Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 1 of 38 PageID #: 567
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`AT CLARKSBURG
`
`
`MERCK SHARP & DOHME CORP.,
`
`Plaintiffs,
`
`v.
`
`MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.,
`
`
`
`
`
`
`
`
`
`C.A. No. 1:19-cv-00101(IMK)
`
`
`
`
`Defendants.
`
`DEFENDANT’S ANSWER TO PLAINTIFF’S COMPLAINT AND COUNTERCLAIMS
`
`Defendant Mylan Pharmaceuticals Inc. (“MPI”), by and through its undersigned counsel,
`
`for its Answer, Affirmative Defenses and Counterclaims to the Complaint filed by Plaintiff
`
`Merck Sharp & Dohme Corp. (“Plaintiff”), state as follows:
`
`GENERAL DENIAL
`
`Pursuant to Fed. R. Civ. P. 8(b)(3), MPI denies all allegations in Plaintiff’s Complaint
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`except those specifically admitted below.
`
`COMPLAINT NO. 1
`
`This is an action for patent infringement under the patent laws of the
`United States, Title 35, United States Code, and for a declaratory judgment of
`patent infringement under 28 U.S.C. §§ 2201 and 2202 and the patent laws of the
`United States, Title 35, United States Code, that arises out of defendants’
`submission of Abbreviated New Drug Application (“ANDA”) Nos. 202473 and
`202478 to the U.S. Food and Drug Administration (“FDA”) seeking approval to
`commercially manufacture, use, offer for sale, sell, and/or import versions of
`JANUVIA® (sitagliptin phosphate) and JANUMET® (metformin hydrochloride;
`sitagliptin phosphate) prior to the expiration of U.S. Patent No. 7,326,708 (“the
`’708 patent”) and U.S. Patent No. 8,414,921 (“the ’921 patent”).
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 1
`
`

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`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 2 of 38 PageID #: 568
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`ANSWER NO. 1
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`Paragraph 1 contains legal conclusions to which no answer is required. To the extent an
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`answer is required, MPI admits that MPI filed Abbreviated New Drug Application (“ANDA”)
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`Nos. 202473 and 202478 with United States Food and Drug Administration (“FDA”) seeking
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`approval for its sitagliptin phosphate and metformin hydrochloride product and sitagliptin
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`phosphate product. To the extent there are allegations not expressly admitted above, such
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`allegations are denied.
`
`COMPLAINT NO. 2
`
`Mylan Pharmaceuticals Inc. notified Merck by letter dated December 28,
`2010 (“Mylan’s ’473 Notice Letter”) that it had submitted to the FDA ANDA
`No. 202473 (“Mylan’s ’473 ANDA”), seeking approval from the FDA to engage
`in the commercial manufacture, use, offering for sale, sale, and/or importation of
`generic sitagliptin phosphate oral tablets (“Mylan’s ’473 ANDA Product”) prior
`to the expiration of the ’708 patent.
`
`ANSWER NO. 2
`
`MPI admits that MPI sent Merck a notice letter dated December 28, 2010, pursuant to the
`
`Federal Food, Drug, and Cosmetic Act (“FDCA”) stating that MPI had submitted ANDA
`
`No. 202473 to FDA. To the extent there are allegations not expressly admitted, such allegations
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`are denied.
`
`COMPLAINT NO. 3
`
`On information and belief, Mylan’s ’473 ANDA Product is a generic
`version of Merck’s JANUVIA® product.
`
`ANSWER NO. 3
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`MPI admits that the product that is the subject of ANDA No. 202473 (“MPI’s ’473
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`ANDA Product”) contains the active ingredient sitagliptin phosphate. MPI lacks sufficient
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`knowledge and information to form a belief as to the truth of the remaining allegations contained
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`in paragraph 3 of the Complaint and, on that basis, denies them.
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 2
`
`

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`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 3 of 38 PageID #: 569
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`COMPLAINT NO. 4
`
`Mylan Pharmaceuticals Inc. notified Merck by letter dated December 28,
`2010 (“Mylan’s First ’478 Notice Letter”) that it had submitted to the FDA
`ANDA No. 202478 (“Mylan’s ’478 ANDA”), seeking approval from the FDA to
`engage in the commercial manufacture, use, offering for sale, sale, and/or
`importation of generic metformin hydrochloride and sitagliptin phosphate oral
`tablets (“Mylan’s ’478 ANDA Product”) prior to the expiration of the ’708 patent.
`
`ANSWER NO. 4
`
`MPI admits that MPI sent Merck a notice letter dated December 28, 2010, pursuant to the
`
`FDCA stating that MPI had submitted ANDA No. 202478 to FDA. To the extent there are
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`allegations not expressly admitted, such allegations are denied.
`
`COMPLAINT NO. 5
`
`Mylan Pharmaceuticals Inc. notified Merck by letter dated September 13,
`2013 (“Mylan’s Second ’478 Notice Letter”) that it had amended Mylan’s ’478
`ANDA to additionally seek approval from the FDA to engage in the commercial
`manufacture, use, offering for sale, sale, and/or importation of Mylan’s ’478
`ANDA Product prior to the expiration of the ’921 patent.
`
`ANSWER NO. 5
`
`MPI admits that MPI sent Merck a notice letter dated September 13, 2013, pursuant to
`
`the FDCA stating that MPI had submitted ANDA No. 202478 to FDA. To the extent there are
`
`allegations not expressly admitted, such allegations are denied.
`
`COMPLAINT NO. 6
`
`On information and belief, Mylan’s ’478 ANDA Product is a generic
`version of Merck’s JANUMET® product
`
`ANSWER NO. 6
`
`MPI admits that the product that is the subject of ANDA No. 202478 (“MPI’s ’478
`
`ANDA Product”) contains the active ingredients sitagliptin phosphate and metformin
`
`hydrochloride. MPI lacks sufficient knowledge and information to form a belief as to the truth
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 3
`
`

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`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 4 of 38 PageID #: 570
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`of the remaining allegations contained in paragraph 6 of the Complaint and, on that basis, denies
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`them.
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`COMPLAINT NO. 7
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`Mylan’s ’473 Notice Letter, Mylan’s First ’478 Notice Letter, and
`Mylan’s Second ’478 Notice Letter are collectively referred to herein as “Mylan’s
`Notice Letters.” Mylan’s ’473 ANDA and Mylan’s ’478 ANDA are collectively
`referred to herein as “Mylan’s ANDAs.” Mylan’s ’473 ANDA Product and
`Mylan’s ’478 ANDA Product are collectively referred to herein as “Mylan’s
`ANDA Products.”
`
`ANSWER NO. 7
`
`Paragraph 7 contains legal conclusions to which no answer is required. To the extent an
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`answer is required, denied.
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`PARTIES
`
`COMPLAINT NO. 8
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`Plaintiff Merck is a corporation organized and existing under the laws of
`New Jersey, having its corporate offices and principal place of business at One
`Merck Drive, Whitehouse Station, New Jersey 08889.
`
`ANSWER NO. 8
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`MPI lacks sufficient knowledge and information to form a belief as to the truth of the
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`allegations contained in paragraph 8 of the Complaint and, on that basis, denies them.
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`COMPLAINT NO. 9
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`Merck is the holder of New Drug Application (“NDA”) No. 21995 for
`JANUVIA® (sitagliptin phosphate), which has been approved by the FDA.
`
`ANSWER NO. 9
`
`MPI lacks sufficient knowledge and information to form a belief as to the truth of the
`
`allegations contained in paragraph 9 of the Complaint and, on that basis, denies them.
`
`COMPLAINT NO. 10
`Merck is the holder of NDA No. 22044 for JANUMET® (metformin
`hydrochloride; sitagliptin phosphate), which has been approved by the FDA.
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 4
`
`

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`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 5 of 38 PageID #: 571
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`ANSWER NO. 10
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`MPI lacks sufficient knowledge and information to form a belief as to the truth of the
`
`allegations contained in paragraph 10 of the Complaint and, on that basis, denies them.
`
`COMPLAINT NO. 11
`
`On information and belief, defendant Mylan Pharmaceuticals Inc. (“MPI”)
`is a corporation organized and existing under the laws of the State of West
`Virginia, having its principal place of business at 781 Chestnut Ridge Road,
`Morgantown, WV 26505. On information and belief, MPI is in the business of,
`among other things, manufacturing and selling generic versions of branded
`pharmaceutical drugs for the U.S. market.
`
`ANSWER NO. 11
`
`MPI admits that it is incorporated in West Virginia and has its principal place of business
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`at 781 Chestnut Ridge Road, Morgantown, WV 26505. MPI further admits that it is in the
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`business of, among other things, manufacturing and selling generic medicines.
`
`COMPLAINT NO. 12
`
`On 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 Boulevard, Canonsburg, PA 15317. On
`information and belief, Mylan Inc. is in the business of, among other things,
`manufacturing and selling generic versions of branded pharmaceutical drugs
`through various operating subsidiaries, including MPI.
`
`ANSWER NO. 12
`
`MPI admits that Mylan Inc. is incorporated in Pennsylvania and has its principal place of
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`business at 1000 Mylan Boulevard, Robert J. Coury Global Center, Canonsburg, PA 15317.
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`MPI denies that Mylan Inc. is a proper party to this action. To the extent there are allegations
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`not expressly admitted above, such allegations are denied.
`
`COMPLAINT NO. 13
`
`On information and belief, MPI is a wholly owned subsidiary of Mylan
`Inc. MPI and Mylan Inc. are collectively referred to herein as “Mylan.”
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 5
`
`

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`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 6 of 38 PageID #: 572
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`ANSWER NO. 13
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`MPI admits that MPI is wholly owned by Mylan Inc. MPI denies that Mylan Inc. is a
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`proper party to this action. To the extent there are allegations not expressly admitted above, such
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`allegations are denied.
`
`COMPLAINT NO. 14
`
`On information and belief, MPI and Mylan Inc. acted in concert to prepare
`and submit Mylan’s ANDAs to the FDA.
`
`ANSWER NO. 14
`
`MPI admits that it filed ANDA Nos. 202473 and 202478, seeking approval by the FDA.
`
`MPI denies any remaining allegations set forth in paragraph 14.
`
`COMPLAINT NO. 15
`
`On information and belief, MPI and Mylan Inc. know and intend that upon
`approval of Mylan’s ANDAs, MPI and Mylan Inc. will manufacture, market, sell,
`and distribute Mylan’s ANDA Products throughout the United States, including in
`West Virginia. On information and belief, MPI and Mylan Inc. are agents of each
`other and/or operate in concert as integrated parts of the same business group,
`including with respect to Mylan’s ANDA Products, and enter into agreements that
`are nearer than arm’s length. On information and belief, MPI and Mylan Inc.
`participated, assisted, and cooperated in carrying out the acts complained of
`herein.
`
`ANSWER NO. 15
`
`For purposes of this litigation, MPI does not contest personal jurisdiction or venue in
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`West Virginia. MPI denies that Mylan Inc. is a proper party to this action. To the extent there
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`are allegations not expressly admitted above, such allegations are denied.
`
`COMPLAINT NO. 16
`
`On information and belief, following any FDA approval of Mylan’s
`ANDAs, MPI and Mylan will act in concert to distribute and sell Mylan’s ANDA
`Products throughout the United States, including within West Virginia.
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 6
`
`

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`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 7 of 38 PageID #: 573
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`ANSWER NO. 16
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`For purposes of this litigation, MPI does not contest personal jurisdiction or venue in
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`West Virginia. MPI denies that Mylan Inc. is a proper party to this action. To the extent there
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`are allegations not expressly admitted above, such allegations are denied.
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`JURISDICTION
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`COMPLAINT NO. 17
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`This Court has jurisdiction over this action pursuant to 28 U.S.C. §§ 1331,
`1338(a), 2201, and 2202.
`
`ANSWER NO. 17
`
`Paragraph 17 contains legal conclusions to which no answer is required. To the extent an
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`answer is required, MPI denies that this Court has subject matter jurisdiction over allegations
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`related to any alleged infringement under 35 U.S.C. §§ 271(a), (b), (c), and/or (g). MPI denies
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`that Mylan Inc. is a proper party to this action. To the extent there are allegations not expressly
`
`admitted above, such allegations are denied.
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`COMPLAINT NO. 18
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`This Court has personal jurisdiction over Mylan.
`
`ANSWER NO. 18
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`Paragraph 18 contains legal conclusions to which no answer is required. To the extent an
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`answer is required, for the purposes of this litigation, MPI does not contest personal jurisdiction
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`in West Virginia.
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`COMPLAINT NO. 19
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`MPI is subject to personal jurisdiction in West Virginia because, among
`other things, it has purposely availed itself of the benefits and protections of West
`Virginia’s laws such that it should reasonably anticipate being haled into court
`here. In addition, on information and belief, MPI develops, manufactures,
`imports, markets, offers to sell, and/or sells generic drugs throughout the United
`States, including in the State of , and therefore transacts business within the State
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 7
`
`

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`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 8 of 38 PageID #: 574
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`of West Virginia related to Merck’s claims, and/or has engaged in systematic and
`continuous business contacts within the State of West Virginia
`
`ANSWER NO. 19
`
`Paragraph 19 contains legal conclusions to which no answer is required. To the extent an
`
`answer is required, for the purposes of this litigation, MPI does not contest personal jurisdiction
`
`in West Virginia. To the extent there are allegations not expressly admitted above, such
`
`allegations are denied.
`
`COMPLAINT NO. 20
`
`Mylan Inc. is subject to personal jurisdiction in West Virginia because,
`among other things, Mylan Inc., itself and through its wholly owned subsidiary
`MPI, has purposefully availed itself of the benefits and protections of West
`Virginia’s laws such that it should reasonably anticipate being haled into court
`here. On information and belief, Mylan Inc., itself and through its wholly owned
`subsidiary MPI, develops, manufactures, imports, markets, offers to sell, and/or
`sells generic drugs throughout the United States, including in the State of West
`Virginia, and therefore transacts business within the State of West Virginia,
`and/or has engaged in systematic and continuous business contacts within the
`State of West Virginia. In addition, Mylan Inc. is subject to personal jurisdiction
`in West Virginia because, on information and belief, it controls and dominates
`MPI, and therefore the activities of MPI in this jurisdiction are attributed to Mylan
`Inc.
`
`ANSWER NO. 20
`
`Paragraph 20 contains legal conclusions to which no answer is required. To the extent an
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`answer is required, for the purposes of this litigation, MPI does not contest personal jurisdiction
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`in West Virginia. MPI denies that Mylan Inc. is a proper party to this action. To the extent there
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`are allegations not expressly admitted above, such allegations are denied.
`
`COMPLAINT NO. 21
`
`On information and belief, if Mylan’s ANDAs are approved, Mylan will
`manufacture, market, sell, and/or distribute Mylan’s ANDA Products within the
`United States, including in West Virginia, consistent with Mylan’s practices for
`the marketing and distribution of other generic pharmaceutical products. On
`information and belief, Mylan regularly does business in West Virginia, and its
`practices with other generic pharmaceutical products have involved placing those
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 8
`
`

`

`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 9 of 38 PageID #: 575
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`products into the stream of commerce for distribution throughout the United
`States, including in West Virginia. On information and belief, Mylan’s generic
`pharmaceutical products are used and/or consumed within and throughout the
`United States, including in West Virginia. On information and belief, Mylan’s
`ANDA Products will be prescribed by physicians practicing in West Virginia,
`dispensed by pharmacies located within West Virginia, and used by patients in
`West Virginia. Each of these activities would have a substantial effect within
`West Virginia and would constitute infringement of Merck’s patent in the event
`that Mylan’s ANDA Products are approved before the patent expires. Each of
`these activities would have a substantial effect within West Virginia and would
`constitute infringement of Merck’s patent rights in the even that Mylan’s ANDA
`Product is approved before
`
`ANSWER NO. 21
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`For purposes of this litigation, MPI does not contest personal jurisdiction or venue in
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`West Virginia. MPI denies that Mylan Inc. is a proper party to this action. To the extent there
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`are allegations not expressly admitted above, such allegations are denied.
`
`COMPLAINT NO. 22
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`On information and belief, Mylan derives substantial revenue from generic
`pharmaceutical products that are used and/or consumed within West Virginia, and
`that are manufactured by Mylan and/or for which MPI and/or Mylan Inc. is/are
`the named applicant(s) on approved ANDAs. On information and belief, various
`products for which MPI and/or Mylan Inc. is/are the named applicant(s) on
`approved ANDAs are available at retail pharmacies in West Virginia.
`
`ANSWER NO. 22
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`For purposes of this litigation, MPI does not contest personal jurisdiction or venue in
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`West Virginia. MPI denies that Mylan Inc. is a proper party to this action. To the extent there
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`are allegations not expressly admitted above, such allegations are denied.
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`VENUE
`
`COMPLAINT NO. 23
`
`Merck incorporates each of the preceding paragraphs 1–22 as if fully set
`forth herein.
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 9
`
`

`

`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 10 of 38 PageID #: 576
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`ANSWER NO. 23
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`MPI incorporates by reference its responses to the preceding paragraphs as if fully set
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`forth herein.
`
`COMPLAINT NO. 24
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`Venue is proper in this district as to MPI under 28 U.S.C. § 1400(b)
`because MPI is a corporation organized and existing under the laws of the State of
`West Virginia and is subject to personal jurisdiction in this judicial district.
`
`ANSWER NO. 24
`
`Paragraph 24 states a legal conclusion to which no answer is required. To the extent an
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`answer is required, for purposes of this litigation, MPI does not contest venue in this judicial
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`district. MPI denies any remaining allegations set forth in paragraph 24.
`
`COMPLAINT NO. 25
`
`Venue is proper in this district as to Mylan Inc. under 28 U.S.C. § 1400(b)
`because Mylan Inc. is subject to personal jurisdiction in this judicial district, has
`previously consented to venue in this judicial district, and on information and
`belief will consent to venue for the purpose of this case.
`
`ANSWER NO. 25
`
`Paragraph 25 states a legal conclusion to which no answer is required. To the extent an
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`answer is required, for purposes of this litigation, MPI does not contest venue in this judicial
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`district. MPI denies that Mylan Inc. is a proper party to this action. MPI denies any remaining
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`allegations set forth in paragraph 25.
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`THE ’708 PATENT
`
`COMPLAINT NO. 26
`
`Merck incorporates each of the preceding paragraphs 1–25 as if fully set
`forth herein.
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 10
`
`

`

`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 11 of 38 PageID #: 577
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`ANSWER NO. 26
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`MPI incorporates by reference its responses to the preceding paragraphs as if fully set
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`forth herein.
`
`COMPLAINT NO. 27
`
`The inventors named on the ’708 patent are Stephen Howard Cypes, Alex
`Minhua Chen, Russell R. Ferlita, Karl Hansen, Ivan Lee, Vicky K. Vydra, and
`Robert M. Wenslow, Jr.
`
`ANSWER NO. 27
`
`MPI admits that, on its face, the ’708 patent names Stephen Howard Cypes, Alex Minhua
`
`Chen, Russell R. Ferlita, Karl Hansen, Ivan Lee, Vicky K. Vydra, and Robert M. Wenslow, Jr. as
`
`the inventors. MPI lacks sufficient knowledge and information to form a belief as to the truth of
`
`the remaining allegations contained in paragraph 27 of the Complaint, and on that basis, denies
`
`them.
`
`COMPLAINT NO. 28
`
`The ’708 patent, entitled “Phosphoric Acid Salt of a Dipeptidyl
`Peptidase IV Inhibitor” (attached as Exhibit A), was duly and legally issued on
`February 5, 2008.
`
`ANSWER NO. 28
`
`MPI admits that, on its face, the ’708 patent indicates that it is entitled “Phosphoric Acid
`
`Salt of a Dipeptidyl Peptidase IV Inhibitor,” issued on February 5, 2008. MPI denies that the
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`ʼ708 patent was duly and legally issued by the United States Patent and Trademark Office on
`
`February 5, 2008. MPI lacks sufficient knowledge and information to form a belief as to the
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`truth of the remaining allegations contained in paragraph 28 of the Complaint, and on that basis,
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`denies them.
`
`COMPLAINT NO. 29
`
`Merck is the owner and assignee of the ’708 patent.
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 11
`
`

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`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 12 of 38 PageID #: 578
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`ANSWER NO. 29
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`MPI admits that, on its face, the ’708 patent indicates that Merck & Co., Inc. is the
`
`assignee. MPI lacks sufficient knowledge and information to form a belief as to the truth of the
`
`remaining allegations contained in paragraph 29 of the Complaint, and on that basis, denies
`
`them.
`
`COMPLAINT NO. 30
`
`The ’708 patent claims, inter alia, a dihydrogenphosphate salt of 4-oxo-4-
`[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-y1]-1-(2,4,5-
`trifluorophenyl)butan-2-amine of structural formula I, or a hydrate thereof, as
`recited in claim 1 of the ’708 patent.
`
`ANSWER NO. 30
`
`Paragraph 30 contains legal conclusions to which no answer is required. To the extent
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`there are allegations not expressly admitted above, such allegations are denied.
`
`COMPLAINT NO. 31
`JANUVIA®, as well as methods of using JANUVIA®, are covered by one
`or more claims of the ’708 patent, including claim 1 of the ’708 patent, and the
`’708 patent has been listed in connection with JANUVIA® in the FDA’s Orange
`Book.
`
`ANSWER NO. 31
`
`Paragraph 31 contains legal conclusions to which no answer is required. To the extent an
`
`answer is required, MPI admits that FDA’s Orange Book lists the ’708 patent in connection with
`
`JANUVIA®. To the extent there are allegations not expressly admitted above, such allegations
`
`are denied.
`
`COMPLAINT NO. 32
`JANUMET®, as well as methods of using JANUMET®, are covered by
`one or more claims of the ’708 patent, including claim 1 of the ’708 patent, and
`the ’708 patent has been listed in connection with JANUMET® in the FDA’s
`Orange Book.
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 12
`
`

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`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 13 of 38 PageID #: 579
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`ANSWER NO. 32
`
`Paragraph 32 contains legal conclusions to which no answer is required. To the extent an
`
`answer is required, MPI admits that FDA’s Orange Book lists the ’708 patent in connection with
`
`JANUMET®. To the extent there are allegations not expressly admitted above, such allegations
`
`are denied.
`
`THE ’921 PATENT
`
`COMPLAINT NO. 33
`
`Merck incorporates each of the preceding paragraphs 1–32 as if fully set
`forth herein.
`
`ANSWER NO. 33
`
`MPI incorporates by reference its responses to the preceding paragraphs as if fully set
`
`forth herein.
`
`COMPLAINT NO. 34
`
`The inventors named on the ’921 patent are Ashkan Kamali, Laman Alani,
`Kyle A. Fliszar, Soumojeet Ghosh, and Monica Tijerina.
`
`ANSWER NO. 34
`
`MPI admits that, on its face, the ’921 patent names Ashkan Kamali, Laman Alani,
`
`Kyle A. Fliszar, Soumojeet Ghosh, and Monica Tijerina as the inventors. MPI lacks sufficient
`
`knowledge and information to form a belief as to the truth of the remaining allegations contained
`
`in paragraph 34 of the Complaint, and on that basis, denies them.
`
`COMPLAINT NO. 35
`
`The ’921 patent, entitled “Pharmaceutical Compositions of Combinations
`of Dipeptidyl Peptidase-4 Inhibitors with Metformin” (attached as Exhibit B), was
`duly and legally issued on April 9, 2013.
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 13
`
`

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`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 14 of 38 PageID #: 580
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`ANSWER NO. 35
`
`MPI admits that, on its face, the ’921 patent indicates that it is entitled “Pharmaceutical
`
`Compositions of Combinations of Dipeptidyl Peptidase-4 Inhibitors with Metformin,” issued on
`
`April 9, 2013. MPI denies that the ʼ921 patent was duly and legally issued by the United States
`
`Patent and Trademark Office on April 9, 2013. MPI lacks sufficient knowledge and information
`
`to form a belief as to the truth of the remaining allegations contained in paragraph 35 of the
`
`Complaint, and on that basis, denies them.
`
`COMPLAINT NO. 36
`
`Merck is the owner and assignee of the ’921 patent.
`
`ANSWER NO. 36
`
`MPI admits that, on its face, the ’921 patent indicates that Merck Sharp & Dohme Corp.
`
`is the assignee. MPI lacks sufficient knowledge and information to form a belief as to the truth
`
`of the remaining allegations contained in paragraph 36 of the Complaint, and on that basis,
`
`denies them.
`
`COMPLAINT NO. 37
`
`The ’921 patent claims, inter alia, a pharmaceutical composition
`comprising: (a) about 3 to 20% by weight of sitagliptin, or a pharmaceutically
`acceptable salt thereof; (b) about 25 to 94% by weight of metformin
`hydrochloride; (c) about 0.1 to 10% by weight of a lubricant; (d) about 0 to 35%
`by weight of a binding agent; (e) about 0.5 to 1% by weight of a surfactant; and
`(f) about 5 to 15% by weight of a diluent, as recited in claim 1 of the ’921 patent.
`
`ANSWER NO. 37
`
`Paragraph 37 contains legal conclusions to which no answer is required. To the extent
`
`there are allegations not expressly admitted above, such allegations are denied.
`
`COMPLAINT NO. 38
`JANUMET®, as well as methods of using JANUMET®, are covered by
`one or more claims of the ’921 patent, including claim 1 of the ’921 patent, and
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 14
`
`

`

`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 15 of 38 PageID #: 581
`
`the ’921 patent has been listed in connection with JANUMET® in the FDA’s
`Orange Book.
`
`ANSWER NO. 38
`
`Paragraph 38 contains legal conclusions to which no answer is required. To the extent an
`
`answer is required, MPI admits that FDA’s Orange Book lists the ’921 patent in connection with
`
`JANUMET®. To the extent there are allegations not expressly admitted above, such allegations
`
`are denied.
`
`COUNT I – INFRINGEMENT OF THE ’708 PATENT
`(MYLAN’S ’473 ANDA PRODUCT)
`
`COMPLAINT NO. 39
`
`Merck incorporates each of the preceding paragraphs 1–38 as if fully set
`forth herein.
`
`ANSWER NO. 39
`
`MPI incorporates by reference its responses to the preceding paragraphs as if fully set
`
`forth herein.
`
`COMPLAINT NO. 40
`
`In Mylan’s ’473 Notice Letter, Mylan notified Merck of the submission of
`Mylan’s ’473 ANDA to the FDA. The purpose of this submission was to obtain
`approval under the FDCA to engage in the commercial manufacture, use, offer for
`sale, sale and/or importation of Mylan’s ’473 ANDA Product prior to the
`expiration of the ’708 patent.
`
`ANSWER NO. 40
`
`MPI admits that MPI filed ANDA No. 202473 with FDA for MPI’s ’473 ANDA Product.
`
`MPI admits that MPI sent a Notice Letter to Merck regarding the patent certifications contained
`
`in MPI’s ANDA No. 202473. To the extent there are allegations not expressly admitted above,
`
`such allegations are denied.
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 15
`
`

`

`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 16 of 38 PageID #: 582
`
`COMPLAINT NO. 41
`
`In Mylan’s ’473 Notice Letter, Mylan also notified Merck that, as part of
`its ANDA, Mylan had
`filed certifications of
`the
`type described
`in
`Section 505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C. § 355 (j)(2)(A)(vii)(IV),
`with respect to the ’708 patent. On information and belief, Mylan submitted its
`ANDA
`to
`the FDA containing certifications pursuant
`to 21 U.S.C.
`§ 355(j)(2)(A)(vii)(IV) asserting that the ’708 patent is invalid, unenforceable,
`and/or will not be infringed by the manufacture, use, offer for sale, sale, and/or
`importation of Mylan’s ’473 ANDA Product.
`
`ANSWER NO. 41
`
`MPI admits that MPI’s Notice Letter states that MPI’s ANDA No. 202473 contains
`
`certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (paragraph IV certifications) with
`
`respect to the ’708 patent. MPI admits that MPI’s ANDA No. 202473 contains such
`
`paragraph IV certifications. To the extent there are allegations not expressly admitted above,
`
`such allegations are denied.
`
`COMPLAINT NO. 42
`
`In Mylan’s ’473 Notice Letter, Mylan stated that Mylan’s ’473 ANDA
`Product contains sitagliptin phosphate as an active ingredient.
`
`ANSWER NO. 42
`
`MPI admits that MPI filed ANDA No. 202473 with FDA for MPI’s ’473 ANDA Product.
`
`To the extent there are allegations not expressly admitted above, such allegations are denied.
`
`COMPLAINT NO. 43
`
`Mylan’s ’473 ANDA Product, and the use of Mylan’s ’473 ANDA
`Product, are covered by one or more claims of the ’708 patent, including at least
`claim 1 of the ’708 patent, because claim 1 of the ’708 patent covers the
`sitagliptin phosphate contained in Mylan’s ’473 ANDA Product.
`
`ANSWER NO. 43
`
`Denied.
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 16
`
`

`

`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 17 of 38 PageID #: 583
`
`COMPLAINT NO. 44
`
`In Mylan’s ’473 Notice Letter, Mylan did not contest infringement of
`claim 1 of the ’708 patent.
`
`Denied.
`
`ANSWER NO. 44
`
`COMPLAINT NO. 45
`
`Mylan’s submission of Mylan’s ’473 ANDA for the purpose of obtaining
`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
`importation of Mylan’s ’473 ANDA Product before the expiration of the ’708
`patent was an act of infringement of the ’708 patent under 35 U.S.C. §
`271(e)(2)(A).
`
`Denied.
`
`ANSWER NO. 45
`
`COMPLAINT NO. 46
`
`On information and belief, Mylan will engage in the manufacture, use,
`offer for sale, sale, marketing, distribution, and/or importation of Mylan’s ’473
`ANDA Product immediately and imminently upon approval of its ANDA.
`
`Denied.
`
`ANSWER NO. 46
`
`COMPLAINT NO. 47
`
`The manufacture, use, sale, offer for sale, or importation of Mylan’s ’473
`ANDA Product would infringe one or more claims of each of the ’708 patent,
`including at least claim 1 of the ’708 patent.
`
`Denied.
`
`ANSWER NO. 47
`
`COMPLAINT NO. 48
`
`On information and belief, the manufacture, use, sale, offer for sale, or
`importation of Mylan’s ’473 ANDA Product in accordance with, and as directed
`by, its proposed product labeling would infringe one or more claims of the ’708
`patent, including at least claim 1 of the ’708 patent.
`
`Merck Sharp & Dohme Corp. Exhibit 2018
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`Page 17
`
`

`

`Case 1:19-cv-00101-IMK Document 32 Filed 05/31/19 Page 18 of 38 PageID #: 584
`
`Denied.
`
`ANSWER NO. 48
`
`COMPLAINT NO. 49
`
`On information and belief, Mylan plans and intends to, and will, actively
`induce infringement of the ’708 patent when Mylan’s ’473 ANDA is approved,
`and plans and intends to, and will, do so immediately and imminently upon
`approval. Mylan’s activities will be done with knowledge of the ’708 patent and
`specific intent to infringe that patent.
`
`Denied.
`
`ANSWER NO. 49
`
`COMPLAINT NO. 50
`
`On information and belief, Mylan knows that Mylan’s ’473 ANDA
`Product and its proposed labeling are especially made or adapted for use in
`infringing the ’708 patent, that Mylan’s ’473 ANDA Product is not a staple article
`or commodity of commerce, and that Mylan’s ’473 ANDA Product and its
`proposed labeling are not suitable for subst