Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 1 of 136 PageID #: 1909
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`
`ALLERGAN, INC.,
`
` Plaintiff,
`
`v.
`
`TEVA PHARMACEUTICALS USA, INC.,
`AKORN, INC., MYLAN
`PHARMACEUTICALS, INC., and MYLAN,
`INC.,
`
` Defendants.
`
`ALLERGAN, INC.,
`
` Plaintiff,
`
`v.
`
`INNOPHARMA, INC.,
`
` Defendant.
`
`
` Civil Action No. 2:15-cv-1455-WCB
`
` LEAD CASE
`
` JURY TRIAL DEMANDED
`
`
`
`
`
` Civil Action No. 2:15-cv-1504-WCB
`
` MEMBER CASE
`
`
`
`
`
`
`AMENDED COMPLAINT
`
`
`
`For their Amended Complaint against Defendants Teva Pharmaceuticals USA, Inc.
`
`(“Teva”); Akorn, Inc. (“Akorn”); Mylan Pharmaceuticals, Inc. and Mylan, Inc. (collectively
`
`“Mylan”); and InnoPharma, Inc. (“InnoPharma”), 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”), 8,685,930 (“the ‘930 Patent”), and 9,248,191 (“the ‘191 Patent) under the Patent Laws
`
`
`
`1
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`
`ALLERGAN, INC.,
`
` Plaintiff,
`
`v.
`
`TEVA PHARMACEUTICALS USA, INC.,
`AKORN, INC., MYLAN
`PHARMACEUTICALS, INC., and MYLAN,
`INC.,
`
` Defendants.
`
`ALLERGAN, INC.,
`
` Plaintiff,
`
`v.
`
`INNOPHARMA, INC.,
`
` Defendant.
`
`
` Civil Action No. 2:15-cv-1455-WCB
`
` LEAD CASE
`
` JURY TRIAL DEMANDED
`
`
`
`
`
` Civil Action No. 2:15-cv-1504-WCB
`
` MEMBER CASE
`
`
`
`
`
`
`AMENDED COMPLAINT
`
`
`
`For their Amended Complaint against Defendants Teva Pharmaceuticals USA, Inc.
`
`(“Teva”); Akorn, Inc. (“Akorn”); Mylan Pharmaceuticals, Inc. and Mylan, Inc. (collectively
`
`“Mylan”); and InnoPharma, Inc. (“InnoPharma”), 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”), 8,685,930 (“the ‘930 Patent”), and 9,248,191 (“the ‘191 Patent) under the Patent Laws
`
`
`
`1
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 2 of 136 PageID #: 1910
`
`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
`
`declaratory judgment of infringement of the ‘162, ‘048, ‘191 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 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 is a wholly owned subsidiary of Teva
`
`Pharmaceutical Industries Ltd. (“Teva Pharmaceutical”)
`
`7.
`
`On information and belief, Teva 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.
`
`8.
`
`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
`
`
`
`2
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 3 of 136 PageID #: 1911
`
`Court, Suite 300, Lake Forest, Illinois 60045, and a registered agent located at 211 East 7th
`
`Street, Suite 620, Austin, Texas 78701-3218.
`
`9.
`
`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.
`
`10.
`
`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.
`
`11.
`
`On information and belief, Mylan Pharmaceuticals, Inc. is a wholly-owned
`
`subsidiary of Mylan, Inc.
`
`12.
`
`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.
`
`13.
`
`On information and belief, InnoPharma is a corporation organized and existing
`
`under the laws of Delaware, having a principal place of business at 10 Knightsbridge Road,
`
`Piscataway, New Jersey 008854.
`
`Venue and Jurisdiction
`
`This action arises under the patent laws of the United States of America, 35
`
`14.
`
`U.S.C. § 1, et seq. This Court has subject matter jurisdiction over the action under 28 U.S.C. §§
`
`1331 and 1338.
`
`15.
`
`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,
`
`
`
`3
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 4 of 136 PageID #: 1912
`
`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.
`
`16.
`
`Personal Jurisdiction over Teva
`
`This Court has personal jurisdiction over Teva 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 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).
`
`17.
`
`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
`
`manufacture, use, importation, sale, or offer for sale of Cyclosporine Ophthalmic Emulsion,
`
`0.05%, a generic version of Allergan’s RESTASIS® product.
`
`18.
`
`On information and belief, Teva 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.
`
`19.
`
`On information and belief, Teva is a licensed drug distributor of prescription
`
`drugs sold in the State of Texas.
`
`20.
`
`On information and belief, Teva is actively registered with the Texas Secretary of
`
`State to conduct business in Texas.
`
`
`
`4
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 5 of 136 PageID #: 1913
`
`21.
`
`On information and belief, various Teva drug products appear in the Texas
`
`prescription drug formulary.
`
`22.
`
`On information and belief, Teva Pharmaceutical markets and sells numerous
`
`generic drugs, manufactured and supplied by Teva. On information and belief, since 2014 Teva
`
`Pharmaceutical has sold nearly $1.8 billion worth of Teva’s products in Texas, over $330 million
`
`of which were sold in this judicial district.
`
`23.
`
`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.).
`
`24.
`
`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.
`
`25.
`
`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.
`
`26.
`
`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.
`
`
`
`5
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 6 of 136 PageID #: 1914
`
`27.
`
`B.
`
`28.
`
`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).
`
`29.
`
`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
`
`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.
`
`30.
`
`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.
`
`31.
`
`On information and belief, Akorn is a licensed drug distributor of prescription
`
`drugs sold in the State of Texas.
`
`32.
`
`On information and belief, Akorn is actively registered with the Texas Secretary
`
`of State to conduct business in Texas.
`
`33.
`
`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.
`
`
`
`6
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 7 of 136 PageID #: 1915
`
`34.
`
`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.).
`
`35.
`
`On information and belief, Akorn has a registered agent in Texas located at 211
`
`East 7th Street, Suite 620, Austin, Texas 78701-3218.
`
`36.
`
`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.
`
`37.
`
`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.
`
`38.
`
`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.
`
`39.
`
`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.
`
`40.
`
`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.
`
`41.
`
`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
`
`
`
`7
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 8 of 136 PageID #: 1916
`
`distribution channels to take advantage of the Texas market, the second largest market for
`
`prescription drugs in the United States.
`
`42.
`
`C.
`
`43.
`
`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).
`
`44.
`
`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
`
`manufacture, use, importation, sale, or offer for sale of Cyclosporine Ophthalmic Emulsion,
`
`0.05%, a generic version of Allergan’s RESTASIS® product.
`
`45.
`
`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.
`
`46.
`
`On information and belief, Mylan Pharmaceuticals is a licensed drug distributor
`
`of prescription drugs sold in the State of Texas.
`
`47.
`
`On information and belief, Mylan Pharmaceuticals is actively registered with the
`
`Texas Secretary of State to conduct business in Texas.
`
`48.
`
`On information and belief, various Mylan Pharmaceuticals drug products appear
`
`in the Texas prescription drug formulary.
`
`
`
`8
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 9 of 136 PageID #: 1917
`
`49.
`
`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.
`
`50.
`
`On information and belief, Mylan Pharmaceuticals has a registered agent in Texas
`
`located at 211 East 7th Street, Suite 620, Austin, Texas 78701-3218.
`
`51.
`
`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.
`
`52.
`
`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.
`
`53.
`
`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.
`
`54.
`
`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.
`
`55.
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391(c) and 1400(b).
`
`
`
`
`
`
`
`9
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 10 of 136 PageID #: 1918
`
`D.
`
`56.
`
`Personal Jurisdiction over InnoPharma, Inc.
`
`This Court has personal jurisdiction over InnoPharma, 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 InnoPharma Inc.’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).
`
`57.
`
`On information and belief, InnoPharma, Inc. submitted ANDA No. 206835 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.
`
`58.
`
`On information and belief, InnoPharma, Inc. is in the business of researching and
`
`developing generic drug products.
`
`59.
`
`On information and belief, InnoPharma, Inc. partners with other pharmaceutical
`
`companies for the purposes of marketing, manufacturing, selling, and distributing the generic
`
`drug products that InnoPharma, Inc. develops throughout the United States, including in this
`
`judicial district. On its website, InnoPharma, Inc. states that it “focuses on difficult to make
`
`products and has worked with the top 3 generic pharmaceutical companies to commercialize its
`
`products.”
`
`60.
`
`On information and belief, InnoPharma, Inc. does not market, sell, or distribute
`
`drugs itself, but does these activities only through its partners.
`
`61.
`
`On information and belief, Pfizer, Inc. completed an acquisition of InnoPharma,
`
`Inc. on or around September 25, 2014.
`
`
`
`10
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 11 of 136 PageID #: 1919
`
`62.
`
`On information and belief, InnoPharma, Inc. and Pfizer, 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.
`
`63.
`
`Allergan contacted InnoPharma, Inc. regarding its paragraph IV letter, and asked
`
`InnoPharma, Inc. for information regarding its marketing partner for its proposed Cyclosporine
`
`Ophthalmic Emulsion, 0.05% described in ANDA No. 206835. InnoPharma, Inc. refused to
`
`provide Allergan with that information.
`
`64.
`
`Texas is the second largest market for prescription drugs in the United States and
`
`thus a lucrative target for sale of InnoPharma’s proposed Cyclosporine Ophthalmic Emulsion,
`
`0.05% described in ANDA No. 206835.
`
`65.
`
`In view of the lucrative Texas market for generic Restasis, on information and
`
`belief, InnoPharma knows and intends that InnoPharma’s proposed Cyclosporine Ophthalmic
`
`Emulsion, 0.05% described in ANDA No. 206835 will be distributed and sold in Texas.
`
`66.
`
`On information and belief, InnoPharma knows and intends that sales of its
`
`proposed Cyclosporine Ophthalmic Emulsion, 0.05% described in ANDA No. 206835 will
`
`displace sales of Allergan’s RESTASIS® product causing injury to Allergan in Texas.
`
`67.
`
`On information and belief, InnoPharma, Inc. intends to take advantage of the
`
`channels of distribution established by Pfizer, Inc., or Pfizer, Inc.’s subsidiaries, in Texas for the
`
`sale of its proposed Cyclosporine Ophthalmic Emulsion, 0.05% described in ANDA No. 206835.
`
`68.
`
`On October 10, 2015, InnoPharma stipulated that it would not contest personal
`
`jurisdiction or venue in this action. (See Doc. No. 18, Case No. 2:15-cv-1504-JRG, granted at
`
`Doc. No. 19).
`
`69. Venue is proper in this Court under 28 U.S.C. §§ 1391(c) and 1400(b).
`
`
`
`11
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 12 of 136 PageID #: 1920
`
`Factual Background
`
`A.
`
`Patents-In-Suit
`
`1.
`
`U.S. Patent No. 8,629,111
`
`70.
`
`On January 14, 2014, the ‘111 Patent, titled “Methods of Providing Therapeutic
`
`Effects Using Cyclosporine 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.
`
`71.
`
`72.
`
`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.
`
`73.
`
`The ‘111 Patent is listed in Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (the “Orange Book”) for RESTASIS®.
`
`74.
`
`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
`
`75.
`
`On January 21, 2014, the ‘162 Patent, titled “Methods of Providing Therapeutic
`
`Effects Using Cyclosporine 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.
`
`76.
`
`77.
`
`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.
`
`
`
`12
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 13 of 136 PageID #: 1921
`
`78.
`
`79.
`
`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
`
`80.
`
`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.
`
`81.
`
`82.
`
`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.
`
`83.
`
`84.
`
`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
`
`85.
`
`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.
`
`86.
`
`87.
`
`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.
`
`88.
`
`The ‘048 Patent is listed in the Orange Book for RESTASIS®.
`
`
`
`13
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 14 of 136 PageID #: 1922
`
`89.
`
`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
`
`90.
`
`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.
`
`91.
`
`92.
`
`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.
`
`93.
`
`94.
`
`The ‘930 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 ‘930 Patent.
`
`
`
`6.
`
`U.S. Patent No. 9,248,191
`
`95.
`
`On February 2, 2016, the ‘191 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 ‘191 Patent is attached to this complaint as Exhibit 6.
`
`96. Allergan, as assignee, owns the entire right, title, and interest in the ‘191 Patent.
`
`97.
`
`Allergan is the holder of approved New Drug Application ("NDA") No. 50-790
`
`for Cyclosporine Ophthalmic Emulsion, 0.05%, sold under the RESTASIS® trademark.
`
`98. The ‘191 Patent is listed in the Orange Book for RESTASIS®.
`
`
`
`14
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 15 of 136 PageID #: 1923
`
`99.
`
`RESTASIS® and/or methods of using RESTASIS® are covered by at least one
`
`claim of the ‘191 Patent.
`
`
`
`B.
`
`
`
`Acts Giving Rise to This Action
`
`1.
`
`Acts Giving Rise to this Action Against Teva
`
`100. 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.
`
`101. 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.
`
`102. The ‘191 Patent had not issued at the time Teva submitted its certification under
`
`section 505(j) of the FDCA.
`
`103. On information and belief, Teva became aware of the ‘191 Patent no later than
`
`when it was issued by the USPTO and/or listed in the Orange Book as covering methods of using
`
`the approved formulation of RESTASIS®.
`
`104. On information and belief, the FDA has not yet approved Teva’s ANDA No.
`
`203880.
`
`
`
`15
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 16 of 136 PageID #: 1924
`
`105. 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.
`
`106. 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.
`
`107. 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 Akorn
`
`108. 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.
`
`109. 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.
`
`110. The ‘191 Patent had not issued at the time Akorn submitted its certification under
`
`section 505(j) of the FDCA.
`
`
`
`16
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 17 of 136 PageID #: 1925
`
`111. On information and belief, Akorn became aware of the ‘191 Patent no later than
`
`when it was issued by the USPTO and/or listed in the Orange Book as covering methods of using
`
`the approved formulation of RESTASIS®.
`
`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.
`
`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.
`
`
`
`3.
`
`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
`
`
`
`17
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 18 of 136 PageID #: 1926
`
`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. The ‘191 Patent had not issued at the time Mylan submitted its certification under
`
`section 505(j) of the FDCA.
`
`119. On information and belief, Mylan became aware of the ‘191 Patent no later than
`
`when it was issued by the USPTO and/or listed in the Orange Book as covering methods of using
`
`the approved formulation of RESTASIS®.
`
`120. On information and belief, the FDA has not yet approved Mylan’s ANDA No.
`
`205894.
`
`121. 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 before expiration of the patents-in-suit.
`
`122. On information and belief, Mylan continues to seek approval of ANDA No.
`
`205894 from the FDA and intends to continue in the commercial manufacture, marketing, and
`
`sale of its proposed generic version of Allergan’s RESTASIS® product.
`
`123. On information and belief, following FDA approval of its ANDA No. 205894,
`
`Mylan 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 InnoPharma
`
`124. On information and belief, InnoPharma submitted ANDA No. 206835 to the FDA
`
`under section 505(j) of the FDCA, seeking FDA approval to engage in the commercial
`
`
`
`18
`
`
`
`Case 2:15-cv-01455-WCB Document 96 Filed 02/18/16 Page 19 of 136 PageID #: 1927
`
`manufacture, use, importation, sale, or offer for sale of Cyclosporine Ophthalmic Emulsion,
`
`0.05%, a generic version of Allergan’s RESTASIS® product.
`
`125. On information and belief, pursuant to § 505(j)(2)(A)(vii)(IV) of the FDCA,
`
`InnoPharma included with its ANDA No. 206835 a Paragraph IV certification alleging that the
`
`claims of patents liste
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
