Case 1:22-cv-00023-JPB Document 22-7 Filed 05/06/22 Page 1 of 227 PageID #: 1130
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`Exhibit 5
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`Case 1:22-cv-00023-JPB Document 22-7 Filed 05/06/22 Page 2 of 227 PageID #: 1131
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`U.S. District Court
`District of Delaware (Wilmington)
`CIVIL DOCKET FOR CASE #: 1:22−cv−00299−CFC
`
`PATENT
`
`Novo Nordisk Inc. et al v. Alvogen, Inc.
`Assigned to: Judge Colm F. Connolly
`Related Cases: 1:21−cv−01782−CFC
`1:22−cv−00294−CFC
`1:22−cv−00295−CFC
`1:22−cv−00296−CFC
`1:22−cv−00298−CFC
`1:22−cv−00297−CFC
`Cause: 35:271 Patent Infringement
`Plaintiff
`Novo Nordisk Inc.
`
`Plaintiff
`Novo Nordisk A/S
`
`V.
`Defendant
`Alvogen, Inc.
`
`Date Filed
`
`# Docket Text
`
`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
`
`represented by Emily DiBenedetto
`Shaw Keller LLP
`DE
`1105 N Market St
`Ste 12th Floor
`Wilmington, DE 19801
`302−298−0713
`Email: edibenedetto@shawkeller.com
`ATTORNEY TO BE NOTICED
`
`

`

`Case 1:22-cv-00023-JPB Document 22-7 Filed 05/06/22 Page 3 of 227 PageID #: 1132
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`03/04/2022
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`03/04/2022
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`03/04/2022
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`03/04/2022
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`03/04/2022
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`1 COMPLAINT filed against Alvogen, Inc. − Magistrate Consent Notice to Pltf. ( Filing
`fee $ 402, receipt number ADEDC−3817732.) − filed by Novo Nordisk Inc., Novo
`Nordisk A/S. (Attachments: # 1 Exhibit A−J, # 2 Civil Cover Sheet)(mal) (Entered:
`03/04/2022)
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`2 Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (mal)
`(Entered: 03/04/2022)
`
`3 Supplemental information for patent cases involving an Abbreviated New Drug
`Application (ANDA) − Date Patentee(s) Received Notice: 02/08/22. Date of
`Expiration of Patent: see attached.Thirty Month Stay Deadline: 6/5/2025. (mal)
`(Entered: 03/04/2022)
`
`4 Report to the Commissioner of Patents and Trademarks for Patent/Trademark
`Number(s) 8,129,343 B2 ;9,132,239 B2 ;9,457,154 B2 ;9,687,611 B2 ;10,335,462 B2.
`(mal) (Entered: 03/04/2022)
`
`5 Disclosure Statement pursuant to Rule 7.1: identifying 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, Novo Nordisk Inc.. (mal) (Entered:
`03/04/2022)
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`03/04/2022
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`6 Summons Issued as to Alvogen, Inc. on 3/4/2022. (mal) (Entered: 03/04/2022)
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`03/07/2022
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`03/09/2022
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`03/25/2022
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`03/25/2022
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`05/06/2022
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`05/06/2022
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`7 SUMMONS Returned Executed by Novo Nordisk Inc., Novo Nordisk A/S. Alvogen,
`Inc. served on 3/7/2022, answer due 3/28/2022. (Egan, Brian) (Entered: 03/07/2022)
`
`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)
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`8 STIPULATION TO EXTEND TIME to answer, move, or otherwise respond to the
`complaint to May 9, 2022 − filed by Alvogen, Inc.. (DiBenedetto, Emily) (Entered:
`03/25/2022)
`
`SO ORDERED, re 8 STIPULATION TO EXTEND TIME to answer, move, or
`otherwise respond to the complaint to May 9, 2022 filed by Alvogen, Inc., Set/Reset
`Answer Deadlines: Alvogen, Inc. answer due 5/9/2022. Signed by Judge Colm F.
`Connolly on 3/25/2022. (nmf) (Entered: 03/25/2022)
`
`9 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,
`1:22−cv−00299−CFC. (kmd) (Entered: 05/06/2022)
`
`

`

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`Case 1:22-cv-00299-CFC Document 1 Filed 03/04/22 Page 1 of 16 PageID #: 1Case 1:22-cv-00023-JPB Document 22-7 Filed 05/06/22 Page 4 of 227 PageID #: 1133
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. _______________
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`Plaintiffs,
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`v.
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`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
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`ALVOGEN, INC.,
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`
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`Defendant.
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`COMPLAINT
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`Novo Nordisk Inc. and Novo Nordisk A/S (collectively, “Novo Nordisk”), by their
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`
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`undersigned attorneys, for their Complaint against Defendant Alvogen, Inc. (“Alvogen”), allege:
`
`
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`NATURE OF THE ACTION
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`1.
`
`This is an action for patent infringement under the patent laws of the United States,
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`Title 35 of the United States Code, arising from Alvogen’s submission of an Abbreviated New
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`Drug Application (“ANDA”) to the United States Food and Drug Administration (“FDA”), by
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`which Alvogen seeks approval to market a generic version of Novo Nordisk’s pharmaceutical
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`product Ozempic® prior to the expiration of United States Patent Nos. 8,129,343 (the “’343
`
`patent”), 8,920,383 (the “’383 patent”), 9,132,239 (the “’239 patent”), 9,457,154 (the “’154
`
`patent”), 9,687,611 (the “’611 patent”), 9,775,953 (the “’953 patent”), 10,220,155 (the “’155
`
`patent”), 10,335,462 (the “’462 patent”), 11,097,063 (the “’063 patent”), and RE46,363 (the “’363
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`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
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`the laws of the State of Delaware, and has its principal place of business at 800 Scudders Mill
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`Road, Plainsboro, New Jersey 08536.
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`

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`3.
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`Plaintiff Novo Nordisk A/S (“NNAS”) is an entity organized and existing under the
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`laws of the Kingdom of Denmark, and has its principal place of business at Novo Allé,
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`2880 Bagsværd, Denmark. NNI is an indirect, wholly-owned subsidiary of NNAS.
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`4.
`
`On information and belief, Defendant Alvogen, Inc. is a corporation organized and
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`existing under the laws of the State of Delaware, having its principal place of business at
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`10 Bloomfield Avenue, Building B, Pine Brook, New Jersey 07058. On information and belief,
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`Alvogen, Inc. is in the business of making and selling generic pharmaceutical products, which it
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`distributes in the State of Delaware and throughout the United States.
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`JURISDICTION AND VENUE
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`5.
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`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
`
`§§ 1331 and 1338(a).
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`6.
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`This Court has personal jurisdiction over Alvogen by virtue of, inter alia, its
`
`presence in Delaware, being a Delaware corporation; and having engaged in systematic and
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`continuous contacts with the State of Delaware; previously consenting to personal jurisdiction in
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`this Court (see e.g., BioDelivery Sciences Int’l, Inc. v. Alvogen PB Research & Development LLC,
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`C.A. No. 18-cv-01395 (D. Del. Sept. 7, 2018)); and having taken advantage of the rights and
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`protections provided by this Court, including having asserted counterclaims in this jurisdiction
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`(see e.g., Noven Pharms., Inc. v. Alvogen Pine Brook LLC, C.A. No. 17-01429 (D. Del.
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`Oct. 11, 2017)).
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`7.
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`On information and belief, Alvogen intends to sell, offer to sell, use, and/or engage
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`in the commercial manufacture of Alvogen’s Product, directly or indirectly, throughout the United
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`States and in this District. Alvogen’s filing of Alvogen’s ANDA confirms this intention and
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`further subjects Alvogen to the specific personal jurisdiction of this Court.
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`2
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`8.
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`9.
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`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
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`THE PATENTS-IN-SUIT
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`On March 6, 2012, the United States Patent and Trademark Office issued the ’343
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`patent, entitled “Acylated GLP-1 Compounds,” a copy of which is attached to this Complaint as
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`Exhibit A. NNAS is the owner of all right, title, and interest in the ’343 patent.
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`10.
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`On December 30, 2014, the United States Patent and Trademark Office issued the
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`’383 patent, entitled “Dose Mechanism for an Injection Device for Limiting a Dose Setting
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`Corresponding to the Amount of Medicament Left,” a copy of which is attached to this Complaint
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`as Exhibit B. NNAS is the owner of all right, title, and interest in the ’383 patent.
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`11.
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`On September 15, 2015, the United States Patent and Trademark Office issued the
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`’239 patent, entitled “Dial-Down Mechanism for Wind-Up Pen,” a copy of which is attached to
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`this Complaint as Exhibit C. NNAS is the owner of all right, title, and interest in the ’239 patent.
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`12.
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`On October 4, 2016, the United States Patent and Trademark Office issued the ’154
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`patent, entitled “Injection Device with an End of Dose Feedback Mechanism,” a copy of which is
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`attached to this Complaint as Exhibit D. NNAS is the owner of all right, title, and interest in the
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`’154 patent.
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`13.
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`On June 27, 2017, the United States Patent and Trademark Office issued the ’611
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`patent, entitled “Injection Device with Torsion Spring and Rotatable Display,” a copy of which is
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`attached to this Complaint as Exhibit E. NNAS is the owner of all right, title, and interest in the
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`’611 patent.
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`14.
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`On October 3, 2017, the United States Patent and Trademark Office issued the ’953
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`patent, entitled “Dose Mechanism for an Injection Device for Limiting a Dose Setting
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`3
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`Corresponding to the Amount of Medicament Left,” a copy of which is attached to this Complaint
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`as Exhibit F. NNAS is the owner of all right, title, and interest in the ’953 patent.
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`15.
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`On March 5, 2019, the United States Patent and Trademark Office issued the ’155
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`patent, entitled “Syringe Device with a Dose Limiting Mechanism and an Additional Safety
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`Mechanism,” a copy of which is attached to this Complaint as Exhibit G. NNAS is the owner of
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`all right, title, and interest in the ’155 patent.
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`16.
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`On July 2, 2019, the United States Patent and Trademark Office issued the ’462
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`patent, entitled “Use of Long-Acting GLP-1 Peptides,” a copy of which is attached to this
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`Complaint as Exhibit H. NNAS is the owner of all right, title, and interest in the ’462 patent.
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`17.
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`On August 24, 2021, the United States Patent and Trademark Office issued the ’063
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`patent, entitled “Syringe Device with a Dose Limiting Mechanism and an Additional Safety
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`Mechanism,” a copy of which is attached to this Complaint as Exhibit I. NNAS is the owner of
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`all right, title, and interest in the ’063 patent.
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`18.
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`On April 11, 2017, the United States Patent and Trademark Office issued the ’363
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`patent, entitled “Dial-Down Mechanism for Wind-Up Pen,” a copy of which is attached to this
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`Complaint as Exhibit J. NNAS is the owner of all right, title, and interest in the ’363 patent.
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`OZEMPIC®
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`19.
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`NNI holds approved New Drug Application No. 209637 (the “Ozempic® NDA”)
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`for Ozempic® (semaglutide) subcutaneous solution, 2 mg/1.5 ml (1.34 mg/ml) and 4 mg/3 ml
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`(1.34 mg/ml), which NNI sells under the trade name Ozempic®.
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`20.
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`21.
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`The claims of the patents-in-suit cover, inter alia, Ozempic® and/or its use.
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`Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the ’343, ’383,
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`’239, ’154, ’611, ’953, ’155, ’462, ’063, and ’363 patents are listed in the FDA publication,
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`4
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`“Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”), with
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`respect to Ozempic®.
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`ALVOGEN’S ANDA
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`22.
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`On information and belief, Alvogen submitted ANDA No. 215920 (“Alvogen’s
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`ANDA”) to the FDA, pursuant to 21 U.S.C. § 355(j), seeking approval to market a generic version
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`of semaglutide injection, 2 mg/1.5 ml (1.34 mg/ml) and 4 mg/3 ml (1.34 mg/ml) prefilled pens
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`(“Alvogen’s Product”).
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`23.
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`On information and belief, Alvogen’s ANDA refers to and relies upon the
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`Ozempic® NDA and contains data that, according to Alvogen, demonstrate the bioequivalence of
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`Alvogen’s Product and Ozempic®.
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`24.
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`By letter to NNI and NNAS, dated February 7, 2022 (the “Notice Letter”), Alvogen
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`stated
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`that Alvogen’s ANDA contained a certification pursuant
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`to 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV) that the ’343, ’383, ’239, ’154, ’611, ’953, ’155, ’462, ’063, and ’363
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`patents are invalid, unenforceable, and/or will not be infringed by the commercial manufacture,
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`use, or sale of Alvogen’s Product (the “Paragraph IV Certification”). Alvogen attached a
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`memorandum to the Notice Letter in which it purported to allege factual and legal bases for its
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`Paragraph IV Certification. NNI and NNAS file this suit within 45 days of receipt of the
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`Notice Letter.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 8,129,343
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`25.
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`Novo Nordisk re-alleges and incorporates by reference the allegations of
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`Paragraphs 1-24 of this Complaint.
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`5
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`26.
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`Alvogen has infringed the ’343 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
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`submitting Alvogen’s ANDA, by which Alvogen seeks approval from the FDA to manufacture,
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`use, offer to sell, and sell Alvogen’s Product prior to the expiration of the ’343 patent.
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`27.
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`Claims 1-2 and 4-5 of the ’343 patent encompass semaglutide and pharmaceutical
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`compositions comprising semaglutide. Claims 3 and 6 encompass methods of treating type 2
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`diabetes comprising administering to a patient an effective amount of semaglutide. Alvogen’s
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`manufacture, use, offer for sale or sale of Alvogen’s Product within the United States, or
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`importation of Alvogen’s Product into the United States, during the term of the ’343 patent would
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`infringe claims 1-6 of the ’343 patent.
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`28.
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`Upon information and belief, Alvogen’s sale or offer for sale of Alvogen’s Product
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`within the United States, or importation of Alvogen’s Product into the United States, or
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`commercial marketing of Alvogen’s Product in the United States, during the term of and with
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`knowledge of the ’343 patent, would intentionally induce others to use Alvogen’s Product in the
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`United States, thus inducing infringement of claims 3 and 6 of the ’343 patent.
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`29.
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`Novo Nordisk will be harmed substantially and irreparably if Alvogen is not
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`enjoined from infringing the ’343 patent and/or if the FDA is not enjoined from approving
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`Alvogen’s ANDA before the ’343 patent expires.
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`30.
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`31.
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`Novo Nordisk has no adequate remedy at law.
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`Alvogen was aware of the ’343 patent when it submitted its ANDA. Novo Nordisk
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`is entitled to a finding that this case is exceptional and to an award of attorney’s fees under
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`35 U.S.C. § 285.
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`6
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 8,920,383
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`32.
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`Novo Nordisk re-alleges and incorporates by reference the allegations of
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`Paragraphs 1-31 of this Complaint.
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`33.
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`Alvogen has infringed the ’383 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
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`submitting Alvogen’s ANDA, by which Alvogen seeks approval from the FDA to manufacture,
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`use, offer to sell, and sell Alvogen’s Product prior to the expiration of the ’383 patent.
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`34.
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`Claims 1-12 of the ’383 patent are directed to a mechanism for preventing setting
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`of a dose which exceeds the amount of a medicament left in a reservoir in an injection device.
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`Claim 13 of the ’383 patent is directed to a syringe device employing such a mechanism.
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`Alvogen’s manufacture, use, offer for sale or sale of Alvogen’s Product within the United States,
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`or importation of Alvogen’s Product into the United States, during the term of the ’383 patent
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`would infringe claims 1-13 of the ’383 patent.
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`35.
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`Novo Nordisk will be harmed substantially and irreparably if Alvogen is not
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`enjoined from infringing the ’383 patent and/or if the FDA is not enjoined from approving
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`Alvogen’s ANDA before the ’383 patent expires.
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`36.
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`37.
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`Novo Nordisk has no adequate remedy at law.
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`Alvogen was aware of the ’383 patent when it submitted its ANDA. Novo Nordisk
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`is entitled to a finding that this case is exceptional and to an award of attorneys’ fees under
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`35 U.S.C. § 285.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 9,132,239
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`38.
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`Novo Nordisk re-alleges and incorporates by reference the allegations of
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`Paragraphs 1-37 of this Complaint.
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`7
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`39.
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`Alvogen has infringed the ’239 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
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`submitting Alvogen’s ANDA, by which Alvogen seeks approval from the FDA to manufacture,
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`use, offer to sell, and sell Alvogen’s Product prior to the expiration of the ’239 patent.
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`40.
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`Claims 1-3 of the ’239 patent are directed to a dial-down mechanism for an
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`injection device. Alvogen’s manufacture, use, offer for sale or sale of Alvogen’s Product within
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`the United States, or importation of Alvogen’s Product into the United States, during the term of
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`the ’239 patent would infringe claims 1-3 of the ’239 patent.
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`41.
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`Novo Nordisk will be harmed substantially and irreparably if Alvogen is not
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`enjoined from infringing the ’239 patent and/or if the FDA is not enjoined from approving
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`Alvogen’s ANDA before the ’239 patent expires.
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`42.
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`43.
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`Novo Nordisk has no adequate remedy at law.
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`Alvogen was aware of the ’239 patent when it submitted its ANDA. Novo Nordisk
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`is entitled to a finding that this case is exceptional and to an award of attorneys’ fees under
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`35 U.S.C. § 285.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 9,457,154
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`44.
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`Novo Nordisk re-alleges and incorporates by reference the allegations of
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`Paragraphs 1-43 of this Complaint.
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`45.
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`Alvogen has infringed the ’154 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
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`submitting Alvogen’s ANDA, by which Alvogen seeks approval from the FDA to manufacture,
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`use, offer to sell, and sell Alvogen’s Product prior to the expiration of the ’154 patent.
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`46.
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`Claims 1-17 of the ’154 patent are directed to an injection device comprising a dose
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`delivering mechanism which provides an audible feedback signal to a user at the end of injection
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`of a set dose. Alvogen’s manufacture, use, offer for sale or sale of Alvogen’s Product within the
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`8
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`United States, or importation of Alvogen’s Product into the United States, during the term of the
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`’154 patent would infringe claims 1-17 of the ’154 patent.
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`47.
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`Novo Nordisk will be harmed substantially and irreparably if Alvogen is not
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`enjoined from infringing the ’154 patent and/or if the FDA is not enjoined from approving
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`Alvogen’s ANDA before the ’154 patent expires.
`
`48.
`
`49.
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`Novo Nordisk has no adequate remedy at law.
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`Alvogen was aware of the ’154 patent when it submitted its ANDA. Novo Nordisk
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`is entitled to a finding that this case is exceptional and to an award of attorneys’ fees under
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`35 U.S.C. § 285.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 9,687,611
`
`50.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-49 of this Complaint.
`
`51.
`
`Alvogen has infringed the ’611 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Alvogen’s ANDA, by which Alvogen seeks approval from the FDA to manufacture,
`
`use, offer to sell, and sell Alvogen’s Product prior to the expiration of the ’611 patent.
`
`52.
`
`Claims 1-13 and 15 of the ’611 patent are directed to an injection device with a
`
`torsion spring operatively connected to a dose setting member and a rotatably mounted display
`
`member. Claim 14 of the ’611 patent is directed to an injection pen comprising a torsion spring
`
`and a dose indicator barrel having a helical scale. Alvogen’s manufacture, use, offer for sale or
`
`sale of Alvogen’s Product within the United States, or importation of Alvogen’s Product into the
`
`United States, during the term of the ’611 patent would infringe claims 1-15 of the ’611 patent.
`
`9
`
`

`

`
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`53.
`
`Novo Nordisk will be harmed substantially and irreparably if Alvogen is not
`
`enjoined from infringing the ’611 patent and/or if the FDA is not enjoined from approving
`
`Alvogen’s ANDA before the ’611 patent expires.
`
`54.
`
`55.
`
`Novo Nordisk has no adequate remedy at law.
`
`Alvogen was aware of the ’611 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. 9,775,953
`
`56.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-55 of this Complaint.
`
`57.
`
`Alvogen has infringed the ’953 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Alvogen’s ANDA, by which Alvogen seeks approval from the FDA to manufacture,
`
`use, offer to sell, and sell Alvogen’s Product prior to the expiration of the ’953 patent.
`
`58.
`
`Claims 1-10 and 12-25 of the ’953 patent are directed to a mechanism for
`
`preventing setting of a dose which exceeds the amount of medicament left in a reservoir in an
`
`injection device. Claim 11 of the ’953 patent is directed to a syringe device employing such a
`
`mechanism. Alvogen’s manufacture, use, offer for sale or sale of Alvogen’s Product within the
`
`United States, or importation of Alvogen’s Product into the United States, during the term of the
`
`’953 patent would infringe claims 1-25 of the ’953 patent.
`
`59.
`
`Novo Nordisk will be harmed substantially and irreparably if Alvogen is not
`
`enjoined from infringing the ’953 patent and/or if the FDA is not enjoined from approving
`
`Alvogen’s ANDA before the ’953 patent expires.
`
`60.
`
`Novo Nordisk has no adequate remedy at law.
`
`10
`
`

`

`
`
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`
`61.
`
`Alvogen was aware of the ’953 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. 10,220,155
`
`62.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-61 of this Complaint.
`
`63.
`
`Alvogen has infringed the ’155 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Alvogen’s ANDA, by which Alvogen seeks approval from the FDA to manufacture,
`
`use, offer to sell, and sell Alvogen’s Product prior to the expiration of the ’155 patent.
`
`64.
`
`Claims 1-8 of the ’155 patent are directed to a syringe device with a dose limiting
`
`mechanism and a safety mechanism structure which prevent injection of a dose exceeding a set
`
`dose. Alvogen’s manufacture, use, offer for sale or sale of Alvogen’s Product within the United
`
`States, or importation of Alvogen’s Product into the United States, during the term of the ’155
`
`patent would infringe claims 1-8 of the ’155 patent.
`
`65.
`
`Novo Nordisk will be harmed substantially and irreparably if Alvogen is not
`
`enjoined from infringing the ’155 patent and/or if the FDA is not enjoined from approving
`
`Alvogen’s ANDA before the ’155 patent expires.
`
`66.
`
`67.
`
`Novo Nordisk has no adequate remedy at law.
`
`Alvogen was aware of the ’155 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.
`
`11
`
`

`

`
`
`Case 1:22-cv-00299-CFC Document 1 Filed 03/04/22 Page 12 of 16 PageID #: 12Case 1:22-cv-00023-JPB Document 22-7 Filed 05/06/22 Page 15 of 227 PageID #: 1144
`
`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 10,335,462
`
`68.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-67 of this Complaint.
`
`69.
`
`Alvogen has infringed the ’462 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Alvogen’s ANDA, by which Alvogen seeks approval from the FDA to manufacture,
`
`use, offer to sell, and sell Alvogen’s Product prior to the expiration of the ’462 patent.
`
`70.
`
`Claims 1-10 of the ’462 patent are directed to a method of treating type 2 diabetes
`
`comprising administering semaglutide to a subject in need thereof. Alvogen’s manufacture, use,
`
`offer for sale or sale of Alvogen’s Product within the United States, or importation of Alvogen’s
`
`Product into the United States, during the term of the ’462 patent would infringe claims 1-10 of
`
`the ’462 patent.
`
`71.
`
`Upon information and belief, Alvogen’s sale or offer for sale of Alvogen’s Product
`
`within the United States, or importation of Alvogen’s Product into the United States, or
`
`commercial marketing of Alvogen’s Product in the United States, during the term of and with
`
`knowledge of the ’462 patent, would intentionally induce others to use Alvogen’s Product in the
`
`United States, thus inducing infringement of claims 1-10 of the ’462 patent.
`
`72.
`
`Novo Nordisk will be harmed substantially and irreparably if Alvogen is not
`
`enjoined from infringing the ’462 patent and/or if the FDA is not enjoined from approving
`
`Alvogen’s ANDA before the ’462 patent expires.
`
`73.
`
`74.
`
`Novo Nordisk has no adequate remedy at law.
`
`Alvogen 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.
`
`12
`
`

`

`
`
`Case 1:22-cv-00299-CFC Document 1 Filed 03/04/22 Page 13 of 16 PageID #: 13Case 1:22-cv-00023-JPB Document 22-7 Filed 05/06/22 Page 16 of 227 PageID #: 1145
`
`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 11,097,063
`
`75.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-74 of this Complaint.
`
`76.
`
`Alvogen has infringed the ’063 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Alvogen’s ANDA, by which Alvogen seeks approval from the FDA to manufacture,
`
`use, offer to sell, and sell Alvogen’s Product prior to the expiration of the ’063 patent.
`
`77.
`
`Claims 1-7 of the ’063 patent are directed to a syringe device with a dose limiting
`
`mechanism and a safety mechanism structure which prevent ejection of a dose exceeding a set
`
`dose. Alvogen’s manufacture, use, offer for sale or sale of Alvogen’s Product within the United
`
`States, or importation of Alvogen’s Product into the United States, during the term of the ’063
`
`patent would infringe claims 1-7 of the ’063 patent.
`
`78.
`
`Novo Nordisk will be harmed substantially and irreparably if Alvogen is not
`
`enjoined from infringing the ’063 patent and/or if the FDA is not enjoined from approving
`
`Alvogen’s ANDA before the ’063 patent expires.
`
`79.
`
`80.
`
`Novo Nordisk has no adequate remedy at law.
`
`Alvogen was aware of the ’063 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. RE46,363
`
`81.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-80 of this Complaint.
`
`13
`
`

`

`
`
`Case 1:22-cv-00299-CFC Document 1 Filed 03/04/22 Page 14 of 16 PageID #: 14Case 1:22-cv-00023-JPB Document 22-7 Filed 05/06/22 Page 17 of 227 PageID #: 1146
`
`82.
`
`Alvogen has infringed the ’363 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Alvogen’s ANDA, by which Alvogen seeks approval from the FDA to manufacture,
`
`use, offer to sell, and sell Alvogen’s Product prior to the expiration of the ’363 patent.
`
`83.
`
`Claims 1-8 of the ’363 patent are directed to dial-down mechanism for an injection
`
`device. Claims 9 and 10 of the ’363 patent are directed to a medication delivery device comprising
`
`such a dial-down mechanism. Claim 11 of the ’363 patent is directed to a method for using a wind
`
`up injection pen. Alvogen’s manufacture, use, offer for sale or sale of Alvogen’s Product within
`
`the United States, or importation of Alvogen’s Product into the United States, during the term of
`
`the ’363 patent would infringe claims 1-11 of the ’363 patent.
`
`84.
`
`Upon information and belief, Alvogen’s sale or offer for sale of Alvogen’s Product
`
`within the United States, or importation of Alvogen’s Product into the United States, or
`
`commercial marketing of Alvogen’s Product in the United States, during the term of and with
`
`knowledge of the ’363 patent, would intentionally induce others to use Alvogen’s Product in the
`
`United States, thus inducing infringement of claim 11 of the ’363 patent.
`
`85.
`
`Novo Nordisk will be harmed substantially and irreparably if Alvogen is not
`
`enjoined from infringing the ’363 patent and/or if the FDA is not enjoined from approving
`
`Alvogen’s ANDA before the ’363 patent expires.
`
`86.
`
`87.
`
`Novo Nordisk has no adequate remedy at law.
`
`Alvogen was aware of the ’363 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.
`
`14
`
`

`

`
`
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`
`PRAYER FOR RELIEF
`
`
`
`WHEREFORE, Novo Nordisk prays for a judgment in its favor and against Alvogen and
`
`respectfully requests the following relief:
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
`
`I.
`
`J.
`
`K.
`
`A judgment that Alvogen has infringed the ’343 patent;
`
`A judgment that Alvogen has infringed the ’383 patent;
`
`A judgment that Alvogen has infringed the ’239 patent;
`
`A judgment that Alvogen has infringed the ’154 patent;
`
`A judgment that Alvogen has infringed the ’611 patent;
`
`A judgment that Alvogen has infringed the ’953 patent;
`
`A judgment that Alvogen has infringed the ’155 patent;
`
`A judgment that Alvogen has infringed the ’462 patent;
`
`A judgment that Alvogen has infringed the ’063 patent;
`
`A judgment that Alvogen has infringed the ’363 patent;
`
`A judgment ordering that, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date
`
`of any approval of Alvogen’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 ’343, ’383, ’239, ’154, ’611,
`
`’953, ’155, ’462, ’063, and ’363 patents, including any extensions, adjustments, and exclusivities;
`
`L.
`
`A judgment, pursuant to 35 U.S.C. § 271(e)(4)(B), preliminarily and permanently
`
`enjoining Alvogen, 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
`
`Alvogen’s Product within the United States, or importing Alvogen’s Product into the United
`
`States, prior to the expiration of the ’343, ’383, ’239, ’154, ’611, ’953, ’155, ’462, ’063, and ’363
`
`patents, including any extensions, adjustments, and e