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`UNITED STATES DISTRICT COURT
`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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`REGENERON PHARMACEUTICALS,
`INC.,
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` Defendant,
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`REGENERON PHARMACEUTICALS,
` ’631 Patent case
`INC.,
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` Counter Claimant,
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`NOVARTIS PHARMA AG; NOVARTIS
`PHARMACEUTICALS CORPORATION;
`and NOVARTIS TECHNOLOGY LLC,
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` Counter Defendants,
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`REGENERON PHARMACEUTICALS,
`INC.,
` Plaintiff,
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` 1:21-CV-1066
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`-v-
` Antitrust case
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`NOVARTIS PHARMA AG; NOVARTIS
`TECHNOLOGY LLC; NOVARTIS
`PHARMACEUTICALS CORPORATION;
`and VETTER PHARMA
`INTERNATIONAL GMBH,
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` Defendants.
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 2 of 43
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` OF COUNSEL:
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`APPEARANCES:
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`BOND SCHOENECK & KING, PLLC GEORGE R. McGUIRE, ESQ.
` SYRACUSE
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`
`
`
`
`
`
` LOUIS ORBACH, ESQ.
`Attorneys for Novartis Pharma AG
` Novartis Pharmaceuticals
` Corporation, and Novartis
` Technology LLC
`One Lincoln Center
`Syracuse, New York 13202
`
`GOODWIN, PROCTER LAW FIRM
` NEW YORK OFFICE
`
`
`
`
`Attorneys for Novartis Pharma AG
` Novartis Pharmaceuticals
` Corporation, and Novartis
` Technology LLC
`The New York Times Building
`620 Eighth Avenue
`New York, New York 10018
`
`
`GOODWIN, PROCTER LLP
`Attorneys for Novartis Pharma AG
` Novartis Pharmaceuticals
` Corporation, and Novartis
` Technology LLC
`Exchange Place
`100 Northern Avenue
`Boston, Massachusetts 02210
`
`WEIL GOTSHAL & MANGES LLP
`Attorneys for Regeneron
`
`
`
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` Pharmaceuticals, Inc.
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`
`767 Fifth Avenue
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`
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`
`
`New York, New York 10153
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` CALVIN E. WINGFIELD, ESQ.
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` MOLLY GRAMMEL, ESQ.
`
` ANISH R. DESAI, ESQ.
` ELIZABETH WEISWASSER, ESQ.
` ERIC SHAUN HOCHSTADT,
`
` ESQ.
` JESSICA L. FALK, ESQ.
` JOHN REN, ESQ.
`
`
`
`2
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`
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 3 of 43
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` CHRISTOPHER PEPE, ESQ.
` MATTHEW SIEGER, ESQ.
` ROBERT T. VLASIS, III, ESQ.
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`BARCLAY DAMON LLP-SYRACUSE DOUGLAS J. NASH, ESQ.
`Attorneys for Regeneron
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`
`
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` JOHN D. COOK, ESQ.
` Pharmaceuticals, Inc.
`Barclay Damon Tower
`125 East Jefferson Street
`Syracuse, New York 13202
`
`WEIL GOTSHAL & MANGES LLP
`Attorneys for Regeneron
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`
`
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` Pharmaceuticals, Inc.
`
`
`
`
`2001 M Street, Northwest-Suite 600
`Washington, DC 20036
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`HESLIN, ROTHENBERG LAW FIRM SUSAN E. FARLEY, ESQ.
`Attorneys for Vetter Pharma
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` TEIGE P. SHEEHAN, ESQ.
`
`International GMBH
`5 Columbia Circle
`Albany, New York 12203
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`MARSHALL, GERSTEIN &
` BORUN, LLP
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`
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`Attorneys for Vetter Pharma
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`International GMBH
`6300 Willis Tower
`233 S. Wacker Drive
`Chicago, Illinois 60606
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`DAVID N. HURD
`United States District Judge
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` BENJAMIN T. HORTON, ESQ.
` JULIANNE M. HARTZELL, ESQ.
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`MEMORANDUM-DECISION and ORDER
`
` INTRODUCTION
`
` On June 19, 2020, pharmaceutical companies Novartis Pharma AG,
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`Novartis Pharmaceuticals Corporation, and Novartis Technology LLC
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`(together “Novartis”) filed a complaint (the “’631 Patent case”) in this district
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`alleging patent infringement against rival Regeneron Pharmaceuticals, Inc.
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`3
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 4 of 43
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`(“Regeneron”). Essentially, Novartis claims that it has a valid patent for
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`syringes which come pre-filled with a certain medication used to treat
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`degenerative eye disease. By extension, Novartis takes issue with
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`Regeneron’s introduction of a competing prefilled syringe—designed to treat
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`the same disease—into the market notwithstanding its patent.
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` On July 17, 2020, Regeneron fired back with a complaint of its own,
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`alleging four antitrust claims and an additional claim for tortious
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`interference with a contract (the “Antitrust case”). In addition to Novartis,
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`Regeneron also directed some of these claims at Vetter Pharma International
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`GMHB, a pharmaceutical supply chain provider whose niche in the medical
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`marketplace includes filling Novartis’s—and formerly Regeneron’s—syringes.
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` According to Regeneron, Vetter and Novartis conspired together to
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`circumvent a binding contract giving Regeneron an ownership interest in any
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`of Vetter’s innovations. At the same time, Regeneron claims that Vetter and
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`Novartis defrauded the Patent and Trademark Office (“PTO”) to secure for
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`Novartis a stranglehold on the market for prefilled syringes designed to treat
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`degenerative eye disease.
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` There are three separate pending motions in these two cases. First, in the
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`’631 Patent case, Novartis and Regeneron have submitted their opening
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`claim construction briefs in advance of a potential hearing as contemplated
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`by Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996). Second, in
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`4
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 5 of 43
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`the Antitrust case, Novartis and Vetter have both moved to dismiss
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`Regeneron’s complaint against them in its entirety under Federal Rule of
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`Civil Procedure (“Rule”) 12(b)(6). And third, in both cases, Regeneron has
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`moved for a stay in proceedings while the PTO conducts an inter partes
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`review of the validity of Novartis’s patent. All three motions, having been
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`fully briefed, will now be decided on the submissions and without oral
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`argument.
`
` BACKGROUND
`
` At their core, these two cases are about three different drugs: EYLEA,
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`made by Regeneron, and LUCENTIS and BEOVU, both made by Novartis.1
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`Regeneron Pharms., Inc. v. Novartis Pharma AG, 1:21-CV-1066, Dkt. 87
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`(“Antitrust Compl.”), ¶ 5. All three drugs are designed to inhibit the body’s
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`production of vascular endothelial growth factor (“VEGF”), a naturally
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`occurring protein that erodes vision if overproduced, and in particularly
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`extreme cases can cause blindness. Id. ¶¶ 5-6.
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` EYLEA, LUCENTIS, and BEOVU each need to be injected directly into
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`the eye regularly to do their job as “anti-VEGF” agents. Antitrust
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`Compl. ¶ 6. Traditionally, like most injectable liquids, EYLEA, LUCENTIS,
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`1 For the purposes of Novartis and Vetter’s motions to dismiss under Rule 12(b)(6), the Court
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`takes the facts in Regeneron’s complaint as true. The Court notes that in addition to the redacted
`First Amended Complaint on the docket, Regeneron has also filed a “clean” version of that document
`under seal. The Court has consulted the clean version where necessary but will cite to the official
`version.
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`5
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`and BEOVU were transported in vials. Id. The physician would then have to
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`pierce the vial with a syringe, draw some of the drug out, and inject it into
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`the patient’s eye. Id.
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`A. Developing the Prefilled Syringe
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` According to Regeneron, though, it came up with a better idea. Regeneron
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`claims that in 2005, it and Vetter began working together to develop a
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`prefilled syringe (“PFS”) that contained EYLEA. Antitrust Compl. ¶¶ 2, 152.
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`The theory went that a prefilled syringe would remove the intermediate step
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`of drawing out the drug, reducing the risk of contamination and making the
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`process safer. Id. ¶¶ 76-81. As part of their collaboration, Vetter helped
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`Regeneron by filling its syringes during the testing phase for the EYLEA
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`PFS. Id. ¶ 152.
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`
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`In addition to filling the EYLEA PFS systems, though, Regeneron alleges
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`that it and Vetter also worked together to develop and commercialize the
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`EYLEA PFS. Antitrust Compl. ¶ 152. That collaboration was carried out
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`under an agreement styled the EYLEA PFS Development Agreement (the
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`“Development Agreement”). Id.
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` According to Regeneron, by the terms of the Development Agreement,
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`Regeneron could claim ownership rights to “any inventions, improvements,
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`enhancements, or alike made during the Term [of the agreement] and
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`conceived or reduced to practice or generated by Regeneron and/or Vetter”
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`6
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`relating to an anti-VEGF delivered to Vetter by Regeneron. Antitrust Compl.
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`¶ 153. The Development Agreement apparently bore fruit, because the
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`Australian government approved EYLEA FPS in 2012. Id. ¶ 154.
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`
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`In the meantime, Regeneron alleges that Novartis and Vetter were also
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`working together to produce a PFS. Antitrust Compl. ¶ 155. That
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`collaboration was similarly successful, and Novartis and Vetter eventually
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`produced LUCENTIS PFS. Id. ¶ 141. According to Regeneron, several
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`Vetter employees made “significant contributions” along the way. Id.
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`Regeneron further alleges that those significant contributions involved the
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`same anti-VEGF drug from which EYLEA is made. Id. ¶ 143.
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` But Novartis and Vetter’s joint efforts did not go off entirely without a
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`hitch. Apparently, on February 27, 2013, Vetter sent Novartis a letter
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`objecting to certain patent applications that Novartis had filed in Germany
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`and Australia. Antitrust Compl. ¶ 142. At bottom, Vetter objected that
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`Novartis claimed credit for inventions and improvements allegedly made by
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`Vetter personnel. Id.
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` Novartis and Vetter met to discuss the matter, and apparently came to a
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`final agreement signed by both parties by October 2, 2013 (the “2013
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`Amendment”). Antitrust Compl. ¶¶ 145-46. By the terms of that agreement,
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`Novartis agreed that Vetter significantly contributed to developing its PFS
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`patent family. Id. ¶ 146. It must be said, though, that the 2013 Amendment
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`7
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 8 of 43
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`specifically excludes crediting Vetter with contributing to “any [i]nvention.”
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`Id.
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` On January 25, 2013, Novartis filed a patent for the LUCENTIS PFS (“the
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`’631 Patent”). Antitrust Compl. ¶ 143. The ’631 Patent relates back to
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`Novartis’s German patent, and apparently claims the same subject matter.
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`Id. ¶ 144. What Regeneron claims the ’631 Patent does not do, however, is
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`credit any Vetter employee as an inventor. Id. ¶ 147. To the extent any of
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`them qualify, that poses a problem, because 35 U.S.C. § 116 requires that all
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`inventors jointly file for a patent, unless a joint inventor refuses to join in the
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`patent application or cannot be found.
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` The PTO issued the ’631 Patent on December 29, 2015. Antitrust
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`Compl. ¶ 147. Apparently, Novartis only planned on marketing LUCENTIS
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`PFS outside the United States. See Id. ¶ 53. For the purposes of serving the
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`United States (“U.S.”) market, Novartis licensed the patent for the
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`LUCENTIS PFS to a separate company, Genentech, Inc. (“Genentech”). Id.
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`¶¶ 53-54. Genentech then launched LUCENTIS PFS in the U.S. in early
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`2017. Id. ¶ 84. According to Regeneron, Novartis has a 33.3% ownership
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`stake in Genentech’s parent company, Roche. Id. And in any case, when
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`BEOVU PFS—another anti-VEGF—is launched, Novartis appears to intend
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`to market it in the U.S. Id. ¶ 2.
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`8
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 9 of 43
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` Summing up, according to Regeneron, Novartis got the jump on its efforts
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`to market an anti-VEGF PFS. But in doing so, Novartis allegedly recruited
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`Vetter’s help. Regeneron claims that Novartis’s overture towards Vetter
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`violates its rights because any ideas by Vetter relating to EYLEA PSF were
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`contractually Regeneron’s property.
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`
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` And because one of the drugs used in developing the LUCENTA PSF was
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`functionally identical to EYLEA, Regeneron claims that Vetter’s
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`contributions to that patent qualified as relating to EYLEA PSF. From
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`Regeneron’s perspective, Novartis’s exclusion of Vetter’s assistance from the
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`patent application was a calculated move to prevent the ’631 Patent from
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`becoming Regeneron’s property by virtue of the Development Agreement.
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`Antitrust Compl. ¶¶ 147-48.
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`B. Regeneron’s Negotiations with Vetter
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`
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`In the meantime, Regeneron claims that its experiences with Vetter took a
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`sharp and downward turn once the 2013 Amendment was signed. According
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`to Regeneron, in October 2013, the same month the agreement had taken
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`effect, Vetter sent a sublicense demand to Regeneron. Antitrust
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`Compl. ¶ 166. The letter claimed that the EYLEA PFS would be covered
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`under Novartis’s then-pending ’631 Patent. Id. By extension, if Regeneron
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`wanted to continue to try to market EYLEA PFS, it would have to agree to
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`take out a sublicense from Vetter first. Id.
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`9
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 10 of 43
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` However, Vetter would only agree to offer a sublicense if Regeneron
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`agreed to use Vetter exclusively to fill its EYLEA PFS products for the
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`duration of the ’631 Patent, a term of nearly twenty years. Antitrust Compl.
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`¶ 167. In addition, Vetter’s proposed agreement required that Regeneron
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`promise never to challenge the validity of the ’631 Patent. Id. ¶ 170.
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` Previously, Vetter had filled EYLEA vials without any exclusivity
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`requirement, so Regeneron claims that it was wary of the sudden pivot.
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`Antitrust Compl. ¶ 167. On top of that, the lengthy duration of the
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`exclusivity clause gave Regeneron pause. Id. Finally, Regeneron claims that
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`it felt that Vetter and Novartis’s agreement and general relationship with
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`each other raised concerns on Regeneron’s part that Vetter would prioritize
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`Novartis’s interests over its own. Id. ¶ 168.
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` For these reasons and more, Regeneron refused to sign the agreement.
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`Antitrust Compl. ¶ 174. As a result, Vetter stopped filling EYLEA PFS. Id.
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`¶ 175. Regeneron then found a new supplier but claims that doing so required
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`some alterations to EYLEA PFS’s design and took a substantial toll on its
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`time and resources. Id.
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`
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`In 2017, Regeneron claims that it approached Vetter again to discuss
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`working together. Antitrust Compl. ¶ 176. Vetter responded with the same
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`offer it had extended in 2013. Id. Regeneron once again refused. Id.
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`10
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`C. Novartis’s Patent Suit
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` Despite the ’631 Patent, Regeneron released EYLEA PFS sometime
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`around December of 2019. Novartis Pharma AG v. Regeneron Pharms., Inc.,
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`1:20-CV-690, Dkt. 70 (“Patent Compl.”), ¶ 29.2 From Novartis’s perspective,
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`that amounts to infringement, because the ’631 Patent gives Novartis the
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`exclusive right to market prefilled, sterilized syringes containing an
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`anti-VEGF solution. Id. ¶ 15. And according to Novartis, the EYLEA PFS is
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`precisely that. Id. ¶¶ 20-28 (describing attributes of EYLEA PFS that
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`allegedly fall under terms of ’631 Patent).
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` But based on Regeneron’s version of events, there were some internal
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`hoops Novartis needed to jump through before it could bring the infringement
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`suit. Antitrust Compl. ¶ 186. Apparently, the 2013 Amendment contained a
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`clause which gave Vetter the exclusive right to sublicense the ’631 Patent.
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`Id. ¶ 156. But on December 18, 2019—around the same time EYLEA PFS
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`was hitting the market—the 2013 Amendment was itself amended (the “2019
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`Amendment”). Id. ¶ 186. By the terms of the new agreement, Novartis was
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`given sole enforcement authority concerning the ’631 Patent in exchange for a
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`cut of all license income. Id.
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`2 The Court refers to the complaint in the ’631 Patent case solely to provide context to the
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`parties’ disputes. In no way will this complaint be relied upon in reaching a decision on the present
`motion practice, especially Novartis and Vetter’s Rule 12(b)(6) motions.
`11
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 12 of 43
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` On June 19, 2020, after the 2019 Amendment took effect, Novartis sued
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`Regeneron for infringing the ’631 Patent by marketing EYLEA PFS.
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`Novartis, 1:20-CV-690, Dkt. 1. At the same time, Novartis filed a complaint
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`with the United States International Trade Commission (“ITC”) claiming
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`infringement of the same patent. Novartis, 1:20-CV-690, Dkt. 27, p. 1.3
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` On July 28, 2020, Regeneron moved to stay Novartis’s claim before this
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`Court pending resolution of the ITC complaint. Novartis, 1:20-CV-690,
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`Dkt. 27, p. 1. Novartis did not oppose, and the stay was granted on July 30,
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`2020. Id.
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` On April 8, 2021, Novartis voluntarily withdrew its ITC complaint to focus
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`its efforts on this case. Novartis, 1:20-CV-690, Dkt. 38-1, pp. 3-6. The stay
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`was then lifted on June 11, 2021. Novartis, 1:20-CV-690, Text Minute Entry
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`Dated 6/11/2021.
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`D. Regeneron’s Antitrust Suit
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` Regeneron was not sitting idle while Novartis’s patent claim proceeded.
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`On July 17, 2020, Regeneron filed the antitrust claim against both Novartis
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`and Vetter. Regeneron, 1:21-CV-1066, Dkt. 1. Essentially, that complaint
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`alleges that Novartis and Vetter conspired together to freeze Regeneron out
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`of the market for anti-VEGF PFS products by forcing it into a long-term
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`3 Pagination corresponds with CM/ECF.
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`12
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 13 of 43
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`contract with Vetter and requiring it to respect the ’631 Patent. See generally
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`id., passim. To make matters worse, Regeneron sees itself as the rightful
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`owner of the ’631 Patent based on the Development Agreement and accuses
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`Novartis of arranging for Vetter’s breach of that contract. In addition,
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`Regeneron accuses Novartis of intentionally omitting information material to
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`the ’631 Patent relating to a prior art. Antitrust Compl. ¶¶ 219-22.
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` More specifically, Regeneron’s complaint asserts five causes of action:
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`(I) attempted monopolization through a scheme of patent fraud under Walker
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`Process Equipment, Inc. v. Food Machinery & Chemical Corp., 382 U.S. 172
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`(1965) for omitting prior arts in violation of § 2 of the Sherman Act;
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`(II) attempted monopolization in violation of § 2 of the Sherman Act even
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`without Walker Process fraud; (III) unreasonable restraint on trade in
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`violation of § 1 of the Sherman Act; (IV) attempted monopolization through
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`Walker Process fraud for omitting the contributions of Vetter inventors in
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`violation of § 2 of the Sherman Act; and (V) tortious interference with a
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`contract under New York state law.4 Regeneron brings Count III against
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`both Novartis and Vetter. For the remainder, Novartis alone is accused of
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`wrongdoing.
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`E. The Present Motion Practice
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`4 The parties do not dispute that Regeneron’s tortious interference claim comes under New York
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`law.
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`13
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 14 of 43
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` Once the stays were lifted at the conclusion of the ITC proceedings, both
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`cases continued. On October 15, 2021, Novartis and Vetter each moved to
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`dismiss Regeneron’s First Amended Complaint—the current operative
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`pleading in the Antitrust case—for failure to state a claim. Regeneron,
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`1:21-CV-1066, Dkts. 184; 186.
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` But on November 5, 2021, Regeneron moved to stay both the ’631 Patent
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`case and the Antitrust case. Novartis, 1:20-CV-690, Dkt. 98; Regeneron,
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`1:21-CV-1066, Dkt. 216. Apparently, on April 16, 2021, while the ITC
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`complaint was still pending, Regeneron had asked the PTO for an inter partes
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`review to declare the ’631 Patent invalid. Novartis, 1:20-CV-690, Dkt. 98-4,
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`p. 85; Regeneron, 1:21-CV-1066 Dkt. 216-4, p. 85. On October 26, 2021, the
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`PTO agreed. Novartis, 1:20-CV-690, Dkt. 98-3, p. 1; Regeneron, 1:21-CV-1066
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`Dkt. 216-3, p. 1. Thus, Regeneron argues that both cases should be stayed
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`until the PTO has an opportunity to determine whether the ’631 Patent is
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`valid.
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` Finally, on December 23, 2021, Novartis and Regeneron both filed their
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`Markman briefs in the ’631 Patent case. Novartis, 1:20-CV-690, Dkts. 103;
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`104. This decision now follows to resolve all three pending motions.
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` DISCUSSION
`
` The first step in untangling the knot these cases have worked themselves
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`into is deciding which thread to pull on first. To that end, the only dispute
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`14
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 15 of 43
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`concerning the ’631 Patent’s claim construction is whether there is actually a
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`dispute in the first place. There is little harm in reaching that simple
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`question first before considering a stay that would leave that dispute
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`unaddressed. After that, should Novartis and Vetter’s motions to dismiss
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`have merit, the Antitrust case could be dismissed in its entirety, which would
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`obviously moot the question of staying that case. Accordingly, the Court will
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`turn to the motion to dismiss second, and only reach the motion to stay after
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`considering both other active motions.
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`A. Claim Construction
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`“Claim construction is a question of law, the purpose of which is to
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`determine what is covered by the patent’s claims.” Verint Sys. Inc. v. Red Box
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`Recorders Ltd., 166 F. Supp. 3d 364, 374 (S.D.N.Y. 2016) (citing Markman,
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`517 U.S. at 384. That process is geared toward “elaborating the normally
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`terse claim language in order to understand and explain, but not to change,
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`the scope of the claims.” Verint Sys., 166 F. Supp. 3d at 374 (cleaned up)
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`(citing Embrex, Inc. v. Serv. Eng’g Corp., 216 F.3d 1343, 1347
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`(Fed. Cir. 2000)).
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`“When faced with ‘an actual dispute regarding the proper scope’ of a
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`patent claim, the court must construe the allegedly infringed claim to
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`determine its meaning and scope.” PPC Broadband, Inc. v. Corning Optical
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`Commc’ns RF, LLC, 2014 WL 4199244, at *2 (N.D.N.Y. Aug. 21, 2014). But
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 16 of 43
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`the converse is also true: “a trial court need not construe claim terms whose
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`meaning the parties do not dispute.” Holmberg v. United States,
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`124 Fed. Cl. 610, 613 (2016).
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`At any rate, although a court “may have the authority to adopt claim
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`constructions which have not been proposed by either party[, it] should be
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`hesitant to do so.” Holmberg, 124 Fed. Cl. at 613 (citing Yoon Ja Kim v.
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`ConAgra Foods, Inc., 465 F.3d 1312, 1319 (Fed. Cir. 2006)).
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` As required under Local Patent Rule for the Northern District of New
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`York (“Local Patent Rule”) 4.4, both Regeneron and Novartis submitted a
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`joint claim construction setting out their agreed definitions of the terms of
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`the ’631 Patent.5 Novartis, 1:20-CV-690, Dkt. 100. In that document,
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`Novartis agreed with Regeneron’s construction of all terms. See generally id.,
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`passim.
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` But Novartis’s apparent consent does not, it seems, resolve the issue of
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`claim construction on its own. According to Regeneron, Novartis intends to
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`sandbag it and the Court by making arguments at trial contrary to the terms
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`upon which the parties agreed. Specifically, Regeneron claims that Novartis
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`5 Both parties would also file short responsive claim construction briefs on January 24, 2022.
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`Novartis, 1:20-CV-690, Dkts. 109; 111. In Regeneron’s brief, it requested leave to file a reply brief in
`the event that Novartis filed a responsive brief, because Novartis’s initial submission was decidedly
`barebones. However, because Novartis’s responsive brief only dealt with Regeneron’s arguments and
`continues to disavow any true dispute of the claim construction, permitting Regeneron to file a reply
`brief would be a waste of time and effort that this Court will not indulge.
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 17 of 43
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`has not disavowed an intent to argue that a syringe is “terminally sterilized”
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`only if it has been: (1) subjected to stability testing; and (2) protected from
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`further contact after the sterilizing agent has been applied and stability
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`testing conducted.
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` The problem, it seems, is that the proposed construction of “terminally
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`sterilized” makes no mention of those two additional requirements. In
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`Regeneron’s opinion, the only solution is for the Court to take the further step
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`of precluding Novartis from arguing that anything more is required for a
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`syringe to be “terminally sterilized” than what is described in the proposed
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`claim construction.
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` Regeneron is mistaken. After all, if the proposed construction would
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`foreclose Novartis’s argument, then the Court’s adoption of that construction
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`would give Regeneron the relief it is requesting without further tampering.
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`On the other hand, the Court can think of only two possible reasons that
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`adopting the proposed claim would not foreclose that line of argument.
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` First, it may be that the construction of the claim has nothing to do with
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`Novartis’s argument, in which case it would be an overreach for the Court to
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`hamstring Novartis at the claim construction stage. Or second, it may be
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`that Regeneron could have requested a more favorable construction of the
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`claim and failed to do so. In that case, Regeneron is asking the Court to take
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`the disfavored step of adopting a construction without a proposal simply to
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`17
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 18 of 43
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`cover for its own tactical misstep. Holmberg, 124 Fed. Cl. at 613 (holding
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`that courts should be hesitant to adopt claim constructions not proposed by
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`parties). Under none of those circumstances would the Court be moved to
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`produce its own more restrictive version of the proposed claim construction as
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`Regeneron requests.
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` Neither is the Court persuaded by Regeneron’s argument that the Court is
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`obliged to go looking for disputes that do not appear on the face of the
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`Markman briefing. In support of that argument, Regeneron relies on PPC
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`Broadband, 2014 WL 4199244 and Defenshield, Inc. v. First Choice Armor &
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`Equipment, Inc., 2013 WL 5323752 (N.D.N.Y. Sept. 20, 2013).
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` Both of those cases refer to a court’s obligation to resolve disputes in claim
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`construction. See PPC Broadband, 2014 WL 4199244, at *2 (noting that
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`court is obligated to resolve dispute in claim scope to prevent parties from
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`impermissibly arguing claim construction to jury); Defenshield,
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`2013 WL 5323752, at *8-9 (deciding to construe claim despite potential for
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`common meaning to prevent submitting claim construction question to jury).
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` But the purpose for that obligation lies in making sure that the jury isn’t
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`tasked with trying to sort out the definition of a claim when that should be up
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`to the Court. See Sulzer Textil A.G. v. Picanol N.V., 358 F.3d 1356, 1359
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`(Fed. Cir. 2004) (explaining that it is duty of trial court to inform jurors of
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`claim construction rulings on disputed terms); see also O2 Micro Int’l Ltd. v.
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 19 of 43
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`Beyond Innovation Tech. Co., Ltd., 521 F.3d 1351, 1360 (Fed. Cir. 2008)
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`(“When the parties raise an actual dispute regarding the proper scope of [ ]
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`claims, the court, not the jury, must resolve that dispute.”).
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` There is no danger of that in this case because the Court is construing the
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`claim Regeneron argues to be disputed. In fact, the Court is construing it in
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`precisely the manner that Regeneron requested. The jury will thus be
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`instructed on the ’631 Patent’s claims in accordance with Regeneron’s
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`proposed construction, and the Court need not—and will not—devise its own
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`construction beyond what Regeneron requested. See, e.g., Holmberg,
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`124 Fed. Cl. at 613. The Court thus adopts the proposed claim construction
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`in its entirety and will not require a Markman hearing.
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`B. Novartis’s Motion to Dismiss
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` Having settled the matter of claim construction, the Court turns to
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`Novartis and Vetter’s Rule 12(b)(6) motions to dismiss the Antitrust case. To
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`survive a motion to dismiss under that Rule, “a complaint must contain
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`sufficient factual matter, accepted as true, to state a claim to relief that is
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`plausible on its face.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). That
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`factual matter may be drawn from “the facts alleged in the complaint,
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`documents attached to the complaint as exhibits, and documents
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`incorporated by reference in the complaint.” DiFolco v. MSNBC Cable L.L.C.,
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`622 F.3d 104, 111 (2d Cir. 2010).
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 20 of 43
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`Importantly, “the complaint is to be construed liberally, and all reasonable
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`inferences must be drawn in the plaintiff’s favor.” Ginsburg v. City of Ithaca,
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`839 F. Supp. 2d 537, 540 (N.D.N.Y. 2012) (citing Chambers v. Time Warner,
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`Inc., 282 F.3d 147, 152 (2d Cir. 2002)). If the complaint and its additional
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`materials—when viewed through that pro-plaintiff lens—are not enough to
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`raise the plaintiff’s right to relief on a claim above the speculative level, that
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`claim must be dismissed. See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555
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`(2007).
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`1. Antitrust Claims
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`
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`“A patentee has the exclusive right to manufacture, use, and sell his
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`invention.” In re DDAVP Direct Purchaser Antitrust Litig., 585 F.3d 677, 690
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`(2d Cir. 2009) (citing Zenith Radio Corp. v. Hazeltine Rsch., Inc.,
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`395 U.S. 100, 135 (1969)). The purpose behind granting a patent is to
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`incentivize “invention, investment, and disclosure” by granting a “statutory
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`right to exclude” other competitors. Abbott Labs. v. Brennan, 952 F.2d 1346,
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`1355 (Fed. Cir. 1991). By a patent’s very nature, then, “[t]he commercial
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`advantage gained by new technology and its statutory protection by patent do
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`not convert the possessor thereof into a prohibited monopolist.” Id. at 1354.
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`None of that is meant to say that a patent automatically forecloses
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`liability for antitrust violations. Instead, there are at least two ways that a
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`patent holder can run afoul of antitrust law. For the first, “[i]n Walker
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 21 of 43
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`Process, the Supreme Court held that a plaintiff could bring an action under
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`§ 2 of the Sherman Act based on the alleged maintenance and enforcement of
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`a fraudulently[ ] obtained patent.” TransWeb, LLC v. 3M Innovative Props.
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`Co., 812 F.3d 1295, 1306 (Fed. Cir. 2016) (citing Walker Process, 382 U.S. at
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`173-74).
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`The gist of a Walker Process claim is that an unlawful patent should be
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`stripped of its usual immunity from antitrust liability. See Nobelpharma AB
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`v. Implant Innovations, Inc., 141 F.3d 1059, 1068 (Fed. Cir. 1998). Whether a
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`patentholder deserves to lose out on its monopolistic immunity is a question
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`to be answered only under Federal Circuit law. See id. However, questions
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`of antitrust law beyond the alleged patent fraud are decided under the law of
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`each regional circuit. Id.
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`There are two global elements to a Walker Process claim: (1) “that the
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`antitrust-defendant obtained the patent by knowing and willful fraud on the
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`patent office and maintained and enforced the patent with knowledge of the
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`fraudulent procurement;” and (2) all other elements of a Sherman Act
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`monopolization claim are also met. TransWeb, 812 F.3d at 1306.
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`For an attempted monopolization claim under § 2 of the Sherman Act, like
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`those that Regeneron brings against Novartis, the elements are: (1) predatory
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`or anticompetitive conduct; (2) informed by a specific intent to monopolize;
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`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 22 of 43
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`with (3) “a dangerous probability of achieving monopoly power.” New York ex
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`rel. Schneiderman v. Actavis PLC, 787 F.3d 638, 651 (2d Cir. 2015).
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`As for the second means of establishing an antitrust violation even with
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`patent protections in play, the Supreme Court held in Federal Trade
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`Commission v. Actavis, Inc. that a patentholder may, in certain
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`circumstances, be held liable for using the patent to unreasonably restrain
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`trade. 570 U.S. 136, 147 (2013).
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`In any case, though, one essential element of all antitrust claims is the
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`existence of a relevant geographic and product market subjected to the
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`defendant’s anticompe