Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 1 of 123
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
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`CASE NO. 1:20-cv-05502-AJN
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`JURY TRIAL DEMANDED
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`FIRST AMENDED COMPLAINT
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`SUBJECT TO PROTECTIVE ORDER;
`CONTAINS CONFIDENTIAL
`INFORMATION
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`REGENERON PHARMACEUTICALS, INC.
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`Plaintiff,
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`
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`v.
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`NOVARTIS PHARMA AG, NOVARTIS
`TECHNOLOGY LLC, NOVARTIS
`PHARMACEUTICALS CORPORATION,
`VETTER PHARMA INTERNATIONAL
`GMBH
`
`
`Defendants.
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`Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”) files this Complaint against
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`Defendants, Novartis Pharma AG, Novartis Technology LLC, and Novartis Pharmaceuticals
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`Corporation (collectively, “Novartis”) and Vetter Pharma International GmbH (“Vetter”), and
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`alleges, upon knowledge as to itself and otherwise upon information and belief, as follows:
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`NATURE OF ACTION
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`1.
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`Plaintiff Regeneron’s EYLEA® (aflibercept) injection (“EYLEA”) is an innovative
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`biologic drug for the treatment of a variety of severe eye diseases.
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`2.
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`Defendant Novartis developed and recently launched BEOVU® (brolucizumab-
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`dbll) injection (“BEOVU”), which competes against EYLEA to treat a certain eye disease.
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`Novartis, together with Genentech, Inc. (“Genentech”), also co-developed LUCENTIS®
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`(ranibizumab) injection (“LUCENTIS”), which competes against EYLEA to treat most of the
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`same eye diseases. Novartis markets LUCENTIS outside of the United States, and benefits from
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`the sales of LUCENTIS in the United States through its significant financial stake in Roche
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`Holding AG (“Roche”), the parent company of Genentech, which markets LUCENTIS in the
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`Novartis Exhibit 2052.001
`Regeneron v. Novartis, IPR2021-00816
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`

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`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 2 of 123
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`United States.1 Defendant Vetter is an essential supply chain provider of drug “filling” services
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`and is the exclusive filler for Novartis’s LUCENTIS prefilled syringe (“PFS”) product. Upon
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`information and belief, Vetter will be the filler for Novartis’s BEOVU PFS once it launches in the
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`United States. Vetter also has a longstanding relationship with Regeneron, both as a filler for
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`EYLEA vials and as a prior development partner for an EYLEA PFS.
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`3.
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`Defendant Novartis, unwilling to compete on the clinical merits of LUCENTIS or
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`BEOVU against EYLEA, has done everything in its power to try to stop EYLEA through
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`anticompetitive means. BEOVU’s launch has been riddled with serious safety issues, and
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`LUCENTIS is a less effective treatment than EYLEA for certain diabetic eye diseases and requires
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`more frequent injections (per the FDA-approved label) at a time when in-patient trips to medical
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`doctors are difficult with the COVID-19 pandemic.2 Novartis has therefore resorted to various
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`unlawful means, including the enforcement of a fraudulently procured United States patent and an
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`anticompetitive licensing and settlement agreement with Vetter, all as part of a scheme to attempt
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`to monopolize the market and/or unreasonably restrain competition for PFS ophthalmic drug
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`treatments. Defendants’ purpose and intent throughout this scheme has been to prevent, deter, or
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`at least delay the competitive launch of EYLEA PFS for years, to artificially inflate Regeneron’s
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`costs of entry, and now to stop Regeneron altogether from competing in the U.S. market with
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`EYLEA PFS. In addition to Regeneron, physicians and patients have been the victims of this
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`scheme because Novartis’s and Vetter’s actions are aimed at limiting the availability of the most
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`effective and convenient ophthalmic PFS drug treatment—EYLEA PFS.
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`1
`All references to LUCENTIS refer to the product that was co-developed by Novartis and is
`marketed by Novartis outside the United States and by Genentech inside the United States.
`2
`Compare U.S. Food and Drug Administration, Lucentis® (ranibizumab injection), “Highlights of
`Prescribing
`Information, available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/
`125156s111lbl.pdf with U.S. Food and Drug Administration, Eylea® (aflibercept), “Highlights of
`Prescribing Information, available at https://www.regeneron.com/sites/default/files/EYLEA_FPI.pdf.
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`2
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`Novartis Exhibit 2052.002
`Regeneron v. Novartis, IPR2021-00816
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`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 3 of 123
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`4.
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`By this action for injunctive relief and damages, Regeneron seeks to stop
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`Defendants Novartis and Vetter from continuing their illegal conduct in violation of Sections 1
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`and 2 of the Sherman Antitrust Act, 15 U.S.C. §§ 1 and 2.
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`INTRODUCTION
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`5.
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`Regeneron’s EYLEA and Novartis’s LUCENTIS and BEOVU are competing
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`drugs that treat certain eye diseases involving overproduction of a naturally occurring protein in
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`the body called vascular endothelial growth factor (“VEGF”). This VEGF overproduction can
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`cause vision loss and even blindness, and many millions of patients suffer from VEGF-related eye
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`diseases.
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`6.
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`As “anti-VEGF” drugs, EYLEA, LUCENTIS, and BEOVU must be injected with
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`regular frequency into a patient’s eye. The frequency, manner, and safety of injection are important
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`factors in the success of treatment, and the method of administration is therefore significant. In
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`that regard, EYLEA and LUCENTIS were historically sold only in vial form and ultimately loaded
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`into a separate needle or syringe for injection. Recently, however, the market for anti-VEGFs has
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`converted from vial to PFS, which is a more accurate and more convenient method of
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`administration that carries a lower risk of introducing foreign particles into the eye, which can
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`cause severe complications such as endophthalmitis. LUCENTIS and EYLEA are by far the
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`primary approved anti-VEGF PFS available in the United States.3
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`7.
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`There are numerous challenges associated with commercializing a PFS with a
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`complex biologic drug such as EYLEA or LUCENTIS. For example, there are a limited number
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`of companies that can fill the syringe with the drug in accordance with the required sterile
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`conditions, and the existing “fillers” have limited capacity. Vetter is the leading PFS filler and is
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`3
`While Macugen received FDA approval in 2004 for a prefilled syringe to treat one VEGF-related
`eye disease only, it is also an older, less effective treatment that is rarely prescribed anymore, if at all.
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`3
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`Novartis Exhibit 2052.003
`Regeneron v. Novartis, IPR2021-00816
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`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 4 of 123
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`the exclusive PFS filler for Novartis’s LUCENTIS PFS. Regeneron and Vetter also have had a
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`long-standing relationship. For many years, Vetter has provided non-exclusive filling services to
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`Regeneron for EYLEA in vial form. More specifically, starting in 2005, Regeneron and Vetter
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`also embarked on a collaboration to commercialize an EYLEA PFS. This successful collaboration
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`led to regulatory approval for EYLEA PFS in Australia in 2012.
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`8.
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`Unbeknownst to Regeneron, however, as Regeneron and Vetter were jointly
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`working to commercialize an EYLEA PFS, Novartis was pursuing its own mission in 2013 to
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`fraudulently procure a United States patent claiming a PFS containing any anti-VEGF drug,
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`including EYLEA, which Novartis and Vetter would soon use to unreasonably restrain
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`Regeneron’s ability to compete. Given that the prior art already described and disclosed such a
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`PFS, Novartis could secure its patent only by ensuring that the U.S. Patent and Trademark Office
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`(“USPTO”) was not aware of that prior art. And Novartis did just that. By deliberately withholding
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`material prior art from the USPTO, Novartis succeeded in obtaining a patent—U.S. Patent No.
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`9,220,631 (the “’631 Patent”)—broadly claiming a PFS with any anti-VEGF, including EYLEA.4
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`As pled in detail below, specific Novartis employees involved in the prosecution of the ’631 Patent
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`knew of the omitted prior art and also knew the omitted prior art was material because of multiple
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`decisions by a set of USPTO examiners in a separate patent application covering overlapping
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`subject matter that Novartis ultimately abandoned. In order to gain allowance of the ’631 Patent,
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`the Novartis employees made a deliberate decision to withhold the prior art from the different
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`USPTO examiner that was reviewing the application for the ’631 patent.
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`9.
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`The ’631 Patent is additionally and independently unenforceable because Novartis
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`deliberately withheld material information from the USPTO showing that at least one Vetter
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`4
`The ’631 Patent specifically identifies EYLEA and states that “[a]flibercept is the preferred non-
`antibody VEGF antagonist for use with the invention.” ’631 Patent at Col. 6, ll. 42-43.
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`4
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`Novartis Exhibit 2052.004
`Regeneron v. Novartis, IPR2021-00816
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`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 5 of 123
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`employee should have been named as an inventor of the (cid:1932)631 Patent. Novartis’s inventorship
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`deception was revealed to Regeneron for the first time in this case on December 23, 2020, through
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`Vetter’s first document production.5 These documents include agreements between Vetter and
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`Novartis that were not previously made available to Regeneron or to Regeneron’s counsel in the
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`SDNY case, and reveal, among other things,
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` The Novartis patent family
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` includes U.S. Patent
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`-
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`Application No. 13/750,032, which was issued by the USPTO on December 29, 2015, as the ’631
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`Patent. Novartis and Vetter also knew that 35 U.S.C. § 116 requires that when a claimed invention
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`is made by two or more persons jointly, they must apply for a patent jointly, and each inventor
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`must submit the required oath of inventorship to the USPTO. Novartis and Vetter also knew,
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`consistent with § 116, that USPTO regulations require each individual who is a joint inventor of
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`a claimed invention to execute and submit an oath or declaration identifying that individual as a
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`5
`Facts regarding Novartis’s inventorship deception were revealed in this case for the first time on
`December 23, 2020, through Vetter’s first document production. Although Vetter produced these Novartis-
`Vetter agreements and documents in the ITC case on September 21, 2020, the documents are barred from
`use in any other judicial proceedings, including this SDNY action, under the ITC Protective Order.
`Regeneron had repeatedly requested that Novartis re-produce its ITC production in this case, but Novartis
`refused. Therefore, this is the first possible opportunity for Regeneron to amend its antitrust complaint
`based on the Novartis-Vetter agreements revealed in newly produced discovery as Regeneron was unable
`to plead facts relating to the inventorship deception before December 23, 2020.
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`Furthermore, despite being denied a request to stay discovery on November 2, 2020, Novartis and
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`Vetter continue to withhold production of thousands of documents that have already been produced in the
`ITC litigation that are relevant to this inventorship deception. Regeneron would be able to plead its amended
`claims with even greater specificity if Novartis and Vetter were not improperly withholding documents
`from production in this case.
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`5
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`Novartis Exhibit 2052.005
`Regeneron v. Novartis, IPR2021-00816
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`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 6 of 123
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`joint inventor. 37 C.F.R. § 1.63. The consequence of failing to comply with this regulation is that
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`a patent cannot be issued if the named inventors did not invent the subject matter sought to be
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`patented under 35 U.S.C. § 102(f).6
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`10.
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`Despite this requirement, Novartis never identified to the USPTO the Vetter
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`inventor(s), either when submitting the ’631 Patent application, during its pendency, or even after
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`the ’631 Patent issued. Instead, Novartis deliberately concealed the material facts regarding the
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`Vetter inventor(s)’ contributions to the subject matter claimed in the ’631 Patent from the USPTO
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`pursuant to its anticompetitive agreement with Vetter. As pled in detail below, Defendants formed
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`a scheme to conceal the facts of the
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` Acting on that
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`knowledge, Novartis deliberately withheld the facts of the Vetter individual(s)’ inventorship from
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`the USPTO in order to sabotage Regeneron’s ownership rights and ensure that the ’631 Patent
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`could be used to unreasonably restrain Regeneron’s ability to compete in the U.S. anti-VEGF PFS
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`market.
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`11.
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`Further unknown to Regeneron, Novartis and Vetter were vying to control the
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`patent application underlying the ’631 Patent. Using this dispute as a pretense, Novartis and Vetter
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`entered into an anticompetitive conspiracy around 2013 to unreasonably restrain competition in
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`anti-VEGF PFS treatments for ophthalmic diseases. Novartis effectively used the settlement
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`6
`35 U.S.C. § 102(f) states that a person shall be entitled to a patent unless…he did not himself
`invent the subject matter sought to be patented” (emphasis added).
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`6
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`Novartis Exhibit 2052.006
`Regeneron v. Novartis, IPR2021-00816
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`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 7 of 123
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`process for the then-pending application that would become the ’631 Patent to obtain control and
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`influence over Vetter’s PFS filling services so as to inhibit anti-VEGF rivals like Regeneron. In
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`addition,
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` This
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`-
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`“settlement” also enabled Vetter to obfuscate Regeneron’s rightful ownership rights
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`-
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` The quid pro quo was that Novartis extracted a lucrative economic interest in Vetter’s
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`PFS filling services in the form of Vetter’s assent to place onerous and anticompetitive restrictions
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`on Novartis’s rivals—like Regeneron—that had been working with Vetter all along. This
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`anticompetitive agreement co-opted Vetter and enabled Novartis to exert influence over Vetter’s
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`current and future customer relationships so that Novartis could undermine competitors’ efforts to
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`develop and sell competing anti-VEGF PFS drugs. As for Vetter, it stood to benefit from this
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`agreement by becoming the sole filler for all anti-VEGF PFS drugs—since Novartis would wield
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`(cid:76)(cid:87)(cid:86)(cid:3) (cid:73)(cid:85)(cid:68)(cid:88)(cid:71)(cid:88)(cid:79)(cid:72)(cid:81)(cid:87)(cid:79)(cid:92)(cid:3) (cid:83)(cid:85)(cid:82)(cid:70)(cid:88)(cid:85)(cid:72)(cid:71)(cid:3) (cid:1932)(cid:25)(cid:22)(cid:20)(cid:3) (cid:51)(cid:68)(cid:87)(cid:72)(cid:81)(cid:87)(cid:3) (cid:68)(cid:74)ainst any company that tried to compete by using a
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`different PFS filler.
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`12.
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` spells out the anticompetitive nature of Defendants’ 2013 settlement agreement.
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`-
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`7
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`Novartis Exhibit 2052.007
`Regeneron v. Novartis, IPR2021-00816
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`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 8 of 123
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` Vetter gained leverage over Regeneron and then sought to
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`unilaterally change its non-exclusive EYLEA PFS filling relationship with Regeneron to an
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`exclusive one and also to secure a no-challenge clause for Novartis’s yet-to-be-issued ’631
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`Patent—all of which would have given Vetter total control over EYLEA PFS supply for years to
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`come.
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` part of the quid
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`pro quo to ensure that Vetter benefited from its silence on the inventorship issue. The intentional
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`omission of at least one Vetter employee as a named inventor, and the resulting issuance of the
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`’631 Patent to Novartis inventors only, unlawfully deprived Regeneron of its rightful ownership
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`rights
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`13.
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`As pled in detail below, Defendants fraudulently concealed the scope of their
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`anticompetitive agreement from Regeneron until December 23, 2020. Regeneron and Vetter had
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`multiple communications between October 2013 and August 2014, and again in 2017, related to
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`Vetter’s sublicense demand for the ’631 Patent, which included Novartis’s and Vetter’s underlying
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`ownership dispute and settlement agreement. After receiving Vetter’s sublicense demand,
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`Regeneron specifically requested more information from Vetter about Vetter’s licensing rights to
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`the ’631 Patent and the Vetter-Novartis settlement referenced in the demand, including (among
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`others) a February 2014 request for information on the processes covered by the ’631 Patent.
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`Vetter, however, never disclosed to Regeneron that it had created any inventions claimed in the
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`’631 Patent application. Instead, Defendants affirmatively concealed
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`8
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`Novartis Exhibit 2052.008
`Regeneron v. Novartis, IPR2021-00816
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`

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`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 9 of 123
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` Defendants also ensured
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` that Regeneron would
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`not be aware of its ownership rights when Novartis’s application that led to the ’631 Patent was
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`published because the publication did not identify any Vetter inventor(s).
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`14.
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`Immediately following Vetter’s “settlement” with Novartis, and despite the
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`approximately eight year-long collaboration with Regeneron to commercialize an EYLEA PFS,
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`Vetter did just as Novartis had intended. Vetter abruptly reversed course with Regeneron in 2013.
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`Vetter chose the path of illicit profits by colluding with Novartis to control the supply of anti-
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`VEGF PFS treatments. Specifically, Vetter contacted Regeneron in October 2013, claimed that
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`Novartis had a pending patent application without disclosing the Vetter individual(s) inventorship,
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`and demanded that Regeneron take a sublicense to the yet to be issued ’631 Patent before Vetter
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`would continue their collaboration on EYLEA PFS—even though the ’631 Patent would not even
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`issue for two more years. As a condition of continuing their work on EYLEA PFS, Vetter also
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`required that Regeneron submit to two anticompetitive restrictions: (1) Regeneron must use Vetter
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`as its exclusive PFS filler for the next 20 years—i.e., for the entire life of Novartis’s yet to be
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`issued ’631 Patent; and (2) Regeneron must never challenge the validity or enforceability of
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`Novartis’s yet to be issued ’631 Patent.
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`15.
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`Regeneron could not—and did not—accept this offer. First, the unlawful “no
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`challenge” requirement was unacceptable given Regeneron’s own role in developing EYLEA PFS
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`and the extensive prior art (including the prior art Novartis deliberately withheld from the USPTO
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`during prosecution of the ’631 Patent) showing that the claimed PFS in Novartis’s patent was not
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`patentable. And unbeknownst to Regeneron at the time, Novartis and Vetter imposed the
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`anticompetitive “no-challenge clause” to ensure, among other things, that their inventorship
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`9
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`Novartis Exhibit 2052.009
`Regeneron v. Novartis, IPR2021-00816
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`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 10 of 123
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`deception would not be discovered through a potential challenge to the ’631 Patent. Separately,
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`Regeneron could not agree to be locked into an exclusive supply arrangement with Vetter for 20
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`years because it would inhibit the competitiveness of EYLEA PFS. Vetter is the capacity-
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`constrained exclusive supplier of LUCENTIS PFS and Regeneron had certain quality concerns
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`about Vetter as its sole PFS filler—two issues that Vetter failed to address. Consequently,
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`Regeneron had no choice but to decline Vetter’s (and Novartis’s) unlawful demands.
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`16.
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`The overarching goal of Novartis’s and Vetter’s conspiracy has been to control—
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`and unreasonably restrain—competition in anti-VEGF PFS treatments for certain ophthalmic
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`diseases. Their initial plan was to have all anti-VEGF PFS drugs run through Novartis and the PFS
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`filling services for those drugs to run exclusively through Vetter. Regeneron’s EYLEA has been
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`the only real competitive threat to LUCENTIS PFS, giving both Novartis and Vetter (now as a co-
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`conspirator) significant economic motives to lock up Regeneron’s EYLEA PFS business by
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`leveraging Novartis’s fraudulently procured ’631 Patent. To this end, Novartis and Vetter sought
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`to hold Regeneron captive to Vetter’s limited-supply PFS filling services for 20 years as a
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`condition of Regeneron obtaining a covenant that Novartis (or Vetter) would not sue Regeneron
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`on the fraudulently procured ’631 Patent. But when Regeneron rejected Novartis’s and Vetter’s
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`unlawful efforts to coerce Regeneron into an exclusive arrangement, Novartis and Vetter conspired
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`to keep EYLEA PFS out of the market altogether.
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`17.
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`To Novartis’s benefit, Novartis and Vetter agreed to deny Regeneron access to any
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`of Vetter’s essential PFS filling services for EYLEA PFS. Not only did this denial represent an
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`abrupt change in Vetter’s collaboration with Regeneron to commercialize EYLEA PFS, but it also
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`was in stark contrast to Vetter’s then and current relationship with Regeneron filling EYLEA vials
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`without exclusivity. As for commercialization of the EYLEA PFS, Novartis and Vetter knew that
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`10
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`Novartis Exhibit 2052.0010
`Regeneron v. Novartis, IPR2021-00816
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`

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`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 11 of 123
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`Regeneron would need to start over with few to no PFS filler options for this critical aspect of the
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`supply chain, resulting in years of delay and additional, substantial, and unnecessary costs. And
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`that is exactly what happened to Regeneron.
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`18.
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`Novartis and Vetter did not stop there, however. They doubled down on their
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`conspiracy to limit competition from EYLEA PFS after the ’631 Patent issued in December 2015.
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`With the fraudulently procured ’631 Patent in hand by that point, Vetter again demanded the same
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`anticompetitive terms (an exclusive filling agreement and no challenge clause) from Regeneron in
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`late 2017. Regeneron again refused. Two years later, after Regeneron had successfully created a
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`new supply and filler chain for EYLEA PFS and launched it in the United States, Novartis and
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`Vetter undertook a new overt act in furtherance of their anticompetitive conspiracy
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`attempted to conceal their anticompetitive conspiracy
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` Defendants
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`19.
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`Novartis then took the next step in this illicit scheme on June 19, 2020 by filing a
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`patent infringement complaint at the U.S. International Trade Commission (“ITC”) asserting its
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`fraudulently procured ’631 Patent and seeking an exclusion order barring importation of EYLEA
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`PFS components into the United States. And despite ITC rules requiring that Novartis identify all
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`licensees of the ’631 Patent upon filing the complaint, Novartis omitted any identification of Vetter
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`11
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`Novartis Exhibit 2052.0011
`Regeneron v. Novartis, IPR2021-00816
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`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 12 of 123
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`as a licensee in furtherance of the conspiracy to conceal Vetter’s involvement and its employees’
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`role in the inventorship of the ’631 Patent.7 Novartis also filed a companion infringement
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`complaint in the Northern District of New York (“NDNY”) seeking damages and injunctive relief
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`for alleged infringement of ’631 Patent. Despite knowing that the ’631 Patent was fraudulently
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`procured and unenforceable, Novartis filed multiple litigations in yet another attempt to block
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`EYLEA PFS from the U.S. market, or at the very least, to artificially increase Regeneron’s costs
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`even more by erecting anticompetitive barriers to sale.
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`20.
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`Defendants’ anticompetitive conduct has injured and continues to injure patients,
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`physicians, and Regeneron. Instead of competing on the merits, Novartis and Vetter have
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`concocted numerous anticompetitive obstacles to initially try to stop Regeneron from launching—
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`and now from selling—EYLEA PFS. By forcing Regeneron to navigate around artificial and
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`unlawful barriers, Defendants have delayed EYLEA PFS by years in coming to the U.S. market.
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`Defendants imposed additional, substantial, and unnecessary costs on Regeneron to establish a
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`reliable alternative supply and filler chain in order to commercialize EYLEA PFS. Now
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`Defendants are forcing Regeneron to spend time and limited resources defending an ITC action
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`and a patent infringement lawsuit based on a fraudulently procured patent, and would have
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`Regeneron invest millions of dollars and months attempting to develop a contingent supply of
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`EYLEA in vial form to hedge against the possibility that Novartis obtains an exclusion order from
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`the ITC.
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`21. Worst of all, if Novartis’s unlawful efforts succeed, patients and physicians will be
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`deprived of EYLEA PFS altogether. Novartis will regain its monopoly over anti-VEGF PFS
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`7
`As detailed in Regeneron’s Opposition to Defendant’s Motion to Dismiss, Transfer, or Stay,
`Novartis failed to identify Vetter as a licensee until August 3, 2020, after counsel for Regeneron raised this
`omission and 17 days after Regeneron filed the SDNY action naming Vetter as a defendant. See ECF No.
`45 at 6.
`
`12
`
`Novartis Exhibit 2052.0012
`Regeneron v. Novartis, IPR2021-00816
`
`

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`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 13 of 123
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`treatments for ophthalmic diseases and Vetter will remain the sole PFS filler for those treatments.
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`Tellingly, in its ITC submissions, Novartis does not even attempt to claim that any alternative anti-
`
`VEGF PFS exists for EYLEA PFS other than LUCENTIS PFS. And the only other potential near-
`
`term PFS entrant is another Novartis drug, BEOVU, which has serious safety issues. Through the
`
`anticompetitive enforcement of the fraudulently procured ’631 Patent, Novartis is trying to force
`
`physicians and patients to make a difficult choice between LUCENTIS PFS, which offers
`
`numerous advantages through its PFS delivery method, and the EYLEA vial, a medication that is
`
`regarded by many physicians and patients as a superior anti-VEGF eye disease treatment but is
`
`administered using a non-preferred method. This is particularly harmful because physicians are
`
`naturally reluctant to switch a patient who is responding well to one anti-VEGF to another anti-
`
`VEGF treatment. In a competitive marketplace, physicians and patients would not have to make
`
`this difficult tradeoff. They should continue to have access to an anti-VEGF PFS that combines all
`
`of these medical advantages in one—Regeneron’s EYLEA PFS.
`
`22.
`
`Regeneron is compelled to bring this lawsuit to stop Defendants’ unlawful behavior
`
`and to hold Defendants accountable in front of a jury in a public court of law for their
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`anticompetitive conduct.
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`PARTIES TO ACTION
`
`23.
`
`Plaintiff Regeneron is a corporation organized and existing under the laws of the
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`State of New York with its principal place of business located at 777 Old Saw Mill River Road,
`
`Tarrytown, New York 10591. Regeneron is in the business of inventing, developing,
`
`manufacturing, and marketing a variety of innovative pharmaceutical products, including EYLEA
`
`and EYLEA PFS.
`
`24.
`
`Defendant Novartis Pharma AG is a corporation organized and existing under the
`
`laws of Switzerland, with an office and a place of business located at Forum 1 Novartis Campus,
`
`13
`
`Novartis Exhibit 2052.0013
`Regeneron v. Novartis, IPR2021-00816
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`

`

`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 14 of 123
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`CH-4056 Basel, Switzerland.
`
`25.
`
`Defendant Novartis Pharmaceuticals Corporation is a corporation organized and
`
`existing under the laws of the state of Delaware with its principal place of business located at One
`
`Health Plaza, East Hanover, New Jersey 07936. Novartis Pharmaceuticals Corporation is an
`
`affiliate of Novartis Pharma AG.
`
`26.
`
`Defendant Novartis Technology LLC is a corporation organized and existing under
`
`the laws of the state of Delaware with its principal place of business located at One Health Plaza,
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`East Hanover, New Jersey 07936.
`
`27.
`
`Defendant Vetter is a company organized and existing under the laws of Germany,
`
`with its principal place of business located at Eywiesenstrasse 5, 88212 Ravensburg, Germany.
`
`Vetter also operates facilities located in Des Plaines and Skokie, Illinois.8
`
`JURISDICTION AND VENUE
`
`28.
`
`This Court has subject matter jurisdiction over all claims asserted against
`
`Defendants pursuant to 28 U.S.C. § 1331, 28 U.S.C. § 1337(a), 15 U.S.C. § 4, 15 U.S.C. § 15, and
`
`15 U.S.C. § 26.
`
`29.
`
`This Court has personal jurisdiction over Defendants under the U.S. Constitution
`
`and nationwide contacts under Section 12 of the Clayton Act, 15 U.S.C. § 22.
`
`30.
`
`Venue is proper in this District under Section 12 of the Clayton Act, 15 U.S.C. §
`
`22, and under 28 U.S.C. § 1391(b) and (c).
`
`31.
`
`For personal jurisdiction and venue purposes, Defendants can be found in, and
`
`transact business in, this District, including through the marketing and sale of LUCENTIS PFS
`
`and BEOVU. Defendants’ unlawful behavior was specifically intended to, has had, and will
`
`
`8
`Vetter U.S. Locations, available at https://www.vetter-pharma.com/en/about-us/locations/chicago-
`skokie (last visited July 11, 2020).
`
`14
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`Novartis Exhibit 2052.0014
`Regeneron v. Novartis, IPR2021-00816
`
`

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`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 15 of 123
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`continue to have an anticompetitive effect and impact on Regeneron and U.S. consumers in this
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`District, and elsewhere.
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`INTERSTATE COMMERCE
`
`32.
`
`The commercialization, development, manufacturing, marketing, sale, and
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`distribution of EYLEA, LUCENTIS, and BEOVU occurs in interstate commerce.
`
`FACTUAL BACKGROUND9
`
`Anti-VEGF Drugs for Treating Ophthalmic Diseases
`
`Anti-VEGF drugs, like EYLEA and LUCENTIS, are used to treat certain
`
`A.
`
`33.
`
`ophthalmic diseases that can cause vision loss or blindness, including Wet Age-Related Macular
`
`Degeneration, Diabetic Retinopathy, Diabetic Macular Edema, and Macular Edema following
`
`Retinal Vein Occlusion. Another anti-VEGF drug, BEOVU, was recently approved for the
`
`treatment of Wet Age-Related Macular Degeneration only.
`
`34.
`
`These complex biologics work by targeting over-produced VEGF proteins and
`
`blocking or inhibiting them. This reduces abnormal blood vessel growth and leakage in the eye,
`
`which helps to stabilize vision loss, and in some cases, can even reverse vision loss and restore
`
`sight. Anti-VEGF treatments are only effective at maintaining or improving vision when
`
`administered regularly on a continuing basis.
`
`35.
`
`Patients receive treatment for these ophthalmic diseases in a physician’s office. An
`
`ophthalmologist (typically a retinal specialist) must administer anti-VEGF drugs via syringe with
`
`an injection near the retina in the back of the eye, known as an “intravitreal injection.”
`
`
`9
`The factual allegations in this Complaint are made based upon Regeneron’s first-hand knowledge
`with the exception of allegations made upon information and belief regarding Defendants’ conduct.
`
`15
`
`Novartis Exhibit 2052.0015
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`Case 1:20-cv-05502-AJN Document 87 Filed 01/25/21 Page 16 of 123
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`B.
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`Ophthalmic Diseases that Cause Vision Loss and Blindness
`
`i.
`
`Wet Age-Related Macular Degeneration
`
`36. Wet Age-Related Macular Degeneration (“wet AMD”) is the most severe form of
`
`an eye disease that is the leading cause of blindness among older Americans.
`
`37.
`
`An estimated 11 million Americans suffer from some form of AMD, which erodes
`
`central vision. AMD has two forms: wet and dry. While dry AMD leads to a gradual loss of vision,
`
`wet AMD leads to faster vision loss and is the most advanced form of the disease. It is responsible
`
`for 90 percent of all AMD-related blindness.
`
`38. Wet AMD patients see the world as if through distorted lenses: straight lines may
`
`appear bent, central vision may be reduced, colors may be dulled, and patients may see haziness.
`
`Patients may also experience a well-defined blurry or blind spot in their central field of vision:10
`
`39.
`
`
`Day-to-day activities, such as reading, writing, driving, or even recognizing faces,
`
`are difficult for patients with wet AMD. The debilitating effects of wet AMD worsen over time
`
`and can be irreversible. If left untreated, wet AMD may cause permanent blindness.
`
`40. Wet AMD is caused by an overproduction of a naturally occurring VEGF protein
`
`in the body. VEGF’s normal role is to trigger formation of new blood vessels supporting the growth
`
`of the human body’s tissues and organs