v.
`
`INNOPHARMA LICENSING, INC.,
`INNOPHARMA LICENSING, LLC,
`INNOPHARMA, INC., INNOPHARMA,
`LLC, MYLAN PHARMACEUTICALS, INC.,
`and MYLAN INC.
`
`
`Defendants.
`
`Melissa A. Chuderewicz
`PEPPER HAMILTON LLP
`(A Pennsylvania Limited Liability Partnership)
`Suite 400
`301 Carnegie Center
`Princeton, NJ 08543
`Tel: (609) 951-4118
`Fax: (609) 452-1147
`chuderem@pepperlaw.com
`
`Attorneys for Plaintiffs
`SENJU PHARMACEUTICAL CO., LTD.
`BAUSCH & LOMB INCORPORATED, and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`Civil Action No.:
`
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB INCORPORATED and
`BAUSCH & LOMB PHARMA HOLDINGS
`CORP.
`
`
`Plaintiffs,
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Senju Pharmaceutical Co., Ltd., Bausch & Lomb Incorporated and Bausch &
`
`Lomb Pharma Holdings Corp. (collectively, “Plaintiffs”) by way of Complaint against
`
`Defendants Innopharma Licensing, Inc., InnoPharma Licensing, LLC, InnoPharma, Inc., and
`
`InnoPharma, LLC (collectively, “Innopharma”), and Mylan Pharmaceuticals, Inc. and Mylan
`
`
`#33728938 v1 (141707 4)
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`SENJU EXHIBIT 2002
`INNOPHARMA v SENJU
`IPR2016-00091
`
`PAGE 1 OF 20
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`

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`
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`Inc. (collectively, “Mylan”) (Innopharma and Mylan collectively as “Defendants”) allege as
`
`follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Senju Pharmaceutical Co., Ltd. (“Senju”) is a corporation organized and
`
`existing under the laws of Japan, with a principal place of business at 2-5-8, Hirano-machi,
`
`Chuo-ku, Osaka 541-0046, Japan.
`
`2.
`
`Plaintiff Bausch & Lomb Incorporated (“B+L”) is a corporation organized and
`
`existing under the laws of New York, with a place of business at 1400 North Goodman St.,
`
`Rochester, New York 14609. B+L is the registered holder of approved New Drug Application
`
`No. 203168, which covers Prolensa®.
`
`3.
`
`Plaintiff Bausch & Lomb Pharma Holdings Corp. (“B+L Pharma Holdings”) is a
`
`corporation organized and existing under the laws of Delaware, with a place of business at 400
`
`Somerset Corporate Blvd., Bridgewater, New Jersey 08807. B+L Pharma Holdings is a wholly-
`
`owned subsidiary of B+L.
`
`4.
`
`Upon information and belief, defendant Innopharma Licensing, Inc. is a
`
`corporation organized and existing under the laws of Delaware, having a principal place of
`
`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
`
`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
`
`Knightsbridge Road, Picastaway, New Jersey 08854.
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`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.
`
`8.
`
`Upon information and belief, defendant Mylan Pharmaceuticals, Inc. is a
`
`company organized and existing under the laws of West Virginia, having a principal place of
`
`business at 781 Chestnut Ridge Road, Morgantown, West Virginia 26505. Upon information
`
`and belief, Mylan Pharmaceuticals, Inc. is a wholly-owned subsidiary of Mylan Inc. Upon
`
`information and belief, Mylan Pharmaceuticals, Inc. is registered to do business in New Jersey
`
`and has appointed Corporation Service Company, 830 Bear Tavern Road, West Trenton, New
`
`Jersey, as its registered agent for the receipt of service of process.
`
`9.
`
`Upon information and belief, defendant Mylan Inc. is a company organized and
`
`existing under the laws of the Commonwealth of Pennsylvania, having a principal place of
`
`business at 1500 Corporate Drive, Canonsburg, Pennsylvania 15317. Upon information and
`
`belief, Mylan Inc. is registered to do business in New Jersey and has appointed Corporation
`
`Service Company, 830 Bear Tavern Road, West Trenton, New Jersey, as its registered agent for
`
`the receipt of service of process.
`
`NATURE OF THE ACTION
`
`10.
`
` 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”), 8,871,813 (“the ’813
`
`patent), and 8,927,606 (“the ’606 patent”) against Mylan and for infringement of the ’606 patent
`
`against Innopharma, arising under the United States patent laws, Title 35, United States Code, §
`
`100 et 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 Food, Drug, and Cosmetic Act (“the Act”), 21 U.S.C. § 355(j), seeking U.S. Food and
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`#33728938 v1 (141707 4)
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`PAGE 3 OF 20
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`
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`Drug Administration (“FDA”) approval to market generic Bromfenac Ophthalmic Solution
`
`0.07% (“Innopharma Licensing, Inc.’s generic bromfenac ophthalmic solution”).
`
`JURISDICTION AND VENUE
`
`11.
`
`12.
`
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
`
`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
`
`thereby purposefully and systematically conducted and continues to conduct business in this
`
`judicial district.
`
`13.
`
`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
`
`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
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`this judicial district.
`
`14.
`
`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.
`
`15.
`
`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.
`
`16.
`
`Upon information and belief, this court has jurisdiction over Mylan
`
`Pharmaceuticals, Inc. Upon information and belief, Mylan Pharmaceuticals, 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, Mylan
`
`Pharmaceuticals, Inc. purposefully has conducted and continues to conduct business in this
`
`judicial district. Mylan Pharmaceuticals, Inc. is also one of the listed real parties in interest for
`
`Inter Partes Reviews (“IPR”) 2015-00902 and IPR 2015-00903, filed by Innopharma and Mylan
`
`collectively on March 19, 2015.
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`17.
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`Upon information and belief, this court has jurisdiction over Mylan Inc. Upon
`
`information and belief, Mylan 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, Mylan Inc. purposefully has conducted and continues to conduct
`
`business in this judicial district. Mylan Inc. is also one of the listed real parties in interest for
`
`IPR 2015-00902 and IPR 2015-00903, filed by Innopharma and Mylan collectively on March 19,
`
`2015.
`
`18.
`
`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
`
`19.
`
`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
`
`for infringement thereof. Senju is the assignee of the ’431 patent. A copy of the ’431 patent is
`
`attached hereto as Exhibit A.
`
`20.
`
`The PTO issued the ’290 patent on March 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 attached hereto as Exhibit B.
`
`21.
`
`The PTO issued the ’131 patent on June 17, 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 for infringement thereof. Senju is the assignee
`
`of the ’131 patent. A copy of the ’131 patent is attached hereto as Exhibit C.
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`22.
`
`The PTO issued the ’813 patent on October 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 attached hereto as Exhibit D.
`
`23.
`
`The PTO issued the ’606 patent on January 6, 2015. The ’606 patent claims, inter
`
`alia, formulations of bromfenac for ophthalmic administration. Plaintiffs hold all substantial
`
`rights in the ’606 patent and have the right to sue for infringement thereof. Senju is the assignee
`
`of the ’606 patent. A copy of the ’606 patent is attached hereto as Exhibit E.
`
`24.
`
`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 ’606
`
`patent is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations
`
`(“the Orange Book”).
`
`25.
`
`Bromfenac Ophthalmic Solution 0.07% is sold in the United States under the
`
`trademark Prolensa®.
`
`INNOPHARMA LICENSING, INC.’S INFRINGING ANDA SUBMISSION
`
`26.
`
`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).
`
`27.
`
`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®.
`
`28.
`
`Bausch & Lomb received a letter from Innopharma Licensing, Inc. dated March
`
`27, 2015, 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).
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`29.
`
`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®.
`
`30.
`
`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®.
`
`31.
`
`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., InnoPharma, LLC, Mylan Pharmaceuticals, Inc. and Mylan Inc.
`
`COUNT I AGAINST MYLAN
`
`Infringement of the ’431 Patent under § 271(e)(2)
`
`Paragraphs 1-31 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one claim of the ’431
`
`32.
`
`33.
`
`patent by Innopharma Licensing, Inc.’s 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.
`
`34.
`
`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.
`
`35.
`
`Upon information and belief, Mylan 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.
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`36.
`
`37.
`
`2202.
`
`COUNT II AGAINST MYLAN
`
`Declaratory Judgment of Infringement of the ’431 Patent
`
`Paragraphs 1-35 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`38.
`
`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.
`
`39. Mylan 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.
`
`40.
`
`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.
`
`
`
`41.
`
`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.
`
`COUNT III AGAINST MYLAN
`
`Infringement of the ’290 patent under § 271(e)(2)
`
`42.
`
`Paragraphs 1-41 are incorporated herein as set forth above.
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`43.
`
`Under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one claim of the ’290
`
`patent by Innopharma Licensing, Inc.’s 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.
`
`44.
`
`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.
`
`45.
`
`Upon information and belief, Mylan 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 AGAINST MYLAN
`
`Declaratory Judgment of Infringement of the ’290 Patent
`
`Paragraphs 1-45 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`46.
`
`47.
`
`2202.
`
`48.
`
`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.
`
`49. Mylan 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.
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`50.
`
`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.
`
`
`
`51.
`
`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.
`
`52.
`
`53.
`
`COUNT V AGAINST MYLAN
`
`Infringement of the ’131 patent under § 271(e)(2)
`
`Paragraphs 1-51 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one claim of the ’131
`
`patent by Innopharma Licensing, Inc.’s 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 ’131 patent.
`
`54.
`
`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.
`
`55.
`
`Upon information and belief, Mylan 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 AGAINST MYLAN
`
`Declaratory Judgment of Infringement of the ’131 Patent
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`56.
`
`57.
`
`2202.
`
`Paragraphs 1-55 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`58.
`
`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.
`
`59. Mylan 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.
`
`60.
`
`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 ’131 patent.
`
`
`
`61.
`
`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.
`
`62.
`
`63.
`
`COUNT VII AGAINST MYLAN
`
`Infringement of the ’813 patent under § 271(e)(2)
`
`Paragraphs 1-61 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one claim of the ’813
`
`patent by Innopharma Licensing, Inc.’s submitting, or causing to be submitted to the FDA,
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`
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`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.
`
`64.
`
`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.
`
`65.
`
`Upon information and belief, Mylan 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 VIII AGAINST MYLAN
`
`Declaratory Judgment of Infringement of the ’813 Patent
`
`Paragraphs 1-65 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`66.
`
`67.
`
`2202.
`
`68.
`
`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.
`
`69. Mylan 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.
`
`70.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Innopharma Licensing, Inc.’s generic bromfenac ophthalmic solution
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`will directly infringe, contributorily infringe and/or induce infringement of at least one claim of
`
`the ’813 patent.
`
`
`
`71.
`
`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.
`
`72.
`
`73.
`
`COUNT IX AGAINST MYLAN
`
`Infringement of the ’606 Patent under § 271(e)(2)
`
`Paragraphs 1-71 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one claim of the ’606
`
`patent by Innopharma Licensing, Inc.’s 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 ’606 patent.
`
`74.
`
`Upon information and belief, Innopharma Licensing, Inc.’s generic bromfenac
`
`ophthalmic solution will, if approved and marketed, infringe at least one claim of the ’606 patent.
`
`75.
`
`Upon information and belief, Mylan 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 ’606 patent.
`
`COUNT X AGAINST MYLAN
`
`Declaratory Judgment of Infringement of the ’606 Patent
`
`76.
`
`Paragraphs 1-75 are incorporated herein as set forth above.
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`2202.
`
`77.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`78.
`
`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.
`
`79. Mylan 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 ’606 patent, including
`
`Innopharma Licensing, Inc.’s filing of ANDA No. 206326.
`
`80.
`
`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 ’606 patent.
`
`
`
`81.
`
`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 ’606
`
`patent.
`
`82.
`
`83.
`
`COUNT XI AGAINST INNOPHARMA
`
`Infringement of the ’606 Patent under § 271(e)(2)
`
`Paragraphs 1-81 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 ’606 patent by submitting, or causing to be submitted to the FDA, ANDA No.
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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 ’606 patent.
`
`84.
`
`Upon information and belief, Innopharma Licensing, Inc.’s generic bromfenac
`
`ophthalmic solution will, if approved and marketed, infringe at least one claim of the ’606 patent.
`
`85.
`
`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 ’606 patent.
`
`COUNT XII AGAINST INNOPHARMA
`
`Declaratory Judgment of Infringement of the ’606 Patent
`
`Paragraphs 1-85 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`86.
`
`87.
`
`2202.
`
`88.
`
`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.
`
`89.
`
`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 ’606
`
`patent, including Innopharma Licensing, Inc.’s filing of ANDA No. 206326.
`
`90.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Innopharma Licensing, Inc.’s generic bromfenac ophthalmic solution
`
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`will directly infringe, contributorily infringe and/or induce infringement of at least one claim of
`
`the ’606 patent.
`
`
`
`91.
`
`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 ’606
`
`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:
`
`1.
`
`enter judgment that, under 35 U.S.C. § 271(e)(2), Mylan 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), Mylan 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), Mylan 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
`
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`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), Mylan 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.
`
`enter judgment that, under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one
`
`claim of the ’606 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 ’606 patent;
`
`6.
`
`enter judgment that, under 35 U.S.C. § 271(e)(2), Innopharma has infringed at
`
`least one claim of the ’606 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 ’606 patent;
`
`7.
`
`order that the effective date of any approval by the FDA of Innopharma
`
`Licensing, Inc.’s generic bromfenac ophthalmic solution be a date that is not earlier than the
`
`expiration of the ’431 patent, the ’290 patent, the ’131 patent, the ’813 patent, and the ’606
`
`patent, or such later date as the Court may determine;
`
`8.
`
`enjoin Mylan from the commercial manufacture, use, import, offer for sale and/or
`
`sale of Innopharma Licensing, Inc.’s generic bromfenac ophthalmic solution until expiration of
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`the ’431 patent, the ’290 patent, the ’131 patent, th