26
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`Case 1:14-cv-06893-JBS-KMW Document 1-2 Filed 11/03/14 Page 3 of 11 PageID: 27
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`Case 1:14-cv-06893-JBS-KMW Document 1-2 Filed 11/03/14 Page 11 of 11 PageID: 35
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`Case 1:14-cv-06893-JBS-KMW Document 1-3 Filed 11/03/14 Page 1 of 11 PageID: 36
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`EXHIBIT C
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`Page 36 of 59
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`Case 1:14-cv-06893-JBS-KMW Document 1-3 Filed 11/03/14 Page 2 of 11 PageID: 37
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`Case 1:14-cv-06893-JBS-KMW Document 1-4 Filed 11/03/14 Page 1 of 10 PageID: 47
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`EXHIBIT D
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`Case 1:14-cv-06893-JBS-KMW Document 1-4 Filed 11/03/14 Page 2 of 10 PageID: 48
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`Case 1:14-cv-06893-JBS-KMW Document 1-5 Filed 11/03/14 Page 1 of 1 PageID: 57
` CIVIL COVER SHEET
`JS 44 (Rev. 12/12)
`The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as
`provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the
`purpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.)
`I. (a) PLAINTIFFS
`DEFENDANTS
`
`(b) County of Residence of First Listed Plaintiff
`(EXCEPT IN U.S. PLAINTIFF CASES)
`
`(c) Attorneys (Firm Name, Address, Email and Telephone Number)
`
`NOTE:
`
`County of Residence of First Listed Defendant
`(IN U.S. PLAINTIFF CASES ONLY)
`IN LAND CONDEMNATION CASES, USE THE LOCATION OF
`THE TRACT OF LAND INVOLVED.
`
` Attorneys (If Known)
`
`II. BASIS OF JURISDICTION (Place an “X” in One Box Only)
`
`’ 1 U.S. Government
`Plaintiff
`
`’ 3 Federal Question
`(U.S. Government Not a Party)
`
`III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an “X” in One Box for Plaintiff
`(For Diversity Cases Only)
` and One Box for Defendant)
` PTF DEF
` PTF
` DEF
`Incorporated or Principal Place
`Citizen of This State
`’ 1
`’ 1
`’ 4
`’ 4
` of Business In This State
`
`’ 2 U.S. Government
`Defendant
`
`’ 4 Diversity
`(Indicate Citizenship of Parties in Item III)
`
`Citizen of Another State
`
`’ 2
`
`’ 2
`
`Incorporated and Principal Place
`of Business In Another State
`
`’ 5
`
`’ 5
`
`Citizen or Subject of a
` Foreign Country
`
`’ 3
`
`’ 3
`
`Foreign Nation
`
`’ 6
`
`’ 6
`
`BANKRUPTCY
`FORFEITURE/PENALTY
`’ 422 Appeal 28 USC 158
`’ 625 Drug Related Seizure
` of Property 21 USC 881 ’ 423 Withdrawal
`’ 690 Other
` 28 USC 157
`
`OTHER STATUTES
`’ 375 False Claims Act
`’ 400 State Reapportionment
`’ 410 Antitrust
`’ 430 Banks and Banking
`’ 450 Commerce
`’ 460 Deportation
`’ 470 Racketeer Influenced and
` Corrupt Organizations
`’ 480 Consumer Credit
`’ 490 Cable/Sat TV
`’ 850 Securities/Commodities/
` Exchange
`’ 890 Other Statutory Actions
`’ 891 Agricultural Acts
`’ 893 Environmental Matters
`’ 895 Freedom of Information
` Act
`’ 896 Arbitration
`’ 899 Administrative Procedure
` Act/Review or Appeal of
` Agency Decision
`’ 950 Constit