`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`Before the Honorable Clark S. Cheney
`Administrative Law Judge
`
`In the Matter of
`CERTAIN PRE-FILLED SYRINGES
`FOR INTRAVITREAL INJECTION
`AND COMPONENTS THEREOF
`
`
` Investigation No. 337-TA-1207
`
`
`
`
`
`COMPLAINANTS’ UNOPPOSED MOTION TO TERMINATE THE INVESTIGATION
`IN ITS ENTIRETY BASED ON WITHDRAWAL OF COMPLAINT AND REQUEST FOR
`EXPEDITED TREATMENT (MOTION NO. 1207-031)
`
`I.
`
`GROUND RULE 5.1 CERTIFICATION
`
`Complainants Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis
`
`Technology LLC (collectively, “Novartis”) certifies that it has met and conferred with Respondent
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`Regeneron Pharmaceuticals, Inc. (“Regeneron”) and Commission Investigative Staff (“Staff”)
`
`prior to filing this Motion. Regeneron and Staff do not oppose.
`
`II.
`
`INTRODUCTION
`
`Pursuant to Commission Rule 210.21(a)(1), 19 C.F.R. § 210.21(a)(1), and Ground Rule
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`5.8, Novartis respectfully moves to terminate the Investigation in its entirety based on withdrawal
`
`of the Complaint. To conserve substantial resources of the private parties, the Staff, and the
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`Administrative Law Judge, and with the hearing approaching in less than two weeks, Novartis
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`requests expedited treatment of this Motion.
`
`Regeneron Exhibit 1006.001
`
`

`

`III. DISCUSSION
`
`
`
`Novartis has made clear since it filed its Complaint that it does not want a single patient to
`
`be deprived of any necessary treatment resulting from the Commission’s issuance of any remedy
`
`in this Investigation. Indeed, as Novartis stated in its prehearing brief:
`
`Novartis stands by its continued commitment to patients and
`wholeheartedly agrees that a remedial order should not jeopardize
`patients’ access to appropriate treatments. Here, because there is no
`credible evidence that such a risk exists here, [] an exclusion order
`should issue. If the Commission has any credible doubt on that
`score, it should use its broad and flexible remedial powers to fashion
`a remedy that protects the public interest, incentivizes Regeneron to
`convert EYLEA back to the non-infringing vial presentation. The
`Commission should not permit Regeneron to reap profits from its
`continued flaunting of Novartis’s valid patent rights.
`
`Novartis’s Pre-Hr’g Br. at 6 (EDIS Doc. ID 736888); see also Novartis’s Substitute Pre-Hr’g Br.
`
`at 6 (EDIS Doc. ID 737750). Novartis strongly believes it would prevail on the merits in this
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`investigation—indeed, the Administrative Law Judge recently granted Novartis’s motion for
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`partial summary determination that Regeneron directly infringed U.S. Patent No. 9,220,631 (the
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`“Asserted Patent”) and that Novartis satisfied both the technical and economic prongs of the
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`domestic industry requirement. See Order No. 31. Novartis maintains that the Asserted Patent is
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`valid and that Regeneron cannot prove otherwise.
`
`Novartis also believes that there are no public interest concerns that would justify tailoring
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`any remedy that could issue in this Investigation. However, the Staff has suggested otherwise,
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`advocating that the Commission should delay the implementation of any remedy by at least three
`
`years, if it issues one at all. Although Novartis disagrees with Staff, it takes seriously the concerns
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`Staff noted in its pre-hearing brief. As a result, Novartis is withdrawing this Complaint and will,
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`instead, pursue relief in district court.
`
`
`
`2
`
`Regeneron Exhibit 1006.002
`
`

`

`
`
`Novartis submits this motion to terminate the Investigation should be granted. The
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`Commission’s rules permit “[a]ny party [to] move at any time prior to the issuance of an initial
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`determination on violation of Section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337,
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`to terminate an investigation in whole or in part as to any or all respondents, on the basis of
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`withdrawal of the complaint or certain allegations contained therein . . . .” 19 C.F.R. § 210.21(a)(1).
`
`“In the absence of extraordinary circumstances, termination of an investigation will be readily
`
`granted to a complainant during the prehearing stage of an investigation.” Certain Microfluidic
`
`Sys. & Components Thereof & Prods. Containing Same, Inv. No. 337-TA-1100, Order No. 27 at
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`1 (Dec. 10, 2018) (citing Certain Television Sets, Television Receivers, Television Tuners, &
`
`Components Thereof, Inv. No. 337-TA-910, Order No. 50 (Nov. 12, 2014)); see also Certain
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`Subsea Telecommunications Sys. & Components Thereof, Inv. No. 337-TA-1098, Order No. 52
`
`(Dec. 6, 2018); Certain Memory Modules & Components Thereof, Inv. No. 337-TA-1089, Order
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`No. 27 at 2 (Dec. 6, 2018); Certain Toner Cartridges & Components Thereof, Inv. No. 337 TA-
`
`1106, Order No. 33 (Nov. 26, 2018). Here, the Administrative Law Judge has not yet issued his
`
`initial determination on violation. Indeed, the hearing is currently scheduled to begin in about two
`
`weeks. Furthermore, public policy supports termination of the withdrawn complaint in order to
`
`conserve public and private resources. See Certain Modular LED Display Panels & Components
`
`Thereof, Inv. No. 337-TA-1114, Order No. 23 at 2-3 (Oct. 24. 2018); Certain Road Construction
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`Machs. & Components Thereof, Inv. No. 337-TA-1088, Order No. 38 (Oct. 16, 2018).
`
`In addition, good cause exists to grant this motion to terminate and to grant an immediate
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`stay of the procedural schedule pending a ruling from the Administrative Law Judge on Novartis’s
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`motion to terminate the Investigation.1 See, e.g., Certain Muzzle-Loading Firearms &
`
`
`1 Regeneron has also confirmed that it does not oppose a stay pending resolution of this motion.
`3
`
`
`
`Regeneron Exhibit 1006.003
`
`

`

`
`
`Components Thereof, Inv. No. 337-TA-777, Order No. 24 at 2 (Nov. 30, 2011) (granting motion
`
`to suspend the procedural pending a ruling on a motion to terminate); Certain Devices for Mobile
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`Data Commc’n, Inv. No. 337-TA-809, Order No. 60, at 2 (Oct. 12, 2012) (same); Certain Coupler
`
`Devices for Power Supply Facilities, Components Thereof, & Prods. Containing Same, Inv. No.
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`337-TA-590, Order No. 31 (Aug. 23, 2007) (same). The evidentiary hearing is scheduled to begin
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`in less than two weeks. In the interim, responses to motions in limine are due and the parties will
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`be engaging in significant evidentiary hearing preparation. It is unnecessary for the parties to
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`continue to expend resources to litigate issues pending the outcome of Novartis’s motion to
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`terminate. The request for a stay and expedited treatment will therefore conserve the resources of
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`the private parties, the Staff, and the Administrative Law Judge.
`
`Pursuant to Commission Rule 210.21(a)(1), Novartis states that there are no agreements,
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`written or oral, express or implied, by or between the private parties concerning the subject matter
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`of this Investigation (i.e., there are no settlement agreements, licenses, or any other such
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`agreements). In addition, there are no extraordinary circumstances that would justify denying
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`termination of this Investigation based on Novartis withdrawing the Complaint.
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`IV. CONCLUSION
`
`Based on the foregoing, Novartis respectfully requests that this Investigation be terminated
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`in its entirety based on withdrawal of the Complaint and requests an immediate stay of all
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`procedural schedule deadlines pending final resolution of this Motion.
`
`
`
`4
`
`Regeneron Exhibit 1006.004
`
`

`

`Dated: April 8, 2021
`
`Respectfully submitted,
`
`
`
`
`
`
`
`By: /s/ Elizabeth J. Holland
`Elizabeth J. Holland
`Calvin E. Wingfield Jr.
`Daniel Margolis
`Linnea Cipriano
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`Phone: (212) 813-8800
`Email: EHolland@goodwinlaw.com
`Email: CWingfield@goodwinlaw.com
`Email: DMargolis@goodwinlaw.com
`Email: LCipriano@goodwinlaw.com
`Email: DG-NovartisPFS@goodwinlaw.com
`
`William James
`Patrick J. McCarthy
`Brian T. Burgess
`Myomi T. Coad
`Jenny Zhang
`GOODWIN PROCTER LLP
`1900 N Street, N.W.
`Washington, D.C. 20036-1612
`Phone: (202) 346-4000
`Email: WJames@goodwinlaw.com
`Email: PMcCarthy@goodwinlaw.com
`Email: BBurgess@goodwinlaw.com
`Email: MCoad@goodwinlaw.com
`Email: JZhang@goodwinlaw.com
`Email: DG-NovartisPFS@goodwinlaw.com
`
`Joshua Weinger
`Molly R. Grammel
`GOODWIN PROCTER LLP
`100 Northern Avenue
`Boston, MA 02210
`Phone: (617) 570-1000
`Email: JWeinger@goodwinlaw.com
`Email: MGrammel@goodwinlaw.com
`Email: DG-NovartisPFS@goodwinlaw.com
`
`D. Sean Trainor
`O’Melveny & Myers LLP
`
`
`
`5
`
`Regeneron Exhibit 1006.005
`
`

`

`
`
`1625 I St., N.W.
`Washington, D.C. 20006
`Phone: (202) 383-5114
`dstrainor@omm.com
`
`Counsel for Complainants Novartis
`
`
`
`6
`
`
`
`
`
`Regeneron Exhibit 1006.006
`
`

`

`
`
`CERTIFICATE OF SERVICE
`
`
`
`I, Tessa Mager, hereby certify that on this 8th day of April, 2021, copies of the foregoing
`
`were served upon the following parties as indicated:
`
`The Honorable Lisa R. Barton
`Secretary to the Commission
`U.S. International Trade Commission
`500 E Street, S.W., Suite 112
`Washington, D.C. 20436
`
`The Honorable Clark S. Cheney
`Administrative Law Judge
`U.S. International Trade Commission
`500 E Street, S.W.
`Washington, D.C. 20436
`Cheney337@usitc.gov
`
`W. Peter Guarnieri
`The Office of Unfair Import
`Investigations
`U.S. International Trade Commission
`500 E Street, S.W., Suite 401
`Washington, D.C. 20436
`Peter.Guarnieri@usitc.gov
`
`Elizabeth S. Weiswasser
`Anish R. Desai
`Natalie C. Kennedy
`Andrew P. Gesior
`WEIL, GOTSHAL & MANGES LLP
`767 5th Avenue
`New York, NY 10153
`Telephone: (212) 310-8000
`
`Brian E. Ferguson
`Robert T. Vlasis
`Christopher M. Pepe
`Matthew D. Sieger
`Priyata Y. Patel
`WEIL, GOTSHAL & MANGES LLP
`2001 M Street, Suite 600
`Washington, D.C. 20036
`
`
`
`
`
`Via EDIS
`
`Via Electronic Mail
`
`Via Electronic Mail
`
`Via Electronic Mail
`
`7
`
`Regeneron Exhibit 1006.007
`
`

`

`
`
`Telephone: (202) 682-7000
`Regeneron_337ITC_Service@weil.com
`
`Counsel for Regeneron Pharmaceuticals,
`Inc.
`
`/s/ Tessa S. Mager
`Tessa S. Mager
`Paralegal
`
`8
`
`
`
`
`
`
`
`
`
`
`Regeneron Exhibit 1006.008
`
`