Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 1 of 119 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`
`
`ALLERGAN, INC.,
`
`
`
` Plaintiff,
`
`v.
`
`TEVA PHARMACEUTICALS USA, INC.,
`TEVA PHARMACEUTICAL INDUSTRIES
`LTD., APOTEX, INC., APOTEX CORP.,
`AKORN, INC., MYLAN
`PHARMACEUTICALS, INC., and MYLAN,
`INC.,
`
`ALLERGAN, INC.’S COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Allergan, Inc. (“Allergan” or “Plaintiff”), for its Complaint against Defendants
`
`
`
`
`
`Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. (collectively “Teva”);
`
`Apotex, Inc. and Apotex Corp. (collectively “Apotex”); Akorn, Inc. (“Akorn”); and Mylan
`
`Pharmaceuticals, Inc. and Mylan, Inc. (collectively “Mylan”), by its attorneys, alleges as follows:
`
`The Nature of the Action
`
`This is an action for infringement of United States Patent Nos. 8,629,111 (“the
`
`1.
`
`‘111 Patent”), 8,633,162 (“the ‘162 Patent”), 8,642,556 (“the ‘556 Patent”), 8,648,048 (“the ‘048
`
`Patent”), and 8,685,930 (“the ‘930 Patent”) under the Patent Laws of the United States, 35
`
`U.S.C. § 1 et seq., relating to Allergan’s treatment for chronic dry eye, Restasis®.
`
`2.
`
`This is also an action under 35 U.S.C. §§ 2201-02 for a declaratory judgment of
`
`infringement of the ‘111, ‘556, and ‘930 Patents under 35 U.S.C. § 271 (a), (b), and (c), and for a
`
`
`
`1
`
` Civil Action No. 2:15-cv-1455
`
`
`
` JURY TRIAL DEMANDED
`
`
`
` Defendants.
`
`
`
`
`
`0001
`
`MYLAN - EXHIBIT 1023
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`
`
`ALLERGAN, INC.,
`
`
`
` Plaintiff,
`
`v.
`
`TEVA PHARMACEUTICALS USA, INC.,
`TEVA PHARMACEUTICAL INDUSTRIES
`LTD., APOTEX, INC., APOTEX CORP.,
`AKORN, INC., MYLAN
`PHARMACEUTICALS, INC., and MYLAN,
`INC.,
`
`ALLERGAN, INC.’S COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Allergan, Inc. (“Allergan” or “Plaintiff”), for its Complaint against Defendants
`
`
`
`
`
`Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. (collectively “Teva”);
`
`Apotex, Inc. and Apotex Corp. (collectively “Apotex”); Akorn, Inc. (“Akorn”); and Mylan
`
`Pharmaceuticals, Inc. and Mylan, Inc. (collectively “Mylan”), by its attorneys, alleges as follows:
`
`The Nature of the Action
`
`This is an action for infringement of United States Patent Nos. 8,629,111 (“the
`
`1.
`
`‘111 Patent”), 8,633,162 (“the ‘162 Patent”), 8,642,556 (“the ‘556 Patent”), 8,648,048 (“the ‘048
`
`Patent”), and 8,685,930 (“the ‘930 Patent”) under the Patent Laws of the United States, 35
`
`U.S.C. § 1 et seq., relating to Allergan’s treatment for chronic dry eye, Restasis®.
`
`2.
`
`This is also an action under 35 U.S.C. §§ 2201-02 for a declaratory judgment of
`
`infringement of the ‘111, ‘556, and ‘930 Patents under 35 U.S.C. § 271 (a), (b), and (c), and for a
`
`
`
`1
`
` Civil Action No. 2:15-cv-1455
`
`
`
` JURY TRIAL DEMANDED
`
`
`
` Defendants.
`
`
`
`
`
`0001
`
`MYLAN - EXHIBIT 1023
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 2 of 119 PageID #: 2
`
`declaratory judgment of infringement of the ‘162 and ‘048 Patents under 35 U.S.C. § 271 (b) and
`
`(c).
`
`The Parties
`
`Allergan is a corporation organized and existing under the laws of the State of
`
`3.
`
`Delaware with a principal place of business at 2525 Dupont Drive, Irvine, California 92612.
`
`4.
`
`Allergan operates a facility in Waco, Texas where it manufactures and distributes
`
`numerous pharmaceutical products, including RESTASIS® (cyclosporine ophthalmic emulsion,
`
`0.05%). Allergan coordinates the nationwide distribution of RESTASIS® from Texas. Allergan
`
`employs over 800 individuals in Texas, more than in any other state except California.
`
`5.
`
`On information and belief, defendant Teva Pharmaceuticals USA, Inc. (“Teva
`
`USA”) is a corporation organized and existing under the laws of the State of Delaware with its
`
`principal place of business located at 1090 Horsham Road, North Wales, Pennsylvania, 19454-
`
`1090.
`
`6.
`
`On information and belief, Teva USA is a wholly owned subsidiary of Teva
`
`Pharmaceutical Industries Ltd.
`
`7.
`
`On information and belief, Teva Pharmaceutical Industries Ltd. (“Teva
`
`Pharmaceutical”) is a corporation organized and existing under the laws of Israel, with a place of
`
`business at 5 Basel St., Petach Tikva Israel, 49131.
`
`8.
`
`On information and belief, Teva USA and Teva Pharmaceutical are agents of each
`
`other and/or work in active concert with respect to the development, regulatory approval,
`
`marketing, sale, and distribution of pharmaceutical products.
`
`
`
`2
`
`0002
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 3 of 119 PageID #: 3
`
`9.
`
`On information and belief, Apotex, Inc. is a corporation organized and existing
`
`under the laws of Canada with its principal place of business located at 150 Signet Drive,
`
`Toronto, Ontario, Canada M9L 1T9.
`
`10.
`
`On information and belief, Apotex Corp. is a corporation organized and existing
`
`under the laws of the State of Delaware with its principal place of business located at 2400 North
`
`Commerce Parkway, Suite 400, Weston, Florida, 33326.
`
`11.
`
`On information and belief, Apotex, Corp. is a wholly-owned subsidiary of Apotex
`
`Inc.
`
`12.
`
`On information and belief, Apotex, Inc. and Apotex Corp. are agents of each
`
`other and/or work in active concert with respect to the development, regulatory approval,
`
`marketing, sale, and distribution of pharmaceutical products.
`
`13.
`
`On information and belief, Akorn is a corporation organized and existing under
`
`the laws of the State of Louisiana with its principal place of business located at 1925 West Field
`
`Court, Suite 300, Lake Forest, Illinois 60045, and a registered agent located at 211 East 7th
`
`Street, Suite 620, Austin, Texas 78701-3218.
`
`14.
`
`On information and belief, Mylan Pharmaceuticals, Inc. is a corporation
`
`organized and existing under the laws of the State of West Virginia with its principal place of
`
`business located at 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, and a
`
`registered agent located at 211 East 7th Street, Suite 620, Austin, Texas 78701-3218.
`
`15.
`
`On information and belief, Mylan, Inc. is a corporation organized and existing
`
`under the laws of the Commonwealth of Pennsylvania, having its principal place of business
`
`located at 1500 Corporate Drive, Canonsburg, Pennsylvania 15317.
`
`
`
`3
`
`0003
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 4 of 119 PageID #: 4
`
`16.
`
`On information and belief, Mylan Pharmaceuticals, Inc. is a wholly-owned
`
`subsidiary of Mylan, Inc.
`
`17.
`
`On information and belief, Mylan Pharmaceuticals, Inc. and Mylan, Inc. are
`
`agents of each other and/or work in active concert with respect to the development, regulatory
`
`approval, marketing, sale and distribution of pharmaceutical products.
`
`Venue and Jurisdiction
`
`This action arises under the patent laws of the United States of America, 35
`
`18.
`
`U.S.C. § 1, et seq. This Court has subject matter jurisdiction over the action under 28 U.S.C. §§
`
`1331 and 1338.
`
`19.
`
`This Court has personal jurisdiction over each of the Defendants by virtue of the
`
`fact that, inter alia, each Defendant has committed, or aided, abetted, induced, contributed to,
`
`and/or participated in the commission of, a tortious act of patent infringement that has led to
`
`foreseeable harm and injury to Plaintiffs in Texas. This Court has personal jurisdiction over each
`
`of the Defendants for the additional reasons set forth below and for other reasons that will be
`
`presented to the Court if such personal jurisdiction is challenged.
`
`A.
`
`20.
`
`Personal Jurisdiction over Teva USA and Teva Pharmaceutical
`
`This Court has personal jurisdiction over Teva USA and Teva Pharmaceutical by
`
`virtue of their systematic and continuous contact with this jurisdiction, as alleged herein, and
`
`because of the injury to Allergan in this forum arising from Teva’s ANDA filing and the causes
`
`of action Allergan alleges. See Allergan, Inc. v. Actavis, Inc. et al., No 2:14-cv-0063, 2014 WL
`
`7336692, at *5-8 (E.D. Tex. December 23, 2014).
`
`21.
`
`On information and belief, Teva submitted ANDA No. 203880 under section
`
`505(j) of the FDCA, 21 U.S.C. § 355(j), seeking FDA approval to engage in the commercial
`
`
`
`4
`
`0004
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 5 of 119 PageID #: 5
`
`manufacture, use, importation, sale, or offer for sale of Cyclosporine Ophthalmic Emulsion,
`
`0.05%, a generic version of Allergan’s RESTASIS® product.
`
`22.
`
`On information and belief, Teva USA and Teva Pharmaceutical are agents of each
`
`other and/or work in active concert with respect to the development, regulatory approval,
`
`marketing, sale and distribution of pharmaceutical products, including the generic Cyclosporine
`
`Ophthalmic Emulsion, 0.05% described in ANDA No. 203880.
`
`23.
`
`On information and belief, Teva USA is a licensed drug distributor of prescription
`
`drugs sold in the State of Texas.
`
`24.
`
`On information and belief, Teva USA is actively registered with the Texas
`
`Secretary of State to conduct business in Texas.
`
`25.
`
`On information and belief, various Teva drug products appear in the Texas
`
`prescription drug formulary.
`
`26.
`
`On information and belief, Teva Pharmaceutical markets and sells numerous
`
`generic drugs, manufactured and supplied by Teva USA. On information and belief, since 2014
`
`Teva Pharmaceutical has sold nearly $1.8 billion worth of Teva USA’s products in Texas, over
`
`$330 million of which were sold in this judicial district.
`
`27.
`
`Teva has previously been sued in this judicial district without objecting on the
`
`basis of lack of personal jurisdiction. Pozen, Inc. v. Teva Pharmaceuticals USA, Inc., 6:08-cv-
`
`437, D.I. 83 at 2 (E.D. Tex.); Aventis Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.
`
`et al., 2:06-cv-469, D.I. 27 at 2 (E.D. Tex.). Teva has also availed itself to this judicial district
`
`through the assertion of counterclaims. Pozen, Inc. v. Teva Pharmaceuticals USA, Inc., 6:09-cv-
`
`182, D.I. 11 at 2 (E.D. Tex.).
`
`
`
`5
`
`0005
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 6 of 119 PageID #: 6
`
`28.
`
`On information and belief, Teva knows and intends that its proposed
`
`Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 203880 will be
`
`distributed and sold in Texas.
`
`29.
`
`On information and belief, Teva knows and intends that sales of its proposed
`
`Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 203880 will
`
`displace sales of Allergan’s RESTASIS® product causing injury to Allergan in Texas.
`
`30.
`
`On information and belief, Teva intends to take advantage of its established
`
`channels of distribution in Texas for the sale of its proposed Cyclosporine Ophthalmic Emulsion,
`
`0.05% product described in ANDA No. 203880. On information and belief, Teva arranged these
`
`distribution channels to take advantage of the second largest market for prescription drugs in the
`
`United States.
`
`31.
`
`B.
`
`32.
`
`
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391(c) and 1400(b).
`
`Personal Jurisdiction over Apotex, Inc. and Apotex Corp.
`
`This Court has personal jurisdiction over Apotex, Inc. and Apotex Corp. by virtue
`
`of their systematic and continuous contact with this jurisdiction, as alleged herein, and because
`
`of the injury to Allergan in this forum arising from Apotex’s ANDA filing and the causes of
`
`action Allergan raises here, as alleged herein. See Allergan, Inc. v. Actavis, Inc. et al., No 2:14-
`
`cv-0063, 2014 WL 7336692, at *5-8 (E.D. Tex. December 23, 2014).
`
`33.
`
`On information and belief, Apotex, Inc. submitted ANDA No. 207606 under
`
`section 505(j) of the FDCA, 21 U.S.C. § 355(j), seeking FDA approval to engage in the
`
`commercial manufacture, use, importation, sale, or offer for sale of Cyclosporine Ophthalmic
`
`Emulsion, 0.05%, a generic version of Allergan’s RESTASIS® product.
`
`
`
`6
`
`0006
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 7 of 119 PageID #: 7
`
`34.
`
`On information and belief, Apotex, Inc. and Apotex Corp. are agents of each
`
`other and/or work in active concert with respect to the development, regulatory approval,
`
`marketing, sale and distribution of pharmaceutical products, including the generic Cyclosporine
`
`Ophthalmic Emulsion, 0.05% product described in ANDA No. 207606.
`
`35.
`
`On information and belief, Apotex Corp. is a licensed drug distributor of
`
`prescription drugs sold in the State of Texas.
`
`36.
`
`On information and belief, Apotex, Inc. is actively registered with the Texas
`
`Secretary of State to conduct business in Texas.
`
`37.
`
`On information and belief, Apotex, Inc.’s drug products are listed on the Texas
`
`prescription drug formulary.
`
`38.
`
`On information and belief, Apotex Corp. markets and sells numerous generic
`
`drugs, manufactured and supplied by Apotex, Inc. On information and belief, since 2014 Apotex
`
`Corp. has sold nearly $420 million worth of Apotex, Inc.’s products in Texas, over $98 million
`
`of which were sold in this judicial district.
`
`39.
`
`Apotex, Inc. and Apotex Corp. have previously been sued in this judicial district
`
`without objecting on the basis of lack of personal jurisdiction. Allergan, Inc. v. Sandoz, Inc. et
`
`al., 2:12-cv-207, D.I. 28 at 4 (E.D. Tex.); Allergan, Inc. v. Apotex, Inc. and Apotex Corp., 2:12-
`
`cv-530, D.I. 64 at 4 (E.D. Tex.). Apotex, Inc. and Apotex Corp. have also availed themselves to
`
`this judicial district through the assertion of counterclaims. Allergan Sales, LLC v. Apotex, Inc.
`
`and Apotex Corp., 2:12-cv-178, D.I. 17 at 4 (E.D. Tex.); Allergan, Inc. v. Apotex, Inc. and
`
`Apotex Corp., 2:10-cv-200, D.I. 11 at 2 (E.D. Tex.).
`
`
`
`7
`
`0007
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 8 of 119 PageID #: 8
`
`40.
`
`Apotex Inc. and Apotex Corp. have also previously availed themselves to this
`
`judicial district by filing a lawsuit in this judicial district. Apotex, Inc. et al. v. Lupin, Ltd. and
`
`Lupin Pharmaceuticals, Inc., 2:15-cv-599, D.I. 1 (E.D. Tex.).
`
`41.
`
`On information and belief, Apotex, Inc. and Apotex Corp. know and intend that
`
`its proposed Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No.
`
`207606 will be distributed and sold in Texas.
`
`42.
`
`On information and belief, Apotex knows and intends that sales of its proposed
`
`Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 207606 will
`
`displace sales of Allergan’s RESTASIS® product causing injury to Allergan in Texas.
`
`43.
`
`On information and belief, Apotex intends to take advantage of its established
`
`channels of distribution in Texas for the sale of its proposed Cyclosporine Ophthalmic Emulsion,
`
`0.05% product described in ANDA No. 207606. On information and belief, Apotex arranged
`
`these distribution channels to take advantage of the Texas market, the second largest market for
`
`prescription drugs in the United States.
`
`44.
`
`C.
`
`45.
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391(c) and 1400(b).
`
`Personal Jurisdiction over Akorn
`
`This Court has personal jurisdiction over Akorn by virtue of its systematic and
`
`continuous contact with this jurisdiction, as alleged herein, and because of the injury to Allergan
`
`in this forum arising from Akorn’s ANDA filing and the causes of action Allergan alleges. See
`
`Allergan, Inc. v. Actavis, Inc. et al., No 2:14-cv-0063, 2014 WL 7336692, at *5-8 (E.D. Tex.
`
`December 23, 2014).
`
`46.
`
`On information and belief, Akorn submitted ANDA No. 204561 under section
`
`505(j) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j) (“FDCA”), seeking
`
`
`
`8
`
`0008
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 9 of 119 PageID #: 9
`
`approval from the United States Food and Drug Administration (“FDA”) to engage in the
`
`commercial manufacture, use, importation, sale, or offer for sale of Cyclosporine Ophthalmic
`
`Emulsion, 0.05%, a generic version of Allergan’s RESTASIS® product.
`
`47.
`
`On information and belief, Akorn is in the business of developing, manufacturing,
`
`distributing, and selling generic drug products throughout the United States, including for
`
`distribution and sale in this judicial district.
`
`48.
`
`On information and belief, Akorn is a licensed drug distributor of prescription
`
`drugs sold in the State of Texas.
`
`49.
`
`On information and belief, Akorn is actively registered with the Texas Secretary
`
`of State to conduct business in Texas.
`
`50.
`
`On information and belief, since 2014, Akorn has sold nearly $50 million worth
`
`of Akorn’s products in Texas, over $5 million of which were sold in this judicial district.
`
`51.
`
`Akorn has previously been sued in this judicial district without objecting on the
`
`basis of lack of personal jurisdiction. Allergan, Inc. v. Lupin Ltd. et al., 2:11-cv-00530, D.I. 61
`
`at 3 (E.D. Tex.).
`
`52.
`
`On information and belief, Akorn has a registered agent in Texas located at 211
`
`East 7th Street, Suite 620, Austin, Texas 78701-3218.
`
`53.
`
`On information and belief, various Akorn drug products appear on the Formulary
`
`Index of the Texas CHIP/Medicaid Vendor Drug Program, which provides services for over
`
`4,000 Texas pharmacies.
`
`54.
`
`On information and belief, Akorn has entered into arrangements with Texas
`
`entities to have its products appear on the formulary list of Blue Cross Blue Shield Texas, a
`
`major managed care and health plan.
`
`
`
`9
`
`0009
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 10 of 119 PageID #: 10
`
`55.
`
`On information and belief, Akorn has authorized numerous customers in Texas to
`
`distribute Akorn generic products, including AmerisourceBergen Drug Corp., Cardinal Health,
`
`Inc., McKesson Corp., and Walgreen Co.
`
`56.
`
`On information and belief, Akorn knows and intends that its proposed
`
`Cyclosporine Ophthalmic Emulsion, 0.05% described in ANDA No. 204561 will be distributed
`
`and sold in Texas.
`
`57.
`
`On information and belief, Akorn knows and intends that sales of its proposed
`
`Cyclosporine Ophthalmic Emulsion, 0.05% % described in ANDA No. 204561 will displace
`
`sales of Allergan’s RESTASIS® product causing injury to Allergan in Texas.
`
`58.
`
`On information and belief, Akorn intends to take advantage of its established
`
`channels of distribution in Texas for the sale of its proposed Cyclosporine Ophthalmic Emulsion,
`
`0.05% described in ANDA No. 204561. On information and belief, Akorn arranged these
`
`distribution channels to take advantage of the Texas market, the second largest market for
`
`prescription drugs in the United States.
`
`59.
`
`D.
`
`60.
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391(c) and 1400(b).
`
`Personal Jurisdiction over Mylan Pharmaceuticals and Mylan, Inc.
`
`This Court has personal jurisdiction over Mylan Pharmaceuticals, Inc. (“Mylan
`
`Pharmaceuticals”) and Mylan, Inc. by virtue of their systematic and continuous contact with this
`
`jurisdiction, as alleged herein, and because of the injury to Allergan in this forum arising from
`
`Mylan’s ANDA filing and the causes of action Allergan alleges. See Allergan, Inc. v. Actavis,
`
`Inc. et al., No 2:14-cv-0063, 2014 WL 7336692, at *5-8 (E.D. Tex. December 23, 2014).
`
`61.
`
`On information and belief, Mylan submitted ANDA No. 205894 under section
`
`505(j) of the FDCA, 21 U.S.C. § 355(j), seeking FDA approval to engage in the commercial
`
`
`
`10
`
`0010
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 11 of 119 PageID #: 11
`
`manufacture, use, importation, sale, or offer for sale of Cyclosporine Ophthalmic Emulsion,
`
`0.05%, a generic version of Allergan’s RESTASIS® product.
`
`62.
`
`On information and belief, Mylan Pharmaceuticals and Mylan, Inc. are agents of
`
`each other and/or work in active concert with respect to the development, regulatory approval,
`
`marketing, sale and distribution of pharmaceutical products, including the generic Cyclosporine
`
`Ophthalmic Emulsion, 0.05% product described in ANDA No. 205894.
`
`63.
`
`On information and belief, Mylan Pharmaceuticals is a licensed drug distributor
`
`of prescription drugs sold in the State of Texas.
`
`64.
`
`On information and belief, Mylan Pharmaceuticals is actively registered with the
`
`Texas Secretary of State to conduct business in Texas.
`
`65.
`
`On information and belief, various Mylan Pharmaceuticals drug products appear
`
`in the Texas prescription drug formulary.
`
`66.
`
`On information and belief, Mylan, Inc. markets and sells numerous generic drugs,
`
`manufactured and supplied by Mylan Pharmaceuticals. On information and belief, since 2014
`
`Mylan, Inc. has sold over $1.3 billion worth of Mylan Pharmaceuticals’ products in Texas, over
`
`$460 million of which were sold in this judicial district.
`
`67.
`
`On information and belief, Mylan Pharmaceuticals has a registered agent in Texas
`
`located at 211 East 7th Street, Suite 620, Austin, Texas 78701-3218.
`
`68.
`
`On information and belief, Mylan, Inc. has further availed itself to the laws of
`
`Texas through its subsidiary, Mylan Institutional, Inc., which is located at 12720 Dairy Ashford
`
`Road, Sugar Land, Texas 77478.
`
`
`
`11
`
`0011
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 12 of 119 PageID #: 12
`
`69.
`
`On information and belief, Mylan knows and intends that its proposed
`
`Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 205894 will be
`
`distributed and sold in Texas.
`
`70.
`
`On information and belief, Mylan knows and intends that sales of its proposed
`
`Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 205894 will
`
`displace sales of Allergan’s RESTASIS® product causing injury to Allergan in Texas.
`
`71.
`
`On information and belief, Mylan intends to take advantage of its established
`
`channels of distribution in Texas for the sale of its proposed Cyclosporine Ophthalmic Emulsion,
`
`0.05% product described in ANDA No. 205894. On information and belief, Mylan arranged
`
`these distribution channels to take advantage of the Texas market, the second largest market for
`
`prescription drugs in the United States.
`
`72.
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391(c) and 1400(b).
`
`Factual Background
`
`A.
`
`Patents-In-Suit
`
`1.
`
`U.S. Patent No. 8,629,111
`
`73.
`
`On January 14, 2014, the ‘111 Patent, titled “Methods of Providing Therapeutic
`
`Effects Using Cyclosporin Components,” was duly and legally issued by the United States Patent
`
`and Trademark Office (“USPTO”) to inventors Andrew Acheampong, Diane D. Tang-Liu, James
`
`N. Chang, and David F. Power. A true and correct copy of the ‘111 Patent is attached to this
`
`complaint as Exhibit 1.
`
`74.
`
`75.
`
`Allergan, as assignee, owns the entire right, title, and interest in the ‘111 Patent.
`
`Allergan is the holder of approved New Drug Application (“NDA”) No. 50-790
`
`for Cyclosporine Ophthalmic Emulsion, 0.05%, sold under the RESTASIS® trademark.
`
`
`
`12
`
`0012
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 13 of 119 PageID #: 13
`
`76.
`
`The ‘111 Patent is listed in Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (the “Orange Book”) for RESTASIS®.
`
`77.
`
`RESTASIS® and/or methods of using RESTASIS® are covered by at least one
`
`claim of the ‘111 Patent.
`
`
`
`
`
`2.
`
`U.S. Patent No. 8,633,162
`
`78.
`
`On January 21, 2014, the ‘162 Patent, titled “Methods of Providing Therapeutic
`
`Effects Using Cyclosporin Components,” was duly and legally issued by the USPTO to inventors
`
`Andrew Acheampong, Diane D. Tang-Liu, James N. Chang, and David F. Power. A true and
`
`correct copy of the ‘162 Patent is attached to this complaint as Exhibit 2.
`
`79.
`
`80.
`
`Allergan, as assignee, owns the entire right, title, and interest in the ‘162 Patent.
`
`Allergan is the holder of approved New Drug Application (“NDA”) No. 50-790
`
`for Cyclosporine Ophthalmic Emulsion, 0.05%, sold under the RESTASIS® trademark.
`
`81.
`
`82.
`
`The ‘162 Patent is listed in the Orange Book for RESTASIS®.
`
`RESTASIS® and/or methods of using RESTASIS® are covered by at least one
`
`claim of the ‘162 Patent.
`
`
`
`
`
`3.
`
`U.S. Patent No. 8,642,556
`
`83.
`
`On February 4, 2014, the ‘556 Patent, titled “Methods of Providing Therapeutic
`
`Effects Using Cyclosporin Components,” was duly and legally issued by the USPTO to inventors
`
`Andrew Acheampong, Diane D. Tang-Liu, James N. Chang, and David F. Power. A true and
`
`correct copy of the ‘556 Patent is attached to this complaint as Exhibit 3.
`
`84.
`
`85.
`
`Allergan, as assignee, owns the entire right, title, and interest in the ‘556 Patent.
`
`Allergan is the holder of approved New Drug Application (“NDA”) No. 50-790
`
`for Cyclosporine Ophthalmic Emulsion, 0.05%, sold under the RESTASIS® trademark.
`
`
`
`13
`
`0013
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 14 of 119 PageID #: 14
`
`86.
`
`87.
`
`The ‘556 Patent is listed in the Orange Book for RESTASIS®.
`
`RESTASIS® and/or methods of using RESTASIS® are covered by at least one
`
`claim of the ‘556 Patent.
`
`
`
`
`
`4.
`
`U.S. Patent No. 8,648,048
`
`88.
`
`On February 11, 2014, the ‘048 Patent, titled “Methods of Providing Therapeutic
`
`Effects Using Cyclosporin Components,” was duly and legally issued by the USPTO to inventors
`
`Andrew Acheampong, Diane D. Tang-Liu, James N. Chang, and David F. Power. A true and
`
`correct copy of the ‘048 Patent is attached to this complaint as Exhibit 4.
`
`89.
`
`90.
`
`Allergan, as assignee, owns the entire right, title, and interest in the ‘048 Patent.
`
`Allergan is the holder of approved New Drug Application (“NDA”) No. 50-790
`
`for Cyclosporine Ophthalmic Emulsion, 0.05%, sold under the RESTASIS® trademark.
`
`91.
`
`92.
`
`The ‘048 Patent is listed in the Orange Book for RESTASIS®.
`
`RESTASIS® and/or methods of using RESTASIS® are covered by at least one
`
`claim of the ‘048 Patent.
`
`
`
`
`
`5.
`
`U.S. Patent No. 8,685,930
`
`93.
`
`On April 1, 2014, the ‘930 Patent, titled “Methods of Providing Therapeutic
`
`Effects Using Cyclosporin Components,” was duly and legally issued by the USPTO to inventors
`
`Andrew Acheampong, Diane D. Tang-Liu, James N. Chang, and David F. Power. A true and
`
`correct copy of the ‘930 Patent is attached to this complaint as Exhibit 5.
`
`94.
`
`95.
`
`Allergan, as assignee, owns the entire right, title, and interest in the ‘930 Patent.
`
`Allergan is the holder of approved New Drug Application (“NDA”) No. 50-790
`
`for Cyclosporine Ophthalmic Emulsion, 0.05%, sold under the RESTASIS® trademark.
`
`96.
`
`The ‘930 Patent is listed in the Orange Book for RESTASIS®.
`
`
`
`14
`
`0014
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 15 of 119 PageID #: 15
`
`97.
`
`RESTASIS® and/or methods of using RESTASIS® are covered by at least one
`
`claim of the ‘930 Patent.
`
`
`
`B.
`
`
`
`Acts Giving Rise to This Action
`
`1.
`
`Acts Giving Rise to this Action Against Teva
`
`98.
`
`On information and belief, Teva submitted ANDA No. 203880 to the FDA under
`
`section 505(j) of the FDCA, seeking FDA approval to engage in the commercial manufacture,
`
`use, importation, sale, or offer for sale of Cyclosporine Ophthalmic Emulsion, 0.05%, a generic
`
`version of Allergan’s RESTASIS® product.
`
`99.
`
`On information and belief, pursuant to § 505(j)(2)(A)(vii)(IV) of the FDCA, Teva
`
`included with its ANDA No. 203880 a Paragraph IV certification alleging that the claims of
`
`patents listed in the Orange Book as covering RESTASIS® are invalid, unenforceable, and/or
`
`will not be infringed by the manufacture, use, or sale of Teva’s Cyclosporine Ophthalmic
`
`Emulsion, 0.05% product described in ANDA No. 203880. Plaintiff received written
`
`notification of ANDA No. 203880 and its § 505(j)(2)(A)(vii)(IV) allegations with respect to the
`
`‘111, ‘162, ‘556, ‘048, and ‘930 patents on or about July 23, 2015.
`
`100. On information and belief, the FDA has not yet approved Teva’s ANDA No.
`
`203880.
`
`101. On information and belief, Teva has made, and continues to make, substantial
`
`preparation in the United States to manufacture, offer to sell, sell, and/or import a generic version
`
`of Allergan’s RESTASIS® product before expiration of the patents-in-suit.
`
`102. On information and belief, Teva continues to seek approval of ANDA No. 203880
`
`from the FDA and intends to continue in the commercial manufacture, marketing, and sale of its
`
`proposed generic version of Allergan’s RESTASIS® product.
`
`
`
`15
`
`0015
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 16 of 119 PageID #: 16
`
`103. On information and belief, following FDA approval of its ANDA No. 203880,
`
`Teva will sell the approved generic version of Allergan’s RESTASIS® product throughout the
`
`United States, including in Texas and this judicial district.
`
`
`
`
`
`2.
`
`Acts Giving Rise to this Action Against Apotex
`
`104. On information and belief, Apotex submitted ANDA No. 207606 to the FDA
`
`under section 505(j) of the FDCA, seeking FDA approval to engage in the commercial
`
`manufacture, use, importation, sale, or offer for sale of Cyclosporine Ophthalmic Emulsion,
`
`0.05%, a generic version of Allergan’s RESTASIS® product.
`
`105. On information and belief, pursuant to § 505(j)(2)(A)(vii)(IV) of the FDCA,
`
`Apotex included with its ANDA No. 207606 a Paragraph IV certification alleging that the claims
`
`of patents listed in the Orange Book as covering RESTASIS® are invalid, unenforceable, and/or
`
`will not be infringed by the manufacture, use, or sale of Apotex’s Cyclosporine Ophthalmic
`
`Emulsion, 0.05% product. Plaintiff received written notification of ANDA No. 207606 and its §
`
`505(j)(2)(A)(vii)(IV) allegations with respect to the ‘111, ‘162, ‘556, ‘048, and ‘930 patents on
`
`or about July 24, 2015.
`
`106. On information and belief, the FDA has not yet approved Apotex’s ANDA No.
`
`207606.
`
`107. On information and belief, Apotex has made, and continues to make, substantial
`
`preparation in the United States to manufacture, offer to sell, sell, and/or import a generic version
`
`of Allergan’s RESTASIS® product before expiration of the patents-in-suit.
`
`108. On information and belief, Apotex continues to seek approval of ANDA No.
`
`207606 from the FDA and intends to continue in the commercial manufacture, marketing, and
`
`
`
`16
`
`0016
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 17 of 119 PageID #: 17
`
`sale of a generic version of Allergan’s RESTASIS® product before expiration of the patents-in-
`
`suit.
`
`109. On information and belief, following FDA approval of its ANDA No. 207606,
`
`Apotex will sell the approved generic version of Allergan’s RESTASIS® product throughout the
`
`United States, including in Texas and this judicial district.
`
`3.
`
`Acts Giving Rise to this Action Against Akorn
`
`110. On information and belief, Akorn submitted ANDA No. 204561 to the FDA
`
`under section 505(j) of the FDCA, seeking FDA approval to engage in the commercial
`
`manufacture, use, importation, sale, or offer for sale of Cyclosporine Ophthalmic Emulsion,
`
`0.05%, a generic version of Allergan’s RESTASIS® product.
`
`111. On information and belief, pursuant to § 505(j)(2)(A)(vii)(IV) of the FDCA,
`
`Akorn included with its ANDA No. 204561 a Paragraph IV certification alleging that the claims
`
`of patents listed in the Orange Book as covering RESTASIS® are invalid, unenforceable, and/or
`
`will not be infringed by the manufacture, use, or sale of Akorn’s Cyclosporine Ophthalmic
`
`Emulsion, 0.05% product described in ANDA No. 204561. Plaintiff received written
`
`notification of ANDA No. 204561 and its § 505(j)(2)(A)(vii)(IV) allegations with respect to the
`
`‘111, ‘162, ‘556, ‘048, and ‘930 patents on or about July 13, 2015.
`
`112. On information and belief, the FDA has not yet approved Akorn’s ANDA No.
`
`204561.
`
`113. On information and belief, Akorn has made, and continues to make, substantial
`
`preparation in the United States to manufacture, offer to sell, sell, and/or import a generic version
`
`of Allergan’s RESTASIS® product before expiration of the patents-in-suit.
`
`
`
`17
`
`0017
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 18 of 119 PageID #: 18
`
`114. On information and belief, Akorn continues to seek approval of ANDA No.
`
`204561 from the FDA and intends to continue in the commercial manufacture, marketing, and
`
`sale of its generic version of Allergan’s RESTASIS® product before expiration of the patents-in-
`
`suit.
`
`115. On information and belief, following FDA approval of its ANDA No. 204561,
`
`Akorn will sell the approved generic version of Allergan’s RESTASIS® product throughout the
`
`United States, including in Texas and this judicial district.
`
`
`
`4.
`
`Acts Giving Rise to this Action Against Mylan
`
`116. On information and belief, Mylan submitted ANDA No. 205894 to the FDA
`
`under section 505(j) of the FDCA, seeking FDA approval to engage in the commercial
`
`manufacture, use, importation, sale, or offer for sale of Cyclosporine Ophthalmic Emulsion,
`
`0.05%, a generic version of Allergan’s RESTASIS® product.
`
`117. On information and belief, pursuant to § 505(j)(2)(A)(vii)(IV) of the FDCA,
`
`Mylan included with its ANDA No. 205894 a Paragraph IV certification alleging that the claims
`
`of patents listed in the Orange Book as covering RESTASIS® are invalid, unenforceable, and/or
`
`will not be infringed by the manufacture, use, or sale of Mylan’s Cyclosporine Ophthalmic
`
`Emulsion, 0.05% product described in ANDA No. 205894. Plaintiff received written
`
`notification of ANDA No. 205894 and its § 505(j)(2)(A)(vii)(IV) allegations with respect to the
`
`‘111, ‘162, ‘556, ‘048, and ‘930 patents on or about July 21, 2015.
`
`118. On information and belief, the FDA has not yet approved Mylan’s ANDA No.
`
`205894.
`
`
`
`18
`
`0018
`
`
`
`Case 2:15-cv-01455 Document 1 Filed 08/24/15 Page 19 of 119 PageID #: 19
`
`119. On information and belief, Mylan has made, and continues to make, substantial
`
`preparation in the United States to manufacture, offer to sell, sell, and/or import a generic version
`
`of Allergan’s RESTASIS® product befo
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