UNITED STATES
`INTERNATIONAL TRADE COMMISSION
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`___________________________________
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`In the Matter of: ) Investigation No.
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`CERTAIN PRE-FILLED SYRINGES FOR ) 337-TA-1207
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`INTRAVITREAL INJECTION AND )
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`COMPONENTS THEREOF )
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`___________________________________
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`Pages:
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`Place:
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`Date:
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`1 through 276
`Washington, D.C.
`December 10, 2020
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`HERITAGE REPORTING CORPORATION
`Official Reporters
`1220 L Street, N.W., Suite 206
`Washington, D.C. 20005
`(202) 628-4888
`www.hrccourtreporters.com
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`Novartis Exhibit 2049.001
`Regeneron v. Novartis, IPR2020-01317
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`

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` 1
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` 1 UNITED STATES INTERNATIONAL TRADE COMMISSION
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` 2 Washington, D.C.
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` 3 BEFORE THE HONORABLE CLARK S. CHENEY
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` 4 Administrative Law Judge
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` 5 ___________________________________
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` 6 In the Matter of: ) Investigation No.
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` 7 CERTAIN PRE-FILLED SYRINGES FOR ) 337-TA-1207
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` 8 INTRAVITREAL INJECTION AND )
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` 9 COMPONENTS THEREOF )
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` 10 ___________________________________
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` 11
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` 12 Remote Hearing
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` 13
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` 14 Thursday, December 10, 2020
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` 15
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` 16 MARKMAN HEARING
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` 17
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` 18 The Hearing commenced remotely, pursuant to the
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` 19 notice of the Judge, at 9:02 a.m. EST.
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` 25 Reported by: Marjorie Peters, FAPR, RMR, CRR
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`Heritage Reporting Corporation
`(202) 628-4888
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`Novartis Exhibit 2049.002
`Regeneron v. Novartis, IPR2020-01317
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`

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` 1 APPEARANCES:
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` 2
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` 3 ** All parties appearing remotely **
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` 4
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` 5 FOR COMPLAINANTS NOVARTIS PHARMA AG, NOVARTIS
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` 6 PHARMACEUTICALS CORPORATION, NOVARTIS TECHNOLOGYLLC:
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` 7
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` 8 ELIZABETH J. HOLLAND, ESQ.
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` 9 DANIEL P. MARGOLIS, Ph.D., ESQ.
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` 10 MOLLY GRAMMEL, ESQ.
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` 11 Goodwin Procter LLP
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` 12 The New York Times Building
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` 13 620 Eighth Avenue
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` 14 New York, New York 10018
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` 15 212-813-8800
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` 16
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` 17 MARK G. DAVIS, ESQ.
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` 18 WILLIAM JAMES, ESQ.
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` 19 PATRICK J. McCARTHY, ESQ.
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` 20 MYOMI T. COAD, ESQ.
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` 21 Goodwin Procter LLP
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` 22 1900 N Street, N.W.
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` 23 Washington, D.C. 20036
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` 24 202-346-4000
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` 25
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`Heritage Reporting Corporation
`(202) 628-4888
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`Novartis Exhibit 2049.003
`Regeneron v. Novartis, IPR2020-01317
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`

`

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` 1 APPEARANCES: (CONTINUED)
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` 2
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` 3 FOR RESPONDENT REGENERON PHARMACEUTICALS, INC.:
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` 4 ANISH R. DESAI, ESQ.
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` 5 ELIZABETH STOTLAND WEISWASSER, ESQ.
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` 6 NATALIE C. KENNEDY, ESQ.
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` 7 ANDREW P. GESIOR, ESQ.
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` 8 Weil, Gotshal & Manges LLP
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` 9 767 Fifth Avenue
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` 10 New York, New York 10153
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` 11 212-310-8000
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` 12
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` 13 BRIAN E. FERGUSON, ESQ.
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` 14 CHRISTOPHER PEPE, ESQ.
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` 15 ROBERT T. VLASIS, ESQ.
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` 16 Weil, Gotshal & Manges LLP
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` 17 2001 M Street, N.W., Suite 600
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` 18 Washington, D.C. 20036
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` 19 202-682-7000
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`Heritage Reporting Corporation
`(202) 628-4888
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`Novartis Exhibit 2049.004
`Regeneron v. Novartis, IPR2020-01317
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`

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` 4
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` 1 APPEARANCES (Continued):
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` 2
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` 3 FOR THE OFFICE OF UNFAIR IMPORT INVESTIGATIONS:
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` 4 W. PETER GUARNIERI, ESQ.
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` 5 ANNE GOALWIN, ESQ.
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` 6 U.S. International Trade Commission
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` 7 500 E Street, S.W.
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` 8 Washington, D.C. 20436
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` 9 202-205-2221
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`Heritage Reporting Corporation
`(202) 628-4888
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`Novartis Exhibit 2049.005
`Regeneron v. Novartis, IPR2020-01317
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`

`

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` 1 P R O C E E D I N G S
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` 2 (9:03 a.m.)
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` 3 JUDGE CHENEY: We're on the record now in
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` 4 Investigation No. 337-TA-1207. This is Certain Pre-Filled
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` 5 Syringes For Intravitreal Injection and Components Thereof.
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` 6 Good morning, everyone. My name is
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` 7 Clark Cheney. I'm the Administrative Law Judge assigned to
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` 8 collect and gather evidence and issue an initial
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` 9 determination in this case.
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` 10 We are gathered today for a claim construction
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` 11 hearing. Before we get too deep into that hearing, let's
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` 12 go around and have the parties enter their appearances,
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` 13 beginning with the counsel for the Complainant,
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` 14 Ms. Holland.
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` 15 MS. HOLLAND: Thank you, Your Honor.
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` 16 Elizabeth Holland of Goodwin Procter for
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` 17 Complainant Novartis.
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` 18 With me from Goodwin Procter and the people who
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` 19 may speak on the record are William James, Daniel Margolis
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` 20 and Mark Davis.
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` 21 JUDGE CHENEY: Welcome, all.
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` 22 MS. HOLLAND: We also have client
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` 23 representatives from Novartis, Your Honor. I don't know if
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` 24 you want them specifically identified.
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` 25 JUDGE CHENEY: I'd be delighted to be introduced
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`Heritage Reporting Corporation
`(202) 628-4888
`
`Novartis Exhibit 2049.006
`Regeneron v. Novartis, IPR2020-01317
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`

`

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` 6
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` 1 to them.
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` 2 MS. HOLLAND: Okay.
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` 3 I'm going to look at my screen to see if I --
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` 4 make sure I catch everybody.
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` 5 So we have Mr. Peter Waibel. We have Ms. Cindy
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` 6 Lopez. Let's see as I go down here. Ms. Paki Banky,
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` 7 Mr. John Hutchinson, and -- I'm looking at the Hollywood
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` 8 Squares here trying to make sure I got everybody.
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` 9 I think that's everybody, Your Honor.
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` 10 JUDGE CHENEY: Thank you. Welcome to all of
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` 11 you. Thank you for being with us in this hearing today.
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` 12 Counsel for the respondents, Mr. Desai.
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` 13 MR. DESAI: For Respondent, Regeneron, I will be
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` 14 presenting along with Elizabeth Weiswasser. We'll be
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` 15 switching seats, which is why you don't see her on the
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` 16 video right now.
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` 17 Also on the line who may be speaking at some
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` 18 point today is Chris Pepe, and then also we have -- from
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` 19 Regeneron, we have Larry Coury, Petra Scamborova, and I
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` 20 believe also Lynda Nguyen and our expert witness,
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` 21 Dr. Rexler.
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` 22 JUDGE CHENEY: Welcome, all. I appreciate the
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` 23 client representatives that are joining us today.
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` 24 I understand this is an important dispute
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` 25 between your companies, and it -- I appreciate the interest
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`Heritage Reporting Corporation
`(202) 628-4888
`
`Novartis Exhibit 2049.007
`Regeneron v. Novartis, IPR2020-01317
`
`

`

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` 7
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` 1 that you've shown in our proceedings.
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` 2 Counsel for the Commission Investigative Staff,
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` 3 please enter your appearance.
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` 4 MR. GUARNIERI: Good morning, Your Honor.
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` 5 Pete Guarnieri on behalf of the Office of Unfair
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` 6 Import Investigations at the ITC. I'll be doing the
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` 7 presenting and speaking today, but I'm also joined by my
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` 8 colleague, Ms. Anne Goalwin.
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` 9 JUDGE CHENEY: Welcome to you both.
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` 10 I will note that today's proceeding is on the
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` 11 public record. Although we're conducting the proceeding
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` 12 over a video platform, we have members of the public that
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` 13 are joining us, that are not signed on to the protective
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` 14 order in this investigation.
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` 15 So please conduct yourselves accordingly.
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` 16 Now, let's talk a little bit about the format of
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` 17 today's proceeding.
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` 18 I received a joint submission from the parties
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` 19 outlining an agreed format for today's proceeding. Under
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` 20 that agreement, we will begin with opening statements.
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` 21 Then we'll have the presentation of evidence and
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` 22 witnesses, with the Complainant going first, followed by
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` 23 the Respondent and then the Staff. And then there will be
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` 24 closing statements.
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` 25 I will let you all know that during the
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`Heritage Reporting Corporation
`(202) 628-4888
`
`Novartis Exhibit 2049.008
`Regeneron v. Novartis, IPR2020-01317
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`

`

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` 269
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` 1 But it also is informative about the standard
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` 2 that the Federal Circuit and other courts are using in
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` 3 dealing with this.
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` 4 I was very interested in Dr. Sawyer's testimony
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` 5 that we know that the next rung is a boundary. That seems
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` 6 to cut against indefiniteness, and sounded very much like
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` 7 the Guangdong case where even though we can't say where it
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` 8 is in between, we know there is something beyond which the
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` 9 claim does not -- is not covered.
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` 10 Those are my initial thoughts.
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` 11 Having heard that, does someone want to try to
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` 12 convince me that I'm mistaken in a post-hearing brief?
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` 13 I'm totally fine with that. I just -- I just
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` 14 want you all to hear where I'm thinking -- how I'm thinking
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` 15 about this case so that you can figure out how to use your
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` 16 resources.
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` 17 To the extent that anyone was hoping that this
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` 18 case was not going to go to trial, this case is going to go
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` 19 to trial.
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` 20 Let me start with you, Ms. Holland.
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` 21 Any thoughts?
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` 22 MS. HOLLAND: No, Your Honor. On behalf of
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` 23 Novartis, we don't -- given what Your Honor just said, we
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` 24 don't see the need for any post-hearing briefing.
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` 25 JUDGE CHENEY: Okay. Mr. Desai, I understand
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`Heritage Reporting Corporation
`(202) 628-4888
`
`Novartis Exhibit 2049.009
`Regeneron v. Novartis, IPR2020-01317
`
`

`

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` 276
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` 1 CERTIFICATE OF REPORTER
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` 2 TITLE: CERTAIN PRE-FILLED SYRINGES FOR INTRAVITREAL
`
` 3 INJECTION AND COMPONENTS THEREOF
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` 4 INVESTIGATION NO: 337-TA-1207
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` 5 HEARING DATE: December 10, 2020
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` 6 LOCATION: Washington, D.C. - Remote
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` 7 NATURE OF HEARING: Markman Hearing
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` 8 I hereby certify that the foregoing/attached
` transcript is a true, correct and complete record of the
` 9 above-referenced proceedings of the U.S. International
` Trade Commission.
` 10 Date: December 11, 2020
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` 11 SIGNED:
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` 12 Signature of the Contractor of the
` Authorized Contractor's Representative
` 13 1220 L Street, N.W, Suite 206
` Washington, D.C. 20005
` 14
` I hereby certify that I am not the Court Reporter
` 15 and that I have proofread the above-referenced transcript
` of the proceedings of the U.S. International Trade
` 16 Commission, against the aforementioned Court Reporter's
` notes and recordings, for accuracy in transcription in the
` 17 spelling, hyphenation, punctuation and speaker
` identification and did not make any changes of a
` 18 substantive nature. The foregoing/attached transcript is a
` true, correct and complete transcription of the
` 19 proceedings.
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` 20 SIGNED:
` Signature of Proofreader
` 21
` I hereby certify that I reported the above-referenced
` 22 proceedings of the U.S. International Trade Commission and
` caused to be prepared from my tapes and notes of the
` 23 proceedings a true, correct and complete verbatim recording
` of the proceedings.
` 24
` SIGNED:
` 25 Signature of the Court Reporter
`
`
`
`
`Heritage Reporting Corporation
`(202) 628-4888
`
`Novartis Exhibit 2049.010
`Regeneron v. Novartis, IPR2020-01317
`
`