`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`
`Plaintiff,
`
`
`v.
`
`
`
`Defendant.
`
`
`
`Case No. 1:22-cv-00061-TSK
`
`Claim Construction Hearing:
`January 6, 2023, 10:00 am
`
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 1 of 16 PageID #: 2375
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
`
`
`
`
`
`JOINT CLAIM CONSTRUCTION CHART
`
`Pursuant to the Court’s Scheduling Order (ECF No. 87), Plaintiff Regeneron
`
`Pharmaceuticals, Inc. (“Regeneron”) and Defendant Mylan Pharmaceuticals Inc. (“Mylan”)
`
`submit the following Joint Claim Construction Chart to assist with the Court’s preparation for the
`
`hearing scheduled for January 6, 2023.
`
`I.
`
`JOINT POSITION ON CLAIM CONSTRUCTION BRIEFING
`
`The Court’s Scheduling Order directs the parties to submit their positions concerning the
`
`length of any claim construction briefing. The parties have conferred and respectfully submit
`
`that their respective opening and responsive claim construction briefs be limited to 30 pages.
`
`II.
`
`CLAIM CONSTRUCTION DISPUTES & SUPPORTING INTRINSIC EVIDENCE
`
`The parties request that the Court resolve the following claim construction disputes.
`
`
`
`
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 2 of 16 PageID #: 2376
`
`Claim Term
`
`[Requesting Party]
`
`Best Corrected Visual
`Acuity (’601 patent,
`claims 5-6, 15-16, 23-
`24, and 31-32; ’572
`patent, claims 2, 3, 8,
`10, 17, 21, and 30)
`
`[Regeneron]
`
`Regeneron’s Proposed
`Construction and Intrinsic
`Evidence1
`
`Mylan’s Proposed
`Construction and Intrinsic
`Evidence2, 3
`
`the best visual acuity that can
`be achieved with the use of a
`corrective lens
`
`’572 patent, 8:32-36, 9:26-27,
`9:50-53, 10:28-30, 10:50-57,
`12:23-27, Table 1.24
`
`Plain and ordinary meaning:
`
`Best Corrected Visual Acuity
`(BCVA), measured in letters, a
`clinical trial endpoint /
`measurement
`
`The entire specification for the
`601 patent, including but not
`limited to: References Cited;
`Related Applications; Examples
`(in particular, Examples 1, 3-4);
`Claims; and, in particular: 7:26-
`45; 8:23-27; 9:18-19; 9:49-51;
`10:26-28; 12:33-40.
`
`The entire prosecution file
`history for the 601 patent,
`including but not limited to:
`RGN-EYLEA-MYLAN-
`00001666-1667; RGN-EYLEA-
`MYLAN-00002482-2483; RGN-
`EYLEA-MYLAN-00002484-
`2493; RGN-EYLEA-MYLAN-
`
`
`1 Regeneron disagrees with Mylan’s characterizations in footnotes 3 and 7 of the parties’ process
`for identifying terms, exchanging preliminary constructions, and preparing this submission and
`its allegations of waiver.
`
`2 Mylan reserves all rights to assert that the claims of the Asserted Patents are invalid under 35
`U.S.C. § 112 as indefinite and/or lacking enablement and/or lacking written description. Nothing
`in this Joint Claim Construction Chart shall be interpreted as a concession by Mylan that the claim
`terms identified herein satisfy the 35 U.S.C. § 112 requirements.
`
`3 Mylan reserves all rights to argue that Regeneron waived the opportunity to have the Mylan
`Proposed Terms construed for failure to present an actual construction of each term beyond their
`statement that each be afforded its “Plain and ordinary meaning in view of the claims and
`specification.” Mylan requested, but Regeneron refused to provide, explanations of what
`Regeneron considers to be the “plain and ordinary meaning” of each disputed claim term.
`
`4 Throughout this document, to the extent a disclosure is cited in the ’572 or ’601 patents, the
`equivalent disclosure in the other patent is also incorporated herein.
`
`
`
`2
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 3 of 16 PageID #: 2377
`
`Claim Term
`
`[Requesting Party]
`
`Regeneron’s Proposed
`Construction and Intrinsic
`Evidence1
`
`Mylan’s Proposed
`Construction and Intrinsic
`Evidence2, 3
`
`00004636; RGN-EYLEA-
`MYLAN-00005312-5313; RGN-
`EYLEA-MYLAN-00005370;
`RGN-EYLEA-MYLAN-
`00005433-5434; RGN-EYLEA-
`MYLAN-00005754-5755; RGN-
`EYLEA-MYLAN-00002494-
`4635; RGN-EYLEA-MYLAN-
`00006349; RGN-EYLEA-
`MYLAN-00006811-6812.
`
`The entire specification for the
`572 patent, including but not
`limited to: References Cited;
`Related Applications; Examples
`(in particular, Examples 1, 3-4);
`Claims; and, in particular: 8:32-
`36; 9:26-27; 10:28-30.
`
`The entire prosecution file
`history for the 601 and 572
`patent, including but not limited
`to: RGN-EYLEA-MYLAN-
`00016655-17043.
`
`The entire record for Inter
`Partes Review Nos. IPR2021-
`00880 (U.S. Patent No.
`9,669,069), IPR2021-00881
`(U.S. Patent No. 9,254,338),
`IPR2022-01225 (U.S. Patent No.
`10,130,681), IPR2022-01226
`(U.S. Patent No. 10,888,601),
`IPR2022-01524 (U.S. Patent No.
`11,253,572).
`
`a synthetic growth medium in
`which the identity and
`concentration of all the
`ingredients are defined and does
`not contain bacterial, yeast,
`animal, or plant extracts or
`
`chemically defined
`medium (CDM) (’715
`patent, claims 1, 15, and
`16; ’280 patent, claims 1
`and 5; ’532 patent,
`claims 1 and 19)
`
`a synthetic growth medium in
`which the identity and
`concentration of all the
`ingredients are defined
`
`
`
`3
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 4 of 16 PageID #: 2378
`
`Claim Term
`
`[Requesting Party]
`
`Regeneron’s Proposed
`Construction and Intrinsic
`Evidence1
`
`Mylan’s Proposed
`Construction and Intrinsic
`Evidence2, 3
`
`[Regeneron]
`
`’715 patent, 30:44-31:5.5
`
`hydrolysates, animal serum, or
`plasma
`
`The entire specification for the
`715 patent,6 including but not
`limited to: References Cited,
`Related Applications, Title,
`Abstract, Figures, Examples
`(cols. 98-146), Asserted Claims,
`and, in particular, the following:
`Figs. 5-8, 12A-12C, 26-31; 2:3-
`3:32; 5:51-6:28; 7:9-20; 17:58-
`64; 21:41-24:21; 24:49-29:3;
`29:38-30:24; 30:44-31:48;
`55:24-37; 58:63-60:57; 62:43-
`64:27; 69:26-76:63; 93:41-
`94:53.
`
`The entire specification for the
`280 patent, including but not
`limited to: Related Applications,
`Title, Abstract, Figures,
`Examples (cols. 97-142),
`Asserted Claims, and, in
`particular, the following: Figs. 5-
`8, 12A-12C, 26-31; 1:65-3:28;
`5:47-6:24; 7:5-16; 15:26-33;
`19:9-21:55; 22:15-26:40; 27:6-
`58; 28:10-29:14; 53:61-54:7;
`57:41-59:33; 60:50-63:4; 68:4-
`75:40; 92:19-93:30.
`
`The entire specification for the
`532 patent, including but not
`limited to: Related Applications,
`Title, Abstract, Figures,
`
`
`5 Throughout this document, to the extent a disclosure is cited in the ’715, ’280, or ’532 patents,
`the equivalent disclosures in the other patents are also incorporated herein.
`
`6 Throughout this document, to the extent a disclosure is cited in the ’715, ’280, or ’532 patents,
`the equivalent disclosures in the other patents are also incorporated herein.
`
`
`
`4
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 5 of 16 PageID #: 2379
`
`Claim Term
`
`[Requesting Party]
`
`Regeneron’s Proposed
`Construction and Intrinsic
`Evidence1
`
`Mylan’s Proposed
`Construction and Intrinsic
`Evidence2, 3
`
`Examples (cols. 98-146),
`Asserted Claims, and, in
`particular, the following: Figs. 5-
`8, 12A-12C, 26-31; 2:5-3:36;
`5:55-6:32; 7:13-23; 17:42-48;
`21:25-24:4; 24:32-28:57; 29:24-
`30:9; 30:28-31:33; 55:6-19;
`58:44-60:36; 62:22-64:6; 69:6-
`76:40; 93:19-94:30.
`
`The entire prosecution file
`history for the 715, 280 and 532
`patents, including but not limited
`to RGN-EYLEA-MYLAN-
`00024664-693; RGN-EYLEA-
`MYLAN-00024866-896; RGN-
`EYLEA-MYLAN-00025995-
`6097; RGN-EYLEA-MYLAN-
`00026848-912; RGN-EYLEA-
`MYLAN-00026920-7029; RGN-
`EYLEA-MYLAN-00027425-
`634; RGN-EYLEA-MYLAN-
`00027635-671; RGN-EYLEA-
`MYLAN-00027672-691; RGN-
`EYLEA-MYLAN-00029579-
`607; RGN-EYLEA-MYLAN-
`00029780-810; RGN-EYLEA-
`MYLAN-00030829-931; RGN-
`EYLEA-MYLAN-00031197-
`306; RGN-EYLEA-MYLAN-
`00031310-374; RGN-EYLEA-
`MYLAN-00031691-900; RGN-
`EYLEA-MYLAN-00031984-
`020; RGN-EYLEA-MYLAN-
`00032021-040; RGN-EYLEA-
`MYLAN-00032839-861; RGN-
`EYLEA-MYLAN-00033395-
`417; RGN-EYLEA-MYLAN-
`00033583-609; RGN-EYLEA-
`MYLAN-00033643-646
`
`U.S. Patent No. 11,312,936
`
`
`
`5
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 6 of 16 PageID #: 2380
`
`Claim Term
`
`[Requesting Party]
`
`Regeneron’s Proposed
`Construction and Intrinsic
`Evidence1
`
`Mylan’s Proposed
`Construction and Intrinsic
`Evidence2, 3
`
`U.S. Provisional Patent
`Application No. 62/944,635,
`including but not limited to
`[0046] (“CDM offers greater
`reproducibility / consistency
`over hydrolysate-based media.)
`and [00166] (“A CDM does not
`include hydrolysate such as, for
`example, soy hydrolysate.”); id.
`at [00165], [00368]
`
`U.S. Provisional Patent
`Application No. 63/065,012,
`including but not limited to
`[0009], [0027], [0182], [0315]-
`[0318], [0466], [0494], [0544],
`[0545]
`
`European Patent Application No.
`20764873.4, including, but not
`limited to 10/4/2022 Reply;
`4/8/2022 Reply;
`PCT/US2020/046809, including
`but not limited to [0010], [0028],
`[0184], [0317]-[0320], [0496],
`[0546]-[0547]
`
`European Patent Application No.
`20765400.5, including, but not
`limited to 4/8/2022 Reply;
`10/4/2022 Reply;
`PCT/US2020/046831, including
`but not limited to [0010], [0028],
`[0184], [0317]-[0320], [0496],
`[0546]-[0547]
`
`European Patent Application No.
`20765397.3, including, but not
`limited to 4/8/2022 Reply;
`10/4/2022 Reply;
`PCT/US2020/046823, including
`but not limited to [0010], [0028],
`
`
`
`6
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 7 of 16 PageID #: 2381
`
`Claim Term
`
`[Requesting Party]
`
`Regeneron’s Proposed
`Construction and Intrinsic
`Evidence1
`
`Mylan’s Proposed
`Construction and Intrinsic
`Evidence2, 3
`
`[0184], [0317]-[0320], [0496],
`[0546]-[0547]
`
`European Patent Application No.
`20775971.3, including, but not
`limited to 4/8/2022 Reply;
`10/4/2022 Reply;
`PCT/US2020/046842, including
`but not limited to [0010], [0028],
`[0184], [0317]-[0320], [0496],
`[0546]-[0547]
`
`European Patent Application No.
`20765403.9, including, but not
`limited to 10/4/2022 Reply;
`PCT/US2020/046846, including
`but not limited to [0010], [0028],
`[0184], [0317]-[0320], [0496],
`[0546]-[0547]
`
`
`
`No construction needed.
`
`
`The entire specification for the
`715 patent, including but not
`limited to: References Cited,
`Related Applications (including
`62/944,635 at [00219]; Example
`16), Title, Abstract, Figures,
`75:4-9; Examples (including
`Examples 5 and 9, and
`associated Figures), and
`Asserted Claims.
`
`The entire prosecution file
`history for the 715 patent.
`
`anti-oxidants (’715
`patent, claims 1, 3, 4,
`16)
`
`[Regeneron]
`
`
`
`Plain and ordinary meaning in
`view of the claims and
`specification, which is not
`limited to “taurine, hypotaurine,
`glycine, thioctic acid,
`glutathione, choline chloride,
`hydrocortisone, Vitamin C,
`Vitamin E and combinations
`thereof”
`
`’715 patent, 21:61-66, 23:52-
`63, 23:64-24:1, 24:17-21, 72:9-
`13, 75:4-9, 75:10-54, 120:46-
`123:18, 140:30-145, 261:20-22,
`261:27-30, 261:31-35, 261:62-
`64, 262:35-37, 263:1-3, Fig. 25,
`Fig. 28
`
`U.S. Patent Application No.
`16/996,030, August 18, 2020
`
`7
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 8 of 16 PageID #: 2382
`
`Claim Term
`
`[Requesting Party]
`
`Regeneron’s Proposed
`Construction and Intrinsic
`Evidence1
`
`Mylan’s Proposed
`Construction and Intrinsic
`Evidence2, 3
`
`Claims for Consideration at
`216-220.
`
`U.S. Patent Application No.
`16/996,030, December 2, 2020
`Non-Final Office Action at 9.
`
`U.S. Patent Application No.
`16/996,030, December 2, 2020
`Non-Final Office Action at 12,
`17.
`
`U.S. Patent Application No.
`16/996,030, Dec. 4, 2020
`Preliminary Amendment at 213-
`17.
`
`U.S. Patent Application No.
`16/996,030, March 2, 2021
`Amendment to Claims at 3-8.
`
`U.S. Patent Application No.
`16/996,030, March 2, 2021
`Response to Non-Final Office
`Action at 16-17, 22.
`
`U.S. Patent Application No.
`16/996,030, March 24, 2021
`Final Office Action at 12-23.
`
`U.S. Patent Application No.
`16/996,030, May 6, 2021 Draft
`Amendments to Claims at 2-7.
`
`U.S. Patent Application No.
`16/996,030, June 11, 2021
`Response After Final Rejection
`at 2-6.
`
`U.S. Patent Application No.
`16/996,030, June 14, 2021
`
`
`
`8
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 9 of 16 PageID #: 2383
`
`Claim Term
`
`[Requesting Party]
`
`Regeneron’s Proposed
`Construction and Intrinsic
`Evidence1
`
`Mylan’s Proposed
`Construction and Intrinsic
`Evidence2, 3
`
`Examiner Interview Summary
`Record.
`
`U.S. Patent Application No.
`16/996,030, June 28, 2021
`Examiner Interview Summary
`Record.
`
`U.S. Patent Application No.
`16/996,030, June 28, 2021
`Notice of Allowability at 3-5.
`
`
`formulated as an
`isotonic solution (’572
`patent, claims 6, 12, 18,
`22)
`
`Plain and ordinary meaning in
`view of the claims and
`specification, which does not
`require the presence of glucose.
`
`[Regeneron]
`
`
`
`“[present in] native
`conformation”
`
`(’865 patent, claims 1,
`16, 17)
`
`[Mylan]
`
`’572 patent, 6:11-12, 6:22-30,
`6:39-41,
`15:64-17:37.
`
`’572 patent, claim 1; claim 15.
`
`This term does not need to be
`construed outside of the context
`of the limitations in which it
`appears (e.g., “wherein at least
`98% of the VEGF antagonist is
`present in native conformation
`following storage at 5° C. for
`two months as measured by size
`exclusion chromatography.”).
`Within that context, it should be
`given its plain and ordinary
`meaning in view of the claims
`and the specification
`
`
`
`
`
`9
`
`No construction needed.
`
`The entire specification for the
`572 patent, including but not
`limited to: References Cited,
`Related Applications, Title,
`Abstract, Figures, Examples,
`Asserted Claims, and, in
`particular, 6:18-34.
`
`The entire prosecution file
`history for the 572 patent.
`
`Plain and ordinary meaning:
`
`[present in] a form that does not
`exhibit chemical or physical
`instability
`
`The entire specification for the
`865 patent, including but not
`limited to: References Cited,
`Related Applications, Title,
`Abstract, Figures, Examples 1-7,
`Asserted Claims, and, in
`particular, the following: 1:40-
`2:10; 2:14-65; 3:1-57; 3:58-4:6;
`4:7-5:3; 5:4-27; 5:51-60; 5:61-
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 10 of 16 PageID #: 2384
`
`Claim Term
`
`[Requesting Party]
`
`Regeneron’s Proposed
`Construction and Intrinsic
`Evidence1
`
`Mylan’s Proposed
`Construction and Intrinsic
`Evidence2, 3
`
`’865 patent, 5:51-6:2, 6:27-58,
`6:60-7:25, 7:42-51, 8:40-44,
`9:1-3, 9:28-30, 9:55-57, 10:24-
`22, 10:50-52, 11:11-15, 12:11-
`13, Tables 1-8.
`
`U.S. Patent Application No.
`11/818,463, Jan. 14, 2007
`Specification.
`
`U.S. Patent Application No.
`16/159,269, July 22, 2019
`Applicant Remarks at 5-6.
`
`U.S. Patent Application No.
`16/582,486, Mar. 2, 2021
`Applicant Remarks at 15-16.
`
`U.S. Patent Application No.
`16/739,559, Jan. 10, 2020
`Applicant Remarks at 4,
`Amendments to the Claims at 2.
`
`U.S. Patent Application No.
`16/739,559, May 5, 2021
`Applicant Remarks at 11-12.
`
`Plain and ordinary meaning in
`view of the claims and
`specification; to the extent there
`is a dispute as to claim scope,
`“organic co-solvent” includes
`polysorbate 20, polysorbate 80,
`polyethylene glycol, or
`propylene glycol, or a
`combination thereof
`
`
`
`’865 patent, 2:39-43, 2:33-38,
`2:49-52, 3:11-16, 3:28-31, 4:11-
`17, 7:2-7.
`
`
`10
`
`6:2; 6:6-23; 6:27-58; 6:60-7:25;
`7;26-8:3.
`
`The entire prosecution file
`history for the 865 patent,
`including but not limited to:
`RGN-EYLEA-MYLAN-
`00015146-48; RGN-EYLEA-
`MYLAN-00015158-64.
`
`Plain and ordinary meaning:
`
`an organic substance added to a
`primary solvent to increase the
`solubility of said VEGF
`antagonist
`
`The entire specification for the
`865 patent, including but not
`limited to: References Cited,
`Related Applications, Title,
`Abstract, Figures, Examples 1-5,
`Asserted Claims, and, in
`particular, the following: 2:39-
`
`“organic co-solvent”
`
`(’865 patent)
`
`[Mylan]
`
`
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 11 of 16 PageID #: 2385
`
`Claim Term
`
`[Requesting Party]
`
`Regeneron’s Proposed
`Construction and Intrinsic
`Evidence1
`
`Mylan’s Proposed
`Construction and Intrinsic
`Evidence2, 3
`
`’865 patent, claims 1-5, 26-30.
`
`U.S. Patent Application No.
`11/818,463, Jan. 30, 2009 Non-
`Final Rejection, at 5.
`
`U.S. Patent Application No.
`13,914,996, Oct. 8, 2013 Non-
`Final Rejection, at 4-5.
`
`U.S. Patent Application No.
`14/330,096, Apr. 2, 2015 Non-
`Final Rejection, at 7.
`
`Plain and ordinary meaning in
`view of the claims and
`specification; to the extent there
`is a dispute as to claim scope,
`this limitation does not exclude
`methods where the cell is
`subsequently cultured in a non-
`chemically defined medium
`
`
`
`
`’715 patent, 2:21-54, 5:53-57,
`17:41-64, 21:41-22:59, 29:38-
`30:13, 30:44-31:48, 32:59-
`34:17, 54:43-54, 55:24-52,
`58:63-59:20, 71:33-76:51,
`81:53-94:53, 93:42-94:53,
`99:35-60, 99:61-104:57,
`120:45-123:18, 123:20-126:28,
`140:25-145:30, Fig. 59.
`
`U.S. Application No.
`17/489,495, Nov. 3, 2021 Non-
`Final Rejection at 3-4.
`
`U.S. Application No.
`17/489,495, December 16, 2021
`
`11
`
`42; 2:49-50; 3:28-31; 4:15-16;
`7:2-7.
`
`The entire prosecution file
`history for the 865 patent.
`
`Plain and ordinary meaning:
`
`harvested from / a clarified
`harvest made using CDM (i.e., a
`synthetic growth medium in
`which the identity and
`concentration of all the
`ingredients are defined and does
`not contain bacterial, yeast,
`animal, or plant extracts or
`hydrolysates, animal serum, or
`plasma).
`
`The entire specification for the
`715 patent, including but not
`limited to: References Cited,
`Related Applications, Title,
`Abstract, Figures, Examples
`(cols. 98-146), Asserted Claims,
`and, in particular, the following:
`Figs. 5-8, 12A-12C, 26-31; 2:3-
`3:32; 5:51-6:28; 7:9-20; 17:58-
`64; 21:41-24:21; 24:49-29:3;
`29:38-30:24; 30:44-31:48;
`55:24-37; 58:63-60:57; 62:43-
`64:27; 69:26-76:63; 93:41-
`94:53.
`
`“a clarified harvest of
`cells cultured in a
`chemically defined
`medium (CDM)”;
`
`“a clarified harvest of a
`cell cultured in a
`chemically defined
`medium (CDM)”
`
`“harvested from a host
`cell cultured in a
`chemically defined
`medium (CDM)”;
`
`“aflibercept from a
`clarified
`harvest…wherein said
`aflibercept is expressed
`by cells cultured in a
`chemically defined
`medium (CDM)”
`
`“aflibercept from a
`clarified harvest
`cultured (CDM)”
`
`(’280 patent, claims 1,
`5; ’532 patent, claims 1,
`
`
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 12 of 16 PageID #: 2386
`
`Claim Term
`
`[Requesting Party]
`
`Regeneron’s Proposed
`Construction and Intrinsic
`Evidence1
`
`Mylan’s Proposed
`Construction and Intrinsic
`Evidence2, 3
`
`19; ’715 patent, claims
`1, 15, 16)
`[Mylan]
`
`Response to Non-Final Office
`Action at 3, 5, 7.
`
`The entire specification for the
`280 patent, including but not
`limited to: Related Applications,
`Title, Abstract, Figures,
`Examples (cols. 97-142),
`Asserted Claims, and, in
`particular, the following: Figs. 5-
`8, 12A-12C, 26-31; 1:65-3:28;
`5:47-6:24; 7:5-16; 15:26-33;
`19:9-21:55; 22:15-26:40; 27:6-
`58; 28:10-29:14; 53:61-54:7;
`57:41-59:33; 60:50-63:4; 68:4-
`75:40; 92:19-93:30.
`
`The entire specification for the
`532 patent, including but not
`limited to: Related Applications,
`Title, Abstract, Figures,
`Examples (cols. 98-146),
`Asserted Claims, and, in
`particular, the following: Figs. 5-
`8, 12A-12C, 26-31; 2:5-3:36;
`5:55-6:32; 7:13-23; 17:42-48;
`21:25-24:4; 24:32-28:57; 29:24-
`30:9; 30:28-31:33; 55:6-19;
`58:44-60:36; 62:22-64:6; 69:6-
`76:40; 93:19-94:30.
`
`The entire prosecution file
`history for the 280, 532 and 715
`patents, including but not limited
`to RGN-EYLEA-MYLAN-
`00030241-260; EYLEA-
`MYLAN-000325-331; RGN-
`EYLEA-MYLAN-00032370-
`392; RGN-EYLEA-MYLAN-
`00033583-609; RGN-EYLEA-
`MYLAN-00033683-692; RGN-
`EYLEA-MYLAN-00043826-
`833; RGN-EYLEA-MYLAN-
`00043900-4138
`
`
`
`12
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 13 of 16 PageID #: 2387
`
`Claim Term
`
`[Requesting Party]
`
`Regeneron’s Proposed
`Construction and Intrinsic
`Evidence1
`
`Mylan’s Proposed
`Construction and Intrinsic
`Evidence2, 3
`
`U.S. Provisional Patent
`Application No. 62/944,635,
`including but not limited to
`[0046] and [00166]
`
`U.S. Provisional Patent
`Application No. 63/065,012
`
`European Patent Application No.
`20764873.4, including, but not
`limited to 10/4/2022 Reply;
`4/8/2022 Reply; 6/28/2021
`Priority Document PCT
`/US2020/046809
`
`European Patent Application No.
`20765400.5, including, but not
`limited to 4/8/2022 Reply;
`10/4/2022 Reply
`
`European Patent Application No.
`20765397.3, including, but not
`limited to 4/8/2022 Reply;
`10/4/2022 Reply
`
`European Patent Application No.
`20775971.3, including, but not
`limited to 4/8/2022 Reply;
`10/4/2022 Reply
`
`European Patent Application No.
`20765403.9, including, but not
`limited to 10/4/2022 Reply
`
`The “exclusion criteria”
`represent informational content
`regarding the patient that is not
`functionally related to other
`claim elements, and therefore,
`should be considered “printed
`matter” that are accorded “no
`patentable weight.”
`
`“wherein exclusion
`criteria for the patient
`include”
`
`(’601 patent, claims 9,
`17, 25, 33; ’572 patent,
`claim 14)
`[Mylan]
`
`The claim limitations are
`appropriately construed as:
`“assessing the patient for (1)
`active ocular inflammation; and
`(2) active ocular or periocular
`infection, and administering
`aflibercept to the patient on the
`
`
`
`13
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 14 of 16 PageID #: 2388
`
`Claim Term
`
`[Requesting Party]
`
`Regeneron’s Proposed
`Construction and Intrinsic
`Evidence1
`
`Mylan’s Proposed
`Construction and Intrinsic
`Evidence2, 3
`
`basis of the foregoing
`assessment.”
`
`The “patient” is not limited to a
`clinical trial subject.
`
`These limitations are not
`“printed matter” and the
`limitations are entitled to
`patentable weight.
`
`’601 patent, 2:4-11, 4:1-12,
`4:13-22, 4:23-46, 8:9-15, 8:39-
`44, 8:66-9:7, 9:58-10:4, 10:5-
`11, 10:24-40, 17:9-15.
`
`See also U.S. Patent
`Application No. 16/159,282,
`August 14, 2019 Applicant
`Remarks at 6-9.
`
`
`
`
`
`To the extent the Court
`determines that this term should
`be accorded patentable weight, it
`should be construed as follows7:
`
`“wherein exclusion criteria for
`the patient to be eligible in the
`clinical study of the said method
`for treating include”
`
`The entire specification for the
`601 patent, including but not
`limited to: References Cited,
`Related Applications, Title,
`Abstract, Figures, Examples (in
`particular, Example 4), and
`Asserted Claims.
`
`The entire prosecution file
`history for the 601 patent,
`including but not limited to:
`RGN-EYLEA-MYLAN-
`00001666; RGN-EYLEA-
`MYLAN-00002269; RGN-
`EYLEA-MYLAN-00002486;
`RGN-EYLEA-MYLAN-
`00002501-2502; RGN-EYLEA-
`MYLAN-00001688-1689; RGN-
`EYLEA-MYLAN-00001721-
`00004635 (list of over 100
`clinicaltrials.org publications,
`setting forth “Exclusion
`Criteria”).
`
`The entire specification for the
`572 patent, including but not
`limited to: References Cited,
`
`
`7 Mylan objects to the inclusion of Regeneron’s argument that “[t]he ‘patient’ is not limited to a
`clinical trial subject.” The claim term “patient” was not proposed for construction by either party.
`Mylan reserves all rights to argue that Regeneron waived the opportunity to have the claim term
`“patient” construed.
`
`
`
`14
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 15 of 16 PageID #: 2389
`
`Claim Term
`
`[Requesting Party]
`
`Regeneron’s Proposed
`Construction and Intrinsic
`Evidence1
`
`Mylan’s Proposed
`Construction and Intrinsic
`Evidence2, 3
`
`Related Applications, Title,
`Abstract, Figures, Examples (in
`particular, Example 4), and
`Asserted Claims.
`
`The entire prosecution file
`history for the 572 patent.
`
`
`
`III.
`
`STIPULATED CONSTRUCTIONS
`
`The parties exchanged proposed terms for construction and met and conferred regarding
`
`various claim construction disputes. In view of the case schedule and issues raised, the parties
`
`have stipulated to the following claim constructions for purposes of this case:
`
`Claim Term
`
`Agreed-Upon Construction
`
`glycosylated (’865
`patent, claim 1)
`
`containing at least one amino acid residue with an attached
`carbohydrate
`
`cumulative
`concentration (’715
`patent, claims 1, 15, and
`16)
`
`the cumulative amount of a component divided by the volume of
`liquid in the bioreactor at the beginning of the production batch,
`including the contribution to the starting volume from any
`inoculum used in the culture
`
`oxidized species (’532
`patent, claim 19)
`
`
`
`the variants of a protein formed by oxidation
`
`Date: November 17, 2022
`
`STEPTOE & JOHNSON PLLC
`
`/s/ Gordon H. Copland
`Gordon H. Copland (WVSB #828)
`William J. O’Brien (WVSB #10549)
`400 White Oaks Boulevard
`Bridgeport, WV 26330
`(304) 933-8162
`
`
`
`
`
`15
`
`
`
`CAREY DOUGLAS KESSLER & RUBY, PLLC
`
`/s/ David R. Pogue
`Steven R. Ruby (WVSB No. 10752)
`David R. Pogue (WVSB No. 10806)
`707 Virginia Street East
`901 Chase Tower (25301)
`P.O. Box 913
`
`
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 102 Filed 11/17/22 Page 16 of 16 PageID #: 2390
`
`gordon.copland@steptoe-johnson.com
`william.obrien@steptoe-johnson.com
`
`Of Counsel (admitted pro hac vice):
`
`William A. Rakoczy
`Heinz J. Salmen
`Eric R. Hunt
`Jeff A. Marx
`Neil B. McLaughlin
`Lauren M. Lesko
`L. Scott Beall
`Thomas H. Ehrich
`Steven J. Birkos
`Katie A. Boda
`Abraham J. Varon
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 W. Hubbard St., Suite 500
`Chicago, IL 60654
`(312) 527-2157
`wrakoczy@rmmslegal.com
`hsalmen@rmmslegal.com
`ehunt@rmmslegal.com
`jmarx@rmmslegal.com
`nmclaughlin@rmmslegal.com
`llesko@rmmslegal.com
`sbeall@rmmslegal.com
`tehrich@rmmslegal.com
`sbirkos@rmmslegal.com
`kboda@rmmslegal.com
`avaron@rmmslegal.com
`
`Attorneys for Defendant
`Mylan Pharmaceuticals Inc.
`
`
`
`
`Charleston, West Virginia 25323
`(304) 345-1234
`sruby@cdkrlaw.com
`drpogue@cdkrlaw.com
`
`Of Counsel:
`
`David I. Berl (admitted PHV)
`Ellen E. Oberwetter (admitted PHV)
`Thomas S. Fletcher (admitted PHV)
`Andrew V. Trask (admitted PHV)
`Teagan J. Gregory (admitted PHV)
`Shaun P. Mahaffy (admitted PHV)
`Arthur J. Argall III (admitted PHV)
`Adam Pan (admitted PHV)
`Nicholas Jordan (admitted PHV)
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue, SW
`Washington, DC 20024
`(202) 434-5000
`dberl@wc.com
`eoberwetter@wc.com
`tfletcher@wc.com
`atrask@wc.com
`tgregory@wc.com
`smahaffy@wc.com
`aargall@wc.com
`apan@wc.com
`njordan@wc.com
`
`Attorneys for Plaintiff Regeneron
`Pharmaceuticals, Inc.
`
`
`
`
`
`16
`
`