Case 3:21-cv-19252 Document 1 Filed 10/22/21 Page 1 of 13 PageID: 1
`
`William P. Deni, Jr.
`J. Brugh Lower
`GIBBONS P.C.
`One Gateway Center
`Newark, New Jersey 07102
`Tel: (973) 596-4500
`Fax: (973) 596-0545
`
`Attorneys for Plaintiffs
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`BAUSCH & LOMB, INC.;
`BAUSCH & LOMB IRELAND LIMITED;
`and EYE THERAPIES, LLC,
`
`Plaintiffs,
`
`v.
`
`HARROW HEALTH, INC.; IMPRIMISRX,
`LLC; IMPRIMISRX NJ, LLC; and
`IMPRIMIS NJOF, LLC,
`
`Defendants.
`
`Civil Action No. 21-19252
`
`Document Electronically Filed
`
`COMPLAINT FOR PATENT INFRINGEMENT AND DEMAND FOR JURY TRIAL
`
`Plaintiffs Bausch & Lomb, Inc., Bausch & Lomb Ireland Limited, and Eye Therapies, LLC
`
`(collectively, “Plaintiffs”) by way of Complaint against Defendants Harrow Health, Inc.,
`
`ImprimisRx, LLC, ImprimisRx NJ, LLC, and Imprimis NJOF, LLC (collectively, “Defendants”)
`
`allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for infringement of United States Patent Nos. 8,765,758 (“the ’758
`
`patent”) and 9,259,425 (“the ’425 patent”), arising under the United States patent laws, Title 35,
`
`United States Code, § 100 et seq., including 35 U.S.C. §§ 271 and 281. This action relates to
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`

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`Case 3:21-cv-19252 Document 1 Filed 10/22/21 Page 2 of 13 PageID: 2
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`Defendants’ making, using, importing, offering to sell, or selling its Epinastine Brimonidine PF
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`product (the “Accused Product”) through its 503A Pharmacy and 503B Outsourcing Facility,
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`which is, for example, advertised with the image below and with the tagline “HERE TO
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`BRIGHTEN YOUR DAY!”:
`
`THE PARTIES
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`2.
`
`Plaintiff Bausch & Lomb, Inc. (“Bausch”) is a corporation organized and existing
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`under the laws of New York with a place of business at 1400 N. Goodman St. Rochester, NY
`
`14609. Bausch is the registered holder of approved New Drug Application (“NDA”) No. 208144,
`
`which covers Lumify® ophthalmic solution/drops (brimonidine tartrate, 0.025%).
`
`3.
`
`Plaintiff Bausch & Lomb Ireland Limited (“Bausch Ireland”) is a company
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`organized and existing under the laws of Ireland, having its registered office at 3013 Lake Drive,
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`Citywest Business Park, Dublin, Ireland. Bausch Ireland exclusively licenses the ’758 patent and
`
`the ’425 patent.
`
`4.
`
`Plaintiff Eye Therapies, LLC (“Eye Therapies”) is a limited liability company
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`organized and existing under the laws of Delaware, having its principal place of business at 26933
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`Camino De Estrella, 2nd Fl., Dana Point, California 92624. Eye Therapies is the owner of the
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`’758 patent and the ’425 patent.
`
`5.
`
`Upon information and belief, Harrow Health, Inc. (“Harrow Health”) is a
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`Delaware corporation having a principal place of business at 102 Woodmont Blvd., Suite 610,
`
`Nashville, TN 37205.
`
`6.
`
`Upon information and belief, ImprimisRx, LLC (“ImprimisRx”) is a limited
`
`liability company organized under the laws of Delaware, having a principal place of business at
`
`12264 El Camino Real, Suite 350, San Diego, CA 92130.
`
`7.
`
`Upon information and belief, ImprimisRx NJ, LLC (“ImprimisRx NJ”) is a
`
`limited liability company organized under the laws of New Jersey, having a principal place of
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`business at 1705 Route 46 W, Suite 4, Ledgewood, NJ 07852, within this judicial district.
`
`8.
`
`Upon information and belief, Imprimis NJOF, LLC (“Imprimis NJOF”) is a
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`limited liability company organized under the laws of New Jersey, having a principal place of
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`business at 1705 Route 46 W, Suite 6B, Ledgewood, NJ 07852, within this judicial district.
`
`9.
`
`Upon information and belief, Harrow Health is the parent corporation of
`
`ImprimisRx, ImprimisRx NJ, and Imprimis NJOF, and the acts complained of herein were done
`
`with the cooperation, participation and assistance of Harrow Health, ImprimisRx, ImprimisRx NJ,
`
`and Imprimis NJOF.
`
`JURISDICTION AND VENUE
`
`10.
`
`11.
`
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331, 1338(a)-(b).
`
`Upon information and belief, this court has jurisdiction over ImprimisRx NJ. Upon
`
`information and belief, ImprimisRx NJ is in the business of, inter alia, developing, manufacturing,
`
`marketing, importing and selling pharmaceutical products, including compounded drug products.
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`Upon information and belief, ImprimisRx NJ directly or indirectly, develops, manufactures,
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`markets, and sells the Accused Product in this judicial district, specifically, where its 503A
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`Compounding Pharmacy and 503B Outsourcing Pharmacy designations are held, and, after
`
`manufacturing the Accused Product in this judicial district, distributes the Accused Product
`
`throughout the United States. Upon information and belief, ImprimisRx NJ purposefully has
`
`conducted and continues to conduct business in this judicial district. Upon information and belief,
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`ImprimisRx NJ is organized under the laws of New Jersey and has its principal place of business
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`at 1705 Route 46 W, Suite 4, Ledgewood, NJ 07852, within this judicial district. Upon information
`
`and belief, ImprimisRx purposefully has conducted and continues to conduct business in this
`
`judicial district in concert with Harrow Health, ImprimisRx and Imprimis NJOF.
`
`12.
`
`Upon information and belief, this court has jurisdiction over Imprimis NJOF. Upon
`
`information and belief, Imprimis NJOF is in the business of, inter alia, developing, manufacturing,
`
`marketing, importing and selling pharmaceutical products, including compounded drug products.
`
`Upon information and belief, Imprimis NJOF directly or indirectly, develops, manufactures,
`
`markets, and sells the Accused Product in this judicial district, specifically, where its 503A
`
`Compounding Pharmacy and 503B Outsourcing Pharmacy designations are held, and, after
`
`manufacturing the Accused Product in this judicial district, distributes the Accused Product
`
`throughout the United States. Upon information and belief, Imprimis NJOF purposefully has
`
`conducted and continues to conduct business in this judicial district. Upon information and belief,
`
`Imprimis NJOF is organized under the laws of New Jersey and has its principal place of business
`
`at 1705 Route 46 W, Suite 6B, Ledgewood, NJ 07852, within this judicial district. Upon
`
`information and belief, Imprimis NJOF purposefully has conducted and continues to conduct
`
`business in this judicial district in concert with Harrow Health, ImprimisRx and ImprimisRx NJ.
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`13.
`
`Upon information and belief, this court has jurisdiction over ImprimisRx. Upon
`
`information and belief, ImprimisRx is in the business of, inter alia, developing, manufacturing,
`
`marketing, importing and selling pharmaceutical products, including compounded drug products.
`
`Upon information and belief, ImprimisRx directly or indirectly, develops, manufactures, markets,
`
`and sells the Accused Product in this judicial district, specifically, where its 503A Compounding
`
`Pharmacy and 503B Outsourcing Pharmacy designations are held, and, after manufacturing the
`
`Accused Product in this judicial district, distributes the Accused Product throughout the United
`
`States. Upon information and belief, ImprimisRx maintains its 503A Pharmacy location and 503B
`
`Outsourcing Facility location in this judicial district. Upon information and belief, ImprimisRx
`
`purposefully has conducted and continues to conduct business in this judicial district in concert
`
`with Harrow Health, ImprimisRx NJ, and Imprimis NJOF.
`
`14.
`
`Upon information and belief, this court has jurisdiction over Harrow Health. Upon
`
`information and belief, Harrow Health is in the business of, inter alia, developing, manufacturing,
`
`marketing, importing and selling pharmaceutical products, including compounded drug products.
`
`Upon information and belief, Harrow Health directly or indirectly, develops, manufactures,
`
`markets, and sells the Accused Product in this judicial district, specifically, where its 503A
`
`Compounding Pharmacy and 503B Outsourcing Pharmacy designations are held, and, after
`
`manufacturing the Accused Product in this judicial district, distributes the Accused Product
`
`throughout the United States. Upon information and belief, Harrow Health, through its wholly-
`
`owned subsidiary ImprimisRx, maintains its 503A Pharmacy location and 503B Outsourcing
`
`Facility location in this judicial district. Upon information and belief, Harrow Health purposefully
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`Case 3:21-cv-19252 Document 1 Filed 10/22/21 Page 6 of 13 PageID: 6
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`has conducted and continues to conduct business in this judicial district in concert with
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`ImprimisRx, ImprimisRx NJ, and Imprimis NJOF.
`
`15.
`
`Upon information and belief, Harrow Health, ImprimisRx, ImprimisRx NJ, and
`
`Imprimis NJOF operate as interrelated corporate entities. Upon information and belief, Harrow
`
`Health is the parent corporation of ImprimisRx, ImprimisRx NJ, and Imprimis NJOF. Upon
`
`information and belief, ImprimisRx markets, offers for sale, and sells product compounded by
`
`ImprimisRx NJ and/or Imprimis NJOF. Upon information and belief, each of Harrow Health,
`
`ImprimisRx, ImprimisRx NJ, and Imprimis NJOF act as an agent of the other and work together
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`to, inter alia, develop, manufacture, market, sell and distribute the Accused Product and other
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`compounded products throughout the United States, including—and in fact manufacturing in and
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`distributing from—this judicial district.
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`16.
`
`Defendants know or should know that Lumify® is manufactured for Bausch and is
`
`patented, at least because that information is included in the label for Lumify® and is publicly
`
`available.
`
`17.
`
`Upon information and belief, venue is proper in this judicial district under 28 U.S.C.
`
`§§ 1391 and 1400(b).
`
`18.
`
`Venue is proper against ImprimisRx NJ, which maintains a regular and
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`established place of business in this judicial district and was formed under the laws of New
`
`Jersey.
`
`19.
`
`Venue is proper against Imprimis NJOF, which maintains a regular and
`
`established place of business in this judicial district and was formed under the laws of New
`
`Jersey.
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`20.
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`Venue is proper against ImprimisRx and Harrow Health as related entities to
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`ImprimisRx NJ and Imprimis NJOF, which, by and through at least ImprimisRx NJ and/or
`
`Imprimis NJOF, maintain a regular and established place of business in this judicial district.
`
`THE PATENTS IN SUIT
`
`21.
`
`The U.S. Patent and Trademark Office (“PTO”) issued the ’758 patent on July 1,
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`2014. The ’758 patent claims, inter alia, methods of increasing whiteness of an eye comprising
`
`administering brimonidine. Plaintiffs hold all substantial rights in the ’758 patent and have the
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`right to sue for infringement thereof. A copy of the ’758 patent is attached hereto as Exhibit 1.
`
`22.
`
`The PTO issued the ’425 patent on February 16, 2016. The ’425 patent claims,
`
`inter alia, methods of reducing redness of an eye and/or increasing whiteness of an eye comprising
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`administering compositions comprising brimonidine. Plaintiffs hold all substantial rights in the
`
`’425 patent and have the right to sue for infringement thereof. A copy of the ’425 patent is attached
`
`hereto as Exhibit 2.
`
`23.
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`Bausch is the holder of NDA No. 208144 for Lumify®, which the FDA approved
`
`on December 22, 2017. In conjunction with NDA No. 208144, the ’425 patent is listed in the
`
`FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (“the Orange Book”).
`
`24.
`
`Brimonidine tartrate ophthalmic solution, 0.025%, is sold in the United States under
`
`the trademark Lumify®.
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`CLAIMS FOR RELIEF
`
`COUNT I FOR PATENT INFRINGEMENT
`
`Infringement of the ’758 Patent
`
`25.
`
`Paragraphs 1-24 are incorporated herein as set forth above.
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`26.
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`Defendants are infringing, inducing infringement of, and/or contributing to the
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`infringement of the ’758 patent by making, using, offering to sell, selling, or importing, within
`
`this district or elsewhere in the United States, products for the methods covered by the ’758
`
`patent and/or by selling, offering for sale and/or importing compositions with instructions for use
`
`or promotions that cause and induce the user to infringe the claims in the ’758 patent, and/or by
`
`selling, offering to sell or importing components or materials, knowing the same to be especially
`
`made or especially adapted for use in an infringement of the ’758 patent.
`
`27.
`
`Defendants are making, using, importing, offering to sell, or selling compositions
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`containing a formulation of, inter alia, brimonidine, that is specifically described and claimed in
`
`the ’758 patent. Defendants are making, using, importing, offering to sell, or selling such
`
`compositions for the use in whitening the eye and/or reducing eye redness, which infringes the
`
`claims of the ’758 patent.
`
`28.
`
`On information and belief, Defendants are selling, offering for sale and/or
`
`importing compositions with instructions for use and promotions that cause and induce the user
`
`to infringe the claims in the ’758 patent, including but not limited to the Accused Product.
`
`29.
`
`On information and belief, Defendants are selling, offering for sale and/or
`
`importing components or materials, knowing the same to be especially made or especially
`
`adapted for use in an infringement of the ’758 patent.
`
`30.
`
`On information and belief, Defendants became aware of the ’758 patent on or
`
`after its issuance date of July 1, 2014. On information and belief, Defendants have willfully
`
`infringed the patent by continuing to make, use, offer for sale, sell, or import the Accused
`
`Product.
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`31.
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`The aforesaid sales and acts by Defendants are without right, license or
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`permission from Plaintiffs.
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`32.
`
`On information and belief, Defendants intend to continue the sales and acts
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`referred to in paragraphs 26-31.
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`33.
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`Plaintiffs have been damaged by Defendants’ infringement of the ’758 patent, and
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`will be irreparably damaged if that infringement is not enjoined.
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`COUNT II FOR PATENT INFRINGEMENT
`
`Infringement of the ’425 Patent
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`Paragraphs 1-33 are incorporated herein as set forth above.
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`Defendants are infringing, inducing infringement of, and/or contributing to the
`
`34.
`
`35.
`
`infringement of the ’425 patent by making, using, offering to sell, selling, or importing, within
`
`this district or elsewhere in the United States, products for the methods covered by the ’425
`
`patent and/or by selling, offering for sale and/or importing compositions with instructions for use
`
`or promotions that cause and induce the user to infringe the claims in the ’425 patent, and/or by
`
`selling, offering to sell or importing components or materials, knowing the same to be especially
`
`made or especially adapted for use in an infringement of the ’425 patent.
`
`36.
`
`Defendants are making, using, importing, offering to sell, or selling compositions
`
`containing a formulation of, inter alia, brimonidine, that is specifically described and claimed in
`
`the ’425 patent. Defendants are making, using, importing, offering to sell, or selling such
`
`compositions for the use in whitening the eye and/or reducing eye redness, which infringes the
`
`claims of the ’425 patent.
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`37.
`
`On information and belief, Defendants are selling, offering for sale and/or
`
`importing compositions with instructions for use and promotions that cause and induce the user
`
`to infringe the claims in the ’425 patent, including but not limited to the Accused Product.
`
`38.
`
`On information and belief, Defendants are selling, offering for sale and/or
`
`importing components or materials, knowing the same to be especially made or especially
`
`adapted for use in an infringement of the ’425 patent.
`
`39.
`
`On information and belief, Defendants became aware of the ’425 patent on or
`
`after its issuance date of February 16, 2016. On information and belief, Defendants have
`
`willfully infringed the patent by continuing to make, use, offer for sale, sell, or import the
`
`Accused Product.
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`40.
`
`The aforesaid sales and acts by Defendants are without right, license or
`
`permission from Plaintiffs.
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`41.
`
`On information and belief, Defendants intend to continue the sales and acts
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`referred to in paragraphs 35-40.
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`42.
`
`Plaintiffs have been damaged by Defendants’ infringement of the ’425 patent, and
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`will be irreparably damaged if that infringement is not enjoined.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request that this Court enter judgment in their favor
`
`and against Defendants on the patent infringement claims set forth above and respectfully request
`
`that this Court:
`
`A.
`
`A judgment and decree that United States Patent No. 8,765,758 remains valid and
`
`enforceable;
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`B.
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`A judgment that Defendants have infringed one or more claims of United States
`
`Patent No. 8,765,758;
`
`C.
`
`A judgment that Defendants have induced infringement of one or more claims of
`
`United States Patent No. 8,765,758;
`
`D.
`
`A judgment that Defendants have contributed to the infringement of one or more
`
`claims of United States Patent No. 8,765,758;
`
`E.
`
`A judgment that Defendants have willfully infringed one or more claims of United
`
`States Patent No. 8,765,758;
`
`F.
`
`A judgment and decree that United States Patent No. 9,259,425 remains valid and
`
`enforceable;
`
`G.
`
`A judgment that Defendants have infringed one or more claims of United States
`
`Patent No. 9,259,425;
`
`H.
`
`A judgment that Defendants have induced infringement of one or more claims of
`
`United States Patent No. 9,259,425;
`
`I.
`
`A judgment that Defendants have contributed to the infringement of one or more
`
`claims of United States Patent No. 9,259,425;
`
`J.
`
`A judgment that Defendants have willfully infringed one or more claims of United
`
`States Patent No. 9,259,425;
`
`K.
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`A permanent injunction restraining and enjoining Defendants, their officers, agents,
`
`attorneys and employees, and those acting in privity or concert with them, from engaging in the
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`commercial manufacture, use, offer to sell, or sale within the United States, or importation into the
`
`United States, of compositions for methods claimed in United States Patent Nos. 8,765,758 and
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`9,259,425 or components or materials especially made or especially adapted for use in an
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`infringement of United States Patent Nos. 8,765,758 and 9,259,425;
`
`L.
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`An accounting of all damages to Plaintiffs arising from Defendants’ infringement,
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`inducement of infringement, contributory infringement and willful infringement, and that such
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`damages be awarded to Plaintiffs together with interest;
`
`N.
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`A permanent injunction ordering Defendants to, inter alia, immediately cease all
`
`distribution and sale of the Accused Product;
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`O.
`
`An order that Defendants recall all of the Accused Product currently in the
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`marketplace;
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`P.
`
`Q.
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`An award of treble damages;
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`A grant of the costs of this action and reasonable attorneys’ fees incurred by
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`Plaintiffs in connection with this action; and
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`R.
`
`Such other and further relief as the Court may deem just and proper.
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`JURY DEMAND
`
`Pursuant to Fed. R. Civ. P. 38, Plaintiffs respectfully demand a trial by jury on all issues
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`properly triable by a jury in this action.
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`Case 3:21-cv-19252 Document 1 Filed 10/22/21 Page 13 of 13 PageID: 13
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`Dated: October 22, 2021
`Newark, New Jersey
`
`
`
`s/ William P. Deni, Jr.
`William P. Deni, Jr.
`J. Brugh Lower
`GIBBONS P.C.
`One Gateway Center
`Newark, New Jersey 07102
`Tel: (973) 596-4500
`Fax: (973) 596-0545
`wdeni@gibbonslaw.com
`jlower@gibbonslaw.com
`
`Of Counsel:
`
`Bryan C. Diner
`Justin J. Hasford
`FINNEGAN, HENDERSON,
`FARABOW, GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Tel: (202) 408-4000
`
`Jessica M. Lebeis (pro hac vice to be submitted)
`FINNEGAN, HENDERSON,
`FARABOW, GARRETT & DUNNER, LLP
`Two Seaport Lane
`Boston, MA 02210-2001
`Tel: (617) 646-1600
`
`Attorneys for Plaintiffs
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