Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 1 of 161 PageID #: 1828
`
`
`
`
`
`
`Exhibit 1
`
`
`
`
`
`
`
`
`
`

`

`Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 2 of 161 PageID #: 1829
`
`U.S. District Court
`District of Delaware (Wilmington)
`CIVIL DOCKET FOR CASE #: 1:22−cv−00294−CFC
`
`PATENT
`
`Novo Nordisk Inc. et al v. Rio Biopharmaceuticals, Inc. et al
`Assigned to: Judge Colm F. Connolly
`Related Cases: 1:21−cv−01782−CFC
`1:22−cv−00299−CFC
`1:22−cv−00296−CFC
`1:22−cv−00295−CFC
`1:22−cv−00298−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
`
`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
`Rio Biopharmaceuticals, Inc.
`
`Defendant
`EMS S/A
`
`Date Filed
`
`# Docket Text
`
`03/04/2022
`
`1 COMPLAINT filed against EMS S/A and Rio Biopharmaceuticals, Inc. − Magistrate
`Consent Notice to Pltf. ( Filing fee $ 402, receipt number ADEDC−3817543.) − filed
`by Novo Nordisk Inc. and Novo Nordisk A/S. (Attachments: # 1 Exhibit A−E, # 2
`
`

`

`Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 3 of 161 PageID #: 1830
`
`03/04/2022
`
`03/04/2022
`
`03/04/2022
`
`03/04/2022
`
`03/04/2022
`
`03/07/2022
`
`03/09/2022
`
`03/11/2022
`
`03/11/2022
`
`03/14/2022
`
`05/06/2022
`
`05/06/2022
`
`Civil Cover Sheet)(mal) (Entered: 03/04/2022)
`
`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: 01/24/2022. Date of
`Expiration of Patent: see attached.Thirty Month Stay Deadline: 06/05/2025. (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 A/S for
`Novo Nordisk A/S; Corporate Parent Novo Nordisk US Holdings, Inc. for Novo
`Nordisk Inc. filed by Novo Nordisk A/S, Novo Nordisk Inc.. (mal) (Entered:
`03/04/2022)
`
`6 Summons Issued as to EMS S/A on 3/4/2022; Rio Biopharmaceuticals, Inc. on
`3/4/2022. (Attachments: # 1 Summons Issued EMS S/A)(mal) (Entered: 03/04/2022)
`
`7 SUMMONS Returned Executed by Novo Nordisk Inc., Novo Nordisk A/S. Rio
`Biopharmaceuticals, 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)
`
`8 WAIVER OF SERVICE returned executed by Novo Nordisk Inc., Novo Nordisk A/S:
`For EMS S/A waiver sent on 3/8/2022, answer due 5/9/2022. (Egan, Brian) (Entered:
`03/11/2022)
`
`9 STIPULATION TO EXTEND TIME for Rio Biopharmaceuticals Inc. and EMS S/A
`to answer, move or otherwise respond to the Complaint to May 9, 2022 − filed by
`Novo Nordisk A/S, Novo Nordisk Inc.. (Egan, Brian) (Entered: 03/11/2022)
`
`SO ORDERED, re 9 STIPULATION TO EXTEND TIME for Rio Biopharmaceuticals
`Inc. and EMS S/A to answer, move or otherwise respond to the Complaint to May 9,
`2022, filed by Novo Nordisk A/S, Novo Nordisk Inc. Reset Answer Deadlines: Rio
`Biopharmaceuticals, Inc. answer due 5/9/2022. Ordered by Judge Colm F. Connolly on
`3/14/2022. (kmd) (Entered: 03/14/2022)
`
`10 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,
`
`
`
`
`
`RIO BIOPHARMACEUTICALS INC. and
`EMS S/A,
`
`
`
`Plaintiffs,
`
`
`
`
`
`
`
`v.
`
`
`
`Defendants.
`
`
`COMPLAINT
`
`Novo Nordisk Inc. and Novo Nordisk A/S (collectively, “Novo Nordisk”), by their
`
`
`
`Case 1:22-cv-00294-CFC Document 1 Filed 03/04/22 Page 1 of 11 PageID #: 1Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 4 of 161 PageID #: 1831
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`
`
`C.A. No. _______________
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`undersigned attorneys, for their Complaint against Defendants Rio Biopharmaceuticals, Inc. and
`
`EMS S/A (collectively, “Rio”), 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 Rio’s submission of an Abbreviated New Drug
`
`Application (“ANDA”) to the United States Food and Drug Administration (“FDA”), by which
`
`Rio 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”),
`
`9,132,239 (the “’239 patent”), 9,457,154 (the “’154 patent”), 9,687,611 (the “’611 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-00294-CFC Document 1 Filed 03/04/22 Page 2 of 11 PageID #: 2Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 5 of 161 PageID #: 1832
`
`
`
`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 Rio Biopharmaceuticals, Inc. is a corporation
`
`organized and existing under the laws of the State of Delaware, having its principal place of
`
`business at 55 Ivan Allen Jr. Boulevard NW, Suite 525, Atlanta, Georgia 30313. On information
`
`and belief, Rio Biopharmaceuticals, Inc. is in the business of making and selling generic
`
`pharmaceutical products, for distribution in the State of Delaware and throughout the
`
`United States.
`
`5.
`
`On information and belief, Defendant EMS S/A is a corporation organized and
`
`existing under the laws of Brazil, having its principal place of business at Rod. Jornalista Francisco
`
`Aguirre Proenca S/N KM 08 Bloco I, II E V Hortolandia, Sao Paulo, 13186-901, Brazil. On
`
`information and belief, EMS S/A is in the business of making and selling generic pharmaceutical
`
`products, for distribution in the State of Delaware and throughout the United States.
`
`6.
`
`On information and belief, Defendant Rio Biopharmaceuticals, Inc. is a wholly
`
`owned subsidiary of Defendant EMS S/A.
`
`7.
`
`On information and belief, Defendants Rio Biopharmaceuticals, Inc. and EMS S/A
`
`acted in concert to prepare and submit ANDA No. 216305 (“Rio’s ANDA”) to the FDA.
`
`8.
`
`On information and belief, following any FDA approval of Rio’s ANDA,
`
`Defendants Rio Biopharmaceuticals, Inc. and EMS S/A will act in concert to distribute and sell a
`
`generic version of semaglutide solution, 2 mg/1.5 ml (1.34 mg/ml) and 4 mg/3 ml (1.34 mg/ml)
`
`(“Rio’s Product”) throughout the United States, including within Delaware.
`
`2
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1 Filed 03/04/22 Page 3 of 11 PageID #: 3Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 6 of 161 PageID #: 1833
`
`
`
`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 Rio Biopharmaceuticals, Inc.
`
`by virtue of, inter alia, its presence in Delaware, being a Delaware corporation; having conducted
`
`business in Delaware; having derived revenue from conducting business in Delaware; and having
`
`engaged in systematic and continuous contacts with the State of Delaware.
`
`11.
`
`This Court has personal jurisdiction over Defendant EMS S/A by virtue of, inter
`
`alia,
`
`its presence
`
`in Delaware
`
`through
`
`that of
`
`its wholly owned
`
`subsidiary,
`
`Rio Biopharmaceuticals, Inc., which is a Delaware corporation, through which it conducts
`
`business in Delaware and will derive revenue from conducting business in Delaware, by
`
`marketing, selling, and/or distributing generic pharmaceutical drug products to residents of
`
`Delaware.
`
`12.
`
`If Defendant EMS S/A’s connections with Delaware are found to be insufficient to
`
`confer personal jurisdiction, then, on information and belief, Defendant EMS S/A is not subject to
`
`jurisdiction in any state’s courts of general jurisdiction and exercising jurisdiction over EMS S/A
`
`in Delaware is consistent with the United States Constitution and laws. See Fed. R. Civ. P. 4(k)(2).
`
`13.
`
`On information and belief, Rio intends to sell, offer to sell, use, and/or engage in
`
`the commercial manufacture of Rio’s Product, directly or indirectly, throughout the United States
`
`and in this District. Rio’s filing of Rio’s ANDA confirms this intention and further subjects Rio
`
`to the specific personal jurisdiction of this Court.
`
`14.
`
`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`3
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1 Filed 03/04/22 Page 4 of 11 PageID #: 4Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 7 of 161 PageID #: 1834
`
`
`
`THE PATENTS-IN-SUIT
`
`15.
`
`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.
`
`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 B. 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 attached to this Complaint as Exhibit C. 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 D. NNAS is the owner of all right, title, and interest in the
`
`’611 patent.
`
`19.
`
`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 E. NNAS is the owner of all right, title, and interest in the ’462 patent.
`
`OZEMPIC®
`
`20.
`
`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®.
`
`21.
`
`The claims of the patents-in-suit cover, inter alia, Ozempic® and/or its use.
`
`4
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1 Filed 03/04/22 Page 5 of 11 PageID #: 5Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 8 of 161 PageID #: 1835
`
`
`
`22.
`
`Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the ’343, ’239,
`
`’154, ’611, and ’462 patents are listed in the FDA publication, “Approved Drug Products with
`
`Therapeutic Equivalence Evaluations” (the “Orange Book”), with respect to Ozempic®.
`
`RIO’S ANDA
`
`23.
`
`On information and belief, Rio submitted ANDA No. 216305 (“Rio’s ANDA”) to
`
`the FDA, pursuant to 21 U.S.C. § 355(j), seeking approval to market a generic version of
`
`semaglutide solution, 2 mg/1.5 ml (1.34 mg/ml) and 4 mg/3 ml (1.34 mg/ml) (“Rio’s Product”).
`
`24.
`
`On information and belief, Rio’s ANDA refers to and relies upon the Ozempic®
`
`NDA and contains data that, according to Rio, demonstrate the bioequivalence of Rio’s Product
`
`and Ozempic®.
`
`25.
`
`By letter to NNI and NNAS, dated January 21, 2022 (the “Notice Letter”),
`
`Rio stated that Rio’s ANDA contained a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
`
`that the ’343, ’239, ’154, ’611, and ’462 patents are invalid, unenforceable, and/or will not be
`
`infringed by the commercial manufacture, use, or sale of Rio’s Product (the “Paragraph IV
`
`Certification”). Rio 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
`
`26.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-25 of this Complaint.
`
`27.
`
`Rio has infringed the ’343 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Rio’s ANDA, by which Rio seeks approval from the FDA to manufacture, use, offer
`
`to sell, and sell Rio’s Product prior to the expiration of the ’343 patent.
`
`5
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1 Filed 03/04/22 Page 6 of 11 PageID #: 6Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 9 of 161 PageID #: 1836
`
`
`
`28.
`
`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. Rio’s
`
`manufacture, use, offer for sale or sale of Rio’s Product within the United States, or importation
`
`of Rio’s Product into the United States, during the term of the ’343 patent would infringe claims
`
`1-6 of the ’343 patent.
`
`29.
`
`Upon information and belief, Rio’s sale or offer for sale of Rio’s Product within
`
`the United States, or importation of Rio’s Product into the United States, or commercial marketing
`
`of Rio’s Product in the United States, during the term of and with knowledge of the ’343 patent,
`
`would intentionally induce others to use Rio’s Product in the United States, thus inducing
`
`infringement of claims 3 and 6 of the ’343 patent.
`
`30.
`
`Novo Nordisk will be harmed substantially and irreparably if Rio is not enjoined
`
`from infringing the ’343 patent and/or if the FDA is not enjoined from approving Rio’s ANDA
`
`before the ’343 patent expires.
`
`31.
`
`32.
`
`Novo Nordisk has no adequate remedy at law.
`
`Rio 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. 9,132,239
`
`33.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-32 of this Complaint.
`
`6
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1 Filed 03/04/22 Page 7 of 11 PageID #: 7Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 10 of 161 PageID #: 1837
`
`
`
`34.
`
`Rio has infringed the ’239 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Rio’s ANDA, by which Rio seeks approval from the FDA to manufacture, use, offer
`
`to sell, and sell Rio’s Product prior to the expiration of the ’239 patent.
`
`35.
`
`Claims 1-3 of the ’239 patent are directed to a dial-down mechanism for an
`
`injection device. Rio’s manufacture, use, offer for sale or sale of Rio’s Product within the United
`
`States, or importation of Rio’s Product into the United States, during the term of the ’239 patent
`
`would infringe claims 1-3 of the ’239 patent.
`
`36.
`
`Novo Nordisk will be harmed substantially and irreparably if Rio is not enjoined
`
`from infringing the ’239 patent and/or if the FDA is not enjoined from approving Rio’s ANDA
`
`before the ’239 patent expires.
`
`37.
`
`38.
`
`Novo Nordisk has no adequate remedy at law.
`
`Rio 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. 9,457,154
`
`39.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-38 of this Complaint.
`
`40.
`
`Rio has infringed the ’154 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Rio’s ANDA, by which Rio seeks approval from the FDA to manufacture, use, offer
`
`to sell, and sell Rio’s Product prior to the expiration of the ’154 patent.
`
`41.
`
`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. Rio’s manufacture, use, offer for sale or sale of Rio’s Product within the United
`
`7
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1 Filed 03/04/22 Page 8 of 11 PageID #: 8Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 11 of 161 PageID #: 1838
`
`
`
`States, or importation of Rio’s Product into the United States, during the term of the ’154 patent
`
`would infringe claims 1-17 of the ’154 patent.
`
`42.
`
`Novo Nordisk will be harmed substantially and irreparably if Rio is not enjoined
`
`from infringing the ’154 patent and/or if the FDA is not enjoined from approving Rio’s ANDA
`
`before the ’154 patent expires.
`
`43.
`
`44.
`
`Novo Nordisk has no adequate remedy at law.
`
`Rio 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
`
`45.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-44 of this Complaint.
`
`46.
`
`Rio has infringed the ’611 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Rio’s ANDA, by which Rio seeks approval from the FDA to manufacture, use, offer
`
`to sell, and sell Rio’s Product prior to the expiration of the ’611 patent.
`
`47.
`
`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. Rio’s manufacture, use, offer for sale or sale of
`
`Rio’s Product within the United States, or importation of Rio’s Product into the United States,
`
`during the term of the ’611 patent would infringe claims 1-15 of the ’611 patent.
`
`8
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1 Filed 03/04/22 Page 9 of 11 PageID #: 9Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 12 of 161 PageID #: 1839
`
`
`
`48.
`
`Novo Nordisk will be harmed substantially and irreparably if Rio is not enjoined
`
`from infringing the ’611 patent and/or if the FDA is not enjoined from approving Rio’s ANDA
`
`before the ’611 patent expires.
`
`49.
`
`50.
`
`Novo Nordisk has no adequate remedy at law.
`
`Rio 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. 10,335,462
`
`51.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`Paragraphs 1-50 of this Complaint.
`
`52.
`
`Rio has infringed the ’462 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Rio’s ANDA, by which Rio seeks approval from the FDA to manufacture, use, offer
`
`to sell, and sell Rio’s Product prior to the expiration of the ’462 patent.
`
`53.
`
`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. Rio’s manufacture, use, offer
`
`for sale or sale of Rio’s Product within the United States, or importation of Rio’s Product into the
`
`United States, during the term of the ’462 patent would infringe claims 1-10 of the ’462 patent.
`
`54.
`
`Upon information and belief, Rio’s sale or offer for sale of Rio’s Product within
`
`the United States, or importation of Rio’s Product into the United States, or commercial marketing
`
`of Rio’s Product in the United States, during the term of and with knowledge of the ’462 patent,
`
`would intentionally induce others to use Rio’s Product in the United States, thus inducing
`
`infringement of claims 1-10 of the ’462 patent.
`
`9
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1 Filed 03/04/22 Page 10 of 11 PageID #: 10Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 13 of 161 PageID #: 1840
`
`
`
`55.
`
`Novo Nordisk will be harmed substantially and irreparably if Rio is not enjoined
`
`from infringing the ’462 patent and/or if the FDA is not enjoined from approving Rio’s ANDA
`
`before the ’462 patent expires.
`
`56.
`
`57.
`
`Novo Nordisk has no adequate remedy at law.
`
`Rio 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 Rio and
`
`respectfully requests the following relief:
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`A judgment that Rio has infringed the ’343 patent;
`
`A judgment that Rio has infringed the ’239 patent;
`
`A judgment that Rio has infringed the ’154 patent;
`
`A judgment that Rio has infringed the ’611 patent;
`
`A judgment that Rio 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 Rio’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, ’239, ’154, ’611, and ’462
`
`patents, including any extensions, adjustments, and exclusivities;
`
`G.
`
`A judgment, pursuant to 35 U.S.C. § 271(e)(4)(B), preliminarily and permanently
`
`enjoining Rio, 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 Rio’s Product
`
`within the United States, or importing Rio’s Product into the United States, prior to the expiration
`
`10
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1 Filed 03/04/22 Page 11 of 11 PageID #: 11Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 14 of 161 PageID #: 1841
`
`
`
`of the ’343, ’239, ’154, ’611, and ’462 patents, including any extensions, adjustments, and
`
`exclusivities;
`
`H.
`
`If Rio commercially manufactures, uses, offers to sell, or sells Rio’s Product within
`
`the United States, or imports Rio’s Product into the United States, prior to the expiration of the
`
`’343, ’239, ’154, ’611, and ’462 patents, including any extensions, adjustments, and exclusivities,
`
`a judgment awarding Novo Nordisk monetary relief, together with interest;
`
`I.
`
`An award of attorneys’ fees in this action as an exceptional case pursuant to
`
`35 U.S.C. § 285;
`
`J.
`
`K.
`
`An award of costs and expenses in this action; and
`
`Such other relief as the Court deems just and proper.
`
`
`
`
`
`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
`
`
`
`
`
`
`
`11
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 1 of 146 PageID #: 12Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 15 of 161 PageID #: 1842
`
`
`
`
`
`
`
`
`
`EXHIBIT A
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 2 of 146 PageID #: 13Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 16 of 161 PageID #: 1843
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 3 of 146 PageID #: 14Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 17 of 161 PageID #: 1844
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 4 of 146 PageID #: 15Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 18 of 161 PageID #: 1845
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 5 of 146 PageID #: 16Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 19 of 161 PageID #: 1846
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 6 of 146 PageID #: 17Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 20 of 161 PageID #: 1847
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 7 of 146 PageID #: 18Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 21 of 161 PageID #: 1848
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 8 of 146 PageID #: 19Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 22 of 161 PageID #: 1849
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 9 of 146 PageID #: 20Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 23 of 161 PageID #: 1850
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 10 of 146 PageID #: 21Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 24 of 161 PageID #: 1851
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 11 of 146 PageID #: 22Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 25 of 161 PageID #: 1852
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 12 of 146 PageID #: 23Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 26 of 161 PageID #: 1853
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 13 of 146 PageID #: 24Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 27 of 161 PageID #: 1854
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 14 of 146 PageID #: 25Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 28 of 161 PageID #: 1855
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 15 of 146 PageID #: 26Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 29 of 161 PageID #: 1856
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 16 of 146 PageID #: 27Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 30 of 161 PageID #: 1857
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 17 of 146 PageID #: 28Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 31 of 161 PageID #: 1858
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 18 of 146 PageID #: 29Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 32 of 161 PageID #: 1859
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 19 of 146 PageID #: 30Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 33 of 161 PageID #: 1860
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 20 of 146 PageID #: 31Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 34 of 161 PageID #: 1861
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 21 of 146 PageID #: 32Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 35 of 161 PageID #: 1862
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 22 of 146 PageID #: 33Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 36 of 161 PageID #: 1863
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 23 of 146 PageID #: 34Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 37 of 161 PageID #: 1864
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 24 of 146 PageID #: 35Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 38 of 161 PageID #: 1865
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 25 of 146 PageID #: 36Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 39 of 161 PageID #: 1866
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 26 of 146 PageID #: 37Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 40 of 161 PageID #: 1867
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 27 of 146 PageID #: 38Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 41 of 161 PageID #: 1868
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 28 of 146 PageID #: 39Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 42 of 161 PageID #: 1869
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 29 of 146 PageID #: 40Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 43 of 161 PageID #: 1870
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 30 of 146 PageID #: 41Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 44 of 161 PageID #: 1871
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 31 of 146 PageID #: 42Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 45 of 161 PageID #: 1872
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 32 of 146 PageID #: 43Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 46 of 161 PageID #: 1873
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 33 of 146 PageID #: 44Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 47 of 161 PageID #: 1874
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 34 of 146 PageID #: 45Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 48 of 161 PageID #: 1875
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 35 of 146 PageID #: 46Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 49 of 161 PageID #: 1876
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 36 of 146 PageID #: 47Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 50 of 161 PageID #: 1877
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 37 of 146 PageID #: 48Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 51 of 161 PageID #: 1878
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 38 of 146 PageID #: 49Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 52 of 161 PageID #: 1879
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 39 of 146 PageID #: 50Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 53 of 161 PageID #: 1880
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 40 of 146 PageID #: 51Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 54 of 161 PageID #: 1881
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 41 of 146 PageID #: 52Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 55 of 161 PageID #: 1882
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22 Page 42 of 146 PageID #: 53Case 1:22-cv-00023-JPB Document 25-1 Filed 05/11/22 Page 56 of 161 PageID #: 1883
`
`

`

`
`
`Case 1:22-cv-00294-CFC Document 1-1 Filed 03/04/22