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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`C.A. No.
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`TEVA PHARMACEUTICALS USA, INC.,
`TEVA PHARMACEUTICAL
`INDUSTRIES LTD., TEVA
`NEUROSCIENCE, INC., and YEDA
`RESEARCH AND DEVELOPMENT CO.,
`LTD.,
`
`
`SYNTHON PHARMACEUTICALS INC.,
`SYNTHON B.V., and SYNTHON S.R.O.
`BLANSKO,
`
`
`
`Defendants.
`
`
`
`
`
`Plaintiffs,
`
`v.
`
`
`
`
`
`
`
`
`
`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
`
`Synthon Pharmaceuticals Inc., Synthon B.V., and Synthon s.r.o. Blansko, (collectively
`
`“Defendants” or “Synthon”).
`
`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 Synthon 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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`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 2 of 20 PageID #: 2
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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
`
`principal place of business at 1090 Horsham Road, North Wales, Pennsylvania 19454-1090.
`
`3.
`
`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
`
`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 at P.O. Box 95, Rehovot, 76100, Israel.
`
`Synthon
`
`6.
`
`Upon information and belief, Synthon Pharmaceuticals Inc. is a corporation
`
`organized and existing under the laws of North Carolina with its principal place of business at
`
`1007 Slater Road, Suite 150, Durham, NC 27703.
`
`7.
`
`Upon information and belief, Synthon B.V. is a corporation organized and
`
`existing under the laws of the Netherlands with its principal place of business at Microweg 22,
`
`P.O. Box 7071, 6503 CM Nijmegen, The Netherlands.
`
`8.
`
`Upon information and belief, Defendant Synthon s.r.o. Blansko is a Czech entity
`
`having a principal place of business at Brnenska 32/cp.597, 678 17 Blansko, Czech Republic.
`
`2
`
`
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`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 3 of 20 PageID #: 3
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`9.
`
`Upon information and belief, Defendants Synthon Pharmaceuticals Inc. and
`
`Synthon s.r.o. Blansko are sister companies with Synthon Holding B.V. as their ultimate parent
`
`company.
`
`10.
`
`11.
`
`JURISDICTION AND VENUE
`
`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.
`
`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
`
`Synthon Pharmaceuticals, Inc.
`
`14.
`
`Upon information and belief, Defendant Synthon Pharmaceuticals, Inc. markets,
`
`distributes and/or sells generic drugs within the state of Delaware and throughout the United
`
`States.
`
`15.
`
`Upon information and belief, Defendant Synthon 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 rendering it at home in Delaware.
`
`16.
`
`Upon information and belief, Synthon routinely files ANDAs in the United States
`
`and markets dozens of generic pharmaceutical products, including, inter alia, levocetirazine
`
`dihydrochloride, pioglitazone hydrochloride, tamsulosin hydrochloride, and zolpidem tartrate.
`
`17.
`
`Upon information and belief, Synthon has agreements with pharmaceutical
`
`retailers, wholesalers or distributors providing for the distribution of its products in the State of
`
`3
`
`
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`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 4 of 20 PageID #: 4
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`Delaware, including, inter alia, levocetirazine dihydrochloride, pioglitazone hydrochloride,
`
`tamsulosin hydrochloride, and zolpidem tartrate.
`
`18.
`
`Upon information and belief, Defendant Synthon Pharmaceuticals Inc. has also
`
`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.
`
`19.
`
`20.
`
`Teva sells COPAXONE® in the State of Delaware.
`
`Upon information and belief, Defendant Synthon 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.
`
`21.
`
`Upon information and belief, Synthon Pharmaceuticals Inc. will market, sell, and
`
`offer for sale its proposed generic version of COPAXONE® 40 mg/mL in the State of Delaware
`
`following FDA approval of that product.
`
`22.
`
`Upon information and belief, as a result of Synthon’s marketing, selling, or
`
`offering for sale of its generic version of COPAXONE® 40 mg/mL in the State of Delaware,
`
`Teva will lose sales of COPAXONE® and be injured in the State of Delaware.
`
`23.
`
`By letter dated October 8, 2014, Synthon Pharmaceuticals, Inc. sent a letter to
`
`Teva Pharmaceuticals USA, Inc., a Delaware corporation, stating that it had filed ANDA
`
`No. 206873 seeking approval to market Synthon’s Glatiramer Acetate Product prior to the
`
`expiration of the ’250 and ’413 patents (“Synthon Notice Letter”).
`
`24.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Synthon Pharmaceuticals, Inc. for the reasons stated herein, including, inter alia, Defendant
`
`4
`
`
`
`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 5 of 20 PageID #: 5
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`Synthon Pharmaceuticals Inc.’s activities in the forum, activities directed at the forum, and
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`significant contacts with the forum, all of which also render Defendant Synthon Pharmaceuticals,
`
`Inc. at home in the forum.
`
`25.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Synthon B.V.
`
`26.
`
`Upon information and belief, Defendant Synthon B.V. is partnering with
`
`Defendant Synthon Pharmaceuticals 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://www.synthon.com/Corporate/News/PressReleases/Synthon-Announces-Filing-of-
`
`Glatiramer-Acetate-40-mg-mL-ANDA-Containing-a-Paragraph-IV-Certification, accessed
`
`10/14/14; see also “Synthon announces successful outcome of the Phase III GATE study with its
`
`generic glatiramer acetate.” Business Wire, March 27, 2014.
`
`27.
`
`Upon information and belief, Defendant Synthon B.V. collaborated and/or acted
`
`in concert with Defendant Synthon Pharmaceuticals 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.
`
`28.
`
`Upon information and belief, Defendant Synthon B.V. (through its subsidiary
`
`Defendant Synthon Pharmaceuticals, Inc.) markets, distributes and/or sells generic drugs within
`
`the State of Delaware and throughout the United States.
`
`29.
`
`Upon information and belief, Defendant Synthon B.V. 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, rendering it at
`
`home in Delaware.
`
`5
`
`
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`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 6 of 20 PageID #: 6
`
`30.
`
`Upon information and belief, Defendant Synthon B.V. 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.
`
`Defendant Synthon B.V. has applied 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, Synthon B.V. caused its agent Synthon
`
`Pharmaceuticals Inc. to send the Synthon Notice Letter to Teva, a Delaware corporation.
`
`32.
`
`Upon information and belief, as a result of Synthon B.V.’s conduct, Synthon will
`
`market, sell, and offer for sale its generic version of COPAXONE® 40 mg/mL in the State of
`
`Delaware following FDA approval of that product.
`
`33.
`
`Upon information and belief, as a result of Synthon’s marketing, selling, or
`
`offering for sale of its generic version of COPAXONE® 40 mg/mL in the State of Delaware,
`
`Teva will lose sales of COPAXONE® and be injured in the State of Delaware.
`
`34.
`
`This Court also has personal jurisdiction over Synthon B.V. under Federal Rule of
`
`Civil Procedure 4(k)(2).
`
`35.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Synthon B.V. for the reasons stated herein, including, inter alia, of Defendant Synthon B.V.’s
`
`activities in the forum, activities directed at the forum, and significant contacts with the forum,
`
`all of which also render Defendant Synthon B.V. at home in the forum.
`
`36.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Synthon s.r.o. Blansko.
`
`6
`
`
`
`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 7 of 20 PageID #: 7
`
`37.
`
`Upon information and belief, Defendant Synthon s.r.o. Blansko is partnering with
`
`Defendant Synthon Pharmaceuticals 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://www.synthon.com/Corporate/News/PressReleases/Synthon-Announces-Filing-of-
`
`Glatiramer-Acetate-40-mg-mL-ANDA-Containing-a-Paragraph-IV-Certification, accessed
`
`10/14/14; see also “Synthon announces successful outcome of the Phase III GATE study with its
`
`generic glatiramer acetate.” Business Wire, March 27, 2014.
`
`38.
`
`Upon information and belief, Defendant Synthon s.r.o. Blansko collaborated
`
`and/or acted in concert with Defendant Synthon Pharmaceuticals 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.
`
`39.
`
`Upon information and belief, Defendant Synthon s.r.o. Blansko (through its
`
`partner subsidiary Defendant Synthon Pharmaceuticals Inc.) markets, distributes and/or sells
`
`generic drugs within the State of Delaware and throughout the United States.
`
`40.
`
`Upon information and belief, Defendant Synthon s.r.o. Blansko 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, rendering
`
`it at home in Delaware.
`
`41.
`
`Upon information and belief, Defendant Synthon s.r.o. Blansko 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.
`
`7
`
`
`
`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 8 of 20 PageID #: 8
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`Defendant Synthon s.r.o. Blankso has applied for FDA approval to market and sell a generic
`
`version of COPAXONE® 40 mg/mL throughout the United States, including in Delaware.
`
`42.
`
`Upon information and belief, Synthon s.r.o. Blansko caused its agent Synthon
`
`Pharmaceuticals Inc. to send the Synthon Notice Letter to Teva, a Delaware corporation.
`
`43.
`
`Upon information and belief, as a result of Synthon s.r.o. Blansko’s conduct,
`
`Synthon will market, sell, and offer for sale its generic version of COPAXONE® 40 mg/mL in
`
`the State of Delaware following FDA approval of that product.
`
`44.
`
`Upon information and belief, as a result of Synthon’s marketing, selling, or
`
`offering for sale of its generic version of COPAXONE® 40 mg/mL in the State of Delaware,
`
`Teva will lose sales of COPAXONE® and be injured in the State of Delaware.
`
`45.
`
`This Court also has personal jurisdiction over Synthon s.r.o. Blansko under
`
`Federal Rule of Civil Procedure 4(k)(2).
`
`46.
`
`Upon information and belief, this Court has personal jurisdiction over Defendant
`
`Synthon s.r.o. Blansko for the reasons stated herein, including, inter alia, of Defendant Synthon
`
`s.r.o. Blansko’s activities in the forum, activities directed at the forum, and significant contacts
`
`with the forum, all of which also render Defendant Synthon s.r.o. Blansko at home in the forum.
`
`47.
`
`Upon information and belief, following any FDA approval of Synthon’s ANDA,
`
`Defendants Synthon Pharmaceuticals Inc., Synthon B.V., and Synthon s.r.o. Blansko will work
`
`in concert with one another to make, use, offer to sell, and sell a generic version of
`
`COPAXONE® 40 mg/mL throughout the United States, including in Delaware.
`
`48.
`
`Upon information and belief, Synthon B.V. and Synthon s.r.o. Blansko will
`
`manufacture Synthon’s proposed generic version of COPAXONE® 40 mg/mL on behalf of
`
`Synthon Pharmaceuticals Inc. and Synthon Pharmaceuticals Inc. will act as the agent of Synthon
`
`8
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`
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`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 9 of 20 PageID #: 9
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`B.V. and/or Synthon s.r.o. Blansko for sale of that product in the United States, including
`
`Delaware.
`
`The ’250 Patent
`
`BACKGROUND
`
`49.
`
`The ’250 patent, entitled “Low Frequency Glatiramer Acetate Therapy” was duly
`
`and legally issued on July 31, 2012.
`
`50.
`
`51.
`
`patent.
`
`52.
`
`53.
`
`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®.
`
`54.
`
`A true and correct copy of the ’250 patent is attached as Exhibit A.
`
`The ’413 Patent
`
`55.
`
`The ’413 patent, entitled “Low Frequency Glatiramer Acetate Therapy” was duly
`
`and legally issued on March 19, 2013.
`
`56.
`
`57.
`
`patent.
`
`58.
`
`59.
`
`60.
`
`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.
`
`9
`
`
`
`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 10 of 20 PageID #: 10
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`Teva’s COPAXONE® Product
`
`61.
`
`Plaintiffs researched, developed, applied for and obtained FDA approval to
`
`manufacture, sell, promote and/or market a glatiramer acetate product known as COPAXONE®.
`
`62.
`
`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.
`
`63.
`
`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 Synthon ANDA
`
`64.
`
`Synthon 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
`
`injection, 40 mg/mL, purported to be generic to Teva’s COPAXONE® (“Synthon’s Glatiramer
`
`Acetate Product”), prior to the expiration of the ’250 and ’413 patents.
`
`65.
`
`FDA assigned the ANDA for Synthon’s Glatiramer Acetate Product the number
`
`206873.
`
`66.
`
`Synthon 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 Synthon’s Glatiramer Acetate Product (“Synthon’s Paragraph IV Certification”).
`
`10
`
`
`
`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 11 of 20 PageID #: 11
`
`67.
`
`By letter dated October 8, 2014, Synthon notified Teva that it had filed ANDA
`
`No. 206873 seeking approval to market Synthon’s Glatiramer Acetate Product prior to the
`
`expiration of the ’250 and ’413 patents (“Synthon Notice Letter”).
`
`68.
`
`69.
`
`Teva received the Synthon Notice Letter no earlier than October 9, 2014.
`
`This Action is being commenced before the expiration of forty-five days from the
`
`date of receipt of the Synthon Notice Letter.
`
`70.
`
`Upon information and belief, Synthon Pharmaceuticals Inc., Synthon B.V., and
`
`Synthon s.r.o. Blansko submitted, collaborated and/or acted in concert in the preparation or
`
`submission of ANDA No. 206873.
`
`COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 8,232,250 BY DEFENDANTS
`
`71.
`
`The allegations of the proceeding paragraphs 1–70 are realleged and incorporated
`
`herein by reference.
`
`72.
`
`The use of Synthon’s Glatiramer Acetate Product is covered by one or more
`
`claims of the ’250 patent.
`
`73.
`
`The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of Synthon’s Glatiramer Acetate Product would infringe one or more claims
`
`of the ’250 patent.
`
`74.
`
`Under 35 U.S.C. § 271(e)(2)(A), Synthon’s submission to FDA of Synthon’s
`
`ANDA to obtain approval for Synthon’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 Synthon’s Glatiramer Acetate Product containing glatiramer acetate, would
`
`infringe one or more claims of the ’250 patent.
`
`11
`
`
`
`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 12 of 20 PageID #: 12
`
`75.
`
`Synthon was aware of the ’250 patent when engaging in these knowing and
`
`purposeful activities and was aware that filing Synthon’s ANDA with Synthon’s Paragraph IV
`
`Certification with respect to the ’250 patent constituted an act of infringement of the ’250 patent.
`
`76.
`
`Upon information and belief, Synthon seeks approval from the FDA to
`
`manufacture, use, offer for sale, sell in and import into the United States Synthon’s Glatiramer
`
`Acetate Product indicated for the treatment of patients with relapsing forms of multiple sclerosis.
`
`Further, upon information and belief, Synthon seeks approval from the FDA to manufacture, use,
`
`offer for sale, sell in and import into the United States Synthon’s Glatiramer Acetate Product,
`
`which will be indicated for administration three times per week with at least 48 hours between
`
`every injection.
`
`77.
`
`Upon information and belief, Synthon plans and intends to, and will, infringe the
`
`’250 patent immediately and imminently upon approval of Synthon’s ANDA.
`
`78.
`
`Upon information and belief, immediately and imminently upon approval of
`
`Synthon’s ANDA, there will be direct infringement of the claims of the ’250 patent under 35
`
`U.S.C. § 271(a).
`
`79.
`
`Upon information and belief, Synthon, 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.
`
`80.
`
`Upon information and belief, Synthon plans and intends to, and will, actively
`
`induce infringement of the ’250 patent when Synthon’s ANDA is approved, and plans and
`
`intends to, and will, do so immediately and imminently upon approval.
`
`81.
`
`Upon information and belief, Synthon knows that Synthon’s Glatiramer Acetate
`
`Product is especially made or adapted for use in infringing the ’250 patent and that Synthon’s
`
`12
`
`
`
`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 13 of 20 PageID #: 13
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`Glatiramer Acetate Product is not suitable for substantial non-infringing uses. Upon information
`
`and belief, Synthon, 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 Synthon’s
`
`ANDA.
`
`82.
`
`The foregoing actions by Synthon 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.
`
`83.
`
`Upon information and belief, Synthon 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.
`
`84.
`
`Teva will be substantially and irreparably harmed by Synthon’s infringing
`
`activities unless the Court enjoins those activities. Teva will have no adequate remedy at law if
`
`Synthon is not enjoined from the commercial manufacture, use, offer to sell, sale in and
`
`importation into the United States of Synthon’s Glatiramer Acetate Product.
`
`85.
`
`Synthon’s activities render this case an exceptional one, and Teva is entitled to an
`
`award of their reasonable attorney fees under 35 U.S.C. § 285.
`
`COUNT II FOR DECLARATORY JUDGMENT OF
`INFRINGMENT OF U.S. PATENT NO. 8,232,250 BY DEFENDANTS
`
`86.
`
`The allegations of the proceeding paragraphs 1–85 are realleged and incorporated
`
`herein by reference.
`
`87.
`
`Upon information and belief, Synthon plans to begin manufacturing, marketing,
`
`selling, offering to sell and/or importing Synthon’s Glatiramer Acetate Product soon after FDA
`
`approval of Synthon’s ANDA.
`
`13
`
`
`
`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 14 of 20 PageID #: 14
`
`88.
`
`Such conduct will constitute direct infringement of one or more claims on the
`
`’250 patent under 35 U.S.C. § 271(a), inducement of infringement of the ’250 patent under 35
`
`U.S.C. § 271(b), and contributory infringement of the ’250 patent under 35 U.S.C. § 271(c).
`
`89.
`
`Synthon’s infringing patent activity complained of herein is imminent and will
`
`begin following FDA approval of Synthon’s ANDA.
`
`90.
`
`As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Teva and Synthon as to liability for the infringement of the ’250
`
`patent. Synthon’s actions have created in Teva a reasonable apprehension of irreparable harm
`
`and loss resulting from Synthon’s threatened imminent actions.
`
`91.
`
`Upon information and belief, Synthon will knowingly and willfully infringe the
`
`’250 patent.
`
`92.
`
`Teva will be irreparably harmed if Synthon is not enjoined from infringing the
`
`’250 patent.
`
`COUNT III FOR INFRINGEMENT OF U.S. PATENT NO. 8,399,413 BY DEFENDANTS
`
`93.
`
`The allegations of the proceeding paragraphs 1–92 are realleged and incorporated
`
`herein by reference.
`
`94.
`
`The use of Synthon’s Glatiramer Acetate Product is covered by one or more
`
`claims of the ’413 patent.
`
`95.
`
`The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of Synthon’s Glatiramer Acetate Product would infringe one or more claims
`
`of the ’413 patent.
`
`96.
`
`Under 35 U.S.C. § 271(e)(2)(A), Synthon’s submission to FDA of Synthon’s
`
`ANDA to obtain approval for Synthon’s Glatiramer Acetate Product with a Paragraph IV
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`Certification related thereto before the expiration of the ’413 patent constitutes an act of
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`14
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`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 15 of 20 PageID #: 15
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`infringement, and if approved, the commercial manufacture, use, offer to sell, sale, or
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`importation of Synthon’s Glatiramer Acetate Product containing glatiramer acetate, would
`
`infringe one or more claims of the ’413 patent.
`
`97.
`
`Synthon was aware of the ’413 patent when engaging in these knowing and
`
`purposeful activities and was aware that filing Synthon’s ANDA with Synthon’s Paragraph IV
`
`Certification with respect to the ’413 patent constituted an act of infringement of the ’413 patent.
`
`98.
`
`Upon information and belief, Synthon seeks approval from the FDA to
`
`manufacture, use, offer for sale, sell in and import into the United States Synthon’s Glatiramer
`
`Acetate Product indicated for the treatment of patients with relapsing forms of multiple sclerosis.
`
`Further, upon information and belief, Synthon seeks approval from the FDA to manufacture, use,
`
`offer for sale, sell in and import into the United States Synthon’s Glatiramer Acetate Product,
`
`which will be indicated for administration three times per week with at least 48 hours between
`
`every injection.
`
`99.
`
`Upon information and belief, Synthon plans and intends to, and will, infringe the
`
`’413 patent immediately and imminently upon approval of Synthon’s ANDA.
`
`100. Upon information and belief, immediately and imminently upon approval of
`
`Synthon’s ANDA, there will be direct infringement of the claims of the ’413 patent under 35
`
`U.S.C. § 271(a).
`
`101. Upon information and belief, Synthon, 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 ’413 patent.
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`15
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`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 16 of 20 PageID #: 16
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`102. Upon information and belief, Synthon plans and intends to, and will, actively
`
`induce infringement of the ’413 patent when Synthon’s ANDA is approved, and plans and
`
`intends to, and will, do so immediately and imminently upon approval.
`
`103. Upon information and belief, Synthon knows that Synthon’s Glatiramer Acetate
`
`Product is especially made or adapted for use in infringing the ’413 patent and that Synthon’s
`
`Glatiramer Acetate Product is not suitable for substantial non-infringing uses. Upon information
`
`and belief, Synthon, under 35 U.S.C. § 271(c), plans and intends to, and will, contribute to the
`
`infringement of the ’413 patent immediately and imminently upon approval of the Synthon’s
`
`ANDA.
`
`104. The foregoing actions by Synthon constitute and/or would constitute infringement
`
`of the ’413 patent, active inducement of infringement of the ’413 patent and/or contribution to
`
`the infringement by others of the ’413 patent.
`
`105. Upon information and belief, Synthon acted without a reasonable basis for
`
`believing that it would not be liable for infringing the ’413 patent, actively inducing infringement
`
`of the ’413 patent and/or contributing to the infringement by others of the ’413 patent.
`
`106. Teva will be substantially and irreparably harmed by Synthon’s infringing
`
`activities unless the Court enjoins those activities. Teva will have no adequate remedy at law if
`
`Synthon is not enjoined from the commercial manufacture, use, offer to sell, sale in and
`
`importation into the United States of Synthon’s Glatiramer Acetate Product.
`
`107. Synthon’s activities render this case an exceptional one, and Teva is entitled to an
`
`award of their reasonable attorney fees under 35 U.S.C. § 285.
`
`16
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`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 17 of 20 PageID #: 17
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`COUNT IV FOR DECLARATORY JUDGMENT OF
`INFRINGMENT OF U.S. PATENT NO. 8,399,413 BY DEFENDANTS
`
`108. The allegations of the proceeding paragraphs 1–107 are realleged and
`
`incorporated herein by reference.
`
`109. Upon information and belief, Synthon plans to begin manufacturing, marketing,
`
`selling, offering to sell and/or importing Synthon’s Glatiramer Acetate Product soon after FDA
`
`approval of Synthon’s ANDA.
`
`110. Such conduct will constitute direct infringement of one or more claims on the
`
`’413 patent under 35 U.S.C. § 271(a), inducement of infringement of the ’413 patent under 35
`
`U.S.C. § 271(b), and contributory infringement of the ’413 patent under 35 U.S.C. § 271(c).
`
`111. Synthon’s infringing patent activity complained of herein is imminent and will
`
`begin following FDA approval of Synthon’s ANDA.
`
`112. As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Teva and Synthon as to liability for the infringement of the ’413
`
`patent. Synthon’s actions have created in Teva a reasonable apprehension of irreparable harm
`
`and loss resulting from Synthon’s threatened imminent actions.
`
`113. Upon information and belief, Synthon will knowingly and willfully infringe the
`
`’413 patent.
`
`114. Teva will be irreparably harmed if Synthon is not enjoined from infringing the
`
`’413 patent.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Teva respectfully request the following relief:
`
`(a)
`
`a judgment that the ’250 and ’413 patents are valid and enforceable;
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`17
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`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 18 of 20 PageID #: 18
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`(b)
`
`a judgment that Defendants’ submission of the ANDA No. 206873, was an act of
`
`infringement of one or more claims of the ’250 and ’413 patents and that the making, using,
`
`offering to sell, selling, marketing, distributing, or importing of Synthon’s Glatiramer Acetate
`
`Product prior to the expiration of the ’250 and ’413 patents will infringe, actively induce
`
`infringement and/or contribute to the infringement of one or more claims of the ’250 and ’413
`
`patents;
`
`(c)
`
`an Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
`
`any FDA approval of the Synthon ANDA No. 206873 or any product the use of which infringes
`
`the ’250 or ’413 patents, shall be a date that is not earlier than the expiration of the ’250 and ’413
`
`patents;
`
`(d)
`
`an Order pursuant to 35 U.S.C. § 271(e)(4)(B) permanently enjoining Defendants
`
`and all persons acting in concert with Defendants from commercially manufacturing, using,
`
`offering for sale, selling, marketing, distributing, or importing Synthon’s Glatiramer Acetate
`
`Product, or any product the use of which infringes the ’250 or ’413 patents, or inducing or
`
`contributing to the infringement of the ’250 or ’413 patents until after the expiration of the ’250
`
`and ’413 patents;
`
`(e)
`
`an Order pursuant to 35 U.S.C. § 283 permanently enjoining Defendants and all
`
`persons acting in concert with Defendants from commercially manufacturing, using, offering for
`
`sale, selling, marketing, distributing, or importing Synthon’s Glatiramer Acetate Product, or any
`
`product or compound the use of which infringes the ’250 or ’413 patents, or inducing or
`
`contributing to the infringement of the ’250 or ’413 patents, until after the expiration of the ’250
`
`and ’413 patents;
`
`18
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`Case 1:14-cv-01419-GMS Document 1 Filed 11/18/14 Page 19 of 20 PageID #: 19
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`(f)
`
`an Order enjoining Defendants and all persons acting in concert with Defendants
`
`from seeking, obtaining, or maintaining approval of the Synthon ANDA No. 206873 before the
`
`expiration of the ’250 and ’413 patents;
`
`(g)
`
`an award of Teva’s damages or other monetary relief to compensate Teva if
`
`Defendants engages in the commercial manufacture, use, offer to sell, sale or marketing or
`
`distribution in, or importation into the United States of Synthon’s Glatiramer Acetate Product, or
`
`any product or compound the use of which infringes the ’250 or ’413 patents, or the inducement
`
`or contribution of the foregoing, prior to the expiration of the ’250 and ’413 patents in
`
`accordance with 35 U.S.C. § 271(e)(4)(C);
`
`(h)
`
`a judgment that this is an exceptional case and an award to Teva of its at