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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, DC
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`Before The Honorable Clark S. Cheney
`Administrative Law Judge
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`In the Matter of
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`CERTAIN PRE-FILLED SYRINGES
`FOR INTRAVITREAL INJECTION AND
`COMPONENTS THEREOF
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`Investigation No. 337-TA-1207
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`COMMISSION INVESTIGATIVE STAFF’S PRE-HEARING BRIEF
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`INV. NO. 337-TA-1207
`STAFF’S PRE-HEARING BRIEF
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`Public Version
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`Regeneron Exhibit 1005.001
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`I.
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`TABLE OF CONTENTS
`INTRODUCTION ................................................................................................... 1
`A.
`Procedural History............................................................................................ 1
`B.
`The Parties ........................................................................................................ 4
`1. Novartis ......................................................................................................... 4
`2.
`Regeneron ...................................................................................................... 4
`C. Overview of the Technology ............................................................................. 5
`1.
`VEGF-antagonists ......................................................................................... 5
`2.
`Pre-filled syringes .......................................................................................... 5
`3.
`Terminal sterilization ................................................................................... 6
`4.
`Siliconization ................................................................................................. 7
`D.
`The ’631 Patent ................................................................................................. 7
`E.
`The Products at Issue ....................................................................................... 9
`1. Novartis’s Domestic Industry Product ......................................................... 9
`2.
`Accused Regeneron Product .......................................................................... 9
`F. Witness Testimony ........................................................................................... 9
`II. JURISDICTION ................................................................................................... 10
`A.
`Subject Matter Jurisdiction ........................................................................... 10
`B.
`Personal Jurisdiction ...................................................................................... 11
`C.
`In Rem Jurisdiction ........................................................................................ 11
`III. LEGAL STANDARDS ....................................................................................... 12
`A.
`Violation of Section 337 .................................................................................. 12
`B.
`Infringement ................................................................................................... 12
`C.
`Invalidity Under 35 U.S.C. § 103 (pre-AIA) .................................................. 13
`D. Written Description ........................................................................................ 15
`E.
`Enablement ..................................................................................................... 16
`F.
`Inventorship .................................................................................................... 17
`G.
`Prior invention by another ............................................................................. 19
`H. Domestic Industry .......................................................................................... 21
`IV. U.S. PATENT NO. 9,220,631 ............................................................................ 24
`A.
`Claim Construction ......................................................................................... 24
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`Level of skill of a Person of Ordinary Skill in the Art ............................... 24
`1.
`Terms with agreed constructions ............................................................... 25
`2.
`Infringement ................................................................................................... 28
`B.
`C. Domestic Industry - Technical Prong ............................................................ 30
`1.
`Claims 1, 3-7, 16-17, 22, and 23 of the ’631 patent .................................... 30
`2.
`Claims 21, 24, and 25 .................................................................................. 31
`D.
`Invalidity ......................................................................................................... 31
`1.
`Obviousness Under 35 U.S.C. § 103 ........................................................... 31
`2.
`Inventorship Under 35 U.S.C. § 102(f) ....................................................... 98
`3.
`Prior Invention By Another Under 35 U.S.C. § 102(g) ............................ 114
`4.
`Enablement and Written Description Under 35 U.S.C. § 112, ¶ 1 ......... 128
`5.
`Indefiniteness Under 35 U.S.C. § 112, ¶ 2 ............................................... 134
`E. Other Defenses ............................................................................................. 134
`V. DOMESTIC INDUSTRY – ECONOMIC PRONG ............................................. 134
`A. Overview of Novartis’s Domestic Activities ................................................. 134
`B.
`Employment of Labor or Capital.................................................................. 138
`1. Novartis’s investments in labor and capital ............................................. 138
`2. Novartis’s investments are significant ..................................................... 141
`3.
`Regeneron’s arguments ............................................................................. 142
`C. Novartis Has Not Made Substantial Investment in Exploitation of the ’631
`Patent ..................................................................................................................... 157
`1.
`Lack of nexus ............................................................................................. 158
`2.
`Investments not substantial ..................................................................... 160
`VI. PUBLIC INTEREST ........................................................................................ 161
`A.
`Legal Standards ............................................................................................ 161
`B.
`Analysis ......................................................................................................... 164
`1.
`Effect on public health and welfare .......................................................... 165
`2.
`Effect on competitive conditions in the United States economy ............. 189
`3.
`Effect on production of like or directly competitive articles in the United
`States .................................................................................................................. 189
`4.
`Effect on United States consumers ........................................................... 190
`C.
`Conclusion ..................................................................................................... 191
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`VII. REMEDY AND BONDING ............................................................................. 192
`A.
`Limited Exclusion Orders ............................................................................ 192
`1.
`Regeneron’s request for a reporting requirement .................................... 193
`2. Novartis’s requests for modifications to the exclusion order ................... 194
`B.
`Cease and Desist Orders .............................................................................. 199
`C.
`Bond .............................................................................................................. 200
`VIII. CONCLUSION ............................................................................................. 202
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`TABLE OF AUTHORITIES
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`Cases
`
`Abbott Lab’ys v. Geneva Pharm., Inc., 182 F.3d 1315, 1319 (Fed. Cir. 1999) ............ 42
`AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1298
`(Fed. Cir. 2014) ......................................................................................................... 16
`ABT Sys., LLC v. Emerson Elec. Co., 797 F.3d 1350, 1360 (Fed. Cir. 2015) ....... 14, 63
`Advanced Cardiovascular Sys. v. SciMed Life Sys., Inc., 261 F.3d 1329 (Fed. Cir.
`2001) ......................................................................................................................... 12
`Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1293 (Fed. Cir. 2013) ........................... 68
`Alloc, Inc. v. Int’l Trade Comm’n, 342 F.3d 1361, 1375 (Fed. Cir. 2003) .................... 22
`Amgen, Inc. v. Int’l Trade Comm’n, 565 F.3d 846, 854 (Fed. Cir. 2009) .................... 10
`Apotex USA, Inc. v. Merck & Co., 254 F.3d 1031, 1035 (Fed. Cir. 2001) ............. 19, 20
`Apple Inc. v. Samsung Elecs. Co., Ltd., 839 F.3d 1034 (Fed. Cir. 2016) .................... 15
`Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en banc)
` ................................................................................................................................ 131
`Automotive Techs. Int'l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1282 (Fed. Cir.
`2007) ......................................................................................................................... 16
`Baker Oil Tools, Inc. v. Geo Vann, Inc., 828 F.2d 1558, 1563 (Fed. Cir. 1987) .......... 41
`BASF Corp. v. SNF Holding Co., 955 F.3d 958, 967 (Fed. Cir. 2020) ........................ 43
`Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551
`(Fed.Cir.1989) ........................................................................................................... 63
`Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1341 n.4 (Fed. Cir. 2016) ........ 13
`Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994) .. 112
`Cellular Commc’ns Equip. LLC v. HTC Corp., No. 6:16-CV-475-KNM, 2018 WL
`4261195, at *3 (E.D. Tex. July 5, 2018) ................................................................. 110
`CFMT, Inc. v. Yieldup Int'l Corp., 349 F.3d 1333, 1338 (Fed. Cir. 2003) ................. 133
`Checkpoint Sys., Inc. v. U.S. Int’l Trade Comm’n, 54 F.3d 756, 761 (Fed. Cir. 1995)
` .................................................................................................................... 20, 21, 127
`City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 136 (1877) .............. 42
`Comcast Corp. v. Int’l Trade Comm’n, 951 F.3d 1301, 1308 (Fed. Cir.) ..................... 12
`Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387 (Fed. Cir. 1988) . 15
`Dippin’ Dots, Inc. v. Mosey, 476 F.3d 1337, 1344 (Fed. Cir. 2007) ............................. 41
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`Dome Pat. L.P. v. Lee, 799 F.3d 1372, 1381 (Fed. Cir. 2015) ...................................... 68
`Dystar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356, 1361 (Fed. Cir. 2006)
` .................................................................................................................................. 14
`Egenera, Inc. v. Cisco Sys., Inc., 972 F.3d 1367, 1376 (Fed. Cir. 2020) ................... 113
`Eon Corp. IP Holdings v. Silver Spring Networks, 815 F.3d 1314, 1319 (Fed. Cir.
`2016) ......................................................................................................................... 25
`Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998) ......... 18, 19
`Fina Oil & Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997); .............. 18, 112
`Fox Grp., Inc. v. Cree, Inc., 700 F.3d 1300, 1305 (Fed. Cir. 2012) ................ 19, 21, 125
`Geo. M. Martin Co. v. All. Mach. Sys. Int'l LLC, 618 F.3d 1294, 1302 (Fed. Cir. 2010)
` .................................................................................................................................. 63
`Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., 139 S. Ct. 628, 633 (2019) ....... 42
`Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., 855 F.3d 1356, 1372 (Fed. Cir.
`2017) ....................................................................................................................... 118
`In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) ...................................... 92
`In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988) ......................................................... 17
`Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317 (Fed. Cir. 2004) ................ 15
`J.T. Eaton & Co. v. Atl. Paste & Glue Co., 106 F.3d 1563, 1571 (Fed. Cir. 1997) ...... 93
`KSR Int’l, Co. v. Teleflex, Inc., 127 S. Ct. 1727 (2007) ............................................... 14, 46
`Kumar v. Ovonic Battery Co., 351 F.3d 1364 (Fed. Cir. 2003) ................................... 26
`LaBounty Mfg. v. Int’l Trade Comm’n, 958 F.2d 1066, 1071 (Fed.Cir.1992) ............. 41
`Lelo Inc. v. International Trade Comm’n, 786 F.3d 879, 883-84 (Fed. Cir. 2015) .... 23,
`152
`Metabolite Lab’ys, Inc. v. Lab’y Corp. of Am. Holdings, 370 F.3d 1354, 1368 (Fed.
`Cir. 2004) .................................................................................................................. 94
`Mettler-Toledo, Inc. v. B-Tek Scales, LLC, 671 F.3d 1291, 1298 (Fed. Cir. 2012) .... 49,
`64, 75
`Millennium Pharms., Inc. v. Sandoz Inc., 862 F.3d 1356 (Fed. Cir. 2017) ................ 15
`Mycogen Plant Sci. v. Monsanto Co., 243 F.3d 1316, 1336 (Fed. Cir. 2001) ...... 19, 115
`Novartis Pharm. Corp. v. W.-Ward Pharm. Int'l Ltd., 923 F.3d 1051, 1059 (Fed. Cir.
`2019) ......................................................................................................................... 68
`Nuvo Pharm. (Ireland) Designated Activity Co. v. Dr. Reddy's Labs. Inc., 923 F.3d
`1368, 1376–77 (Fed. Cir. 2019) ........................................................................ 16, 132
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`O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1360 (Fed. Cir.
`2008) ......................................................................................................................... 25
`Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1312 (Fed. Cir. 2006) ... 49, 64, 75, 93
`Pannu v. Iolab Corp., 155 F.3d 1344, 1351 (Fed. Cir. 1998) ............................... 18, 100
`Perfect Surgical Techniques, Inc. v. Olympus Am., Inc., 841 F.3d 1004, 1015 (Fed.
`Cir. 2016) ................................................................................................................ 114
`Persion Pharm. LLC v. Alvogen Malta Operations Ltd., 945 F.3d 1184, 1192 (Fed.
`Cir. 2019) .................................................................................................................. 65
`Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) ......................................... 13
`PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 (Fed. Cir. 2007) ...... 14
`Quantachrome Corp. v. Micromeritics Instrument Corp., 15 F. App’x 848, 849 (Fed.
`Cir. 2001) .................................................................................................................. 42
`Quantachrome Corp. v. Micromeritics Instrument Corp., 97 F. Supp. 2d 1181, 1187
`(S.D. Fla. 2000) ......................................................................................................... 43
`Santarus, Inc. v. Par Pharmaceutical, Inc., 694 F.3d 1344, 1355-56 (Fed. Cir. 2012)
` .................................................................................................................................. 68
`Sealed Air Corp. v. United States Int’l Trade Comm’n, 645 F.2d 976 (C.C.P.A. 1981)
` .................................................................................................................................. 11
`Spansion, Inc. v. U.S. Int’l Trade Comm’n, 629 F.3d 1331, 1360 (Fed. Cir. 2010) .. 162,
`164
`Storer v. Clark, 860 F.3d 1340, 1345 (Fed. Cir. 2017) ................................................ 17
`Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 (Fed.Cir.2011) .................. 93
`TorPharm, Inc. v. Ranbaxy Pharm., Inc., 336 F.3d 1322, 1327 (Fed. Cir. 2003) ....... 41
`Trovan, Ltd. v. Sokymat SA, Irori, 299 F.3d 1292, 1301 (Fed. Cir. 2002) .................. 17
`Trustees of Bos. Univ. v. Everlight Elecs. Co., 896 F.3d 1357, 1364 (Fed. Cir. 2018)
` .......................................................................................................................... 17, 129
`United States v. Apple Inc., 992 F. Supp. 2d 263, 280 (S.D.N.Y. 2014) ................... 198
`Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1003 (Fed. Cir. 2016) ................ 14
`Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 684 (Fed. Cir. 2015)
` ................................................................................................................................ 133
`W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1550 (Fed.Cir.1983) 20, 127
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`Statutes
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`19 U.S.C. § 1337 ............................................................................................... 1, 10, 200
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`19 U.S.C. § 1337(a)(1)(B) ................................................................................ 11, 12, 113
`19 U.S.C. § 1337(a)(3) .......................................................................................... 22, 142
`19 U.S.C. § 1337(d) .................................................................................................... 192
`19 U.S.C. § 1337(d)(1) ................................................................................ 161, 175, 176
`19 U.S.C. § 1337(f) ..................................................................................................... 199
`19 U.S.C. § 1337(j)(3) ................................................................................................. 195
`35 U.S.C. § 102(f) (pre-AIA)........................................................................... 17, 98, 113
`35 U.S.C. § 102(g)(2) (pre-AIA) ..................................................................... 19, 20, 114
`35 U.S.C. § 103 ............................................................................................................. 13
`35 U.S.C. § 112, ¶ 1 (pre-AIA) ....................................................................... 15, 16, 128
`35 U.S.C. § 112, ¶ 2 (pre-AIA) ................................................................................... 134
`35 U.S.C. § 256 ........................................................................................................... 113
`35 U.S.C. § 271(a) ........................................................................................................ 12
`35 U.S.C. § 282 ............................................................................................................. 13
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`Regulations
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`19 C.F.R. § 210.37(a) .................................................................................................... 13
`19 C.F.R. § 210.50(d) .................................................................................................. 195
`19 C.F.R. § 210.68 ...................................................................................................... 196
`19 C.F.R. § 210.70 ...................................................................................................... 196
`19 C.F.R. § 210.71(a)(1) ...................................................................................... 196, 197
`19 C.F.R. § 210.71(a)(2) .............................................................................................. 196
`19 C.F.R. § 210.76 .............................................................................................. 157, 192
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`Commission Decisions
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`Battery-Powered Ride-On Toy Vehicles, Inv. No. 337-TA-314, USITC Pub. 2420,
`Initial Det. (Aug. 1991) ............................................................................................ 23
`Certain Automated Mechanical Transmission Systems for Medium-Duty and
`Heavy-Duty Trucks, and Components Thereof, Inv. No. 337-TA-503, Comm. Op.,
`at 5 (May 9, 2005)................................................................................................... 162
`Certain Automatic Crankpin Grinders, Inv. No. 337-TA-60, Comm. Det. & Order at
`2, USITC Pub. No. 1022 (1979) ............................................................................. 164
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`Certain Baseband Processor Chips and Chipsets, Transmitter and Receiver (Radio)
`Chips, Power Control Chips, and Products Containing Same, Including Cellular
`Telephone Handsets, Inv. No. 337-TA-543, Comm. Op., at 148–54 (June 19, 2007)
` ................................................................................................................................ 162
`Certain Collapsible Sockets for Mobile Electronic Devices and Components Thereof,
`Inv. 337-TA-1056, Comm’n Op., at 20 (Jul. 9, 2018) ............................................... 23
`Certain Composite Aerogel Insulation Materials and Methods for Manufacturing
`the Same, Inv. No. 337-1003, Comm’n Op., at 62 (Feb. 22, 2018) ........................ 193
`Certain Computers & Computer Peripheral Devices, & Components Thereof, &
`Prod. Containing Same, Inv. No. 337-TA-841, Comm’n Op., 2014 WL 5380098, at
`*24 (Jan. 9, 2014) ............................................................................................. 21, 156
`Certain Crystalline Cefadroxil Monohydrate, Inv. No. 337-TA-293, Comm’n Op.
`(March 15, 1990) ...................................................................................................... 15
`Certain Digital Cameras, Software, & Components Thereof, Inv. No. 337-TA-1059,
`Init. Det. (Aug. 17, 2018) ....................................................................................... 156
`Certain Diltiazem Hydrochloride & Diltiazem Preparations, Inv. No. 337-TA-349,
`Init. Det., 1995 WL 945191, at * 167 (Feb. 1, 1995) ............................................. 140
`Certain Dynamic Random Access Memories, Inv. No. 337-TA-242,USITC Pub. 2034,
`Comm’n Op. (Nov. 1987) .......................................................................................... 23
`Certain Elec. Imaging Devices, Inv. No. 337-TA-850, Comm'n Op., 2018 WL
`11201935, at *48 (Nov. 1, 2018) ............................................................................. 113
`Certain Electric Skin Care Devices, Brushes and Chargers Therefor, and Kits
`Containing the Same, 337-TA-959, Comm’n Op. (Feb. 13, 2017) (EDIS Doc.
`603444) ................................................................................................................... 199
`Certain Electronic Digital Media Devices and Components Thereof, Inv. No. 337-TA-
`796, Comm’n Op., at 99-100 (Sep. 6, 2013) ........................................................... 153
`Certain Fluidized Supporting Apparatus, Inv. No. 337-TA-182/188, Comm. Op., 1984
`WL 63741, at *10-11 (1984) ................................................................................... 164
`Certain Inclined Field Acceleration Tubes, Inv. No. 337-TA-67, Comm. Op. at 21-31,
`USITC Pub. No. 1119 (1980) .................................................................................. 164
`Certain Integrated Circuit Chips and Products Containing the Same, Inv. 337-TA-
`859, Comm’n Op., 2014 WL 12796437, at *28 (Aug. 22, 2014) ............ 146, 158, 160
`Certain Integrated Circuit Telecommunication Chips and Products Containing
`Same, Including Dialing Apparatus, Inv. No. 337-TA-337, Comm. Op. at 41-43
`(Aug. 3, 1993) ......................................................................................................... 200
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`Certain Lithium Ion Batteries, Battery Cells, Battery Modules, Battery Packs,
`Components Thereof, and Processes Therefor, Inv. No. 337-TA-1159, Comm’n Op.,
`at 77-79 (Mar. 4, 2021) ................................................................................... 163, 192
`Certain Magnetic Data Storage Tapes and Cartridges Containing the Same (II), Inv.
`No. 337-TA-1076, Comm. Op. at 64 (Jun. 20, 2019) ............................................. 161
`Certain Magnetic Tape Cartridges & Components Thereof, Inv. No. 337-TA-1058,
`Comm’n Op., 2019 WL 2635509, at *32 (Apr. 9, 2019) ................. 143, 146, 147, 161
`Certain Marine Sonar Imaging Devices, Including Downscan & Sidescan Devices,
`Prod. Containing the Same, & Components Thereof, Inv. No. 337-TA-921, Comm’n
`Op., 2016 WL 10987364, at *39 (Jan. 6, 2016) ..................................... 145, 150, 151
`Certain Microfluidic Devices, Inv. No. 337-TA-1068, Comm. Op., at 1, 22-48, 53-54
`(Jan. 10, 2020) ........................................................................................ 162, 197, 198
`Certain Microsphere Adhesives, Process for Making Same, and Products Containing
`Same, Including Self-Stick Repositionable Notes, Inv. No. 337-TA-366, USITC
`Pub. 3949, Comm’n Op. at 24 (January 1996) ...................................................... 200
`Certain Network Devices, Related Software & Components Thereof (II), Inv. No.
`337-TA-945, Comm'n Opinion, 2018 WL 8648380, at *5 (Jul. 12, 2018) ............... 13
`Certain Non-Volatile Memory Devices & Prod. Containing the Same, Inv. No. 337-
`TA-1046, Comm’n Op., 2018 WL 6012622, at *25 (Oct. 26, 2018) ....... 156, 157, 194
`Certain Personal Data and Mobile Communication Devices and Related Software,
`Inv. No. 337-TA-710, Comm’n Op., 83 (Dec. 29, 2011) .................................. 162, 163
`Certain Printing and Imaging Devices and Components Thereof, Inv. No. 337-TA-
`690, Comm’n Op. at 31 (Feb. 17, 2011) ........................................................... 23, 155
`Certain Purple Protective Gloves, Inv. No. 337-TA-500, Order No. 17, 2004 WL
`2330140, *5-6 (Sept. 23, 2004) ............................................................................... 140
`Certain Road Construction Machines & Components Thereof, Inv. No. 337-TA-1088,
`Comm'n Op., 2019 WL 6003332, at *27 (July 15, 2019) ....................................... 193
`Certain Road Milling Machines & Components Thereof, Inv. No. 337-TA-1067,
`Comm. Op., at 32-33 (Jul. 18, 2019) ...................................................................... 162
`Certain Robotic Vacuum Cleaning Devices and Components Thereof Such as Spare
`Parts, Inv. No. 337-TA-1057, Comm’n Op., at 11-12 (Aug. 1, 2018) ..................... 154
`Certain Rubber Antidegradants, Components Thereof, and Products Containing
`Same, Inv. No. 337-TA-533, Comm’n Op. (July 21, 2006) ............................ 201, 202
`Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof,
`Inv. No. 337-TA-890, Init. Det. (Sep. 16, 2014) ............................. 144, 146, 147, 150
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`Certain Solid State Storage Drives, Stacked Electronics Components, and Products
`Containing Same, Inv. No. 337-TA-1097, Comm’n Op. (June 29, 2018) .............. 137
`Certain Sortation Systems, Parts Thereof, and Products Containing Same, Inv. No.
`337-TA-460, Comm. Op., at 18–20 (Feb. 19, 2003) ............................................... 163
`Certain Stringed Musical Instruments and Components Thereof, Inv. No. 337-TA-
`586, Comm’n Op. at 25 (May 16, 2008) ................................................... 22, 140, 153
`Certain Strontium-Rubidium Radioisotope Infusion Sys., & Components Thereof
`Including Generators, Inv. No. 337-TA-1110, Init. Det., 2019 WL 8752806, *94-95
`(Aug. 1, 2019) ................................................................................. 140, 156, 163, 192
`Certain Subsea Telecommunications Sys. & Components Thereof, Inv. No. 337-TA-
`1098, Init. Det., 2019 WL 2296160 (Apr. 26, 2019) (“Subsea Telecommunications
`Sys.”) ....................................................................................................... 147, 148, 149
`Certain Two-Handle Centerset Faucets & Escutcheons, & Components Thereof, Inv.
`No. 337-TA-422, Comm’n. Op., at 9 (Jul. 21, 2000) .............................................. 161
`Certain UV Curable Coatings for Optical Fibers, Coated Optical Fibers, and
`Products Containing Same, Inv. No. 337-TA-1031, Comm’n Op., at 9 (Jun. 7, 2018)
`(public vers.) ............................................................................................................. 16
`Certain Variable Speed Wind Turbines & Components Thereof, Inv. No. 337-TA-376,
`Commission Opinion at 21 (Sept. 23, 1996) ............................................................ 22
`Certain Video Game Sys. & Wireless Controllers & Components Thereof, Inv. No.
`337-TA-770, Comm’n Op., 2013 WL 12410036, at *42 (Oct. 28, 2013) ................ 143
`Certain Voltage Regulators, Components Thereof and Products Containing Same,
`Inv. No. 337-TA-564, Comm’n Op. (Public Version Oct. 19, 2007) ....................... 201
`Certain Windshield Wiper Devices and Components Thereof, Inv. No. 337-TA-881,
`Initial Det. (May 8, 2014) ......................................................................................... 11
`Certain Wireless Devices with 3G and/or 4G Capabilities & Components Thereof,
`Inv. No. 337-TA-868, Initial Det. at 128 (Jun. 13, 2014) ........................................ 23
`EPROM, EEPROM, Flash Memory, and Flash Microcontroller Semiconductor
`Devices, Inv. No. 337-TA-395, USITC Pub. 3392, Comm’n Op., at 9-10 (Jul. 9,
`1998) ....................................................................................................................... 113
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`INV. NO. 337-TA-1207
`STAFF’S PRE-HEARING BRIEF
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`x
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`Public Version
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`Regeneron Exhibit 1005.011
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`CPreBr.
`CX
`CDX
`CPX
`JX
`RPreBr.
`RX
`RDX
`RPX
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`TABLE OF ABBREVIATIONS
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`Complainant’s Pre-Hearing Brief
`Complainant’s Exhibit
`Complainant’s Demonstrative Exhibit
`Complainant’s Physical Exhibit
`Joint Exhibit
`Respondents’ Pre-Hearing Brief
`Respondents’ Exhibit
`Respondents’ Demonstrative Exhibit
`Respondents’ Physical Exhibit
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`INV. NO. 337-TA-1207
`STAFF’S PRE-HEARING BRIEF
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`xi
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`Public Version
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`Regeneron Exhibit 1005.012
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`I.
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`INTRODUCTION
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`Pursuant to Ground Rule11.2, the Commission Investigative Staff (“Staff”)
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`hereby submits the following Pre-Hearing Brief. In summary, the Staff expects the
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`evidence to show no violation of Section 337 by Respondent Regeneron
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`Pharmaceuticals, Inc. (“Regeneron”) because the asserted claims are invalid.1
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`In the event the Administrative Law Judge finds a violation, however, the
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`Staff expects the evidence to support the issuance of a limited exclusion order and
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`cease and desist order against Regeneron. The Staff further believes the evidence
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`regarding the public interest will show that any Commission orders should be
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`delayed for at least
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` to ensure an uninterrupted supply of the relevant
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`anti-VEGF drugs.
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`A.
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`Procedural History
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`The Complaint in this matter was filed on June 19, 2020. (EDIS Doc. ID
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`713042 (“Complaint”).) The Complaint filed under Section 337 of the Tariff Act
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`1930, as amended, 19 U.S.C. § 1337, alleges infringement of certain claims of U.S.
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`Patent No. 9,220,631 (JX-0001) (“the ’631 patent”) based on the importation into the
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`United States, sale for importation into the United States, and sale within the
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`United States after importation of ce