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
`
`
`
`
`Civil Action No.:
`
`
`
`
`
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB INCORPORATED and
`BAUSCH & LOMB PHARMA HOLDINGS
`CORP.
`
`
`Plaintiffs,
`
`v.
`
`WATSON LABORATORIES, INC.,
`ACTAVIS, INC., and ACTAVIS PHARMA,
`INC.
`
`
`Defendants.
`
`
`
`
`
`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 Watson Laboratories, Inc. (“Watson Labs.”), Actavis, Inc. (“Actavis”), and Actavis
`
`Pharma, Inc. (“Actavis Pharma”) (collectively, “Defendants”) allege as follows:
`
`
`#34691990 v1 (999931.2001)
`
`

`
`
`
`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 Watson Labs. is a corporation organized
`
`and existing under the laws of Nevada, having a principal place of business at 132 Business
`
`Center Drive Corona, CA 92880. Upon information and belief, Watson Labs. is a wholly-owned
`
`subsidiary of Actavis.
`
`5.
`
`Upon information and belief, defendant Actavis is a corporation organized and
`
`existing under the laws of Nevada, having a principal place of business at Morris Corporate
`
`Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054.
`
`6.
`
`Upon information and belief, defendant Actavis Pharma is a corporation
`
`organized and existing under the laws of Delaware, having a principal place of business at
`
`Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054. Upon
`
`information and belief, Actavis Pharma is a wholly-owned subsidiary of Actavis.
`
`#34691990 v1 (999931.2001)
`
`-2-
`
`Page 2
`
`

`
`
`
`NATURE OF THE ACTION
`
`7.
`
` 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”) 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
`
`Watson Labs.’ 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 Drug Administration (“FDA”) approval to market generic Bromfenac Ophthalmic Solution
`
`0.07% (“Watson Labs.’ generic bromfenac ophthalmic solution”).
`
`JURISDICTION AND VENUE
`
`8.
`
`9.
`
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
`
`Upon information and belief, this Court has jurisdiction over Watson Labs. Upon
`
`information and belief, Watson Labs. is in the business of licensing, manufacturing, distributing
`
`and selling pharmaceutical products, including generic drug products. Upon information and
`
`belief, Watson Labs. 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 the Watson Labs.’ generic bromfenac ophthalmic solution. Upon information and
`
`belief, Watson Labs. purposefully has conducted and continues to conduct business in this
`
`judicial district.
`
`10.
`
`Upon information and belief, this Court has jurisdiction over Actavis. Upon
`
`information and belief, Actavis is in the business of licensing, manufacturing, distributing and
`
`selling pharmaceutical products, including generic drug products. Upon information and belief,
`
`Actavis 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
`
`#34691990 v1 (999931.2001)
`
`-3-
`
`Page 3
`
`

`
`
`
`Watson Labs.’ generic bromfenac ophthalmic solution. Upon information and belief, Actavis
`
`purposefully has conducted and continues to conduct business in this judicial district.
`
`11.
`
`Upon information and belief, this court has jurisdiction over Actavis Pharma.
`
`Upon information and belief, Actavis Pharma directly, or indirectly, manufactures, markets and
`
`sells generic drug products, including generic drug products manufactured by Watson Labs.
`
`and/or Actavis, throughout the United States and in this judicial district. Upon information and
`
`belief, Actavis Pharma purposefully has conducted and continues to conduct business in this
`
`judicial district.
`
`12.
`
`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
`
`13.
`
`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.
`
`14.
`
`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.
`
`15.
`
`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.
`
`#34691990 v1 (999931.2001)
`
`-4-
`
`Page 4
`
`

`
`
`
`16.
`
`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.
`
`17.
`
`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.
`
`18.
`
`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”).
`
`19.
`
`Bromfenac Ophthalmic Solution 0.07% is sold in the United States under the
`
`trademark Prolensa®.
`
`WATSON LABS.’ INFRINGING ANDA SUBMISSION
`
`20.
`
`Upon information and belief, Waston Labs. filed with the FDA ANDA No.
`
`206085, under Section 505(j) of the Act and 21 U.S.C. § 355(j).
`
`21.
`
`Upon information and belief, Watson Labs.’ ANDA No. 206085 seeks FDA
`
`approval to sell in the United States Watson Labs.’ generic bromfenac ophthalmic solution,
`
`intended to be a generic version of Prolensa®.
`
`22.
`
`Bausch & Lomb received a letter from Watson Labs. dated June 1, 2015,
`
`purporting to be a Notice of Certification for ANDA No. 206085 (“Watson Labs.’ 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).
`
`#34691990 v1 (999931.2001)
`
`-5-
`
`Page 5
`
`

`
`
`
`23. Watson Labs.’ notice letter alleges that Watson Labs. has submitted to the FDA
`
`ANDA No. 206085 seeking FDA approval to sell generic bromfenac ophthalmic solution,
`
`intended to be a generic version of Prolensa®.
`
`24.
`
`Upon information and belief, ANDA No. 206085 seeks approval of Watson
`
`Labs.’ generic bromfenac ophthalmic solution that is the same, or substantially the same, as
`
`Prolensa®.
`
`25.
`
`Upon information and belief, Watson Labs.’ actions relating to ANDA No.
`
`206085 complained of herein were done with the cooperation, the participation, the assistance of,
`
`and at least in part for the benefit of Actavis and Actavis Pharma.
`
`COUNT I
`
`Infringement of the ’431 Patent under § 271(e)(2)
`
`Paragraphs 1-25 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Defendants have infringed at least one claim of the
`
`26.
`
`27.
`
`’431 patent by Watson Labs.’ submitting, or causing to be submitted to the FDA, ANDA No.
`
`206085 seeking approval for the commercial marketing of Watson Labs.’ generic bromfenac
`
`ophthalmic solution before the expiration date of the ’431 patent.
`
`28.
`
`Upon information and belief, Watson Labs.’ generic bromfenac ophthalmic
`
`solution will, if approved and marketed, infringe at least one claim of the ’431 patent.
`
`29.
`
`Upon information and belief, Defendants will, through the manufacture, use
`
`import, offer for sale and/or sale of Watson Labs.’ generic bromfenac ophthalmic solution,
`
`directly infringe, contributorily infringe and/or induce infringement of at least one claim of the
`
`’431 patent.
`
`#34691990 v1 (999931.2001)
`
`COUNT II
`
`-6-
`
`Page 6
`
`

`
`
`
`30.
`
`31.
`
`2202.
`
`Declaratory Judgment of Infringement of the ’431 Patent
`
`Paragraphs 1-29 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`32.
`
`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.
`
`33.
`
`Defendants have made, and will continue to make, substantial preparation in the
`
`United States to manufacture, use, offer to sell, sell and/or import Watson Labs.’ generic
`
`bromfenac ophthalmic solution before the expiration date of the ’431 patent, including Watson
`
`Labs.’ filing of ANDA No. 206085.
`
`34.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Watson Labs.’ generic bromfenac ophthalmic solution will directly
`
`infringe, contributorily infringe and/or induce infringement of at least one claim of the ’431
`
`patent.
`
`35.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Watson Labs.’ generic bromfenac
`
`ophthalmic solution will constitute infringement of at least one claim of the ’431 patent.
`
`COUNT III
`
`Infringement of the ’290 patent under § 271(e)(2)
`
`Paragraphs 1-35 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Defendants have infringed at least one claim of the
`
`36.
`
`37.
`
`’290 patent by Watson Labs.’ submitting, or causing to be submitted to the FDA, ANDA No.
`
`#34691990 v1 (999931.2001)
`
`-7-
`
`Page 7
`
`

`
`
`
`206085 seeking approval for the commercial marketing of Watson Labs.’ generic bromfenac
`
`ophthalmic solution before the expiration date of the ’290 patent.
`
`38.
`
`Upon information and belief, Watson Labs.’ generic bromfenac ophthalmic
`
`solution will, if approved and marketed, infringe at least one claim of the ’290 patent.
`
`39.
`
`Upon information and belief, Defendants will, through the manufacture, use
`
`import, offer for sale and/or sale of Watson Labs.’ generic bromfenac ophthalmic solution,
`
`directly infringe, contributorily infringe and/or induce infringement of at least one claim of the
`
`’290 patent.
`
`40.
`
`41.
`
`2202.
`
`COUNT IV
`
`Declaratory Judgment of Infringement of the ’290 Patent
`
`Paragraphs 1-39 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`42.
`
`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.
`
`43.
`
`Defendants have made, and will continue to make, substantial preparation in the
`
`United States to manufacture, use, offer to sell, sell and/or import Watson Labs.’ generic
`
`bromfenac ophthalmic solution before the expiration date of the ’290 patent, including Watson
`
`Labs.’ filing of ANDA No. 206085.
`
`44.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Watson Labs.’ generic bromfenac ophthalmic solution will directly
`
`#34691990 v1 (999931.2001)
`
`-8-
`
`Page 8
`
`

`
`
`
`infringe, contributorily infringe and/or induce infringement of at least one claim of the ’290
`
`patent.
`
`45.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Watson Labs.’ generic bromfenac
`
`ophthalmic solution will constitute infringement of at least one claim of the ’290 patent.
`
`COUNT V
`
`Infringement of the ’131 patent under § 271(e)(2)
`
`Paragraphs 1-45 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Defendants have infringed at least one claim of the
`
`46.
`
`47.
`
`’131 patent by Watson Labs.’ submitting, or causing to be submitted to the FDA, ANDA No.
`
`206085 seeking approval for the commercial marketing of Watson Labs.’ generic bromfenac
`
`ophthalmic solution before the expiration date of the ’131 patent.
`
`48.
`
`Upon information and belief, Watson Labs.’ generic bromfenac ophthalmic
`
`solution will, if approved and marketed, infringe at least one claim of the ’131 patent.
`
`49.
`
`Upon information and belief, Defendants will, through the manufacture, use
`
`import, offer for sale and/or sale of Watson Labs.’ generic bromfenac ophthalmic solution,
`
`directly infringe, contributorily infringe and/or induce infringement of at least one claim of the
`
`’131 patent.
`
`50.
`
`51.
`
`2202.
`
`COUNT VI
`
`Declaratory Judgment of Infringement of the ’131 Patent
`
`Paragraphs 1-49 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`#34691990 v1 (999931.2001)
`
`-9-
`
`Page 9
`
`

`
`
`
`52.
`
`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.
`
`53.
`
`Defendants have made, and will continue to make, substantial preparation in the
`
`United States to manufacture, use, offer to sell, sell and/or import Watson Labs.’ generic
`
`bromfenac ophthalmic solution before the expiration date of the ’131 patent, including Watson
`
`Labs.’ filing of ANDA No. 206085.
`
`54.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Watson Labs.’ generic bromfenac ophthalmic solution will directly
`
`infringe, contributorily infringe and/or induce infringement of at least one claim of the ’131
`
`patent.
`
`55.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Watson Labs.’ generic bromfenac
`
`ophthalmic solution will constitute infringement of at least one claim of the ’131 patent.
`
`COUNT VII
`
`Infringement of the ’813 patent under § 271(e)(2)
`
`Paragraphs 1-55 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Defendants have infringed at least one claim of the
`
`56.
`
`57.
`
`’813 patent by Watson Labs.’ submitting, or causing to be submitted to the FDA, ANDA No.
`
`206085 seeking approval for the commercial marketing of Watson Labs.’ generic bromfenac
`
`ophthalmic solution before the expiration date of the ’813 patent.
`
`58.
`
`Upon information and belief, Watson Labs.’ generic bromfenac ophthalmic
`
`solution will, if approved and marketed, infringe at least one claim of the ’813 patent.
`
`#34691990 v1 (999931.2001)
`
`-10-
`
`Page 10
`
`

`
`
`
`59.
`
`Upon information and belief, Defendants will, through the manufacture, use
`
`import, offer for sale and/or sale of Watson Labs.’ generic bromfenac ophthalmic solution,
`
`directly infringe, contributorily infringe and/or induce infringement of at least one claim of the
`
`’813 patent.
`
`60.
`
`61.
`
`2202.
`
`COUNT VIII
`
`Declaratory Judgment of Infringement of the ’813 Patent
`
`Paragraphs 1-59 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`62.
`
`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.
`
`63.
`
`Defendants have made, and will continue to make, substantial preparation in the
`
`United States to manufacture, use, offer to sell, sell and/or import Watson Labs.’ generic
`
`bromfenac ophthalmic solution before the expiration date of the ’813 patent, including Watson
`
`Labs.’ filing of ANDA No. 206085.
`
`64.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Watson Labs.’ generic bromfenac ophthalmic solution will directly
`
`infringe, contributorily infringe and/or induce infringement of at least one claim of the ’813
`
`patent.
`
`65.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Watson Labs.’ generic bromfenac
`
`ophthalmic solution will constitute infringement of at least one claim of the ’813 patent.
`
`#34691990 v1 (999931.2001)
`
`-11-
`
`Page 11
`
`

`
`
`
`66.
`
`67.
`
`COUNT IX
`
`Infringement of the ’606 Patent under § 271(e)(2)
`
`Paragraphs 1-65 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Defendants have infringed at least one claim of the
`
`’606 patent by Watson Labs.’ submitting, or causing to be submitted to the FDA, ANDA No.
`
`206085 seeking approval for the commercial marketing of Watson Labs.’ generic bromfenac
`
`ophthalmic solution before the expiration date of the ’606 patent.
`
`68.
`
`Upon information and belief, Watson Labs.’ generic bromfenac ophthalmic
`
`solution will, if approved and marketed, infringe at least one claim of the ’606 patent.
`
`69.
`
`Upon information and belief, Defendants will, through the manufacture, use
`
`import, offer for sale and/or sale of Watson Labs.’ generic bromfenac ophthalmic solution,
`
`directly infringe, contributorily infringe and/or induce infringement of at least one claim of the
`
`’606 patent.
`
`70.
`
`71.
`
`2202.
`
`COUNT X
`
`Declaratory Judgment of Infringement of the ’606 Patent
`
`Paragraphs 1-69 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`72.
`
`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.
`
`73.
`
`Defendants have made, and will continue to make, substantial preparation in the
`
`United States to manufacture, use, offer to sell, sell and/or import Watson Labs.’ generic
`
`#34691990 v1 (999931.2001)
`
`-12-
`
`Page 12
`
`

`
`
`
`bromfenac ophthalmic solution before the expiration date of the ’606 patent, including Watson
`
`Labs.’ filing of ANDA No. 206085.
`
`74.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Watson Labs.’ generic bromfenac ophthalmic solution will directly
`
`infringe, contributorily infringe and/or induce infringement of at least one claim of the ’606
`
`patent.
`
`75.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Watson Labs.’ 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), Defendants have infringed at
`
`least one claim of the ’431 patent through Watson Labs.’ submission of ANDA No. 206085 to
`
`the FDA to obtain approval for the commercial manufacture, use, import, offer for sale and/or
`
`sale in the United States of Watson Labs.’ generic bromfenac ophthalmic solution before the
`
`expiration of the ’431 patent;
`
`2.
`
`enter judgment that, under 35 U.S.C. § 271(e)(2), Defendants have infringed at
`
`least one claim of the ’290 patent through Watson Labs.’ submission of ANDA No. 206085 to
`
`the FDA to obtain approval for the commercial manufacture, use, import, offer for sale and/or
`
`sale in the United States of Watson Labs.’ generic bromfenac ophthalmic solution before the
`
`expiration of the ’290 patent;
`
`#34691990 v1 (999931.2001)
`
`-13-
`
`Page 13
`
`

`
`
`
`3.
`
`enter judgment that, under 35 U.S.C. § 271(e)(2), Defendants have infringed at
`
`least one claim of the ’131 patent through Watson Labs.’ submission of ANDA No. 206085 to
`
`the FDA to obtain approval for the commercial manufacture, use, import, offer for sale and/or
`
`sale in the United States of Watson Labs.’ generic bromfenac ophthalmic solution before the
`
`expiration of the ’131 patent;
`
`4.
`
`enter judgment that, under 35 U.S.C. § 271(e)(2), Defendants have infringed at
`
`least one claim of the ’813 patent through Watson Labs.’ submission of ANDA No. 206085 to
`
`the FDA to obtain approval for the commercial manufacture, use, import, offer for sale and/or
`
`sale in the United States of Watson Labs.’ generic bromfenac ophthalmic solution before the
`
`expiration of the ’813 patent;
`
`5.
`
`enter judgment that, under 35 U.S.C. § 271(e)(2), Defendants have infringed at
`
`least one claim of the ’606 patent through Watson Labs.’ submission of ANDA No. 206085 to
`
`the FDA to obtain approval for the commercial manufacture, use, import, offer for sale and/or
`
`sale in the United States of Watson Labs.’ generic bromfenac ophthalmic solution before the
`
`expiration of the ’606 patent;
`
`6.
`
`order that the effective date of any approval by the FDA of Watson Labs.’ 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;
`
`7.
`
`enjoin Defendants from the commercial manufacture, use, import, offer for sale
`
`and/or sale of Watson Labs.’ generic bromfenac ophthalmic solution until 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;
`
`#34691990 v1 (999931.2001)
`
`-14-
`
`Page 14
`
`

`
`
`
`8.
`
`enjoin Defendants and all persons acting in concert with Defendants from
`
`seeking, obtaining or maintaining approval of Watson Labs.’ ANDA No. 206085 until expiration
`
`of the ’431 patent, the ’290 patent, the ’131 patent, and the ’813 patent, and the ’606 patent;
`
`9.
`
`declare this to be an exceptional case under 35 U.S.C. §§ 285 and 271(e)(4) and
`
`award Plaintiffs costs, expenses and disbursements in this action, including reasonable attorneys
`
`fees;
`
`10.
`
`award Plaintiffs such further and additional relief as this Court deems just and
`
`Respectfully submitted,
`
`
`
`s/Melissa A. Chuderewicz
`Melissa A. Chuderewicz
`PEPPER HAMILTON, LLP
`(A Pennsylvania Limited Liability Partnership)
`301 Carnegie Center
`Suite 400
`Princeton, NJ, 08543-5276
`(609) 951-4118
`chuderem@pepperlaw.com
`
`Attorneys for Plaintiffs
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB INCORPORATED and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`proper.
`
`
`
`Dated: July 16, 2015
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`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
`
`#34691990 v1 (999931.2001)
`
`-15-
`
`Page 15