IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`AT CLARKSBURG
`
`
`
`CASE NO.: 1:15-cv-69-IMK_
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`NOVEN PHARMACEUTICALS, INC. and
`HISAMITSU PHARMACEUTICAL CO., INC.
`
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`Plaintiffs,
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`v.
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`MYLAN TECHNOLOGIES INC., MYLAN
`PHARMACEUTICALS INC., and MYLAN INC.
`
`
`Defendants.
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`)
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`DEFENDANTS’ ANSWER TO AMENDED COMPLAINT AND COUNTERCLAIMS
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`Defendants Mylan Technologies, Inc. (“MTI”), Mylan Pharmaceuticals Inc. (“MPI”), and
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`Mylan Inc. (collectively, “Defendants”) answer and respond to each of the allegations of
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`Plaintiffs Noven Pharmaceuticals, Inc. and Hisamitsu Pharmaceutical Co., Inc. (collectively,
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`“Plaintiffs”) Amended Complaint as follows:
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`THE PARTIES
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`1.
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`Plaintiff Noven Pharmaceuticals, Inc. is a Delaware corporation with a principal place of
`business at 11960 S.W. 144th Street, Miami, Florida 33186.
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`ANSWER: Defendants lack sufficient knowledge and information to form a belief as
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`to the truth of the allegations contained in paragraph 1 of the Amended Complaint and, on that
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`basis, deny them.
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`2.
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`Plaintiff Hisamitsu Pharmaceutical Co., Inc. is a Japanese corporation with a principal
`place of business at Saga, Tosu, Tashirodiakan-machi, 408, Japan 841-0017.
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`ANSWER: Defendants lack sufficient knowledge and information to form a belief as
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`to the truth of the allegations contained in paragraph 2 of the Amended Complaint and, on that
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`basis, deny them.
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`NCI Exhibit 2006
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`3.
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`Plaintiff Noven Pharmaceuticals, Inc. is a wholly-owned subsidiary of Hisamitsu
`Pharmaceutical Co., Inc.
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`ANSWER: Defendants lack sufficient knowledge and information to form a belief as
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`to the truth of the allegations contained in paragraph 3 of the Amended Complaint and, on that
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`basis, deny them.
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`4.
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`Upon information and belief, defendant MTI is a corporation organized and existing
`under the laws of the State of West Virginia, having a principal place of business at 110
`Lake Street, St. Albans, Vermont 05478.
`
`ANSWER: Admitted.
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`5.
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`Upon information and belief, defendant MTI is a wholly owned subsidiary of Mylan Inc.
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`ANSWER: Admitted.
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`6.
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`Upon information and belief, defendant MTI is engaged in the manufacture for sale of
`pharmaceutical products, including transdermal pharmaceutical products.
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`ANSWER: Defendants admit that MTI develops and manufactures pharmaceutical
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`products for sale in the United States. To the extent not expressly admitted herein, Defendants
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`deny the remaining allegations of paragraph 6.
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`7.
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`Upon information and belief, defendant MPI is a corporation organized and existing
`under the laws of the State of West Virginia, having a principal place of business at 781
`Chestnut Ridge Road, Morgantown, West Virginia 26505.
`
`ANSWER: Admitted.
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`8.
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`Upon information and belief, defendant MPI is a wholly owned subsidiary of Mylan Inc.
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`ANSWER: Admitted.
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`9.
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`Upon information and belief, defendant Mylan Inc. is a corporation organized and
`existing under the laws of the State of Pennsylvania, having its principal place of
`business at 1000 Mylan Blvd., Canonsburg, Pennsylvania 15317.
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`ANSWER: Admitted.
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`10.
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`Upon information and belief, defendant Mylan, Inc. controls and/or dominates
`defendants MTI and MPI.
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`ANSWER: Denied.
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`NCI Exhibit 2006
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`11.
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`Upon information and belief, defendants Mylan are in the business of, among other
`things, developing, preparing, manufacturing, selling, marketing, and distributing
`generic pharmaceutical products throughout the United States, including West Virginia.
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`ANSWER: Defendants admit
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`that MPI and MTI develop and manufacture
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`pharmaceutical products for sale in the United States. To the extent not expressly admitted
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`herein, Defendants deny the remaining allegations of paragraph 11.
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`NATURE OF THE ACTION
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`12.
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`This is a civil action for patent infringement of U.S. Patent Nos. 6,841,716 (“the ’716
`patent”) and 8,231,906 (“the ’906 patent”) (collectively, the “patents-in-suit”) arising
`under the United States Patent Laws, Title 35, United States Code § 100, et. seq., and in
`particular under 35 U.S.C. § 271. This action relates to Abbreviated New Drug
`Application (“ANDA”) No. 206685, which Defendants filed or caused to be filed under
`21 U.S.C. § 355(j) with the United States Food and Drug Administration (“FDA”), for
`approval to market a generic copy of Noven’s Minivelle® product, which is sold in the
`United States.
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`ANSWER: Paragraph 12 contains legal conclusions to which no answer is required.
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`To the extent an answer is required, Defendants admit that Plaintiffs purport to bring a civil
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`action for alleged infringement of the ’716 and ’906 patents under the Patent Laws of the United
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`States, 35 U.S.C. § 100 et seq. and under 35 U.S.C. § 271. Defendants admit that ANDA No.
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`206685 was filed with the FDA, in compliance with 21 U.S.C. § 355(j), seeking approval for
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`Estradiol Transdermal System USP “Twice-Weekly” (0.025 mg/day, 0.0375 mg/day, 0.05
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`mg/day, 0.075 mg/day, and 0.1 mg/day) prior to the expiration of the ’716 and ’906 patents.
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`Defendants deny that Mylan Inc. and MPI are proper parties to this action. To the extent not
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`expressly admitted herein, Defendants deny the remaining allegations of paragraph 12.
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`JURISDICTION AND VENUE
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`13.
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`This is a civil action for patent infringement arising under the Patent Laws of the United
`States, including 35 U.S.C. § 271.
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`ANSWER: Paragraph 13 contains legal conclusions to which no answer is required.
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`To the extent an answer is required, Defendants admit that Plaintiffs purport to bring a civil
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`NCI Exhibit 2006
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`action for alleged patent infringement under the Patent Laws of the United States, including 35
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`U.S.C. § 271. To the extent not expressly admitted herein, Defendants deny the remaining
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`allegations of paragraph 13.
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`14.
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`This Court has subject matter jurisdiction under 28 U.S.C. §§1331 and 1338(a).
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`ANSWER: Paragraph 14 contains legal conclusions to which no answer is required.
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`To the extent an answer is required, Defendants admit that this Court has subject matter
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`jurisdiction over this action with respect to MTI. Defendants deny that Mylan Inc. and MPI are
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`proper parties to this action. To the extent not expressly admitted herein, Defendants deny the
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`remaining allegations of paragraph 14.
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`15.
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`This Court has personal jurisdiction over Defendant MPI because Defendant MPI is a
`corporation organized under the laws of the State of West Virginia and maintains a
`principal place of business at 781 Chestnut Ridge Rd., Morgantown, West Virginia
`26505.
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`ANSWER: Paragraph 15 contains legal conclusions to which no answer is required.
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`To the extent that an answer is required, Defendants admit that MPI is incorporated under the
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`laws of the State of West Virginia and that it has a principal place of business in the State of
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`West Virginia. Defendants deny that Mylan Inc. and MPI are proper parties to this action. For
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`purposes of this action only, Defendants do not contest personal jurisdiction. To the extent not
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`expressly admitted herein, Defendants deny the remaining allegations of paragraph 15.
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`16.
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`This court has personal jurisdiction over Defendant MTI because Defendant MTI is a
`corporation organized under the laws of the State of West Virginia.
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`ANSWER: Paragraph 16 contains legal conclusions to which no answer is required.
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`To the extent that an answer is required, Defendants admit that MTI is incorporated under the
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`laws of the State of West Virginia. For purposes of this action only, Defendants do not contest
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`personal jurisdiction with respect to MTI. To the extent not expressly admitted herein,
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`Defendants deny the remaining allegations of paragraph 16.
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`NCI Exhibit 2006
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`17.
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`This court also has personal jurisdiction over each of the Mylan Defendants because upon
`information and belief (1) MTI, MPI, and Mylan Inc. are registered to do business in the
`State of West Virginia and share an agent for service of process in West Virginia, the
`Corporation Service Company, 209 West Washington Street, Charleston, West Virginia
`25302; (2) Defendant Mylan Inc. and MPI have submitted to jurisdiction in this District
`in numerous patent cases; and (3) Defendant Mylan Inc. has purposefully availed itself of
`the privilege of doing business in the State of West Virginia and the Northern District of
`West Virginia by continuously and systematically placing goods into the stream of
`commerce for distribution throughout the United States, including the State of West
`Virginia and the Northern District of West Virginia, and/or by selling, directly or through
`its agents, pharmaceutical products in the State of West Virginia and the Northern District
`of West Virginia.
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`ANSWER: Paragraph 17 contains legal conclusions to which no answer is required.
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`For purposes of this action only, Defendants do not contest personal jurisdiction. Defendants
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`deny that Mylan Inc. and MPI are proper parties to this action. To the extent not expressly
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`admitted herein, Defendants deny the remaining allegations of paragraph 17.
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`18.
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`Upon information and belief, MPI and MTI are registered pursuant to W. Va. Code §30-
`5-2 (2014) to distribute generic pharmaceutical products in West Virginia and hold
`current and valid “Wholesale Distributor” licenses from the West Virginia Board of
`Pharmacy. MPI also holds a current and valid “Manufacturer” license from the West
`Virginia Board of Pharmacy.
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`ANSWER: Paragraph 18 contains legal conclusions to which no answer is required.
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`For purposes of this action only, Defendants do not contest personal jurisdiction. Defendants
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`deny that Mylan Inc. and MPI are proper parties to this action. To the extent not expressly
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`admitted herein, Defendants deny the remaining allegations of paragraph 18.
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`19.
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`Upon information and belief, Mylan Inc. regularly does or solicits business in West
`Virginia, engages in other persistent courses of conduct in West Virginia, and/or derives
`substantial revenue from services or things used or consumed in West Virginia by Mylan
`Inc. or its affiliates and agents, including MTI and MPI, demonstrating that Mylan Inc.
`has continuous and systematic contacts with West Virginia.
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`ANSWER: Paragraph 19 contains legal conclusions to which no answer is required.
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`For purposes of this action only, Defendants do not contest personal jurisdiction. Defendants
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`NCI Exhibit 2006
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`deny that Mylan Inc. and MPI are proper parties to this action. To the extent not expressly
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`admitted herein, Defendants deny the remaining allegations of paragraph 19.
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`20.
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`21.
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`22.
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`Upon information and belief, Defendants are agents of each other and/or work in concert
`with each other with respect to the development, regulatory approval, marketing, sale and
`distribution of pharmaceutical products throughout the United States including in West
`Virginia, including the generic Estradiol Transdermal System, USP “Twice-Weekly” in
`0.025mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day dosage
`strengths described in Defendants’ ANDA No. 206685 (“the generic product”), which are
`accused of infringing the Minivelle® patents.
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`ANSWER: Denied.
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`Upon information and belief, Defendants MPI and Mylan Inc. acted in concert with MTI
`in the preparation, development, and filing of ANDA No. 206685 and its underlying
`subject matter.
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`ANSWER: Denied.
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`If ANDA No. 206685 is approved, the generic product will, among other things, be
`marketed and distributed in West Virginia, and/or prescribed by physicians practicing and
`dispensed by pharmacies located within West Virginia, all of which will have a
`substantial effect on West Virginia.
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`ANSWER: The allegations in Paragraph 22 are speculative, and on that basis
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`Defendants deny them.
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`23.
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`Defendants know and intend that the generic product will be distributed and sold in the
`United States, including in West Virginia.
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`ANSWER: Denied.
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`24.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b).
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`ANSWER: Paragraph 24 contains legal conclusions to which no answer is required.
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`To the extent an answer is required, for purposes of this action only, Defendants do not dispute
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`that venue is proper in this Court. Defendants deny that Mylan Inc. and MPI are proper parties
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`to this action. To the extent not expressly admitted herein, Defendants deny the remaining
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`allegations of paragraph 24.
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`NCI Exhibit 2006
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`25.
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`On April 23, 2015, Plaintiffs filed a complaint against the Mylan Defendants for patent
`infringement in the United States District Court for the District of Delaware based on the
`filing of ANDA No. 206685. The resulting Delaware action is presently pending. A copy
`of the complaint in the Delaware action (the “Delaware Minivelle® Action), excluding
`exhibits, is attached hereto as Exhibit A. The Delaware complaint alleges essentially the
`same acts of infringement as the present complaint.
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`ANSWER: Defendants admit that on April 23, 2015, Noven Pharmaceuticals, Inc. and
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`Hisamitsu Pharmaceutical Co., Inc. filed a complaint against MTI, MPI, and Mylan Inc. in the
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`District of Delaware alleging infringement of the ’716 and ’906 patents. Defendants admit that
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`Exhibit A purports to be a copy of the complaint in the Delaware action. To the extent not
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`expressly admitted herein, Defendants deny the remaining allegations of paragraph 25.
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`26.
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`Plaintiff Noven Pharmaceuticals, Inc. also filed on March 20, 2015 a related patent
`infringement action involving Minivelle® and a different generic defendant in the United
`States District Court for the District of Delaware (Noven Pharmaceuticals, Inc. v. Actavis
`Laboratories UT, Inc., Civ. Action No. 1:15-cv-00249-LPS (D. Del. 2015) (Doc. #1)).
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`ANSWER: Defendants lack sufficient knowledge and information to form a belief as
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`to the truth of the allegations contained in paragraph 26 and, on that basis, deny them.
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`27.
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`28.
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`Based on the Mylan Defendants’ continuous and systematic business contacts with
`Delaware, Defendants should be subject to personal jurisdiction in the District of
`Delaware; however, Defendants may assert that they are not subject to such jurisdiction.
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`ANSWER: Denied.
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`Plaintiffs are therefore filing the instant complaint, which has identical infringement
`claims against the Mylan Defendants as the Delaware Minivelle® Action, a so called
`Hatch-Waxman “protective suit,” to preserve its right for a 30-month stay under 21
`U.S.C. § 355(j)(5)(B)(iii). If Mylan challenges jurisdiction in the Delaware Minivelle®
`Action, Plaintiffs intend to move this Court to stay or transfer the instant action pending
`resolution of any jurisdictional challenge in the Delaware Minivelle® Action.
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`ANSWER: Paragraph 28 contains legal conclusions and statements to which no
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`answer is required. To the extent an answer is required, denied.
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`FACTUAL BACKGROUND
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`29.
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`The ’716 patent, entitled “Patch” was duly and legally issued by the United States Patent
`and Trademark Office (“USPTO”) on January 11, 2005.
` Plaintiff Hisamitsu
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`Pharmaceutical Co., Inc. is the owner of all title, right, and interest in and to the ’716
`patent by assignment and therefore has the full right to sue and recover for the
`infringement thereof. A copy of the ’716 patent is attached as Exhibit B.
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`ANSWER: Paragraph 29 contains legal conclusions to which no answer is required.
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`To the extent an answer is required, Defendants admit that Exhibit B purports to be a copy of the
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`’716 patent, and that, on its face, the ’716 patent lists a “Date of Patent” of January 11, 2005 and
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`identifies Hisamitsu Pharmaceutical Co., Inc. as an “Assignee.” Defendants lack sufficient
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`knowledge and information to form a belief as to the truth of the remaining allegations of
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`paragraph 29, and on that basis deny the remaining allegations of paragraph 29.
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`30.
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`The ’906 patent, entitled “Transdermal Estrogen Device And Delivery,” was duly and
`legally issued by the USPTO on July 31, 2012 and certificates of correction were issued
`on June 18, 2013 and July 22, 2014. Plaintiff Noven Pharmaceuticals, Inc. is the owner
`of all title, right, and interest in and to the ’906 patent by assignment and therefore has the
`full right to sue and recover for the infringement thereof. A copy of the ’906 patent and
`certificates of correction are attached as Exhibit C.
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`ANSWER: Paragraph 30 contains legal conclusions to which no answer is required.
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`To the extent an answer is required, Defendants admit that Exhibit C purports to be a copy of the
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`’906 patent and that, on its face, the ’906 patent lists a “Date of Patent” of July 31, 2012 and
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`identifies Noven Pharmaceuticals, Inc. as an “Assignee.” To the extent not expressly admitted
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`herein, Defendants deny the remaining allegations of paragraph 30.
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`31.
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`Noven is the holder of New Drug Application No. 203752 for the manufacture and sale of
`Estradiol Transdermal System USP (Twice-Weekly), which it sells under the registered
`trademark Minivelle®. Pursuant to Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §
`355(b)(1) (“FFD&C Act”), and corresponding FDA regulations, Noven has listed the
`patents-in-suit in the FDA’s Orange Book as covering Minivelle® and methods for using
`it.
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`ANSWER: Paragraph 31 contains legal conclusions to which no answer is required.
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`To the extent an answer is required, Defendants admit that the records of the FDA indicate that
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`Noven Pharmaceuticals, Inc. is the holder of New Drug Application (“NDA”) No. 203752.
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`Defendants further admit that the records of the FDA indicate that NDA No. 203752 covers a
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`NCI Exhibit 2006
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`Estradiol Transdermal System USP “Twice-Weekly” 0.025 mg/day, 0.0375 mg/day, 0.05
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`mg/day, 0.075 mg/day, and 0.1 mg/day product having the proprietary name “Minivelle”.
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`Defendants further admit that the records of the FDA indicate that the ’716 and ’906 patents are
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`listed in the FDA’s Orange Book as associated with Minivelle®. To the extent not expressly
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`admitted herein, Defendants deny the remaining allegations of paragraph 31.
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`32.
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`Upon information and belief, pursuant to FFD&C Act 21 U.S.C. § 505(j), Defendants
`filed ANDA No. 206685 with the FDA. Defendants’ ANDA seeks FDA approval to
`market and sell the generic product prior to the expiration of the patents-in-suit.
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`ANSWER: Defendants admit that MTI is identified in ANDA No. 206685 as the
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`entity that submitted ANDA No. 206685 under 21 U.S.C. § 355(j). Defendants further admit
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`that § 355(j) and the ANDA speak for themselves and are the best sources for their respective
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`contents. To the extent not expressly admitted herein, Defendants deny the remaining
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`allegations of paragraph 32.
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`33.
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`Upon information and belief, Mylan’s ANDA No. 206685 identified Noven’s Minivelle®
`product and included a written certification, as required by the FFD&C Act 21 U.S.C. §
`355(j)(2)(A)(vii)(IV) (the “Paragraph IV certification”), alleging that the claims of the
`patents-in-suit are invalid or otherwise will not be infringed by Mylan’s generic product.
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`ANSWER: Defendants admit that ANDA No. 206685 included certifications under 21
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`U.S.C. § 355(j)(2)(A)(vii)(IV). Defendant’s further admit that 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
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`and the certifications speak for themselves and are the best sources for their respective contents.
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`To the extent not expressly admitted herein, Defendants deny the remaining allegations of
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`paragraph 33.
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`NCI Exhibit 2006
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`34.
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`On or about March 12, 2015 Noven received a letter from MTI purporting to be a written
`notice that Mylan had filed ANDA No. 206685 seeking approval to market its generic
`product prior to the expiration of the patents-in-suit, pursuant to FFD&C Act, 21 U.S.C. §
`505(j)(2)(B)(iv) (“Paragraph IV letter I”). In this letter MTI claimed that it had sought to
`obtain approval to engage in the commercial manufacture, use, or sale of Estradiol
`Transdermal System, USP “Twice Weekly” 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day,
`and 0.1 mg/day.
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`ANSWER: Defendants admit that MTI provided written notice to Plaintiffs by a first
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`notice letter (“Notice Letter I”) that ANDA 206685 had been filed with a certification provided
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`for in 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that the ’716 and ’906 patents are invalid, unenforceable,
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`and/or will not be infringed by the products that are the subject of ANDA 206685. To the extent
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`not expressly admitted herein, Defendants deny the remaining allegations of paragraph 34.
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`35.
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`On or about May 4, 2015 Noven received another letter from MTI purporting to be
`written notice that Mylan was further seeking approval in ANDA No. 206685 to engage
`in the commercial manufacture, use, or sale of Estradiol Transdermal, USP “Twice-
`Weekly” 0.025 mg/day (“Paragraph IV letter II”). Paragraph IV letters I and II included
`notice of Mylan’s allegations that the patents-in-suit are invalid, unenforceable, and/or
`not infringed by Mylan’s generic product.
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`ANSWER: Defendants admit that MTI provided written notice to Plaintiffs by a
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`second notice letter (“Notice Letter II”) that ANDA 206685 had been filed with a certification
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`provided for in 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that the ’716 and ’906 patents are invalid,
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`unenforceable, and/or will not be infringed by the products that are the subject of ANDA
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`206685. To the extent not expressly admitted herein, Defendants deny the remaining allegations
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`of paragraph 35.
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`36. Mylan’s submission of ANDA No. 206685, including the Paragraph IV certifications, to
`the FDA constituted infringement of the patents-in-suit under 35 U.S.C. § 271(e)(2).
`Moreover, upon information and belief, Mylan’s anticipated commercial manufacture,
`use, sale, offer for sale, or importation of the generic product upon approval and before
`expiration of the patents-in-suit will infringe at least one claim of each of the patents-in-
`suit under 35 U.S.C. § 271(a), (b), and/or (c).
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`ANSWER: Denied.
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`NCI Exhibit 2006
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`37. Mylan purported to include an Offer of Confidential Access (“the Mylan Offer”) to
`Noven to ANDA No. 206685 along with its Paragraph IV Letters. Under the FFD&C
`Act, 21 U.S.C. § 355(j)(5)(C)(III), an Offer of Confidential Access “shall contain such
`restrictions as to persons entitled to access, and on the use and disposition of any
`information accessed, as would apply had a protective order been entered for the purpose
`of protecting trade secrets and other confidential information.”
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`ANSWER: Paragraph 37 contains legal conclusions to which no answer is required.
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`To the extent an answer is required, Defendants admit that MTI provided Plaintiffs with an Offer
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`of Confidential Access (“OCA”) to the confidential information contained in ANDA No.
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`206685. To the extent not expressly admitted herein, Defendants deny the remaining allegations
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`of paragraph 37.
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`38.
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`39.
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`40.
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`The Mylan Offer contained various restrictions, above and beyond those that would apply
`under a typical protective order, on who could view the ANDA and remedies in the event
`of a violation or breach. For example, the Mylan Offer substantially limited the fields of
`practice of outside and in-house counsel who might view the ANDA. In addition, the
`restrictions imposed by the Mylan Offer were not sufficiently directed to the purpose of
`protecting trade secrets and other confidential business information.
`
`ANSWER: Denied.
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`Since receiving Mylan’s Paragraph IV letter I, Plaintiffs have attempted to negotiate with
`Mylan to procure a copy of the ANDA and to reach agreement on the terms and
`conditions of the Mylan Offer. These negotiations have been unsuccessful and the parties
`did not reach agreement. For example, Mylan’s most recent proposal continues to unduly
`limit the fields of practice and other activities of outside and in-house counsel who would
`accept access to the ANDA and goes beyond such restrictions as would apply had a
`protective order been entered.
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`ANSWER: Denied.
`
`Plaintiffs are not aware of any other means for obtaining information regarding Mylan’s
`proposed generic product within the 45-day statutory period. In the absence of such
`information, Plaintiffs resort to the judicial process and the aid of discovery to obtain,
`under appropriate judicial safeguards, such information as is required to confirm its
`allegations of infringement and to present to the court evidence that Mylan’s proposed
`generic product falls within the scope of one or more claims of the patents-in-suit.
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`ANSWER: Denied.
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`41.
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`Noven commenced this action within 45 days of receiving the Paragraph IV letter.
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`ANSWER: Defendants admit that the Complaint was filed on April 24, 2015 and that
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`date is within 45 days from the date on which MTI sent Notice Letter I. To the extent not
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`expressly admitted herein, Defendants deny the remaining allegations of paragraph 41.
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`COUNT I: INFRINGEMENT OF U.S. PATENT NO. 6,841,716
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`42.
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`Paragraphs 1-41 are incorporated by reference as though fully set forth herein.
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`ANSWER: Defendants reassert and incorporate by reference their answers to
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`paragraphs 1-41 as if fully set forth herein.
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`43. Mylan’s submission of ANDA No. 206685 and its Paragraph IV certification seeking
`FDA approval to commercially manufacture, use, sell, offer to sell, or import the generic
`product prior to the expiration of the ’716 Patent constituted patent infringement under 35
`U.S.C. § 271(e)(2).
`
`ANSWER: Denied.
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`44.
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`45.
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`46.
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`Upon information and belief, Mylan will infringe the ’716 patent under U.S.C. § 271(a)
`by making, using, selling, offering to sell, or importing the generic product in the United
`States upon the FDA’s approval of ANDA No. 206685.
`
`ANSWER: Denied.
`
`Upon information and belief, Mylan will infringe the ’716 patent under U.S.C. § 271(b)
`by intentionally encouraging, aiding, and abetting acts of direct infringement of the ’716
`patent, with knowledge of said patent and said infringement, upon the FDA’s approval of
`ANDA No. 206685.
`
`ANSWER: Denied.
`
`Upon information and belief, Mylan will infringe the ’716 patent under U.S.C. § 271(c)
`by selling and offering to sell the generic product in the United States, with knowledge of
`the ’716 patent and that there is no substantial non-infringing use of the generic product,
`upon the FDA’s approval of ANDA No. 206685.
`
`ANSWER: Denied.
`
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`

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`47.
`
`48.
`
`Pursuant to 35 U.S.C. § 283 and 35 U.S.C. § 271(e)(4)(B), Noven is entitled to a
`permanent injunction against further infringement. Noven will be substantially and
`irreparably harmed if Mylan’s direct infringement of the ’716 patent is not enjoined.
`Further, Noven does not have an adequate remedy at law.
`
`ANSWER: Denied.
`
`Upon information and belief, Mylan was aware of the ’716 patent prior to filing ANDA
`No. 206685, as well as the statutory provisions and regulations set forth in 21 U.S.C. §
`355 and 21 C.F.R. § 314.95, and acted without a reasonable basis for a good faith belief
`that they would not be liable for infringing the ’716 patent.
`
`ANSWER: Denied.
`
`COUNT II: INFRINGEMENT OF U.S. PATENT NO. 8,231,906
`
`49.
`
`Paragraphs 1-48 are incorporated by reference as though fully set forth herein.
`
`ANSWER: Defendants reassert and incorporate by reference their answers to
`
`paragraphs 1-48 as if fully set forth herein.
`
`50. Mylan’s submission of ANDA No. 206685 and its Paragraph IV certification seeking
`FDA approval to commercially manufacture, use, sell, offer to sell, or import the generic
`product prior to the expiration of the ’906 Patent constituted patent infringement under 35
`U.S.C. § 271(e)(2).
`
`ANSWER: Denied.
`
`51.
`
`52.
`
`Upon information and belief, Mylan will infringe the ’906 patent under U.S.C. § 271(a)
`by making, using, selling, offering to sell, or importing the generic product in the United
`States upon the FDA’s approval of ANDA No. 206685.
`
`ANSWER: Denied.
`
`Upon information and belief, Mylan will infringe the ’906 patent under U.S.C. § 271(b)
`by intentionally encouraging, aiding, and abetting acts of direct infringement of the ’906
`patent, with knowledge of said patent and said infringement, upon the FDA’s approval of
`ANDA No. 206685.
`
`ANSWER: Denied.
`
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`

`
`53.
`
`54.
`
`55.
`
`Upon information and belief, Mylan will infringe the ’906 patent under U.S.C. § 271(c)
`by selling and offering to sell the generic product in the United States, with knowledge of
`the ’906 patent and that there is no substantial non-infringing use of the generic product,
`upon the FDA’s approval of ANDA No. 206685.
`
`ANSWER: Denied.
`
`Pursuant to 35 U.S.C. § 283 and 35 U.S.C. § 271(e)(4)(B), Noven is entitled to a
`permanent injunction against further infringement. Noven will be substantially and
`irreparably harmed if Defendants’ direct infringement of the ’906 patent is not enjoined.
`Further, Noven does not have an adequate remedy at law.
`
`ANSWER: Denied.
`
`Upon information and belief, Mylan was aware of the ’906 patent prior to filing ANDA
`No. 206685, as well as the statutory provisions and regulations set forth in 21 U.S.C. §
`355 and 21 C.F.R. § 314.95, and acted without a reasonable basis for a good faith belief
`that they would not be liable for infringing the ’906 patent.
`
`ANSWER: Denied.
`
`PRAYER FOR RELIEF
`
`Defendants deny that Plaintiffs are entitled to any of the relief sought in Paragraphs A-F
`
`of the Amended Complaint.
`
`GENERAL DENIAL
`
`Any allegation in Plaintiffs’ Amended Complaint not expressly admitted by Defendants
`
`is hereby denied. Having answered Plaintiffs’ Amended Complaint, Defendants deny that
`
`Plaintiffs are entitled to the relief requested in Plaintiffs’ Prayer for Relief or to any relief
`
`whatsoever.
`
`SEPARATE DEFENSES
`
`Without prejudice to the denials set forth in its Answer to the Amended Complaint, and
`
`without admitting any allegations of the Amended Complaint not otherwise admitted,
`
`Defendants assert the following separate defenses to the Amended Complaint without assuming
`
`the burden of proof on any such defense that would otherwise rest on the Plaintiffs:
`
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`NCI Exhibit 2006
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`FIRST SEPARATE DEFENSE
`
`Plaintiffs have failed to state a claim upon which relief can be granted.
`
`SECOND SEPARATE DEFENSE
`
`The claims of the ’716 and ’906 patents are invalid for failure to satisfy one or more of
`
`the conditions for patentability contained in 35 U.S.C. §§ 101, 102, 103, 112 and/or double
`
`patenting.
`
`THIRD SEPARATE DEFENSE
`
`Defendants have not directly or indirectly infringed the ’716 or ’906 patents. The
`
`manufacture, use, offer for sale, sale, and/or importation of the products that are the subject of
`
`ANDA No. 206685 do not and will not infringe any valid or enforceable claim of the ’716 or
`
`’906 patents.
`
`FOURTH SEPARATE DEFENSE
`
`By virtue of the prosecution proceedings before the USPTO of the patent applications
`
`leading to the ’716 and ’906 patents, Plaintiffs are estopped from maintaining that any valid or
`
`enforceable claim of the ’716 or ’906 patents are infringed by the products that are the subject of
`
`ANDA No. 206685.
`
`FIFTH SEPARATE DEFENSE
`
`Mylan Inc. and MPI are improper parties to this action.
`
`SIXTH SEPARATE DEFENSE
`
`Defendants reserve all defenses, at law or equity, which may now exist or in the future be
`
`available on discovery and further factual investigation in this case.
`
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`NCI Exhibit 2006
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`

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`COUNTERCLAIMS
`
`For its counterclaims against Plaintiffs/Counterclaim Defendants Noven Pharmaceuticals,
`
`Inc. (“Noven”) and Hisamitsu Pharmaceutical Co., Inc. (“Hisamitsu”) (collectively, “Plaintiffs”),
`
`Defendant/Counterclaim Plaintiff Mylan Technologies, Inc. (“MTI”) states as follows:
`
`PARTIES
`
`1.
`
`MTI is a corporation organized and existing under the laws of the State of West
`
`Virginia, having a place of business at 110 Lake Street, St. Albans, Vermont 05478.
`
`2.
`
`Upon information and belief, Noven is a Delaware corporation with its principal
`
`place of business at 11960 S.W. 144th Street, Miami, Florida 33186.
`
`3.
`
`Up