`Jeffrey Soos (js@saiber.com)
`Katherine A. Escanlar (kae@saiber.com)
`SAIBER LLC
`One Gateway Center, 10th Floor
`Newark, New Jersey 07102
`Telephone: (973) 662-3333
`Facsimile: (973) 286-2465
`
`Deepro R. Mukerjee (deepro.mukerjee@alston.com)
`Lance A. Soderstrom (lance.soderstrom@alston.com)
`ALSTON & BIRD LLP
`90 Park Avenue
`New York, NY 10016
`(212) 210-9400
`
`Attorneys for Defendants InnoPharma Licensing, Inc.,
`InnoPharma Licensing LLC, InnoPharma, Inc.,
`and InnoPharma, LLC
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and BAUSCH &
`LOMB PHARMA HOLDINGS CORP.,
`
`
`
`Plaintiffs,
`
`v.
`
`INNOPHARMA LICENSING, INC.,
`INNOPHARMA LICENSING LLC,
`INNOPHARMA, INC., and INNOPHARMA,
`LLC,
`
`Defendants.
`
`
`
`Civil Action No.:
`1:14-cv-06893-JBS-KMW
`
`Document Filed Electronically
`
`ANSWER, SEPARATE DEFENSES AND COUNTERCLAIMS OF
`DEFENDANTS INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA, INC., AND INNOPHARMA LLC
`
`Defendants InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma, Inc.,
`
`and InnoPharma, LLC (collectively “InnoPharma” or “Defendants”) by and through their
`
`
`PAGE 1 OF 37
`
`SENJU EXHIBIT 2003
`INNOPHARMA v SENJU
`IPR2016-00090
`
`
`
`counsel, hereby answer the Complaint of Plaintiffs Senju Pharmaceutical Co., Ltd., Bausch &
`
`Lomb Incorporated, and Bausch & Lomb Pharma Holdings Corp., (collectively, “Plaintiffs”) and
`
`assert their separate defenses and counterclaims 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.
`
`ANSWER: Defendants lack knowledge or information sufficient to form a belief as to
`
`the truth of the allegations in Paragraph 1 of the Complaint and therefore deny them.
`
`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
`
`(“NDA”) No. 203168, which covers Prolensa®.
`
`ANSWER: Defendants aver that the Orange Book as of the date of this answer currently
`
`lists B+L as the purported registered holder of New Drug Application (“NDA”) No. 203168,
`
`which purportedly covers Prolensa®. Defendants lack knowledge or information sufficient to
`
`form a belief as to the truth of the remaining allegations in Paragraph 2 of the Complaint and
`
`therefore deny them.
`
`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 700
`
`Route 202/206, Bridgewater, New Jersey 08807. B+L Pharma Holdings is a wholly-owned
`
`subsidiary of B+L.
`
`ANSWER: Defendants lack knowledge or information sufficient to form a belief as to
`
`the truth of the allegations in Paragraph 3 of the Complaint and therefore deny them.
`
`
`
`
`2
`
`PAGE 2 OF 37
`
`
`
`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 (sic), New Jersey 08854.
`
`ANSWER: Admitted.
`
`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 (sic), New Jersey 08854.
`
`ANSWER: Admitted.
`
`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 (sic), New Jersey 08854.
`
`ANSWER: Admitted.
`
`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 (sic), New Jersey 08854.
`
`ANSWER: Admitted.
`
`NATURE OF THE ACTION
`
`8.
`
`This is an action for infringement of United States Patent No. 8,129,431 (“the
`
`’431 patent”), 8,669,290 (“the ’290 patent”), 8,754,131 (“the ’131 patent”), and 8,871,813
`
`(“the ’813 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 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
`
`
`
`
`3
`
`PAGE 3 OF 37
`
`
`
`Drug Administration (“FDA”) approval to market generic Bromfenac Ophthalmic Solution
`
`0.07% (“InnoPharma Licensing, Inc.’s generic bromfenac ophthalmic solution”).
`
`ANSWER: Defendants admit that Plaintiffs’ Complaint purports to state an action for
`
`patent infringement. Defendants further admit that the Complaint filed by Plaintiffs purports to
`
`state an action relating to an Abbreviated New Drug Application (“ANDA”) No. 206326
`
`purportedly filed by InnoPharma Licensing, Inc. with the United States Food and Drug
`
`Administration (“FDA”). To the extent an answer to any factual allegation not otherwise
`
`addressed herein is required, Defendants deny said allegation.
`
`JURISDICTION AND VENUE
`
`9.
`
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and
`
`1338(a).
`
`ANSWER: For the purposes of this action only, Defendants do not contest subject matter
`
`jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338(a). To the extent an answer to any factual
`
`allegation not otherwise addressed herein is required, Defendants deny said allegation.
`
`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 (sic), New Jersey 08854,
`
`
`
`
`4
`
`PAGE 4 OF 37
`
`
`
`and has thereby purposefully and systematically conducted and continues to conduct business in
`
`this judicial district.
`
`ANSWER: To conserve the resources of the parties and the Court, InnoPharma
`
`Licensing, Inc. does not contest personal jurisdiction in this judicial district for the limited
`
`purpose of this action only and for the limited purpose of the product covered by ANDA No.
`
`206326 which is the subject of the Complaint. InnoPharma Licensing, Inc. denies the remaining
`
`allegations in Paragraph 10 of the Complaint.
`
`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
`
`business is, on information and belief, at 10 Knightsbridge Road, Picastaway (sic), New Jersey
`
`08854, and has thereby purposefully and systematically conducted and continues to conduct
`
`business in this judicial district.
`
`ANSWER: To conserve the resources of the parties and the Court, InnoPharma
`
`Licensing, LLC does not contest personal jurisdiction in this judicial district for the limited
`
`purpose of this action only and for the limited purpose of the product covered by ANDA No.
`
`206326 which is the subject of the Complaint. InnoPharma Licensing, LLC denies the remaining
`
`allegations in Paragraph 11 of the Complaint.
`
`
`
`
`5
`
`PAGE 5 OF 37
`
`
`
`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.
`
`ANSWER: To conserve the resources of the parties and the Court, InnoPharma, Inc.
`
`does not contest personal jurisdiction in this judicial district for the limited purpose of this
`
`action only and for the limited purpose of the product covered by ANDA No. 206326 which is
`
`the subject of the Complaint. InnoPharma, Inc. otherwise denies the remaining allegations in
`
`Paragraph 12 of the Complaint.
`
`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.
`
`ANSWER: To conserve the resources of the parties and the Court, InnoPharma, LLC
`
`does not contest personal jurisdiction in this judicial district for the limited purpose of this action
`
`only and for the limited purpose of the product covered by ANDA No. 206326 which is the
`
`subject of the Complaint. InnoPharma, LLC otherwise denies the remaining allegations in
`
`Paragraph 13 of the Complaint.
`
`
`
`
`6
`
`PAGE 6 OF 37
`
`
`
`14. Upon information and belief, venue is proper in this judicial district under 28
`
`U.S.C. §§ 1391(c) and (d), and § 1400(b).
`
`ANSWER: To conserve the resources of the parties and the Court, Defendants do not
`
`contest venue in this judicial district for the limited purpose of this action only. Defendants
`
`otherwise deny the remaining allegations of Paragraph 14 of the Complaint.
`
`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 for infringement thereof. Senju is the assignee of the ’431 patent. A copy of the ’431
`
`patent is attached hereto as Exhibit A.
`
`ANSWER: Defendants admit that the face of the ’431 patent purports the date of the
`
`issuance of the patent to be March 6, 2012. Defendants further admit that the face of the ’431
`
`patent currently lists Senju as the assignee of the ’431 patent. Defendants admit that what
`
`purports to be a copy of the ’431 patent is attached to the Complaint as Exhibit A. Defendants
`
`lack knowledge or information sufficient to form a belief about the truth of the remaining
`
`allegations of Paragraph 15 of the Complaint and therefore deny them.
`
`16.
`
`The U.S. Patent and Trademark Office (“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.
`
`ANSWER: Defendants admit that the face of the ’290 patent purports the date of the
`
`issuance of the patent to be March 11, 2014. Defendants further admit that the face of the ’290
`
`
`
`
`7
`
`PAGE 7 OF 37
`
`
`
`patent currently lists Senju as the assignee of the ’290 patent. Defendants admit that what
`
`purports to be a copy of the ’290 patent is attached to the Complaint as Exhibit B. Defendants
`
`lack knowledge or information sufficient to form a belief about the truth of the remaining
`
`allegations of Paragraph 16 of the Complaint and therefore deny them.
`
`17.
`
`The U.S. Patent and Trademark Office (“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.
`
`ANSWER: Defendants admit that the face of the ’131 patent purports the date of the
`
`issuance of the patent to be June 17, 2014. Defendants further admit that the face of the ’131
`
`patent currently lists Senju as the assignee of the ’131 patent. Defendants admit that what
`
`purports to be a copy of the ’131 patent is attached to the Complaint as Exhibit C. Defendants
`
`lack knowledge or information sufficient to form a belief about the truth of the remaining
`
`allegations of Paragraph 17 of the Complaint and therefore deny them.
`
`18.
`
`The U.S. Patent and Trademark Office (“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.
`
`ANSWER: Defendants admit that the face of the ’813 patent purports the date of the
`
`issuance of the patent to be October 28, 2014. Defendants further admit that the face of the
`
`’813 patent currently lists Senju as the assignee of the ’813 patent. Defendants admit that what
`
`
`
`
`8
`
`PAGE 8 OF 37
`
`
`
`purports to be a copy of the ’813 patent is attached to the Complaint as Exhibit D. Defendants
`
`lack knowledge or information sufficient to form a belief about the truth of the remaining
`
`allegations of Paragraph 18 of the Complaint and therefore deny them.
`
`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 patent,
`
`the ’290, the ’131, and the ’813 patents are listed in the FDA’s Approved Drug Products with
`
`Therapeutic Equivalence Evaluations (“the Orange Book”).
`
`ANSWER: Defendants admit that the Orange Book as of the date of this answer
`
`currently lists B+L as the purported registered holder of New Drug Application No. 203168.
`
`Defendants further admit that the Orange Book indicates that the FDA approved Prolensa® on
`
`April 5, 2013. Defendants lack knowledge or information sufficient to form a belief as to the
`
`remaining allegations of Paragraph 19 of the Complaint, including footnote 1 thereto, and
`
`therefore deny them.
`
`20.
`
`Bromfenac Ophthalmic Solution 0.07% is sold in the United States under the
`
`trademark Prolensa®.
`
`ANSWER: Defendants lack knowledge or information sufficient to form a belief as to
`
`the truth of the allegations in Paragraph 20 of the Complaint and therefore denies them.
`
`AS TO ALLEGED INNOPHARMA LICENSING, INC.’S INFRINGING ANDA
`SUBMISSION
`
`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).
`
`ANSWER: Defendants admit that InnoPharma Licensing, Inc. caused submission of an
`
`Abbreviated New Drug Application (“ANDA”) under § 505(j)(2) of the Federal Food, Drug and
`
`Cosmetic Act (21 U.S.C. §355(j)(2)(B)(ii)). Defendants further admit that the FDA assigned this
`
`
`
`
`9
`
`PAGE 9 OF 37
`
`
`
`application ANDA No. 206326. Defendants lack knowledge or information sufficient to form a
`
`belief as to the truth of the remaining allegations in Paragraph 21 of the Complaint and therefore
`
`deny them.
`
`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®.
`
`ANSWER: Defendants aver that InnoPharma Licensing, Inc. caused submission of an
`
`Abbreviated New Drug Application (“ANDA”) under § 505(j)(2) of the Federal Food, Drug and
`
`Cosmetic Act (21 U.S.C. §355(j)(2)(B)(ii)). Defendants further aver that the FDA assigned this
`
`application ANDA No. 206326. Defendants lack knowledge or information sufficient to form a
`
`belief as to the truth of the remaining allegations in Paragraph 22 of the Complaint and therefore
`
`deny them.
`
`23.
`
`B+L 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).
`
`ANSWER: Defendants aver that by letter dated September 19, 2014 InnoPharma
`
`Licensing, Inc. sent the requisite Notification pursuant to 21 U.S.C. § 355(j)(2)(B) to Senju
`
`Pharmaceutical, Co., Ltd. and Bausch & Lomb and, in that Notification, InnoPharma Licensing,
`
`Inc. advised, among other things, that it had submitted an ANDA seeking FDA approval for
`
`bromfenac ophthalmic solution. Defendants deny the remaining allegations of Paragraph 23 of
`
`the Complaint.
`
`
`
`
`10
`
`PAGE 10 OF 37
`
`
`
`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®.
`
`ANSWER: Defendants aver that InnoPharma Licensing, Inc. caused submission of an
`
`Abbreviated New Drug Application (“ANDA”) under § 505(j)(2) of the Federal Food, Drug and
`
`Cosmetic Act (21 U.S.C. §355(j)(2)(B)(ii)). Defendants further aver that the FDA assigned this
`
`application ANDA No. 206326. Defendants deny the remaining allegations of Paragraph 24 of
`
`the Complaint.
`
`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®.
`
`ANSWER: Defendants aver that InnoPharma Licensing, Inc. caused submission of an
`
`Abbreviated New Drug Application (“ANDA”) under § 505(j)(2) of the Federal Food, Drug and
`
`Cosmetic Act (21 U.S.C. §355(j)(2)(B)(ii)). Defendants further aver that the FDA assigned this
`
`application ANDA No. 206326. Defendants deny the remaining allegations of Paragraph 25 of
`
`the Complaint.
`
`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.
`
`ANSWER: Defendants deny the allegations in Paragraph 26 of the Complaint.
`
`11
`
`
`
`
`
`
`PAGE 11 OF 37
`
`
`
`COUNT I
`
`Infringement of the ’431 Patent under § 271(e)(2)
`
`27.
`
`Paragraphs 1-26 are incorporated herein as set forth above.
`
`ANSWER: Defendants repeat and incorporate by reference their responses contained in
`
`Paragraphs 1-26 as if fully set forth herein.
`
`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.
`
`ANSWER: Defendants deny the allegations in Paragraph 28 of the Complaint.
`
`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.
`
`ANSWER: Defendants deny the allegations in Paragraph 29 of the Complaint.
`
`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.
`
`ANSWER: Defendants deny the allegations in Paragraph 30 of the Complaint.
`
`COUNT II
`
`Declaratory Judgment of Infringement of the ’431 Patent
`
`31.
`
`Paragraphs 1-30 are incorporated herein as set forth above.
`
`ANSWER: Defendants repeat and incorporate by reference their responses contained in
`
`Paragraphs 1-30 as if fully set forth herein.
`
`
`
`
`12
`
`PAGE 12 OF 37
`
`
`
`32.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`2202.
`
`ANSWER: Paragraph 32 of the Complaint contains conclusions to which no answer is
`
`required. To the extent an answer is required, Defendants deny the allegations in Paragraph 32
`
`of the Complaint.
`
`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.
`
`ANSWER: Paragraph 33 of the Complaint contains conclusions to which no answer is
`
`required. To the extent an answer is required, Defendants deny the allegations in Paragraph 33
`
`of the Complaint.
`
`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.
`
`ANSWER: Defendants aver that InnoPharma Licensing Inc. caused submission of an
`
`Abbreviated New Drug Application (“ANDA”) under § 505(j)(2) of the Federal Food, Drug and
`
`Cosmetic Act (21 U.S.C. §355(j)(2)(B)(ii)). Defendants aver that the FDA assigned this
`
`application ANDA No. 206326. Defendants deny the remaining allegations of Paragraph 34 of
`
`the Complaint.
`
`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
`
`
`
`
`13
`
`PAGE 13 OF 37
`
`
`
`will directly infringe, contributorily infringe and/or induce infringement of at least one claim of
`
`the ’431 patent.
`
`ANSWER: Defendants deny the allegations in Paragraph 35 of the Complaint.
`
`36.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for 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.
`
`ANSWER: Defendants deny the allegations contained in Paragraph 36 of the
`
`Complaint.
`
`COUNT III
`
`Infringement of the ’290 Patent under § 271(e)(2)
`
`37.
`
`Paragraphs 1-36 are incorporated herein as set forth above.
`
`ANSWER: Defendants repeat and incorporate by reference their responses contained in
`
`Paragraphs 1-36 as if fully set forth herein.
`
`38.
`
`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.
`
`ANSWER: Defendants deny the allegations in Paragraph 38 of the Complaint.
`
`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.
`
`ANSWER: Defendants deny the allegations in Paragraph 39 of the Complaint.
`
`
`
`
`14
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`PAGE 14 OF 37
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`
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`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.
`
`ANSWER: Defendants deny the allegations in Paragraph 40 of the Complaint.
`
`COUNT IV
`
`Declaratory Judgment of Infringement of the ’290 Patent
`
`41.
`
`Paragraphs 1-40 are incorporated herein as set forth above.
`
`ANSWER: Defendants repeat and incorporate by reference their responses contained in
`
`Paragraphs 1-40 as if fully set forth herein.
`
`42.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`2202.
`
`ANSWER: Paragraph 42 of the Complaint contains conclusions to which no answer is
`
`required. To the extent an answer is required, Defendants deny the allegations in Paragraph 42
`
`of the Complaint.
`
`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.
`
`ANSWER: Paragraph 43 of the Complaint contains conclusions to which no answer is
`
`required. To the extent an answer is required, Defendants deny the allegations in Paragraph 43
`
`of the Complaint.
`
`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
`
`
`
`
`15
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`PAGE 15 OF 37
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`
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`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.
`
`ANSWER: Defendants aver that InnoPharma Licensing Inc. caused submission of an
`
`Abbreviated New Drug Application (“ANDA”) under § 505(j)(2) of the Federal Food, Drug and
`
`Cosmetic Act (21 U.S.C. §355(j)(2)(B)(ii)). Defendants aver that the FDA assigned this
`
`application ANDA No. 206326. Defendants deny the remaining allegations of Paragraph 44 of
`
`the Complaint.
`
`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.
`
`ANSWER: Defendants deny the allegations in Paragraph 45 of the Complaint.
`
`46.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for 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.
`
`ANSWER: Defendants deny the allegations contained in Paragraph 46 of the
`
`Complaint.
`
`COUNT V
`
`Infringement of the ’131 Patent under § 271(e)(2)
`
`47.
`
`Paragraphs 1-46 are incorporated herein as set forth above.
`
`ANSWER: Defendants repeat and incorporate by reference their responses contained in
`
`Paragraphs 1-46 as if fully set forth herein.
`
`
`
`
`16
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`PAGE 16 OF 37
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`
`
`48.
`
`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 ’131 patent.
`
`ANSWER: Defendants deny the allegations in Paragraph 48 of the Complaint.
`
`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.
`
`ANSWER: Defendants deny the allegations in Paragraph 49 of the Complaint.
`
`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.
`
`ANSWER: Defendants deny the allegations in Paragraph 50 of the Complaint.
`
`COUNT VI
`
`Declaratory Judgment of Infringement of the ’131 Patent
`
`51.
`
`Paragraphs 1-50 are incorporated herein as set forth above.
`
`ANSWER: Defendants repeat and incorporate by reference their responses contained in
`
`Paragraphs 1-50 as if fully set forth herein.
`
`52.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`2202.
`
`ANSWER: Paragraph 52 of the Complaint contains legal conclusions to which no
`
`answer is required. To the extent an answer is required, Defendants deny the allegations in
`
`Paragraph 52 of the Complaint.
`
`
`
`
`17
`
`PAGE 17 OF 37
`
`
`
`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.
`
`ANSWER: Paragraph 53 of the Complaint contains conclusions to which no answer is
`
`required. To the extent an answer is required, Defendants deny the allegations in Paragraph 53
`
`of the Complaint.
`
`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.
`
`ANSWER: Defendants aver that InnoPharma Licensing Inc. caused submission of an
`
`Abbreviated New Drug Application (“ANDA”) under § 505(j)(2) of the Federal Food, Drug and
`
`Cosmetic Act (21 U.S.C. §355(j)(2)(B)(ii)). Defendants aver that the FDA assigned this
`
`application ANDA No. 206326. Defendants deny the remaining allegations of Paragraph 54 of
`
`the Complaint.
`
`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
`
`will directly infringe, contributorily infringe and/or induce infringement of at least one claim of
`
`the ’131 patent.
`
`ANSWER: Defendants deny the allegations in Paragraph 55 of the Complaint.
`
`56.
`
`Plaintiffs are entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, and/or importation of InnoPharma Licensing Inc.’s generic
`
`
`
`
`18
`
`PAGE 18 OF 37
`
`
`
`bromfenac ophthalmic solution will constitute infringement of at least one claim of the ’131
`
`patent.
`
`ANSWER: Defendants deny the allegations contained in Paragraph 56 of the
`
`Complaint.
`
`COUNT VII
`
`Infringement of the ’813 Patent under § 271(e)(2)
`
`57.
`
`Paragraphs 1-56 are incorporated herein as set forth above.
`
`ANSWER: Defendants repeat and incorporate by reference their responses contained in
`
`Paragraphs 1-56 as if fully set forth herein.
`
`58.
`
`Under 35 U.S.C. § 271(e)(2), InnoPharma Licensing, Inc. has infringed at least one
`
`claim of the ’131 (sic) 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.
`
`ANSWER: Defendants deny the allegations in Paragraph 58 of the Complaint.
`
`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.
`
`ANSWER: Defendants deny the allegations in Paragraph 59 of the Complaint.
`
`60.
`
`Upon information and belief, InnoPharma L