throbber
Case 1:22-cv-00023-JPB Document 25-3 Filed 05/11/22 Page 1 of 49 PageID #: 2036
`
`
`
`
`
`
`Exhibit 3
`
`
`
`
`
`
`
`
`
`

`

`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
`
`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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.
`
`
`
`
`
`
`
`8
`
`

`

`
`
`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
`
`
`
`
`
`
`OF COUNSEL:
`
`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
`
`March 4, 2022
`
`
`
`
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/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
`
`Attorney for Novo Nordisk Inc. and
`Novo Nordisk A/S
`
`9
`
`

`

`
`
`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
`
`
`
`
`
`
`
`
`
`EXHIBIT A
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`EXHIBIT B
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`
`
`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
`
`

`

`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
`
`
`
`
`  
`

`   !"#$%"$& '#"$$"#$% $$"  (#$ !)(('$""&$*#$%! &(#%$*! " (#( !#! +) %,-#./0("#!
`( %%,-# )!&) "!& '/#(( %,-")%#1$& $&"2$"% "#"!$ ("', 
3 /! +) %& ")!&"1 4&1) "& "
`() (!&$"#"$*"%4"!"567789:6;<=>;9?:68?:8:7@;8ABC78?D8;E968D?<FGH
`IJKLMNOPP
`QPOQNO
`ðñÂòÄæ¿ÁáÂæÃÂÑÂÙÆÆÓðñÂòÄÐóËÁÙËÆÑòàÃÆËáÄêòÄËì
`¾¿À¿¾¿ÁÂÃÄÅþÆÇÈÉʾ¿À¿¾¿ÁÂÃÄÅËÌÄ
`þÆÇÈÉÊÆËÂÃáËóÑËáàóÆËÁÑáàÂÇ
`JRL1)$"-&!%$&S !"T!"%U#$"&&
`1)$"-&!%$&S !"T!"%V&$%#$"
`57@>7A;89:8=G6G8AWB9:;9DD8>B676H
`59:8=G6G8AWB9:;9DD8>B6768?:WXH
`YZ[\ ]YT^YV1ZYV[_Y^]ZY1^ [ /2 [`[TZ1^]ZYZS
``[^1ZST^YV]YaZTa[V
`JˆL‰^"" $-!5Dpu8:kmŠ8BzzumyyŠ8kdz8;mjm†…edm8:‹ŒmuH
`^"" $-!59b8cdefdH
`ÍÎÏÈÉÐÇÑÒÈÉÓÑÔÕÖÏÎ×ØÙÚÎÎÏÔÓ¾ÏÛÜÚÝÔÓËÎÔÜÞßàÖÉÉ×ÝÝááÐ
`âãäâ¾ÚÎÞÜÙÈÎå×ÞÄÞÎ××ÞÓæÏÝçÏÉÒÞÚÉÓÂÑâèéäâ
`êëäãìíîéïèãää
`ItOMPMOMNMN85Ajklm8kd8n@o8pd8?dm8qer8beu8Ajkpdvpbb
`IgNPhiQO5Ajklm8kd8n@o8pd8?dm8qer8?djsH
`5Deu8wpxmuypvs8>kymy8?djsH
`kdz8?dm8qer8beu8wmbmdzkdvH8
`{
2 | $'$"
`{}S% #~)!"$
`MP QP
`MP QP
`5=G6G8Cexmudmdv8:ev8k8AkuvsH
`U#$"&&
`1"€$&! "#"
`{
{ 
]$ ( #"%euU $(#U#
`{ {
`&)!$!!]$! "#"
`{‚2 | $'$"
`{ V !"-
`1"€$&^$"  "#"
`{‚ { ‚ ]$ ( #"%kdzU $(#U#
`{ƒ {ƒ
`59dzplkvm8>pvp„mdy…p†8eb8Akuvpmy8pd89vm8999H
`V&$%#$"
`&)!$!!]$^$"  "#"
`1"€$  ),‡"&#
`{} { } S *$Y#"$
`{
` {
`
`IONiPi5Ajklm8kd8n@o8pd8?dm8qer8?djsH
`S *$1)$" -
`
`14 & \Y#") & )"1%V! ("$!
`ON
`
`gNOiM
`Ni
`PPiŽMON
`MONOhi MONOhi {
`‚ƒV )*#"% €) 
`{
]$!) #$
`{ ‚‚^((#‚‘2 1
ƒ‘
`{} ƒS#!1#'!^"
`&U ( "-‚
2 1‘‘
{ ‚}“"% #.#
`{}
`~)#'}
2 1
`{
‚ _# $
`{}
^ (#$
`{}
`ƒU !$#]$‡) -’
`{
`3 Z"
`{
} _ ^"
`{}
ƒ^ (#$U %)"
`‚‘2 1
ƒ
`} ‚3#
`U %)"T#,"-
`{
Y*"#,]$!" )'$"
`T#,"-
`{}
` `#"1# 
`{  "#"#(( "$'$"
`{
ƒ  -&Z (#-'$" {}‚ ^!!#)"/T,”
`{
^$"" )!"
`U# '#)"#
`MM•
`”[$& '$"&)%*'$"
` #$%
`U !$#]$‡) -
`{‘‚ 1(- *"!
`{ } #$4!#$%#$4$*
`{
ƒ
_%# ^"
`{}} S% #['(- !–
`U %)"T#,"-
`{‘} U#"$"
`{ ƒ 1'' 
`{‘}ƒU#"$"’^,, #"%
`{
` V( "#"$
`{
ƒ‚ -&V&#)"%
`T#,"-
`{}
`‘^!,!"!U !$#
`Y.V )*^((#"$ { #4" ]$&)$%#$%
` ")%$"T#$!
`{} _# $
`]$‡) -U %)"
`[0)%!a" #$!
`{} ƒ_# $U %)"
`T#,"-
`1 )("Z *#$€#"$!
`{‘  #%'# 4
`{
ƒ} -&Z (#-'$"
`T#,"-
`{ ‘ 1$!)' 1 %"
`MONMM
`Ng
`Ni
`&a" #$–!$&"!
`{}ƒ _" a
`{
S# T#,  "#$%# %!
`{} Z" S #)%
`{‘
`
`]^
}3ƒ&&
`{ 3 1#, #"a
`^"
`{

`  "4% !– )"!
`{}ƒƒ_" a
`{}
 )"$T$%$*
`{‘
`‚#4T)$*3‚}
`{‘ƒ  ) "! 1''%"!
`U %)"T#,"-
`{ ‚ T#, _#$#*'$"
`{}‘ Z" U !$#
`{‘
`}V]“1 V]““ ƒ*
`[0#$*
`{
3 Z" 1$" #"
`{
3ƒ1$" #"U %)"T#,"- {}
` Z" U !$#
`#"$!
`U ( "-V#'#*
`{‘
`  ]V"—a]
`{‘3 Z"  "#")" -^"$!
`{ #.#-T#, ^"
`]$‡) -
`{}‘ƒU ( "-V#'#*
`{‘
`ƒ ] ƒ*
`{‘3
^* )") #^"!
`{
3
`S #$!
`{}
`‚U !$#]$‡) -’
`U %)"T#,"-
`{ ƒ
S#'-#$%_%#
`{‘3}[$ $'$"#_#"" !
`T#^"
`_%#_#( #"
`{‘3ƒS %'&]$& '#"$
`MOMO { 3 Z" T#, T"*#"$
`^"
`NMM
`•
`PQNN˜i
`{‚
T#$%1$%'$#"$
`{ Z" 1*"!
`{ 3
['(-" '$" {‘ #0!2 U#$"&& {‘3
`^ ," #"$
`KR™Kš›œžšŸ
`{‘33^%'$!" #"U %) 
`{‚‚ S !) 
`{
a"$*
`{
`}^$V"#$
`]$' ) "-^"
` V&$%#$"
`{‚} $"T#!”[‡"'$" { ‚['(-'$"
`{ƒ
_"$!"a##"
`{‘
]   %U# "-
`^" . ^((#&
`{‚  "!"T#$%
`{ }`)!$*
` $"$
`^*$-V!$
`‚
`2 1
` 3
`{3ƒ 1$!"")"$#"-&
`{ƒ} |$ #
`^''%#"$!
`{‚ ƒ "U %)"T#,"-
`{‚3 ^Z" #U ( "- { ƒ^' . V!#,"!’{ƒ}ƒV#"U$#"-
` "#" "#")"!
`¡¡•NO
`['(-'$"
`{
`‚Y#") #€#"$^((#"$
`¢£™œŸ
`{
`^' . V!#,"!’{ƒ _#$%#')!”Z" {
`ƒZ" ]''* #"$
`^"$!
`Z"
`{ƒƒ 1*"!
`{ ‘[%)#"$
`{ƒƒƒU !$1$%"$
`{ƒ
` 1V"#$’
`1$%"$!&
`1$&$'$"
`I•O5Ajklm8kd8n@o8pd8?dm8qer8?djsH
`{‘_)"%!" "
`{
`_)"%!" "
`{ƒ #$!& %& '
`
`{} '#$%%& '
`{ $!"#"%
`
` "#"1) "{
Z *$#U %$* {‚'%& '
`T"*#"$’
`^((#"1) "
`($%
`T"*#"$’
`^

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket