Case 1:18-cv-00184-IMK Document 1 Filed 09/27/18 Page 1 of 24 PageID #: 1
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`___________
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`SEP 2 72018
`
`VALEANT PHARMACEUTICALS NORTH
`AMERICA LLC; VALEANT
`PHARMACEUTICALS IRELAND LTD.;
`DOW PHARMACEUTICAL SCIENCES, INC.;
`and KAKEN PHARMACEUTICAL CO., LTD.,
`
`Civil Action No.:
`
`I
`
`Plaintiffs,
`
`v.
`
`MYLAN PHARMACEUTICALS INC.;
`MYLAN LABORATORIES LTD.; and
`MYLAN INC.,
`
`Defendants.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Valeant Pharmaceuticals North America LLC (“Valeant”), Valeant
`
`Pharmaceuticals Ireland Ltd. (“Valeant Ireland”), Dow Pharmaceutical Sciences, Inc. (“Dow”),
`
`and Kaken Pharmaceutical Co., Ltd.
`
`(“Kaken”)
`
`(collectively, “Plaintiffs”) by way of this
`
`Complaint against Mylan Pharmaceuticals Inc. (“Mylan Pharmaceuticals”), Mylan Laboratories
`
`Ltd. (“Mylan Labs”), and Mylan Inc. (collectively, “Mylan”) allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Valeant is a limited liability company organized and existing under the
`
`laws of Delaware having its principal place of business at 400 Somerset Corporate Boulevard,
`
`Bridgewater, New Jersey 08807.
`
`2.
`
`Plaintiff Valeant Ireland is a company existing under the laws of Ireland having
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`an office at 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland.
`
`3.
`
`Plaintiff Dow is a corporation organized and existing under the laws of Delaware
`
`having its principal place of business at 1330 Redwood Way, Petaluma, California 94954.
`
`4.
`
`Plaintiff Kaken is a corporation organized and existing under the laws of Japan
`
`having its principal place of business at 20th Floor, Bunkyo Green Court, 28-8, Honkomagome
`
`2-chome, Bunkyo-ku, Tokyo 113-8650, Japan.
`
`5.
`
`Upon information and belief, Mylan Pharmaceuticals is a corporation organized
`
`and existing under the laws of West Virginia, having a place of business at 781 Chestnut Ridge
`
`Road, Morgantown, WV 26505. Upon information and belief, Mylan Pharmaceuticals is a
`
`wholly-owned subsidiary of Mylan Inc. and an agent or affiliate of Mylan Labs.
`
`6.
`
`Upon information and belief, Mylan Labs is a corporation organized and existing
`
`under the laws of India, having a place of business at Plot No. 564/A/22, Road No. 92, Jubilee
`
`Hills 500034, Hyderabad, India. Upon information and belief, Mylan Labs is a wholly-owned
`
`subsidiary of Mylan Inc. and an agent or affiliate of Mylan Pharmaceuticals.
`
`7.
`
`Upon information and belief, Mylan Inc. is a corporation organized and existing
`
`under the laws of the Commonwealth of Pennsylvania, having a place of business at 1000 Mylan
`
`Blvd., Canonsburg, PA 15317.
`
`NATURE OF THE ACTION
`
`8.
`
`This is 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”) arising under the United States patent laws, Title 35,
`
`United States Code, § 100 et seq., including 35 U.S.C. §sS 271 and 281. This action relates to
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`Mylan’s filing of an Abbreviated New Drug Application (“ANDA”) under section 505(j) of the
`
`Federal Food, Drug, and Cosmetic Act (“the Act”), 21 U.S.C. § 355(j), seeking U.S. Food and
`
`Drug Administration (“FDA”) approval to market its generic efinaconazole topical solution, 10%
`
`(“Mylan’s generic efinaconazole topical solution”).
`
`JURISDICTION AND VENUE
`
`9.
`
`This Court has subject matter jurisdiction under 28 U.S.C. § 1331, 1338(a), and
`
`2201-02.
`
`10.
`
`Upon information and belief,
`
`this Court has
`
`jurisdiction over Mylan
`
`Pharmaceuticals. Upon information and belief, Mylan Pharmaceuticals is in the business of,
`
`inter alia, developing, manufacturing, marketing,
`
`importing, and selling pharmaceutical
`
`products, including generic drug products. Upon information and belief, Mylan Pharmaceuticals
`
`directly, or
`
`indirectly, develops, manufactures, markets, and sells generic drug products
`
`throughout the United States and in this judicial district, and this judicial district is a likely
`
`destination for Mylan’s generic efinaconazole topical solution. Upon information and belief,
`
`Mylan Pharmaceuticals purposefully has conducted and continues to conduct business in this
`
`judicial district. Upon information and belief, Mylan Pharmaceuticals is a corporation organized
`
`and existing under the laws of West Virginia, having a place of business at 781 Chestnut Ridge
`
`Road, Morgantown, WV 26505. Upon information and belief, Mylan Pharmaceuticals has
`
`previously submitted to the jurisdiction of this Court and has further previously availed itself of
`
`this Court by asserting counterclaims in other civil actions initiated in this jurisdiction. Mylan’s
`
`notice letter invoked the jurisdiction and venue of this judicial district.
`
`11.
`
`Mylan Pharmaceuticals has taken the costly, significant step of applying to the
`
`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
`
`Virginia and elsewhere. Mylan Pharmaceuticals’ ANDA filings constitute formal acts that
`
`reliably indicate plans to engage in marketing of the proposed generic drugs. Upon information
`
`and belief, Mylan Pharmaceuticals intends to direct sales of its drugs into the Northern District of
`
`West Virginia, among other places, once it has the requested FDA approval to market them.
`
`Upon information and belief, Mylan Pharmaceuticals will engage in marketing of its proposed
`
`ANDA products in the Northern District of West Virginia upon approval of its ANDA.
`
`12.
`
`Upon information and belief, this Court has jurisdiction over Mylan Labs. Upon
`
`information and belief, Mylan Labs is in the business of, inter alia, developing, manufacturing,
`
`marketing,
`
`importing, and selling pharmaceutical products,
`
`including generic drug products.
`
`Upon information and belief, Mylan Labs directly, or
`
`indirectly, develops, manufactures,
`
`markets, and sells generic drug products throughout the United States and in this judicial district,
`
`and this judicial district is a likely destination for Mylan’s generic efinaconazole topical solution.
`
`Upon information and belief, Mylan Labs purposefully has conducted and continues to conduct
`
`business in this judicial district. Upon information and belief, Mylan Labs is registered to do
`
`business in this judicial district. Upon information and belief, Mylan Labs has previously
`
`submitted to the jurisdiction of this Court and has further previously availed itself of this Court
`
`by asserting counterclaims in other civil actions initiated in this jurisdiction.
`
`13.
`
`Upon information and belief, this Court has jurisdiction over Mylan Inc. Upon
`
`information and belief, Mylan Inc. is in the business of, inter alia, developing, manufacturing,
`
`marketing,
`
`importing, and selling pharmaceutical products,
`
`including generic drug products.
`
`Upon information and belief, Mylan Inc. directly, or indirectly, develops, manufactures, markets,
`
`and 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
`
`in this judicial district through at least its wholly owned subsidiary Mylan Pharmaceuticals.
`
`Upon information and belief, Mylan Inc.
`
`is registered to do business in this judicial district.
`
`Upon information and belief, Mylan Inc. has previously submitted to the jurisdiction of this
`
`Court and has further previously availed itself of this Court by asserting counterclaims in other
`
`civil actions initiated in this jurisdiction.
`
`14.
`
`Mylan knows or should know that
`
`Jublia® is manufactured for Valeant
`
`Pharmaceuticals North America LLC in Bridgewater, NJ 08807 USA at
`
`least because that
`
`information is included in the label and prescribing information for Jublia®.
`
`15.
`
`Upon information and belief, venue is proper in this judicial district under
`
`28 U.S.C. § 1391(c) and (d), and § 1400(b).
`
`THE PATENTS IN SUIT
`
`16.
`
`The United States Patent and Trademark Office (“PTO”) issued the ‘506 patent
`
`on May 8, 2007. The ‘506 patent claims, generally speaking, inter alia, methods for treating
`
`onychomycosis by administering efinaconazole. Plaintiffs hold all substantial rights in the ‘506
`
`patent and have the right
`
`to sue for infringement
`
`thereof.
`
`The ‘506 patent
`
`is valid and
`
`enforceable. A copy of the ‘506 patent is attached hereto as Exhibit A.
`
`17.
`
`The PTO issued the ‘494 patent on October 18, 2011. The ‘494 patent claims,
`
`generally speaking, inter alia, methods for treatment of a disorder of the nail or nail bed by
`
`applying pharmaceutical compositions consisting essentially of a vehicle that is volatile and/or
`
`that rapidly penetrates a nail following application onto the surface of the nail, a triazole
`
`antifungal active pharmaceutical ingredient (encompassing efinaconazole) and a wetting agent.
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`Plaintiffs hold all substantial rights in the ‘494 patent and have the right to sue for infringement
`
`thereof. The ‘494 patent is valid and enforceable. A copy of the ‘494 patent is attached hereto
`
`as Exhibit B.
`
`18.
`
`The PTO issued the ‘978 patent on July 16, 2013. The ‘978 patent claims,
`
`generally speaking inter alia, pharmaceutical compositions consisting essentially of a vehicle
`
`that is volatile and/or that rapidly penetrates a nail following application onto the surface of the
`
`nail, a triazole antifungal active pharmaceutical ingredient (encompassing efinaconazole) and a
`
`wetting agent. Plaintiffs hold all substantial rights in the ‘978 patent and have the right to sue for
`
`infringement thereof. The ‘978 patent is valid and enforceable. A copy of the ‘978 patent is
`
`attached hereto as Exhibit C.
`
`19.
`
`The PTO issued the ‘009 patent on April 5, 2016. The ‘009 patent claims,
`
`generally speaking,
`
`inter alia, pharmaceutical compositions for the topical
`
`treatment of a
`
`disorder of the nail or nail bed including efinaconazole, ethanol, cyclomethicone, diisopropyl
`
`adipate, Cl 2-15 alkyl lactate and antioxidant. Plaintiffs hold all substantial rights in the ‘009
`
`patent and have the right
`
`to sue for infringement
`
`thereof.
`
`The ‘009 patent
`
`is valid and
`
`enforceable. A copy of the ‘009 patent is attached hereto as Exhibit D.
`
`20.
`
`The PTO issued the ‘272 patent on February 14, 2017. The ‘272 patent claims,
`
`generally speaking, inter alia, methods for the treatment of onychomycosis by topically applying
`
`pharmaceutical compositions including efinaconazole, ethanol, diisopropyl adipate, C 12-15 alkyl
`
`lactate and cyclomethicone. Plaintiffs hold all substantial rights in the ‘272 patent and have the
`
`right to sue for infringement thereof. The ‘272 patent is valid and enforceable. A copy of the
`
`‘272 patent is attached hereto as Exhibit E.
`
`21.
`
`The PTO issued the ‘394 patent on May 30, 2017. The ‘394 patent claims,
`
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`generally speaking, inter alia, compositions including efinaconazole, water, C 12-15 alkyl lactate,
`
`diisopropyl adipate, cyclomethicone, ethanol, BHT, a salt of EDTA, and citric acid, and methods
`
`of treating a fungal infection with the same compositions. Plaintiffs hold all substantial rights in
`
`the ‘394 patent and have the right to sue for infringement thereof. The ‘394 patent is valid and
`
`enforceable. A copy of the ‘394 patent is attached hereto as Exhibit F.
`
`22.
`
`The PTO issued the ‘698 patent on January 9, 2018. The ‘698 patent claims,
`
`generally speaking, inter alia, pharmaceutical formulations comprising ethanol, cyclomethicone,
`
`diisopropyl adipate and mixed C 12-15 alkyl lactates, and methods for the treatment of a disorder
`
`of the nail or nail bed by applying the same compositions. Plaintiffs hold all substantial rights in
`
`the ‘698 patent and have the right to sue for infringement thereof. The ‘698 patent is valid and
`
`enforceable. A copy of the ‘698 patent is attached hereto as Exhibit G.
`
`23.
`
`The PTO issued the ‘955 patent on January 30, 2018. The ‘955 patent claims,
`
`generally speaking,
`
`inter alia, methods for the treatment of onychomycosis by applying a
`
`pharmaceutical composition including efinaconazole, ethanol, diisopropyl adipate, C 12-15 alkyl
`
`lactate and cyclomethicone. Plaintiffs hold all substantial rights in the ‘955 patent and have the
`
`right to sue for infringement thereof. The ‘955 patent is valid and enforceable. A copy of the
`
`‘955 patent is attached hereto as Exhibit H.
`
`24.
`
`Dow is the holder of New Drug Application (“NDA”) No. 203567 for Jublia®,
`
`which the FDA approved on June 6, 2014.
`
`In conjunction with NDA No. 203567, the ‘506
`
`patent, the ‘494 patent, the ‘978 patent, the ‘009 patent, the ‘272 patent, the ‘394 patent, the ‘698
`
`patent, and the ‘955 patent are listed in the FDA’s Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (“the Orange Book”).
`
`25.
`
`Efinaconazole topical solution, 10% is sold in the United States under the
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`trademark Jublia®.
`
`MYLAN’S INFRINGING ANDA SUBMISSION
`
`26.
`
`Upon information and belief, Mylan Pharmaceuticals filed or caused to be filed
`
`with the FDA ANDA No. 212064, under Section 505(j) of the Act and 21 U.S.C. § 355(j).
`
`27.
`
`Upon information and belief, Mylan Pharmaceuticals’ ANDA No. 212064 seeks
`
`FDA approval
`
`to sell
`
`in the United States Mylan’ s generic efinaconazole topical solution,
`
`intended to be a generic version of Jublia®.
`
`28.
`
`Dow received a letter dated August 13, 2018 from Mylan purporting to be a
`
`Notice of Certification for ANDA No. 212064 (“Mylan’s notice letter”) under Section
`
`505(j)(2)(B)(ii) and (iv), 21 U.S.C. § 355j)(2)(B)(iv) and 21 C.F.R. § 3 14.95(c) that included a
`
`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
`
`29.
`
`Mylan’s notice letter alleges that Mylan Pharmaceuticals has submitted to the
`
`FDA ANDA No. 212064 seeking FDA approval to sell Mylan’s generic efinaconazole topical
`
`solution, intended to be a generic version of Jublia®.
`
`30.
`
`Upon information and belief, ANDA No. 212064 seeks approval of Mylan’s
`
`generic efinaconazole topical solution that is the same, or substantially the same, as Jublia®.
`
`COUNT I AGAINST MYLAN
`
`Infringement of the ‘506 Patent under § 271(e)(2)
`
`Paragraphs 1-30 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one claim of the ‘506
`
`31.
`
`32.
`
`patent by submitting, or causing to be submitted to the FDA, ANDA No. 212064 seeking
`
`approval for the commercial marketing of Mylan’ s generic efinaconazole topical solution before
`
`the expiration date of the ‘506 patent.
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`33.
`
`Upon information and belief, Mylan’s generic efinaconazole topical solution
`
`will, if approved and marketed, infringe, either literally or under the doctrine of equivalents, at
`
`least one claim of the ‘506 patent.
`
`34.
`
`Upon information and belief, Mylan will, through the manufacture, use, import,
`
`offer for sale, and/or sale of Mylan’s generic efinaconazole topical solution, directly infringe,
`
`contributorily infringe, and/or induce infringement of at least one claim of the ‘506 patent.
`
`35.
`
`If Mylan’s marketing and sale of its generic efinaconazole topical solution prior
`
`to the expiration of the ‘506 patent
`
`is not enjoined, Plaintiffs will suffer substantial and
`
`irreparable harm for which there is no adequate remedy at law.
`
`COUNT II AGAINST MYLAN
`
`Declaratory Judgment of Infringement of the ‘506 Patent
`
`Paragraphs 1-35 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. § 2201 and
`
`36.
`
`37.
`
`2202.
`
`38.
`
`There is an actual case or controversy such that
`
`the court may entertain
`
`Plaintiffs’
`
`request
`
`for declaratory relief consistent with Article III of the United States
`
`Constitution, and this actual case or controversy requires a declaration of rights by this Court.
`
`39.
`
`Mylan has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, use, offer to sell, sell, and/or import Mylan’s generic efinaconazole
`
`topical solution before the expiration date of the ‘506 patent, including Mylan’ s filing of ANDA
`
`No. 212064.
`
`40.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`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 ‘506 patent.
`
`41.
`
`Plaintiffs
`
`are entitled to a declaratory judgment
`
`that
`
`future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Mylan’s generic efinaconazole
`
`topical solution will constitute infringement of at least one claim of the ‘506 patent.
`
`COUNT III AGAINST MYLAN
`
`Infringement of the ‘494 Patent under § 271(e)(2)
`
`Paragraphs 1-41 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one claim of the ‘494
`
`42.
`
`43.
`
`patent by submitting, or causing to be submitted to the FDA, ANDA No. 212064 seeking
`
`approval for the commercial marketing of Mylan’ s generic efinaconazole topical solution before
`
`the expiration date of the ‘494 patent.
`
`44.
`
`Upon information and belief, Mylan’s generic efinaconazole topical solution
`
`will, if approved and marketed, infringe, either literally or under the doctrine of equivalents, at
`
`least one claim of the ‘494 patent.
`
`45.
`
`Upon information and belief, Mylan will, through the manufacture, use, import,
`
`offer for sale, and/or sale of Mylan’s generic efinaconazole topical solution, directly infringe,
`
`contributorily infringe, and/or induce infringement of at least one claim of the ‘494 patent.
`
`46.
`
`If Mylan’s marketing and sale of its generic efinaconazole topical solution prior
`
`to the expiration of the ‘494 patent
`
`is not enjoined, Plaintiffs will suffer substantial and
`
`irreparable harm for which there is no adequate remedy at law.
`
`COUNT IV AGAINST MYLAN
`
`Declaratory Judgment of Infringement of the ‘494 Patent
`
`Paragraphs 1-46 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. § 2201 and
`
`10
`
`47.
`
`48.
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`2202.
`
`49.
`
`There is an actual case or controversy such that
`
`the Court may entertain
`
`Plaintiffs’
`
`request
`
`for declaratory relief consistent with Article III of the United States
`
`Constitution, and this actual case or controversy requires a declaration of rights by this Court.
`
`50.
`
`Mylan has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, use, offer to sell, sell, and/or import Mylan’s generic efinaconazole
`
`topical solution before the expiration date of the ‘494 patent, including Mylan’s filing of ANDA
`
`No. 212064.
`
`51.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Mylan’ s generic efinaconazole topical solution will directly infringe,
`
`contributorily infringe, and/or induce infringement of at least one claim of the ‘494 patent.
`
`52.
`
`Plaintiffs are entitled to a declaratory judgment
`
`that
`
`future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Mylan’s generic efinaconazole
`
`topical solution will constitute infringement of at least one claim of the ‘494 patent.
`
`COUNT V AGAINST MYLAN
`
`Infringement of the ‘978 Patent under § 271(e)(2)
`
`Paragraphs 1-52 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one claim of the ‘978
`
`53.
`
`54.
`
`patent by submitting, or causing to be submitted to the FDA, ANDA No. 212064 seeking
`
`approval for the commercial marketing of Mylan’ s generic efinaconazole topical solution before
`
`the expiration date of the ‘978 patent.
`
`55.
`
`Upon information and belief, Mylan’s generic efinaconazole topical solution
`
`will, if approved and marketed, infringe, either literally or under the doctrine of equivalents, at
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`least one claim of the ‘978 patent.
`
`56.
`
`Upon information and belief, Mylan will, through the manufacture, use, import,
`
`offer for sale, and/or sale of Mylan’s generic efinaconazole topical solution, directly infringe,
`
`contributorily infringe, and/or induce infringement of at least one claim of the ‘978 patent.
`
`57.
`
`If Mylan’s marketing and sale of its generic efinaconazole topical solution prior
`
`to the expiration of the ‘978 patent
`
`is not enjoined, Plaintiffs will suffer substantial and
`
`irreparable harm for which there is no adequate remedy at law.
`
`COUNT VI AGAINST MYLAN
`
`Declaratory Judgment of Infringement of the ‘978 Patent
`
`Paragraphs 1-57 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. § 2201 and
`
`58.
`
`59.
`
`2202.
`
`60.
`
`There is an actual case or controversy such that
`
`the Court may entertain
`
`Plaintiffs’
`
`request
`
`for declaratory relief consistent with Article III of the United States
`
`Constitution, and this actual case or controversy requires a declaration of rights by this Court.
`
`61.
`
`Mylan has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, use, offer to sell, sell, and/or import Mylan’s generic efinaconazole
`
`topical solution before the expiration date of the ‘978 patent, including Mylan’s filing of ANDA
`
`No. 212064.
`
`62.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Mylan’s generic efinaconazole topical solution will directly infringe,
`
`contributorily infringe, and/or induce infringement of at least one claim of the ‘978 patent.
`
`63.
`
`Plaintiffs are entitled to a declaratory judgment
`
`that
`
`future commercial
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`manufacture, use, offer for sale, sale, and/or importation of Mylan’ s generic efinaconazole
`
`topical solution will constitute infringement of at least one claim of the ‘978 patent.
`
`COUNT VII AGAINST MYLAN
`
`Infringement of the ‘009 Patent under § 271(e)(2)
`
`Paragraphs 1-63 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one claim of the ‘009
`
`64.
`
`65.
`
`patent by submitting, or causing to be submitted to the FDA, ANDA No. 212064 seeking
`
`approval for the commercial marketing of Mylan’ s generic efinaconazole topical solution before
`
`the expiration date of the ‘009 patent.
`
`66.
`
`Upon information and belief, Mylan’s generic efinaconazole topical solution
`
`will, if approved and marketed, infringe, either literally or under the doctrine of equivalents, at
`
`least one claim of the ‘009 patent.
`
`67.
`
`Upon information and belief, Mylan will, through the manufacture, use, import,
`
`offer for sale, and/or sale of Mylan’s generic efinaconazole topical solution, directly infringe,
`
`contributorily infringe, and/or induce infringement of at least one claim of the ‘009 patent.
`
`68.
`
`If Mylan’s marketing and sale of its generic efinaconazole topical solution prior
`
`to the expiration of the ‘009 patent
`
`is not enjoined, Plaintiffs will suffer substantial and
`
`irreparable harm for which there is no adequate remedy at law.
`
`COUNT VIII AGAINST MYLAN
`
`Declaratory Judgment of Infringement of the ‘009 Patent
`
`Paragraphs 1-68 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. § 2201 and
`
`69.
`
`70.
`
`2202.
`
`71.
`
`There is an actual case or controversy such that
`
`the Court may entertain
`
`13
`
`

`

`Case 1:18-cv-00184-IMK Document 1 Filed 09/27/18 Page 14 of 24 PageID #: 14
`
`Plaintiffs’
`
`request
`
`for declaratory relief consistent with Article III of the United States
`
`Constitution, and this actual case or controversy requires a declaration of rights by this Court.
`
`72.
`
`Mylan has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, use, offer to sell, sell, and/or import Mylan’s generic efinaconazole
`
`topical solution before the expiration date of the ‘009 patent, including Mylan’ s filing of ANDA
`
`No. 212064.
`
`73.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Mylan’ s generic efinaconazole topical solution will directly infringe,
`
`contributorily infringe, and/or induce infringement of at least one claim of the ‘009 patent.
`
`74.
`
`Plaintiffs are entitled to a declaratory judgment
`
`that
`
`future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Mylan’s generic efinaconazole
`
`topical solution will constitute infringement of at least one claim of the ‘009 patent.
`
`COUNT IX AGAINST MYLAN
`
`Infringement of the ‘272 Patent under § 271(e)(2)
`
`Paragraphs 1-74 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one claim of the ‘272
`
`75.
`
`76.
`
`patent by submitting, or causing to be submitted to the FDA, ANDA No. 212064 seeking
`
`approval for the commercial marketing of Mylan’ s generic efinaconazole topical solution before
`
`the expiration date of the ‘272 patent.
`
`77.
`
`Upon information and belief, Mylan’s generic efinaconazole topical solution
`
`will, if approved and marketed, infringe, either literally or under the doctrine of equivalents, at
`
`least one claim of the ‘272 patent.
`
`78.
`
`Upon information and belief, Mylan will, through the manufacture, use, import,
`
`14
`
`

`

`Case 1:18-cv-00184-IMK Document 1 Filed 09/27/18 Page 15 of 24 PageID #: 15
`
`offer for sale, and/or sale of Mylan’ s generic efinaconazole topical solution, directly infringe,
`
`contributorily infringe, and/or induce infringement of at least one claim of the ‘272 patent.
`
`79.
`
`If Mylan’s marketing and sale of its generic efinaconazole topical solution prior
`
`to the expiration of the ‘272 patent
`
`is not enjoined, Plaintiffs will suffer substantial and
`
`irreparable harm for which there is no adequate remedy at law.
`
`COUNT X AGAINST MYLAN
`
`Declaratory Judgment of Infringement of the ‘272 Patent
`
`Paragraphs 1-79 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. § 2201 and
`
`80.
`
`81.
`
`2202.
`
`82.
`
`There is an actual case or controversy such that the Court may entertain Plaintiffs’
`
`request for declaratory relief consistent with Article III of the United States constitution, and this
`
`actual case or controversy requires a declaration of rights by this Court.
`
`83.
`
`Mylan has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, use, offer to sell, sell, and/or import Mylan’s generic efinaconazole
`
`topical solution before the expiration date of the ‘272 patent, including Mylan’ s filing of ANDA
`
`No. 212064.
`
`84.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Mylan’s generic efinaconazole topical solution will directly infringe,
`
`contributorily infringe, and/or induce infringement of at least one claim of the ‘272 patent.
`
`85.
`
`Plaintiffs
`
`are entitled to a declaratory judgment
`
`that
`
`future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Mylan’ s generic efinaconazole
`
`topical solution will constitute infringement of at least one claim of the ‘272 patent.
`
`15
`
`

`

`Case 1:18-cv-00184-IMK Document 1 Filed 09/27/18 Page 16 of 24 PageID #: 16
`
`COUNT XI AGAINST MYLAN
`
`Infringement of the ‘394 Patent under § 271(e)(2)
`
`Paragraphs 1-85 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one claim of the ‘394
`
`86.
`
`87.
`
`patent by submitting, or causing to be submitted to the FDA, ANDA No. 212064 seeking
`
`approval for the commercial marketing of Mylan’s generic efinaconazole topical solution before
`
`the expiration date of the ‘394 patent.
`
`88.
`
`Upon information and belief, Mylan’s generic efinaconazole topical solution
`
`will, if approved and marketed, infringe, either literally or under the doctrine of equivalents, at
`
`least one claim of the ‘394 patent.
`
`89.
`
`Upon information and belief, Mylan will, through the manufacture, use, import,
`
`offer for sale, and/or sale of Mylan’s generic efinaconazole topical solution, directly infringe,
`
`contributorily infringe, and/or induce infringement of at least one claim of the ‘394 patent.
`
`90.
`
`If Mylan’s marketing and sale of its generic efinaconazole topical solution prior
`
`to the expiration of the ‘394 patent
`
`is not enjoined, Plaintiffs will suffer substantial and
`
`irreparable harm for which there is no adequate remedy at law.
`
`COUNT XII AGAINST MYLAN
`
`Declaratory Judgment of Infringement of the ‘394 Patent
`
`Paragraphs 1-90 are incorporated herein as set forth above.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. § 2201 and
`
`91.
`
`92.
`
`2202.
`
`93.
`
`There is an actual case or controversy such that the Court may entertain Plaintiffs’
`
`request for declaratory relief consistent with Article III of the United States Constitution, and this
`
`actual case or controversy requires a declaration of rights by this Court.
`
`16
`
`

`

`Case 1:18-cv-00184-IMK Document 1 Filed 09/27/18 Page 17 of 24 PageID #: 17
`
`94.
`
`Mylan has made, and will continue to make, substantial preparation in the United
`
`States to manufacture, use, offer to sell, sell, and/or import Mylan’s generic efinaconazole
`
`topical solution before the expiration date of the ‘394 patent, including Mylan’ s filing of ANDA
`
`No. 212064.
`
`95.
`
`Upon information and belief, any commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Mylan’ s generic efinaconazole topical solution will directly infringe,
`
`contributorily infringe, and/or induce infringement of at least one claim of the ‘394 patent.
`
`96.
`
`Plaintiffs
`
`are entitled to a declaratory judgment
`
`that
`
`future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Mylan’s generic efinaconazole
`
`topical solution will constitute infringement of at least one claim of the ‘394 patent.
`
`COUNT XIII AGAINST MYLAN
`
`Infringement of the ‘698 Patent under § 271(e)(2)
`
`Paragraphs 1-96 are incorporated herein as set forth above.
`
`Under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one claim of the ‘698
`
`97.
`
`98.
`
`patent by submitting, or causing to be submitted to the FDA, ANDA No. 212064 seeking
`
`approval for the commercial marketing of Mylan’s generic efinaconazole topical solution before
`
`the expiration date of the ‘698 patent.
`
`99.
`
`Upon information and belief, Mylan’s generic efinaconazole topical solution
`
`will, if approved and marketed, infringe, either literally or under the doctrine of equivalents, at
`
`least one claim of the ‘698 patent.
`
`100.
`
`Upon information and belief, Mylan will, through the manufacture, use, import,
`
`offer for sale, and/or sale of Mylan’s generic efinaconazole topical solution, directly infringe,
`
`contributorily infringe, and/or induce infringement of at least one claim of the ‘698 patent.
`
`101.
`
`If Mylan’ s marketing and sale of its generic efinaconazole topical solution prior
`
`17
`
`

`

`Case 1:18-cv-00184-IMK Document 1 Filed 09/27/18 Page 18 of 24 PageID #: 18
`
`to the expiration of the ‘698 patent
`
`is not enjoined, Plaintiffs will suffer substantial and
`
`irreparable harm for which there is no adequate remedy at law.
`
`COUNT XIV AGAINST MYLAN
`
`Declaratory Judgment of Infringement of the ‘698 Patent
`
`102.
`
`Paragraphs 1-101 are incorporated herein as set forth above.
`
`103.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. § 2201 and
`
`2202.
`
`104.
`
`There is an actual case or controversy such that the Court may entertain Plaintiffs’
`
`request for declaratory relief consistent with Article III of the United States Constitution, and this
`
`actual case or controversy requires a declaration