`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
` Plaintiffs,
`
`
`
`v.
`
`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
`
`
`
`
`
`VIATRIS INC. and MYLAN
`PHARMACEUTICALS INC.
`
`
`
`
`
` Defendants.
`
`
`
`
`
`
`
`
`
`C.A. No. 1:23-cv-00013-TSK
`
`
`
`
`
`PLAINTIFFS’ ANSWER TO COUNTERCLAIMS
`
`Plaintiffs Novo Nordisk Inc. and Novo Nordisk A/S (collectively, “Plaintiffs”), by their
`
`undersigned attorneys, for their Answer to the counterclaims of Mylan Pharmaceuticals Inc.
`
`(“MPI”) (together with Viatris Inc., the “Defendants”) allege:
`
`
`
`PARTIES
`
`1.
`
`Plaintiffs admit, upon information and belief, based on facts alleged in MPI’s
`
`Counterclaims, that MPI purports to have a principal place of business at 3711 Collins Ferry
`
`Road, Morgantown, West Virginia 26505.
`
`2.
`
`Plaintiffs admit that, by letter to Novo Nordisk Inc. and Novo Nordisk A/S dated
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`December 16, 2022, MPI stated that it was the owner of ANDA No. 27705 (“Defendants’
`
`ANDA”), which MPI submitted to the FDA seeking approval for semaglutide injection, 0.25
`
`mg/0.5 mL, 0.5 mg/0.5 mL, 1 mg/0.5 mL, 1.7 mg/0.75 mL, and 2.4 mg/0.75 mL single-dose
`
`prefilled pens (“Defendants’ Proposed ANDA Product”). Plaintiffs otherwise lack knowledge or
`
`
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`Case 1:23-cv-00013-TSK Document 28 Filed 04/21/23 Page 2 of 13 PageID #: 394
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`
`
`
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`information sufficient to form a belief as to the truth of the allegations of Paragraph 2 of the
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`counterclaims and therefore deny those allegations.
`
`3.
`
`4.
`
`Plaintiffs admit the allegations of Paragraph 3.
`
`Plaintiffs admit the allegations of Paragraph 4.
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`NATURE OF THE ACTION
`
`5.
`
`Paragraph 5 contains conclusions of law to which no answer is required. To the
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`extent an answer is required, Plaintiffs admit that MPI purports to seek a declaratory judgement
`
`under the patent laws, 35 U.S.C. § 100 et seq., and the Declaratory Judgment Act, 28 U.S.C. §
`
`2201 et seq., that United States Patent Nos. 8,129,343 (“’343 patent”), 8,536,122 (“’122 patent”),
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`9,764,003 (“’003 patent”), 10,888,605 (“’605 patent”), and 11,318,191 (“’191 patent”)
`
`(collectively, the “patents-in-suit”) are invalid and/or not infringed. Plaintiffs deny the
`
`remaining allegations of Paragraph 5.
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`JURISDICTION AND VENUE
`
`6.
`
`Paragraph 6 contains conclusions of law to which no answer is required. To the
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`extent an answer is required, Plaintiffs do not contest that this Court has subject matter
`
`jurisdiction under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`7.
`
`Paragraph 7 contains conclusions of law to which no answer is required. To the
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`extent an answer is required, Plaintiffs do not contest that this Court has personal jurisdiction in
`
`this judicial district for the limited purpose of this action only.
`
`8.
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`Paragraph 8 contains conclusions of law to which no answer is required. To the
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`extent an answer is required, Plaintiffs do not contest venue in this judicial district for the limited
`
`purpose of this action only.
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`2
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`Case 1:23-cv-00013-TSK Document 28 Filed 04/21/23 Page 3 of 13 PageID #: 395
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`
`
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`
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`9.
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`Plaintiffs admit that an actual and justiciable controversy currently exists between
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`Plaintiffs and Defendants as to the infringement and validity of the patents-in-suit.
`
`BACKGROUND
`
`10.
`
`Plaintiffs admit, on information and belief, that MPI (as an agent or alter ego of
`
`Viatris), submitted Abbreviated New Drug Application (“ANDA”) No. 217705 (“Defendants’
`
`ANDA”) seeking to obtain FDA approval for semaglutide injection, 0.25 mg/0.5 mL, 0.5 mg/0.5
`
`mL, 1 mg/0.5 mL, 1.7 mg/0.75 mL, and 2.4 mg/0.75 mL single-dose prefilled pens
`
`(“Defendants’ Proposed ANDA Product”). Plaintiffs otherwise lack knowledge or information
`
`sufficient to form a belief as to the truth of the allegations of Paragraph 10 of the counterclaims
`
`and therefore denies those allegations.
`
`11.
`
`Plaintiffs admit that NNI holds approved New Drug Application (“NDA”) No.
`
`215256 for WEGOVY® (semaglutide) injection, for subcutaneous use, administered with 0.25
`
`mg/0.5 mL, 0.5 mg/0.5 mL, 1 mg/0.5 mL, 1.7 mg/0.75 mL and 2.4 mg/0.75 mL Pre-filled
`
`Single-dose Pens under Section 505(b) of the Federal Food Drug and Cosmetic Act (“FFDCA”).
`
`12.
`
`Plaintiffs admit that the patents in suit are listed in FDA’s Approved Drug
`
`Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”)
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`in connection with WEGOVY® and the related NDA No. 215256 and claim at least the drug
`
`listed in NDA No. 215256, a method of using, or a kit containing that drug.
`
`13.
`
`14.
`
`15.
`
`16.
`
`17.
`
`Plaintiffs admit the allegations of Paragraph 13.
`
`Plaintiffs admit the allegations of Paragraph 14.
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`Plaintiffs admit the allegations of Paragraph 15.
`
`Plaintiffs admit the allegations of Paragraph 16.
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`Plaintiffs admit the allegations of Paragraph 17.
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`3
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`
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`Case 1:23-cv-00013-TSK Document 28 Filed 04/21/23 Page 4 of 13 PageID #: 396
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`
`
`
`
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`18.
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`19.
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`Plaintiffs admit the allegations of Paragraph 18.
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`Plaintiffs admit that Defendants’ ANDA purports to provide “Paragraph IV”
`
`certifications under 21 U.S.C. §505(j)(2)(A)(vii)(IV) that the patents-in-suit are invalid,
`
`unenforceable, and/or will not be infringed by the commercial manufacture, use, or sale of
`
`Defendants’ Proposed ANDA Product. Plaintiffs deny that the patents-in-suit are invalid,
`
`unenforceable, and/or will not be infringed by the commercial manufacture, use, or sale of
`
`Defendants’ Proposed ANDA Product. Plaintiffs deny the remaining allegations of Paragraph
`
`19.
`
`20.
`
`Plaintiffs admit that, on December 16, 2022, MPI sent Plaintiffs a letter titled
`
`“Notice of Paragraph IV Certification Regarding U.S. Patent Nos.: 8,129,343; 8,536,122;
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`9,764,003; 10,888,605; and 1,318,191” (“MPI’s Notice Letter”) that purported to provide
`
`Plaintiffs written notice of MPI’s Paragraph IV Certifications, pursuant to 21 U.S.C. §
`
`355(j)(2)(B) and asserted that the claims of the patents-in-suit are invalid, unenforceable, and/or
`
`will not be infringed by Defendants’ ANDA or the products or activities described therein.
`
`Plaintiffs deny that the claims of the patents-in-suit are invalid, unenforceable, and/or will not be
`
`infringed by Defendants’ ANDA or the products or activities described therein. Plaintiffs deny
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`the remaining allegations of Paragraph 20.
`
`21.
`
`Plaintiffs admit that MPI’s Notice Letter purported to include legal and factual
`
`bases for the Paragraph IV certifications included in Defendants’ ANDA, pursuant to 21 U.S.C.
`
`§ 355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95(c)(6). Plaintiffs deny the remaining allegations of
`
`Paragraph 21.
`
`22.
`
`Plaintiffs admit they filed the present lawsuit alleging infringement of the patents-
`
`in-suit on January 27, 2023. The remaining allegations in Paragraph 22 contain conclusions of
`
`4
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`
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`Case 1:23-cv-00013-TSK Document 28 Filed 04/21/23 Page 5 of 13 PageID #: 397
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`
`
`
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`law to which no answer is required. To the extent an answer is required, Plaintiffs admit that, as
`
`of the submission of Defendants’ ANDA, an actual and justiciable controversy exists between
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`Plaintiffs and Defendants as to the infringement of the patents-in-suit, including as to whether
`
`Defendants’ Proposed ANDA Product would infringe, induce infringement, or contribute to the
`
`infringement of at least one valid and enforceable claim of the patents-in-suit. Plaintiffs deny the
`
`remaining allegations of Paragraph 22.
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`
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`FIRST COUNTERCLAIM: DECLARATORY JUDGMENT OF NON-INFRINGEMENT
`
`OF U.S. PATENT NO. 8,129,343
`
`23.
`
`Plaintiffs incorporate by reference the averments contained in Paragraphs 1-22 of
`
`this Answer to MPI’s Counterclaims.
`
`24.
`
`25.
`
`Plaintiffs deny the allegations of Paragraph 24.
`
`Plaintiffs admit that they assert that Defendants’ Proposed ANDA Product
`
`infringes the claims of the ’343 patent and will continue to assert such infringement. Plaintiffs
`
`deny the remaining allegations of Paragraph 25.
`
`26.
`
`27.
`
`Plaintiffs deny the allegations of Paragraph 26.
`
`Plaintiffs admit that an actual and justiciable controversy exists between Plaintiffs
`
`and Defendants as to infringement of the ’343 patent. Plaintiffs deny the remaining allegations
`
`of Paragraph 27.
`
`28.
`
`The allegations in Paragraph 28 contain conclusions of law to which no answer is
`
`required. To the extent an answer is required, Plaintiffs deny that Defendants’ Proposed ANDA
`
`Product does not infringe the claims of the ’343 patent. Plaintiffs deny the remaining allegations
`
`of Paragraph 28.
`
`5
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`Case 1:23-cv-00013-TSK Document 28 Filed 04/21/23 Page 6 of 13 PageID #: 398
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`
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`
`
`
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`29.
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`Plaintiffs deny the allegations of Paragraph 29.
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`SECOND COUNTERCLAIM: DECLARATORY JUDGMENT OF INVALIDITY
`
`OF U.S. PATENT NO. 8,129,343
`
`30.
`
`Plaintiffs incorporate by reference the averments contained in Paragraphs 1-29 of
`
`this Answer to MPI’s Counterclaims.
`
`31.
`
`32.
`
`Plaintiffs deny the allegations of Paragraph 31.
`
`Plaintiffs admit that they assert that Defendants’ Proposed ANDA Product
`
`infringes the claims of the ’343 patent and will continue to assert such infringement. Plaintiffs
`
`deny the remaining allegations of Paragraph 32.
`
`33.
`
`34.
`
`Plaintiffs deny the allegations of Paragraph 33.
`
`Plaintiffs admit that an actual and justiciable controversy exists between Plaintiffs
`
`and Defendants as to the validity of the ’343 patent. Plaintiffs admit that the claims of the ’343
`
`patent are valid and enforceable. Plaintiffs deny the remaining allegations of Paragraph 34.
`
`35.
`
`The allegations in Paragraph 35 contain conclusions of law to which no answer is
`
`required. To the extent an answer is required, Plaintiffs deny that the claims of the ’343 patent
`
`are invalid. Plaintiffs deny the remaining allegations of Paragraph 35.
`
`36.
`
`Plaintiffs deny the allegations of Paragraph 36.
`
`
`THIRD COUNTERCLAIM: DECLARATORY JUDGMENT OF NON-INFRINGEMENT
`
`OF U.S. PATENT NO. 8,536,122
`
`
`
`37.
`
`Plaintiffs incorporate by reference the averments contained in Paragraphs 1-36 of
`
`this Answer to MPI’s Counterclaims.
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`6
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`Case 1:23-cv-00013-TSK Document 28 Filed 04/21/23 Page 7 of 13 PageID #: 399
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`
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`
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`38.
`
`39.
`
`Plaintiffs deny the allegations of Paragraph 38.
`
`Plaintiffs admit that they assert that MPI’s Proposed ANDA Product infringes the
`
`claims of the ’122 patent and will continue to assert such infringement. Plaintiffs deny the
`
`remaining allegations of Paragraph 39.
`
`40.
`
`41.
`
`Plaintiffs deny the allegations of Paragraph 40.
`
`Plaintiffs admit that an actual and justiciable controversy exists between Plaintiffs
`
`and Defendants as to infringement of the ’122 patent. Plaintiffs deny the remaining allegations
`
`of Paragraph 41.
`
`42.
`
`The allegations in Paragraph 42 contain conclusions of law to which no answer is
`
`required. To the extent an answer is required, Plaintiffs deny that MPI’s Proposed ANDA
`
`Product does not infringe the claims of the ’122 patent. Plaintiffs deny the remaining allegations
`
`of Paragraph 42.
`
`43.
`
`Plaintiffs deny the allegations of Paragraph 43.
`
`
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`FOURTH COUNTERCLAIM: DECLARATORY JUDGMENT OF INVALIDITY
`
`OF U.S. PATENT NO. 8,536,122
`
`44.
`
`Plaintiffs incorporate by reference the averments contained in Paragraphs 1-43 of
`
`this Answer to MPI’s Counterclaims.
`
`45.
`
`46.
`
`Plaintiffs deny the allegations of Paragraph 45.
`
`Plaintiffs admit that they assert that Defendants’ Proposed ANDA Product
`
`infringes the claims of the ’122 patent and will continue to assert such infringement. Plaintiffs
`
`deny the remaining allegations of Paragraph 46.
`
`47.
`
`Plaintiffs deny the allegations of Paragraph 47.
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`7
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`Case 1:23-cv-00013-TSK Document 28 Filed 04/21/23 Page 8 of 13 PageID #: 400
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`
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`48.
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`Plaintiffs admit that an actual and justiciable controversy exists between Plaintiffs
`
`and Defendants as to the validity of the ’122 patent. Plaintiffs admit that the claims of the ’122
`
`patent are valid and enforceable. Plaintiffs deny the remaining allegations of Paragraph 48.
`
`49.
`
`Plaintiffs deny the allegations of Paragraph 49.
`
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`FIFTH COUNTERCLAIM: DECLARATORY JUDGMENT OF NON-INFRINGEMENT
`
`OF U.S. PATENT NO. 9,764,003
`
`MPI incorporates by reference the allegations in the foregoing Paragraphs of its counterclaims.
`
`
` Plaintiffs incorporate by reference the averments contained in Paragraphs 1-49 of
`
`50.
`
`this Answer to MPI’s Counterclaims.
`
`51.
`
`52.
`
`Plaintiffs deny the allegations of Paragraph 51.
`
`Plaintiffs admit that they assert that Defendants’ Proposed ANDA Product
`
`infringes the claims of the ’003 patent and will continue to assert such infringement. Plaintiffs
`
`deny the remaining allegations of Paragraph 52.
`
`53.
`
`54.
`
`Plaintiffs deny the allegations of Paragraph 53.
`
`Plaintiffs admit that an actual and justiciable controversy exists between Plaintiffs
`
`and Defendants as to infringement of the ’003 patent. Plaintiffs deny the remaining allegations
`
`of Paragraph 54.
`
`55.
`
`Plaintiffs deny the allegations of Paragraph 55.
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`SIXTH COUNTERCLAIM: DECLARATORY JUDGMENT OF INVALIDITY
`
`OF U.S. PATENT NO. 9,764,003
`
`
`
`
`
`8
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`Case 1:23-cv-00013-TSK Document 28 Filed 04/21/23 Page 9 of 13 PageID #: 401
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`
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`
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`56.
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`Plaintiffs incorporate by reference the averments contained in Paragraphs 1-55 of
`
`this Answer to MPI’s Counterclaims.
`
`57.
`
`58.
`
`Plaintiffs deny the allegations of Paragraph 57.
`
`Plaintiffs admit that they assert that Defendants’ Proposed ANDA Product
`
`infringes the claims of the ’003 patent and will continue to assert such infringement. Plaintiffs
`
`deny the remaining allegations of Paragraph 58.
`
`59.
`
`60.
`
`Plaintiffs deny the allegations of Paragraph 59.
`
`Plaintiffs admit that an actual and justiciable controversy exists between Plaintiffs
`
`and Defendants as to the validity of the ’003 patent. Plaintiffs admit that the claims of the ’003
`
`patent are valid and enforceable. Plaintiffs deny the remaining allegations of Paragraph 60.
`
`61.
`
`The allegations in Paragraph 61 contain conclusions of law to which no answer is
`
`required. To the extent an answer is required, Plaintiffs deny that the claims of the ’003 patent
`
`are invalid. Plaintiffs deny the remaining allegations of Paragraph 61.
`
`62.
`
`Plaintiffs deny the allegations of Paragraph 62.
`
`
`
`
`
`SEVENTH COUNTERCLAIM: DECLARATORY JUDGMENT OF NON-
`
`INFRINGEMENT OF U.S. PATENT NO. 10,888,605
`
`63.
`
`Plaintiffs incorporate by reference the averments contained in Paragraphs 1-62 of
`
`this Answer to MPI’s Counterclaims.
`
`64.
`
`Plaintiffs deny the allegations of Paragraph 64.
`
`Unless Plaintiffs are enjoined, Plaintiffs will continue to assert that MPI’s Proposed ANDA
`Product is infringing the claims of the ’605 patent and will interfere with MPI’s business with
`respect to MPI’s Proposed ANDA Product and its manufacture, use, offer for sale, and sale.
`
`
`9
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`Case 1:23-cv-00013-TSK Document 28 Filed 04/21/23 Page 10 of 13 PageID #: 402
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`
`
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`
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`65.
`
`Plaintiffs admit that they assert that Defendants’ Proposed ANDA Product
`
`infringes the claims of the ’605 patent and will continue to assert such infringement. Plaintiffs
`
`deny the remaining allegations of Paragraph 65.
`
`66.
`
`67.
`
`Plaintiffs deny the allegations of Paragraph 66.
`
`Plaintiffs admit that an actual and justiciable controversy exists between Plaintiffs
`
`and Defendants as to infringement of the ’605 patent. Plaintiffs deny the remaining allegations
`
`of Paragraph 67.
`
`68.
`
`The allegations in Paragraph 68 contain conclusions of law to which no answer is
`
`required. To the extent an answer is required, Plaintiffs deny that Defendants’ Proposed ANDA
`
`Product does not infringe the claims of the ’605 patent. Plaintiffs deny the remaining allegations
`
`of Paragraph 68.
`
`69.
`
`Plaintiffs deny the allegations of Paragraph 69.
`
`
`
`
`
`EIGHTH COUNTERCLAIM: DECLARATORY JUDGMENT OF INVALIDITY
`
`OF U.S. PATENT NO. 10,888,605
`
`70.
`
`Plaintiffs incorporate by reference the averments contained in Paragraphs 1-69 of
`
`this Answer to MPI’s Counterclaims.
`
`71.
`
`72.
`
`Plaintiffs deny the allegations of Paragraph 71.
`
`Plaintiffs admit that they assert that Defendants’ Proposed ANDA Product
`
`infringes the claims of the ’605 patent and will continue to assert such infringement. Plaintiffs
`
`deny the remaining allegations of Paragraph 72.
`
`73.
`
`Plaintiffs deny the allegations of Paragraph 73.
`
`10
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`Case 1:23-cv-00013-TSK Document 28 Filed 04/21/23 Page 11 of 13 PageID #: 403
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`
`
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`
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`74.
`
`Plaintiffs admit that an actual and justiciable controversy exists between Plaintiffs
`
`and Defendants as to the validity of the ’605 patent. Plaintiffs admit that the claims of the ’605
`
`patent are valid and enforceable. Plaintiffs deny the remaining allegations of Paragraph 74.
`
`75.
`
`Plaintiffs deny the allegations of Paragraph 75.
`
`
`NINTH COUNTERCLAIM: DECLARATORY JUDGMENT OF NON-INFRINGEMENT
`
`OF U.S. PATENT NO. 11,318,191
`
`
`
`76.
`
`Plaintiffs incorporate by reference the averments contained in Paragraphs 1-75 of
`
`this Answer to MPI’s Counterclaims.
`
`77.
`
`78.
`
`Plaintiffs deny the allegations of Paragraph 77.
`
`Plaintiffs admit that they assert that Defendants’ Proposed ANDA Product
`
`infringes the claims of the ’191 patent and will continue to assert such infringement. Plaintiffs
`
`deny the remaining allegations of Paragraph 78.
`
`79.
`
`80.
`
`Plaintiffs deny the allegations of Paragraph 79.
`
`Plaintiffs admit that an actual and justiciable controversy exists between Plaintiffs
`
`and Defendants as to infringement of the ’191 patent. Plaintiffs deny the remaining allegations
`
`of Paragraph 80.
`
`81.
`
`Plaintiffs deny the allegations of Paragraph 81.
`
`
`
`
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`TENTH COUNTERCLAIM: DECLARATORY JUDGMENT OF INVALIDITY
`
`OF U.S. PATENT NO. 11,318,191
`
`82.
`
`Plaintiffs incorporate by reference the averments contained in Paragraphs 1-81 of
`
`this Answer to MPI’s Counterclaims.
`
`11
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`
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`Case 1:23-cv-00013-TSK Document 28 Filed 04/21/23 Page 12 of 13 PageID #: 404
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`
`
`
`
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`83.
`
`84.
`
`Plaintiffs deny the allegations of Paragraph 83.
`
`Plaintiffs admit that they assert that MPI’s Proposed ANDA Product infringes the
`
`claims of the ’191 patent and will continue to assert such infringement. Plaintiffs deny the
`
`remaining allegations of Paragraph 84.
`
`85.
`
`86.
`
`Plaintiffs deny the allegations of Paragraph 85.
`
`Plaintiffs admit that an actual and justiciable controversy exists between Plaintiffs
`
`and MPI as to the validity of the ’191 patent. Plaintiffs admit that the claims of the ’191 patent
`
`are valid and enforceable. Plaintiffs deny the remaining allegations of Paragraph 86.
`
`87.
`
`The allegations in Paragraph 87 contain conclusions of law to which no answer is
`
`required. To the extent an answer is required, Plaintiffs deny that the claims of the ’191 patent
`
`are invalid. Plaintiffs deny the remaining allegations of Paragraph 87.
`
`88.
`
`Plaintiffs deny the allegations of Paragraph 88.
`
`PLAINTIFFS’ RESPONSE TO PRAYER FOR RELIEF
`
`Plaintiffs deny that Defendants are entitled to any of their requested relief or to any
`
`different relief.
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`PLAINTIFFS’ DEFENSES TO COUNTERCLAIMS
`
`Plaintiffs hereby re-allege and incorporate by reference the allegations set forth in their
`
`Complaint in this action.
`
`First Defense
`
`Defendants’ Counterclaims fail to state a claim upon which relief may be granted.
`
`
`
`
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`12
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`
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`
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`REQUEST FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully seek an Order:
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Dismissing each of Defendants’ Counterclaims with prejudice;
`
`Denying Defendants the relief they request in their counterclaims;
`
`Entering judgment in favor of Plaintiffs against Defendants;
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`Declaring this case to be exceptional and awarding Plaintiffs their reasonable
`
`attorneys’ fees pursuant to 35 U.S.C. § 285;
`
`Awarding Plaintiffs’ costs and expenses in this action; and
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`Granting such other relief, in law or equity, as the Court deems just and proper.
`
`
`
`
`
`
`
`
`Of Counsel:
`
`Nicholas Groombridge
`Josephine Young
`Peter Sandel
`Jenny Wu
`Daniel Klein
`Naz E. Wehrli
`Joshua Reich
`Scott Miller
`GROOMBRIDGE, WU, BAUGHMAN
` & STONE LLP
`565 Fifth Ave
`Suite 2900
`New York, NY 10017
`(332) 269-0030
`
`Dated: April 21, 2023
`
`
`
`
`
`/s/ James F. Companion
`James F. Companion (#790)
`Sandra K. Law (#6071)
`SCHRADER COMPANION DUFF & LAW, PLLC
`401 Main Street
`Wheeling, WV 26003
`(304) 233-3390
`jfc@schraderlaw.com
`skl@schraderlaw.com
`
`Attorneys for Novo Nordisk Inc and Novo
`Nordisk A/S
`
`
`
`
`13
`
`