Case 1:22-cv-00023-JPB Document 25-4 Filed 05/11/22 Page 1 of 231 PageID #: 2085
`
`Exhibit 4
`
`

`

`Case 1:22-cv-00023-JPB Document 25-4 Filed 05/11/22 Page 2 of 231 PageID #: 2086
`
`U.S. District Court
`District of Delaware (Wilmington)
`CIVIL DOCKET FOR CASE #: 1:22−cv−00298−CFC
`
`PATENT
`
`Novo Nordisk Inc. et al v. Dr. Reddy's Laboratories Ltd. 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−00294−CFC
`1:22−cv−00297−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
`
`Plaintiff
`Novo Nordisk A/S
`
`V.
`Defendant
`Dr. Reddy's Laboratories Ltd.
`
`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 Dominick T. Gattuso
`Heyman Enerio Gattuso & Hirzel LLP
`300 Delaware Avenue, Suite 200
`Wilmington, DE 19801
`(302)472−7311
`Fax: (302) 472−7301
`Email: dgattuso@hegh.law
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Jovial Wong
`Email: jwong@winston.com
`
`

`

`Case 1:22-cv-00023-JPB Document 25-4 Filed 05/11/22 Page 3 of 231 PageID #: 2087
`
`Defendant
`Dr. Reddy's Laboratories Inc.
`
`Counter Claimant
`Dr. Reddy's Laboratories Inc.
`
`Counter Claimant
`Dr. Reddy's Laboratories Ltd.
`
`V.
`Counter Defendant
`Novo Nordisk A/S
`
`Counter Defendant
`Novo Nordisk Inc.
`
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Sharon Lin
`Email: slin@winston.com
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`represented by Dominick T. Gattuso
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Jovial Wong
`(See above for address)
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Sharon Lin
`(See above for address)
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`represented by Dominick T. Gattuso
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Sharon Lin
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`represented by Dominick T. Gattuso
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Sharon Lin
`(See above for address)
`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 Jack B. Blumenfeld
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`

`

`Case 1:22-cv-00023-JPB Document 25-4 Filed 05/11/22 Page 4 of 231 PageID #: 2088
`
`Brian P. Egan
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Date Filed
`
`# Docket Text
`
`03/04/2022
`
`03/04/2022
`
`03/04/2022
`
`03/04/2022
`
`03/04/2022
`
`03/04/2022
`
`03/09/2022
`
`03/10/2022
`
`03/10/2022
`
`03/10/2022
`
`03/10/2022
`
`05/02/2022
`
`05/02/2022
`
`05/03/2022
`
`1 COMPLAINT for PATENT INFRINGEMENT filed against Dr. Reddy's Laboratories
`Inc., Dr. Reddy's Laboratories Ltd. − Magistrate Consent Notice to Pltf. ( Filing fee $
`402, receipt number ADEDC−3817704.) − filed by Novo Nordisk Inc., Novo Nordisk
`A/S. (Attachments: # 1 Exhibit A−J, # 2 Civil Cover Sheet)(cna, ) (Entered:
`03/04/2022)
`
`2 Notice, Consent and Referral forms re: U.S. Magistrate Judge jurisdiction. (cna, )
`(Entered: 03/04/2022)
`
`3 Supplemental information for patent cases involving an Abbreviated New Drug
`Application (ANDA) − Date Patentee(s) Received Notice: 2/3/2022. Date of
`Expiration of Patent: See Attached.Thirty Month Stay Deadline: 6/5/2025. (cna, )
`(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.
`(cna, ) (Entered: 03/04/2022)
`
`5 Disclosure Statement pursuant to Rule 7.1: identifying Corporate Parent Novo Nordisk
`US Holdings Inc. for Novo Nordisk A/S, Novo Nordisk Inc. filed by Novo Nordisk
`A/S, Novo Nordisk Inc.. (cna, ) (Entered: 03/04/2022)
`
`Summons Issued as to Dr. Reddy's Laboratories Inc. on 3/4/2022; Dr. Reddy's
`Laboratories Ltd. on 3/4/2022. (cna, ) (Entered: 03/04/2022)
`
`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)
`
`6 WAIVER OF SERVICE returned executed by Novo Nordisk Inc., Novo Nordisk A/S:
`For Dr. Reddy's Laboratories Inc. waiver sent on 3/4/2022, answer due 5/3/2022.
`(Egan, Brian) (Entered: 03/10/2022)
`
`7 WAIVER OF SERVICE returned executed by Novo Nordisk Inc., Novo Nordisk A/S:
`For Dr. Reddy's Laboratories Ltd. waiver sent on 3/4/2022, answer due 5/3/2022.
`(Egan, Brian) (Entered: 03/10/2022)
`
`8 STIPULATION TO EXTEND TIME for defendants to answer, move, or otherwise
`respond to the Complaint to May 3, 2022 − filed by Novo Nordisk A/S, Novo Nordisk
`Inc.. (Egan, Brian) (Entered: 03/10/2022)
`
`SO ORDERED, re 8 STIPULATION TO EXTEND TIME for defendants to answer,
`move, or otherwise respond to the Complaint to May 3, 2022, filed by Novo Nordisk
`A/S, Novo Nordisk Inc. Ordered by Judge Colm F. Connolly on 3/10/2022. (kmd)
`(Entered: 03/10/2022)
`
`9 MOTION for Pro Hac Vice Appearance of Attorney Jovial Wong, Sharon Lin, and
`Alison M. King of Winston & Strawn LLP − filed by Dr. Reddy's Laboratories Inc.,
`Dr. Reddy's Laboratories Ltd.. (Gattuso, Dominick) (Entered: 05/02/2022)
`
`SO ORDERED, re 9 MOTION for Pro Hac Vice Appearance of Attorney Jovial
`Wong, Sharon Lin, and Alison M. King of Winston & Strawn LLP, filed by Dr.
`Reddy's Laboratories Inc., Dr. Reddy's Laboratories Ltd. Ordered by Judge Colm F.
`Connolly on 5/2/2022. (kmd) (Entered: 05/02/2022)
`
`Pro Hac Vice Attorney Sharon Lin for Dr. Reddy's Laboratories Inc. and Dr. Reddy's
`Laboratories Ltd. added for electronic noticing. Pursuant to Local Rule 83.5 (d).,
`Delaware counsel shall be the registered users of CM/ECF and shall be required to file
`all papers. (srs) (Entered: 05/03/2022)
`
`

`

`Case 1:22-cv-00023-JPB Document 25-4 Filed 05/11/22 Page 5 of 231 PageID #: 2089
`
`05/03/2022
`
`05/03/2022
`
`05/03/2022
`
`05/04/2022
`
`05/05/2022
`
`05/05/2022
`
`05/06/2022
`
`05/06/2022
`
`10 ANSWER to 1 Complaint, , COUNTERCLAIM against All Plaintiffs by Dr. Reddy's
`Laboratories Inc., Dr. Reddy's Laboratories Ltd..(Gattuso, Dominick) (Entered:
`05/03/2022)
`
`11 Disclosure Statement pursuant to Rule 7.1: No Parents or Affiliates Listed filed by Dr.
`Reddy's Laboratories Inc., Dr. Reddy's Laboratories Ltd.. (Gattuso, Dominick)
`(Entered: 05/03/2022)
`
`12 STIPULATION TO EXTEND TIME to produce a copy of its Abbreviated New Drug
`Application to Plaintiffs to May 5, 2022 − filed by Dr. Reddy's Laboratories Inc., Dr.
`Reddy's Laboratories Ltd.. (Gattuso, Dominick) (Entered: 05/03/2022)
`
`13 SO ORDERED, re 12 STIPULATION TO EXTEND TIME to produce a copy of its
`Abbreviated New Drug Application to Plaintiffs to May 5, 2022, filed by Dr. Reddy's
`Laboratories Inc., Dr. Reddy's Laboratories Ltd. Signed by Judge Colm F. Connolly on
`5/4/2022. (kmd) (Entered: 05/04/2022)
`
`14 NOTICE OF SERVICE of Defendants Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's
`Laboratories, Inc.'s ANDA No. 216417, bearing Bates numbers DRL_0000001−
`DRL_0010816 filed by Dr. Reddy's Laboratories Inc., Dr. Reddy's Laboratories
`Ltd..(Gattuso, Dominick) (Entered: 05/05/2022)
`
`Pro Hac Vice Attorney Jovial Wong for Dr. Reddy's Laboratories Inc. and Dr. Reddy's
`Laboratories Ltd. added for electronic noticing. Pursuant to Local Rule 83.5 (d).,
`Delaware counsel shall be the registered users of CM/ECF and shall be required to file
`all papers. (mpb) (Entered: 05/05/2022)
`
`15 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)
`
`

`

`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
`
`
`
`
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
`
`
`
`Plaintiffs,
`
`
`
`
`
`
`
`v.
`
`
`
`Defendants.
`
`
`COMPLAINT
`
`Novo Nordisk Inc. and Novo Nordisk A/S (collectively, “Novo Nordisk”), by their
`
`
`
`Case 1:22-cv-00298-CFC Document 1 Filed 03/04/22 Page 1 of 18 PageID #: 1Case 1:22-cv-00023-JPB Document 25-4 Filed 05/11/22 Page 6 of 231 PageID #: 2090
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`
`
`C.A. No. _______________
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`undersigned attorneys, for their Complaint against Defendants Dr. Reddy’s Laboratories, Ltd. and
`
`Dr. Reddy’s Laboratories, Inc. (collectively, “Dr. Reddy’s”), 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 Dr. Reddy’s submission of an Abbreviated New
`
`Drug Application (“ANDA”) to the United States Food and Drug Administration (“FDA”), by
`
`which Dr. Reddy’s seeks approval to market a generic version of Novo Nordisk’s pharmaceutical
`
`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
`
`patent”) which cover inter alia, Ozempic® and/or its use.
`
`
`
`

`

`
`
`Case 1:22-cv-00298-CFC Document 1 Filed 03/04/22 Page 2 of 18 PageID #: 2Case 1:22-cv-00023-JPB Document 25-4 Filed 05/11/22 Page 7 of 231 PageID #: 2091
`
`
`
`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.
`
`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 Dr. Reddy’s Laboratories, Inc. is a
`
`corporation organized and existing under the laws of the State of New Jersey, having its principal
`
`place of business at 107 College Road East, Princeton, New Jersey 08540. On information and
`
`belief, Dr. Reddy’s Laboratories, 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.
`
`5.
`
`On information and belief, Defendant Dr. Reddy’s Laboratories, Ltd. is a
`
`corporation organized and existing under the laws of India, having its principal place of business
`
`at Door No. 8-2-337, Road No. 3, Banjara Hills, Hyderabad, Telangana 500034, India. On
`
`information and belief, Dr. Reddy’s Laboratories, Ltd. 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 Dr. Reddy’s Laboratories, Inc. is a wholly
`
`owned subsidiary of Defendant Dr. Reddy’s Laboratories, Ltd.
`
`2
`
`

`

`
`
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`
`
`
`7.
`
`On information and belief, Defendants Dr. Reddy’s Laboratories, Inc. and
`
`Dr. Reddy’s Laboratories, Ltd. acted in concert to prepare and submit ANDA No. 216417
`
`(“Dr. Reddy’s ANDA”) to the FDA.
`
`8.
`
`On information and belief, following any FDA approval of Dr. Reddy’s ANDA,
`
`Defendants Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. will act in concert
`
`to distribute and sell a generic version of semaglutide injection, 2 mg/1.5 ml and 4 mg/3 ml
`
`(“Dr. Reddy’s Product”) throughout the United States, including within Delaware.
`
`JURISDICTION AND VENUE
`
`9.
`
`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
`
`§§ 1331 and 1338(a).
`
`10.
`
`This Court has personal jurisdiction over Defendant Dr. Reddy’s Laboratories, Inc.
`
`by virtue of, inter alia, its presence in Delaware, having conducted business in the State of
`
`Delaware; and having engaged in systematic and continuous contacts with the State of 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 counterclaims in this
`
`jurisdiction (see e.g., Novartis Pharms. Corp. v. Dr. Reddy’s Laboratories, Inc., C.A. No. 19-
`
`02053 (D. Del. Oct. 29, 2019); Merck Sharp & Dohme Corp. v. Dr. Reddy’s Laboratories, Inc.,
`
`C.A. No. 20-00847 (D. Del. June 24, 2020)).
`
`11.
`
`This Court has personal jurisdiction over Defendant Dr. Reddy’s Laboratories, 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., Novartis Pharms. Corp. v. Dr. Reddy’s Laboratories, Inc.,
`
`C.A. No. 19-02053 (D. Del. Oct. 29, 2019)); and having taken advantage of the rights and
`
`3
`
`

`

`
`
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`
`
`
`protections provided by this Court, including having asserted counterclaims in this jurisdiction
`
`(see e.g., Merck Sharp & Dohme Corp. v. Dr. Reddy’s Laboratories, Inc., C.A. No. 20-00847
`
`(D. Del. June 24, 2020); Genzyme Corp. et al. v. Dr. Reddy’s Laboratories, Inc., C.A. No. 19-
`
`02045 (D. Del. Oct. 29, 2019)).
`
`12.
`
`On information and belief, Dr. Reddy’s intends to sell, offer to sell, use, and/or
`
`engage in the commercial manufacture of Dr. Reddy’s Product, directly or indirectly, throughout
`
`the United States and in this District. Dr. Reddy’s filing of Dr. Reddy’s ANDA confirms this
`
`intention and further subjects Dr. Reddy’s to the specific personal jurisdiction of this Court.
`
`13.
`
`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`THE PATENTS-IN-SUIT
`
`14.
`
`On March 6, 2012, the United States Patent and Trademark Office issued the ’343
`
`patent, entitled “Acylated GLP-1 Compounds,” a copy of which is attached to this Complaint as
`
`Exhibit A. NNAS is the owner of all right, title, and interest in the ’343 patent.
`
`15.
`
`On December 30, 2014, the United States Patent and Trademark Office issued the
`
`’383 patent, entitled “Dose Mechanism for an Injection Device for Limiting a Dose Setting
`
`Corresponding to the Amount of Medicament Left,” a copy of which is attached to this Complaint
`
`as Exhibit B. NNAS is the owner of all right, title, and interest in the ’383 patent.
`
`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 C. NNAS is the owner of all right, title, and interest in the ’239 patent.
`
`17.
`
`On October 4, 2016, the United States Patent and Trademark Office issued the ’154
`
`patent, entitled “Injection Device with an End of Dose Feedback Mechanism,” a copy of which is
`
`4
`
`

`

`
`
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`
`
`
`attached to this Complaint as Exhibit D. NNAS is the owner of all right, title, and interest in the
`
`’154 patent.
`
`18.
`
`On June 27, 2017, the United States Patent and Trademark Office issued the ’611
`
`patent, entitled “Injection Device with Torsion Spring and Rotatable Display,” a copy of which is
`
`attached to this Complaint as Exhibit E. NNAS is the owner of all right, title, and interest in the
`
`’611 patent.
`
`19.
`
`On October 3, 2017, the United States Patent and Trademark Office issued the ’953
`
`patent, entitled “Dose Mechanism for an Injection Device for Limiting a Dose Setting
`
`Corresponding to the Amount of Medicament Left,” a copy of which is attached to this Complaint
`
`as Exhibit F. NNAS is the owner of all right, title, and interest in the ’953 patent.
`
`20.
`
`On March 5, 2019, the United States Patent and Trademark Office issued the ’155
`
`patent, entitled “Syringe Device with a Dose Limiting Mechanism and an Additional Safety
`
`Mechanism,” a copy of which is attached to this Complaint as Exhibit G. NNAS is the owner of
`
`all right, title, and interest in the ’155 patent.
`
`21.
`
`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 H. NNAS is the owner of all right, title, and interest in the ’462 patent.
`
`22.
`
`On August 24, 2021, the United States Patent and Trademark Office issued the ’063
`
`patent, entitled “Syringe Device with a Dose Limiting Mechanism and an Additional Safety
`
`Mechanism,” a copy of which is attached to this Complaint as Exhibit I. NNAS is the owner of
`
`all right, title, and interest in the ’063 patent.
`
`5
`
`

`

`
`
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`
`
`
`23.
`
`On April 11, 2017, the United States Patent and Trademark Office issued the ’363
`
`patent, entitled “Dial-Down Mechanism for Wind-Up Pen,” a copy of which is attached to this
`
`Complaint as Exhibit J. NNAS is the owner of all right, title, and interest in the ’363 patent.
`
`OZEMPIC®
`
`24.
`
`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®.
`
`25.
`
`26.
`
`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 ’343, ’383,
`
`’239, ’154, ’611, ’953, ’155, ’462, ’063, and ’363 patents are listed in the FDA publication,
`
`“Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”), with
`
`respect to Ozempic®.
`
`DR. REDDY’S ANDA
`
`27.
`
`On information and belief, Dr. Reddy’s submitted ANDA No. 216417
`
`(“Dr. Reddy’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 and 4 mg/3 ml (“Dr. Reddy’s Product”).
`
`28.
`
`On information and belief, Dr. Reddy’s ANDA refers to and relies upon the
`
`Ozempic® NDA and contains data that, according to Dr. Reddy’s, demonstrate the bioequivalence
`
`of Dr. Reddy’s Product and Ozempic®.
`
`29.
`
`By letter to NNI and NNAS, dated February 2, 2022 (the “Notice Letter”),
`
`Dr. Reddy’s stated that Dr. Reddy’s ANDA contained a certification pursuant to 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV) that the ’343, ’383, ’239, ’154, ’611, ’953, ’155, ’462, ’063, and ’363
`
`patents are invalid, unenforceable, and/or will not be infringed by the commercial manufacture,
`
`6
`
`

`

`
`
`Case 1:22-cv-00298-CFC Document 1 Filed 03/04/22 Page 7 of 18 PageID #: 7Case 1:22-cv-00023-JPB Document 25-4 Filed 05/11/22 Page 12 of 231 PageID #: 2096
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`
`
`use, or sale of Dr. Reddy’s Product (the “Paragraph IV Certification”). Dr. Reddy’s attached a
`
`memorandum to the Notice Letter in which it purported to allege factual and legal bases for its
`
`Paragraph IV Certification. NNI and NNAS file this suit within 45 days of receipt of the Notice
`
`Letter.
`
`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 8,129,343
`
`30.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-29 of this Complaint.
`
`31.
`
`Dr. Reddy’s has infringed the ’343 patent, pursuant to 35 U.S.C. § 271(e)(2)(A),
`
`by submitting Dr. Reddy’s ANDA, by which Dr. Reddy’s seeks approval from the FDA to
`
`manufacture, use, offer to sell, and sell Dr. Reddy’s Product prior to the expiration of the
`
`’343 patent.
`
`32.
`
`Claims 1-2 and 4-5 of the ’343 patent encompass semaglutide and pharmaceutical
`
`compositions comprising semaglutide. Claims 3 and 6 encompass a method of treating type 2
`
`diabetes comprising administering to a patient an effective amount of semaglutide. Dr. Reddy’s
`
`manufacture, use, offer for sale or sale of Dr. Reddy’s Product within the United States, or
`
`importation of Dr. Reddy’s Product into the United States, during the term of the ’343 patent would
`
`infringe claims 1-6 of the ’343 patent.
`
`33.
`
`Upon information and belief, Dr. Reddy’s sale or offer for sale of Dr. Reddy’s
`
`Product within the United States, or importation of Dr. Reddy’s Product into the United States, or
`
`commercial marketing of Dr. Reddy’s Product in the United States, during the term of and with
`
`knowledge of the ’343 patent, would intentionally induce others to use Dr. Reddy’s Product in the
`
`United States, thus inducing infringement of claims 3 and 6 of the ’343 patent.
`
`7
`
`

`

`
`
`Case 1:22-cv-00298-CFC Document 1 Filed 03/04/22 Page 8 of 18 PageID #: 8Case 1:22-cv-00023-JPB Document 25-4 Filed 05/11/22 Page 13 of 231 PageID #: 2097
`
`
`
`34.
`
`Novo Nordisk will be harmed substantially and irreparably if Dr. Reddy’s is not
`
`enjoined from infringing the ’343 patent and/or if the FDA is not enjoined from approving
`
`Dr. Reddy’s ANDA before the ’343 patent expires.
`
`35.
`
`36.
`
`Novo Nordisk has no adequate remedy at law.
`
`Dr. Reddy’s was aware of the ’343 patent when it submitted its ANDA. Novo
`
`Nordisk is entitled to a finding that this case is exceptional and to an award of attorney’s fees under
`
`35 U.S.C. § 285.
`
`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 8,920,383
`
`37.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-36 of this Complaint.
`
`38.
`
`Dr. Reddy’s has infringed the ’383 patent, pursuant to 35 U.S.C. § 271(e)(2)(A),
`
`by submitting Dr. Reddy’s ANDA, by which Dr. Reddy’s seeks approval from the FDA to
`
`manufacture, use, offer to sell, and sell Dr. Reddy’s Product prior to the expiration of the
`
`’383 patent.
`
`39.
`
`Claims 1-12 of the ’383 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
`
`13 of the ’383 patent is directed to a syringe device employing such a mechanism. Dr. Reddy’s
`
`manufacture, use, offer for sale or sale of Dr. Reddy’s Product within the United States, or
`
`importation of Dr. Reddy’s Product into the United States, during the term of the ’383 patent would
`
`infringe claims 1-13 of the ’383 patent.
`
`40.
`
`Novo Nordisk will be harmed substantially and irreparably if Dr. Reddy’s is not
`
`enjoined from infringing the ’383 patent and/or if the FDA is not enjoined from approving
`
`Dr. Reddy’s ANDA before the ’383 patent expires.
`
`8
`
`

`

`
`
`Case 1:22-cv-00298-CFC Document 1 Filed 03/04/22 Page 9 of 18 PageID #: 9Case 1:22-cv-00023-JPB Document 25-4 Filed 05/11/22 Page 14 of 231 PageID #: 2098
`
`
`
`41.
`
`42.
`
`Novo Nordisk has no adequate remedy at law.
`
`Dr. Reddy’s was aware of the ’383 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. 9,132,239
`
`43.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-42 of this Complaint.
`
`44.
`
`Dr. Reddy’s has infringed the ’239 patent, pursuant to 35 U.S.C. § 271(e)(2)(A),
`
`by submitting Dr. Reddy’s ANDA, by which Dr. Reddy’s seeks approval from the FDA to
`
`manufacture, use, offer to sell, and sell Dr. Reddy’s Product prior to the expiration of the
`
`’239 patent.
`
`45.
`
`Claims 1-3 of the ’239 patent are directed to a dial-down mechanism for an
`
`injection device. Dr. Reddy’s manufacture, use, offer for sale or sale of Dr. Reddy’s Product
`
`within the United States, or importation of Dr. Reddy’s Product into the United States, during the
`
`term of the ’239 patent would infringe claims 1-3 of the ’239 patent.
`
`46.
`
`Novo Nordisk will be harmed substantially and irreparably if Dr. Reddy’s is not
`
`enjoined from infringing the ’239 patent and/or if the FDA is not enjoined from approving
`
`Dr. Reddy’s ANDA before the ’239 patent expires.
`
`47.
`
`48.
`
`Novo Nordisk has no adequate remedy at law.
`
`Dr. Reddy’s 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.
`
`9
`
`

`

`
`
`Case 1:22-cv-00298-CFC Document 1 Filed 03/04/22 Page 10 of 18 PageID #: 10Case 1:22-cv-00023-JPB Document 25-4 Filed 05/11/22 Page 15 of 231 PageID #: 2099
`
`
`
`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 9,457,154
`
`49.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-48 of this Complaint.
`
`50.
`
`Dr. Reddy’s has infringed the ’154 patent, pursuant to 35 U.S.C. § 271(e)(2)(A),
`
`by submitting Dr. Reddy’s ANDA, by which Dr. Reddy’s seeks approval from the FDA to
`
`manufacture, use, offer to sell, and sell Dr. Reddy’s Product prior to the expiration of the
`
`’154 patent.
`
`51.
`
`Claims 1-17 of the ’154 patent are directed to an injection device comprising a dose
`
`delivering mechanism which provides an audible feedback signal to a user at the end of injection
`
`of a set dose. Dr. Reddy’s manufacture, use, offer for sale or sale of Dr. Reddy’s Product within
`
`the United States, or importation of Dr. Reddy’s Product into the United States, during the term of
`
`the ’154 patent would infringe claims 1-17 of the ’154 patent.
`
`52.
`
`Novo Nordisk will be harmed substantially and irreparably if Dr. Reddy’s is not
`
`enjoined from infringing the ’154 patent and/or if the FDA is not enjoined from approving
`
`Dr. Reddy’s ANDA before the ’154 patent expires.
`
`53.
`
`54.
`
`Novo Nordisk has no adequate remedy at law.
`
`Dr. Reddy’s was aware of the ’154 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. 9,687,611
`
`55.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-54 of this Complaint.
`
`10
`
`

`

`
`
`Case 1:22-cv-00298-CFC Document 1 Filed 03/04/22 Page 11 of 18 PageID #: 11Case 1:22-cv-00023-JPB Document 25-4 Filed 05/11/22 Page 16 of 231 PageID #: 2100
`
`
`
`56.
`
`Dr. Reddy’s has infringed the ’611 patent, pursuant to 35 U.S.C. § 271(e)(2)(A),
`
`by submitting Dr. Reddy’s ANDA, by which Dr. Reddy’s seeks approval from the FDA to
`
`manufacture, use, offer to sell, and sell Dr. Reddy’s Product prior to the expiration of the
`
`’611 patent.
`
`57.
`
`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. Dr. Reddy’s manufacture, use, offer for sale or
`
`sale of Dr. Reddy’s Product within the United States, or importation of Dr. Reddy’s Product into
`
`the United States, during the term of the ’611 patent would infringe claims 1-15 of the ’611 patent.
`
`58.
`
`Novo Nordisk will be harmed substantially and irreparably if Dr. Reddy’s is not
`
`enjoined from infringing the ’611 patent and/or if the FDA is not enjoined from approving
`
`Dr. Reddy’s ANDA before the ’611 patent expires.
`
`59.
`
`60.
`
`Novo Nordisk has no adequate remedy at law.
`
`Dr. Reddy’s 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
`
`61.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-60 of this Complaint.
`
`62.
`
`Dr. Reddy’s has infringed the ’953 patent, pursuant to 35 U.S.C. § 271(e)(2)(A),
`
`by submitting Dr. Reddy’s ANDA, by which Dr. Reddy’s seeks approval from the FDA to
`
`11
`
`

`

`
`
`Case 1:22-cv-00298-CFC Document 1 Filed 03/04/22 Page 12 of 18 PageID #: 12Case 1:22-cv-00023-JPB Document 25-4 Filed 05/11/22 Page 17 of 231 PageID #: 2101
`
`
`
`manufacture, use, offer to sell, and sell Dr. Reddy’s Product prior to the expiration of the
`
`’953 patent.
`
`63.
`
`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. Dr. Reddy’s manufacture, use, offer for sale or sale of Dr. Reddy’s Product within
`
`the United States, or importation of Dr. Reddy’s Product into the United States, during the term of
`
`the ’953 patent would infringe claims 1-25 of the ’953 patent.
`
`64.
`
`Novo Nordisk will be harmed substantially and irreparably if Dr. Reddy’s is not
`
`enjoined from infringing the ’953 patent and/or if the FDA is not enjoined from approving
`
`Dr. Reddy’s ANDA before the ’953 patent expires.
`
`65.
`
`66.
`
`Novo Nordisk has no adequate remedy at law.
`
`Dr. Reddy’s 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
`
`67.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-66 of this Complaint.
`
`68.
`
`Dr. Reddy’s has infringed the ’155 patent, pursuant to 35 U.S.C. § 271(e)(2)(A),
`
`by submitting Dr. Reddy’s ANDA, by which Dr. Reddy’s seeks approval from the FDA to
`
`manufacture, use, offer to sell, and sell Dr. Reddy’s Product prior to the expiration of the
`
`’155 patent.
`
`12
`
`

`

`
`
`Case 1:22-cv-00298-CFC Document 1 Filed 03/04/22 Page 13 of 18 PageID #: 13Case 1:22-cv-00023-JPB Document 25-4 Filed 05/11/22 Page 18 of 231 PageID #: 2102
`
`
`
`69.
`
`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 ejection of a dose exceeding a set
`
`dose. Dr. Reddy’s manufacture, use, offer for sale or sale of Dr. Reddy’s Product within the United
`
`States, or importation of Dr. Reddy’s Product into the United States, during the term of the ’155
`
`patent would infringe claims 1-8 of the ’155 patent.
`
`70.
`
`Novo Nordisk will be harmed substantially and irreparably if Dr. Reddy’s is not
`
`enjoined from infringing the ’155 patent and/or if the FDA is not enjoined from approving
`
`Dr. Reddy’s ANDA before the ’155 patent expires.
`
`71.
`
`72.
`
`Novo Nordisk has no adequate remedy at law.
`
`Dr. Reddy’s 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.
`
`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 10,335,462
`
`73.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-72 of this Complaint.
`
`74.
`
`Dr. Reddy’s has infringed the ’462 patent, pursuant to 35 U.S.C. § 271(e)(2)(A),
`
`by submitting Dr. Reddy’s ANDA, by which Dr. Reddy’s seeks approval from the FDA to
`
`manufacture, use, offer to sell, and sell Dr. Reddy’s Product prior to the expiration of the
`
`’462 patent.
`
`75.
`
`Claims 1-10 of the ’462 p