Case 1:20-cv-00690-DNH-CFH Document 70 Filed 08/02/21 Page 1 of 12
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF NEW YORK
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`NOVARTIS PHARMA AG, NOVARTIS
`PHARMACEUTICALS CORPORATION,
`and NOVARTIS TECHNOLOGY LLC,
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`Plaintiffs,
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`v.
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`REGENERON PHARMACEUTICALS,
`INC.,
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`Defendant.
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`
`
`Civil Action No. 1:20-cv-00690 (TJM-
`CFH)
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`) DEMAND FOR JURY TRIAL
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`FIRST AMENDED COMPLAINT AND ANSWER TO COUNTERCLAIM
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`Plaintiffs Novartis Pharma AG (“NPAG”), Novartis Pharmaceuticals Corporation (“NPC”)
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`and Novartis Technology LLC (“NT”) (collectively, “Plaintiffs” or “Novartis”) bring this action
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`against Defendant Regeneron Pharmaceuticals, Inc. (“Regeneron”) for infringement of U.S. Patent
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`No. 9,220,631 (“the ’631 patent”).
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`INTRODUCTION
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`1.
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`Wet age-related macular degeneration (“Wet AMD”) is the leading cause of vision
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`loss in individuals over 50. Drugs called vascular endothelial growth factor (“VEGF”)-antagonists
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`can be used to treat Wet AMD and other devastating ophthalmic conditions, but must be injected
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`into the eye by a physician. The injection itself carries a risk of complications including infection,
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`inflammation, introduction of particles into the eye, and even potentially blindness. To address
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`the problems associated with injection of VEGF-antagonists into the eye, Novartis scientists
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`invented groundbreaking pre-filled, sterilized syringes that permit more safe, effective and
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`Case 1:20-cv-00690-DNH-CFH Document 70 Filed 08/02/21 Page 2 of 12
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`efficient injections of VEGF-antagonists into the eye. These inventions are disclosed and claimed
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`in the ’631 patent.
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`2.
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`Regeneron manufactures and markets in the United States a product called
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`EYLEA® (“EYLEA®”), which is provided in vial and pre-filled syringe (“PFS”) presentations
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`(“EYLEA® PFS”), both of which contain the VEGF-antagonist aflibercept. EYLEA® PFS
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`unlawfully uses Novartis’s patented syringe technology and infringes the ’631 patent.
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`THE PARTIES
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`3.
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`Plaintiff Novartis Pharma AG is a company organized and existing under the laws
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`of Switzerland, with a principal place of business at Forum 1 Novartis Campus, CH-4056 Basel,
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`Switzerland.
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`4.
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`Plaintiff Novartis Pharmaceuticals Corporation is a Delaware corporation with a
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`principal place of business at One Health Plaza, East Hanover, New Jersey, 07936.
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`5.
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`Plaintiff Novartis Technology LLC is a Delaware corporation with a principal place
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`of business at One Health Plaza, East Hanover, New Jersey, 07936.
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`6.
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`On information and belief, Regeneron is a New York corporation with its principal
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`place of business at 777 Old Saw Mill River Road, Tarrytown, New York 10591.
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`7.
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`On information and belief, Regeneron has an established facility in this District at
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`81 Columbia Turnpike, Rensselaer, New York 12144.
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`JURISDICTION AND VENUE
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`8.
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`9.
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`This is an action for patent infringement arising under 35 U.S.C. § 271.
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`The Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
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`10.
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`The Court has personal jurisdiction over Regeneron because it is domiciled in New
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`York.
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`Case 1:20-cv-00690-DNH-CFH Document 70 Filed 08/02/21 Page 3 of 12
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`11.
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`Venue is proper in this District under 28 U.S.C. §§ 1400(b) and 1391. On
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`information and belief, Regeneron has a regular and established place of business in Rensselaer,
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`New York, which is within this District, and Regeneron has committed acts of infringement within
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`the District.
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`BACKGROUND
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`12.
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`On December 29, 2015, the United States Patent and Trademark Office duly and
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`legally issued the ’631 patent, entitled “Syringe,” to inventors Juergen Sigg, Christophe Royer,
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`Andrew M. Bryant, Heinrich M. Buettgen, and Marie Picci. A true and correct copy of the ’631
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`patent is attached as Exhibit A.
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`13.
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`The ’631 patent is valid and presumed valid under 35 U.S.C. § 282. The ’631 patent
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`is also enforceable.
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`14.
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`Novartis owns the right, title and interest in the ’631 patent necessary to bring this
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`action, including the exclusive right to enforce the patent in the United States.
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`15.
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`The ’631 patent discloses and claims certain novel terminally sterilized, pre-filled
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`syringes that include VEGF-antagonists. Claim 1, for example, reads as follows:
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`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:
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`(a) the syringe has a nominal maximum fill volume of between about 0.5
`ml and about 1 ml,
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`(b) the syringe barrel comprises from about 1 µg to 100 [µ]g silicone oil,
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`(c) the VEGF antagonist solution comprises no more than 2 particles > 50
`µm in diameter per ml and wherein the syringe has a stopper break loose force of
`less than about 11N.
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`(the ’631 patent (Exhibit A) at cl. 1).
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`16.
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`EYLEA® PFS is a syringe pre-filled with the VEGF-antagonist aflibercept and
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`approved for the treatment of, among other things, Wet AMD. On information and belief,
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`EYLEA® PFS is covered by one or more claims of the ’631 patent.
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`COUNT I: INFRINGEMENT OF THE ’631 PATENT
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`17.
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`Novartis realleges and incorporates by reference the allegations in the preceding
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`paragraphs as though fully stated herein.
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`18.
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`Regeneron was found by an administrative law judge of the International Trade
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`Commission (“ITC”) in a Section 337 Investigation captioned Certain Pre-filled Syringes for
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`Intravitreal Injection and Components Thereof, Inv. No. 337-TA-1207 (U.S. ITC Jun. 19, 2020)
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`(the “ITC Investigation”) to infringe several claims of the ʼ631 patent.
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`19.
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`Regeneron’s EYLEA® PFS satisfies each and every element, either literally or
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`under the doctrine of equivalents, of one or more claims of the ’631 patent, including at least
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`claim 1 as follows.
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`EYLEA® PFS is a pre-filled, terminally sterilized syringe for intravitreal injection.
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`The EYLEA® PFS syringe comprises a glass body forming a barrel, a stopper, and
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`20.
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`21.
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`a plunger.
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`22.
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`The EYLEA® PFS contains an ophthalmic solution which comprises a VEGF-
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`antagonist. The drug product in the EYLEA® PFS is a solution of the VEGF-antagonist
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`aflibercept provided at a strength of 40 mg/mL, and the approved indications for EYLEA® PFS
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`are ophthalmic.
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`23.
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`The EYLEA® PFS has a nominal maximum fill volume of between about 0.5 mL
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`and about 1 mL.
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`24.
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`The EYLEA® PFS barrel comprises about 1 μg to 100 μg silicone oil.
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`25.
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`The VEGF antagonist solution in the EYLEA® PFS comprises no more than 2
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`particles >50 μm in diameter per mL.
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`26.
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`27.
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`The EYLEA® PFS has a stopper break loose force of less than about 11N.
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`The EYLEA® PFS is presented in one blister pack containing one EYLEA® 2
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`mg/0.05 mL sterile, single-dose pre-filled glass syringe.
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`28.
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`The VEGF-antagonist aflibercept in the EYLEA® PFS is administered by
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`intravitreal injection.
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`29.
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`Since at least December 2019, Regeneron has made, used, offered for sale, sold,
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`and or imported, and continues to make, use, offer for sale, sell, and/or import, the infringing
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`EYLEA® PFS product in the United States. Such conduct constitutes direct infringement, either
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`literally or under the doctrine of equivalents, of one or more claims of the ’631 patent under 35
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`U.S.C. § 271(a).
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`30.
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`Regeneron has actively encouraged infringement of at least claim 24 of the ’631
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`patent by providing physicians with instructions to administer EYLEA® PFS to treat patients
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`suffering from choroidal neovascularization, wet age-related macular degeneration, macular
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`edema secondary to retinal vein occlusion, choroidal neovascularization secondary to pathologic
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`myopia, diabetic macular edema, diabetic retinopathy, and/or proliferative retinopathy. On
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`information and belief, the physicians have infringed and will continue to infringe at least claim
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`24 by treating such patients in this manner.
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`31.
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`Regeneron has actively induced infringement of one or more claims of the ’631
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`patent, either literally or under the doctrine of equivalents, in violation of 35 U.S.C. § 271(b).
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`32.
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`Regeneron’s unlawful infringement activities have caused and will continue to
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`cause Novartis substantial harm.
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`33.
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`The harm Novartis has suffered and will continue to suffer is irreparable and cannot
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`be sufficiently compensated through monetary damages. This harm includes, but is not limited to,
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`loss of business opportunities, loss of market share, price erosion, loss of goodwill, and direct and
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`indirect competition. Accordingly, Novartis is entitled to preliminary and permanent injunctive
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`relief. The public interest would not be disserved by injunctive relief.
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`34.
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`Regeneron’s infringement of the ’631 patent is willful, justifying the assessment of
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`treble damages pursuant to 35 U.S.C. § 284.
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`35.
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`Regeneron has admitted in discovery responses in the ITC investigation that it has
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`been aware of the ʼ631 patent since its issuance, and was aware of the application that eventually
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`issued as the ʼ631 patent even before that time.
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`36.
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`In a complaint it filed against Novartis in the Southern District of New York,
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`Regeneron alleged that in late 2013, “Vetter contacted Regeneron, claiming that Novartis had a
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`pending patent application covering EYLEA PFS” and that Vetter offered a sublicense “for the
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`application that would eventually become the ’631 patent.” Complaint ¶ 166, Regeneron Pharms.,
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`Inc. v. Novartis Pharma AG et al., No. 20-cv-5502 (S.D.N.Y. July 17, 2020) (ECF No. 1).
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`37.
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`Regeneron also alleged in the SDNY complaint that once the ʼ631 patent issued
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`Vetter again approached Regeneron with the offer to sublicense Novartis’s PFS technology. Id.
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`¶ 18.
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`38.
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`Regeneron further alleged that in February 2014 Regeneron specifically requested
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`from Vetter “information regarding the process covered by the ’631 patent.” See id. ¶ 179.
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`39.
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`Regeneron has marketed its EYLEA® PFS with the knowledge that it infringed one
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`or more claims of the ʼ631 patent. In the ITC Investigation, Regeneron conceded that the
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`EYLEA® PFS infringed multiple claims of the ʼ631 patent. On information and belief, Regeneron
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`knew or should have known that the EYLEA® PFS infringed multiple claims of the ’631 patent
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`before it conceded that fact in the ITC Investigation and before this suit was filed.
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`40.
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`On information and belief, Regeneron also had no reasonable basis for believing
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`that the ’631 patent was invalid or otherwise unenforceable.
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`41.
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`Internal Regeneron documents indicate that Regeneron knew that it would not have
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`freedom to operate unless it took a license to the ʼ631 patent. Accordingly, Regeneron knew or
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`should have known that marketing EYLEA® PFS would infringe the ’631 patent and, on
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`information and belief, did not believe that the ʼ631 patent was invalid or unenforceable.
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`42.
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`On information and belief, despite Regeneron’s knowledge of the ʼ631 patent and
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`that it required a sublicense to the ʼ631 patent in order to have freedom to operate for its EYLEA®
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`pre-filled syringe, Regeneron declined to license the ʼ631 patent and instead chose to willfully
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`infringe it by launching the EYLEA® pre-filled syringe product in December 2019.
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`PRAYER FOR RELIEF
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`WHEREFORE, Novartis respectfully requests that this Court enter judgment in its favor
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`and against Regeneron as follows:
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`A.
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`A judgment that Regeneron has infringed the ’631 patent;
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`B.
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`An award of damages to Novartis for Regeneron’s infringement, together with pre-
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`and post-judgment interest and costs pursuant to 35 U.S.C. § 284, including
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`supplemental damages for any continuing post-verdict infringement up until entry
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`of the final judgment;
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`C.
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`Treble damages pursuant to 35 U.S.C. § 284;
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`D.
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`A finding that this case is “exceptional” under 35 U.S.C. § 285 and an award of
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`attorneys’ fees and costs;
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`E.
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`Orders preliminarily and permanently enjoining Regeneron and its officers,
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`employees, agents, servants, and those in privity with them from continuing to
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`infringe the ’631 patent; and
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`F.
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`Any further and additional relief as this Court deems just and proper.
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`JURY DEMAND
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`Pursuant to Federal Rule of Civil Procedure 38(b), Novartis demands a trial by jury on all
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`issues triable by jury.
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`ANSWER TO COUNTERCLAIM
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`Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology
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`LLC (collectively, “Novartis”) hereby answers the Counterclaim of Regeneron Pharmaceuticals,
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`Inc. (“Regeneron”) as follows:
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`THE PARTIES
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`1.
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`Novartis is without knowledge or information to answer the allegations in this
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`paragraph, on and that basis denies them.
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`2.
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`Admitted that Novartis Pharma AG is a corporation organized and existing under
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`the laws of Switzerland, with a principal place of business at Forum 1 Novartis Campus, CH-4056
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`Basel, Switzerland.
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`3.
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`Admitted that Novartis Pharmaceuticals Corporation is a corporation organized and
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`existing under the laws of Delaware, with a principal place of business at One Health Plaza, East
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`Hanover, New Jersey, 07936.
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`4.
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`Admitted that Novartis Technology LLC is a corporation organized and existing
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`under the laws of Delaware, with a principal place of business at One Health Plaza, East Hanover,
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`New Jersey, 07936.
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`JURISDICTION AND VENUE
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`5.
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`6.
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`7.
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`This paragraph contains conclusions of law to which no response is required.
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`This paragraph contains conclusions of law to which no response is required.
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`This paragraph contains conclusions of law to which no response is required. For
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`purposes of this action only, Novartis does not contest personal jurisdiction in this District.
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`8.
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`This paragraph contains conclusions of law to which no response is required. For
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`purposes of this action only, Novartis does not contest venue in this District.
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`COUNTERCLAIM I
`(Declaratory Judgment of Invalidity of the ’631 Patent)
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`9.
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`Admitted that Novartis owns the right, title and interest in the ’631 patent necessary
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`to bring its First Amended Complaint in this action, including the exclusive right to enforce the
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`patent in the United States. Admitted that on December 29, 2015, the United States Patent and
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`Trademark Office duly and legally issued the ’631 patent, entitled “Syringe.” Admitted that a true
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`and correct copy of the ’631 patent was attached to Novartis’s Complaint (and Novartis’s
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`Amended Complaint) as Exhibit A. Admitted that the ʼ631 patent was assigned by the named
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`inventors to Novartis Pharma AG. Admitted that in November 2020, the U.S. Patent and
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`Trademark Office was notified of an assignment transferring ownership of the ʼ631 patent to
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`Novartis Technology LLC, Novartis Pharmaceuticals Corporation, and Novartis Pharma AG, the
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`three Novartis plaintiffs. The remainder of this paragraph contains conclusions of law to which
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`no response is required.
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`10.
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`Admitted that Novartis alleges that Regeneron’s EYLEA® PFS infringes at least
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`one claim of the ’631 Patent.
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`11.
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`Admitted that this paragraph purports to reproduce claim 1 of the ʼ631 patent.
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`12.
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`Denied.
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`13.
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`14.
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`This paragraph contains conclusions of law to which no response is required.
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`Admitted that Regeneron purports to state a claim for declaratory judgment, but
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`denied that Regeneron is entitled to the declaratory relief it seeks. This paragraph contains
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`conclusions of law to which no response is required.
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`15.
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`Denied.
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`RESPONSE TO PRAYER FOR RELIEF
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`No response is required to Regeneron’s prayer for relief. To the extent that a response is
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`deemed required, Novartis denies that Regeneron is entitled to the relief it seeks or to any relief at
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`all for the allegations made in the Counterclaim. Regeneron’s prayer should therefore be denied
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`in its entirety and with prejudice.
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`
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`Dated: August 2, 2021
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`By:
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`Of Counsel:
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`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
`
`William G. James
`Myomi T. Coad
`Goodwin Procter LLP
`1900 N St. N.W.
`Washington, D.C. 20036-1612
`Phone: (202) 346-4000
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`ACTIVE/111183564.6
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`BOND, SCHOENECK & KING, PLLC
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`s/ George R. McGuire
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`George R. McGuire (Bar Roll No. 509058)
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`Louis Orbach (Bar Roll No. 507815)
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`Attorneys for Plaintiffs Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and
`Novartis Technology LLC
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`Fax: (202) 346-4444
`wjames@goodwinlaw.com
`mcoad@goodwinlaw.com
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`Molly R. Grammel
`Josh Weinger
`Goodwin Procter LLP
`100 Northern Avenue
`Boston, MA 02210
`Phone: (617) 570-1000
`Fax: (617) 523-1231
`mgrammel@goodwinlaw.com
`jweinger@goodwinlaw.com
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