Case 1:20-cv-05502-AJN Document 109 Filed 04/07/21 Page 1 of 4
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`O’Melveny & Myers LLP
`1625 Eye Street, NW
`Washington, DC 20006-4061
`
`T: +1 202 383 5300
`F: +1 202 383 5414
`omm.com
`
`VIA ECF
`
`April 7, 2021
`
`Hon. Alison J. Nathan
`United States District Court
`Southern District of New York
`40 Foley Square, Room 2102
`New York, NY 10007
`
`Ian Simmons
`D: +1 202 383 5106
`isimmons@omm.com
`
`Re: Regeneron Pharmaceuticals, Inc. v. Novartis Pharma
`AG, et al., Case No. 1:20-cv-05502-AJN (S.D.N.Y.)
`
`Dear Judge Nathan:
`
`Pursuant to Your Honor’s Individual Rule of Practice
`1.A., Defendants Novartis Pharma AG, Novartis Technology
`LLC, and Novartis Pharmaceuticals Corporation (“Novartis”)
`respectfully advise the Court that tomorrow Novartis will
`file in the related proceeding before the International
`Trade Commission (“ITC”) - Certain Pre-Filled Syringes for
`Intravitreal Injection and Components Thereof, USITC No.
`337-TA-1207 (I.T.C. June 19, 2020) (“ITC Action”) - the
`Complainants’ Unopposed Motion to Terminate The
`Investigation in Its Entirety Based on Withdrawal Of
`Complaint And To Stay The Procedural Schedule And Request
`For Expedited Treatment (“Motion”).
`
`Yesterday, Novartis informed the ITC’s Office of Unfair
`Import Investigations (“OUII” or “Staff”)1 and counsel for
`Regeneron Pharmaceuticals, Inc. (“Regeneron”) of the Motion
`and sought their respective consent for the filing. The
`OUII consented promptly. Regeneron has provided no
`
`1 The OUII “[p]erforms substantive litigation activities as an independent party
`representing the public interest in section 337 investigations by developing
`relevant information and advocating on behalf of the public an independent
`position on the issues so that the Commission and its Administrative Law Judges
`can discharge the statutory decision-making responsibilities in such
`investigations.” See https://www.usitc.gov/offices/ouii.
`
`Century City • Los Angeles • Newport Beach • New York • San Francisco • Silicon Valley • Washington, DC
`Beijing • Brussels • Hong Kong • London • Seoul • Shanghai • Singapore • Tokyo
`
`Regeneron Exhibit 1084.001
`
`

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`Case 1:20-cv-05502-AJN Document 109 Filed 04/07/21 Page 2 of 4
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`confirmation that it would not oppose Novartis’s Motion.
`Novartis also has informed the Chambers of the
`Administrative Law Judge (attached as Exhibit 1) of
`tomorrow’s impending Motion.
`
`As will be explained in the Motion, which Novartis will
`file with this Court tomorrow, the Administrative Law Judge
`recently granted Novartis’s motion for partial summary
`determination in the ITC Action that Regeneron infringed
`U.S. Patent No. 9,220,631 (the “’631 Patent”), a
`determination stemming from Regeneron’s concession that it
`infringes the ’631 patent. Mem. in Supp. Compls.’ Mot. for
`Partial Summ. J. as to Direct Infringement, Certain Pre-
`Filled Syringes for Intravitreal Injection and Components
`Thereof, USITC Inv. No. 337-TA-1207, at 20 (Feb. 18, 2021).
`
`In its prehearing brief2, the OUII expressed its
`preliminary view that, after Novartis proved a violation of
`Section 337 on the merits, the ITC should delay the
`implementation of any remedy by at least three years, if it
`issues one at all. Although Novartis disagrees with the
`OUII’s position, Novartis “takes seriously the concerns the
`Staff noted in its prehearing brief” and “will instead,
`pursue relief in district court.” In terminating the ITC
`Action, Novartis will conserve substantial resources of the
`parties and of the ITC.
`
`In addition to public interest considerations, the
`OUII’s brief supported Novartis’s positions that Regeneron
`infringes the ‘631 Patent and that the patent is not
`invalid based on prior invention (35 U.S.C. § 102(g)),
`indefiniteness or lack of written description (35 U.S.C. §
`112).
`
`But the OUII asserted that the ’631 Patent may be
`invalid as obvious (35 U.S.C. § 103) and for failing to
`identify the correct inventors under 35 U.S.C. § 102(f).
`Novartis disagrees with the OUII’s interpretation of the
`fact and expert record and the relevant caselaw, and firmly
`believes that Regeneron cannot prove the invalidity of
`the ’631 Patent at trial by clear and convincing evidence.
`
`2 A public version of the prehearing brief should be filed shortly, and Novartis
`will submit a copy to the Court immediately thereafter.
`
`Regeneron Exhibit 1084.002
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`

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`Case 1:20-cv-05502-AJN Document 109 Filed 04/07/21 Page 3 of 4
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`Novartis notes the OUII’s prehearing brief is just that — a
`brief submitted by a party to the case advocating its
`position on the issues in the case. Certainly, the OUII’s
`prehearing brief is not a finding (binding or otherwise) by
`the ITC (or its Administrative Law Judges).3
`
`In light of the OUII’s position on the public interest,
`tomorrow Novartis will, in addition to withdrawing the ITC
`complaint, promptly ask via letter the U.S. District Court
`for the Northern District of New York to lift the stay in
`Novartis Pharma AG et al. v Regeneron Pharmaceuticals,
`Inc., Case No. 1:20-cv-00690-TJM-CFH (N.D.N.Y.) (“N.D.N.Y.
`Action”).4 Novartis will vigorously prosecute its patent
`infringement claim in the U.S. District Court for the
`Northern District of New York. Upon filing the letter with
`the N.D.N.Y., Novartis’s Patent Counsel at Goodwin Proctor
`will promptly reach out to counsel for Regeneron to meet
`and confer on a schedule for that Action.
`
`In light of this development, and consistent with Your
`Honor’s Individual Rule of Practice 3.E., Novartis
`respectfully reiterates Novartis’s request that the Court
`schedule oral argument on Novartis’s Motion to Dismiss,
`Transfer, or Stay. (See ECF No. 40).
`
`Respectfully submitted,
`
`Ian Simmons
`of O’MELVENY & MYERS LLP
`
`3 According to the Federal Circuit, ITC determinations do not have preclusive
`effect on district courts because Congress cautioned that the “Commission’s
`findings neither purport to be, nor can they be, regarded as binding
`interpretations of the U.S. patent laws in particular factual contexts.”
`Texas Instruments Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558, 1559
`(Fed. Cir. 1996) (citing S. REP. No. 1298, 93d Cong., 2d Sess. 196 (1974),
`reprinted in U.S.C.C.A.N. 7186, 7329).
`4 As explained in Novartis’s September 4, 2020 Memorandum of Law in Support of
`Novartis’s Motion to Dismiss, Transfer, or Stay (ECF No. 41), and as the Court
`may recall, the N.D.N.Y. Action was filed by Novartis but stayed by Regeneron,
`all prior to the filing by Regeneron of this action.
`
`Regeneron Exhibit 1084.003
`
`

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`Case 1:20-cv-05502-AJN Document 109 Filed 04/07/21 Page 4 of 4
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`cc: Elizabeth J. Holland
`William G. James
`Elizabeth S. Weiswasser
`Eric S. Hochstadt
`Benjamin G. Bradshaw
`
`Attachment
`
`Regeneron Exhibit 1084.004
`
`

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`Case 1:20-cv-05502-AJN Document 109-1 Filed 04/07/21 Page 1 of 3
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`EXHIBIT 1
`
`Regeneron Exhibit 1084.005
`
`

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`Case 1:20-cv-05502-AJN Document 109-1 Filed 04/07/21 Page 2 of 3
`
`From:
`Sent:
`To:
`Cc:
`Subject:
`
`Dear Patricia,
`
`Trainor, D. Sean
`Wednesday, April 7, 2021 10:31 AM
`Chow, Patricia; DG-NovartisPFS; Regeneron_337ITC_Service; Guarnieri, Peter
`337CM
`RE: 337-TA-1207: scheduling case management conference
`
`In view of the approaching hearing and Friday’s case management conference, we are writing to inform you
`that Novartis will be filing a motion to terminate the investigation based on its withdrawal of the complaint. We
`informed Regeneron and the Staff yesterday afternoon and will file the motion as soon as Regeneron provides
`its position on the motion. Staff has already indicated its non-opposition and waived the two-day notice
`requirement.
`
`Regards,
`Sean
`
`D. Sean Trainor
`O: +1-202-383-5114
`M: +1-240-687-2031
`dstrainor@omm.com
`
`From: Chow, Patricia <Patricia.Chow@usitc.gov>
`Sent: Monday, April 5, 2021 3:58 PM
`To: DG-NovartisPFS <DG-NovartisPFS@goodwinlaw.com>; Trainor, D. Sean <dstrainor@omm.com>;
`Regeneron_337ITC_Service <Regeneron_337ITC_Service@weil.com>; Guarnieri, Peter <Peter.Guarnieri@usitc.gov>
`Cc: 337CM <337CM@usitc.gov>
`Subject: 337-TA-1207: scheduling case management conference
`
`[EXTERNAL MESSAGE]
`
`Dear Counsel:
`
`Judge Cheney would like to have a case management conference with the parties this week to discuss procedural and
`logistical issues associated with the upcoming evidentiary hearing. Specific items for discussion include (1) the physical
`location and virtual appearance of counsel and witnesses, (2) the presentation of evidence designated as confidential by
`non-parties, and (3) practice sessions on the Webex platform. Additionally, the parties may use the Webex platform
`after the conclusion of the conference to practice for the evidentiary hearing.
`
`The case management conference will begin at 10:00 a.m. on Friday, April 9, 2021. Connection information will be sent
`in a separate email.
`
`Please let me know if you have an unworkable conflict with this time and if you plan to use the Webex session to
`practice after the conclusion of the conference.
`
`Regards,
`Patricia
`
`Patricia E. Chow (she/her/hers)
`
`Regeneron Exhibit 1084.006
`
`

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`Case 1:20-cv-05502-AJN Document 109-1 Filed 04/07/21 Page 3 of 3
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`Attorney Advisor to Judge Clark S. Cheney
`Office of the Administrative Law Judges
`U.S. International Trade Commission
`500 E Street, SW
`Washington, DC 20436
`
`Regeneron Exhibit 1084.007
`
`