Case 1:14-cv-01172-GMS Document 1 Filed 09/10/14 Page 1 of 15 PageID #: 1
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`TEVA PHARMACEUTICALS USA, INC.,
`TEVA PHARMACEUTICAL
`INDUSTRIES LTD., TEVA
`NEUROSCIENCE, INC., and YEDA
`RESEARCH AND DEVELOPMENT CO.,
`LTD.,
`
`
`
`C.A. No.
`
`
`
`
`
`
`Defendants.
`
`COMPLAINT
`
`Plaintiffs Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd., Teva
`
`Neuroscience, Inc. and Yeda Research and Development Co., Ltd. (collectively “Plaintiffs” or
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`“Teva”) bring this action for patent infringement and declaratory judgment against Defendants
`
`Doctor Reddy’s Laboratories, Ltd. (“DRL Ltd.”) and Doctor Reddy’s Laboratories, Inc. (“DRL
`
`Inc.”) (collectively referred to as “DRL”).
`
`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 DRL 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 relapsing-
`
`forms of multiple sclerosis, prior to the expiration of the ’250 and ’413 patents.
`
`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`Plaintiffs,
`
`
`v.
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`
`
`DOCTOR REDDY’S LABORATORIES,
`LTD. AND DOCTOR REDDY’S
`LABORATORIES, INC.,
`
`
`

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`Case 1:14-cv-01172-GMS Document 1 Filed 09/10/14 Page 2 of 15 PageID #: 2
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`Teva
`
`THE PARTIES
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`2.
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`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.
`
`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.
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`Yeda Research and Development Co. Ltd. (“Yeda”) is an Israeli company with its
`
`principal place of business is at P.O. Box 95, Rehovot, 76100, Israel.
`
`DRL
`
`6.
`
`Upon information and belief, Doctor Reddy’s Laboratories Ltd. is a corporation
`
`organized and existing under the laws of India with its principal place of business at 8- 2- 337,
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`Road No. 3, Banjara Hills, Hyderabad, Telangana 500 034, India.
`
`7.
`
`Upon information and belief, Doctor Reddy’s Laboratories Inc. is a corporation
`
`organized and existing under the laws of New Jersey with its principal place of business at 107
`
`College Road East, Princeton, NJ 08540, and is a wholly-owned subsidiary of Doctor Reddy’s
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`Laboratories Ltd.
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`JURISDICTION AND VENUE
`
`8.
`
`9.
`
`This action for patent infringement arises under 35 U.S.C. § 271.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. §§ 1331 and 1338(a), and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`10.
`
`Venue is proper in this Judicial District under 28 U.S.C. § 1400(b) and § 1391.
`
`2
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`

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`11.
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`12.
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`Upon information and belief, this Court has personal jurisdiction over DRL.
`
`DRL has admitted that DRL Inc. and DRL Ltd. are subject to personal jurisdiction
`
`in this district. See Genzyme Corporation et al. v. Dr. Reddy’s Laboratories Ltd. et al., C.A.
`
`No. 13-01506 (D. Del).
`
`13.
`
`Upon information and belief, Defendant Dr. Reddy’s Laboratories, Ltd. (through
`
`its wholly-owned subsidiary Defendant Dr. Reddy’s Laboratories, Inc.) markets, distributes
`
`and/or sells generic drugs throughout the United States and within the State of Delaware. Upon
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`information and belief, Dr. Reddy’s Laboratories, 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. Defendant Dr. Reddy’s
`
`Laboratories, Ltd. 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
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`injury to Teva, which manufactures COPAXONE®, for sale and use throughout the United
`
`States, including the State of Delaware. Dr. Reddy’s Laboratories, Ltd. has applied for FDA
`
`approval to market and sell a generic version of COPAXONE® 40 mg/mL throughout the
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`United States, including in Delaware. Further, upon information and belief, DRL, affiliates of
`
`DRL and/or subsidiaries of DRL are registered with the Delaware Board of Pharmacy as a
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`“Distributor/Manufacturer” and “Pharmacy-Wholesale” of drug products.
`
`14.
`
`Upon information and belief, Defendant Dr. Reddy’s Laboratories, Inc. markets,
`
`distributes and/or sells generic drugs throughout the United States and within the State of
`
`Delaware. Upon information and belief, Dr. Reddy’s Laboratories, 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. Defendant
`
`3
`
`
`

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`Dr. Reddy’s Laboratories, Inc. has also committed, or aided, abetted, contributed to and/or
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`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. Dr. Reddy’s Laboratories, 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.
`
`15.
`
`Upon information and belief, this Court also has personal jurisdiction over DRL
`
`because it previously has been sued in this district, did not challenge this Court’s assertion of
`
`personal jurisdiction over it, and availed itself of this forum by asserting counterclaims for the
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`purpose of litigating a patent infringement dispute. See, e.g., Genzyme Corporation et al. v. Dr.
`
`Reddy’s Laboratories Ltd. et al., C.A. No. 13-01506 (D. Del.); Teijin Ltd. et al. v. Dr. Reddy’s
`
`Laboratories Ltd. et al., C.A. No. 13-01780 (D. Del.); Pfizer et al. v. Dr. Reddy’s Laboratories
`
`Ltd. et al., C.A. No. 13-00989 (D. Del.); Fresenius Kabi USA LLC v. Dr. Reddy’s Laboratories
`
`Ltd. et al., C.A. No. 13-00925 (D. Del.); Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy’s
`
`Laboratories, Ltd. et al., C.A. No. 14-00157 (D. Del.).
`
`BACKGROUND
`
`The ’250 Patent
`
`16.
`
`The ’250 patent, entitled “Low Frequency Glatiramer Acetate Therapy” was duly
`
`and legally issued on July 31, 2012.
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`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
`
`17.
`
`18.
`
`patent.
`
`19.
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`Teva Ltd. is the exclusive licensee of the ’250 patent.
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`4
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`

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`20.
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`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®.
`
`21.
`
`A true and correct copy of the ’250 patent is attached as Exhibit A.
`
`The ’413 Patent
`
`22.
`
`The ’413 patent, entitled “Low Frequency Glatiramer Acetate Therapy” was duly
`
`and legally issued on March 19, 2013.
`
`23.
`
`24.
`
`patent.
`
`25.
`
`26.
`
`27.
`
`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®.
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`A true and correct copy of the ’413 patent is attached as Exhibit B.
`
`Teva’s COPAXONE® Product
`
`28.
`
`Plaintiffs researched, developed, applied for and obtained FDA approval to
`
`manufacture, sell, promote and/or market a glatiramer acetate product known as COPAXONE®.
`
`29.
`
`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.
`
`30.
`
`Teva’s innovative COPAXONE® product is supplied as single-dose prefilled
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`syringes that contain 40mg/ml glatiramer acetate for injection, manufactured by Teva
`
`Pharmaceutical Industries Ltd., and marketed and sold in the United States by Teva
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`Neuroscience, Inc.
`
`5
`
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`

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`The DRL ANDA
`
`31.
`
`DRL 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® (“DRL’s Glatiramer
`
`Acetate Product”), prior to the expiration of the ’250 and ’413 patents.
`
`32.
`
`FDA assigned the ANDA for DRL’s Glatiramer Acetate Product the number
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`206767.
`
`33.
`
`DRL 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 DRL’s Glatiramer Acetate Product (“DRL’s Paragraph IV Certification”).
`
`34.
`
`By letter dated August 1, 2014, DRL notified Teva that it had filed ANDA
`
`No. 206767 seeking approval to market DRL’s Glatiramer Acetate Product prior to the
`
`expiration of the ’250 and ’413 patents (“DRL Notice Letter”).
`
`35.
`
`36.
`
`Teva received the DRL Notice Letter no earlier than August 6, 2014.
`
`This Action is being commenced before the expiration of forty-five days from the
`
`date of receipt of the DRL Notice Letter.
`
`37.
`
`Upon information and belief, both Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s
`
`Laboratories, Ltd. submitted, collaborated and/or acted in concert in the preparation or
`
`submission of ANDA No. 206767.
`
`6
`
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`

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`COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 8,232,250 BY DRL
`
`38.
`
`The allegations of the proceeding paragraphs 1–37 are realleged and incorporated
`
`herein by reference.
`
`39.
`
`The use of DRL’s Glatiramer Acetate Product is covered by one or more claims
`
`of the ’250 patent.
`
`40.
`
`The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of DRL’s Glatiramer Acetate Product would infringe one or more claims of
`
`the ’250 patent.
`
`41.
`
`Under 35 U.S.C. § 271(e)(2)(A), DRL’s submission to FDA of DRL’s ANDA to
`
`obtain approval for DRL’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 DRL’s
`
`Glatiramer Acetate Product containing glatiramer acetate, would infringe one or more claims of
`
`the ’250 patent.
`
`42.
`
`DRL was aware of the ’250 patent when engaging in these knowing and
`
`purposeful activities and was aware that filing DRL’s ANDA with DRL’s Paragraph IV
`
`Certifications with respect to the ’250 patent constituted an act of infringement of the ’250
`
`patent.
`
`43.
`
`Upon information and belief, DRL seeks approval from the FDA to manufacture,
`
`use, offer for sale, sell in and import into the United States DRL’s Glatiramer Acetate Product
`
`indicated for the treatment of patients with relapsing forms of multiple sclerosis. Further, upon
`
`information and belief, DRL seeks approval from the FDA to manufacture, use, offer for sale,
`
`sell in and import into the United States DRL’s Glatiramer Acetate Product, which will be
`
`indicated for administration three times per week with at least 48 hours between every injection.
`7
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`

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`44.
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`Upon information and belief, DRL plans and intends to, and will, infringe the
`
`’250 patent immediately and imminently upon approval of DRL’s ANDA.
`
`45.
`
`Upon information and belief, immediately and imminently upon approval of
`
`DRL’s ANDA, there will be direct infringement of the claims of the ’250 patent under 35 U.S.C.
`
`§ 271(a).
`
`46.
`
`Upon information and belief, DRL, 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.
`
`47.
`
`Upon information and belief, DRL plans and intends to, and will, actively induce
`
`infringement of the ’250 patent when DRL’s ANDA are approved, and plans and intends to, and
`
`will, do so immediately and imminently upon approval.
`
`48.
`
`Upon information and belief, DRL knows that DRL’s Glatiramer Acetate Product
`
`are especially made or adapted for use in infringing the ’250 patent and that DRL’s Glatiramer
`
`Acetate Product is not suitable for substantial non-infringing uses. Upon information and belief,
`
`DRL, 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 DRL’s ANDA.
`
`49.
`
`The foregoing actions by DRL 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.
`
`50.
`
`Upon information and belief, DRL 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.
`
`8
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`

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`51.
`
`Teva will be substantially and irreparably harmed by DRL’s infringing activities
`
`unless the Court enjoins those activities. Teva will have no adequate remedy at law if DRL is
`
`not enjoined from the commercial manufacture, use, offer to sell, sale in and importation into the
`
`United States of DRL’s Glatiramer Acetate Product.
`
`52.
`
`DRL’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 DRL
`
`53.
`
`The allegations of the proceeding paragraphs 1–52 are realleged and incorporated
`
`herein by reference.
`
`54.
`
`Upon information and belief, DRL plans to begin manufacturing, marketing,
`
`selling, offering to sell and/or importing DRL’s Glatiramer Acetate Product soon after FDA
`
`approval of DRL’s ANDA.
`
`55.
`
`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).
`
`56.
`
`DRL’s infringing patent activity complained of herein is imminent and will begin
`
`following FDA approval of DRL’s ANDA.
`
`57.
`
`As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Teva and DRL as to liability for the infringement of the ’250
`
`patent. DRL’s actions have created in Teva a reasonable apprehension of irreparable harm and
`
`loss resulting from DRL’s threatened imminent actions.
`
`58.
`
`Upon information and belief, DRL will knowingly and willfully infringe the ’250
`
`patent.
`
`9
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`59.
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`Teva will be irreparably harmed if DRL is not enjoined from infringing the ’250
`
`patent.
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`COUNT III FOR INFRINGEMENT OF U.S. PATENT NO. 8,399,413 BY DRL
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`60.
`
`The allegations of the proceeding paragraphs 1–59 are realleged and incorporated
`
`herein by reference.
`
`61.
`
`The use of DRL’s Glatiramer Acetate Product is covered by one or more claims
`
`of the ’413 patent.
`
`62.
`
`The commercial manufacture, use, offer for sale, sale, marketing, distribution
`
`and/or importation of DRL’s Glatiramer Acetate Product would infringe one or more claims of
`
`the ’413 patent.
`
`63.
`
`Under 35 U.S.C. § 271(e)(2)(A), DRL’s submission to FDA of DRL’s ANDA to
`
`obtain approval for DRL’s Glatiramer Acetate Product with a Paragraph IV Certification related
`
`thereto before the expiration of the ’413 patent constitutes an act of infringement, and if
`
`approved, the commercial manufacture, use, offer to sell, sale, or importation of DRL’s
`
`Glatiramer Acetate Product containing glatiramer acetate, would infringe one or more claims of
`
`the ’413 patent.
`
`64.
`
`DRL was aware of the ’413 patent when engaging in these knowing and
`
`purposeful activities and was aware that filing DRL’s ANDA with DRL’s Paragraph IV
`
`Certifications with respect to the ’413 patent constituted an act of infringement of the ’413
`
`patent.
`
`65.
`
`Upon information and belief, DRL seeks approval from the FDA to manufacture,
`
`use, offer for sale, sell in and import into the United States DRL’s Glatiramer Acetate Product
`
`indicated for the treatment of patients with relapsing forms of multiple sclerosis. Further, upon
`
`information and belief, DRL seeks approval from the FDA to manufacture, use, offer for sale,
`10
`
`
`

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`sell in and import into the United States DRL’s Glatiramer Acetate Product, which will be
`
`indicated for administration three times per week with at least 48 hours between every injection.
`
`66.
`
`Upon information and belief, DRL plans and intends to, and will, infringe the
`
`’413 patent immediately and imminently upon approval of DRL’s ANDA.
`
`67.
`
`Upon information and belief, immediately and imminently upon approval of
`
`DRL’s ANDA, there will be direct infringement of the claims of the ’413 patent under 35 U.S.C.
`
`§ 271(a).
`
`68.
`
`Upon information and belief, DRL, 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.
`
`69.
`
`Upon information and belief, DRL plans and intends to, and will, actively induce
`
`infringement of the ’413 patent when DRL’s ANDA is approved, and plans and intends to, and
`
`will, do so immediately and imminently upon approval.
`
`70.
`
`Upon information and belief, DRL knows that DRL’s Glatiramer Acetate Product
`
`is especially made or adapted for use in infringing the ’413 patent and that DRL’s Glatiramer
`
`Acetate Product is not suitable for substantial non-infringing uses. Upon information and belief,
`
`DRL, 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 DRL’s ANDA.
`
`71.
`
`The foregoing actions by DRL 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.
`
`11
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`

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`72.
`
`Upon information and belief, DRL 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.
`
`73.
`
`Teva will be substantially and irreparably harmed by DRL’s infringing activities
`
`unless the Court enjoins those activities. Teva will have no adequate remedy at law if DRL is
`
`not enjoined from the commercial manufacture, use, offer to sell, sale in and importation into the
`
`United States of DRL’s Glatiramer Acetate Product.
`
`74.
`
`DRL’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 IV FOR DECLARATORY JUDGMENT OF
`INFRINGMENT OF U.S. PATENT NO. 8,399,413 BY DRL
`
`75.
`
`The allegations of the proceeding paragraphs 1–74 are realleged and incorporated
`
`herein by reference.
`
`76.
`
`Upon information and belief, DRL plans to begin manufacturing, marketing,
`
`selling, offering to sell and/or importing DRL’s Glatiramer Acetate Product soon after FDA
`
`approval of DRL’s ANDA.
`
`77.
`
`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).
`
`78.
`
`DRL’s infringing patent activity complained of herein is imminent and will begin
`
`following FDA approval of DRL’s ANDA.
`
`79.
`
`As a result of the foregoing facts, there is a real, substantial, and continuing
`
`justiciable controversy between Teva and DRL as to liability for the infringement of the ’413
`
`12
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`

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`Case 1:14-cv-01172-GMS Document 1 Filed 09/10/14 Page 13 of 15 PageID #: 13
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`patent. DRL’s actions have created in Teva a reasonable apprehension of irreparable harm and
`
`loss resulting from DRL’s threatened imminent actions.
`
`80.
`
`Upon information and belief, DRL will knowingly and willfully infringe the ’413
`
`patent.
`
`81.
`
`Teva will be irreparably harmed if DRL is not enjoined from infringing the ’413
`
`patent.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Teva respectfully request the following relief:
`
`(a)
`
`(b)
`
`a judgment that the ’250 and ’413 patents are valid and enforceable;
`
`a judgment that DRL’s submission of the ANDA No. 206767, 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 DRL’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 DRL ANDA No. 206767 or any product the use of which infringes the
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`’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 DRL and
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`all persons acting in concert with DRL from commercially manufacturing, using, offering for
`
`sale, selling, marketing, distributing, or importing DRL’s Glatiramer Acetate Product, or any
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`Case 1:14-cv-01172-GMS Document 1 Filed 09/10/14 Page 14 of 15 PageID #: 14
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`product the use of which infringes the ’250 or ’413 patents, or inducing or contributing to the
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`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 DRL and all persons
`
`acting in concert with DRL from commercially manufacturing, using, offering for sale, selling,
`
`marketing, distributing, or importing DRL’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
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`infringement of the ’250 or ’413 patents until after the expiration of the ’250 and ’413 patents;
`
`(f)
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`an Order enjoining DRL and all persons acting in concert with DRL from seeking,
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`obtaining, or maintaining approval of the DRL ANDA No. 206767 before the expiration of the
`
`’250 and ’413 patents;
`
`(g)
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`an award of Teva’s damages or other monetary relief to compensate Teva if DRL
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`engages in the commercial manufacture, use, offer to sell, sale or marketing or distribution in, or
`
`importation into the United States of DRL’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)
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`a judgment that this is an exceptional case and awarding Teva its attorneys’ fees
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`under 35 U.S.C. § 285;
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`an award of Teva’s reasonable costs and expenses in this action; and
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`an award of any further and additional relief to Teva as this Court deems just and
`
`(i)
`
`(j)
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`proper.
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`Case 1:14-cv-01172-GMS Document 1 Filed 09/10/14 Page 15 of 15 PageID #: 15
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`Respectfully submitted,
`
`
`/s/ Karen E. Keller
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`SHAW KELLER LLP
`300 Delaware Avenue, Suite 1120
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`Attorneys for Plaintiffs Teva Pharmaceuticals
`USA, Inc., Teva Pharmaceutical Industries
`Ltd., Teva Neuroscience, Inc. and Yeda
`Research and Development Co., Ltd.
`
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`15
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`
`
`OF COUNSEL:
`David M. Hashmall
`Elizabeth J. Holland
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`(212) 813-8800
`
`Daryl L. Wiesen
`John T. Bennett
`Nicholas K. Mitrokostas
`GOODWIN PROCTER LLP
`Exchange Place
`53 State Street
`Boston, MA 02109
`(617) 570-1000
`
`William G. James II
`GOODWIN PROCTER LLP
`901 New York Ave. NW
`Washington, DC 20001
`(202) 346-4000
`
`Dated: September 10, 2014