Case 1:19-cv-00037-IMK Document 1 Filed 03/11/19 Page 1 of 10 PageID #: 1
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`___________
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
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`Li.
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`ii 2O
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`Ll/fr2j4’W
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`VALEANT PHARMACEUTICALS NORTH
`AMERICA LLC; VALEANT
`PHARMACEUTICALS IRELAND LTD.;
`DOW PHARMACEUTICAL SCIENCES, INC.;
`and KAKEN PHARMACEUTICAL CO., LTD.,
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`Civil Action No.:
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`/ q
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`/
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`V
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`Plaintiffs,
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`V.
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`MYLAN PHARMACEUTICALS INC.;
`MYLAN LABORATORIES LTD.; and
`MYLAN INC.,
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`Defendants.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Valeant Pharmaceuticals North America LLC (“Valeant”), Valeant
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`Pharmaceuticals Ireland Ltd. (“Valeant Ireland”), Dow Pharmaceutical Sciences, Inc. (“Dow”),
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`and Kaken Pharmaceutical Co., Ltd.
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`(“Kaken”) (collectively, “Plaintiffs”) by way of this
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`Complaint against Mylan Pharmaceuticals Inc. (“Mylan Pharmaceuticals”), Mylan Laboratories
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`Ltd. (“Mylan Labs”), and Mylan Inc. (collectively, “Mylan”) allege as follows:
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`THE PARTIES
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`1.
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`Plaintiff Valeant is a limited liability company organized and existing under the
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`laws of Delaware having its principal place of business at 400 Somerset Corporate Boulevard,
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`Bridgewater, New Jersey 08807.
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`2.
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`Plaintiff Valeant Ireland is a company existing under the laws of Ireland having
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`Case 1:19-cv-00037-IMK Document 1 Filed 03/11/19 Page 2 of 10 PageID #: 2
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`an office at 3013 Lake Drive. Citywest Business Campus, Dublin 24, Ireland.
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`3.
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`Plaintiff Dow is a corporation organized and existing under the laws of Delaware
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`having its principal place of business at 1330 Redwood Way, Petaluma, California 94954.
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`4.
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`Plaintiff Kaken is a corporation organized and existing under the laws of Japan
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`having its principal place of business at 20th Floor, Bunkyo Green Court, 28-8, Honkornagome 2-
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`chome, Bunkyo-ku, Tokyo 113-8650, Japan.
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`5.
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`Upon information and belief, Mylan Pharmaceuticals is a corporation organized
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`and existing under the laws of West Virginia, having a place of business at 781 Chestnut Ridge
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`Road, Morgantown, WV 26505. Upon information and belief, Mylan Pharmaceuticals is a wholly-
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`owned subsidiary of Mylan Inc. and an agent or affiliate of Mylan Labs.
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`6.
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`Upon information and belief, Mylan Labs is a corporation organized and existing
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`under the laws of India, having a place of business at Plot No. 564/A/22, Road No. 92, Jubilee
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`Hills 500034, Hyderabad, India. Upon information and belief, Mylan Labs is a wholly-owned
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`subsidiary of Mylan Inc. and an agent or affiliate of Mylan Pharmaceuticals.
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`7.
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`Upon information and belief, Mylan Inc. is a corporation organized and existing
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`under the laws of the Commonwealth of Pennsylvania, having a place of business at 1000 Mylan
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`Blvd., Canonsburg, PA 15317.
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`NATURE OF THE ACTION
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`8.
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`This is an action for infringement of United States Patent No. 10,105,444 (“the
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`‘444 patent”) arising under the United States patent laws, Title 35, United States Code, § 100 et
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`seq., including 35 U.S.C. §S 271 and 281. This action relates to Mylan’s filing of an Abbreviated
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`New Drug Application (“ANDA”) under section 505(j) of the Federal Food, Drug, and Cosmetic
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`Act (“the Act”), 21 U.S.C. § 355(j), seeking U.S. Food and Drug Administration (“FDA”) approval
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`Case 1:19-cv-00037-IMK Document 1 Filed 03/11/19 Page 3 of 10 PageID #: 3
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`to market its generic efinaconazole topical solution, 10% (“Mylan’s generic efinaconazole topical
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`solution”). 1
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`JURISDICTION AND VENUE
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`9.
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`This Court has subject matter jurisdiction under 28 U.S.C. §S 1331, 1338(a), and
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`2201—02.
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`10.
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`Upon information and belief,
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`this Court has
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`jurisdiction over Mylan
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`Pharmaceuticals. Upon information and belief, Mylan Pharmaceuticals is in the business of, inter
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`alia, developing, manufacturing, marketing,
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`importing, and selling pharmaceutical products,
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`including generic drug products. Upon information and belief, Mylan Pharmaceuticals directly,
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`or indirectly, develops, manufactures, markets, and sells generic drug products throughout the
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`United States and in this judicial district, and this judicial district is a likely destination for Mylan’s
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`generic efinaconazole topical solution. Upon information and belief, Mylan Pharmaceuticals
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`purposefully has conducted and continues to conduct business in this judicial district. Upon
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`information and belief, Mylan Pharmaceuticals is a corporation organized and existing under the
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`laws of West Virginia, having a place of business at 781 Chestnut Ridge Road, Morgantown, WV
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`26505. Upon information and belief, Mylan Pharmaceuticals has previously submitted to the
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`jurisdiction of this Court and has further previously availed itself of this Court by asserting
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`counterclaims in other civil actions initiated in this jurisdiction. Mylan’s notice letter invoked the
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`jurisdiction and venue of this judicial district.
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`1
`Plaintiffs previously brought an action for infringement of United States Patent Nos.
`7,214,506 (“the ‘506 patent”), 8,039,494 (“the ‘494 patent”), 8,486,978 (“the ‘978 patent”),
`9,302,009 (“the ‘009 patent”), 9,566,272 (“the ‘272 patent”), 9,662,394 (“the ‘394 patent”),
`9,861,698 (“the ‘698 patent”), and 9,877,955 (“the ‘955 patent”). That action is currently pending
`in this Court as Case No. 1:1 8-cv-1 84-IMK, and Plaintiffs hereby incorporate by reference their
`Complaint against Mylan (ECF No. 1) in that action.
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`11.
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`Mylan Pharmaceuticals has taken the costly, significant step of applying to the
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`FDA for approval to engage in future activities—including the marketing of its generic drugs—
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`that will be purposefully directed at, upon information and belief, the Northern District of West
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`Virginia and elsewhere. Mylan Pharmaceuticals’ ANDA filings constitute formal acts that reliably
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`indicate plans to engage in marketing of the proposed generic drugs. Upon information and belief,
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`Mylan Pharmaceuticals intends to direct sales of its drugs into the Northern District of West
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`Virginia, among other places, once it has the requested FDA approval to market them. Upon
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`information and belief, Mylan Pharmaceuticals will engage in marketing of its proposed ANDA
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`products in the Northern District of West Virginia upon approval of its ANDA.
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`12.
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`Upon information and belief, this Court has jurisdiction over Mylan Labs. Upon
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`information and belief, Mylan Labs is in the business of, inter alia, developing, manufacturing,
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`marketing, importing, and selling pharmaceutical products, including generic drug products. Upon
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`information and belief, Mylan Labs directly, or indirectly, develops, manufactures, markets, and
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`sells generic drug products throughout the United States and in this judicial district, and this
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`judicial district is a likely destination for Mylan’ s generic efinaconazole topical solution. Upon
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`information and belief, Mylan Labs purposefully has conducted and continues to conduct business
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`in this judicial district. Upon information and belief, Mylan Labs is registered to do business in
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`this judicial district. Upon information and belief, Mylan Labs has previously submitted to the
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`jurisdiction of this Court and has further previously availed itself of this Court by asserting
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`counterclaims in other civil actions initiated in this jurisdiction.
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`13.
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`Upon information and belief, this Court has jurisdiction over Mylan Inc. Upon
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`information and belief, Mylan Inc. is in the business of, inter alia, developing, manufacturing,
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`marketing, importing, and selling pharmaceutical products, including generic drug products. Upon
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`information and belief, Mylan Inc. directly, or indirectly, develops, manufactures, markets, and
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`sells generic drug products throughout the United States and in this judicial district, and this
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`judicial district is a likely destination for Mylan’s generic efinaconazole topical solution. Upon
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`information and belief, Mylan Inc. purposefully has conducted and continues to conduct business
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`in this judicial district through at least its wholly owned subsidiary Mylan Pharmaceuticals. Upon
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`information and belief, Mylan Inc.
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`is registered to do business in this judicial district. Upon
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`information and belief, Mylan Inc. has previously submitted to the jurisdiction of this Court and
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`has further previously availed itself of this Court by asserting counterclaims in other civil actions
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`initiated in this jurisdiction.
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`14.
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`Mylan knows or should know that
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`Jublia® is manufactured for Valeant
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`Pharmaceuticals North America LLC in Bridgewater, NJ 08807 USA at
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`least because that
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`information is included in the label and prescribing information for Jublia®.
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`15.
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`Upon information and belief, venue is proper in this judicial district under
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`28 U.S.C. § 1391(c) and (d), and § 1400(b).
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`THE PATENT IN SUIT
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`16.
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`The United States Patent and Trademark Office (“PTO”) issued the ‘444 patent on
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`October 23, 2018.
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`The ‘444 patent claims, generally speaking,
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`inter alia, pharmaceutical
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`formulations including ethanol, cyclomethicone, diisopropyl adipate, C 12-15 alkyl lactate and
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`antioxidant. Plaintiffs hold all substantial rights in the ‘444 patent and have the right to sue for
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`infringement thereof. The ‘444 patent is valid and enforceable. A copy of the ‘444 patent is
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`attached hereto as Exhibit A.
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`17.
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`Dow is the holder of New Drug Application (“NDA”) No. 203567 for Jublia®,
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`which the FDA approved on June 6, 2014. In conjunction with NDA No. 203567, the ‘444 patent
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`is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (“the
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`Orange Book”).
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`18.
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`Efinaconazole topical solution, 10% is sold in the United States under the
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`trademark Jublia®.
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`MYLAN’S INFRINGING ANDA SUBMISSION
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`19.
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`Upon information and belief Mylan Pharmaceuticals filed or caused to be filed
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`with the FDA ANDA No. 212064, under Section 505(j) of the Act and 21 U.S.C. § 355(j).
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`20.
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`Upon information and belief, Mylan Pharmaceuticals’ ANDA No. 212064 seeks
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`FDA approval to sell in the United States Mylan’s generic efinaconazole topical solution, intended
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`to be a generic version of Jublia®.
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`21.
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`Plaintiffs received a letter dated February 8, 2019 from Mylan purporting to be a
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`Notice of Certification for ANDA No. 212064 (“Mylan’s notice letter”) under Section
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`505(j)(2)(B)(ii) and (iv), 21 U.S.C. § 355(j)(2)(B)(iv) and 21 C.F.R. § 3 14.95(c) that included a
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`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
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`22.
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`Mylan’s notice letter alleges that Mylan Pharmaceuticals has submitted to the FDA
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`ANDA No. 212064 seeking FDA approval to sell Mylan’s generic efinaconazole topical solution,
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`intended to be a generic version of Jublia®.
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`23.
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`Upon information and belief, ANDA No. 212064 seeks approval of Mylan’s
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`generic efinaconazole topical solution that is the same, or substantially the same, as Jublia®.
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`COUNT I AGAINST MYLAN
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`Infringement of the ‘444 Patent under § 271(e)(2)
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`Paragraphs 1-23 are incorporated herein as set forth above.
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`Under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one claim of the ‘444
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`24.
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`25.
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`patent by submitting, or causing to be submitted to the FDA, ANDA No. 212064 seeking approval
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`for the commercial marketing of Mylan’s generic efinaconazole topical solution before the
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`expiration date of the ‘444 patent.
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`26.
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`Upon information and belief, Mylan’s generic efinaconazole topical solution will,
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`if approved and marketed, infringe, either literally or under the doctrine of equivalents, at least one
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`claim of the ‘444 patent.
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`27.
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`Upon information and belief, Mylan will, through the manufacture, use, import,
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`offer for sale, and/or sale of Mylan’s generic efinaconazole topical solution, directly infringe,
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`contributorily infringe, and/or induce infringement of at least one claim of the ‘444 patent.
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`28.
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`If Mylan’s marketing and sale of its generic efinaconazole topical solution prior
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`to the expiration of the ‘444 patent is not enjoined, Plaintiffs will suffer substantial and irreparable
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`harm for which there is no adequate remedy at law.
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`COUNT II AGAINST MYLAN
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`Declaratory Judgment of Infringement of the ‘444 Patent
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`Paragraphs 1-28 are incorporated herein as set forth above.
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`These claims arise under the Declaratory Judgment Act, 28 U.S.C. § 2201 and
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`29.
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`30.
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`2202.
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`31.
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`There is an actual case or controversy such that the court may entertain Plaintiffs’
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`request for declaratory relief consistent with Article III of the United States constitution, and this
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`actual case or controversy requires a declaration of rights by this Court.
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`32.
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`Mylan has made, and will continue to make, substantial preparation in the United
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`States to manufacture, use, offer to sell, sell, and/or import Mylan’s generic efinaconazole topical
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`solution before the expiration date of the ‘444 patent, including Mylan’s filing of ANDA No.
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`212064.
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`33.
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`Upon information and belief, any commercial manufacture, use, offer for sale,
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`sale, and/or importation of Mylan’s generic efinaconazole topical solution will directly infringe,
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`contributorily infringe, and/or induce infringement of at least one claim of the ‘444 patent.
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`34.
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`Plaintiffs
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`are entitled to a declaratory judgment
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`that
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`future commercial
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`manufacture, use, offer for sale, sale, and/or importation of Mylan’s generic efinaconazole topical
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`solution will constitute infringement of at least one claim of the ‘444 patent.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request that the Court enter judgment in their favor
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`and against Mylan on the patent infringement claims set forth above and respectfully request that
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`this Court:
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`1.
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`enter judgment that, under 35 U.S.C. § 271 (e)(2), Mylan has infringed at least one
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`claim of the ‘444 patent by submitting or causing to be submitted ANDA No. 212064 to the FDA
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`to obtain approval for the commercial manufacture, use, import, offer for sale, and/or sale in the
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`United States of Mylan’s generic efinaconazole topical solution before the expiration of the ‘444
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`patent;
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`2.
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`order that the effective date of any approval by the FDA of Mylan’s generic
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`efinaconazole topical solution be a date that is not earlier than the expiration of the ‘444 patent, or
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`such later date as the Court may determine;
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`3.
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`enjoin Mylan from the commercial manufacture, use, import, offer for sale, and/or
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`sale of Mylan’s generic efinaconazole topical solution until expiration of the ‘444 patent, or such
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`later date as the Court may determine;
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`4.
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`enjoin Mylan and all persons acting in concert with Mylan from seeking,
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`Case 1:19-cv-00037-IMK Document 1 Filed 03/11/19 Page 9 of 10 PageID #: 9
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`obtaining, or maintaining approval of Mylan’s ANDA No. 212064 until expiration of the ‘444
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`patent;
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`5.
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`declare this to be an exceptional case under 35 U.S.C. § 285 and 271(e)(4) and
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`award Plaintiffs costs, expenses, and disbursements in this action, including reasonable attorney’s
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`fees;
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`proper.
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`6.
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`award Plaintiffs such further and additional relief as this Court deems just and
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`Dated: March 11, 2019
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`Respectfully submitted,
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`ScHRADER COMPANION DUFF & LAw, PLLC
`
`/s/James F. Companion
`James F. Companion (#790)
`401 Main Street
`Wheeling, WV 26003
`(304) 233-3390
`jfcschraderlaw.com
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`Counselfor Plaintiffs
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`Of Counsel:
`Thomas P. Steindler (pro hac vice to be submitted)
`Nicole M. Jantzi (pro hac vice to be submitted)
`Paul M. Schoeiihard (pro hac vice to be submitted)
`Ian B. Brooks (pro hac vice to be submitted)
`MCDERMOTT WILL & EMERY LLP
`The McDermott Building
`500 North Capitol Street, NW
`Washington, DC 20001-153 1
`(202) 756-8000
`
`Attorneysfor Plaintiffs
`Valeant Pharmaceuticals North America LLC,
`Valeant Pharmaceuticals Ireland Ltd., and
`Dow Pharmaceutical Sciences, Inc.
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`John D. Livingstone (pro hac vice to be submitted)
`FINNEGAN, HENDERSON,
`FARABOW, GARRETT & DUNNER, LLP
`271 17th Street, NW
`Suite 1400
`Atlanta, GA 30363-6209
`(404) 653-6400
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`Naoki Yoshida (pro hac vice to be submitted)
`FINNEGAN, HENDERSON,
`FARABOW, GARRETT & DUNNER, LLP
`33rd Floor, Shiroyama Trust Tower
`3-1, Toranomon 4-chome, Minato-ku
`Tokyo, 105-6033 Japan
`+81-3-3431-6943
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`Attorneys for Plaintiff
`Kaken Pharmaceutical Co., Ltd.
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`10
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