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Case 1:16-cv-00563-SLR Document 1 Filed 06/30/16 Page 1 of 11 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`ALCON PHARMACEUTICALS LTD. and
`ALCON RESEARCH, LTD.,
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`
`
`C.A. No.
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`))))))))))
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`IMPRIMIS PHARMACEUTICALS, INC.,
`
`
`
`
`
`Plaintiffs,
`
`v.
`
`
`
`Defendant.
`
`
`
`
`
`
`
`
`
`
`COMPLAINT
`
`Plaintiffs Alcon Pharmaceuticals Ltd. and Alcon Research, Ltd. (collectively
`
`“Alcon”), by their attorneys, for their Complaint, allege as follows:
`
`1.
`
`This is an action for patent infringement under the patent laws of the
`
`United States, Title 35, United States Code, that arises out of Imprimis Pharmaceuticals, Inc.’s
`
`(“Imprimis”) manufacture and sale of ophthalmic drug products containing moxifloxacin
`
`hydrochloride, which infringes two Alcon U.S. patents.
`
`PARTIES
`
`2.
`
`Plaintiff Alcon Pharmaceuticals Ltd. is a corporation organized and
`
`existing under the laws of Switzerland, having its principal place of business at Rue Louis
`
`d’Affry 6, Case Postale, 1701 Fribourg, Switzerland.
`
`3.
`
`Plaintiff Alcon Research, Ltd. is a corporation organized and existing
`
`under the laws of the State of Delaware, having its principal place of business at 6201 South
`
`Freeway, Fort Worth, Texas 76134.
`
`

`
`Case 1:16-cv-00563-SLR Document 1 Filed 06/30/16 Page 2 of 11 PageID #: 2
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`4.
`
`Upon information and belief, defendant Imprimis is a corporation
`
`organized and existing under the laws of the State of Delaware, having its principal place of
`
`business at 12264 El Camino Real, Suite 350, San Diego, California 92130.
`
`JURISDICTION AND VENUE
`
`5.
`
`Jurisdiction and venue are proper in this district pursuant to 28 U.S.C.
`
`§§ 1331, 1338(a), and 1391 and 1400(b).
`
`6.
`
`This Court has personal jurisdiction over Imprimis because Imprimis has
`
`availed itself of the legal protections of the State of Delaware by, among other things,
`
`incorporating in Delaware. By incorporating in Delaware, Imprimis is “at home” in Delaware
`
`for purposes of personal jurisdiction. In addition, upon information and belief, Imprimis
`
`manufactures, markets and/or sells drug products throughout the United States and within the
`
`State of Delaware and therefore transacts business within the State of Delaware related to
`
`Plaintiffs’ claims, and/or has engaged in systematic and continuous business contacts within the
`
`State of Delaware.
`
`7.
`
`Venue is proper in this District because Imprimis resides in this District
`
`and because Imprimis is subject to personal jurisdiction in this District.
`
`COUNT I-INFRINGEMENT OF THE ’830 PATENT
`
`8.
`
`Alcon incorporates each of the preceding paragraphs 1-7 as if fully set
`
`forth herein.
`
`
`
`9.
`
`United States Patent No. 6,716,830 (“the ’830 patent”), titled “Ophthalmic
`
`Antibiotic Compositions Containing Moxifloxacin” (Exhibit A hereto), was duly and legally
`
`issued on April 6, 2004 to Alcon, Inc., as assignee of Gerald Cagle, Robert L. Abshire, David W.
`
`Stroman, and John M. Yanni.
`
`2
`
`

`
`Case 1:16-cv-00563-SLR Document 1 Filed 06/30/16 Page 3 of 11 PageID #: 3
`
`10.
`
`Alcon, Inc.’s interest in the ’830 patent has been subsequently assigned to
`
`Alcon Pharmaceuticals Ltd. Alcon Pharmaceuticals Ltd. owns the ’830 patent and has been and
`
`will be substantially and irreparably damaged by infringement of the ’830 patent.
`
`11.
`
`Alcon Research, Ltd. has been granted an exclusive license under the ’830
`
`patent. Alcon Research, Ltd. has been and will be substantially and irreparably damaged by
`
`infringement of the ’830 patent.
`
`12.
`
`The ’830 patent claims, inter alia, topical ophthalmic pharmaceutical
`
`compositions comprising moxifloxacin or a pharmaceutically useful hydrate or salt thereof in a
`
`concentration of 0.1 to 1.0 wt. % of moxifloxacin and a pharmaceutically acceptable vehicle
`
`therefor. The ’830 patent also claims such compositions that further comprise a glucocorticoid,
`
`or a prostaglandin H synthetase inhibitor.
`
`13.
`
`Alcon manufactures and sells VIGAMOX® ophthalmic solution, an
`
`antibiotic eye drop containing moxifloxacin hydrochloride. VIGAMOX® is covered by the ’830
`
`patent. Since its launch in 2003, doctors have prescribed VIGAMOX® more than 30 million
`
`times, and VIGAMOX® has established and maintained strong branded market share in the
`
`ophthalmic anti-infective drug category. VIGAMOX® is indicated for treatment of bacterial
`
`conjunctivitis, and is also prescribed by physicians for use in conjunction with cataract, LASIK,
`
`and other ocular surgeries.
`
`14.
`
`Upon information and belief, Imprimis manufactures, markets, offers for
`
`sale, and sells topical ophthalmic pharmaceutical compositions comprising moxifloxacin
`
`hydrochloride in a concentration of 0.1 to 1.0 wt %, and a pharmaceutically acceptable vehicle
`
`therefor (“Imprimis’s moxifloxacin ophthalmic products”), including Imprimis’s Pred-Moxi,
`
`Pred-Moxi-Ketor, Pred-Moxi-Nepaf, and Tri-Moxi products. Ex. C.
`
`3
`
`

`
`Case 1:16-cv-00563-SLR Document 1 Filed 06/30/16 Page 4 of 11 PageID #: 4
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`15.
`
`Upon information and belief, Imprimis’s Pred-Moxi, Pred-Moxi-Ketor,
`
`and Pred-Moxi-Nepaf products further contain prednisolone, a glucocorticoid compound.
`
`16.
`
`Upon information and belief, Imprimis’s Pred-Moxi-Ketor product further
`
`contains ketorolac, a prostaglandin H synthetase inhibitor.
`
`17.
`
`Upon information and belief, Imprimis’s Pred-Moxi-Nepaf product further
`
`contains nepafenac, a prostaglandin H synthetase inhibitor.
`
`18.
`
`Upon information and belief, Imprimis’s Tri-Moxi product further
`
`contains triamcinolone, a glucocorticoid compound.
`
`19.
`
`Imprimis’s marketing literature states that Imprimis’s Pred-Moxi, Pred-
`
`Moxi-Ketor, Pred-Moxi-Nepafenac, and Tri-Moxi products are each “topical eye drop
`
`formulations.” Ex. C.
`
`20.
`
`According to a June 7, 2016 Imprimis investor presentation, Imprimis’s
`
`goal is to “disrupt[]” the “>$1B[illion] Eye Drop Market,” specifically targeting Alcon’s sales of
`
`VIGAMOX®. Ex. D at 11-12. According to that same presentation, Imprimis intends to
`
`undercut the cost of certain treatment regimens utilizing VIGAMOX® by up to 92%, and claims
`
`to have captured more than “10% market share related to pre[-] and post[-]operative eye drops
`
`for cataract surgery.” Id. at 13.
`
`21.
`
`Imprimis’s moxifloxacin ophthalmic compositions are covered by one or
`
`more claims of the ’830 patent.
`
`22.
`
`Upon information and belief, Imprimis has knowledge of the claims of the
`
`’830 patent. Upon information and belief, Imprimis has cited the ’830 patent in submissions to
`
`the United States Patent and Trademark Office in conjunction with the prosecution of Imprimis’s
`
`own patent applications. Upon information and belief, Imprimis has notice of this Court’s
`
`4
`
`

`
`Case 1:16-cv-00563-SLR Document 1 Filed 06/30/16 Page 5 of 11 PageID #: 5
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`October 19, 2009, opinion affirming the validity of claim 1 of the ’830 patent, which covers
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`Imprimis’s moxifloxacin ophthalmic products. Notwithstanding this knowledge, Imprimis has
`
`continued to manufacture, offer for sale, sell, and distribute its moxifloxacin ophthalmic
`
`compositions during the term of the ’830 patent, and intends to continue doing so. Accordingly,
`
`Imprimis has willfully, wantonly, and deliberately engaged in acts of infringement of the ’830
`
`patent.
`
`23.
`
`The manufacture, use, sale, offer for sale, or importation of Imprimis’s
`
`moxifloxacin ophthalmic compositions infringes one or more claims of the ’830 patent.
`
`
`
`24.
`
`The foregoing actions by Imprimis constitute and/or will constitute
`
`infringement, and active inducement of infringement, of the ’830 patent.
`
`25.
`
`Upon information and belief, Imprimis has acted with full knowledge of
`
`the ’830 patent and without a reasonable basis for believing that it would not be liable for
`
`infringement of the ’830 patent and/or active inducement of infringement of the ’830 patent.
`
`26.
`
`As a result of Imprimis’s wrongful acts, Alcon has suffered irreparable
`
`injury. Unless Imprimis is enjoined from infringing and inducing infringement of the ’830
`
`patent, Alcon will suffer additional irreparable injury. Alcon has no adequate remedy at law.
`
`27.
`
`Imprimis’s infringement has damaged Alcon, which is entitled to recover
`
`from Imprimis the damages resulting from Imprimis’s wrongful acts in an amount to be
`
`determined at trial, and in any event no less than a reasonable royalty.
`
`28.
`
`Imprimis’s willful, wanton, and deliberate infringement of the ’830 patent
`
`justifies an award to Alcon of increased damages under 35 U.S.C. § 284, and attorneys’ fees and
`
`costs incurred under 35 U.S.C. § 285.
`
`
`
`
`
`5
`
`

`
`Case 1:16-cv-00563-SLR Document 1 Filed 06/30/16 Page 6 of 11 PageID #: 6
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`COUNT II-INFRINGEMENT OF THE ’070 PATENT
`
`Alcon incorporates each of the preceding paragraphs 1-28 as if fully set
`
`29.
`
`forth herein.
`
`
`
`30.
`
`United States Patent No. 7,671,070 (“the ’070 patent”), titled “Method of
`
`Treating Ophthalmic Infections with Moxifloxacin Compositions” (Exhibit B hereto), was duly
`
`and legally issued on March 2, 2010 to Alcon, Inc., as assignee of Gerald Cagle, Robert L.
`
`Abshire, David W. Stroman, and John M. Yanni.
`
`31.
`
`Alcon, Inc.’s interest in the ’070 patent has been subsequently assigned to
`
`Alcon Pharmaceuticals Ltd. Alcon Pharmaceuticals Ltd. owns the ’070 patent and has been and
`
`will be substantially and irreparably damaged by infringement of the ’070 patent.
`
`32.
`
`Alcon Research, Ltd. has been granted an exclusive license under the ’070
`
`patent. Alcon Research, Ltd. has been and will be substantially and irreparably damaged by
`
`infringement of the ’070 patent.
`
`33.
`
`The ’070 patent claims, inter alia, a method of treating ophthalmic
`
`infections, which comprises topically applying to the eye a therapeutically effective amount of a
`
`pharmaceutical composition comprising moxifloxacin or a pharmaceutically useful hydrate or
`
`salt thereof in a concentration of 0.1 to 1.0 wt. % of moxifloxacin and a pharmaceutically
`
`acceptable vehicle therefor. The ’070 patent also claims such methods of treatment with
`
`compositions that further comprise a glucocorticoid, or a prostaglandin H synthetase inhibitor.
`
`34.
`
`The approved use of VIGAMOX® is covered by one or more claims of
`
`the ’070 patent.
`
`35.
`
`Upon information and belief, Imprimis manufactures, markets, offers for
`
`sale, and sells topical ophthalmic pharmaceutical compositions comprising moxifloxacin
`
`6
`
`

`
`Case 1:16-cv-00563-SLR Document 1 Filed 06/30/16 Page 7 of 11 PageID #: 7
`
`hydrochloride in a concentration of 0.1 to 1.0 wt %, and a pharmaceutically acceptable vehicle
`
`therefor (“Imprimis’s moxifloxacin ophthalmic products”), including Imprimis’s Pred-Moxi,
`
`Pred-Moxi-Ketor, Pred-Moxi-Nepaf, and Tri-Moxi products. Ex. C.
`
`36.
`
`Upon information and belief, Imprimis’s Pred-Moxi, Pred-Moxi-Ketor,
`
`and Pred-Moxi-Nepaf products further contain prednisolone, a glucocorticoid compound.
`
`37.
`
`Upon information and belief, Imprimis’s Pred-Moxi-Ketor product further
`
`contains ketorolac, a prostaglandin H synthetase inhibitor.
`
`38.
`
`Upon information and belief, Imprimis’s Pred-Moxi-Nepaf product further
`
`contains nepafenac, a prostaglandin H synthetase inhibitor.
`
`39.
`
`Upon information and belief, Imprimis’s Tri-Moxi product further
`
`contains triamcinolone, a glucocorticoid compound.
`
`40.
`
`Imprimis’s marketing literature states that Imprimis’s Pred-Moxi, Pred-
`
`Moxi-Ketor, Pred-Moxi-Nepafenac, and Tri-Moxi products are each “topical eye drop
`
`formulations.” Ex. C.
`
`41.
`
`Upon information and belief, patients have used, and will continue to use,
`
`Imprimis’s moxifloxacin ophthalmic products to practice the methods claimed by the ’070
`
`patent.
`
`42.
`
`Upon
`
`information and belief, Imprimis
`
`instructs patients to treat
`
`ophthalmic infections by topically applying Imprimis’s moxifloxacin ophthalmic products to the
`
`eye. For example, Imprimis’s Order Form for Pred-Moxi, Pred-Moxi-Ketor, and Pred-Moxi-
`
`Nepaf instructs patients to “[i]nstill” those products “into the affected eye(s)” as further directed
`
`by the prescribing physician. Ex. E. Imprimis further provides patient instruction sheets on
`
`which the prescriber is to detail the schedule and duration of treatment with its products. E.g.
`
`7
`
`

`
`Case 1:16-cv-00563-SLR Document 1 Filed 06/30/16 Page 8 of 11 PageID #: 8
`
`Ex. F. In addition, Imprimis’s marketing materials state that Imprimis’s moxifloxacin
`
`ophthalmic products are “[c]ombination topical eye drops for patients following LASIK, PRK,
`
`cataract, and other ocular surgeries,” and encourage patients and doctors to “[p]lace an order
`
`today.” Ex. G.
`
`43.
`
`Upon information and belief, the use of the Imprimis’s moxifloxacin
`
`ophthalmic products as directed by Imprimis would infringe one or more claims of the ’070
`
`patent.
`
`44.
`
`Upon information and belief, Imprimis has actively induced infringement
`
`of the ’070 patent, and intends to continue actively inducing infringement of the ’070 patent.
`
`45.
`
`Upon information and belief, Imprimis knows that its moxifloxacin
`
`ophthalmic products are especially made or adapted for use in infringing the ’070 patent, are not
`
`a staple article or commodity of commerce, and that Imprimis’s moxifloxacin ophthalmic
`
`products, along with Imprimis’s instructions, are not suitable for substantial noninfringing use.
`
`Upon information and belief, Imprimis has contributed, and will continue to contribute, to
`
`infringement of the ’070 patent.
`
`46.
`
`Upon information and belief, Imprimis has knowledge of the claims of the
`
`’070 patent. Notwithstanding this knowledge, Imprimis has continued to manufacture, offer for
`
`sale, sell, and distribute its moxifloxacin ophthalmic compositions, along with instructions for
`
`their use, during the term of the ’070 patent, and intends to continue doing so. Accordingly,
`
`Imprimis has willfully, wantonly, and deliberately engaged in acts of infringement of the ’070
`
`patent.
`
`8
`
`

`
`Case 1:16-cv-00563-SLR Document 1 Filed 06/30/16 Page 9 of 11 PageID #: 9
`
`47.
`
`The foregoing actions by Imprimis constitute and/or will constitute active
`
`inducement of infringement of the ’070 patent, and contribution to the infringement by others of
`
`the ’070 patent.
`
`48.
`
`Upon information and belief, Imprimis has acted with full knowledge of
`
`the ’070 patent and without a reasonable basis for believing that it would not be liable for active
`
`inducement of infringement of the ’070 patent, and/or contributing to the infringement by others
`
`of the ’070 patent.
`
`49.
`
`As a result of Imprimis’s wrongful acts, Alcon has suffered irreparable
`
`injury. Unless Imprimis is enjoined from inducing infringement and contributing to the
`
`infringement of, the ’070 patent, Alcon will suffer additional irreparable injury. Alcon has no
`
`adequate remedy at law.
`
`50.
`
`Imprimis’s infringement has damaged Alcon, which is entitled to recover
`
`from Imprimis the damages resulting from Imprimis’s wrongful acts in an amount to be
`
`determined at trial, and in any event no less than a reasonable royalty.
`
`51.
`
`Imprimis’s willful, wanton, and deliberate infringement of the ’070 patent
`
`justifies an award to Alcon of increased damages under 35 U.S.C. § 284, and attorneys’ fees and
`
`costs incurred under 35 U.S.C. § 285.
`
`WHEREFORE, Plaintiffs request the following relief:
`
`(a)
`
`A judgment that United States Patent Nos. 6,716,830 and 7,671,070 are
`
`valid and enforceable, and have been infringed by Imprimis;
`
`(b)
`
`A preliminary and permanent injunction against any infringement, or
`
`inducement of infringement, by Imprimis of United States Patent No. 6,716,830, through the
`
`commercial manufacture, use, sale, offer for sale, or importation into the United States of
`
`9
`
`

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`Case 1:16-cv-00563-SLR Document 1 Filed 06/30/16 Page 10 of 11 PageID #: 10
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`Imprimis’s moxifloxacin ophthalmic products, or any other drug product that is covered by that
`
`patent;
`
`(c)
`
`A preliminary and permanent injunction against any inducement of
`
`infringement, or contribution to infringement, by Imprimis of United States Patent No.
`
`7,671,070, through the commercial manufacture, use, sale, offer for sale, or importation into the
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`United States of Imprimis’s moxifloxacin ophthalmic products, or any other drug product whose
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`use is covered by that patent;
`
`(d)
`
`(e)
`
`An award of damages pursuant to 35 U.S.C. § 284;
`
`A declaration that Imprimis’s infringement was willful and deliberate, and
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`an increase to the award of damages of three times the amount found or assessed by the Court, in
`
`accordance with 35 U.S.C. § 284;
`
`(f)
`
`(g)
`
`An award for an accounting of damages from Imprimis’s infringement;
`
`A declaration that this in an exceptional case and an award of attorneys’
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`fees pursuant to 35 U.S.C. § 285;
`
`(h)
`
`(i)
`
`Costs and expenses in this action; and
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`Such further and other relief as this Court may deem just and proper.
`
`
`
`
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Jack B. Blumenfeld
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Rodger D. Smith II (#3778)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`rsmith@mnat.com
`
`Attorneys for Plaintiffs
`
`10
`
`
`
`

`
`Case 1:16-cv-00563-SLR Document 1 Filed 06/30/16 Page 11 of 11 PageID #: 11
`
`OF COUNSEL:
`
`Bruce R. Genderson
`Adam L. Perlman
`Scott K. Dasovich
`Elise M. Baumgarten
`Williams & Connolly LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`
`June 30, 2016
`
`11

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