Case 1:17-cv-00227-VAC-MPT Document 1 Filed 03/03/17 Page 1 of 9 PageID #: 1
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`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
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`
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`TEVA PHARMACEUTICALS USA, INC.,
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`
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`
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`
`
`v.
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
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`Plaintiffs,
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`Defendant.
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`C.A. No. _______________
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`
`
`COMPLAINT
`
`Novo Nordisk Inc. and Novo Nordisk A/S (collectively, “Novo Nordisk”), by their
`
`undersigned attorneys, for their Complaint against Defendant Teva Pharmaceuticals USA, Inc.
`
`(“Teva”), allege:
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`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 Teva’s filing of an Abbreviated New Drug
`
`Application (“ANDA”) with the United States Food and Drug Administration (“FDA”), by which
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`Teva seeks approval to market a generic version of Novo Nordisk’s pharmaceutical product
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`Victoza® prior to the expiration of United States Patent Nos. 6,268,343 (the “ʼ343 patent”),
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`8,114,833 (the “ʼ833 patent”), 8,846,618 (the “ʼ618 patent”), 9,265,893 (the “ʼ893 patent”), and
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`RE41,956 (the “RE ʼ956 patent”), which cover, inter alia, Victoza® and/or its use.
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`THE PARTIES
`
`2.
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`Plaintiff Novo Nordisk Inc. (“NNI”) is a corporation organized and existing
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`under the laws of the State of Delaware, and has its principal place of business at 800 Scudders
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`Mill Road, Plainsboro, New Jersey, 08536.
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`
`
`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
`
`
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`
`
`
`
`
`
`
`
`
`v.
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Plaintiffs,
`
`Defendant.
`
`
`
`
`
`
`C.A. No. _______________
`
`
`
`COMPLAINT
`
`Novo Nordisk Inc. and Novo Nordisk A/S (collectively, “Novo Nordisk”), by their
`
`undersigned attorneys, for their Complaint against Defendant Teva Pharmaceuticals USA, Inc.
`
`(“Teva”), 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 Teva’s filing of an Abbreviated New Drug
`
`Application (“ANDA”) with the United States Food and Drug Administration (“FDA”), by which
`
`Teva seeks approval to market a generic version of Novo Nordisk’s pharmaceutical product
`
`Victoza® prior to the expiration of United States Patent Nos. 6,268,343 (the “ʼ343 patent”),
`
`8,114,833 (the “ʼ833 patent”), 8,846,618 (the “ʼ618 patent”), 9,265,893 (the “ʼ893 patent”), and
`
`RE41,956 (the “RE ʼ956 patent”), which cover, inter alia, Victoza® 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.
`
`
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`Case 1:17-cv-00227-VAC-MPT Document 1 Filed 03/03/17 Page 2 of 9 PageID #: 2
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`3.
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`Plaintiff Novo Nordisk A/S (“NNAS”) is an entity organized and existing
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`under the 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.
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`On information and belief, Teva is a corporation organized and existing
`
`under the laws of the State of Delaware, having a principal place of business at 1090 Horsham
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`Road, North Wales, Pennsylvania, 19454. On information and belief, Teva is in the business of
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`making and selling generic pharmaceutical products, which it distributes in the State of Delaware
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`and throughout the United States.
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`THE PATENTS-IN-SUIT
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`5.
`
`On July 31, 2001, the United States Patent and Trademark Office issued the
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`ʼ343 patent, entitled “Derivatives of GLP-1 Analogs,” a copy of which is attached to this
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`Complaint as Exhibit A. NNAS is the owner of all right, title, and interest in the ’343 patent.
`
`6.
`
`On February 14, 2012, the United States Patent and Trademark Office
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`issued the ʼ833 patent, entitled “Propylene Glycol-Containing Peptide Formulations Which Are
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`Optimal for Production and For Use in Injection Devices,” a copy of which is attached to this
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`Complaint as Exhibit B. NNAS is the owner of all right, title, and interest in the ’833 patent.
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`7.
`
`On September 30, 2012, the United States Patent and Trademark Office
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`issued the ʼ618 patent, entitled “Stable Formulation of Modified GLP-1,” a copy of which is
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`attached to this Complaint as Exhibit C. NNAS is the owner of all right, title, and interest in the
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`’618 patent.
`
`8.
`
`On February 23, 2016, the United States Patent and Trademark Office
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`issued the ʼ893 patent, entitled “Injection Button,” a copy of which is attached to this Complaint as
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`Exhibit D. NNAS is the owner of all right, title, and interest in the ’893 patent.
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`2
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`Case 1:17-cv-00227-VAC-MPT Document 1 Filed 03/03/17 Page 3 of 9 PageID #: 3
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`9.
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`On November 23, 2010, the United States Patent and Trademark Office
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`issued the RE ʼ956 patent, entitled “Dose Setting Limiter,” a copy of which is attached to this
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`Complaint as Exhibit E. NNAS is the owner of all right, title, and interest in the RE ’956 patent.
`
`VICTOZA®
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`10.
`
`NNI holds approved New Drug Application No. 022341 (“the Victoza®
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`NDA”) for Liraglutide Recombinant Solution Injection, 18 mg/3 ml (6 mg/ml), which NNI sells
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`under the trade name Victoza®.
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`11.
`
`Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the ʼ343,
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`ʼ833, ʼ618, ʼ893, and RE ʼ956 patents are listed in the FDA publication, “Approved Drug Products
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`with Therapeutic Equivalence Evaluations” (the “Orange Book”), with respect to Victoza®.
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`TEVA’S ANDA
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`12.
`
`On information and belief, Teva has submitted ANDA No. 210084
`
`(“Teva’s ANDA”) to the FDA, pursuant to 21 U.S.C. § 355(j), seeking approval to market a
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`generic version of liraglutide recombinant solution injection, 18 mg/3 ml (6 mg/ml) (“Teva’s
`
`Product”).
`
`13.
`
`On information and belief, Teva’s ANDA refers to and relies upon the
`
`Victoza® NDA and contains data that, according to Teva, demonstrate the bioequivalence of
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`Teva’s Product and Victoza®.
`
`14.
`
`By letter to NNI, dated January 20, 2017, Teva stated that Teva’s ANDA
`
`contained certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that the ʼ343, ʼ833, ʼ618,
`
`ʼ893, and RE ʼ956 patents are invalid, unenforceable, or will not be infringed by the commercial
`
`manufacture, use, or sale of Teva’s Product (the “Paragraph IV Certifications”). Teva attached a
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`memorandum to its January 20, 2017 letter, in which it alleged factual and legal bases for its
`
`Paragraph IV Certifications.
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`3
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`Case 1:17-cv-00227-VAC-MPT Document 1 Filed 03/03/17 Page 4 of 9 PageID #: 4
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`15.
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`Novo Nordisk attempted to negotiate confidential access to Teva’s ANDA
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`prior to filing this lawsuit, pursuant to 21 U.S.C. § 355(j)(5)(C)(i)(III). Because Teva imposed
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`unacceptable restrictions on its offer of confidential access to its ANDA, Novo Nordisk was
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`unable to review any of Teva’s ANDA before filing this action. Novo Nordisk’s infringement
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`claims are therefore based on 35 U.S.C. § 271(e)(2)(A), which makes the filing of an ANDA
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`containing a Paragraph IV certification an act of patent infringement, as well as the information
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`presently available to Novo Nordisk.
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`JURISDICTION AND VENUE
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`16.
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`This Court has subject matter jurisdiction over this action pursuant to 28
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`U.S.C. §§ 1331 and 1338(a).
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`17.
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`This Court has personal jurisdiction over Teva by virtue of, inter alia, its
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`presence in Delaware, being a Delaware corporation, having conducted business in Delaware,
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`being registered to do business in Delaware, having derived revenue from conducting business in
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`Delaware, previously consenting to personal jurisdiction in this Court, and having engaged in
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`systematic and continuous contacts with the State of Delaware.
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`18.
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`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 6,268,343
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`19.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`paragraphs 1-18 of this Complaint.
`
`20.
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`Teva has infringed the ʼ343 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
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`submitting Teva’s ANDA, by which Teva seeks approval from the FDA to sell, offer to sell, use,
`
`and/or engage in the commercial manufacture of Teva’s Product prior to the expiration of the ʼ343
`
`patent.
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`4
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`
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`Case 1:17-cv-00227-VAC-MPT Document 1 Filed 03/03/17 Page 5 of 9 PageID #: 5
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`21.
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`Teva’s sale, offer for sale, use, or commercial manufacture of Teva’s
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`Product within the United States, or importation of Teva’s Product into the United States, during
`
`the term of the ʼ343 patent would infringe at least claims 1-3, 14, 28, 29, 31, 32, 33 and 39 of the
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`ʼ343 patent under 35 U.S.C. §§ 271(a), (b), and/or (c).
`
`22.
`
`Upon information and belief, Teva’s sale or offer for sale of Teva’s Product
`
`within the United States, or importation of Teva’s Product into the United States, or commercial
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`marketing of Teva’s Product in the United States, during the term of and with knowledge of the
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`ʼ343 patent, would intentionally induce others to use Teva’s Product in the United States, thus
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`inducing infringement of claim 39 of the ʼ343 patent.
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`23.
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`Novo Nordisk will be harmed substantially and irreparably if Teva is not
`
`enjoined from infringing the ʼ343 patent.
`
`24.
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`25.
`
`Novo Nordisk has no adequate remedy at law.
`
`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. 8,114,833
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`26.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`paragraphs 1-18 of this Complaint.
`
`27.
`
`Teva has infringed the ʼ833 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Teva’s ANDA, by which Teva seeks approval from the FDA to sell, offer to sell, use,
`
`and/or engage in the commercial manufacture of Teva’s Product prior to the expiration of the ʼ833
`
`patent.
`
`28.
`
`Teva’s sale, offer for sale, use, or commercial manufacture of Teva’s
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`Product within the United States, or importation of Teva’s Product into the United States, during
`
`5
`
`
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`Case 1:17-cv-00227-VAC-MPT Document 1 Filed 03/03/17 Page 6 of 9 PageID #: 6
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`the term of the ʼ833 patent would infringe claims 1-31 of the ʼ833 patent under 35 U.S.C. §§
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`271(a), (b), and/or (c).
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`29.
`
`Novo Nordisk will be harmed substantially and irreparably if Teva is not
`
`enjoined from infringing the ʼ833 patent.
`
`30.
`
`31.
`
`Novo Nordisk has no adequate remedy at law.
`
`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. 8,846,618
`
`32.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`paragraphs 1-18 of this Complaint.
`
`33.
`
`Teva has infringed the ʼ618 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Teva’s ANDA, by which Teva seeks approval from the FDA to sell, offer to sell, use,
`
`and/or engage in the commercial manufacture of Teva’s Product prior to the expiration of the ʼ618
`
`patent.
`
`34.
`
`Teva’s sale, offer for sale, use, or commercial manufacture of Teva’s
`
`Product within the United States, or importation of Teva’s Product into the United States, during
`
`the term of the ʼ618 patent would infringe at least claims 1-3 and 5-14 of the ʼ618 patent under 35
`
`U.S.C. §§ 271(a), (b), and/or (c).
`
`35.
`
`Novo Nordisk will be harmed substantially and irreparably if Teva is not
`
`enjoined from infringing the ʼ618 patent.
`
`36.
`
`37.
`
`Novo Nordisk has no adequate remedy at law.
`
`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.
`
`6
`
`
`
`Case 1:17-cv-00227-VAC-MPT Document 1 Filed 03/03/17 Page 7 of 9 PageID #: 7
`
`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 9,265,893
`
`38.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`paragraphs 1-18 of this Complaint.
`
`39.
`
`Teva has infringed the ʼ893 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
`
`submitting Teva’s ANDA, by which Teva seeks approval from the FDA to sell, offer to sell, use,
`
`and/or engage in the commercial manufacture of Teva’s Product prior to the expiration of the ʼ893
`
`patent.
`
`40.
`
`Teva’s sale, offer for sale, use, or commercial manufacture of Teva’s
`
`Product within the United States, or importation of Teva’s Product into the United States, during
`
`the term of the ʼ893 patent would infringe claims 1-6 of the ʼ893 patent under 35 U.S.C. §§ 271(a),
`
`(b), and/or (c).
`
`41.
`
`Novo Nordisk will be harmed substantially and irreparably if Teva is not
`
`enjoined from infringing the ʼ893 patent.
`
`42.
`
`43.
`
`Novo Nordisk has no adequate remedy at law.
`
`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. RE41,956
`
`44.
`
`Novo Nordisk re-alleges and incorporates by reference the allegations of
`
`paragraphs 1-18 of this Complaint.
`
`45.
`
`Teva has infringed the RE ʼ956 patent, pursuant to 35 U.S.C. §
`
`271(e)(2)(A), by submitting Teva’s ANDA, by which Teva seeks approval from the FDA to sell,
`
`offer to sell, use, and/or engage in the commercial manufacture of Teva’s Product prior to the
`
`expiration of the RE ʼ956 patent.
`
`7
`
`
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`Case 1:17-cv-00227-VAC-MPT Document 1 Filed 03/03/17 Page 8 of 9 PageID #: 8
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`46.
`
`Teva’s sale, offer for sale, use, or commercial manufacture of Teva’s
`
`Product within the United States, or importation of Teva’s Product into the United States, during
`
`the term of the RE ʼ956 patent would infringe claims 1-19 of the RE ʼ956 patent under 35 U.S.C.
`
`§§ 271(a), (b), and/or (c).
`
`47.
`
`Novo Nordisk will be harmed substantially and irreparably if Teva is not
`
`enjoined from infringing the RE ʼ956 patent.
`
`48.
`
`49.
`
`Novo Nordisk has no adequate remedy at law.
`
`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
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`WHEREFORE, Novo Nordisk prays for a judgment in its favor and against Teva
`
`and respectfully requests the following relief:
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`A judgment that Teva has infringed the ʼ343 patent;
`
`A judgment that Teva has infringed the ʼ833 patent;
`
`A judgment that Teva has infringed the ʼ618 patent;
`
`A judgment that Teva has infringed the ʼ893 patent;
`
`A judgment that Teva has infringed the RE ʼ956 patent;
`
`A judgment, pursuant to 35 U.S.C. § 271(e)(4)(B) preliminarily and
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`permanently enjoining Teva, 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 Teva’s Product within the United States, or importing Teva’s Product into the United
`
`States, prior to the expiration of the ʼ343, ʼ833, ʼ618, ʼ893, and RE ʼ956 patents, including any
`
`extensions, adjustments, and exclusivities;
`
`8
`
`
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`Case 1:17-cv-00227-VAC-MPT Document 1 Filed 03/03/17 Page 9 of 9 PageID #: 9
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`G.
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`A judgment ordering that, pursuant to 35 U.S.C. § 271(e)(4)(A), the
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`effective date of any approval of Teva’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 ʼ343, ʼ833, ʼ618,
`
`ʼ893, and RE ʼ956 patents, including any extensions, adjustments, and exclusivities;
`
`H.
`
`If Teva commercially manufactures, uses, offers to sell, or sells Teva’s
`
`Product within the United States, or imports Teva’s Product into the United States, prior to the
`
`expiration of any of the ʼ343, ʼ833, ʼ618, ʼ893, and RE ʼ956 patents, including any extensions,
`
`adjustments, and exclusivities, a judgment awarding Novo Nordisk monetary relief, together with
`
`I.
`
`Attorneys’ fees in this action as an exceptional case pursuant to 35 U.S.C. §
`
`J.
`
`K.
`
`Costs and expenses in this action; and
`
`Such other relief as the Court deems just and proper.
`
`
`
`
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Jack B. Blumenfeld
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
`
`
`Attorneys for Novo Nordisk Inc. and
`Novo Nordisk A/S
`
`9
`
`interest;
`
`285;
`
`
`
`
`
`
`
`
`
`OF COUNSEL:
`
`Jeffrey J. Oelke
`Alison Hanstead
`John Scheibeler
`Ryan P. Johnson
`WHITE & CASE LLP
`1155 Avenue of the Americas
`New York, NY 10036
`(212) 819-8200
`
`March 3, 2017
`
`
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