Case 1:14-cv-01278-GMS Document 1 Filed 10/06/14 Page 1 of 20 PageID #: 1
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`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`TEVA PHARMACEUTICAL
`INDUSTRIES LTD., TEVA
`NEUROSCIENCE, INC., and YEDA
`RESEARCH AND DEVELOPMENT CO.,
`LTD.,
`
`
`
`
`
`Plaintiffs,
`
`
`
`
`
`
`
`
`
` C.A. No. _______________
`
`
`)))))))))))))
`
`
`
`v.
`
`MYLAN PHARMACEUTICALS INC.,
`MYLAN INC. and NATCO PHARMA
`LTD.,
`
`
`
`
`
`
`
`Defendants.
`
`COMPLAINT
`
`
`
`Plaintiffs Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd.,
`
`Teva Neuroscience, Inc. and Yeda Research and Development Co., Ltd. (collectively “Plaintiffs”
`
`or “Teva”) bring this action for patent infringement and declaratory judgment against Defendants
`
`Mylan Pharmaceuticals Inc., Mylan Inc., and Natco Pharma Ltd. (collectively “Defendants” or
`
`“Mylan”).
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action by Teva for infringement of United States Patent No. 8,232,250
`
`(“the ’250 patent”) and United States Patent No. 8,399,413 (“the ’413 patent”). This action
`
`arises out of the filing of an Abbreviated New Drug Application (“ANDA”) by Mylan seeking
`
`approval by the United States Food and Drug Administration (“FDA”) to sell generic versions of
`
`COPAXONE® 40 mg/mL injection, Teva’s innovative treatment for patients with
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`
`

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`Case 1:14-cv-01278-GMS Document 1 Filed 10/06/14 Page 2 of 20 PageID #: 2
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`
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`relapsing-remitting forms of multiple sclerosis, prior to the expiration of the ’250 and ’413
`
`patents.
`
`Teva
`
`THE PARTIES
`
`2.
`
`Teva Pharmaceuticals USA, Inc. (“Teva USA”) is a Delaware corporation with its
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`principal place of business at 1090 Horsham Road, North Wales, Pennsylvania 19454-1090.
`
`3.
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`Teva Pharmaceutical Industries Ltd. (“Teva Ltd.”) is an Israeli company with its
`
`principal place of business at 5 Basel Street, P.O. Box 3190, Petah Tikva, 49131, Israel.
`
`4.
`
`Teva Neuroscience, Inc. (“Teva Neuroscience”), is a Delaware corporation with
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`its principal place of business at 901 E. 104th Street, Suite 900, Kansas City, Missouri 64131.
`
`5.
`
`Yeda Research and Development Co. Ltd. (“Yeda”) is an Israeli company with its
`
`principal place of business is P.O. Box 95, Rehovot, 76100, Israel.
`
`Mylan
`
`6.
`
`Upon information and belief, Mylan Pharmaceuticals Inc. is a corporation
`
`organized and existing under the laws of West Virginia with its principal place of business at 781
`
`Chestnut Ridge Rd., Morgantown, WV 26505.
`
`7.
`
`8.
`
`Mylan Pharmaceuticals Inc. is a wholly-owned subsidiary of Mylan Inc.
`
`Upon information and belief, Mylan Inc. is a corporation organized and existing
`
`under the laws of Pennsylvania with its principal place of business at 1500 Corporate Drive,
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`Canonsburg, PA 15317.
`
`9.
`
`Upon information and belief, Natco Pharma Ltd. is an Indian company with its
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`principal place of business at Natco House, Road No. 2, Banjara Hills, Hyderabad 500 033,
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`India.
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`2
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`Case 1:14-cv-01278-GMS Document 1 Filed 10/06/14 Page 3 of 20 PageID #: 3
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`10.
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`11.
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`JURISDICTION AND VENUE
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`This action for patent infringement arises under 35 U.S.C. § 271.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331 and 1338(a), and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`12.
`
`13.
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`Venue is proper in this Judicial District under 28 U.S.C. § 1400(b) and § 1391.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Mylan Pharmaceuticals Inc.
`
`14.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. has availed
`
`itself of this forum by bringing a civil action in this forum. See, e.g., Mylan Pharmaceuticals
`
`Inc. et al. v. Eurand Inc. et al., C.A. No. 10-00306 (D. Del.); Mylan Pharmaceuticals Inc. et al.
`
`v. Kremers Urban Development Co., C.A. No. 02-01628 (D. Del.); Mylan Pharmaceuticals Inc.
`
`et al. v. Galderma Laboratories Inc. et al., C.A. No. 10-00892 (D. Del.); DuPont Merck
`
`Pharmaceutical Co. et al. v. Bristol-Myers Squibb Co. et al., C.A. No. 95-00290 (D. Del.).
`
`15.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. is registered
`
`to conduct business with the State of Delaware and maintains as a registered agent Corporation
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`Service Company, 2711 Centerville Road, Suite 400, Wilmington, Delaware 19808.
`
`16.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. is registered
`
`pursuant to Del. Code Ann. Tit. 24, § 2540 to distribute its generic pharmaceutical products in
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`Delaware.
`
`17.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. holds
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`current and valid “Distributor/Manufacturer CSR” and “Pharmacy-Wholesale” licenses from the
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`Delaware Board of Pharmacy.
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`3
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`18.
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`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. markets,
`
`distributes and/or sells generic drugs throughout the United States and within the State of
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`Delaware.
`
`19.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. has engaged
`
`in and maintained systematic and continuous business contacts within the State of Delaware, and
`
`has purposefully availed itself of the benefits and protections of the laws of Delaware.
`
`20.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. has
`
`committed, or aided, abetted, contributed to and/or participated in the commission of the tortious
`
`action of patent infringement that has led to foreseeable harm and injury to Teva, which
`
`manufactures COPAXONE®, for sale and use throughout the United States, including the State
`
`of Delaware.
`
`21.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. has applied
`
`for FDA approval to market and sell a generic version of COPAXONE® 40 mg/mL throughout
`
`the United States, including in Delaware.
`
`22.
`
`Upon information and belief, this Court also has personal jurisdiction over
`
`Defendant Mylan Pharmaceuticals Inc. because it previously has been sued in this district
`
`without challenging this Court’s assertion of personal jurisdiction over it and availed itself of this
`
`forum by asserting counterclaims for the purpose of litigating a patent infringement dispute. See,
`
`e.g., Alcon Research Ltd. v. Mylan Inc. et al., C.A. No. 13-01332 (D. Del.); UCB Inc. et al. v.
`
`Mylan Inc. et al., C.A. No. 13-01214 (D. Del.); Forest Laboratories Inc. et al v. Mylan Inc. et
`
`al., C.A. No. 13-01605 (D. Del.).
`
`23.
`
`Upon information and belief, Defendant Mylan Pharmaceuticals Inc.’s systematic
`
`and continuous business contacts within Delaware render it at home in Delaware.
`
`4
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`24.
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`Upon information and belief, Defendant Mylan Pharmaceuticals Inc. consented to
`
`jurisdiction in Delaware by registering to conduct business with the State of Delaware and
`
`maintaining a registered agent in Delaware.
`
`25.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Mylan Pharmaceuticals Inc. for the reasons stated herein, including, inter alia, Defendant Mylan
`
`Pharmaceuticals Inc.’s activities in the forum, activities directed at the forum, significant
`
`contacts with the forum, and consent, all of which render Defendant Mylan Pharmaceuticals Inc.
`
`at home in the forum.
`
`26.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Mylan Inc.
`
`27.
`
`Upon information and belief, Defendant Mylan Inc. has availed itself of this
`
`forum by bringing a civil action in this forum. See, e.g., Mylan Pharmaceuticals Inc. et al. v.
`
`Eurand Inc. et al., C.A. No. 10-00306 (D. Del.); Mylan Pharmaceuticals Inc. et al. v. Kremers
`
`Urban Development Co., C.A. No. 02-01628 (D. Del.); Mylan Pharmaceuticals Inc. et al. v.
`
`Galderma Laboratories Inc. et al., C.A. No. 10-00892 (D. Del.); DuPont Merck Pharmaceutical
`
`Co. et al. v. Bristol-Myers Squibb Co. et al., C.A. No. 95-00290 (D. Del.).
`
`28.
`
`Upon information and belief, Defendant Mylan Inc. (through its wholly-owned
`
`subsidiary Defendant Mylan Pharmaceuticals Inc.) markets, distributes and/or sells generic drugs
`
`throughout the United States and within the State of Delaware.
`
`29.
`
`Upon information and belief, Defendant Mylan Inc. has engaged in and
`
`maintained systematic and continuous business contacts within the State of Delaware, and has
`
`purposefully availed itself of the benefits and protections of the laws of Delaware.
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`5
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`30.
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`Upon information and belief, Defendant Mylan Inc. collaborated and/or acted in
`
`concert with Defendants Mylan Pharmaceuticals Inc. and Natco Pharma Ltd. to apply for FDA
`
`approval to market and sell a generic version of COPAXONE® 40 mg/mL throughout the
`
`United States, including in Delaware.
`
`31.
`
`Upon information and belief, Defendant Mylan Inc. is partnering with Defendant
`
`Natco Pharma Ltd. to attempt to bring a three-times-a-week generic COPAXONE® (glatiramer
`
`acetate injection, 40 mg/mL) to market in the U.S. See http://natcopharma.co.in/index.php/news-
`
`for-dump/185-news90 (accessed 10/02/14); see also Natco Pharma Ltd.’s 31st Annual Report
`
`2013-2014 at 26.
`
`32.
`
`Upon information and belief, Defendant Mylan Inc. has committed, or aided,
`
`abetted, contributed to and/or participated in the commission of the tortious action of patent
`
`infringement that has led to foreseeable harm and injury to Teva, which manufactures
`
`COPAXONE®, for sale and use throughout the United States, including the State of Delaware.
`
`33.
`
`Upon information and belief, this Court also has personal jurisdiction over
`
`Defendant Mylan Inc. because it previously has been sued in this district without challenging this
`
`Court’s assertion of personal jurisdiction over it and has availed itself of this forum by asserting
`
`counterclaims for the purpose of litigating a patent infringement dispute. See, e.g., Alcon
`
`Research Ltd. v. Mylan Inc. et al., C.A. No. 13-01332 (D. Del.); UCB Inc. et al. v. Mylan Inc. et
`
`al., C.A. No. 13-01214 (D. Del.); Forest Laboratories Inc. et al v. Mylan Inc. et al., C.A. No.
`
`13-01605 (D. Del.).
`
`34.
`
`Upon information and belief, Defendant Mylan Inc.’s systematic and continuous
`
`business contacts within Delaware render it at home in Delaware.
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`6
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`35.
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`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Mylan Inc. for the reasons stated herein, including, inter alia, Defendant Mylan Inc.’s activities
`
`in the forum, activities directed at the forum, and significant contacts with the forum, all of
`
`which render Defendant Mylan Inc. at home in the forum.
`
`36.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Natco Pharma Ltd.
`
`37.
`
`Upon information and belief, Defendant Natco Pharma Ltd. is partnering with
`
`Defendant Mylan Inc. to attempt to bring a three-times-a-week generic COPAXONE®
`
`(glatiramer acetate injection, 40 mg/mL) to market in the U.S. See
`
`http://natcopharma.co.in/index.php/news-for-dump/185-news90 (accessed 10/02/14); see also
`
`Natco Pharma Ltd.’s 31st Annual Report 2013-2014 at 26.
`
`38.
`
`Upon information and belief, Defendant Natco Pharma Ltd. is in the business of,
`
`among other things, manufacturing and marketing pharmaceutical substances and finished
`
`dosage forms for Indian, U.S. and other international markets.
`
`39.
`
`Upon information and belief, Defendant Natco Pharma Ltd. manufactures and
`
`formulates drugs that are imported into the United States for distribution and sale throughout the
`
`United States and within the State of Delaware.
`
`40.
`
`Upon information and belief, Defendant Natco Pharma Inc., is a wholly owned
`
`subsidiary of Natco Pharma Ltd. See Natco Pharma Ltd.’s 31st Annual Report 2013-2014.
`
`41.
`
`Upon information and belief, Natco Pharma Inc. is a corporation organized and
`
`existing under the laws of Delaware with its principle place of business at 297 Mine Bank Road,
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`Wellsville, PA 17365.
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`7
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`42.
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`Upon information and belief, Defendant Natco Pharma Ltd. has engaged in and
`
`maintained systematic and continuous business contacts within the State of Delaware, and has
`
`purposefully availed itself of the benefits and protections of the laws of Delaware, including
`
`through its wholly owned subsidiary Natco Pharma Inc., a Delaware company, by, among other
`
`things, making, marketing, shipping, using, offering to sell or selling, or causing others to use,
`
`offer to sell, or sell, Natco pharmaceutical products in this Judicial District, and deriving
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`substantial revenue from such activities.
`
`43.
`
`Upon information and belief, Defendant Natco Pharma Ltd. collaborated and/or
`
`acted in concert with Defendants Mylan Pharmaceuticals Inc. and Mylan Inc. to apply for FDA
`
`approval to market and sell a generic version of COPAXONE® 40 mg/mL throughout the
`
`United States, including in Delaware.
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`44.
`
`Upon information and belief, following any FDA approval of Mylan’s ANDA,
`
`Defendants Mylan Pharmaceuticals Inc., Mylan Inc. and Natco Pharma Ltd. will work in concert
`
`with one another to make, use, offer to sell, and/or sell a generic version of COPAXONE® 40
`
`mg/mL throughout the United States, including in Delaware.
`
`45.
`
`Upon information and belief, Defendant Natco Pharma Ltd. has committed, or
`
`aided, abetted, contributed to and/or participated in the commission of, the tortious action of
`
`patent infringement that has led to foreseeable harm and injury to Teva, which manufactures
`
`COPAXONE®, for sale and use throughout the United States, including the State of Delaware.
`
`46.
`
`Upon information and belief, this Court also has personal jurisdiction over
`
`Defendant Natco Pharma Ltd. because it previously has been sued in this district without
`
`challenging this Court’s assertion of personal jurisdiction over it and has availed itself of this
`
`forum by asserting counterclaims for the purpose of litigating a patent infringement dispute. See,
`
`8
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`

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`Case 1:14-cv-01278-GMS Document 1 Filed 10/06/14 Page 9 of 20 PageID #: 9
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`
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`e.g., Cephalon Inc. v. Breckenridge Pharmaceutical Inc. et al., C.A. No. 14-00671 (D. Del.);
`
`Cephalon Inc. et al. v. Breckenridge Pharmaceutical Inc. et al., C.A. No. 11-01070 (D. Del.).
`
`47.
`
`Upon information and belief, Defendant Natco Pharma Ltd.’s systematic and
`
`continuous business contacts within Delaware render it at home in Delaware.
`
`48.
`
`Upon information and belief, this Court also has personal jurisdiction over Natco
`
`Pharma Ltd. under Federal Rule of Civil Procedure 4(k)(2).
`
`49.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Natco Pharma Ltd. for the reasons stated herein, including inter alia Defendant Natco Pharma
`
`Ltd.’s activities in the forum, activities directed at the forum, and significant contacts with the
`
`forum, all of which render Defendant Natco Pharma Ltd. at home in the forum.
`
`The ’250 Patent
`
`BACKGROUND
`
`50.
`
`The ’250 patent, entitled “Low Frequency Glatiramer Acetate Therapy” was duly
`
`and legally issued on July 31, 2012.
`
`51.
`
`52.
`
`patent.
`
`53.
`
`54.
`
`Ety Klinger is the named inventor of the ’250 patent.
`
`Yeda is the sole owner by assignment of all rights, title and interest in the ’250
`
`Teva Ltd. is the exclusive licensee of the ’250 patent.
`
`The ’250 patent is listed in the FDA publication “Approved Drug Products with
`
`Therapeutic Equivalence Evaluations,” commonly referred to as “the Orange Book” (“Orange
`
`Book”), with respect to COPAXONE®.
`
`55.
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`A true and correct copy of the ’250 patent is attached as Exhibit A.
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`9
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`The ’413 Patent
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`56.
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`The ’413 patent, entitled “Low Frequency Glatiramer Acetate Therapy” was duly
`
`and legally issued on March 19, 2013.
`
`57.
`
`58.
`
`patent.
`
`59.
`
`60.
`
`61.
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`Ety Klinger is the named inventor of the ’413 patent.
`
`Yeda is the sole owner by assignment of all rights, title and interest in the ’413
`
`Teva Ltd. is the exclusive licensee of the ’413 patent.
`
`The ’413 patent is listed in the Orange Book with respect to COPAXONE®.
`
`A true and correct copy of the ’413 patent is attached as Exhibit B.
`
`Teva’s COPAXONE® Product
`
`62.
`
`Plaintiffs researched, developed, applied for and obtained FDA approval to
`
`manufacture, sell, promote and/or market a glatiramer acetate product known as COPAXONE®.
`
`63.
`
`Teva USA is the holder of New Drug Application (“NDA”) number 02-0622,
`
`approved by the United States Food and Drug Administration (“FDA”) for the use of glatiramer
`
`acetate, marketed as COPAXONE®, for the treatment of patients with relapsing forms of
`
`multiple sclerosis such as relapsing-remitting multiple sclerosis.
`
`64.
`
`Teva’s innovative COPAXONE® product is supplied as single-dose prefilled
`
`syringes that contain 40 mg/mL glatiramer acetate for injection, manufactured by Teva
`
`Pharmaceutical Industries Ltd., and marketed and sold in the United States by Teva
`
`Neuroscience, Inc.
`
`The Mylan ANDA
`
`65. Mylan filed an ANDA under 21 U.S.C. § 355(j) seeking FDA approval to
`
`manufacture, use, offer for sale, sell in and import into the United States glatiramer acetate
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`10
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`injection, 40 mg/mL, purported to be generic to Teva’s COPAXONE® (“Mylan’s Glatiramer
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`Acetate Product”), prior to the expiration of the ’250 and ’413 patents.
`
`66.
`
`FDA assigned the ANDA for Mylan’s Glatiramer Acetate Product the number
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`206936.
`
`67. Mylan also filed with the FDA a certification pursuant to 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV) alleging that the claims of the ’250 and ’413 patents are invalid,
`
`unenforceable, and/or would not be infringed by the manufacture, use, importation, sale or offer
`
`for sale of its Mylan’s Glatiramer Acetate Product (“Mylan’s Paragraph IV Certification”).
`
`68.
`
`By letter dated August 28, 2014, Mylan notified Teva that it had filed ANDA
`
`No. 206936 seeking approval to market Mylan’s Glatiramer Acetate Product prior to the
`
`expiration of the ’250 and ’413 patents (“Mylan Notice Letter”).
`
`69.
`
`70.
`
`Teva received the Mylan Notice Letter no earlier than August 28, 2014.
`
`This Action is being commenced before the expiration of forty-five days from the
`
`date of receipt of the Mylan Notice Letter.
`
`71.
`
`Upon information and belief, Mylan Inc., Mylan Pharmaceuticals Inc., and Natco
`
`Pharma Ltd. submitted, collaborated and/or acted in concert in the preparation or submission of
`
`ANDA No. 206936.
`
`COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 8,232,250 BY DEFENDANTS
`
`72.
`
`The allegations of the proceeding paragraphs 1–71 are realleged and incorporated
`
`herein by reference.
`
`73.
`
`The use of Mylan’s Glatiramer Acetate Product is covered by one or more claims
`
`of the ’250 patent.
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`11
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`74.
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`The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of Mylan’s Glatiramer Acetate Product would infringe one or more claims of
`
`the ’250 patent.
`
`75.
`
`Under 35 U.S.C. § 271(e)(2)(A), Mylan’s submission to FDA of Mylan’s ANDA
`
`to obtain approval for Mylan’s Glatiramer Acetate Product with a Paragraph IV Certification
`
`related thereto before the expiration of the ’250 patent constitutes an act of infringement, and if
`
`approved, the commercial manufacture, use, offer to sell, sale, or importation of Mylan’s
`
`Glatiramer Acetate Product containing glatiramer acetate, would infringe one or more claims of
`
`the ’250 patent.
`
`76. Mylan was aware of the ’250 patent when engaging in these knowing and
`
`purposeful activities and was aware that filing Mylan’s ANDA with Mylan’s Paragraph IV
`
`Certifications with respect to the ’250 patent constituted an act of infringement of the ’250
`
`patent.
`
`77.
`
`Upon information and belief, Mylan seeks approval from the FDA to
`
`manufacture, use, offer for sale, sell in and import into the United States Mylan’s Glatiramer
`
`Acetate Product indicated for the treatment of patients with relapsing forms of multiple sclerosis.
`
`Further, upon information and belief, Mylan seeks approval from the FDA to manufacture, use,
`
`offer for sale, sell in and import into the United States Mylan’s Glatiramer Acetate Product,
`
`which will be indicated for administration three times per week with at least 48 hours between
`
`every injection.
`
`78.
`
`Upon information and belief, Mylan plans and intends to, and will, infringe the
`
`’250 patent immediately and imminently upon approval of Mylan’s ANDA.
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`12
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`79.
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`Upon information and belief, immediately and imminently upon approval of
`
`Mylan’s ANDA, there will be direct infringement of the claims of the ’250 patent under 35
`
`U.S.C. § 271(a).
`
`80.
`
`Upon information and belief, Mylan, under 35 U.S.C. § 271(b), acted in concert,
`
`actively supported, participated in, encouraged, and/or induced the infringement of one or more
`
`claims of the ’250 patent.
`
`81.
`
`Upon information and belief, Mylan plans and intends to, and will, actively
`
`induce infringement of the ’250 patent when Mylan’s ANDA is approved, and plans and intends
`
`to, and will, do so immediately and imminently upon approval.
`
`82.
`
`Upon information and belief, Mylan knows that Mylan’s Glatiramer Acetate
`
`Product is especially made or adapted for use in infringing the ’250 patent and that Mylan’s
`
`Glatiramer Acetate Product is not suitable for substantial non-infringing uses. Upon information
`
`and belief, Mylan, under 35 U.S.C. § 271(c), plans and intends to, and will, contribute to the
`
`infringement of the ’250 patent immediately and imminently upon approval of the Mylan’s
`
`ANDA.
`
`83.
`
`The foregoing actions by Mylan constitute and/or would constitute infringement
`
`of the ’250 patent, active inducement of infringement of the ’250 patent and/or contribution to
`
`the infringement by others of the ’250 patent.
`
`84.
`
`Upon information and belief, Mylan acted without a reasonable basis for
`
`believing that it would not be liable for infringing the ’250 patent, actively inducing infringement
`
`of the ’250 patent and/or contributing to the infringement by others of the ’250 patent.
`
`85.
`
`Teva will be substantially and irreparably harmed by Mylan’s infringing activities
`
`unless the Court enjoins those activities. Teva will have no adequate remedy at law if Mylan is
`
`13
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`not enjoined from the commercial manufacture, use, offer to sell, sale in and importation into the
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`United States of Mylan’s Glatiramer Acetate Product.
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`86. Mylan’s activities render this case an exceptional one, and Teva is entitled to an
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`award of their reasonable attorney fees under 35 U.S.C. § 285.
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`COUNT II FOR DECLARATORY JUDGMENT OF
`INFRINGMENT OF U.S. PATENT NO. 8,232,250 BY DEFENDANTS
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`87.
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`The allegations of the proceeding paragraphs 1–86 are realleged and incorporated
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`herein by reference.
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`88.
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`Upon information and belief, Mylan plans to begin manufacturing, marketing,
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`selling, offering to sell and/or importing Mylan’s Glatiramer Acetate Product soon after FDA
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`approval of Mylan’s ANDA.
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`89.
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`Such conduct will constitute direct infringement of one or more claims on the
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`’250 patent under 35 U.S.C. § 271(a), inducement of infringement of the ’250 patent under 35
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`U.S.C. § 271(b), and contributory infringement of the ’250 patent under 35 U.S.C. § 271(c).
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`90. Mylan’s infringing patent activity complained of herein is imminent and will
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`begin following FDA approval of Mylan’s ANDA.
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`91.
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`As a result of the foregoing facts, there is a real, substantial, and continuing
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`justiciable controversy between Teva and Mylan as to liability for the infringement of the ’250
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`patent. Mylan’s actions have created in Teva a reasonable apprehension of irreparable harm and
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`loss resulting from Mylan’s threatened imminent actions.
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`92.
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`Upon information and belief, Mylan will knowingly and willfully infringe the
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`’250 patent.
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`93.
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`Teva will be irreparably harmed if Mylan is not enjoined from infringing the ’250
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`patent.
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`Case 1:14-cv-01278-GMS Document 1 Filed 10/06/14 Page 15 of 20 PageID #: 15
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`COUNT III FOR INFRINGEMENT OF U.S. PATENT NO. 8,399,413 BY DEFENDANTS
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`94.
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`The allegations of the proceeding paragraphs 1–93 are realleged and incorporated
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`herein by reference.
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`95.
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`The use of Mylan’s Glatiramer Acetate Product is covered by one or more claims
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`of the ’413 patent.
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`96.
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`The commercial manufacture, use, offer for sale, sale, marketing, distribution
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`and/or importation of Mylan’s Glatiramer Acetate Product would infringe one or more claims of
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`the ’413 patent.
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`97.
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`Under 35 U.S.C. § 271(e)(2)(A), Mylan’s submission to FDA of Mylan’s ANDA
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`to obtain approval for Mylan’s Glatiramer Acetate Product with a Paragraph IV Certification
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`related thereto before the expiration of the ’413 patent constitutes an act of infringement, and if
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`approved, the commercial manufacture, use, offer to sell, sale, or importation of Mylan’s
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`Glatiramer Acetate Product containing glatiramer acetate, would infringe one or more claims of
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`the ’413 patent.
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`98. Mylan was aware of the ’413 patent when engaging in these knowing and
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`purposeful activities and was aware that filing Mylan’s ANDA with Mylan’s Paragraph IV
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`Certifications with respect to the ’413 patent constituted an act of infringement of the ’413
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`patent.
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`99.
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`Upon information and belief, Mylan seeks approval from the FDA to
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`manufacture, use, offer for sale, sell in and import into the United States Mylan’s Glatiramer
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`Acetate Product indicated for the treatment of patients with relapsing forms of multiple sclerosis.
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`Further, upon information and belief, Mylan seeks approval from the FDA to manufacture, use,
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`offer for sale, sell in and import into the United States Mylan’s Glatiramer Acetate Product,
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`which will be indicated for administration three times per week with at least 48 hours between
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`every injection.
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`100. Upon information and belief, Mylan plans and intends to, and will, infringe the
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`’413 patent immediately and imminently upon approval of Mylan’s ANDA.
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`101. Upon information and belief, immediately and imminently upon approval of
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`Mylan’s ANDA, there will be direct infringement of the claims of the ’413 patent under 35
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`U.S.C. § 271(a).
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`102. Upon information and belief, Mylan, under 35 U.S.C. § 271(b), acted in concert,
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`actively supported, participated in, encouraged, and/or induced the infringement of one or more
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`claims of the ’413 patent.
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`103. Upon information and belief, Mylan plans and intends to, and will, actively
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`induce infringement of the ’413 patent when Mylan’s ANDA is approved, and plans and intends
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`to, and will, do so immediately and imminently upon approval.
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`104. Upon information and belief, Mylan knows that Mylan’s Glatiramer Acetate
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`Product is especially made or adapted for use in infringing the ’413 patent and that Mylan’s
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`Glatiramer Acetate Product is not suitable for substantial non-infringing uses. Upon information
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`and belief, Mylan, under 35 U.S.C. § 271(c), plans and intends to, and will, contribute to the
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`infringement of the ’413 patent immediately and imminently upon approval of Mylan’s ANDA.
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`105. The foregoing actions by Mylan constitute and/or would constitute infringement
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`of the ’413 patent, active inducement of infringement of the ’413 patent and/or contribution to
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`the infringement by others of the ’413 patent.
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`Case 1:14-cv-01278-GMS Document 1 Filed 10/06/14 Page 17 of 20 PageID #: 17
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`106. Upon information and belief, Mylan acted without a reasonable basis for
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`believing that it would not be liable for infringing the ’413 patent, actively inducing infringement
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`of the ’413 patent and/or contributing to the infringement by others of the ’413 patent.
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`107. Teva will be substantially and irreparably harmed by Mylan’s infringing activities
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`unless the Court enjoins those activities. Teva will have no adequate remedy at law if Mylan is
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`not enjoined from the commercial manufacture, use, offer to sell, sale in and importation into the
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`United States of Mylan’s Glatiramer Acetate Product.
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`108. Mylan’s activities render this case an exceptional one, and Teva is entitled to an
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`award of their reasonable attorney fees under 35 U.S.C. § 285.
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`COUNT IV FOR DECLARATORY JUDGMENT OF
`INFRINGMENT OF U.S. PATENT NO. 8,399,413 BY DEFENDANTS
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`109. The allegations of the proceeding paragraphs 1–108 are realleged and
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`incorporated herein by reference.
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`110. Upon information and belief, Mylan plans to begin manufacturing, marketing,
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`selling, offering to sell and/or importing Mylan’s Glatiramer Acetate Product soon after FDA
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`approval of Mylan’s ANDA.
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`111. Such conduct will constitute direct infringement of one or more claims on the
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`’413 patent under 35 U.S.C. § 271(a), inducement of infringement of the ’413 patent under 35
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`U.S.C. § 271(b), and contributory infringement of the ’413 patent under 35 U.S.C. § 271(c).
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`112. Mylan’s infringing patent activity complained of herein is imminent and will
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`begin following FDA approval of Mylan’s ANDA.
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`113. As a result of the foregoing facts, there is a real, substantial, and continuing
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`justiciable controversy between Teva and Mylan as to liability for the infringement of the ’413
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`Case 1:14-cv-01278-GMS Document 1 Filed 10/06/14 Page 18 of 20 PageID #: 18
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`patent. Mylan’s actions have created in Teva a reasonable apprehension of irreparable harm and
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`loss resulting from Mylan’s threatened imminent actions.
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`114. Upon information and belief, Mylan will knowingly and willfully infringe the
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`’413 patent.
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`115. Teva will be irreparably harmed if Mylan is not enjoined from infringing the ’413
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`patent.
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`PRAYER FOR RELIEF
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`WHEREFORE, Teva respectfully request the following relief:
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`(a)
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`(b)
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`a judgment that the ’250 and ’413 patents are valid and enforceable;
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`a judgment that Defendants’ submission of the ANDA No. 206936, was an act of
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`infringement of one or more claims of the ’250 and ’413 patents and that the making, using,
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`offering to sell, selling, marketing, distributing, or importing of Mylan’s Glatiramer Acetate
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`Product prior to the expiration of the ’250 and ’413 patents will infringe, actively induce
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`infringement and/or contribute to the infringement of one or more claims of the ’250 and ’413
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`patents;
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`(c)
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`an Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
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`any FDA approval of the Mylan ANDA No. 206936 or any product the use of which infringes
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`the ’250 or ’413 patents, shall be a date that is not earlier than the expiration of the ’250 and ’413
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`patents;
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`(d)
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`an Order pursuant to 35 U.S.C. § 271(e)(4)(B) permanently enjoining Defendants
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`and all persons acting in concert with Defendants from commercially manufacturing, using,
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`offering for sale, selling, marketing, distributing, or importing Mylan’s Glatiramer Acetate
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`Product, or any product the use of which infringes the ’250 or ’413 patents, or inducing or
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`Case 1:14-cv-01278-GMS Document 1 Filed 10/06/14 Page 19 of 20 PageID #: 19
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`contributing to the infringement of the ’250 or ’413 patents until after the expiration of the ’250
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`and ’413 patents;
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`(e)
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`an Order pursuant to 35 U.S.C. § 283 permanently enjoining Defendants and all
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`persons acting in concert with Defendants from commercially manufacturing, using, offering for
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`sale, selling, marketing, distributing, or importing Mylan’s Glatiramer Acetate Product, or any
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`product or compound the use of which infringes the ’250 or ’413 patents, or inducing or
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`contributing to the infringement of the ’250 or ’413 patents, until after the expiration of the ’250
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`and ’413 patents;
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`(f)
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`an Order enjoining Defendants and