throbber
Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 1 of 43
`
`
`
`
`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF NEW YORK
`- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
`NOVARTIS PHARMA AG; NOVARTIS
`PHARMACEUTICALS CORPORATION;
`and NOVARTIS TECHNOLOGY LLC,
`
` Plaintiffs,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`-v-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`REGENERON PHARMACEUTICALS,
`INC.,
`
` Defendant,
`
`
`
`
`
`
`
`
`- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1:20-CV-690
`REGENERON PHARMACEUTICALS,
` ’631 Patent case
`INC.,
`
` Counter Claimant,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`-v-
`
`
`
`
`
`
`
`
`
`
`
`NOVARTIS PHARMA AG; NOVARTIS
`PHARMACEUTICALS CORPORATION;
`and NOVARTIS TECHNOLOGY LLC,
`
` Counter Defendants,
`
`
`
`
`
`
`- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
`REGENERON PHARMACEUTICALS,
`INC.,
` Plaintiff,
`
`
`
`
`
`
`
`
` 1:21-CV-1066
`
`
`
`
`
`
`
`
`
`
`
`-v-
` Antitrust case
`
`
`
`
`
`
`
`
`
`
`
`
`
`NOVARTIS PHARMA AG; NOVARTIS
`TECHNOLOGY LLC; NOVARTIS
`PHARMACEUTICALS CORPORATION;
`and VETTER PHARMA
`INTERNATIONAL GMBH,
`
` Defendants.
`
`
`
`
`
`
`
`
`- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
`
`
`
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 2 of 43
`
`
`
`
`
`
`
`
`
`
`
`
`
` OF COUNSEL:
`
`APPEARANCES:
`
`BOND SCHOENECK & KING, PLLC GEORGE R. McGUIRE, ESQ.
` SYRACUSE
`
`
`
`
`
`
`
` 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
`
`
`
`
` Pharmaceuticals, Inc.
`
`
`
`
`767 Fifth Avenue
`
`
`
`
`
`
`New York, New York 10153
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` CALVIN E. WINGFIELD, ESQ.
`
`
`
`
` MOLLY GRAMMEL, ESQ.
`
` ANISH R. DESAI, ESQ.
` ELIZABETH WEISWASSER, ESQ.
` ERIC SHAUN HOCHSTADT,
`
` ESQ.
` JESSICA L. FALK, ESQ.
` JOHN REN, ESQ.
`
`
`
`2
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 3 of 43
`
` CHRISTOPHER PEPE, ESQ.
` MATTHEW SIEGER, ESQ.
` ROBERT T. VLASIS, III, ESQ.
`
`BARCLAY DAMON LLP-SYRACUSE DOUGLAS J. NASH, ESQ.
`Attorneys for Regeneron
`
`
`
`
` JOHN D. COOK, ESQ.
` Pharmaceuticals, Inc.
`Barclay Damon Tower
`125 East Jefferson Street
`Syracuse, New York 13202
`
`WEIL GOTSHAL & MANGES LLP
`Attorneys for Regeneron
`
`
`
`
` Pharmaceuticals, Inc.
`
`
`
`
`2001 M Street, Northwest-Suite 600
`Washington, DC 20036
`
`HESLIN, ROTHENBERG LAW FIRM SUSAN E. FARLEY, ESQ.
`Attorneys for Vetter Pharma
`
`
` TEIGE P. SHEEHAN, ESQ.
`
`International GMBH
`5 Columbia Circle
`Albany, New York 12203
`
`MARSHALL, GERSTEIN &
` BORUN, LLP
`
`
`
`
`Attorneys for Vetter Pharma
`
`International GMBH
`6300 Willis Tower
`233 S. Wacker Drive
`Chicago, Illinois 60606
`
`
`
`
`
`
`DAVID N. HURD
`United States District Judge
`
`
`
`
`
`
`
`
` BENJAMIN T. HORTON, ESQ.
` JULIANNE M. HARTZELL, ESQ.
`
`MEMORANDUM-DECISION and ORDER
`
` INTRODUCTION
`
` On June 19, 2020, pharmaceutical companies Novartis Pharma AG,
`
`Novartis Pharmaceuticals Corporation, and Novartis Technology LLC
`
`(together “Novartis”) filed a complaint (the “’631 Patent case”) in this district
`
`alleging patent infringement against rival Regeneron Pharmaceuticals, Inc.
`
`
`
`3
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 4 of 43
`
`(“Regeneron”). Essentially, Novartis claims that it has a valid patent for
`
`syringes which come pre-filled with a certain medication used to treat
`
`degenerative eye disease. By extension, Novartis takes issue with
`
`Regeneron’s introduction of a competing prefilled syringe—designed to treat
`
`the same disease—into the market notwithstanding its patent.
`
` On July 17, 2020, Regeneron fired back with a complaint of its own,
`
`alleging four antitrust claims and an additional claim for tortious
`
`interference with a contract (the “Antitrust case”). In addition to Novartis,
`
`Regeneron also directed some of these claims at Vetter Pharma International
`
`GMHB, a pharmaceutical supply chain provider whose niche in the medical
`
`marketplace includes filling Novartis’s—and formerly Regeneron’s—syringes.
`
` According to Regeneron, Vetter and Novartis conspired together to
`
`circumvent a binding contract giving Regeneron an ownership interest in any
`
`of Vetter’s innovations. At the same time, Regeneron claims that Vetter and
`
`Novartis defrauded the Patent and Trademark Office (“PTO”) to secure for
`
`Novartis a stranglehold on the market for prefilled syringes designed to treat
`
`degenerative eye disease.
`
` There are three separate pending motions in these two cases. First, in the
`
`’631 Patent case, Novartis and Regeneron have submitted their opening
`
`claim construction briefs in advance of a potential hearing as contemplated
`
`by Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996). Second, in
`
`
`
`4
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 5 of 43
`
`the Antitrust case, Novartis and Vetter have both moved to dismiss
`
`Regeneron’s complaint against them in its entirety under Federal Rule of
`
`Civil Procedure (“Rule”) 12(b)(6). And third, in both cases, Regeneron has
`
`moved for a stay in proceedings while the PTO conducts an inter partes
`
`review of the validity of Novartis’s patent. All three motions, having been
`
`fully briefed, will now be decided on the submissions and without oral
`
`argument.
`
` BACKGROUND
`
` At their core, these two cases are about three different drugs: EYLEA,
`
`made by Regeneron, and LUCENTIS and BEOVU, both made by Novartis.1
`
`Regeneron Pharms., Inc. v. Novartis Pharma AG, 1:21-CV-1066, Dkt. 87
`
`(“Antitrust Compl.”), ¶ 5. All three drugs are designed to inhibit the body’s
`
`production of vascular endothelial growth factor (“VEGF”), a naturally
`
`occurring protein that erodes vision if overproduced, and in particularly
`
`extreme cases can cause blindness. Id. ¶¶ 5-6.
`
` EYLEA, LUCENTIS, and BEOVU each need to be injected directly into
`
`the eye regularly to do their job as “anti-VEGF” agents. Antitrust
`
`Compl. ¶ 6. Traditionally, like most injectable liquids, EYLEA, LUCENTIS,
`
`
`1 For the purposes of Novartis and Vetter’s motions to dismiss under Rule 12(b)(6), the Court
`
`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.
`
`
`
`5
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 6 of 43
`
`and BEOVU were transported in vials. Id. The physician would then have to
`
`pierce the vial with a syringe, draw some of the drug out, and inject it into
`
`the patient’s eye. Id.
`
`A. Developing the Prefilled Syringe
`
` According to Regeneron, though, it came up with a better idea. Regeneron
`
`claims that in 2005, it and Vetter began working together to develop a
`
`prefilled syringe (“PFS”) that contained EYLEA. Antitrust Compl. ¶¶ 2, 152.
`
`The theory went that a prefilled syringe would remove the intermediate step
`
`of drawing out the drug, reducing the risk of contamination and making the
`
`process safer. Id. ¶¶ 76-81. As part of their collaboration, Vetter helped
`
`Regeneron by filling its syringes during the testing phase for the EYLEA
`
`PFS. Id. ¶ 152.
`
`
`
`In addition to filling the EYLEA PFS systems, though, Regeneron alleges
`
`that it and Vetter also worked together to develop and commercialize the
`
`EYLEA PFS. Antitrust Compl. ¶ 152. That collaboration was carried out
`
`under an agreement styled the EYLEA PFS Development Agreement (the
`
`“Development Agreement”). Id.
`
` According to Regeneron, by the terms of the Development Agreement,
`
`Regeneron could claim ownership rights to “any inventions, improvements,
`
`enhancements, or alike made during the Term [of the agreement] and
`
`conceived or reduced to practice or generated by Regeneron and/or Vetter”
`
`
`
`6
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 7 of 43
`
`relating to an anti-VEGF delivered to Vetter by Regeneron. Antitrust Compl.
`
`¶ 153. The Development Agreement apparently bore fruit, because the
`
`Australian government approved EYLEA FPS in 2012. Id. ¶ 154.
`
`
`
`In the meantime, Regeneron alleges that Novartis and Vetter were also
`
`working together to produce a PFS. Antitrust Compl. ¶ 155. That
`
`collaboration was similarly successful, and Novartis and Vetter eventually
`
`produced LUCENTIS PFS. Id. ¶ 141. According to Regeneron, several
`
`Vetter employees made “significant contributions” along the way. Id.
`
`Regeneron further alleges that those significant contributions involved the
`
`same anti-VEGF drug from which EYLEA is made. Id. ¶ 143.
`
` But Novartis and Vetter’s joint efforts did not go off entirely without a
`
`hitch. Apparently, on February 27, 2013, Vetter sent Novartis a letter
`
`objecting to certain patent applications that Novartis had filed in Germany
`
`and Australia. Antitrust Compl. ¶ 142. At bottom, Vetter objected that
`
`Novartis claimed credit for inventions and improvements allegedly made by
`
`Vetter personnel. Id.
`
` Novartis and Vetter met to discuss the matter, and apparently came to a
`
`final agreement signed by both parties by October 2, 2013 (the “2013
`
`Amendment”). Antitrust Compl. ¶¶ 145-46. By the terms of that agreement,
`
`Novartis agreed that Vetter significantly contributed to developing its PFS
`
`patent family. Id. ¶ 146. It must be said, though, that the 2013 Amendment
`
`
`
`7
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 8 of 43
`
`specifically excludes crediting Vetter with contributing to “any [i]nvention.”
`
`Id.
`
` On January 25, 2013, Novartis filed a patent for the LUCENTIS PFS (“the
`
`’631 Patent”). Antitrust Compl. ¶ 143. The ’631 Patent relates back to
`
`Novartis’s German patent, and apparently claims the same subject matter.
`
`Id. ¶ 144. What Regeneron claims the ’631 Patent does not do, however, is
`
`credit any Vetter employee as an inventor. Id. ¶ 147. To the extent any of
`
`them qualify, that poses a problem, because 35 U.S.C. § 116 requires that all
`
`inventors jointly file for a patent, unless a joint inventor refuses to join in the
`
`patent application or cannot be found.
`
` The PTO issued the ’631 Patent on December 29, 2015. Antitrust
`
`Compl. ¶ 147. Apparently, Novartis only planned on marketing LUCENTIS
`
`PFS outside the United States. See Id. ¶ 53. For the purposes of serving the
`
`United States (“U.S.”) market, Novartis licensed the patent for the
`
`LUCENTIS PFS to a separate company, Genentech, Inc. (“Genentech”). Id.
`
`¶¶ 53-54. Genentech then launched LUCENTIS PFS in the U.S. in early
`
`2017. Id. ¶ 84. According to Regeneron, Novartis has a 33.3% ownership
`
`stake in Genentech’s parent company, Roche. Id. And in any case, when
`
`BEOVU PFS—another anti-VEGF—is launched, Novartis appears to intend
`
`to market it in the U.S. Id. ¶ 2.
`
`
`
`8
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 9 of 43
`
` Summing up, according to Regeneron, Novartis got the jump on its efforts
`
`to market an anti-VEGF PFS. But in doing so, Novartis allegedly recruited
`
`Vetter’s help. Regeneron claims that Novartis’s overture towards Vetter
`
`violates its rights because any ideas by Vetter relating to EYLEA PSF were
`
`contractually Regeneron’s property.
`
`
`
` And because one of the drugs used in developing the LUCENTA PSF was
`
`functionally identical to EYLEA, Regeneron claims that Vetter’s
`
`contributions to that patent qualified as relating to EYLEA PSF. From
`
`Regeneron’s perspective, Novartis’s exclusion of Vetter’s assistance from the
`
`patent application was a calculated move to prevent the ’631 Patent from
`
`becoming Regeneron’s property by virtue of the Development Agreement.
`
`Antitrust Compl. ¶¶ 147-48.
`
`B. Regeneron’s Negotiations with Vetter
`
`
`
`In the meantime, Regeneron claims that its experiences with Vetter took a
`
`sharp and downward turn once the 2013 Amendment was signed. According
`
`to Regeneron, in October 2013, the same month the agreement had taken
`
`effect, Vetter sent a sublicense demand to Regeneron. Antitrust
`
`Compl. ¶ 166. The letter claimed that the EYLEA PFS would be covered
`
`under Novartis’s then-pending ’631 Patent. Id. By extension, if Regeneron
`
`wanted to continue to try to market EYLEA PFS, it would have to agree to
`
`take out a sublicense from Vetter first. Id.
`
`
`
`9
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 10 of 43
`
` However, Vetter would only agree to offer a sublicense if Regeneron
`
`agreed to use Vetter exclusively to fill its EYLEA PFS products for the
`
`duration of the ’631 Patent, a term of nearly twenty years. Antitrust Compl.
`
`¶ 167. In addition, Vetter’s proposed agreement required that Regeneron
`
`promise never to challenge the validity of the ’631 Patent. Id. ¶ 170.
`
` Previously, Vetter had filled EYLEA vials without any exclusivity
`
`requirement, so Regeneron claims that it was wary of the sudden pivot.
`
`Antitrust Compl. ¶ 167. On top of that, the lengthy duration of the
`
`exclusivity clause gave Regeneron pause. Id. Finally, Regeneron claims that
`
`it felt that Vetter and Novartis’s agreement and general relationship with
`
`each other raised concerns on Regeneron’s part that Vetter would prioritize
`
`Novartis’s interests over its own. Id. ¶ 168.
`
` For these reasons and more, Regeneron refused to sign the agreement.
`
`Antitrust Compl. ¶ 174. As a result, Vetter stopped filling EYLEA PFS. Id.
`
`¶ 175. Regeneron then found a new supplier but claims that doing so required
`
`some alterations to EYLEA PFS’s design and took a substantial toll on its
`
`time and resources. Id.
`
`
`
`In 2017, Regeneron claims that it approached Vetter again to discuss
`
`working together. Antitrust Compl. ¶ 176. Vetter responded with the same
`
`offer it had extended in 2013. Id. Regeneron once again refused. Id.
`
`
`
`
`
`10
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 11 of 43
`
`C. Novartis’s Patent Suit
`
` Despite the ’631 Patent, Regeneron released EYLEA PFS sometime
`
`around December of 2019. Novartis Pharma AG v. Regeneron Pharms., Inc.,
`
`1:20-CV-690, Dkt. 70 (“Patent Compl.”), ¶ 29.2 From Novartis’s perspective,
`
`that amounts to infringement, because the ’631 Patent gives Novartis the
`
`exclusive right to market prefilled, sterilized syringes containing an
`
`anti-VEGF solution. Id. ¶ 15. And according to Novartis, the EYLEA PFS is
`
`precisely that. Id. ¶¶ 20-28 (describing attributes of EYLEA PFS that
`
`allegedly fall under terms of ’631 Patent).
`
` But based on Regeneron’s version of events, there were some internal
`
`hoops Novartis needed to jump through before it could bring the infringement
`
`suit. Antitrust Compl. ¶ 186. Apparently, the 2013 Amendment contained a
`
`clause which gave Vetter the exclusive right to sublicense the ’631 Patent.
`
`Id. ¶ 156. But on December 18, 2019—around the same time EYLEA PFS
`
`was hitting the market—the 2013 Amendment was itself amended (the “2019
`
`Amendment”). Id. ¶ 186. By the terms of the new agreement, Novartis was
`
`given sole enforcement authority concerning the ’631 Patent in exchange for a
`
`cut of all license income. Id.
`
`
`2 The Court refers to the complaint in the ’631 Patent case solely to provide context to the
`
`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
`
`
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 12 of 43
`
` On June 19, 2020, after the 2019 Amendment took effect, Novartis sued
`
`Regeneron for infringing the ’631 Patent by marketing EYLEA PFS.
`
`Novartis, 1:20-CV-690, Dkt. 1. At the same time, Novartis filed a complaint
`
`with the United States International Trade Commission (“ITC”) claiming
`
`infringement of the same patent. Novartis, 1:20-CV-690, Dkt. 27, p. 1.3
`
` On July 28, 2020, Regeneron moved to stay Novartis’s claim before this
`
`Court pending resolution of the ITC complaint. Novartis, 1:20-CV-690,
`
`Dkt. 27, p. 1. Novartis did not oppose, and the stay was granted on July 30,
`
`2020. Id.
`
` On April 8, 2021, Novartis voluntarily withdrew its ITC complaint to focus
`
`its efforts on this case. Novartis, 1:20-CV-690, Dkt. 38-1, pp. 3-6. The stay
`
`was then lifted on June 11, 2021. Novartis, 1:20-CV-690, Text Minute Entry
`
`Dated 6/11/2021.
`
`D. Regeneron’s Antitrust Suit
`
` Regeneron was not sitting idle while Novartis’s patent claim proceeded.
`
`On July 17, 2020, Regeneron filed the antitrust claim against both Novartis
`
`and Vetter. Regeneron, 1:21-CV-1066, Dkt. 1. Essentially, that complaint
`
`alleges that Novartis and Vetter conspired together to freeze Regeneron out
`
`of the market for anti-VEGF PFS products by forcing it into a long-term
`
`
`3 Pagination corresponds with CM/ECF.
`
`12
`
`
`
`
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 13 of 43
`
`contract with Vetter and requiring it to respect the ’631 Patent. See generally
`
`id., passim. To make matters worse, Regeneron sees itself as the rightful
`
`owner of the ’631 Patent based on the Development Agreement and accuses
`
`Novartis of arranging for Vetter’s breach of that contract. In addition,
`
`Regeneron accuses Novartis of intentionally omitting information material to
`
`the ’631 Patent relating to a prior art. Antitrust Compl. ¶¶ 219-22.
`
` More specifically, Regeneron’s complaint asserts five causes of action:
`
`(I) attempted monopolization through a scheme of patent fraud under Walker
`
`Process Equipment, Inc. v. Food Machinery & Chemical Corp., 382 U.S. 172
`
`(1965) for omitting prior arts in violation of § 2 of the Sherman Act;
`
`(II) attempted monopolization in violation of § 2 of the Sherman Act even
`
`without Walker Process fraud; (III) unreasonable restraint on trade in
`
`violation of § 1 of the Sherman Act; (IV) attempted monopolization through
`
`Walker Process fraud for omitting the contributions of Vetter inventors in
`
`violation of § 2 of the Sherman Act; and (V) tortious interference with a
`
`contract under New York state law.4 Regeneron brings Count III against
`
`both Novartis and Vetter. For the remainder, Novartis alone is accused of
`
`wrongdoing.
`
`E. The Present Motion Practice
`
`
`4 The parties do not dispute that Regeneron’s tortious interference claim comes under New York
`
`law.
`
`
`
`13
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 14 of 43
`
` Once the stays were lifted at the conclusion of the ITC proceedings, both
`
`cases continued. On October 15, 2021, Novartis and Vetter each moved to
`
`dismiss Regeneron’s First Amended Complaint—the current operative
`
`pleading in the Antitrust case—for failure to state a claim. Regeneron,
`
`1:21-CV-1066, Dkts. 184; 186.
`
` But on November 5, 2021, Regeneron moved to stay both the ’631 Patent
`
`case and the Antitrust case. Novartis, 1:20-CV-690, Dkt. 98; Regeneron,
`
`1:21-CV-1066, Dkt. 216. Apparently, on April 16, 2021, while the ITC
`
`complaint was still pending, Regeneron had asked the PTO for an inter partes
`
`review to declare the ’631 Patent invalid. Novartis, 1:20-CV-690, Dkt. 98-4,
`
`p. 85; Regeneron, 1:21-CV-1066 Dkt. 216-4, p. 85. On October 26, 2021, the
`
`PTO agreed. Novartis, 1:20-CV-690, Dkt. 98-3, p. 1; Regeneron, 1:21-CV-1066
`
`Dkt. 216-3, p. 1. Thus, Regeneron argues that both cases should be stayed
`
`until the PTO has an opportunity to determine whether the ’631 Patent is
`
`valid.
`
` Finally, on December 23, 2021, Novartis and Regeneron both filed their
`
`Markman briefs in the ’631 Patent case. Novartis, 1:20-CV-690, Dkts. 103;
`
`104. This decision now follows to resolve all three pending motions.
`
` DISCUSSION
`
` The first step in untangling the knot these cases have worked themselves
`
`into is deciding which thread to pull on first. To that end, the only dispute
`
`
`
`14
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 15 of 43
`
`concerning the ’631 Patent’s claim construction is whether there is actually a
`
`dispute in the first place. There is little harm in reaching that simple
`
`question first before considering a stay that would leave that dispute
`
`unaddressed. After that, should Novartis and Vetter’s motions to dismiss
`
`have merit, the Antitrust case could be dismissed in its entirety, which would
`
`obviously moot the question of staying that case. Accordingly, the Court will
`
`turn to the motion to dismiss second, and only reach the motion to stay after
`
`considering both other active motions.
`
`A. Claim Construction
`
`“Claim construction is a question of law, the purpose of which is to
`
`determine what is covered by the patent’s claims.” Verint Sys. Inc. v. Red Box
`
`Recorders Ltd., 166 F. Supp. 3d 364, 374 (S.D.N.Y. 2016) (citing Markman,
`
`517 U.S. at 384. That process is geared toward “elaborating the normally
`
`terse claim language in order to understand and explain, but not to change,
`
`the scope of the claims.” Verint Sys., 166 F. Supp. 3d at 374 (cleaned up)
`
`(citing Embrex, Inc. v. Serv. Eng’g Corp., 216 F.3d 1343, 1347
`
`(Fed. Cir. 2000)).
`
`“When faced with ‘an actual dispute regarding the proper scope’ of a
`
`patent claim, the court must construe the allegedly infringed claim to
`
`determine its meaning and scope.” PPC Broadband, Inc. v. Corning Optical
`
`Commc’ns RF, LLC, 2014 WL 4199244, at *2 (N.D.N.Y. Aug. 21, 2014). But
`
`
`
`15
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 16 of 43
`
`the converse is also true: “a trial court need not construe claim terms whose
`
`meaning the parties do not dispute.” Holmberg v. United States,
`
`124 Fed. Cl. 610, 613 (2016).
`
`At any rate, although a court “may have the authority to adopt claim
`
`constructions which have not been proposed by either party[, it] should be
`
`hesitant to do so.” Holmberg, 124 Fed. Cl. at 613 (citing Yoon Ja Kim v.
`
`ConAgra Foods, Inc., 465 F.3d 1312, 1319 (Fed. Cir. 2006)).
`
` As required under Local Patent Rule for the Northern District of New
`
`York (“Local Patent Rule”) 4.4, both Regeneron and Novartis submitted a
`
`joint claim construction setting out their agreed definitions of the terms of
`
`the ’631 Patent.5 Novartis, 1:20-CV-690, Dkt. 100. In that document,
`
`Novartis agreed with Regeneron’s construction of all terms. See generally id.,
`
`passim.
`
` But Novartis’s apparent consent does not, it seems, resolve the issue of
`
`claim construction on its own. According to Regeneron, Novartis intends to
`
`sandbag it and the Court by making arguments at trial contrary to the terms
`
`upon which the parties agreed. Specifically, Regeneron claims that Novartis
`
`
`5 Both parties would also file short responsive claim construction briefs on January 24, 2022.
`
`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.
`16
`
`
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 17 of 43
`
`has not disavowed an intent to argue that a syringe is “terminally sterilized”
`
`only if it has been: (1) subjected to stability testing; and (2) protected from
`
`further contact after the sterilizing agent has been applied and stability
`
`testing conducted.
`
` The problem, it seems, is that the proposed construction of “terminally
`
`sterilized” makes no mention of those two additional requirements. In
`
`Regeneron’s opinion, the only solution is for the Court to take the further step
`
`of precluding Novartis from arguing that anything more is required for a
`
`syringe to be “terminally sterilized” than what is described in the proposed
`
`claim construction.
`
` Regeneron is mistaken. After all, if the proposed construction would
`
`foreclose Novartis’s argument, then the Court’s adoption of that construction
`
`would give Regeneron the relief it is requesting without further tampering.
`
`On the other hand, the Court can think of only two possible reasons that
`
`adopting the proposed claim would not foreclose that line of argument.
`
` First, it may be that the construction of the claim has nothing to do with
`
`Novartis’s argument, in which case it would be an overreach for the Court to
`
`hamstring Novartis at the claim construction stage. Or second, it may be
`
`that Regeneron could have requested a more favorable construction of the
`
`claim and failed to do so. In that case, Regeneron is asking the Court to take
`
`the disfavored step of adopting a construction without a proposal simply to
`
`
`
`17
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 18 of 43
`
`cover for its own tactical misstep. Holmberg, 124 Fed. Cl. at 613 (holding
`
`that courts should be hesitant to adopt claim constructions not proposed by
`
`parties). Under none of those circumstances would the Court be moved to
`
`produce its own more restrictive version of the proposed claim construction as
`
`Regeneron requests.
`
` Neither is the Court persuaded by Regeneron’s argument that the Court is
`
`obliged to go looking for disputes that do not appear on the face of the
`
`Markman briefing. In support of that argument, Regeneron relies on PPC
`
`Broadband, 2014 WL 4199244 and Defenshield, Inc. v. First Choice Armor &
`
`Equipment, Inc., 2013 WL 5323752 (N.D.N.Y. Sept. 20, 2013).
`
` Both of those cases refer to a court’s obligation to resolve disputes in claim
`
`construction. See PPC Broadband, 2014 WL 4199244, at *2 (noting that
`
`court is obligated to resolve dispute in claim scope to prevent parties from
`
`impermissibly arguing claim construction to jury); Defenshield,
`
`2013 WL 5323752, at *8-9 (deciding to construe claim despite potential for
`
`common meaning to prevent submitting claim construction question to jury).
`
` But the purpose for that obligation lies in making sure that the jury isn’t
`
`tasked with trying to sort out the definition of a claim when that should be up
`
`to the Court. See Sulzer Textil A.G. v. Picanol N.V., 358 F.3d 1356, 1359
`
`(Fed. Cir. 2004) (explaining that it is duty of trial court to inform jurors of
`
`claim construction rulings on disputed terms); see also O2 Micro Int’l Ltd. v.
`
`
`
`18
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 19 of 43
`
`Beyond Innovation Tech. Co., Ltd., 521 F.3d 1351, 1360 (Fed. Cir. 2008)
`
`(“When the parties raise an actual dispute regarding the proper scope of [ ]
`
`claims, the court, not the jury, must resolve that dispute.”).
`
` There is no danger of that in this case because the Court is construing the
`
`claim Regeneron argues to be disputed. In fact, the Court is construing it in
`
`precisely the manner that Regeneron requested. The jury will thus be
`
`instructed on the ’631 Patent’s claims in accordance with Regeneron’s
`
`proposed construction, and the Court need not—and will not—devise its own
`
`construction beyond what Regeneron requested. See, e.g., Holmberg,
`
`124 Fed. Cl. at 613. The Court thus adopts the proposed claim construction
`
`in its entirety and will not require a Markman hearing.
`
`B. Novartis’s Motion to Dismiss
`
` Having settled the matter of claim construction, the Court turns to
`
`Novartis and Vetter’s Rule 12(b)(6) motions to dismiss the Antitrust case. To
`
`survive a motion to dismiss under that Rule, “a complaint must contain
`
`sufficient factual matter, accepted as true, to state a claim to relief that is
`
`plausible on its face.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). That
`
`factual matter may be drawn from “the facts alleged in the complaint,
`
`documents attached to the complaint as exhibits, and documents
`
`incorporated by reference in the complaint.” DiFolco v. MSNBC Cable L.L.C.,
`
`622 F.3d 104, 111 (2d Cir. 2010).
`
`
`
`19
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 20 of 43
`
`
`
`Importantly, “the complaint is to be construed liberally, and all reasonable
`
`inferences must be drawn in the plaintiff’s favor.” Ginsburg v. City of Ithaca,
`
`839 F. Supp. 2d 537, 540 (N.D.N.Y. 2012) (citing Chambers v. Time Warner,
`
`Inc., 282 F.3d 147, 152 (2d Cir. 2002)). If the complaint and its additional
`
`materials—when viewed through that pro-plaintiff lens—are not enough to
`
`raise the plaintiff’s right to relief on a claim above the speculative level, that
`
`claim must be dismissed. See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555
`
`(2007).
`
`1. Antitrust Claims
`
`
`
`“A patentee has the exclusive right to manufacture, use, and sell his
`
`invention.” In re DDAVP Direct Purchaser Antitrust Litig., 585 F.3d 677, 690
`
`(2d Cir. 2009) (citing Zenith Radio Corp. v. Hazeltine Rsch., Inc.,
`
`395 U.S. 100, 135 (1969)). The purpose behind granting a patent is to
`
`incentivize “invention, investment, and disclosure” by granting a “statutory
`
`right to exclude” other competitors. Abbott Labs. v. Brennan, 952 F.2d 1346,
`
`1355 (Fed. Cir. 1991). By a patent’s very nature, then, “[t]he commercial
`
`advantage gained by new technology and its statutory protection by patent do
`
`not convert the possessor thereof into a prohibited monopolist.” Id. at 1354.
`
`None of that is meant to say that a patent automatically forecloses
`
`liability for antitrust violations. Instead, there are at least two ways that a
`
`patent holder can run afoul of antitrust law. For the first, “[i]n Walker
`
`
`
`20
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 21 of 43
`
`Process, the Supreme Court held that a plaintiff could bring an action under
`
`§ 2 of the Sherman Act based on the alleged maintenance and enforcement of
`
`a fraudulently[ ] obtained patent.” TransWeb, LLC v. 3M Innovative Props.
`
`Co., 812 F.3d 1295, 1306 (Fed. Cir. 2016) (citing Walker Process, 382 U.S. at
`
`173-74).
`
`The gist of a Walker Process claim is that an unlawful patent should be
`
`stripped of its usual immunity from antitrust liability. See Nobelpharma AB
`
`v. Implant Innovations, Inc., 141 F.3d 1059, 1068 (Fed. Cir. 1998). Whether a
`
`patentholder deserves to lose out on its monopolistic immunity is a question
`
`to be answered only under Federal Circuit law. See id. However, questions
`
`of antitrust law beyond the alleged patent fraud are decided under the law of
`
`each regional circuit. Id.
`
`There are two global elements to a Walker Process claim: (1) “that the
`
`antitrust-defendant obtained the patent by knowing and willful fraud on the
`
`patent office and maintained and enforced the patent with knowledge of the
`
`fraudulent procurement;” and (2) all other elements of a Sherman Act
`
`monopolization claim are also met. TransWeb, 812 F.3d at 1306.
`
`For an attempted monopolization claim under § 2 of the Sherman Act, like
`
`those that Regeneron brings against Novartis, the elements are: (1) predatory
`
`or anticompetitive conduct; (2) informed by a specific intent to monopolize;
`
`
`
`21
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 112 Filed 01/31/22 Page 22 of 43
`
`with (3) “a dangerous probability of achieving monopoly power.” New York ex
`
`rel. Schneiderman v. Actavis PLC, 787 F.3d 638, 651 (2d Cir. 2015).
`
`As for the second means of establishing an antitrust violation even with
`
`patent protections in play, the Supreme Court held in Federal Trade
`
`Commission v. Actavis, Inc. that a patentholder may, in certain
`
`circumstances, be held liable for using the patent to unreasonably restrain
`
`trade. 570 U.S. 136, 147 (2013).
`
`
`
`In any case, though, one essential element of all antitrust claims is the
`
`existence of a relevant geographic and product market subjected to the
`
`defendant’s anticompe

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket