Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 1 of 8
`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 1 of 8
`
`FOR THE NORTHERN DISTRICT OF NEW YORK
`
`
`IN THE UNITED STATES DISTRICT COURT
`
`)
`
`j
`NOVARTIS PHARMA AG, NOVARTIS
`PHARMACEUTICALS CORPORATION, and)
`NOVARTIS TECHNOLOGY LLC,
`) Civil Action No.
`)
`
`1;20-cv-690 (TJM/CFH)
`1;20_cv_690 (TJM/CFH)
`
`DEMAND FOR JURY TRIAL
`
`) ) ) )
`
`Plaintiffs,
`
`V.
`
`REGENERON PHARMACEUTICALS, INC., )
`)
`
`) ) ) W
`
`Defendant.
`
`Plaintiffs Novartis Pharma AG (“NPAG”), Novartis Pharmaceuticals Corporation (“NPC”)
`
`and Novartis Technology LLC (“NT”) (collectively, “Plaintiffs” or “Novartis”) bring this action
`
`against Defendant Regeneron Pharmaceuticals, Inc. (“Regeneron”) for infringement of U.S. Patent
`
`No. 9,220,631 (“the ’631 patent”).
`
`INTRODUCTION
`
`1.
`
`Wet age-related macular degeneration (“Wet AMD”) is the leading cause of vision
`
`loss in individuals over 50. Drugs called vascular endothelial growth factor (“VEGF”)-antagonists
`
`can be used to treat Wet AND and other devastating ophthalmic conditions, but must be injected
`
`into the eye by a physician. The injection itself carries a risk of complications including infection,
`
`inflammation, introduction of particles into the eye, and even potentially blindness. To address
`
`the problems associated with injection of VEGF-antagonists into the eye, Novartis scientists
`
`invented groundbreaking pre-filled, sterilized syringes that permit more safe, effective and
`
`-1-
`ACTIVE/1037541252
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`35621663 6/19/2020
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`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 1 of 8
`
`FOR THE NORTHERN DISTRICT OF NEW YORK
`
`
`IN THE UNITED STATES DISTRICT COURT
`
`)
`
`j
`NOVARTIS PHARMA AG, NOVARTIS
`PHARMACEUTICALS CORPORATION, and)
`NOVARTIS TECHNOLOGY LLC,
`) Civil Action No.
`)
`
`1;20-cv-690 (TJM/CFH)
`1;20_cv_690 (TJM/CFH)
`
`DEMAND FOR JURY TRIAL
`
`) ) ) )
`
`Plaintiffs,
`
`V.
`
`REGENERON PHARMACEUTICALS, INC., )
`)
`
`) ) ) W
`
`Defendant.
`
`Plaintiffs Novartis Pharma AG (“NPAG”), Novartis Pharmaceuticals Corporation (“NPC”)
`
`and Novartis Technology LLC (“NT”) (collectively, “Plaintiffs” or “Novartis”) bring this action
`
`against Defendant Regeneron Pharmaceuticals, Inc. (“Regeneron”) for infringement of U.S. Patent
`
`No. 9,220,631 (“the ’631 patent”).
`
`INTRODUCTION
`
`1.
`
`Wet age-related macular degeneration (“Wet AMD”) is the leading cause of vision
`
`loss in individuals over 50. Drugs called vascular endothelial growth factor (“VEGF”)-antagonists
`
`can be used to treat Wet AND and other devastating ophthalmic conditions, but must be injected
`
`into the eye by a physician. The injection itself carries a risk of complications including infection,
`
`inflammation, introduction of particles into the eye, and even potentially blindness. To address
`
`the problems associated with injection of VEGF-antagonists into the eye, Novartis scientists
`
`invented groundbreaking pre-filled, sterilized syringes that permit more safe, effective and
`
`-1-
`ACTIVE/1037541252
`
`35621663 6/19/2020
`
`
`
`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 2 of 8
`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 2 of 8
`
`efficient injections of VEGF-antagonists into the eye. These inventions are disclosed and claimed
`
`in the ’631 patent.
`
`2.
`
`Regeneron manufactures and markets in the United States a product called
`
`EYLEA® (“EYLEA”), which is provided in vial and pre-filled syringe (“PFS”) presentations
`
`(“EYLEA PFS”), both of which contain the VEGF-antagonist aflibercept.
`
`EYLEA PFS
`
`unlawfully uses Novartis’s patented syringe technology and infringes the ’631 patent.
`
`THE PARTIES
`
`3.
`
`Plaintiff Novartis Pharma AG is a company organized and existing under the laws
`
`of Switzerland, with a principal place of business at Forum 1 Novartis Campus, CH-4056 Basel,
`
`Switzerland.
`
`4.
`
`Plaintiff Novartis Pharmaceuticals Corporation is a Delaware corporation with a
`
`principal place of business at One Health Plaza, East Hanover, New Jersey, 07936.
`
`5.
`
`PlaintiffNovartis Technology LLC is a Delaware corporation with a principal place
`
`of business at One Health Plaza, East Hanover, New Jersey, 07936.
`
`6.
`
`On information and belief, Regeneron is a New York corporation with its principal
`
`place of business at 777 Old Saw Mill River Road, Tarrytown, New York 10591.
`
`7.
`
`On information and belief, Regeneron has an established facility in this District at
`
`81 Columbia Turnpike, Rensselaer, New York 12144.
`
`JURISDICTION AND VENUE
`
`8.
`
`9.
`
`This is an action for patent infringement arising under 35 U.S.C. § 271.
`
`The Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
`
`10.
`
`The Court has personal jurisdiction over Regeneron because it is domiciled in New
`
`York.
`
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`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 3 of 8
`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 3 of 8
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`ll.
`
`Venue is proper in this District under 28 U.S.C. §§ 1400(b) and 1391. On
`
`information and belief, Regeneron has a regular and established place of business in Rensselaer,
`
`New York, which is within this District, and Regeneron has committed acts of infringement within
`
`the District.
`
`BACKGROUND
`
`12.
`
`On December 29, 2015, the United States Patent and Trademark Office duly and
`
`legally issued the ’631 patent, entitled “Syringe,” to inventors Juergen Sigg, Christophe Royer,
`
`Andrew M. Bryant, Heinrich M. Buettgen, and Marie Picci. A true and correct copy of the ’631
`
`patent is attached as Exhibit A.
`
`13.
`
`The ’631 patent is valid and presumed valid under 35 U.S.C. 282. The ’631 patent
`
`is also enforceable.
`
`l4.
`
`Novartis owns the right, title and interest in the ’631 patent necessary to bring this
`
`action, including the exclusive right to enforce the patent in the United States.
`
`15.
`
`The ’631 patent discloses and claims certain novel terminally sterilized, pre-filled
`
`syringes that include VEGF-antagonists. Claim 1, for example, reads as follows:
`
`1. A pre-filled, terminally sterilized syringe for intravitreal injection, the syringe
`comprising a glass body forming a barrel, a stopper and a plunger and containing
`an ophthalmic solution which comprises a VEGF-antagonist, wherein:
`
`(a) the syringe has a nominal maximum fill volume of between about 0.5
`ml and about 1 ml,
`
`(b) the syringe barrel comprises from about 1 pg to 100 [u] g silicone oil,
`
`(c) the VEGF antagonist solution comprises no more than 2 particles > 50
`pm in diameter per ml and wherein the syringe has a stopper break loose force of
`less than about 1 IN.
`
`(the ’631 patent (Exhibit A) at cl. 1).
`
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`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 4 of 8
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`On information and belief, the EYLEA PFS barrel comprises about 1 μg to 100 μg
`
`comprises no more than 2 particles >50 μm in diameter per ml.
`
`
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`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 5 of 8
`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 5 of 8
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`25.
`
`On information and belief, the EYLEA PFS has a stopper break loose force of less
`
`than about UN.
`
`26.
`
`On information and belief, EYLEA PFS is presented in one blister pack containing
`
`one EYLEA 2 mg/0.05 mL sterile, single-dose pre-filled glass syringe.
`
`27.
`
`On information and belief, the VEGF-antagonist aflibercept in the EYLEA PFS is
`
`administered by intravitreal injection.
`
`28.
`
`On information and belief, Regeneron has made, used, offered for sale, sold, and or
`
`imported, and continues to make, use, offer for sale, sell, and/or import, the infringing EYLEA
`
`PFS product in the United States. Such conduct constitutes direct infringement, either literally or
`
`under the doctrine of equivalents, of one or more claims of the ’631 patent under 35 U.S.C.
`
`§ 27 l (a).
`
`29.
`
`On information and belief, Regeneron has actively encouraged infringement of at
`
`least claim 24 of the ’631 patent by providing physicians with instructions to administer EYLEA
`
`PFS to treat patients suffering from choroidal neovascularization, wet age-related macular
`
`degeneration, macular edema secondary to retinal vein occlusion, choroidal neovascularization
`
`secondary to pathologic myopia, diabetic macular edema, diabetic retinopathy, and/or proliferative
`
`retinopathy. On information and belief, the physicians have infringed and will continue to infringe
`
`at least claim 24 by treating such patients in this manner.
`
`30.
`
`On information and belief, Regeneron has actively induced infringement of one or
`
`more claims of the ’631 patent, either literally or under the doctrine of equivalents, in violation of
`
`35 U.S.C. § 271(b).
`
`31.
`
`Regeneron’s unlawful infringement activities have caused and will continue to
`
`cause Novartis substantial harm.
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`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 6 of 8
`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 6 of 8
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`32.
`
`The harm Novartis has suffered and will continue to suffer is irreparable and cannot
`
`be sufficiently compensated through monetary damages. This harm includes, but is not limited to,
`
`loss of business opportunities, loss of market share, price erosion, loss of goodwill, and direct and
`
`indirect competition. Accordingly, Novartis is entitled to preliminary and permanent injunctive
`
`relief. The public interest would not be disserved by injunctive relief
`
`33.
`
`On information and belief, Regeneron’s infringement of the ’631 patent is willful,
`
`justifying the assessment of treble damages pursuant to 35 U.S.C. § 284.
`
`34.
`
`On information and belief, Regeneron has been aware ofthe ’631 patent’s existence
`
`and has no reasonable basis for believing that its manufacturing, importing, offering for sale, or
`
`selling EYLEA PFS does not infringe the ’631 patent. On information and belief, Regeneron has
`
`no reasonable basis for believing that the ’631 patent is invalid or otherwise unenforceable.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Novartis respectfully requests that this Court enter judgment in its favor
`
`and against Regeneron as follows:
`
`A.
`
`B.
`
`C.
`
`D.
`
`A judgment that Regeneron has infringed the ’631 patent;
`
`An award of damages to Novartis for Regeneron’s infringement, together with pre-
`
`and post-judgment interest and costs pursuant to 35 U.S.C. § 284,
`
`including
`
`supplemental damages for any continuing post-verdict infringement up until entry
`
`of the final judgment;
`
`Treble damages pursuant to 35 U.S.C. § 284;
`
`A finding that this case is “exceptional” under 35 U.S.C. § 285 and an award of
`
`attorneys’ fees and costs;
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`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 7 of 8
`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 7 of 8
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`E.
`
`Orders preliminarily and permanently enjoining Regeneron and its officers,
`
`employees, agents, servants, and those in privity with them from continuing to
`
`infringe the ’631 patent; and
`
`F.
`
`Any further and additional relief as this Court deems just and proper.
`
`JURY DEMAND
`
`Pursuant to Federal Rule of Civil Procedure 38(b), Novartis demands a trial by jury on all
`
`issues triable by jury.
`
`Dated: June 19, 2020
`
`s/ George R. McGuire
`
`George R. McGuire (Bar Roll No. 509058)
`
`Louis Orbach (Bar Roll No. 507815)
`
`BOND, SCHOENECK & KING, PLLC
`One Lincoln Center
`
`Syracuse, NY 13202
`P: (315) 218-8000
`F: (315) 218-8100
`
`W l
`
`orbach@bsk. com
`
`Of Counsel:
`
`Elizabeth J. Holland
`
`Calvin E. Wingfield Jr.
`Linnea P. Cipriano
`Goodwin Procter LLP
`
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`Phone: (212) 813-8800
`Fax: (212) 355-3333
`eholland@goodwinlaw.com
`cwingfield@goodwinlaw.com
`lcipriano@goodwinlaw.com
`
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`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 8 of 8
`Case 1:20-cv-00690-TJM-CFH Document 1 Filed 06/19/20 Page 8 of 8
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`William G. James
`
`Myomi T. Coad
`Goodwin Procter LLP
`
`1900 N St. NW.
`
`Washington, DC. 20036-1612
`Phone: (202) 346-4000
`Fax: (202) 346-4444
`wjames@goodwinlaw.com
`mcoad@goodwinlaw.com
`
`Josh Weinger
`Goodwin Procter LLP
`
`100 Northern Avenue
`
`Boston, MA 02210
`Phone: (617) 570-1000
`Fax: (617) 523-1231
`jweinger@goodwinlaw.com
`
`-8-
`ACTIVE/1037541252
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