Arnold B. Calmann (abc@saiber.com)
`Jeffrey S. 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)
`Leah W. Feinman (leah.feinman@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
`
`Civil Action No.:
`1:15-cv-03240-JBS-KMW
`
`Document Filed Electronically
`
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and BAUSCH &
`LOMB PHARMA HOLDINGS CORP.,
`
`
`
`Plaintiffs,
`
`v.
`
`INNOPHARMA LICENSING, INC.,
`INNOPHARMA LICENSING LLC,
`INNOPHARMA, INC., INNOPHARMA,
`LLC, MYLAN PHARMACEUTICALS INC.,
`and MYLAN INC.,
`
`Defendants.
`
`
`
`
`
`
`
`
`SENJU EXHIBIT 2003
`INNOPHARMA v SENJU
`IPR2016-00091
`
`PAGE 1 OF 27
`
`

`
`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 counsel,
`
`hereby answer the Complaint of Plaintiffs Senju Pharmaceutical Co., Ltd., Bausch & Lomb Inc.,
`
`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
`
`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 400
`
`
`
`
`2
`
`PAGE 2 OF 27
`
`

`
`Somerset Corporate Blvd., 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.
`
`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, with the proviso that the township in which InnoPharma Licensing,
`
`Inc.’s principle place of business is located is named “Piscataway,” not “Picastaway.”
`
`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, with the proviso that the township in which InnoPharma Licensing
`
`LLC’s principle place of business is located is named “Piscataway,” not “Picastaway.”
`
`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, with the proviso that the township in which InnoPharma, Inc.’s
`
`principle place of business is located is named “Piscataway,” not “Picastaway.”
`
`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.
`
`
`
`
`3
`
`PAGE 3 OF 27
`
`

`
`ANSWER: Admitted, with the proviso that the township in which InnoPharma, LLC’s
`
`principle place of business is located is named “Piscataway,” not “Picastaway.”
`
`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.
`
`ANSWER: As Mylan Pharmaceuticals Inc. has been dismissed from this litigation (ECF
`
`No. 13), no answer is required to this Paragraph.
`
`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.
`
`ANSWER: As Mylan Inc. has been dismissed from this litigation (ECF No. 13), no
`
`answer is required to this Paragraph.
`
`NATURE OF THE ACTION
`
`10.
`
`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”), 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
`
`
`
`
`4
`
`PAGE 4 OF 27
`
`

`
`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 Drug Administration (“FDA”) approval to market generic Bromfenac
`
`Ophthalmic Solution 0.07% (“InnoPharma Licensing, Inc.’s generic bromfenac ophthalmic
`
`solution”).
`
`ANSWER: As Mylan Inc. and Mylan Pharmaceuticals Inc. (collectively, “Mylan”) have
`
`been dismissed from this litigation (ECF No. 13), no answer is required to the allegations in this
`
`Paragraph relating to Mylan. 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
`
`11.
`
`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.
`
`12. 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
`
`
`
`
`5
`
`PAGE 5 OF 27
`
`

`
`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, 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 12 of the Complaint.
`
`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 (sic), New Jersey 08854, and has
`
`thereby purposefully and systematically conducted and continues to conduct business in this
`
`judicial district.
`
`
`
`
`6
`
`PAGE 6 OF 27
`
`

`
`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 13 of the Complaint.
`
`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.
`
`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 14 of
`
`the Complaint.
`
`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.
`
`
`
`
`7
`
`PAGE 7 OF 27
`
`

`
`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 15 of
`
`the Complaint.
`
`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.
`
`ANSWER: As Mylan Pharmaceuticals Inc. has been dismissed from this litigation (ECF
`
`No. 13), no answer is required to this Paragraph.
`
`17. 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.
`
`
`
`
`8
`
`PAGE 8 OF 27
`
`

`
`ANSWER: As Mylan Inc. has been dismissed from this litigation (ECF No. 13), no
`
`answer is required to this Paragraph.
`
`18. 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 18 of the Complaint.
`
`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.
`
`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 19 of the Complaint and therefore deny them.
`
`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.
`
`
`
`
`9
`
`PAGE 9 OF 27
`
`

`
`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
`
`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 20 of the Complaint and therefore deny them.
`
`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.
`
`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 21 of the Complaint and therefore deny them.
`
`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.
`
`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 purports
`
`
`
`
`10
`
`PAGE 10 OF 27
`
`

`
`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 22 of the Complaint and therefore deny them.
`
`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.
`
`ANSWER: Defendants admit that the face of the ’606 patent purports the date of the
`
`issuance of the patent to be January 6, 2015. Defendants further admit that the face of the ’606
`
`patent currently lists Senju as the assignee of the ’606 patent. Defendants admit that what purports
`
`to be a copy of the ’606 patent is attached to the Complaint as Exhibit E. Defendants lack
`
`knowledge or information sufficient to form a belief about the truth of the remaining allegations
`
`of Paragraph 23 of the Complaint and therefore deny them.
`
`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”).
`
`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 further admit that the Orange Book lists the ’606 patent in conjunction with NDA No.
`
`203168. Defendants lack knowledge or information sufficient to form a belief as to the remaining
`
`allegations of Paragraph 24 of the Complaint and therefore deny them.
`
`
`
`
`11
`
`PAGE 11 OF 27
`
`

`
`25.
`
`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 25 of the Complaint and therefore deny them.
`
`AS TO ALLEGED 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).
`
`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
`
`application ANDA No. 206326. Defendants lack knowledge or information sufficient to form a
`
`belief as to the truth of the remaining allegations in Paragraph 26 of the Complaint and therefore
`
`deny them.
`
`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®.
`
`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 27 of the Complaint and therefore
`
`deny them.
`
`
`
`
`12
`
`PAGE 12 OF 27
`
`

`
`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).
`
`ANSWER: Defendants aver that by letter dated March 27, 2015 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 28 of the Complaint.
`
`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®.
`
`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 29 of
`
`the Complaint.
`
`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®.
`
`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
`
`
`
`
`13
`
`PAGE 13 OF 27
`
`

`
`application ANDA No. 206326. Defendants deny the remaining allegations of Paragraph 30 of
`
`the Complaint.
`
`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.
`
`ANSWER: As Mylan has been dismissed from this litigation (ECF No. 13), no answer is
`
`required to the allegations in this Paragraph relating to Mylan. Defendants deny the remaining
`
`allegations in Paragraph 31 of the Complaint.
`
`COUNTS I THROUGH X AGAINST MYLAN
`
`32-81.
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`ANSWER: As Mylan has been dismissed from this litigation (ECF No. 13), and Counts I
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`through X and paragraphs 32 through 81 are directed solely to Mylan, no answer is required to
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`these Counts or the allegations set forth therein.
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`COUNT XI AGAINST INNOPHARMA
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`Infringement of the ’606 Patent under § 271(e)(2)
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`82. Paragraphs 1-81 are incorporated herein as set forth above.
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`ANSWER: Defendants repeat and incorporate by reference their responses contained in
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`Paragraphs 1-81 as if fully set forth herein.
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`83.
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`Under 35 U.S.C. § 271(e)(2), InnoPharma Licensing, Inc. has infringed at least one
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`claim of the ’606 patent by submitting, or causing to be submitted to the FDA, ANDA No. 206326
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`seeking approval for the commercial marketing of InnoPharma Licensing, Inc.’s generic bromfenac
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`ophthalmic solution before the expiration date of the ’606 patent.
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`PAGE 14 OF 27
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`ANSWER: Defendants deny the allegations in Paragraph 83 of the Complaint.
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`84.
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`Upon information and belief, InnoPharma Licensing, Inc.’s generic bromfenac
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`ophthalmic solution will, if approved and marketed, infringe at least one claim of the ’606 patent.
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`ANSWER: Defendants deny the allegations in Paragraph 84 of the Complaint.
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`85.
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`Upon information and belief, InnoPharma Licensing, Inc. will, through the
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`manufacture, use import, offer for sale and/or sale of InnoPharma Licensing, Inc.’s generic
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`bromfenac ophthalmic solution, directly infringe, contributorily infringe and/or induce
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`infringement of at least one claim of the ’606 patent.
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`ANSWER: Defendants deny the allegations in Paragraph 85 of the Complaint.
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`COUNT XII AGAINST INNOPHARMA
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`Declaratory Judgment of Infringement of the ’606 Patent
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`86.
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`Paragraphs 1-85 are incorporated herein as set forth above.
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`ANSWER: Defendants repeat and incorporate by reference their responses contained in
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`Paragraphs 1-85 as if fully set forth herein.
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`87.
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`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
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`2202.
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`ANSWER: Paragraph 87 of the Complaint contains conclusions to which no answer is
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`required. To the extent an answer is required, Defendants deny the allegations in Paragraph 87 of
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`the Complaint.
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`88.
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`There is an actual case or controversy such that the Court may entertain Plaintiffs’
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`request for declaratory relief consistent with Article III of the United States Constitution, and this
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`actual case or controversy requires a declaration of rights by this Court.
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`PAGE 15 OF 27
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`ANSWER: Paragraph 88 of the Complaint contains conclusions to which no answer is
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`required. To the extent an answer is required, Defendants deny the allegations in Paragraph 88
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`of the Complaint.
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`89.
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`InnoPharma Licensing, Inc. has made, and will continue to make, substantial
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`preparation in the United States to manufacture, use, offer to sell, sell and/or import InnoPharma
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`Licensing Inc.’s generic bromfenac ophthalmic solution before the expiration date of the ’606
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`patent, including InnoPharma Licensing Inc.’s filing of ANDA No. 206326.
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`ANSWER: Defendants aver that InnoPharma Licensing, Inc. caused submission of an
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`Abbreviated New Drug Application (“ANDA”) under § 505(j)(2) of the Federal Food, Drug and
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`Cosmetic Act (21 U.S.C. §355(j)(2)(B)(ii)). Defendants aver that the FDA assigned this
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`application ANDA No. 206326. Defendants deny the remaining allegations of Paragraph 89 of
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`the Complaint.
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`90.
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`Upon information and belief, any commercial manufacture, use, offer for sale, sale,
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`and/or importation of InnoPharma Licensing Inc.’s generic bromfenac ophthalmic solution will
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`directly infringe, contributorily infringe and/or induce infringement of at least one claim of the
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`’606 patent.
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`ANSWER: Defendants deny the allegations in Paragraph 90 of the Complaint.
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`91.
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`Plaintiffs are entitled to a declaratory judgment that future commercial
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`manufacture, use, offer for sale, and/or importation of InnoPharma Licensing Inc.’s generic
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`bromfenac ophthalmic solution will constitute infringement of at least one claim of the ’606 patent.
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`ANSWER: Defendants deny the allegations contained in Paragraph 91 of the Complaint.
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`16
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`PAGE 16 OF 27
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`PRAYER FOR RELIEF
`Defendants deny that Plaintiffs are entitled to any of the relief requested in Paragraphs 1-
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`13 of the Prayer for Relief in Plaintiffs’ Complaint or otherwise.
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`SEPARATE DEFENSES
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`Without prejudice to the denials set forth in its Answer, without admitting any averments
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`of the Complaint not otherwise admitted, and without undertaking any of the burdens imposed by
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`law on the Plaintiffs, Defendants aver and assert the following Separate Defenses to the Complaint:
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`FIRST SEPARATE DEFENSE
`(Invalidity)
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`1.
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`On information and belief, the claims of the ’606 patent are invalid and/or
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`unenforceable for failure to comply with one or more of the requirements of the Patent Laws of
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`the United States, 35 U.S.C. § 1 et seq., including but not limited to §§ 101, 102, 103, and 112.
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`SECOND SEPARATE DEFENSE
`(Non-Infringement)
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`2.
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`The manufacture, sale, use, offer for sale, or importation of Defendants’ proposed
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`bromfenac product that is the subject of ANDA No. 206326, would not infringe, either directly or
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`indirectly, any valid and enforceable claim of the ’606 patent, either literally or under the doctrine
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`of equivalents.
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`THIRD SEPARATE DEFENSE
`(Prosecution History Estoppel)
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`3.
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`Plaintiffs are estopped and/or precluded from asserting that any proposed
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`bromfenac product that is the subject of ANDA No. 206326 infringes or will infringe the ’606
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`patent by reason of actions taken and statements made by the applicants of those patents to the
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`United States Patent and Trademark Office (“PTO”) during prosecution of the applications which
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`led to the patent.
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`PAGE 17 OF 27
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`FOURTH SEPARATE DEFENSE
`(Failure to State a Claim)
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`4.
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`Plaintiffs’ Complaint fails to state a claim upon which relief can be granted within
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`the meaning of Rule 12(b)(6) of the Federal Rules of Civil Procedure.
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`FIFTH SEPARATE DEFENSE
`(No Exceptional Case)
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`5.
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`Defendants’ actions in defending this case do not give rise to an exceptional case
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`under 35 U.S.C. §§ 271(e)(4) and 285.
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`SIXTH SEPARATE DEFENSE
`(Unenforceability)
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`6.
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`Any additional defenses or counterclaims that discovery may reveal, including
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`unenforceability of the ’606 patent.
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`SEVENTH SEPARATE DEFENSE
`(Injunctive Relief)
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`7.
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`Plaintiffs are not entitled to injunctive relief because Plaintiffs cannot prove (1) that
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`they have suffered irreparable injury; (2) that there is no adequate remedy at law; (3) that a remedy
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`in equity is warranted; and (4) that the public interest warrants an injunction.
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`COUNTERCLAIMS OF DEFENDANTS
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`Pursuant to Rule 13 of the Federal Rules of Civil Procedure, Defendants/Counterclaim-
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`Plaintiffs InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma, Inc., and
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`InnoPharma, LLC (collectively “InnoPharma” or “Defendants/Counterclaim-Plaintiffs”), aver and
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`assert
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`the
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`following Counterclaims against Plaintiffs/Counterclaim-Defendants Senju
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`Pharmaceutical Co., Ltd., Bausch & Lomb Incorporated, and Bausch & Lomb Pharma Holdings
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`18
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`PAGE 18 OF 27
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`Corp. (collectively, “Senju et al.”) for a declaratory judgment of patent non-infringement and
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`invalidity (or unenforceability), and allege as follows:
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`THE PARTIES
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`1.
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`Upon information and belief, and based on Plaintiffs/Counterclaim-Defendants’
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`allegations, Senju Pharmaceutical Co., Ltd. (“Senju”) is a corporation organized and existing under
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`the laws of Japan, with a principal p