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`Exhibit 3
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`Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 2 of 49 PageID #: 2037
`
`U.S. District Court
`District of Delaware (Wilmington)
`CIVIL DOCKET FOR CASE #: 1:22−cv−00297−CFC
`
`PATENT
`
`Novo Nordisk Inc. et al v. Zydus Worldwide DMCC et al
`Assigned to: Judge Colm F. Connolly
`Related Cases: 1:21−cv−01782−CFC
`1:22−cv−00295−CFC
`1:22−cv−00296−CFC
`1:22−cv−00299−CFC
`1:22−cv−00298−CFC
`1:22−cv−00294−CFC
`Cause: 35:271 Patent Infringement
`Plaintiff
`Novo Nordisk Inc.
`
`Date Filed: 03/04/2022
`Jury Demand: None
`Nature of Suit: 835 Patent − Abbreviated
`New Drug Application(ANDA)
`Jurisdiction: Federal Question
`
`represented by Jack B. Blumenfeld
`Morris, Nichols, Arsht & Tunnell LLP
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658−9200
`Email: Jbbefiling@mnat.com
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Brian P. Egan
`Morris, Nichols, Arsht & Tunnell LLP
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`302−351−9454
`Email: began@mnat.com
`ATTORNEY TO BE NOTICED
`
`represented by Jack B. Blumenfeld
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Brian P. Egan
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Plaintiff
`Novo Nordisk A/S
`
`V.
`Defendant
`Zydus Worldwide DMCC
`
`Defendant
`Zydus Pharmaceuticals (USA) Inc.
`
`Defendant
`Cadila Healthcare Ltd.
`
`Date Filed
`
`# Docket Text
`
`
`
`Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 3 of 49 PageID #: 2038
`
`03/04/2022
`
`03/04/2022
`
`03/04/2022
`
`03/04/2022
`
`03/04/2022
`
`03/04/2022
`
`03/04/2022
`
`1 COMPLAINT filed against Cadila Healthcare Ltd., Zydus Pharmaceuticals (USA)
`Inc., Zydus Worldwide DMCC − Magistrate Consent Notice to Pltf. ( Filing fee $ 402,
`receipt number ADEDC−3817668.) − filed by Novo Nordisk Inc., Novo Nordisk A/S.
`(Attachments: # 1 Exhibit A, # 2 Civil Cover Sheet)(srs) (Entered: 03/04/2022)
`
`2 Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (srs)
`(Entered: 03/04/2022)
`
`3 Supplemental information for patent cases involving an Abbreviated New Drug
`Application (ANDA) − Date Patentee(s) Received Notice: 02/01/2022. Date of
`Expiration of Patent: U.S. Patent No. 9,132,239 expires 2/1/2032 and U.S. Patent No.
`10,335,462 expires on 6/21/2033.Thirty Month Stay Deadline: 6/5/2025. (srs)
`(Entered: 03/04/2022)
`
`4 Report to the Commissioner of Patents and Trademarks for Patent/Trademark
`Number(s) 9,132,239 B2 ;10,335,462 B2. (srs) (Entered: 03/04/2022)
`
`5 Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Novo A/S and
`Corporate Parent Novo Nordisk US Holdings, Inc. for Novo Nordisk Inc.; Corporate
`Parent Novo A/S for Novo Nordisk A/S − filed by Novo Nordisk A/S and Novo
`Nordisk Inc. (srs) (Entered: 03/04/2022)
`
`6 Summons Issued as to Zydus Worldwide DMCC on 3/4/2022. (srs) (Entered:
`03/04/2022)
`
`7 Summons Issued as to Zydus Pharmaceuticals (USA) Inc. on 3/4/2022. (srs) (Entered:
`03/04/2022)
`
`03/04/2022
`
`8 Summons Issued as to Cadila Healthcare Ltd. on 3/4/2022. (srs) (Entered: 03/04/2022)
`
`03/09/2022
`
`03/14/2022
`
`03/14/2022
`
`03/14/2022
`
`03/14/2022
`
`03/14/2022
`
`05/06/2022
`
`05/06/2022
`
`Case Assigned to Judge Colm F. Connolly. Please include the initials of the Judge
`(CFC) after the case number on all documents filed. Associated Cases:
`1:22−cv−00294−CFC through 1:22−cv−00299−CFC (rjb) (Entered: 03/09/2022)
`
`9 WAIVER OF SERVICE returned executed by Novo Nordisk Inc., Novo Nordisk A/S:
`For Cadila Healthcare Ltd. waiver sent on 3/10/2022, answer due 5/9/2022. (Egan,
`Brian) (Entered: 03/14/2022)
`
`10 WAIVER OF SERVICE returned executed by Novo Nordisk Inc., Novo Nordisk A/S:
`For Zydus Worldwide DMCC waiver sent on 3/10/2022, answer due 5/9/2022. (Egan,
`Brian) (Entered: 03/14/2022)
`
`11 WAIVER OF SERVICE returned executed by Novo Nordisk Inc., Novo Nordisk A/S:
`For Zydus Pharmaceuticals (USA) Inc. waiver sent on 3/10/2022, answer due
`5/9/2022. (Egan, Brian) (Entered: 03/14/2022)
`
`12 STIPULATION TO EXTEND TIME for Defendants Zydus Worldwide DMCC,
`Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. to answer, move or
`otherwise respond to Plaintiffs Complaint to May 9, 2022 − filed by Novo Nordisk
`A/S, Novo Nordisk Inc.. (Egan, Brian) (Entered: 03/14/2022)
`
`SO ORDERED, re 12 STIPULATION TO EXTEND TIME for Defendants Zydus
`Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. to
`answer, move or otherwise respond to Plaintiffs Complaint to May 9, 2022, filed by
`Novo Nordisk A/S, Novo Nordisk Inc. Ordered by Judge Colm F. Connolly on
`3/14/2022. (kmd) (Entered: 03/14/2022)
`
`13 MOTION for Pro Hac Vice Appearance of Attorney Jeffrey J. Oelke, Ryan P.
`Johnson, Robert E. Counihan, Laura T. Moran, Erica R. Sutter, Kara Czekai, and
`Olivia Wheeling − filed by Novo Nordisk A/S, Novo Nordisk Inc.. (Egan, Brian)
`(Entered: 05/06/2022)
`
`SO ORDERED, re (15 in 1:22−cv−00298−CFC, 10 in 1:22−cv−00294−CFC, 13 in
`1:22−cv−00297−CFC, 10 in 1:22−cv−00296−CFC, 9 in 1:22−cv−00299−CFC)
`MOTION for Pro Hac Vice Appearance of Attorney Jeffrey J. Oelke, Ryan P.
`Johnson, Robert E. Counihan, Laura T. Moran, Erica R. Sutter, Kara Czekai, and
`Olivia Wheeling, filed by Novo Nordisk A/S, Novo Nordisk Inc. Ordered by Judge
`Colm F. Connolly on 5/6/2022. Associated Cases: 1:22−cv−00294−CFC,
`1:22−cv−00296−CFC, 1:22−cv−00297−CFC, 1:22−cv−00298−CFC,
`
`
`
`Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 4 of 49 PageID #: 2039
`
`1:22−cv−00299−CFC. (kmd) (Entered: 05/06/2022)
`
`
`
`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
`
`
`
`
`
`ZYDUS WORLDWIDE DMCC, ZYDUS
`PHARMACEUTICALS (USA) INC. and
`CADILA HEALTHCARE LTD.,
`
`
`
`Plaintiffs,
`
`
`
`
`
`
`
`v.
`
`
`
`Defendants.
`
`
`COMPLAINT
`
`Novo Nordisk Inc. and Novo Nordisk A/S (collectively, “Novo Nordisk”), by their
`
`
`
`Case 1:22-cv-00297-CFC Document 1 Filed 03/04/22 Page 1 of 9 PageID #: 1Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 5 of 49 PageID #: 2040
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`
`
`C.A. No. _______________
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`undersigned attorneys, for their Complaint against Defendants Zydus Worldwide DMCC, Zydus
`
`Pharmaceuticals (USA) Inc., and Cadila Healthcare Ltd. (collectively, “Zydus”), allege:
`
`
`
`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 Zydus’s submission of an Abbreviated New Drug
`
`Application (“ANDA”) to the United States Food and Drug Administration (“FDA”), by which
`
`Zydus seeks approval to market a generic version of Novo Nordisk’s pharmaceutical product
`
`Ozempic® prior to the expiration of United States Patent Nos. 9,132,239 (the “’239 patent”) and
`
`10,335,462 (the “’462 patent”), which cover inter alia, Ozempic® and/or its use.
`
`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.
`
`
`
`
`
`
`
`Case 1:22-cv-00297-CFC Document 1 Filed 03/04/22 Page 2 of 9 PageID #: 2Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 6 of 49 PageID #: 2041
`
`
`
`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.
`
`4.
`
`On information and belief, Defendant Zydus Worldwide DMCC is a corporation
`
`organized and existing under the laws of the United Arab Emirates, having its principal place of
`
`business at Armada Tower 2, P2, Cluster P, 9 Floor, Office 908, Al Thanyah 5, Hadaeq
`
`Mohammed Bin Rashid, Dubai, United Arab Emirates. On information and belief, Zydus
`
`Worldwide DMCC is in the business of making and selling generic pharmaceutical products,
`
`which it distributes in the State of Delaware and throughout the United States.
`
`5.
`
`On information and belief, Defendant Zydus Pharmaceuticals (USA) Inc. is a
`
`corporation organized and existing under the laws of the State of New Jersey, having its principal
`
`place of business at 73 Route 31 North, Pennington, New Jersey 08534. On information and belief,
`
`Zydus Pharmaceuticals (USA) Inc. is in the business of making and selling generic pharmaceutical
`
`products, which it distributes in the State of Delaware and throughout the United States.
`
`6.
`
`On information and belief, Defendant Cadila Healthcare Ltd. is a corporation
`
`organized and existing under the laws of India, having its principal place of business at Zydus
`
`Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle,
`
`S.G. Highway, Ahmedabad, Gandhinagar GJ 382 481, India. On information and belief, Cadila
`
`Healthcare Ltd. is in the business of making and selling generic pharmaceutical products, which
`
`is distributes in the State of Delaware and throughout the United States.
`
`7.
`
`On information and belief, Defendants Zydus Worldwide DMCC and Zydus
`
`Pharmaceuticals (USA) Inc. are wholly owned indirect subsidiaries of Defendant Cadila
`
`Healthcare Ltd.
`
`2
`
`
`
`
`
`Case 1:22-cv-00297-CFC Document 1 Filed 03/04/22 Page 3 of 9 PageID #: 3Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 7 of 49 PageID #: 2042
`
`
`
`8.
`
`On information and belief, Defendants Zydus Worldwide DMCC, Zydus
`
`Pharmaceuticals (USA) Inc., and Cadila Healthcare Ltd. acted in concert to prepare and submit
`
`ANDA No. 215704 (“Zydus’s ANDA”) to the FDA.
`
`9.
`
`On information and belief, following any FDA approval of Zydus’s ANDA,
`
`Defendants Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc., and Cadila Healthcare
`
`Ltd. will act in concert to distribute and sell a generic version of semaglutide injection, 2 mg/1.5 ml
`
`(1.34 mg/ml) prefilled pen and 4 mg/3 ml (1.34 mg/ml) prefilled pen (“Zydus’s Product”)
`
`throughout the United States, including within Delaware.
`
`JURISDICTION AND VENUE
`
`10.
`
`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
`
`§§ 1331 and 1338(a).
`
`11.
`
`This Court has personal jurisdiction over Defendant Zydus Worldwide DMCC by
`
`virtue of, inter alia, its presence in Delaware, having conducted business in Delaware; having
`
`derived revenue from conducting business in Delaware; previously consenting to personal
`
`jurisdiction in this Court (see e.g., UCB, Inc. v. Zydus Worldwide DMCC, et al., C.A. No. 16-
`
`01023 (D. Del. Feb. 27, 2017)); and having taken advantage of the rights and protections provided
`
`by this Court, including having asserted counterclaims in this jurisdiction (see e.g., Pharmacyclics
`
`LLC v. Zydus Worldwide DMCC, et al., C.A. No. 20-00560 (D. Del. Apr. 24, 2020)).
`
`12.
`
`This Court has personal jurisdiction over Defendant Zydus Pharmaceuticals (USA)
`
`Inc. by virtue of, inter alia, its presence in Delaware; having derived revenue from conducting
`
`business in Delaware; previously consenting to personal jurisdiction in this Court; and having
`
`taken advantage of the rights and protections provided by this Court, including having asserted
`
`3
`
`
`
`
`
`Case 1:22-cv-00297-CFC Document 1 Filed 03/04/22 Page 4 of 9 PageID #: 4Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 8 of 49 PageID #: 2043
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`
`
`counterclaims in this jurisdiction (see e.g., Boehringer Ingelheim Pharmaceuticals et al. v. Zydus
`
`Pharmaceuticals (USA) Inc. et al., C.A. No. 19-01501 (D. Del. Aug. 9, 2019)).
`
`13.
`
`This Court has personal jurisdiction over Defendant Cadila Healthcare Ltd. by
`
`virtue of, inter alia, its presence in Delaware, having conducted business in Delaware; having
`
`derived revenue from conducting business in Delaware; previously consenting to personal
`
`jurisdiction in this Court (see e.g., Pharmacyclics LLC, et al. v. Zydus Worldwide DMCC, et al.,
`
`C.A. No. 18-00275 (D. Del. Feb. 16, 2018)); and having taken advantage of the rights and
`
`protections provided by this Court, including having asserted counterclaims in this jurisdiction
`
`(see e.g., Acadia Pharmaceuticals Inc. v. Zydus Pharmaceuticals (USA) Inc., C.A. No. 20-01021
`
`(D. Del. Jul. 30, 2020); Allergan USA, Inc. v. Sun Pharmaceutical Industries Ltd., C.A. No. 19-
`
`02317 (D. Del. Dec. 20, 2019)).
`
`14.
`
`On information and belief, Zydus intends to sell, offer to sell, use, and/or engage in
`
`the commercial manufacture of Zydus’s Product, directly or indirectly, throughout the United
`
`States and in this District. Zydus’s filing of Zydus’s ANDA confirms this intention and further
`
`subjects Zydus to the specific personal jurisdiction of this Court.
`
`15.
`
`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`THE PATENTS-IN-SUIT
`
`16.
`
`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 A. NNAS is the owner of all right, title, and interest in the ’239 patent.
`
`17.
`
`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 B. NNAS is the owner of all right, title, and interest in the ’462 patent.
`
`4
`
`
`
`
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`Case 1:22-cv-00297-CFC Document 1 Filed 03/04/22 Page 5 of 9 PageID #: 5Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 9 of 49 PageID #: 2044
`
`
`
`OZEMPIC®
`
`18.
`
`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®.
`
`19.
`
`20.
`
`The claims of the patents-in-suit cover, inter alia, Ozempic® and/or its use.
`
`Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the ’239 and
`
`’462 patents are listed in the FDA publication, “Approved Drug Products with Therapeutic
`
`Equivalence Evaluations” (the “Orange Book”), with respect to Ozempic®.
`
`ZYDUS’S ANDA
`
`21.
`
`On information and belief, Zydus submitted ANDA No. 215704 (“Zydus’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) prefilled pen and 4 mg/3 ml (1.34 mg/ml)
`
`prefilled pen (“Zydus’s Product”).
`
`22.
`
`On information and belief, Zydus’s ANDA refers to and relies upon the Ozempic®
`
`NDA and contains data that, according to Zydus, demonstrate the bioequivalence of Zydus’s
`
`Product and Ozempic®.
`
`23.
`
`By letter to NNI and NNAS, dated January 27, 2022 (the “Notice Letter”), sent by
`
`Zydus Pharmaceuticals (USA) Inc. as agent of Zydus Worldwide DMCC, Zydus stated that
`
`Zydus’s ANDA contained a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that the
`
`’239 and ’462 patents are invalid, unenforceable, and/or will not be infringed by the commercial
`
`manufacture, use, or sale of Zydus’s Product (the “Paragraph IV Certification”). Zydus attached
`
`a memorandum to the Notice Letter in which it purported to allege factual and legal bases for its
`
`5
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`
`
`
`
`Case 1:22-cv-00297-CFC Document 1 Filed 03/04/22 Page 6 of 9 PageID #: 6Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 10 of 49 PageID #: 2045
`
`
`
`Paragraph IV Certification. NNI and NNAS file this suit within 45 days of receipt of the
`
`Notice Letter.
`
`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 9,132,239
`
`24.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-23 of this Complaint.
`
`25.
`
`Zydus has infringed the ’239 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Zydus’s ANDA, by which Zydus seeks approval from the FDA to manufacture, use,
`
`offer to sell, and sell Zydus’s Product prior to the expiration of the ’239 patent.
`
`26.
`
`Claims 1-3 of the ’239 patent are directed to a dial-down mechanism for an
`
`injection device. Zydus’s manufacture, use, offer for sale or sale of Zydus’s Product within the
`
`United States, or importation of Zydus’s Product into the United States, during the term of the ’239
`
`patent would infringe claims 1-3 of the ’239 patent.
`
`27.
`
`Novo Nordisk will be harmed substantially and irreparably if Zydus is not enjoined
`
`from infringing the ’239 patent and/or if the FDA is not enjoined from approving Zydus’s ANDA
`
`before the ’239 patent expires.
`
`28.
`
`29.
`
`Novo Nordisk has no adequate remedy at law.
`
`Zydus was aware of the ’239 patent when it submitted its ANDA. Novo Nordisk
`
`is entitled to a finding that this case is exceptional and to an award of attorneys’ fees under
`
`35 U.S.C. § 285.
`
`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 10,335,462
`
`30.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-29 of this Complaint.
`
`6
`
`
`
`
`
`Case 1:22-cv-00297-CFC Document 1 Filed 03/04/22 Page 7 of 9 PageID #: 7Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 11 of 49 PageID #: 2046
`
`
`
`31.
`
`Zydus has infringed the ’462 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Zydus’s ANDA, by which Zydus seeks approval from the FDA to manufacture, use,
`
`offer to sell, and sell Zydus’s Product prior to the expiration of the ’462 patent.
`
`32.
`
`Claims 1-10 of the ’462 patent are directed to methods of treating type 2 diabetes
`
`comprising administering semaglutide to a subject in need thereof. Zydus’s manufacture, use,
`
`offer for sale or sale of Zydus’s Product within the United States, or importation of Zydus’s
`
`Product into the United States, during the term of the ’462 patent would infringe claims 1-10 of
`
`the ’462 patent.
`
`33.
`
`Upon information and belief, Zydus’s sale or offer for sale of Zydus’s Product
`
`within the United States, or importation of Zydus’s Product into the United States, or commercial
`
`marketing of Zydus’s Product in the United States, during the term of and with knowledge of the
`
`’462 patent, would intentionally induce others to use Zydus’s Product in the United States, thus
`
`inducing infringement of claims 1-10 of the ’462 patent.
`
`34.
`
`Novo Nordisk will be harmed substantially and irreparably if Zydus is not enjoined
`
`from infringing the ’462 patent and/or if the FDA is not enjoined from approving Zydus’s ANDA
`
`before the ’462 patent expires.
`
`35.
`
`36.
`
`Novo Nordisk has no adequate remedy at law.
`
`Zydus was aware of the ’462 patent when it submitted its ANDA. Novo Nordisk
`
`is entitled to a finding that this case is exceptional and to an award of attorneys’ fees under
`
`35 U.S.C. § 285.
`
`PRAYER FOR RELIEF
`
`
`
`WHEREFORE, Novo Nordisk prays for a judgment in its favor and against Zydus and
`
`respectfully requests the following relief:
`
`7
`
`
`
`
`
`Case 1:22-cv-00297-CFC Document 1 Filed 03/04/22 Page 8 of 9 PageID #: 8Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 12 of 49 PageID #: 2047
`
`
`
`A.
`
`B.
`
`C.
`
`A judgment that Zydus has infringed the ’239 patent;
`
`A judgment that Zydus has infringed the ’462 patent;
`
`A judgment ordering that, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date
`
`of any approval of Zydus’s ANDA, under § 505(j) of the Federal Food, Drug, and Cosmetic Act
`
`(21 U.S.C. § 355(j)), shall not be earlier than the expiration of the ’239 and ’462 patents, including
`
`any extensions, adjustments, and exclusivities;
`
`D.
`
`A judgment, pursuant to 35 U.S.C. § 271(e)(4)(B), preliminarily and permanently
`
`enjoining Zydus, its officers, agents, servants, and employees, and those persons in active concert
`
`or participation with any of them, from manufacturing, using, offering to sell, or selling Zydus’s
`
`Product within the United States, or importing Zydus’s Product into the United States, prior to the
`
`expiration of the ’239 and ’462 patents, including any extensions, adjustments, and exclusivities;
`
`E.
`
`If Zydus commercially manufactures, uses, offers to sell, or sells Zydus’s Product
`
`within the United States, or imports Zydus’s Product into the United States, prior to the expiration
`
`of the ’239 and ’462 patents, including any extensions, adjustments, and exclusivities, a judgment
`
`awarding Novo Nordisk monetary relief, together with interest;
`
`F.
`
`An award of attorneys’ fees in this action as an exceptional case pursuant to
`
`35 U.S.C. § 285;
`
`An award of costs and expenses in this action; and
`
`Such other relief as the Court deems just and proper.
`
`G.
`
`H.
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`Case 1:22-cv-00297-CFC Document 1 Filed 03/04/22 Page 9 of 9 PageID #: 9Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 13 of 49 PageID #: 2048
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`OF COUNSEL:
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`Jeffrey J. Oelke
`Ryan P. Johnson
`Robert E. Counihan
`Laura T. Moran
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010-6035
`(212) 430-2600
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`March 4, 2022
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Brian P. Egan
`_____________________________________
`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
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`Attorney for Novo Nordisk Inc. and
`Novo Nordisk A/S
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 1 of 35 PageID #: 10Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 14 of 49 PageID #: 2049
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`EXHIBIT A
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 2 of 35 PageID #: 11Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 15 of 49 PageID #: 2050
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 3 of 35 PageID #: 12Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 16 of 49 PageID #: 2051
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 4 of 35 PageID #: 13Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 17 of 49 PageID #: 2052
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 5 of 35 PageID #: 14Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 18 of 49 PageID #: 2053
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 6 of 35 PageID #: 15Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 19 of 49 PageID #: 2054
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 7 of 35 PageID #: 16Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 20 of 49 PageID #: 2055
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 8 of 35 PageID #: 17Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 21 of 49 PageID #: 2056
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 9 of 35 PageID #: 18Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 22 of 49 PageID #: 2057
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 10 of 35 PageID #: 19Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 23 of 49 PageID #: 2058
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`EXHIBIT B
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 11 of 35 PageID #: 20Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 24 of 49 PageID #: 2059
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 12 of 35 PageID #: 21Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 25 of 49 PageID #: 2060
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 13 of 35 PageID #: 22Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 26 of 49 PageID #: 2061
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 14 of 35 PageID #: 23Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 27 of 49 PageID #: 2062
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 15 of 35 PageID #: 24Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 28 of 49 PageID #: 2063
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 16 of 35 PageID #: 25Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 29 of 49 PageID #: 2064
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 17 of 35 PageID #: 26Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 30 of 49 PageID #: 2065
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 18 of 35 PageID #: 27Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 31 of 49 PageID #: 2066
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 19 of 35 PageID #: 28Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 32 of 49 PageID #: 2067
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 20 of 35 PageID #: 29Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 33 of 49 PageID #: 2068
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 21 of 35 PageID #: 30Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 34 of 49 PageID #: 2069
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 22 of 35 PageID #: 31Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 35 of 49 PageID #: 2070
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 23 of 35 PageID #: 32Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 36 of 49 PageID #: 2071
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 24 of 35 PageID #: 33Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 37 of 49 PageID #: 2072
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 25 of 35 PageID #: 34Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 38 of 49 PageID #: 2073
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 26 of 35 PageID #: 35Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 39 of 49 PageID #: 2074
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 27 of 35 PageID #: 36Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 40 of 49 PageID #: 2075
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 28 of 35 PageID #: 37Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 41 of 49 PageID #: 2076
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 29 of 35 PageID #: 38Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 42 of 49 PageID #: 2077
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 30 of 35 PageID #: 39Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 43 of 49 PageID #: 2078
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 31 of 35 PageID #: 40Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 44 of 49 PageID #: 2079
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 32 of 35 PageID #: 41Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 45 of 49 PageID #: 2080
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 33 of 35 PageID #: 42Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 46 of 49 PageID #: 2081
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 34 of 35 PageID #: 43Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 47 of 49 PageID #: 2082
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`Case 1:22-cv-00297-CFC Document 1-1 Filed 03/04/22 Page 35 of 35 PageID #: 44Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 48 of 49 PageID #: 2083
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`Case 1:22-cv-00297-CFC Document 1-2 Filed 03/04/22 Page 1 of 1 PageID #: 45Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 49 of 49 PageID #: 2084
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