Case 1:19-cv-01551-CFC Document 1 Filed 08/20/19 Page 1 of 12 PageID #: 1
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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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`))))))))))
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`undersigned attorneys, for their Complaint against Defendant Mylan Institutional LLC
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`(“Mylan”), allege:
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`
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement under the patent laws of the United
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`States, Title 35 of the United States Code, arising from Mylan’s submission of an Abbreviated
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`New Drug Application (“ANDA”) to the United States Food and Drug Administration (“FDA”),
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`by which Mylan seeks approval to market a generic version of Novo Nordisk’s pharmaceutical
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`product Victoza® prior to the expiration of United States Patent Nos. 6,268,343 (the “’343
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`patent”), 7,762,994 (the “’994 patent”), 8,114,833 (the “’833 patent”), 8,579,869 (the “’869
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`patent”), 8,846,618 (the “’618 patent”), 9,265,893 (the “’893 patent”), and RE41,956 (the “RE
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`’956 patent”), which cover inter alia, Victoza® and/or its use.
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`THE PARTIES
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`2.
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`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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`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
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`MYLAN INSTITUTIONAL LLC,
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`Plaintiffs,
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`v.
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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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`MYLAN INST. EXHIBIT 1118 PAGE 1
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`MYLAN INST. EXHIBIT 1118 PAGE 1
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`3.
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`Plaintiff Novo Nordisk A/S (“NNAS”) is an entity organized and existing under
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`the laws of the Kingdom of Denmark, and has its principal place of business at Novo Allé, 2880
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`Bagsværd, Denmark. NNI is an indirect, wholly-owned subsidiary of NNAS.
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`4.
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`On information and belief, Defendant Mylan Institutional LLC is a limited
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`liability company organized and existing under the laws of the State of Delaware, having its
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`principal place of business at 4901 Hiawatha Drive, Rockford, Illinois 61103. On information
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`and belief, Mylan Institutional LLC is in the business of making and selling generic
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`pharmaceutical products, which it distributes in the State of Delaware and throughout the United
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`States.
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`THE PATENTS-IN-SUIT
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`5.
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`On July 31, 2001, the United States Patent and Trademark Office issued the ’343
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`patent, entitled “Derivatives of GLP-1 Analogs,” a copy of which is attached to this Complaint
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`as Exhibit A. NNAS is the owner of all right, title, and interest in the ’343 patent.
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`6.
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`On July 27, 2010, the United States Patent and Trademark Office issued the ’994
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`patent, entitled “Needle Mounting System and a Method for Mounting a Needle Assembly,” a
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`copy of which is attached to this Complaint as Exhibit B. NNAS is the owner of all right, title,
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`and interest in the ’994 patent.
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`7.
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`On February 14, 2012, the United States Patent and Trademark Office issued the
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`’833 patent, entitled “Propylene Glycol-Containing Peptide Formulations Which Are Optimal for
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`Production and For Use in Injection Devices,” a copy of which is attached to this Complaint as
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`Exhibit C. NNAS is the owner of all right, title, and interest in the ’833 patent.
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`8.
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`On November 12, 2013, the United States Patent and Trademark Office issued the
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`’869 patent, entitled “Needle Mounting System and a Method for Mounting a Needle
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`2
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`Assembly,” a copy of which is attached to this Complaint as Exhibit D. NNAS is the owner of
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`all right, title, and interest in the ’869 patent.
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`9.
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`On September 30, 2014, the United States Patent and Trademark Office issued the
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`’618 patent, entitled “Stable Formulation of Modified GLP-1,” a copy of which is attached to
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`this Complaint as Exhibit E. NNAS is the owner of all right, title, and interest in the ’618 patent.
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`10.
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`On February 23, 2016, the United States Patent and Trademark Office issued the
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`’893 patent, entitled “Injection Button,” a copy of which is attached to this Complaint as
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`Exhibit F. NNAS is the owner of all right, title, and interest in the ’893 patent.
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`11.
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`On November 23, 2010, the United States Patent and Trademark Office issued the
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`RE ’956 patent, entitled “Dose Setting Limiter,” a copy of which is attached to this Complaint as
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`Exhibit G. NNAS is the owner of all right, title, and interest in the RE ’956 patent.
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`VICTOZA®
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`12.
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`NNI holds approved New Drug Application No. 022341 (the “Victoza® NDA”)
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`for Liraglutide Recombinant Solution Injection, 18 mg/3 ml (6 mg/ml), which NNI sells under
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`the trade name Victoza®.
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`13.
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`Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the ’343, ’994,
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`’833, ’869, ’618, ’893, and RE ’956 patents are listed in the FDA publication, “Approved Drug
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`Products with Therapeutic Equivalence Evaluations” (the “Orange Book”), with respect to
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`Victoza®.
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`MYLAN’S ANDA
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`14.
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`On information and belief, Mylan submitted ANDA No. 213155 (“Mylan’s
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`ANDA”) to the FDA, pursuant to 21 U.S.C. § 355(j), seeking approval to market a generic
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`version of liraglutide injection solution, 18 mg/3 ml (6 mg/ml) (“Mylan’s Product”).
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`3
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`15.
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`On information and belief, Mylan’s ANDA refers to and relies upon the Victoza®
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`NDA and contains data that, according to Mylan, demonstrate the bioequivalence of Mylan’s
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`Product and Victoza®.
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`16.
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`By letter to NNI and NNAS, dated July 8, 2019 for next day delivery on July 9,
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`2019 (the “Notice Letter”), Mylan stated that Mylan’s ANDA contained certifications pursuant
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`to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that the ’343, ’994, ’833, ’869, ’618, ’893, and RE ’956
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`patents are invalid, unenforceable, or will not be infringed by the commercial manufacture, use,
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`or sale of Mylan’s Product (the “Paragraph IV Certifications”). Mylan attached a memorandum
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`to the Notice Letter in which it purported to allege factual and legal bases for its Paragraph IV
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`Certifications. NNI and NNAS file this suit within 45 days of receipt of the Notice Letter.
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`JURISDICTION AND VENUE
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`17.
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`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
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`§§ 1331 and 1338(a).
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`18.
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`This Court has personal jurisdiction over Mylan by virtue of, inter alia, it being
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`organized as a Delaware limited liability company; 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; having taken advantage of
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`the rights and protections provided by this Court, including having asserted counterclaims in this
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`jurisdiction (see, e.g., Helsinn Healthcare S.A. v. Mylan, Inc. et al, No. 14-709 (D. Del.);
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`Spectrum Pharms., Inc. v. InnoPharma, Inc. et al, No. 12-260 (D. Del.)); and having engaged in
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`systematic and continuous contacts with the State of Delaware.
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`19.
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`On information and belief, Mylan intends to sell, offer to sell, use, and/or engage
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`in the commercial manufacture of Mylan’s Product, directly or indirectly, throughout the United
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`4
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`States and in this District. Mylan’s filing of Mylan’s ANDA confirms this intention and subjects
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`Mylan to the specific personal jurisdiction of this Court. See Acorda Therapeutics, Inc. v. Mylan
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`Pharms., Inc., 817 F.3d 755, 759-60 (Fed. Cir. 2016), cert. denied, 137 S. Ct. 625 (2017).
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`20.
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`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b). On
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`information and belief, Mylan is an entity organized and existing under the laws of the State of
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`Delaware. See TC Heartland LLC v. Kraft Foods Grp. Brands LLC, 137 S. Ct. 1514, 1517
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`(2017).
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 6,268,343
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`21.
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`Novo Nordisk re-alleges and incorporates by reference the allegations of
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`Paragraphs 1-20 of this Complaint.
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`22. Mylan has infringed the ’343 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
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`submitting Mylan’s ANDA, by which Mylan seeks approval from the FDA to sell, offer to sell,
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`use, and/or engage in the commercial manufacture of Mylan’s Product prior to the expiration of
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`the ’343 patent.
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`23.
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`Claims 1-3 and 14 of the ’343 patent encompass liraglutide; claims 28, 29, 31, 32
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`and 33 of the ’343 patent encompass pharmaceutical compositions comprising liraglutide; and
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`claim 39 of the ’343 patent encompasses a method of treating diabetes comprising administering
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`to a patient a therapeutically effective amount of liraglutide. In the Notice Letter, Mylan has not
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`contested its infringement of claims 1-2, 14 or 28-40 of the ’343 patent. Mylan’s sale, offer for
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`sale, use, or commercial manufacture of Mylan’s Product within the United States or importation
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`of Mylan’s Product into the United States, during the term of the ’343 patent would infringe at
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`least claims 1-3, 14, 28, 29, 31, 32, 33, and 39 of the ’343 patent under 35 U.S.C. §§ 271(a), (b),
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`and/or (c).
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`5
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`24.
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`Upon information and belief, Mylan’s sale or offer for sale of Mylan’s Product
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`within the United States, or importation of Mylan’s Product into the United States or commercial
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`marketing of Mylan’s Product in the United States, during the term of and with knowledge of the
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`’343 patent, would intentionally induce others to use Mylan’s Product in the United States, thus
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`inducing infringement of claim 39 of the ’343 patent.
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`25.
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`Novo Nordisk will be harmed substantially and irreparably if Mylan is not
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`enjoined from infringing the ’343 patent.
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`26.
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`27.
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`Novo Nordisk has no adequate remedy at law.
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`Novo Nordisk is entitled to a finding that this case is exceptional and to an award
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`of attorneys’ fees under 35 U.S.C. § 285.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 7,762,994
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`28.
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`Novo Nordisk re-alleges and incorporates by reference the allegations of
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`Paragraphs 1-27 of this Complaint.
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`29. Mylan has infringed the ’994 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
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`submitting Mylan’s ANDA, by which Mylan seeks approval from the FDA to sell, offer to sell,
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`use, and/or engage in the commercial manufacture of Mylan’s Product prior to the expiration of
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`the ’994 patent.
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`30.
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`Claims 1-8 of the ’994 patent encompass a mounting system for mounting two
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`different needle arrangements. Mylan’s sale, offer for sale, use, or commercial manufacture of
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`Mylan’s Product within the United States or importation of Mylan’s Product into the United
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`States, during the term of the ’994 patent would infringe claims 1-8 of the ’994 patent under
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`35 U.S.C. §§ 271(a), (b), and/or (c).
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`31.
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`Novo Nordisk will be harmed substantially and irreparably if Mylan is not
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`enjoined from infringing the ’994 patent.
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`6
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`32.
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`33.
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`Novo Nordisk has no adequate remedy at law.
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`Novo Nordisk is entitled to a finding that this case is exceptional and to an award
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`of attorneys’ fees under 35 U.S.C. § 285.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 8,114,833
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`34.
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`Novo Nordisk re-alleges and incorporates by reference the allegations of
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`Paragraphs 1-33 of this Complaint.
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`35. Mylan has infringed the ’833 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
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`submitting Mylan’s ANDA, by which Mylan seeks approval from the FDA to sell, offer to sell,
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`use, and/or engage in the commercial manufacture of Mylan’s Product prior to the expiration of
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`the ’833 patent.
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`36.
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`Claims 1-15 of the ’833 patent are directed to formulations comprising a GLP-1
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`agonist, a disodium phosphate dihydrate buffer, and propylene glycol. Claims 16-31 are directed
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`to methods for preparing such formulations or methods of reducing deposits or reducing
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`clogging by replacing the isotonicity agent in a formulation with propylene glycol. In the Notice
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`Letter, Mylan has not contested infringement of any claims of the ’833 patent. Mylan’s sale,
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`offer for sale, use, or commercial manufacture of Mylan’s Product within the United States or
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`importation of Mylan’s Product into the United States, during the term of the ’833 patent would
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`infringe claims 1-31 of the ’833 patent under 35 U.S.C. §§ 271(a), (b), and/or (c).
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`37.
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`Novo Nordisk will be harmed substantially and irreparably if Mylan is not
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`enjoined from infringing the ’833 patent.
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`38.
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`39.
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`Novo Nordisk has no adequate remedy at law.
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`Novo Nordisk is entitled to a finding that this case is exceptional and to an award
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`of attorneys’ fees under 35 U.S.C. § 285.
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`7
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 8,579,869
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`40.
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`Novo Nordisk re-alleges and incorporates by reference the allegations of
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`Paragraphs 1-39 of this Complaint.
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`41. Mylan has infringed the ’869 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
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`submitting Mylan’s ANDA, by which Mylan seeks approval from the FDA to sell, offer to sell,
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`use, and/or engage in the commercial manufacture of Mylan’s Product prior to the expiration of
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`the ’869 patent.
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`42.
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`Claims 1-6 of the ’869 patent are directed to a needle mount. Mylan’s sale, offer
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`for sale, use, or commercial manufacture of Mylan’s Product within the United States or
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`importation of Mylan’s Product into the United States, during the term of the ’869 patent would
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`infringe claims 1-6 of the ’869 patent under 35 U.S.C. §§ 271(a), (b), and/or (c).
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`43.
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`Novo Nordisk will be harmed substantially and irreparably if Mylan is not
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`enjoined from infringing the ’869 patent.
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`44.
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`45.
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`Novo Nordisk has no adequate remedy at law.
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`Novo Nordisk is entitled to a finding that this case is exceptional and to an award
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`of attorneys’ fees under 35 U.S.C. § 285.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 8,846,618
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`46.
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`Novo Nordisk re-alleges and incorporates by reference the allegations of
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`Paragraphs 1-45 of this Complaint.
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`47. Mylan has infringed the ’618 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
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`submitting Mylan’s ANDA, by which Mylan seeks approval from the FDA to sell, offer to sell,
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`use, and/or engage in the commercial manufacture of Mylan’s Product prior to the expiration of
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`the ’618 patent.
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`8
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`48.
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`Claims 1-3 and 5-14 of the ’618 patent are directed to pharmaceutical
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`formulations comprising
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`liraglutide and certain excipients wherein
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`the pharmaceutical
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`formulation has a pH from 7.5 to 9.4. In the Notice Letter, Mylan has not contested infringement
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`of any claims of the ’618 patent. Mylan’s sale, offer for sale, use, or commercial manufacture of
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`Mylan’s Product within the United States or importation of Mylan’s Product into the United
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`States, during the term of the ’618 patent would infringe claims 1-3 and 5-14 of the ’618 patent
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`under 35 U.S.C. §§ 271(a), (b), and/or (c).
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`49.
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`Novo Nordisk will be harmed substantially and irreparably if Mylan is not
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`enjoined from infringing the ’618 patent.
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`50.
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`51.
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`Novo Nordisk has no adequate remedy at law.
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`Novo Nordisk is entitled to a finding that this case is exceptional and to an award
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`of attorneys’ fees under 35 U.S.C. § 285.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 9,265,893
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`52.
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`Novo Nordisk re-alleges and incorporates by reference the allegations of
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`Paragraphs 1-51 of this Complaint.
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`53. Mylan has infringed the ’893 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
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`submitting Mylan’s ANDA, by which Mylan seeks approval from the FDA to sell, offer to sell,
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`use, and/or engage in the commercial manufacture of Mylan’s Product prior to the expiration of
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`the ’893 patent.
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`54.
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`Claims 1-6 of the ’893 patent are directed to a push button connection for an
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`injection device. Mylan’s sale, offer for sale, use, or commercial manufacture of Mylan’s
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`Product within the United States or importation of Mylan’s Product into the United States,
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`during the term of the ’893 patent would infringe claims 1-6 of the ’893 patent under 35 U.S.C.
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`§§ 271(a), (b), and/or (c).
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`55.
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`Novo Nordisk will be harmed substantially and irreparably if Mylan is not
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`enjoined from infringing the ’893 patent.
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`56.
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`57.
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`Novo Nordisk has no adequate remedy at law.
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`Novo Nordisk is entitled to a finding that this case is exceptional and to an award
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`of attorneys’ fees under 35 U.S.C. § 285.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. RE 41,956
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`58.
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`Novo Nordisk re-alleges and incorporates by reference the allegations of
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`Paragraphs 1-57 of this Complaint.
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`59. Mylan has infringed the RE ’956 patent, pursuant to 35 U.S.C. § 271(e)(2)(A), by
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`submitting Mylan’s ANDA, by which Mylan seeks approval from the FDA to sell, offer to sell,
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`use, and/or engage in the commercial manufacture of Mylan’s Product prior to the expiration of
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`the RE ’956 patent.
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`60.
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`Claims 1 and 2 of the RE ’956 patent are directed to a dose limiting mechanism.
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`Mylan’s sale, offer for sale, use, or commercial manufacture of Mylan’s Product within the
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`United States or importation of Mylan’s Product into the United States, during the term of the
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`RE ’956 patent would infringe claims 1 and 2 of the RE ’956 patent under 35 U.S.C. §§ 271(a),
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`(b), and/or (c).
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`61.
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`Novo Nordisk will be harmed substantially and irreparably if Mylan is not
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`enjoined from infringing the RE ’956 patent.
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`62.
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`63.
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`Novo Nordisk has no adequate remedy at law.
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`Novo Nordisk is entitled to a finding that this case is exceptional and to an award
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`of attorneys’ fees under 35 U.S.C. § 285.
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`PRAYER FOR RELIEF
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`WHEREFORE, Novo Nordisk prays for a judgment in its favor and against Mylan and
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`respectfully requests the following relief:
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`A.
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`B.
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`C.
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`D.
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`E.
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`F.
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`G.
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`H.
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`A judgment that Mylan has infringed the ’343 patent;
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`A judgment that Mylan has infringed the ’994 patent;
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`A judgment that Mylan has infringed the ’833 patent;
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`A judgment that Mylan has infringed the ’869 patent;
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`A judgment that Mylan has infringed the ’618 patent;
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`A judgment that Mylan has infringed the ’893 patent;
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`A judgment that Mylan has infringed the RE ’956 patent;
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`A judgment, pursuant to 35 U.S.C. § 271(e)(4)(B), preliminarily and permanently
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`enjoining Mylan, its officers, agents, servants, and employees, and those persons in active
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`concert or participation with any of them, from manufacturing, using, offering to sell, or selling
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`Mylan’s Product within the United States, or importing Mylan’s Product into the United States,
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`prior to the expiration of the ’343, ’994, ’833, ’869, ’618, ’893, and RE ’956 patents, including
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`any extensions, adjustments, and exclusivities;
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`I.
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`A judgment ordering that, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date
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`of any approval of Mylan’s ANDA, under § 505(j) of the Federal Food, Drug, and Cosmetic Act
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`(21 U.S.C. § 355(j)), shall not be earlier than the expiration of the ’343, ’994, ’833, ’869, ’618,
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`’893, and RE ’956 patents, including any extensions, adjustments, and exclusivities;
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`J.
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`If Mylan commercially manufactures, uses, offers to sell, or sells Mylan’s Product
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`within the United States, or imports Mylan’s Product into the United States, prior to the
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`expiration of the ’343, ’994, ’833, ’869, ’618, ’893, and RE ’956 patents, including any
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`extensions, adjustments, and exclusivities, a judgment awarding Novo Nordisk monetary relief,
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`together with interest;
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`K.
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`L.
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`M.
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`Attorneys’ fees in this action as an exceptional case pursuant to 35 U.S.C. § 285;
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`Costs and expenses in this action; and
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`Such other relief as the Court deems just and proper.
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`OF COUNSEL:
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`Jeffrey J. Oelke
`Ryan P. Johnson
`Laura T. Moran
`So Yeon Choe
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010-6035
`(212) 430-2600
`
`August 20, 2019
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Jack B. Blumenfeld
`_____________________________________
`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`began@mnat.com
`
`Attorney for Novo Nordisk Inc. and
`Novo Nordisk A/S
`
`
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`12
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`MYLAN INST. EXHIBIT 1118 PAGE 12
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`MYLAN INST. EXHIBIT 1118 PAGE 12
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`