IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`
`
` Civil Action No. 2:16-cv-401
`
`
`
` JURY TRIAL DEMANDED
`
`
`
`ALLERGAN, INC.,
`
` Plaintiff,
`
`v.
`
`FAMY CARE LIMITED,
`
` Defendant.
`
`
`
`
`
`
`ALLERGAN, INC.’S COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Allergan, Inc. (“Allergan” or “Plaintiff”), for its Complaint against Defendant
`
`Famy Care Limited (“Famy Care”) 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
`
`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, and ’191 Patents under 35 U.S.C. § 271
`
`(b) and (c).
`
`
`
`
`
`
`
`1
`
`FAMY CARE - EXHIBIT 1023-0001
`
`
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`
`
` Civil Action No. 2:16-cv-401
`
`
`
` JURY TRIAL DEMANDED
`
`
`
`ALLERGAN, INC.,
`
` Plaintiff,
`
`v.
`
`FAMY CARE LIMITED,
`
` Defendant.
`
`
`
`
`
`
`ALLERGAN, INC.’S COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Allergan, Inc. (“Allergan” or “Plaintiff”), for its Complaint against Defendant
`
`Famy Care Limited (“Famy Care”) 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
`
`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, and ’191 Patents under 35 U.S.C. § 271
`
`(b) and (c).
`
`
`
`
`
`
`
`1
`
`FAMY CARE - EXHIBIT 1023-0001
`
`
`
`The Parties
`
`Allergan is a corporation organized and existing under the laws of the State of
`
`3.
`
`Delaware with a 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, Famy Care is organized and exists under the laws of
`
`the Republic of India and has a principal place of business at 3rd Floor, Brady House, 12/14,
`
`Veer Nariman Road, Fort, Mumbai – 400 001, Maharashtra, India.
`
`6.
`
`On its Paragraph IV Notification, Famy Care lists its attorney, William Rakoczy
`
`as its agent in the United States authorized to accept service of process. On information and
`
`belief, Famy Care has no physical location in the United States.
`
`Venue and Jurisdiction
`
`7.
`
`This action arises under the patent laws of the United States of America, 35
`
`U.S.C. § 1, et seq. This Court has subject matter jurisdiction over the action under 28 U.S.C. §§
`
`1331 and 1338.
`
`8.
`
`This Court has personal jurisdiction over Famy Care 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 Famy Care’s ANDA filing and the causes of action Allergan
`
`raises, as alleged herein. See Acorda Therapeutics Inc. et al. v. Mylan Pharmaceuticals Inc. et
`
`al., No. 2015-1456 (Fed. Cir. March 18, 2016).
`
`
`
`2
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`FAMY CARE - EXHIBIT 1023-0002
`
`
`
`9.
`
`Alternatively, if this Court does not have jurisdiction over Famy Care because of
`
`its contacts with this jurisdiction as described below, this Court has personal jurisdiction over
`
`Famy Care under Federal Rule of Civil Procedure 4(k)(2).
`
`10.
`
`On information and belief, Famy Care submitted ANDA No. 208469 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.
`
`11.
`
`On information and belief, Famy Care is in the business of researching and
`
`developing generic drug products.
`
`12.
`
`On information and belief, Famy Care has engaged in continuous and systematic
`
`contacts with the United States by, among other things, entering into an exclusive partnership
`
`with Mylan, Inc. that dates back to 2008 to file ANDAs for generic contraceptive products and to
`
`supply such products to customers in the United States. See Exhibit 1.
`
`13.
`
`On information and belief, in the United States, Famy Care and Mylan Inc. have a
`
`portfolio of 12 approved products. As of November 2015, Famy Care and Mylan Inc. had
`
`ANDAs for 30 drugs pending the approval of the FDA. See Exhibit 1.
`
`14.
`
`On information and belief, Famy Care partners with Mylan Inc. for the purposes
`
`of marketing, selling, and distributing the generic drug products that Famy Care develops
`
`throughout the United States, including in this judicial district.
`
`15.
`
`On information, and belief, Mylan Pharmaceuticals is an agent of Mylan Inc. and
`
`works in active concert with Mylan Inc. to market, sell, and distribute pharmaceutical products.
`
`16.
`
`On information and belief, Mylan Pharmaceuticals is a licensed drug distributor
`
`of prescription drugs sold in the State of Texas.
`
`
`
`3
`
`FAMY CARE - EXHIBIT 1023-0003
`
`
`
`17.
`
`On information and belief, Mylan Pharmaceuticals is actively registered with the
`
`Texas Secretary of State to conduct business in Texas.
`
`18.
`
`On information and belief, Mylan Pharmaceuticals has a registered agent in Texas
`
`located at 211 East 7th Street, Suite 620, Austin Texas 78701-3218.
`
`19.
`
`On information and belief, Mylan Inc. markets and sells numerous generic drugs
`
`in Texas. On information and belief, since 2014 Mylan Inc. has sold over $1.3 billion worth of
`
`products in Texas, over $460 million of which were sold in this judicial district.
`
`20.
`
`Texas is the second largest market for prescription drugs in the United States and
`
`thus a lucrative target for sale of Famy Care’s proposed Cyclosporine Ophthalmic Emulsion,
`
`0.05% described in ANDA No. 208469.
`
`21.
`
`In view of the lucrative Texas market for generic RESTASIS®, on information
`
`and belief, Famy Care knows and intends that its proposed Cyclosporine Ophthalmic Emulsion,
`
`0.05% described in ANDA No. 208469 will be distributed and sold in Texas, including through
`
`the extensive distribution networks established by Famy Care’s distribution partner, Mylan Inc.
`
`and/or Mylan Pharmaceuticals.
`
`22.
`
`On information and belief, Famy Care knows and intends that sales of its
`
`proposed Cyclosporine Ophthalmic Emulsion, 0.05% described in ANDA No. 208469 will
`
`displace sales of Allergan’s RESTASIS® product causing injury to Allergan in Texas.
`
`23.
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391(c) and 1400(b).
`
`
`
`
`
`
`
`
`
`
`
`4
`
`FAMY CARE - EXHIBIT 1023-0004
`
`
`
`Factual Background
`
`A.
`
`Patents-In-Suit
`
`1.
`
`U.S. Patent No. 8,629,111
`
`24.
`
`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 2.
`
`25.
`
`26.
`
`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.
`
`27.
`
`The ’111 Patent is listed in Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (the “Orange Book”) for RESTASIS®.
`
`28.
`
`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
`
`29.
`
`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 3.
`
`30.
`
`31.
`
`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.
`
`
`
`5
`
`FAMY CARE - EXHIBIT 1023-0005
`
`
`
`32.
`
`33.
`
`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
`
`34.
`
`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 4.
`
`35.
`
`36.
`
`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.
`
`37.
`
`38.
`
`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
`
`39.
`
`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 5.
`
`40.
`
`41.
`
`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.
`
`42.
`
`The ’048 Patent is listed in the Orange Book for RESTASIS®.
`
`
`
`6
`
`FAMY CARE - EXHIBIT 1023-0006
`
`
`
`43.
`
`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
`
`44.
`
`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 6.
`
`45.
`
`46.
`
`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.
`
`47.
`
`48.
`
`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
`
`49.
`
`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 7.
`
`50.
`
`51.
`
`Allergan, as assignee, owns the entire right, title, and interest in the ’191 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.
`
`52.
`
`The ’191 Patent is listed in the Orange Book for RESTASIS®.
`
`
`
`7
`
`FAMY CARE - EXHIBIT 1023-0007
`
`
`
`53.
`
`RESTASIS® and/or methods of using RESTASIS® are covered by at least one
`
`claim of the ’191 Patent.
`
`
`
`B.
`
`54.
`
`Acts Giving Rise to This Action
`
`On information and belief, Famy Care submitted ANDA No. 208469 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.
`
`55.
`
`On information and belief, pursuant to § 505(j)(2)(A)(vii)(IV) of the FDCA,
`
`Famy Care included with its ANDA No. 208469 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 Famy Care’s Cyclosporine
`
`Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469. Plaintiff received
`
`written notification of ANDA No. 208469 and its § 505(j)(2)(A)(vii)(IV) allegations with respect
`
`to the ’111, ’162, ’556, ’048, ’930, and ’191 patents on or about March 1, 2016.
`
`56.
`
`On information and belief, the FDA has not yet approved Famy Care’s ANDA
`
`No. 208469.
`
`57.
`
`On information and belief, Famy Care 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.
`
`58.
`
`On information and belief, Famy Care continues to seek approval of ANDA No.
`
`208469 from the FDA and intends to continue in the commercial manufacture, marketing, and
`
`sale of its proposed generic version of Allergan’s RESTASIS® product.
`
`
`
`8
`
`FAMY CARE - EXHIBIT 1023-0008
`
`
`
`59.
`
`On information and belief, following FDA approval of its ANDA No. 208469,
`
`Famy Care will sell the approved generic version of Allergan’s RESTASIS® product throughout
`
`the United States, including in Texas and this judicial district.
`
`Count I
`(Infringement of the ’111 Patent Under 35 U.S.C. § 271(e)(2) by Famy Care’s Proposed
`Generic Cyclosporine Ophthalmic Emulsion, 0.05%)
`
`Allergan incorporates each of the preceding paragraphs as if fully set forth herein.
`
`60.
`
`61.
`
`Famy Care submitted ANDA No. 208469 to the FDA under section 505(j) of the
`
`FDCA to obtain approval to engage in the commercial manufacture, use, offer for sale, sale, or
`
`importation of its proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product
`
`throughout the United States. By submitting this application, Famy Care has committed an act
`
`of infringement of the ’111 Patent under 35 U.S.C. § 271(e)(2)(A).
`
`62.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation of Famy
`
`Care’s proposed Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No.
`
`208469 will constitute an act of direct infringement of the ’111 Patent.
`
`63.
`
`On information and belief, Famy Care became aware of the ’111 Patent no later
`
`than the date on which that patent was listed in the Orange Book.
`
`64.
`
`On information and belief, Famy Care knows or should know that the commercial
`
`offer for sale and sale of Famy Care’s proposed Cyclosporine Ophthalmic Emulsion, 0.05%
`
`product described in ANDA No. 208469, will constitute an act of induced infringement and will
`
`contribute to actual infringement of the ’111 Patent.
`
`65.
`
`On information and belief, Famy Care knows or should know that its proposed
`
`generic Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469 will
`
`be especially made for or especially adapted for an infringement of the ’111 Patent, and is not a
`
`
`
`9
`
`FAMY CARE - EXHIBIT 1023-0009
`
`
`
`staple article or commodity of commerce suitable for substantial non-infringing use, and that its
`
`commercial manufacture, use, offer for sale, sale, and/or importation of its proposed generic
`
`Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469 will
`
`actively contribute to the actual infringement of the ’111 Patent.
`
`66.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation of Famy
`
`Care’s proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA
`
`No. 208469 in violation of Allergan’s patent rights will cause harm to Allergan for which
`
`damages are inadequate.
`
`Count II
`(Declaratory Judgment of Infringement of the ’111 Patent
`Under 35 U.S.C. § 271(a) by Famy Care)
`
`Allergan incorporates each of the preceding paragraphs as if fully set forth herein.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`67.
`
`68.
`
`2202.
`
`69.
`
`There is an actual case or controversy such that the Court may entertain
`
`Allergan’s request for declaratory relief consistent with Article III of the United States
`
`Constitution, and that actual case or controversy requires a declaration of rights by this Court.
`
`70.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation of Famy
`
`Care’s proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA
`
`No. 208469 will constitute an act of direct infringement of one or more claims of the ’111 Patent.
`
`71.
`
`On information and belief, Famy Care will engage in the commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Famy Care’s proposed generic
`
`Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469
`
`immediately and imminently upon approval of ANDA No. 208469.
`
`
`
`10
`
`FAMY CARE - EXHIBIT 1023-0010
`
`
`
`72.
`
`The foregoing actions by Famy Care will constitute infringement of the ’111
`
`Patent.
`
`73.
`
`Famy Care will commit those acts of infringement without license or
`
`authorization.
`
`74.
`
`Allergan is entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Famy Care’s proposed generic
`
`Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469 by Famy
`
`Care will infringe the ’111 Patent.
`
`75.
`
`Unless Famy Care is enjoined from infringing the ’111 Patent, Allergan will
`
`suffer irreparable injury for which damages are an inadequate remedy.
`
`Count III
`(Declaratory Judgment of Infringement of the ’111 Patent Under 35 U.S.C. § 271(b) and (c)
`by Famy Care’s Proposed Generic Cyclosporine Ophthalmic Emulsion, 0.05%)
`
`Allergan incorporates each of the preceding paragraphs as if fully set forth herein.
`
`76.
`
`77.
`
`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`2202.
`
`78.
`
`There is an actual case or controversy such that the Court may entertain
`
`Allergan’s request for declaratory relief consistent with Article III of the United States
`
`Constitution, and that actual case or controversy requires a declaration of rights by this Court.
`
`79.
`
`80.
`
`Famy Care has actual knowledge of the ’111 Patent.
`
`On information and belief, Famy Care became aware of the ’111 Patent no later
`
`than the date on which that patent was listed in the Orange Book.
`
`
`
`11
`
`FAMY CARE - EXHIBIT 1023-0011
`
`
`
`81.
`
`On information and belief, Famy Care has acted with full knowledge of the ’111
`
`Patent and without a reasonable basis for believing that it would not be liable for actively
`
`inducing or contributing to the infringement of the ’111 Patent.
`
`82.
`
`The commercial manufacture, use, sale, offer for sale, and/or importation of Famy
`
`Care’s proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA
`
`No. 208469 will induce the actual infringement of the ’111 Patent.
`
`83.
`
`On information and belief, Famy Care knows or should know that its commercial
`
`manufacture, use, sale, offer for sale, and/or importation of its proposed generic Cyclosporine
`
`Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469 will actively induce the
`
`actual infringement of the ’111 Patent.
`
`84.
`
`On information and belief, Famy Care will encourage another’s infringement of
`
`the ’111 Patent by and through the commercial manufacture, use, sale, offer for sale, and/or
`
`importation of its proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product
`
`described in ANDA No. 208469, which is covered by certain claims of the ’111 Patent.
`
`85.
`
`Famy Care’s acts of infringement will be done with knowledge of the ’111 Patent
`
`and with the intent to encourage infringement.
`
`86.
`
`The foregoing actions by Famy Care will constitute active inducement of
`
`infringement of the ’111 Patent.
`
`87.
`
`On information and belief, Famy Care knows or should know that its proposed
`
`generic Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469 will
`
`be especially made or especially adapted for use in an infringement of the ’111 Patent, and is not
`
`a staple article or commodity of commerce suitable for substantial non-infringing use.
`
`
`
`12
`
`FAMY CARE - EXHIBIT 1023-0012
`
`
`
`88.
`
`The commercial manufacture, use, sale, offer for sale, and/or importation of Famy
`
`Care’s proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product will contribute to
`
`the actual infringement of the ’111 Patent.
`
`89.
`
`On information and belief, Famy Care knows or should know that its offer for
`
`sale, sale, and/or importation of its proposed generic Cyclosporine Ophthalmic Emulsion, 0.05%
`
`product described in ANDA No. 208469 will contribute to the actual infringement of the ’111
`
`Patent.
`
`90.
`
`The foregoing actions by Famy Care will constitute contributory infringement of
`
`the ’111 Patent.
`
`91.
`
`On information and belief, Famy Care intends to, and will, actively induce and
`
`contribute to the infringement of the ’111 Patent when ANDA No. 208469 is approved, and plan
`
`and intend to, and will, do so immediately and imminently upon approval.
`
`92.
`
`Allergan is entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Famy Care’s proposed generic
`
`Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469 by Famy
`
`Care will induce and/or contribute to the infringement of the ’111 Patent.
`
`93.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of Famy
`
`Care’s proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA
`
`No. 208469, which will actively induce and/or contribute to infringement of the ’111 Patent, in
`
`violation of Allergan’s patent rights, will cause harm to Allergan for which damages are
`
`inadequate.
`
`
`
`13
`
`FAMY CARE - EXHIBIT 1023-0013
`
`
`
`94.
`
`Unless Famy Care is enjoined from actively inducing and contributing to the
`
`infringement of the ’111 Patent, Allergan will suffer irreparable injury for which damages are an
`
`inadequate remedy.
`
`95.
`
`On information and belief, despite having actual notice of the ’111 Patent, Famy
`
`Care continues to willfully, wantonly, and deliberately prepare to actively induce and/or
`
`contribute to infringement of the ’111 Patent in disregard of Allergan’s rights, making this case
`
`exceptional and entitling Allergan to reasonable attorneys’ fees pursuant to 35 U.S.C. § 285.
`
`Count IV
`(Infringement of the ’162 Patent Under 35 U.S.C. § 271(e)(2) by Famy Care’s Proposed
`Generic Cyclosporine Ophthalmic Emulsion, 0.05%)
`
`Allergan incorporates each of the preceding paragraphs as if fully set forth herein.
`
`96.
`
`97.
`
`Famy Care submitted ANDA No. 208469 to the FDA under section 505(j) of the
`
`FDCA to obtain approval to engage in the commercial manufacture, use, offer for sale, sale, or
`
`importation of its proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product
`
`throughout the United States. By submitting this application, Famy Care has committed an act
`
`of infringement of the ’162 Patent under 35 U.S.C. § 271(e)(2)(A).
`
`98.
`
`On information and belief, Famy Care became aware of the ’162 Patent no later
`
`than the date on which that patent was listed in the Orange Book.
`
`99.
`
`On information and belief, Famy Care knows or should know that the commercial
`
`offer for sale and sale of Famy Care’s proposed Cyclosporine Ophthalmic Emulsion, 0.05%
`
`product described in ANDA No. 208469, will constitute an act of induced infringement and will
`
`contribute to actual infringement of the ’162 Patent.
`
`100. On information and belief, Famy Care knows or should know that its proposed
`
`generic Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469 will
`
`
`
`14
`
`FAMY CARE - EXHIBIT 1023-0014
`
`
`
`be especially made for or especially adapted for an infringement of the ’162 Patent, and is not a
`
`staple article or commodity of commerce suitable for substantial non-infringing use, and that its
`
`commercial manufacture, use, offer for sale, sale, and/or importation of its proposed generic
`
`Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469 will
`
`actively contribute to the actual infringement of the ’162 Patent.
`
`101. The commercial manufacture, use, offer for sale, sale, and/or importation of Famy
`
`Care’s proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA
`
`No. 208469 in violation of Allergan’s patent rights will cause harm to Allergan for which
`
`damages are inadequate.
`
`Count V
`(Declaratory Judgment of Infringement of the ’162 Patent Under 35 U.S.C. § 271(b) and (c)
`by Famy Care’s Proposed Generic Cyclosporine Ophthalmic Emulsion, 0.05%)
`
`102. Allergan incorporates each of the preceding paragraphs as if fully set forth herein
`
`103. These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`2202.
`
`104. There is an actual case or controversy such that the Court may entertain
`
`Allergan’s request for declaratory relief consistent with Article III of the United States
`
`Constitution, and that actual case or controversy requires a declaration of rights by this Court.
`
`105. Famy Care has actual knowledge of the ’162 Patent.
`
`106. On information and belief, Famy Care became aware of the ’162 Patent no later
`
`than the date on which that patent was listed in the Orange Book.
`
`107. On information and belief, Famy Care has acted with full knowledge of the ’162
`
`Patent and without a reasonable basis for believing that it would not be liable for actively
`
`inducing or contributing to the infringement of the ’162 Patent.
`
`
`
`15
`
`FAMY CARE - EXHIBIT 1023-0015
`
`
`
`108. The commercial manufacture, use, sale, offer for sale, and/or importation of Famy
`
`Care’s proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA
`
`No. 208469 will induce the actual infringement of the ’162 Patent.
`
`109. On information and belief, Famy Care knows or should know that its commercial
`
`manufacture, use, sale, offer for sale, and/or importation of its proposed generic Cyclosporine
`
`Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469 will actively induce the
`
`actual infringement of the ’162 Patent.
`
`110. On information and belief, Famy Care will encourage another’s infringement of
`
`the ’162 Patent by and through the commercial manufacture, use, sale, offer for sale, and/or
`
`importation of its proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product
`
`described in ANDA No. 208469, which is covered by certain claims of the ’162 Patent.
`
`111. Famy Care’s acts of infringement will be done with knowledge of the ’162 Patent
`
`and with the intent to encourage infringement.
`
`112. The foregoing actions by Famy Care will constitute active inducement of
`
`infringement of the ’162 Patent.
`
`113. On information and belief, Famy Care knows or should know that its proposed
`
`generic Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469 will
`
`be especially made or especially adapted for use in an infringement of the ’162 Patent, and is not
`
`a staple article or commodity of commerce suitable for substantial non-infringing use.
`
`114. The commercial manufacture, use, sale, offer for sale, and/or importation of Famy
`
`Care’s proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA
`
`No. 208469 will contribute to the actual infringement of the ’162 Patent.
`
`
`
`16
`
`FAMY CARE - EXHIBIT 1023-0016
`
`
`
`115. On information and belief, Famy Care knows or should know that its offer for
`
`sale, sale, and/or importation of its proposed generic Cyclosporine Ophthalmic Emulsion, 0.05%
`
`product described in ANDA No. 208469 will contribute to the actual infringement of the ’162
`
`Patent.
`
`116. The foregoing actions by Famy Care will constitute contributory infringement of
`
`the ’162 Patent.
`
`117. On information and belief, Famy Care intends to, and will, actively induce and
`
`contribute to the infringement of the ’162 Patent when ANDA No. 208469 is approved, and plan
`
`and intend to, and will, do so immediately and imminently upon approval.
`
`118. Allergan is entitled to a declaratory judgment that future commercial
`
`manufacture, use, offer for sale, sale, and/or importation of Famy Care’s proposed generic
`
`Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469 by Famy
`
`Care will induce and/or contribute to the infringement of the ’162 Patent.
`
`119. The commercial manufacture, use, offer for sale, sale and/or importation of Famy
`
`Care’s proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA
`
`No. 208469, which will actively induce and/or contribute to infringement of the ’162 Patent, in
`
`violation of Allergan’s patent rights, will cause harm to Allergan for which damages are
`
`inadequate.
`
`120. Unless Famy Care is enjoined from actively inducing and contributing to the
`
`infringement of the ’162 Patent, Allergan will suffer irreparable injury for which damages are an
`
`inadequate remedy.
`
`121. On information and belief, despite having actual notice of the ’162 Patent, Famy
`
`Care continues to willfully, wantonly, and deliberately prepare to actively induce and/or
`
`
`
`17
`
`FAMY CARE - EXHIBIT 1023-0017
`
`
`
`contribute to infringement of the ’162 Patent in disregard of Allergan’s rights, making this case
`
`exceptional and entitling Allergan to reasonable attorneys’ fees pursuant to 35 U.S.C. § 285.
`
`Count VI
`(Infringement of the ’556 Patent Under 35 U.S.C. § 271(e)(2) by InnoPharma’s Proposed
`Generic Cyclosporine Ophthalmic Emulsion, 0.05%)
`
`122. Allergan incorporates each of the preceding paragraphs as if fully set forth herein.
`
`123. Famy Care submitted ANDA No. 208469 to the FDA under section 505(j) of the
`
`FDCA to obtain approval to engage in the commercial manufacture, use, offer for sale, sale, or
`
`importation of its proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product
`
`throughout the United States. By submitting this application, Famy Care has committed an act
`
`of infringement of the ’556 Patent under 35 U.S.C. § 271(e)(2)(A).
`
`124. The commercial manufacture, use, offer for sale, sale, and/or importation of Famy
`
`Care’s proposed Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No.
`
`208469 will constitute an act of direct infringement of the ’556 Patent.
`
`125. On information and belief, Famy Care became aware of the ’556 Patent no later
`
`than the date on which that patent was listed in the Orange Book.
`
`126. On information and belief, Famy Care knows or should know that the commercial
`
`offer for sale and sale of Famy Care’s proposed Cyclosporine Ophthalmic Emulsion, 0.05%
`
`product described in ANDA No. 208469, will constitute an act of induced infringement and will
`
`contribute to actual infringement of the ’556 Patent.
`
`127. On information and belief, Famy Care knows or should know that its proposed
`
`generic Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469 will
`
`be especially made for or especially adapted for an infringement of the ’556 Patent, and is not a
`
`staple article or commodity of commerce suitable for substantial non-infringing use, and that its
`
`
`
`18
`
`FAMY CARE - EXHIBIT 1023-0018
`
`
`
`commercial manufacture, use, offer for sale, sale, and/or importation of its proposed generic
`
`Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA No. 208469 will
`
`actively contribute to the actual infringement of the ’556 Patent.
`
`128. The commercial manufacture, use, offer for sale, sale, and/or importation of Famy
`
`Care’s proposed generic Cyclosporine Ophthalmic Emulsion, 0.05% product described in ANDA
`
`No. 208469 in violation of Allergan’s patent rights will cause harm to Allergan for which
`
`damages are inadequate.
`
`Count VII
`(Declaratory Judgment of Infringement of the ’556 Patent
`Under 35 U.S.C. § 271(a) by Famy Care)
`
`129. Allergan incorporates each of the preceding paragraphs as if fully set forth herein.
`
`130. These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`2202.
`
`131. There is an actual case or controversy such that the Court may entertain
`
`Allergan’s request for declaratory relief consistent with Article III of the
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