throbber
Case 1:15-cv-00145-JPB Document 1 Filed 08/25/15 Page 1 of 15 PageID #: 1
`Case 1:15-cv-00145-JPB Document 1 Filed 08/25/15 Page 1 of 15 PageID #: 1
`
`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF WEST VIRGINIA
`
`BOEHRINGER INGELHEIM
`PHARMACEUTICALS INC., BOEHRINGER
`INGELHEIM INTERNATIONAL GMBH,
`BOEHRINGER INGELHEIM CORPORATION,
`and BOEHRINGER INGELHEIM PHARMA
`
`EELEB
`
`AUG 25 2015
`
`U.S. DISTRICT COURT-WVNQ
`WHEEL'NG' WV 25003
`
`GMBH & CO. KG,
`
`Plaintiffs,
`
`V.
`
`MYLAN PHARMACEUTICALS INC., MYLAN
`INC., and MYLAN LABORATORIES LIMITED,
`
`Defendants.
`
`
`VVVVVVVVVVVVVVV
`
`Civil Action No. LLB/V ’1 45
`
`COMPLAINT
`
`Plaintiffs, Boehringer Ingelheim Pharmaceuticals Inc.; Boehringer Ingelheim International
`
`GmbH; Boehringer Ingelheim Corporation; and Boehringer Ingelheim Pharma GmbH & Co. KG
`
`(collectively, “Boehringer” or “Plaintiffs”), by their undersigned attorneys, for their Complaint
`
`against Defendants Mylan Pharmaceuticals Inc.; Mylan Inc.; and Mylan Laboratories Limited
`
`hereby allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement arising under the Food and Drug Laws and
`
`Patent Laws of the United States, Titles 21 and 35 of the United States Code, respectively, arising
`
`from Defendants” submissions of Abbreviated New Drug Applications (“ANDAs”) to the Food
`
`and Drug Administration (“FDA”) seeking approval to manufacture and sell generic versions of
`
`Plaintiffs’ TRADJENTA® (linagliptin) and JENTADUETO® (linagliptin and metformin
`
`hydrochloride) tablets prior to the expiration of United States Patent Nos. 8,673,927, 8,846,695,
`
`and 8,853,156.
`
`

`

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`THE PARTIES
`
`2.
`
`Plaintiff Boehringer Ingelheim Pharmaceuticals Inc. (“BIPI”) is a corporation
`
`organized and existing under the laws of the State of Delaware, having a principal place of business
`
`at 900 Ridgebury Rd., Ridgefield, CT 06877.
`
`3.
`
`Plaintiff, Boehringer Ingelheim International GmbH (“B11”) is a private limited
`
`liability company organized and existing under the laws of Germany, having a principal place of
`
`business at Binger Strasse 173, 55216 Ingelheim, Germany.
`
`4.
`
`Plaintiff Boehringer Ingelheim Pharma GmbH & Co. KG (“BIPKG”) is a limited
`
`liability partnership organized and existing under the laws of Germany, having a principal place
`
`of business at Binger Strasse 173, 55216 Ingelheim, Germany.
`
`5.
`
`Plaintiff Boehringer Ingelheim Corporation (“BIC”) is a corporation organized and
`
`existing under the laws of Delaware, having a principal place of business at 900 Ridgebury Road,
`
`Ridgefield, CT, 06877.
`
`6.
`
`7.
`
`BIPI, BII, BIPKG and BIC are collectively referred to hereinafter as “Boehringer.”
`
`On information and belief, Defendant Mylan Pharmaceuticals Inc.
`
`(“Mylan
`
`Pharms”) is a corporation organized and existing under the laws of the State of West Virginia,
`
`having a principal place of business at 781 Chestnut Ridge Road, Morgantown, West Virginia
`
`26505.
`
`8.
`
`On information and belief, Mylan Pharms is in the business of, among other things,
`
`developing, preparing, manufacturing, selling, marketing, and distributing generic pharmaceutical
`
`products throughout the United States, including in the State of West Virginia.
`
`

`

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`9.
`
`On information and belief, Defendant Mylan Inc. is a corporation organized and
`
`existing under the laws of the State of Pennsylvania, having a principal place of business at Robert
`
`J. Coury Global Center, 1000 Mylan Blvd, Canonsburg, Pennsylvania 15317.
`
`10.
`
`On information and belief, Defendant Mylan Laboratories Limited (“Mylan Labs”)
`
`is a corporation organized and existing under the laws of India and has a principal place of business
`
`at Plot No. 564/A/22, Road No. 92, Jubilee Hills 500034, Hyderabad, India.
`
`11.
`
`On information and belief, Mylan Pharms is a wholly owned subsidiary of Mylan
`
`Labs, which, in turn is a wholly-owned subsidiary of Mylan Inc.
`
`12.
`
`On information and belief, the acts of Mylan Pharms complained of herein were
`
`done with the cooperation, participation, and assistance of Mylan Inc. and Mylan Labs.
`
`13.
`
`Mylan Pharms, Mylan Labs, and Mylan Inc. are collectively referred to herein as
`
`“Mylan.”
`
`14.
`
`A complaint against Mylan, among other defendants, containing the same
`
`allegations as set forth herein was filed in the United States District Court for the District of New
`
`Jersey on August 4, 2015. Boehringer timely files the instant complaint in order to preserve its
`
`rights under 21 U.S.C. § 355(c)(3)(C) in the event that Mylan challenges the personal jurisdiction
`
`of the United States District Court for the District of New Jersey.
`
`JURISDICTION AND VENUE
`
`15.
`
`This action arises under the patent laws of the United States, 35 U.S.C. §§ 100 et
`
`seq., generally, and 35 U.S.C. § 271(c)(2), specifically, and this Court has jurisdiction over the
`
`subject matter ofthis action under 28 U.S.C. §§ 1331 and 1338(a).
`
`

`

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`16.
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391 and/or 1400(b).
`
`PERSONAL JURISDICTION OVER MYLAN PHARMS.
`
`17.
`
`Plaintiffs reallege all preceding paragraphs as if fully set forth herein.
`
`18.
`
`On information and belief, Mylan Pharms develops, manufactures, and/or
`
`distributes generic drugs for sale and use throughout the United States, including in this judicial
`
`district.
`
`19.
`
`This Court has personal jurisdiction over Mylan Pharms because, inter alia, Mylan
`
`Pharms, on information and belief: (I) has substantial, continuous, and systematic contacts with
`
`this judicial district; (2) is incorporated in the State of West Virginia and maintains a principal
`
`place of business in this judicial district; (3) makes its generic drug products available in this
`
`judicial district; (4) intends to market, sell, or distribute Mylan’s ANDA Products to residents of
`
`this judicial district; (5) maintains a broad distributorship network within this judicial district; and
`
`(6) enjoys substantial income from sales of its generic pharmaceutical products in this judicial
`
`district.
`
`20.
`
`Additionally, on information and belief, Mylan Pharms has previously been sued
`
`in this judicial district without objecting on the basis of lack of personal jurisdiction and has availed
`
`itself of this judicial district through the assertion of counterclaims and by filing suit in the
`
`Northern District of West Virginia.
`
`PERSONAL JURISDICTION OVER MYLAN INC.
`
`21.
`
`Plaintiffs reallege all preceding paragraphs as if fully set forth herein.
`
`

`

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`22.
`
`On information and belief, Mylan Inc. develops, manufactures, and/or distributes
`
`generic drugs for sale and use throughout the United States, including in this judicial district.
`
`23.
`
`This Court has personal jurisdiction over Mylan Inc. because, inter alia, Mylan
`
`Inc., on information and belief: (1) intends to market, sell, or distribute Mylan’s ANDA Products
`
`to residents of this State; (2) controls Defendant Mylan Pharms, which is incorporated in the State
`
`of West Virginia and maintains a principal place of business in this judicial district; (3) makes its
`
`generic drug products available in this State through Mylan Pharm, which is incorporated in the
`
`State of West Virginia and maintains a principal place of business in this judicial district; (4)
`
`maintains a broad distributorship network within this State; and (5) enjoys substantial income from
`
`sales of its generic pharmaceutical products in this State.
`
`24.
`
`Additionally, on information and belief, Mylan Inc. has previously been sued in
`
`this judicial district without objecting on the basis of lack of personal jurisdiction and has availed
`
`itself of this judicial district through the assertion of counterclaims.
`
`PERSONAL JURISDICTION OVER MYLAN LABS
`
`25.
`
`Plaintiffs reallege all preceding paragraphs as if fully set forth herein.
`
`26.
`
`On information and belief, Mylan Labs develops, manufactures, and/or distributes
`
`generic drugs for sale and use throughout the United States, including in this judicial district.
`
`27.
`
`This Court has personal jurisdiction over Mylan Labs because, inter alia, Mylan
`
`Labs, on information and belief: (l) intends to market, sell, or distribute Mylan’s ANDA Products
`
`to residents of this judicial district; (2) controls Defendant Mylan Pharm, which is incorporated
`
`in the State of West Virginia and maintains a principal place of business in this judicial district;
`
`

`

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`(3) makes its generic drug products available in this State through Mylan Pharm, which is
`
`incorporated in the State of West Virginia and maintains a principal place of business in this
`
`judicial district; (4) maintains a broad distributorship network within this State; and (5) enjoys
`
`substantial income from sales of its generic pharmaceutical products in this State.
`
`28.
`
`Additionally, on information and belief, Mylan Labs has previously been sued in
`
`this judicial district without objecting on the basis of lack of personal jurisdiction and has availed
`
`itself of this judicial district through the assertion of counterclaims.
`
`BACKGROUND
`
`U.S. Patent No. 8,673,927
`
`29.
`
`On March 18, 2014, the PTO duly and legally issued United States Patent No.
`
`8,673,927 (“the ‘927 patent”) entitled “Uses of DPP-IV Inhibitors” to inventors Klaus Dugi, Frank
`
`Himmelsbach, and Michael Mark. A true and correct copy of the ‘927 patent is attached as Exhibit
`
`1.
`
`U.S. Patent No. 8,846,695
`
`30.
`
`On September 30, 2014, the PTO duly and legally issued United States Patent No.
`
`8,846,695 (“the ‘695 patent”) entitled “Treatment For Diabetes In Patients With Inadequate
`
`Glycemic Control Despite Metformin Therapy Comprising A DPP—IV Inhibitor” to inventor Klaus
`
`Dugi. A true and correct copy of the ‘695 patent is attached as Exhibit 2.
`
`U.S. Patent No. 8,853,156
`
`31.
`
`On October 7, 2014, the PTO duly and legally issued United States Patent No.
`
`8,853,156 (“the ‘156 patent”) entitled “Treatment For Diabetes In Patients Inappropriate For
`
`

`

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`Case 1:15-cv-00145-JPB Document 1 Filed 08/25/15 Page 7 of 15 PageID #: 7
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`Metformin Therapy” to inventors Klaus Dugi, Eva Ulrike Graefe-Mody, Ruth Harper, and Hans-
`
`Jurgen Woerle. A true and correct copy of the ‘ 156 patent is attached at Exhibit 3.
`
`TRADJENTA® AND JENTADUETO®
`
`32.
`
`BIPI is the holder of New Drug Application (“NDA”) No. 201280 (“the NDA”) for
`
`linagliptin, for oral use, in 5 mg dosage, which is sold under the trade name TRADJENTA®.
`
`33.
`
`BIPI is the holder of NDA No. 201281 for linagliptin and metformin hydrochloride
`
`tablets, for oral use, in 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/ 1000 mg dosages, which are
`
`sold under the trade name JENTADUETO®.
`
`34.
`
`TRADJENTA® and JENTADUETO® are listed in the FDA’s Approved Drug
`
`Products with Therapeutic Equivalence Evaluations database (“Orange Book”) as having New
`
`Chemical Exclusivity until May 2, 2016.
`
`35.
`
`Pursuant to 21 U.S.C. § 355(b)(1), and attendant FDA regulations, the ‘927, ‘695,
`
`and ‘156 patents are listed in the “Orange Book” with respect to TRADJENTA®.
`
`36.
`
`Pursuant to 21 U.S.C. § 35 5(b)(1), and attendant FDA regulations, the ‘927, and
`
`‘695 patents are listed in the Orange Book with respect to JENTADUETO® in 2.5 mg/500 mg,
`
`2.5 mg/850 mg, and 2.5 mg/1000 mg dosages.
`
`37.
`
`The ‘927, ‘695, and ‘ 156 patents cover the TRADJENTA® product.
`
`38.
`
`The ‘927, and ‘695 patents cover the JENTADUETO® product.
`
`ACTS GIVING RISE TO THIS ACTION
`
`COUNT I - INFRINGEMENT OF THE ‘927 PATENT
`
`

`

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`39.
`
`Plaintiffs reallege all preceding paragraphs as if fully set forth herein.
`
`40.
`
`On information and belief, Mylan submitted ANDA Nos. 208431 and 208430 (the
`
`“Mylan ANDAs”) to the FDA, pursuant to 21 U.S.C. § 3550'), seeking approval to market
`
`linagliptin, for oral use, in 5 mg dosage (the “Mylan Linagliptin Product”) and linagliptin and
`
`metformin, for oral use, in 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1000 mg dosages (“the
`
`Mylan Combination Products”), respectively. The Mylan Linagliptin Product and the Mylan
`
`Combination Products are herein collectively referred to as the “Mylan ANDA Products.”
`
`41.
`
`Mylan ANDA No. 208431 refers to and relies upon the TRADJENTA® NDA and
`
`contains data that, according to Mylan, demonstrate the bioequivalence of the Mylan Linagliptin
`
`Product and TRADJENTA®.
`
`42.
`
`Mylan ANDA No. 208430 refers to and relies upon the JENTADUETO® NDA
`
`and contains data that, according to Mylan, demonstrate the bioequivalence of the Mylan
`
`Combination Products and JENTADUETO®.
`
`43.
`
`Plaintiffs received letters from Mylan on or about July 13, 2015 and July 15, 2015,
`
`stating that Mylan had included certifications in the DRL ANDAs, pursuant to 21 U.S.C.
`
`§ 35 5(j)(2)(A)(vii)(IV), that, inter alia, certain claims of the ‘927, ‘695, and ‘ 156 patents are either
`
`invalid or will not be infringed by the commercial manufacture, use, or sale of the Mylan ANDA
`
`Products (the “Mylan Paragraph IV Certifications”).
`
`44.
`
`Mylan has infringed at least one claim of the ‘927 patent, pursuant to 35 U.S.C.
`
`§ 271(c)(2)(A), by submitting, or causing to be submitted the Mylan ANDAs, by which Mylan
`
`

`

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`Case 1:15-cv-00145-JPB Document 1 Filed 08/25/15 Page 9 of 15 PageID #: 9
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`seeks approval from the FDA to engage in the manufacture, use, offer to sell, sale, or importation
`
`of the Mylan ANDA Products prior to the expiration of the ‘927 patent.
`
`45.
`
`Mylan has declared its intent to manufacture, use, offer to sell, or sell in the United
`
`States or to import into the United States, the Mylan ANDA Products in the event that the FDA
`
`approves the Mylan ANDAs. Accordingly, an actual and immediate controversy exists regarding
`
`Mylan’s infringement of the ‘927 patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
`
`46.
`
`Mylan’s manufacture, use, offer to sell, or sale of the Mylan ANDA Products in the
`
`United States or importation of the Mylan ANDA Products into the United States during the term
`
`of the ‘927 patent would further infringe at least one claim of the ‘927 patent under 35 U.S.C.
`
`§§ 271 (a), (b), and/or (c).
`
`47.
`
`On information and belief, the Mylan ANDA Products, when offered for sale, sold,
`
`and/or imported, and when used as directed, would be used in a manner that would directly infringe
`
`at least one of the claims of the ‘927 patent either literally or under the doctrine of equivalents.
`
`48.
`
`On information and belief, the use of Mylan’s ANDA Products constitutes a
`
`material part of at least one of the claims of the “927 patent; Mylan knows that its ANDA Products
`
`are especially made or adapted for use in infringing at least one of the claims of the ‘927 patent,
`
`either literally or under the doctrine of equivalents; and its ANDA Products are not staple articles
`
`of commerce or commodities of commerce suitable for substantial noninfringing use.
`
`49.
`
`On information and belief, the offering to sell, sale, and/or importation of the Mylan
`
`ANDA Products would contributorily infringe at least one of the claims of the ‘927 patent, either
`
`literally or under the doctrine of equivalents.
`
`

`

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`50.
`
`On information and belief, Mylan had knowledge of the ‘927 patent and, by its
`
`promotional activities and package inserts for its ANDA Products, knows or should know that it
`
`will aid and abet another’s direct infringement of at least one of the claims of the ‘927 patent,
`
`either literally or under the doctrine of equivalents.
`
`51.
`
`On information and belief, the offering to sell, sale, and/or importation of the Mylan
`
`ANDA Products would actively induce infringement of at least one of the claims ofthe ‘927 patent,
`
`either literally or under the doctrine of equivalents.
`
`52.
`
`Plaintiffs will be substantially and irreparably harmed if Mylan is not enjoined from
`
`infringing the ‘927 patent.
`
`53.
`
`This is an exceptional case within the meaning of 35 U.S.C. § 285, which warrants
`
`reimbursement of Boehringer’s reasonable attorney fees.
`
`COUNT II - INFRINGEMENT OF THE ‘695 PATENT
`
`54.
`
`Plaintiffs reallege all preceding paragraphs as if fully set forth herein.
`
`55.
`
`Mylan has infringed at least one claim of the ‘695 patent, pursuant to 35 U.S.C.
`
`§ 271(e)(2)(A), by submitting, or causing to be submitted the Mylan ANDAS, by which Mylan
`
`seeks approval from the FDA to engage in the manufacture, use, offer to sell, sale, or importation
`
`of the Mylan ANDA Products prior to the expiration of the ‘695 patent.
`
`56.
`
`Mylan declared its intent to manufacture, use, offer to sell, or sell in the United
`
`States or to import into the United States, the Mylan ANDA Products in the event that the FDA
`
`approves the Mylan ANDAS. Accordingly, an actual and immediate controversy exists regarding
`
`Mylan’s infringement of the ‘695 patent under 35 U.S.C. §§ 271 (a), (b), and/or (c).
`
`10
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`

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`57.
`
`Mylan’s manufacture, use, offer to sell, or sale of the Mylan ANDA Products in the
`
`United States or importation of the Mylan ANDA Products into the United States during the term
`
`of the ‘695 patent would filrther infringe at least one claim of the ‘695 patent under 35 U.S.C.
`
`§§ 271 (a), (b), and/or (c).
`
`58.
`
`On information and belief, the Mylan ANDA Products, when offered for sale, sold,
`
`and/or imported, and when used as directed, would be used in a manner that would directly infringe
`
`at least one of the claims of the ‘695 patent either literally or under the doctrine of equivalents.
`
`59.
`
`On information and belief, the use of Mylan’s ANDA Products constitutes a
`
`material part of at least one of the claims of the ‘695 patent; Mylan knows that its ANDA Products
`
`are especially made or adapted for use in infringing at least one of the claims of the ‘695 patent,
`
`either literally or under the doctrine of equivalents; and its ANDA Products are not staple articles
`
`of commerce or commodities of commerce suitable for substantial noninfringing use.
`
`60.
`
`On information and belief, the offering to sell, sale, and/or importation of the Mylan
`
`ANDA Products would contributorily infringe at least one of the claims of the ‘695 patent, either
`
`literally or under the doctrine of equivalents.
`
`61.
`
`On information and belief, Mylan had knowledge of the ‘695 patent and, by its
`
`promotional activities and package inserts for its ANDA Products, knows or should know that it
`
`will aid and abet another’s direct infringement of at least one of the claims of the ‘695 patent,
`
`either literally or under the doctrine of equivalents.
`
`11
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`

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`62.
`
`On information and belief, the offering to sell, sale, and/or importation ofthe Mylan
`
`ANDA Products would actively induce infringement of at least one of the claims ofthe ‘695 patent,
`
`either literally or under the doctrine of equivalents.
`
`63.
`
`Plaintiffs will be substantially and irreparably harmed if Mylan is not enjoined from
`
`infringing the ‘695 patent.
`
`64.
`
`This is an exceptional case within the meaning of 35 U.S.C. § 285, which warrants
`
`reimbursement of Boehringer’s reasonable attorney fees.
`
`COUNT III - INFRINGEMENT OF THE ‘156 PATENT
`
`65.
`
`Plaintiffs reallege all preceding paragraphs as if fully set forth herein.
`
`66.
`
`Mylan has infringed at least one claim of the ‘156 patent, pursuant to 35 U.S.C.
`
`§ 271(c)(2)(A), by submitting, or causing to be submitted Mylan ANDA No. 208431, by which
`
`Mylan seeks approval from the FDA to engage in the manufacture, use, offer to sell, sale, or
`
`importation of the Mylan Linagliptin Product prior to the expiration of the ‘ 156 patent.
`
`67.
`
`Mylan has declared its intent to manufacture, use, offer to sell, or sell in the United
`
`States or to import into the United States, the Mylan Linagliptin Product in the event that the FDA
`
`approves Mylan ANDA No. 208431. Accordingly, an actual and immediate controversy exists
`
`regarding Mylan’s infringement of the ‘ 156 patent under 35 U.S.C. §§ 271 (a), (b), and/or (0).
`
`68.
`
`Mylan’s manufacture, use, offer to sell, or sale of the Mylan Linagliptin Product in
`
`the United States or importation of the Mylan Linagliptin Product into the United States during
`
`the term of the ‘ 156 patent would further infringe at least one claim of the ‘ 156 patent under 35
`
`U.S.C. §§ 271 (a), (b), and/or (c).
`
`12
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`69.
`
`On information and belief, the Mylan Linagliptin Product, when offered for sale,
`
`sold, and/or imported, and when used as directed, would be used in a manner that would directly
`
`infringe at least one of the claims of the ‘156 patent either literally or under the doctrine of
`
`equivalents.
`
`70.
`
`On information and belief, the use of Mylan’s Linagliptin Product constitutes a
`
`material part of at least one of the claims of the ‘156 patent; Mylan knows that its Linagliptin
`
`Product is especially made or adapted for use in infringing at least one of the claims of the ‘156
`
`patent, either literally or under the doctrine of equivalents; and its Linagliptin Product is not a
`
`staple article of commerce or commodity of commerce suitable for substantial noninfringing use.
`
`71.
`
`On information and belief, the offering to sell, sale, and/or importation ofthe Mylan
`
`Linagliptin Product would contributorily infringe at least one of the claims of the ‘156 patent,
`
`either literally or under the doctrine of equivalents.
`
`72.
`
`On information and belief, Mylan had knowledge of the ‘156 patent and, by its
`
`promotional activities and package inserts for its Linagliptin Product, knows or should know that
`
`it will aid and abet another’s direct infringement of at least one of the claims of the ‘156 patent,
`
`either literally or under the doctrine of equivalents.
`
`73.
`
`On information and belief, the offering to sell, sale, and/or importation ofthe Mylan
`
`Linagliptin Product would actively induce infringement of at least one of the claims of the ‘156
`
`patent, either literally or under the doctrine of equivalents.
`
`74.
`
`Plaintiffs will be substantially and irreparably harmed if Mylan is not enjoined from
`
`infringing the ‘ 156 patent.
`
`13
`
`

`

`Case 1:15-cv-00145-JPB Document 1 Filed 08/25/15 Page 14 of 15 PageID #: 14
`Case 1:15-cv-00145-JPB Document 1 Filed 08/25/15 Page 14 of 15 PageID #: 14
`
`75.
`
`This is an exceptional case Within the meaning of 35 U.S.C. § 285, which warrants
`
`reimbursement of Boehringer’s reasonable attorney fees.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request that the Court enter judgment against
`
`Defendants and for the following relief:
`
`a. A Judgment be entered that Mylan has infringed at least one claim of the ‘927, ‘695, and ‘156
`
`patents by submitting the Mylan ANDAs;
`
`b. A Judgment be entered that this case is exceptional, and that Plaintiffs are entitled to their
`
`reasonable attorneys’ fees pursuant to 35 U.S.C. § 285;
`
`c. That Defendants, their officers, agents, servants, employees, and those persons acting in active
`
`concert or participation with all or any of them from be preliminarily and permanently enjoined
`
`from: (i) engaging in the commercial manufacture, use, offer to sell, or sale Within the United
`
`States, or importation into the United States, of drugs or methods of administering drugs
`
`claimed in the ‘927, ‘695, and ‘ 156 patents, and (ii) seeking, obtaining or maintaining approval
`
`of ANDAs until the expiration of the “927, “695, and ‘156 patents or such other later time as
`
`the Court may determine;
`
`d. A judgment ordering that pursuant to 35 U.S.C. § 271(c)(4)(A), the effective date of any
`
`approval of Defendants’ ANDAs under § 505(j) of the Federal Food, Drug and Cosmetic Act
`
`(21 U.S.C. § 35 5 0)) shall not be earlier than the latest of the expiration dates of the ‘927, ‘695,
`
`‘156 patents, including any extensions;
`
`14
`
`

`

`Case 1:15-cv-00145-JPB Document 1 Filed 08/25/15 Page 15 of 15 PageID #: 15
`Case 1:15-cv-00145-JPB Document 1 Filed 08/25/15 Page 15 of 15 PageID #: 15
`
`e. That Boehringer be awarded monetary relief if Defendants commercially use, offer to sell, or
`
`sell their respective proposed generic versions of TRADJENTA® and/or JENTADUETO® or
`
`any other product that infringes or induces or contributes to the infringement of the ‘927, ‘695,
`
`and/or ‘ 156 patents, within the United States, prior to the expiration of those patents, including
`
`any extensions, and that any such monetary relief be awarded to Boehringer with prejudgment
`
`interest;
`
`f. Costs and expenses in this action; and
`
`g.
`
`Such other and further relief as the Court deems just and appropriate.
`
`DATED: August 25, 2015
`
`Respectfully submitted,
`
`SCHRADER BYRD & COMPANION, PLLC
`
`OfCounsel:
`
`Daniel Forchheimer
`Leora Ben~Ami
`Jeanna M, Wacker
`Mira Mulvaney
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4679
`
`/s/ James F. Com anion
`James F. Companion (#790)
`Yolonda G. Lambert (#2130)
`The Maxwell Centre
`32-20th Street, Suite 500
`Wheelmg, WV 26003
`(304) 233-3390
`ch@schraderlaw.com
`ygl@schraderlaw.com
`
`Counselfor Plaintiffi
`
`15
`
`

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