Case 1:22-cv-00023-JPB Document 19 Filed 04/08/22 Page 1 of 82 PageID #: 484
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
`
`Plaintiffs,
`
`v.
`
`MYLAN PHARMACEUTICALS INC.,
`
`Defendant.
`
`C.A. No. 1:22-cv-23-JPB
`
`
`MYLAN PHARMACEUTICALS INC.’S ANSWER, SEPARATE DEFENSES, AND
`COUNTERCLAIMS TO COMPLAINT
`
`Mylan Pharmaceuticals Inc. (“MPI”) by its undersigned attorneys, answers and responds
`
`to the Complaint for Patent Infringement of plaintiffs Nordisk Inc. and Novo Nordisk A/S
`
`(collectively, “Novo Nordisk”), as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the patent laws of the United States, Title
`35 of the United States Code, arising from Mylan’s submission of an Abbreviated New
`Drug Application (“ANDA”) to the United States Food and Drug Administration
`(“FDA”), by which Mylan seeks approval to market a generic version of Novo
`Nordisk’s pharmaceutical product Ozempic® prior to the expiration 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 patent”), 8,920,383 (the “’383 patent”),
`9,108,002 (the “’002 patent”), 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”) which cover
`inter alia, Ozempic® and/or its use.
`
`ANSWER: Paragraph 1 states a legal conclusion to which no answer is required. To the extent
`
`a response is required, MPI admits that Plaintiffs’ complaint purports to bring an action for patent
`
`infringement under the patent laws of the United States, 35 U.S.C. § 100 et seq. To the extent any
`
`further answer is required, MPI admits it submitted an Abbreviated New Drug Application
`
`-1-
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`

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`Case 1:22-cv-00023-JPB Document 19 Filed 04/08/22 Page 2 of 82 PageID #: 485
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`(“ANDA”) seeking approval by the United States Food and Drug Administration (“FDA”) for
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`semaglutide injection 2 mg/1.5 mL (1.34 mg/mL); 4 mg/3 mL (1.34 mg/mL). MPI admits its
`
`ANDA was filed with a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to
`
`the ’833 patent, the ’343 patent, the ’122 patent, the ’969 patent, the ’383 patent, the ’002
`
`patent, the ’239 patent, the ’154 patent, the ’180 patent, the ’611 patent, the ’953 patent,
`
`the ’757 patent, the ’155 patent, the ’462 patent, the ’616 patent, the ’652 patent, the ’063
`
`patent, and the ’363 patent. MPI is without knowledge or information sufficient to form a belief
`
`as to any remaining allegations set forth in paragraph 1 and, therefore, denies those allegations.
`
`THE PARTIES
`
`2.
`
`Plaintiff Novo Nordisk Inc. (“NNI”) is a corporation organized and existing under the
`laws of the State of Delaware, and has its principal place of business at 800 Scudders
`Mill Road, Plainsboro, New Jersey 08536.
`
`ANSWER: MPI is without knowledge or information sufficient to form a belief as to the
`
`allegations set forth in paragraph 2 and, therefore, denies those allegations.
`
`3.
`
`Plaintiff Novo Nordisk A/S (“NNAS”) is an entity organized and existing under the laws
`of the Kingdom of Denmark, and has its principal place of business at Novo Allé,
`2880 Bagsværd, Denmark. NNI is an indirect, wholly-owned subsidiary of NNAS.
`
`ANSWER: MPI is without knowledge or information sufficient to form a belief as to the
`
`allegations set forth in paragraph 3 and, therefore, denies those allegations.
`
`4.
`
`On information and belief, Defendant Mylan Pharmaceuticals Inc. 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, West Virginia 26505. On
`information and belief, Mylan Pharmaceuticals Inc. is in the business of making and
`selling generic pharmaceutical products, which it distributes in the State of West Virginia
`and throughout the United States.
`
`ANSWER: MPI admits that it is a corporation organized and existing under the laws of the
`
`State of West Virginia. MPI admits that it develops and manufactures pharmaceutical products.
`
`MPI denies the remaining allegations set forth in paragraph 4.
`
`-2-
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`

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`Case 1:22-cv-00023-JPB Document 19 Filed 04/08/22 Page 3 of 82 PageID #: 486
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`JURISDICTION AND VENUE
`
`5.
`
`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. §§ 1331
`and 1338(a).
`
`ANSWER: Paragraph 5 states a legal conclusion to which no answer is required. To the extent
`
`an answer is required, MPI admits that this Court has subject matter jurisdiction under 28 U.S.C.
`
`§§ 1131 and 1338(a).
`
`6.
`
`This Court has personal jurisdiction over Defendant Mylan Pharmaceuticals Inc. by
`virtue of, inter alia, its presence in West Virginia, being a West Virginia corporation;
`and having engaged in systematic and continuous contacts with the State of West Virginia;
`previously consenting to personal jurisdiction in this Court; and having taken advantage
`of the rights and protections provided by this Court, including having asserted
`counterclaims in this jurisdiction (see e.g., Merck Sharp & Dohme BV v. Mylan
`Pharmaceuticals Inc., C.A. No. 20-00061 (N.D. W. Va. Apr. 2, 2020); Celgene Corp. v.
`Mylan Pharmaceuticals Inc., C.A. No. 20-00003 (N.D. W. Va. Jan. 3, 2020)).
`
`ANSWER: Paragraph 6 states a legal conclusion to which no answer is required. To the extent
`
`an answer is required, MPI admits that it is a corporation organized and existing under the laws of
`
`West Virginia, MPI has a principal place of business in West Virginia, and MPI does not contest
`
`personal jurisdiction in this action. MPI denies the remaining allegations set forth in paragraph 6.
`
`7.
`
`On information and belief, Mylan intends to sell, offer to sell, use, and/or engage in the
`commercial manufacture of Mylan’s Product, directly or indirectly, throughout the
`United States and in this District. Mylan’s filing of Mylan’s ANDA confirms this
`intention and further subjects Mylan to the specific personal jurisdiction of this Court.
`
`ANSWER: Paragraph 7 states a legal conclusion to which no answer in required. To the extent
`
`an answer is required, MPI does not contest personal jurisdiction in this action. MPI denies the
`
`remaining allegations set forth in paragraph 7.
`
`8.
`
`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`ANSWER: Paragraph 8 states a legal conclusion to which no answer is required. To the extent
`
`and answer is required, MPI does not contest venue in this action. MPI denies the remaining
`
`allegations set forth in paragraph 8.
`
`-3-
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`

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`Case 1:22-cv-00023-JPB Document 19 Filed 04/08/22 Page 4 of 82 PageID #: 487
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`THE PATENTS-IN-SUIT
`
`9.
`
`On February 14, 2012, the United States Patent and Trademark Office issued the ’833
`patent, entitled “Propylene Glycol-Containing Peptide Formulations Which Are Optimal
`for Production and for Use in Injection Devices,” a copy of which is attached to this
`Complaint as Exhibit A. NNAS is the owner of all right, title, and interest in the ’833
`patent.
`
`ANSWER: MPI admits that the ’833 patent is entitled “Propylene Glycol-Containing Peptide
`
`Formulations Which Are Optimal for Production and for Use in Injection Devices.” MPI
`
`acknowledges that what purports to be a copy of the ’833 patent was attached as Exhibit A to the
`
`Complaint. MPI is without knowledge or information sufficient to form a belief as to the remaining
`
`allegations set forth in paragraph 9 and, therefore, denies those allegations.
`
`10.
`
`On March 6, 2012, the United States Patent and Trademark Office issued the ’343 patent,
`entitled “Acylated GLP-1 Compounds,” a copy of which is attached to this Complaint
`as Exhibit B. NNAS is the owner of all right, title, and interest in the ’343 patent.
`
`ANSWER: MPI admits that the ’343 patent is entitled “Acylated GLP-1 Compounds.” MPI
`
`acknowledges that what purports to be a copy of the ’343 patent was attached as Exhibit B to the
`
`Complaint. MPI is without knowledge or information sufficient to form a belief as to the remaining
`
`allegations set forth in paragraph 10 and, therefore, denies those allegations.
`
`11.
`
`On September 17, 2013, the United States Patent and Trademark Office issued the ’122
`patent, entitled “Acylated GLP-1 Compounds,” a copy of which is attached to this
`Complaint as Exhibit C. NNAS is the owner of all right, title, and interest in the ’122
`patent.
`
`ANSWER: MPI admits that the ’122 patent is entitled “Acylated GLP-1 Compounds.” MPI
`
`acknowledges that what purports to be a copy of the ’122 patent was attached as Exhibit C to the
`
`Complaint. MPI is without knowledge or information sufficient to form a belief as to the remaining
`
`allegations set forth in paragraph 11 and, therefore, denies those allegations.
`
`12. On April 1, 2014, the United States Patent and Trademark Office issued the ’969 patent,
`entitled “Injection Device with Torsion Spring and Rotatable Display,” a copy of which
`is attached to this Complaint as Exhibit D. NNAS is the owner of all right, title, and
`interest in the ’969 patent.
`
`-4-
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`

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`ANSWER: MPI admits that the ’969 patent is entitled “Injection Device with Torsion Spring
`
`and Rotatable Display.” MPI acknowledges that what purports to be a copy of the ’969 patent was
`
`attached as Exhibit D to the Complaint. MPI is without knowledge or information sufficient to
`
`form a belief as to the remaining allegations set forth in paragraph 12 and, therefore, denies those
`
`allegations.
`
`13.
`
`On December 30, 2014, the United States Patent and Trademark Office issued the ’383
`patent, entitled “Dose Mechanism for an Injection Device for Limiting a Dose
`Setting Corresponding to the Amount of Medicament Left,” a copy of which is attached
`to this Complaint as Exhibit E. NNAS is the owner of all right, title, and interest in the
`’383 patent.
`
`ANSWER: MPI admits that the ’383 patent is entitled “Dose Mechanism for an Injection
`
`Device for Limiting a Dose Setting Corresponding to the Amount of Medicament Left.” MPI
`
`acknowledges that what purports to be a copy of the ’383 patent was attached as Exhibit E to the
`
`Complaint. MPI is without knowledge or information sufficient to form a belief as to the remaining
`
`allegations set forth in paragraph 13 and, therefore, denies those allegations.
`
`14. On August 18, 2015, the United States Patent and Trademark Office issued the ’002 patent,
`entitled “Automatic Injection Device with a Top Release Mechanism,” a copy of which
`is attached to this Complaint as Exhibit F. NNAS is the owner of all right, title, and
`interest in the ’002 patent.
`
`ANSWER: MPI admits that the ’002 patent is entitled “Automatic Injection Device with a Top
`
`Release Mechanism.” MPI acknowledges that what purports to be a copy of the ’002 patent was
`
`attached as Exhibit F to the Complaint. MPI is without knowledge or information sufficient to
`
`form a belief as to the remaining allegations set forth in paragraph 14 and, therefore, denies those
`
`allegations.
`
`15.
`
`On September 15, 2015, the United States Patent and Trademark Office issued the ’239
`patent, entitled “Dial-Down Mechanism for Wind-Up Pen,” a copy of which is attached
`to this Complaint as Exhibit G. NNAS is the owner of all right, title, and interest in the
`’239 patent.
`
`-5-
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`ANSWER: MPI admits that the ’239 patent is entitled “Dial-Down Mechanism for Wind-Up
`
`Pen.” MPI acknowledges that what purports to be a copy of the ’239 patent was attached as Exhibit
`
`G to the Complaint. MPI is without knowledge or information sufficient to form a belief as to the
`
`remaining allegations set forth in paragraph 15 and, therefore, denies those allegations.
`
`16. On October 4, 2016, the United States Patent and Trademark Office issued the ’154 patent,
`entitled “Injection Device with an End of Dose Feedback Mechanism,” a copy of which
`is attached to this Complaint as Exhibit H. NNAS is the owner of all right, title, and
`interest in the ’154 patent.
`
`ANSWER: MPI admits that the ’154 patent is entitled “Injection Device with an End of Dose
`
`Feedback Mechanism.” MPI acknowledges that what purports to be a copy of the ’154 patent was
`
`attached as Exhibit H to the Complaint. MPI is without knowledge or information sufficient to
`
`form a belief as to the remaining allegations set forth in paragraph 16 and, therefore, denies those
`
`allegations.
`
`17. On April 11, 2017, the United States Patent and Trademark Office issued the ’180 patent,
`entitled “Automatic Injection Device with a Top Release Mechanism,” a copy of which
`is attached to this Complaint as Exhibit I. NNAS is the owner of all right, title, and
`interest in the ’180 patent.
`
`ANSWER: MPI admits that the ’180 patent is entitled “Automatic Injection Device with a Top
`
`Release Mechanism.” MPI acknowledges that what purports to be a copy of the ’180 patent was
`
`attached as Exhibit I to the Complaint. MPI is without knowledge or information sufficient to form
`
`a belief as to the remaining allegations set forth in paragraph 17 and, therefore, denies those
`
`allegations.
`
`18. On June 27, 2017, the United States Patent and Trademark Office issued the ’611 patent,
`entitled “Injection Device with Torsion Spring and Rotatable Display,” a copy of which
`is attached to this Complaint as Exhibit J. NNAS is the owner of all right, title, and
`interest in the ’611 patent.
`
`ANSWER: MPI admits that the ’611 patent is entitled “Injection Device with Torsion Spring
`
`and Rotatable Display.” MPI acknowledges that what purports to be a copy of the ’611 patent was
`
`-6-
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`attached as Exhibit J to the Complaint. MPI is without knowledge or information sufficient to form
`
`a belief as to the remaining allegations set forth in paragraph 18 and, therefore, denies those
`
`allegations.
`
`19.
`
`On October 3, 2017, the United States Patent and Trademark Office issued the ’953 patent,
`entitled “Dose Mechanism for an Injection Device for Limiting a Dose Setting
`Corresponding to the Amount of Medicament Left,” a copy of which is attached to this
`Complaint as Exhibit K. NNAS is the owner of all right, title, and interest in the ’953
`patent.
`
`ANSWER: MPI admits that the ’953 patent is entitled “Dose Mechanism for an Injection
`
`Device for Limiting a Dose Setting Corresponding to the Amount of Medicament Left.” MPI
`
`acknowledges that what purports to be a copy of the ’953 patent was attached as Exhibit K to the
`
`Complaint. MPI is without knowledge or information sufficient to form a belief as to the remaining
`
`allegations set forth in paragraph 19 and, therefore, denies those allegations.
`
`20. On January 9, 2018, the United States Patent and Trademark Office issued the ’757 patent,
`entitled “Injection Device with an End of Dose Feedback Mechanism,” a copy of which
`is attached to this Complaint as Exhibit L. NNAS is the owner of all right, title, and
`interest in the ’757 patent.
`
`ANSWER: MPI admits that the ’757 patent is entitled “Injection Device with an End of Dose
`
`Feedback Mechanism.” MPI acknowledges that what purports to be a copy of the ’757 patent was
`
`attached as Exhibit L to the Complaint. MPI is without knowledge or information sufficient to
`
`form a belief as to the remaining allegations set forth in paragraph 20 and, therefore, denies those
`
`allegations.
`
`21.
`
`On March 5, 2019, the United States Patent and Trademark Office issued the ’155 patent,
`entitled “Syringe Device with a Dose Limiting Mechanism and an Additional Safety
`Mechanism,” a copy of which is attached to this Complaint as Exhibit M. NNAS is the
`owner of all right, title, and interest in the ’155 patent.
`
`ANSWER: MPI admits that the ’155 patent is entitled “Syringe Device with a Dose Limiting
`
`Mechanism and an Additional Safety Mechanism.” MPI acknowledges that what purports to be
`
`a copy of the ’155 patent was attached as Exhibit M to the Complaint. MPI is without knowledge
`
`-7-
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`

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`or information sufficient to form a belief as to the remaining allegations set forth in paragraph 21
`
`and, therefore, denies those allegations.
`
`22.
`
`On July 2, 2019, the United States Patent and Trademark Office issued the ’462 patent,
`entitled “Use of Long-Acting GLP-1 Peptides,” a copy of which is attached to this
`Complaint as Exhibit N. NNAS is the owner of all right, title, and interest in the ’462
`patent.
`
`ANSWER: MPI admits that the ’462 patent is entitled “Use of Long-Acting GLP-1 Peptides.”
`
`MPI acknowledges that what purports to be a copy of the ’462 patent was attached as Exhibit N to
`
`the Complaint. MPI is without knowledge or information sufficient to form a belief as to the
`
`remaining allegations set forth in paragraph 22 and, therefore, denies those allegations.
`
`23. On July 23, 2019, the United States Patent and Trademark Office issued the ’616 patent,
`entitled “Injection Device with an End of Dose Feedback Mechanism,” a copy of which
`is attached to this Complaint as Exhibit O. NNAS is the owner of all right, title, and
`interest in the ’616 patent.
`
`ANSWER: MPI admits that the ’616 patent is entitled “Injection Device with an End of Dose
`
`Feedback Mechanism.” MPI acknowledges that what purports to be a copy of the ’616 patent was
`
`attached as Exhibit O to the Complaint. MPI is without knowledge or information sufficient to
`
`form a belief as to the remaining allegations set forth in paragraph 23 and, therefore, denies those
`
`allegations.
`
`24. On August 13, 2019, the United States Patent and Trademark Office issued the ’652 patent,
`entitled “Automatic Injection Device with a Top Release Mechanism,” a copy of which
`is attached to this Complaint as Exhibit P. NNAS is the owner of all right, title, and
`interest in the ’652 patent.
`
`ANSWER: MPI admits that the ’652 patent is entitled “Automatic Injection Device with a Top
`
`Release Mechanism.” MPI acknowledges that what purports to be a copy of the ’652 patent was
`
`attached as Exhibit P to the Complaint. MPI is without knowledge or information sufficient to
`
`form a belief as to the remaining allegations set forth in paragraph 24 and, therefore, denies those
`
`allegations.
`
`-8-
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`

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`25.
`
`On August 24, 2021, the United States Patent and Trademark Office issued the ’063 patent,
`entitled “Syringe Device with a Dose Limiting Mechanism and an Additional Safety
`Mechanism,” a copy of which is attached to this Complaint as Exhibit Q. NNAS is the
`owner of all right, title, and interest in the ’063 patent.
`
`ANSWER: MPI admits that the ’063 patent is entitled “Syringe Device with a Dose Limiting
`
`Mechanism and an Additional Safety Mechanism.” MPI acknowledges that what purports to be
`
`a copy of the ’063 patent was attached as Exhibit Q to the Complaint. MPI is without knowledge
`
`or information sufficient to form a belief as to the remaining allegations set forth in paragraph 25
`
`and, therefore, denies those allegations.
`
`26.
`
`On April 11, 2017, the United States Patent and Trademark Office issued the ’363 patent,
`entitled “Dial-Down Mechanism for Wind-Up Pen,” a copy of which is attached to this
`Complaint as Exhibit R. NNAS is the owner of all right, title, and interest in the ’363
`patent.
`
`ANSWER: MPI admits that the ’363 patent is entitled “Dial-Down Mechanism for Wind-Up
`
`Pen.” MPI acknowledges that what purports to be a copy of the ’363 patent was attached as Exhibit
`
`R to the Complaint. MPI is without knowledge or information sufficient to form a belief as to the
`
`remaining allegations set forth in paragraph 26 and, therefore, denies those allegations.
`
`OZEMPIC®
`
`27.
`
`NNI holds approved New Drug Application No. 209637 (the “Ozempic® NDA”) for
`Ozempic® (semaglutide) subcutaneous solution, 2 mg/1.5 ml (1.34 mg/ml) and 4 mg/3 ml
`(1.34 mg/ml), which NNI sells under the trade name Ozempic®.
`
`ANSWER: MPI avers that the Orange Book maintained by FDA lists Novo Nordisk Inc. as the
`
`holder of NDA 209637 for Ozempic® in 2 mg/1.5 ml (1.34 mg/ml) and 4 mg/3 ml (1.34 mg/ml)
`
`strengths. MPI is without knowledge or information sufficient to form a belief as to the remaining
`
`allegations set forth in paragraph 27 and, therefore, denies those allegations.
`
`28.
`
`The claims of the patents-in-suit cover, inter alia, Ozempic® and/or its use.
`
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`ANSWER: Paragraph 28 states a legal conclusion to which no answer is required. To the extent
`
`an answer is required, MPI is without knowledge or information sufficient to form a belief as to
`
`the allegations set forth in paragraph 28 and, therefore, denies those allegations.
`
`29.
`
`Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the ’833, ’343,
`’122, ’969, ’383, ’002, ’239, ’154, ’180, ’611, ’953, ’757, ’155, ’462, ’616, ’652,
`’063, and ’363 patents are listed in the FDA publication, “Approved Drug Products
`with Therapeutic Equivalence Evaluations” (the “Orange Book”), with respect to
`Ozempic®.
`
`ANSWER: Paragraph 29 states a legal conclusion to which no answer is required. To the extent
`
`an answer is required, MPI avers that the Orange Book maintained by FDA lists the ’833, ’343,
`
`’122, ’969, ’383, ’002, ’239, ’154, ’180, ’611, ’953, ’757, ’155, ’462, ’616, ’652, ’063, and
`
`’363 patents in connection with Ozempic®, at least some of which MPI asserts are improperly
`
`listed, as alleged in MPI’s counterclaims. MPI denies the remaining allegations set forth in
`
`paragraph 29.
`
`MYLAN’S ANDA
`
`30.
`
`On information and belief, Mylan submitted ANDA No. 216991 (“Mylan’s ANDA”) to
`the FDA, pursuant to 21 U.S.C. § 355(j), seeking approval to market a generic version of
`semaglutide injection, 2 mg/1.5 ml (1.34 mg/ml) and 4 mg/3 ml (1.34 mg/ml)
`(“Mylan’s Product”).
`
`ANSWER: MPI admits that it submitted ANDA No. 216991 to the FDA under 21 U.S.C.
`
`§ 355(j) seeking approval for semaglutide injection, 2 mg/1.5 mL (1.34 mg/mL) and 4 mg/3 mL
`
`(1.34 mg/mL). MPI denies the remaining allegations set forth in paragraph 30.
`
`31.
`
`On information and belief, Mylan’s ANDA refers to and relies upon the Ozempic® NDA
`and contains data that, according to Mylan, demonstrate the bioequivalence of Mylan’s
`Product and Ozempic®.
`
`ANSWER: MPI admits that ANDA No. 216991 refers to Ozempic® as the reference listed
`
`drug. MPI denies the remaining allegations set forth in paragraph 31.
`
`32.
`
`By letter to NNI and NNAS, dated February 4, 2022 (the “Notice Letter”), Mylan stated
`that Mylan’s ANDA contained a certification pursuant
`to 21 U.S.C. §
`
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`355(j)(2)(A)(vii)(IV) that the ’833, ’343, ’122, ’969, ’383, ’002, ’239, ’154, ’180, ’611,
`’953, ’757, ’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
`Product (the “Paragraph IV Certification”). Mylan attached a memorandum to the
`Notice Letter in which it purported to allege factual and legal bases for its Paragraph
`IV Certification. NNI and NNAS file this suit within 45 days of receipt of the Notice
`Letter.
`
`ANSWER: MPI admits that it notified NNI and NNAS that ANDA No. 216691 included a
`
`Paragraph IV Certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with respect to the ’833,
`
`’343, ’122, ’969, ’383, ’002, ’239, ’154, ’180, ’611, ’953, ’757, ’155, ’462, ’616, ’652, ’063,
`
`and ’363 patents. MPI admits that it sent the Notice Letter to Plaintiffs on February 4, 2022, and
`
`Plaintiffs filed suit on March 18, 2022. MPI denies the remaining allegations in paragraph 32.
`
`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 8,114,833
`
`33.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of Paragraphs
`1-32 of this Complaint.
`
`ANSWER: MPI incorporates its responses to paragraphs 1-32 as if fully set forth herein.
`
`34. Mylan has infringed the ’833 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`submitting Mylan’s ANDA, by which Mylan seeks approval from the FDA to
`manufacture, use, offer to sell, and sell Mylan’s Product prior to the expiration of the ’833
`patent.
`
`ANSWER: Paragraph 34 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, MPI denies the allegations set forth in paragraph 34.
`
`35.
`
`Claims 1-15 of the ’833 patent are directed to GLP-1 formulations. Claims 16-31 are
`directed to methods for preparing such formulations or methods of reducing deposits
`or reducing clogging by replacing the isotonicity agent in a formulation with
`propylene glycol. Mylan’s manufacture, use, offer for sale or sale of Mylan’s Product
`within the United States, or importation of Mylan’s Product into the United States, during
`the term of the ’833 patent would infringe claims 1-31 of the ’833 patent.
`
`ANSWER: Paragraph 35 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, MPI denies the allegations set forth in paragraph 35.
`
`-11-
`
`

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`Case 1:22-cv-00023-JPB Document 19 Filed 04/08/22 Page 12 of 82 PageID #: 495
`
`36.
`
`Novo Nordisk will be harmed substantially and irreparably if Mylan is not enjoined from
`infringing the ’833 patent and/or if the FDA is not enjoined from approving Mylan’s
`ANDA before the ’833 patent expires.
`
`ANSWER: Paragraph 36 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, MPI denies the allegations set forth in paragraph 36.
`
`37.
`
`Novo Nordisk has no adequate remedy at law.
`
`ANSWER: Paragraph 37 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, MPI denies the allegations set forth in paragraph 37.
`
`38. Mylan was aware of the ’833 patent when it submitted its ANDA. Novo Nordisk is
`entitled to a finding that this case is exceptional and to an award of attorney’s fees
`under 35 U.S.C. § 285.
`
`ANSWER: Paragraph 38 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, MPI admits that its original ANDA submission included a copy of
`
`the entry for NDA No. 209637 in FDA’s Orange Book, current as of December 4, 2021. MPI
`
`denies the remaining allegations set forth in paragraph 38.
`
`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 8,129,343
`
`39.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of Paragraphs
`1-38 of this Complaint.
`
`ANSWER: MPI incorporates its responses to paragraphs 1-38 as if fully set forth herein.
`
`40. Mylan has infringed the ’343 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`submitting Mylan’s ANDA, by which Mylan seeks approval from the FDA to
`manufacture, use, offer to sell, and sell Mylan’s Product prior to the expiration of the ’343
`patent.
`
`ANSWER: Paragraph 40 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, MPI denies the allegations set forth in paragraph 40.
`
`41.
`
`Claims 1-2 and 4-5 of the ’343 patent encompass semaglutide and pharmaceutical
`compositions comprising semaglutide. Claims 3 and 6 encompass methods of treating
`type 2 diabetes comprising administering to a patient an effective amount of
`semaglutide. Mylan’s manufacture, use, offer for sale or sale of Mylan’s Product within
`
`-12-
`
`

`

`Case 1:22-cv-00023-JPB Document 19 Filed 04/08/22 Page 13 of 82 PageID #: 496
`
`the United States, or importation of Mylan’s Product into the United States, during the term
`of the ’343 patent would infringe claims 1-6 of the ’343 patent.
`
`ANSWER: Paragraph 41 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, MPI denies the allegations set forth in paragraph 41.
`
`42.
`
`Upon information and belief, Mylan’s sale or offer for sale of Mylan’s Product within
`the United States, or importation of Mylan’s Product into the United States, or commercial
`marketing of Mylan’s Product in the United States, during the term of and with knowledge
`of the ’343 patent, would intentionally induce others to use Mylan’s Product in the
`United States, thus inducing infringement of claims 3 and 6 of the ’343 patent.
`
`ANSWER: Paragraph 42 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, MPI denies the allegations set forth in paragraph 42.
`
`43.
`
`Novo Nordisk will be harmed substantially and irreparably if Mylan is not enjoined from
`infringing the ’343 patent and/or if the FDA is not enjoined from approving Mylan’s
`ANDA before the ’343 patent expires.
`
`ANSWER: Paragraph 43 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, MPI denies the allegations set forth in paragraph 43.
`
`44.
`
`Novo Nordisk has no adequate remedy at law.
`
`ANSWER: Paragraph 44 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, MPI denies the allegations set forth in paragraph 44.
`
`45. Mylan was aware of the ’343 patent when it submitted its ANDA. Novo Nordisk is
`entitled to a finding that this case is exceptional and to an award of attorney’s fees
`under 35 U.S.C. § 285.
`
`ANSWER: Paragraph 45 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, MPI admits that its original ANDA submission included a copy of
`
`the entry for NDA No. 209637 in FDA’s Orange Book, current as of December 4, 2021. MPI
`
`denies the remaining allegations set forth in paragraph 45.
`
`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 8,536,122
`
`46.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of Paragraphs
`1-45 of this Complaint.
`
`-13-
`
`

`

`Case 1:22-cv-00023-JPB Document 19 Filed 04/08/22 Page 14 of 82 PageID #: 497
`
`ANSWER: MPI incorporates its responses to paragraphs 1-45 as if fully set forth herein.
`
`47. Mylan has infringed the ’122 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`submitting Mylan’s ANDA, by which Mylan seeks approval from the FDA to
`manufacture, use, offer to sell, and sell Mylan’s Product prior to the expiration of the ’122
`patent.
`
`ANSWER: Paragraph 47 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, MPI denies the allegations set forth in paragraph 47.
`
`48.
`
`Claims 1-14 of the ’122 patent encompass GLP-1 compounds and pharmaceutical
`compositions comprising GLP-1 compounds. Claims 15 and 16 encompass methods of
`treating type 2 diabetes comprising administering to a subject in need an effective
`amount of a claimed GLP-1 compound. Mylan’s manufacture, use, offer for sale or sale
`of Mylan’s Product within the United States, or importation of Mylan’s Product into the
`United States, during the term of the ’122 patent would infringe claims 1-16 of the ’122
`patent.
`
`ANSWER: Paragraph 48 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, MPI denies the allegations set forth in paragraph 48.
`
`49.
`
`Upon information and belief, Mylan’s sale or offer for sale of Mylan’s Product within
`the United States, or importation of Mylan’s Product into the United States, or commercial
`marketing of Mylan’s Product in the United States, during the term of and with knowledge
`of the ’122 patent, would intentionally induce others to use Mylan’s Product in the
`United States, thus inducing infringement of claims 15 and 16 of the ’122 patent.
`
`ANSWER: Paragraph 49 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, MPI denies the allegations set forth in paragraph 49.
`
`50.
`
`Novo Nordisk will be harmed substantially and irreparably if Mylan is not enjoined from
`infringing the ’122 patent and/or if the FDA is not enjoined from approving Mylan’s
`ANDA before the ’122 patent expires.
`
`ANSWER: Paragraph 50 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, M