Case 1:22-cv-00023-JPB Document 21 Filed 04/29/22 Page 1 of 44 PageID #: 568
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
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`))
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`) Civil Action No. 1:22-cv-23-JPB
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`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`Defendant.
`
`
`
`
`
`PLAINTIFFS’ ANSWER TO MYLAN PHARMACEUTICALS INC.’S
`COUNTERCLAIMS
`
`Plaintiffs Novo Nordisk Inc. and Novo Nordisk A/S (collectively, “Plaintiffs”), by their
`
`undersigned attorneys, for their Answer to Mylan Pharmaceuticals Inc.’s (“Mylan”) Counterclaims
`
`allege:
`
`Paragraphs 1 through 144 of Mylan’s Answer respond to Paragraphs 1 through 144 of
`
`Plaintiffs’ Complaint and therefore do not require a response. To the extent that a response is
`
`required, Plaintiffs incorporate by reference the allegations of Paragraphs 1 through 144 of their
`
`Complaint, and deny the allegations set forth in Mylan’s First through Forty-Second Separate
`
`Defenses.
`
`THE PARTIES
`
`1.
`
`Plaintiffs admit, upon information and belief, based on facts alleged in
`
`Mylan’s Counterclaims, that Mylan has a principal place of business at 3711 Collins Ferry Road,
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`Morgantown, West Virginia 26505.
`
`2.
`
`Plaintiffs admit that by letter to Novo Nordisk Inc. and Novo Nordisk A/S,
`
`dated February 4, 2022, Mylan stated that it was the owner of ANDA No. 216991 (“Mylan’s
`
`1
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`

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`Case 1:22-cv-00023-JPB Document 21 Filed 04/29/22 Page 2 of 44 PageID #: 569
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`ANDA”), which Mylan submitted to the FDA seeking approval for semaglutide injection, 2 mg/1.5
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`mL (1.34 mg/mL); 4 mg/3 ml (1.34 mg/ml) (“Mylan’s Proposed ANDA Product”). Plaintiffs
`
`otherwise deny knowledge or information sufficient to form a belief as to the truth of the
`
`allegations contained in Paragraph 2 of the Counterclaims and on that basis deny the allegations
`
`contained therein.
`
`3.
`
`Plaintiffs admit the allegations contained in Paragraph 3 of the
`
`Counterclaims.
`
`4.
`
`Plaintiffs admit the allegations contained in Paragraph 4 of the
`
`Counterclaims.
`
`NATURE OF THE ACTION
`
`5.
`
`Paragraph 5 contains conclusions of law to which no answer is required. To
`
`the 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 for the limited purpose of this
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`action only. Plaintiffs deny the Court has subject matter jurisdiction under 21 U.S.C. §
`
`355(j)(5)(C)(ii)(I).
`
`6.
`
`Paragraph 6 contains conclusions of law to which no answer is required. To
`
`the extent an answer is required, Plaintiffs do not contest venue in this judicial district for the
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`limited purpose of this action only.
`
`7.
`
`Paragraph 7 contains conclusions of law to which no answer is required. To
`
`the extent an answer is required, Plaintiffs do not contest personal jurisdiction in this judicial
`
`district for the limited purpose of this action only.
`
`8.
`
`Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement and validity of United States Patent Nos. 8,114,833 (the “’833
`
`patent”), 8,129,343 (the “’343 patent”), 8,536,122 (the “’122 patent”), 8,684,969 (the “’969
`
`2
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`
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`

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`Case 1:22-cv-00023-JPB Document 21 Filed 04/29/22 Page 3 of 44 PageID #: 570
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`patent”), 8,920,383 (the “’383 patent”), 9,108,002 (the “’002 patent”), and 9,132,239 (the “’239
`
`patent”), 9,457,154 (the “’154 patent”), 9,616,180 (the “’180 patent”), 9,687,611 (the “’611
`
`patent”), 9,775,953 (the “’953 patent”), 9,861,757 (the “’757 patent”), 10,220,155 (the “’155
`
`patent”), 10,335,462 (the “’462 patent”), 10,357,616 (the “’616 patent”), 10,376,652 (the “’652
`
`patent”), 11,097,063 (the “’063 patent”), and RE46,363 (the “’363 patent”), (collectively, the
`
`“Asserted Patents”). Plaintiffs deny the remaining allegations contained in Paragraph 8 of the
`
`Counterclaims.
`
`9.
`
`Paragraph 9 contains conclusions of law to which no answer is required. To
`
`the extent an answer is required, Plaintiffs admit that Mylan purports to seek an order under 21
`
`U.S.C. § 355(j)(5)(C)(ii)(I). Plaintiffs deny the remaining allegations contained in Paragraph 9 of
`
`the Counterclaims.
`
`BACKGROUND
`
`10.
`
`Plaintiffs admit that 21 U.S.C. § 355(b)(1) states the following:
`
`[Applicants] shall submit to the Secretary as part of the
`application […] (viii) the patent number and expiration date
`of each patent for which a claim of patent infringement could
`reasonably be asserted if a person not licensed by the owner
`of the patent engaged in the manufacture, use, or sale of the
`drug, and that— (I) claims the drug for which the applicant
`submitted the application and is a drug substance (active
`ingredient) patent or a drug product (formulation or
`composition) patent; or (II) claims a method of using such
`drug for which approval is sought or has been granted in the
`application.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 10 of the Counterclaims.
`
`11.
`
`Plaintiffs admit that 21 C.F.R. § 314.53(b)(1) states the following:
`
`An applicant … must submit to its NDA the required
`information, on the required FDA declaration form, … for
`each patent that claims the drug or a method of using the
`drug that is the subject of the NDA or amendment or
`supplement to it and with respect to which a claim of patent
`
`3
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`

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`infringement could reasonably be asserted if a person not
`licensed by the owner of the patent engaged in the
`manufacture, use, or sale of the drug product … such patents
`consist of drug substance (active ingredient) patents, drug
`product (formulation and composition) patents, and method-
`of-use patents.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 11 of the Counterclaims.
`
`12.
`
`Paragraph 12 contains conclusions of law to which no answer is required.
`
`To the extent an answer is required, Plaintiffs deny the allegations contained in Paragraph 12 of
`
`the Counterclaims.
`
`13.
`
`Plaintiffs admit that the FDA publishes the patent information from NDA
`
`applicants in the FDA publication entitled “Approved Drug Products with Therapeutic
`
`Equivalence Evaluations” (the “Orange Book”). Plaintiffs otherwise deny knowledge or
`
`information sufficient to form a belief as to the truth of the allegations contained in Paragraph 13
`
`of the Counterclaims and on that basis deny the allegations contained therein.
`
`14.
`
`Paragraph 14 contains conclusions of law to which no answer is required,
`
`to the extent an answer is required, Plaintiffs deny the allegations contained in Paragraph 14 of the
`
`Counterclaims.
`
`15.
`
`Plaintiffs admit that Novo Nordisk Inc. submitted patent listing information
`
`in connection with NDA No. 209637. Plaintiffs deny the remaining allegations contained in
`
`Paragraph 15 of the Counterclaims.
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`16.
`
`Plaintiffs admit the allegations contained in Paragraph 16 of the
`
`Counterclaims.
`
`17.
`
`Plaintiffs admit that by letter to Novo Nordisk Inc. and Novo Nordisk A/S,
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`dated February 4, 2022 (“Mylan’s Notice Letter”), Mylan stated that its ANDA contains
`
`certifications, pursuant
`
`to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Mylan’s Paragraph IV
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`4
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`

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`Case 1:22-cv-00023-JPB Document 21 Filed 04/29/22 Page 5 of 44 PageID #: 572
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`Certifications”), that the ’833, ’343, ’122, ’969, ’383, ’002, ’239, ’154, ’180, ’611, ’953, ’757,
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`’155, ’462, ’616, ’652, ’063, and ’363 patents are invalid, unenforceable, and/or will not be
`
`infringed by the commercial manufacture, use, or sale of Mylan’s Proposed ANDA Product.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 17 of the Counterclaims.
`
`18.
`
`Plaintiffs admit that Mylan’s Notice Letter purports to include a statement
`
`of the legal and factual basis for Mylan’s Paragraph IV Certifications. Plaintiffs deny that the
`
`positions taken in Mylan’s Paragraph IV Certifications are correct.
`
`19.
`
`Plaintiffs admit
`
`that Plaintiffs filed
`
`this
`
`instant
`
`lawsuit alleging
`
`infringement of the ’833, ’343, ’122, ’969, ’383, ’002, ’239, ’154, ’180, ’611, ’953, ’757, ’155,
`
`’462, ’616, ’652, ’063, and ’363 patents. The remaining allegations in Paragraph 19 contain
`
`conclusions of law to which no answer is required. To the extent an answer is required, Plaintiffs
`
`admit that a controversy currently exists between Plaintiffs and Mylan as to the infringement of
`
`the ’833, ’343, ’122, ’969, ’383, ’002, ’239, ’154, ’180, ’611, ’953, ’757, ’155, ’462, ’616, ’652,
`
`’063, and ’363 patents. Plaintiffs deny the remaining allegations contained in Paragraph 19 of the
`
`Counterclaims.
`
`FIRST COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 8,114,833)
`
`20.
`
`Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-19 of this Answer.
`
`21.
`
`Plaintiffs admit the allegations contained in Paragraph 21 of the
`
`Counterclaims.
`
`22.
`
`Plaintiffs deny the allegations contained in Paragraph 22 of the
`
`Counterclaims.
`
`5
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`23.
`
`Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’833 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 23 of the Counterclaims.
`
`24.
`
`Plaintiffs deny the allegations contained in Paragraph 24 of the
`
`Counterclaims.
`
`25.
`
`Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’833 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 25 of the Counterclaims.
`
`26.
`
`Plaintiffs deny the allegations contained in Paragraph 26 of the
`
`Counterclaims.
`
`SECOND COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent 8,129,343)
`
`27.
`
`Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-26 of this Answer.
`
`28.
`
`Plaintiffs admit the allegations contained in Paragraph 28 of the
`
`Counterclaims.
`
`29.
`
`Plaintiffs deny the allegations contained in Paragraph 29 of the
`
`Counterclaims.
`
`30.
`
`Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’343 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 30 of the Counterclaims.
`
`31.
`
`Plaintiffs deny the allegations contained in Paragraph 31 of the
`
`Counterclaims.
`
`6
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`32.
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`Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’343 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 32 of the Counterclaims.
`
`33.
`
`Plaintiffs deny the allegations contained in Paragraph 33 of the
`
`Counterclaims.
`
`THIRD COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 8,536,122)
`
`34.
`
`Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-33 of this Answer.
`
`35.
`
`Plaintiffs admit the allegations contained in Paragraph 35 of the
`
`Counterclaims.
`
`36.
`
`Plaintiffs deny the allegations contained in Paragraph 36 of the
`
`Counterclaims.
`
`37.
`
`Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’122 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 37 of the Counterclaims.
`
`38.
`
`Plaintiffs deny the allegations contained in Paragraph 38 of the
`
`Counterclaims.
`
`39.
`
`Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’122 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 39 of the Counterclaims.
`
`40.
`
`Plaintiffs deny the allegations contained in Paragraph 40 of the
`
`Counterclaims.
`
`7
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`

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`Case 1:22-cv-00023-JPB Document 21 Filed 04/29/22 Page 8 of 44 PageID #: 575
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`FOURTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 8,684,969)
`
`41.
`
`Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-40 of this Answer.
`
`42.
`
`Plaintiffs admit the allegations contained in Paragraph 42 of the
`
`Counterclaims.
`
`43.
`
`Plaintiffs deny the allegations contained in Paragraph 43 of the
`
`Counterclaims.
`
`44.
`
`Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’969 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 44 of the Counterclaims.
`
`45.
`
`Plaintiffs deny the allegations contained in Paragraph 45 of the
`
`Counterclaims.
`
`46.
`
`Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’969 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 46 of the Counterclaims.
`
`47.
`
`Plaintiffs deny the allegations contained in Paragraph 47 of the
`
`Counterclaims.
`
`FIFTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 8,920,383)
`
`48.
`
`Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-47 of this Answer.
`
`49.
`
`Plaintiffs admit the allegations contained in Paragraph 49 of the
`
`Counterclaims.
`
`8
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`

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`Case 1:22-cv-00023-JPB Document 21 Filed 04/29/22 Page 9 of 44 PageID #: 576
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`50.
`
`Plaintiffs deny the allegations contained in Paragraph 50 of the
`
`Counterclaims.
`
`51.
`
`Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’383 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 51 of the Counterclaims.
`
`52.
`
`Plaintiffs deny the allegations contained in Paragraph 52 of the
`
`Counterclaims.
`
`53.
`
`Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’383 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 53 of the Counterclaims.
`
`54.
`
`Plaintiffs deny the allegations contained in Paragraph 54 of the
`
`Counterclaims.
`
`SIXTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent 9,108,002)
`
`55.
`
`Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-54 of this Answer.
`
`56.
`
`Plaintiffs admit the allegations contained in Paragraph 56 of the
`
`Counterclaims.
`
`57.
`
`Plaintiffs deny the allegations contained in Paragraph 57 of the
`
`Counterclaims.
`
`58.
`
`Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’002 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 58 of the Counterclaims.
`
`9
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`59.
`
`Plaintiffs deny the allegations contained in Paragraph 59 of the
`
`Counterclaims.
`
`60.
`
`Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’002 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 60 of the Counterclaims.
`
`61.
`
`Plaintiffs deny the allegations contained in Paragraph 61 of the
`
`Counterclaims.
`
`SEVENTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 9,132,239)
`
`62.
`
`Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-61 of this Answer.
`
`63.
`
`Plaintiffs admit the allegations contained in Paragraph 63 of the
`
`Counterclaims.
`
`64.
`
`Plaintiffs deny the allegations contained in Paragraph 64 of the
`
`Counterclaims.
`
`65.
`
`Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’239 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 65 of the Counterclaims.
`
`66.
`
`Plaintiffs deny the allegations contained in Paragraph 66 of the
`
`Counterclaims.
`
`67.
`
`Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’239 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 67 of the Counterclaims.
`
`10
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`

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`68.
`
`Plaintiffs deny the allegations contained in Paragraph 68 of the
`
`Counterclaims.
`
`EIGHTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 9,457,154)
`
`69.
`
`Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-68 of this Answer.
`
`70.
`
`Plaintiffs admit the allegations contained in Paragraph 70 of the
`
`Counterclaims.
`
`71.
`
`Plaintiffs deny the allegations contained in Paragraph 71 of the
`
`Counterclaims.
`
`72.
`
`Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’154 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 72 of the Counterclaims.
`
`73.
`
`Plaintiffs deny the allegations contained in Paragraph 73 of the
`
`Counterclaims.
`
`74.
`
`Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’154 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 74 of the Counterclaims.
`
`75.
`
`Plaintiffs deny the allegations contained in Paragraph 75 of the
`
`Counterclaims.
`
`NINTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 9,616,180)
`
`76.
`
`Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-75 of this Answer.
`
`11
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`

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`77.
`
`Plaintiffs admit the allegations contained in Paragraph 77 of the
`
`Counterclaims.
`
`78.
`
`Plaintiffs deny the allegations contained in Paragraph 78 of the
`
`Counterclaims.
`
`79.
`
`Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’180 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 79 of the Counterclaims.
`
`80.
`
`Plaintiffs deny the allegations contained in Paragraph 80 of the
`
`Counterclaims.
`
`81.
`
`Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’180 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 81 of the Counterclaims.
`
`82.
`
`Plaintiffs deny the allegations contained in Paragraph 82 of the
`
`Counterclaims.
`
`TENTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 9,687,611)
`
`83.
`
`Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-82 of this Answer.
`
`84.
`
`Plaintiffs admit the allegations contained in Paragraph 84 of the
`
`Counterclaims.
`
`85.
`
`Plaintiffs deny the allegations contained in Paragraph 85 of the
`
`Counterclaims.
`
`12
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`

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`86.
`
`Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’611 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 86 of the Counterclaims.
`
`87.
`
`Plaintiffs deny the allegations contained in Paragraph 87 of the
`
`Counterclaims.
`
`88.
`
`Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’611 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 88 of the Counterclaims.
`
`89.
`
`Plaintiffs deny the allegations contained in Paragraph 89 of the
`
`Counterclaims.
`
`ELEVENTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 9,775,953)
`
`90.
`
`Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-89 of this Answer.
`
`91.
`
`Plaintiffs admit the allegations contained in Paragraph 91 of the
`
`Counterclaims.
`
`92.
`
`Plaintiffs deny the allegations contained in Paragraph 92 of the
`
`Counterclaims.
`
`93.
`
`Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’953 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 93 of the Counterclaims.
`
`94.
`
`Plaintiffs deny the allegations contained in Paragraph 94 of the
`
`Counterclaims.
`
`13
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`Case 1:22-cv-00023-JPB Document 21 Filed 04/29/22 Page 14 of 44 PageID #: 581
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`95.
`
`Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’953 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 95 of the Counterclaims.
`
`96.
`
`Plaintiffs deny the allegations contained in Paragraph 96 of the
`
`Counterclaims.
`
`TWELFTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 9,861,757)
`
`97.
`
`Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-96 of this Answer.
`
`98.
`
`Plaintiffs admit the allegations contained in Paragraph 98 of the
`
`Counterclaims.
`
`99.
`
`Plaintiffs deny the allegations contained in Paragraph 99 of the
`
`Counterclaims.
`
`100. Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’757 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 100 of the Counterclaims.
`
`101. Plaintiffs deny the allegations contained in Paragraph 101 of the
`
`Counterclaims.
`
`102. Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’757 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 102 of the Counterclaims.
`
`103. Plaintiffs deny the allegations contained in Paragraph 103 of the
`
`Counterclaims.
`
`14
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`

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`Case 1:22-cv-00023-JPB Document 21 Filed 04/29/22 Page 15 of 44 PageID #: 582
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`THIRTEENTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 10,220,155)
`
`104. Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-103 of this Answer.
`
`105. Plaintiffs admit the allegations contained in Paragraph 105 of the
`
`Counterclaims.
`
`106. Plaintiffs deny the allegations contained in Paragraph 106 of the
`
`Counterclaims.
`
`107. Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’155 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 107 of the Counterclaims.
`
`108. Plaintiffs deny the allegations contained in Paragraph 108 of the
`
`Counterclaims.
`
`109. Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’155 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 109 of the Counterclaims.
`
`110. Plaintiffs deny the allegations contained in Paragraph 110 of the
`
`Counterclaims.
`
`FOURTEENTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 10,335,462)
`
`111. Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-110 of this Answer.
`
`112. Plaintiffs admit the allegations contained in Paragraph 112 of the
`
`Counterclaims.
`
`15
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`Case 1:22-cv-00023-JPB Document 21 Filed 04/29/22 Page 16 of 44 PageID #: 583
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`113. Plaintiffs deny the allegations contained in Paragraph 113 of the
`
`Counterclaims.
`
`114. Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’462 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 114 of the Counterclaims.
`
`115. Plaintiffs deny the allegations contained in Paragraph 115 of the
`
`Counterclaims.
`
`116. Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’462 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 116 of the Counterclaims.
`
`117. Plaintiffs deny the allegations contained in Paragraph 117 of the
`
`Counterclaims.
`
`FIFTEENTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 10,357,616)
`
`118. Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-117 of this Answer.
`
`119. Plaintiffs admit the allegations contained in Paragraph 119 of the
`
`Counterclaims.
`
`120. Plaintiffs deny the allegations contained in Paragraph 120 of the
`
`Counterclaims.
`
`121. Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’616 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 121 of the Counterclaims.
`
`16
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`Case 1:22-cv-00023-JPB Document 21 Filed 04/29/22 Page 17 of 44 PageID #: 584
`
`122. Plaintiffs deny the allegations contained in Paragraph 122 of the
`
`Counterclaims.
`
`123. Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’616 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 123 of the Counterclaims.
`
`124. Plaintiffs deny the allegations contained in Paragraph 124 of the
`
`Counterclaims.
`
`SIXTEENTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 10,376,652)
`
`125. Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-124 of this Answer.
`
`126. Plaintiffs admit the allegations contained in Paragraph 126 of the
`
`Counterclaims.
`
`127. Plaintiffs deny the allegations contained in Paragraph 127 of the
`
`Counterclaims.
`
`128. Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’652 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 128 of the Counterclaims.
`
`129. Plaintiffs deny the allegations contained in Paragraph 129 of the
`
`Counterclaims.
`
`130. Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’652 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 130 of the Counterclaims.
`
`17
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`Case 1:22-cv-00023-JPB Document 21 Filed 04/29/22 Page 18 of 44 PageID #: 585
`
`131. Plaintiffs deny the allegations contained in Paragraph 131 of the
`
`Counterclaims.
`
`SEVENTEENTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. 11,097,063)
`
`132. Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-131 of this Answer.
`
`133. Plaintiffs admit the allegations contained in Paragraph 133 of the
`
`Counterclaims.
`
`134. Plaintiffs deny the allegations contained in Paragraph 134 of the
`
`Counterclaims.
`
`135. Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’063 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 135 of the Counterclaims.
`
`136. Plaintiffs deny the allegations contained in Paragraph 136 of the
`
`Counterclaims.
`
`137. Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’063 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 137 of the Counterclaims.
`
`138. Plaintiffs deny the allegations contained in Paragraph 138 of the
`
`Counterclaims.
`
`EIGHTEENTH COUNTERCLAIM
`(Declaratory Judgment of Non-Infringement of U.S. Patent No. RE46,363)
`
`139. Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-138 of this Answer.
`
`18
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`Case 1:22-cv-00023-JPB Document 21 Filed 04/29/22 Page 19 of 44 PageID #: 586
`
`140. Plaintiffs admit the allegations contained in Paragraph 140 of the
`
`Counterclaims.
`
`141. Plaintiffs deny the allegations contained in Paragraph 141 of the
`
`Counterclaims.
`
`142. Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’363 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 142 of the Counterclaims.
`
`143. Plaintiffs deny the allegations contained in Paragraph 143 of the
`
`Counterclaims.
`
`144. Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the infringement of the ’363 patent. Plaintiffs deny the remaining allegations
`
`contained in Paragraph 144 of the Counterclaims.
`
`145. Plaintiffs deny the allegations contained in Paragraph 145 of the
`
`Counterclaims.
`
`NINETEENTH COUNTERCLAIM
`(Declaratory Judgment of Invalidity of U.S. Patent No. 8,114,833)
`
`146. Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-145 of this Answer.
`
`147. Plaintiffs deny the allegations contained in Paragraph 147 of the
`
`Counterclaims.
`
`148. Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’833 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 148 of the Counterclaims.
`
`19
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`Case 1:22-cv-00023-JPB Document 21 Filed 04/29/22 Page 20 of 44 PageID #: 587
`
`149. Plaintiffs deny the allegations contained in Paragraph 149 of the
`
`Counterclaims.
`
`150. Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the validity of the ’833 patent. Plaintiffs deny the remaining allegations contained in
`
`Paragraph 150 of the Counterclaims.
`
`151. Plaintiffs deny the allegations contained in Paragraph 151 of the
`
`Counterclaims.
`
`TWENTIETH COUNTERCLAIM
`(Declaratory Judgment of Invalidity of U.S. Patent No. 8,129,343)
`
`152. Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-151 of this Answer.
`
`153. Plaintiffs deny the allegations contained in Paragraph 153 of the
`
`Counterclaims.
`
`154. Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’343 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 154 of the Counterclaims.
`
`155. Plaintiffs deny the allegations contained in Paragraph 155 of the
`
`Counterclaims.
`
`156. Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the validity of the ’343 patent. Plaintiffs deny the remaining allegations contained in
`
`Paragraph 156 of the Counterclaims.
`
`157. Plaintiffs deny the allegations contained in Paragraph 157 of the
`
`Counterclaims.
`
`20
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`Case 1:22-cv-00023-JPB Document 21 Filed 04/29/22 Page 21 of 44 PageID #: 588
`
`TWENTY-FIRST COUNTERCLAIM
`(Declaratory Judgment of Invalidity of U.S. Patent No. 8,536,122)
`
`158. Plaintiffs hereby re-allege and incorporate by reference the averments
`
`contained in Paragraphs 1-157 of this Answer.
`
`159. Plaintiffs deny the allegations contained in Paragraph 159 of the
`
`Counterclaims.
`
`160. Plaintiffs admit that they assert that Mylan’s Proposed ANDA Product
`
`infringes the asserted claims of the ’122 patent and will continue to assert such infringement.
`
`Plaintiffs deny the remaining allegations contained in Paragraph 160 of the Counterclaims.
`
`161. Plaintiffs deny the allegations contained in Paragraph 161 of the
`
`Counterclaims.
`
`162. Plaintiffs admit that a controversy currently exists between Plaintiffs and
`
`Mylan as to the validity of the ’122 patent. Plaintiffs deny the remaining allegations contained in
`
`Paragraph 162 of the Counterclaims.
`
`163. Plaintiffs deny the allegations contained in Paragraph 163 of the
`
`Counterclaims.
`
`TWENTY-SECOND COUNTERCLAIM
`(Declaratory Judgmen