Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 1 of 40 PageID #: 47512
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`AT CLARKSBURG
`
`
`
`
`Case No. 1:22-cv-00061-TSK
`
`
`CONFIDENTIAL:
`
`FILED UNDER SEAL
`
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`
`Defendant.
`
`Plaintiff,
`
`
`v.
`
`
`
`
`
`
`
`DEFENDANT MYLAN PHARMACEUTICALS INC.’S
`RESPONSIVE CLAIM CONSTRUCTION BRIEF
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 2 of 40 PageID #: 47513
`
`TABLE OF CONTENTS
`
`I. 
`
`II. 
`
`INTRODUCTION. ............................................................................................................. 1 
`
`RESPONSIVE ARGUMENT: The 865 Patent Claim Terms. .......................................... 2 
`
`A. 
`
`“Organic Co-Solvent” ............................................................................................. 2 
`
`1. 
`
`2. 
`
`3. 
`
`Regeneron fails to assist the Court in construing the claim term. .............. 3 
`
`Neither the claims nor the specification establishes that the
`“organic co-solvent” is polysorbate. .......................................................... 4 
`
`Regeneron misstates the parties’ dispute and Mylan’s construction. ......... 6 
`
`B. 
`
`“[Present In] Native Conformation.” ...................................................................... 8 
`
`1. 
`
`2. 
`
`3. 
`
`Regeneron’s non-construction reflects legal error and fails its
`burden. ........................................................................................................ 8 
`
`The “as measured by size exclusion chromatography” limitation is
`indefinite and superfluous under Regeneron’s proposal. ............................ 9 
`
`Mylan’s proposal is grounded in the intrinsic evidence. .......................... 10 
`
`III. 
`
`RESPONSIVE ARGUMENT: The Dosing Patents Claim Terms. ................................. 11 
`
`A. 
`
`B. 
`
`C. 
`
`Regeneron’s demand to take patients out of the clinical trial context
`converts its claim language into superfluous statements of intended effect. ........ 11 
`
`“Best Corrected Visual Acuity” (BCVA). ............................................................ 13 
`
`“Wherein Exclusion Criteria For The Patient Include” (“Exclusion
`Criteria”). .............................................................................................................. 18 
`
`1. 
`
`2. 
`
`The “exclusion criteria” are unpatentable printed matter. ........................ 18 
`
`The intrinsic evidence confirms the clinical trial context. ........................ 20 
`
`IV. 
`
`RESPONSIVE ARGUMENT: The Tustian Patents Claim Terms. ................................. 21 
`
`A. 
`
`“Chemically Defined Medium (CDM)” ............................................................... 21 
`
`1. 
`
`2. 
`
`3. 
`
`The specification definition excludes extracts (i.e. hydrolysates). ........... 21 
`
`The specification and 635 provisional application are consistent. ........... 22 
`
`Hydrolysate is not an individual plant-derived component. ..................... 23 
`
`i
`
`

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`Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 3 of 40 PageID #: 47514
`
`B. 
`
`“Clarified Harvest of Cells/Harvested From a Host Cell Cultured in a
`[CDM]” ................................................................................................................. 24 
`
`1. 
`
`2. 
`
`3. 
`
`“Comprising” cannot be used to eviscerate other express claim
`terms. ......................................................................................................... 24 
`
`The claims themselves make clear that the cell culture occurs in
`CDM. ........................................................................................................ 26 
`
`Regeneron’s attempt to expand claim scope should be rejected. .............. 28 
`
`C. 
`
`“Anti-Oxidants” And “Formulated As An Isotonic Solution” ............................. 30 
`
`V. 
`
`CONCLUSION ................................................................................................................. 30 
`
`
`
`
`
`
`ii
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 4 of 40 PageID #: 47515
`
`TABLE OF AUTHORITIES
`Cases 
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
`239 F.3d 1343 (Fed. Cir. 2001) .............................................................................................. 1, 3
`
`AstraZeneca LP v. Apotex, Inc.,
`633 F.3d 1042 (Fed. Cir. 2010) ................................................................................................ 19
`
`Avid Tech., Inc. v. Harmonic, Inc.,
`812 F.3d 1040 (Fed. Cir. 2016) .................................................................................................. 3
`
`Bard Peripheral Vascular, Inc. v. AngioDynamics, Inc.,
`No. 15-218, 2019 WL 1996022 (D. Del. Feb. 11, 2019) .......................................................... 20
`
`Baxter Healthcare Corp. v. Mylan Lab’ys Ltd.,
`346 F. Supp. 3d 643 (D.N.J. 2016) ............................................................................................. 2
`
`Bristol-Myers Squibb Co. v. Ben Venue Lab’ys, Inc.,
`246 F.3d 1368 (Fed. Cir. 2001) ......................................................................................... passim
`
`Chef Am., Inc. v. Lamb-Weston, Inc.,
`358 F.3d 1371 (Fed. Cir. 2004) ................................................................................................ 15
`
`CIAS, Inc. v. All. Gaming Corp.,
`504 F.3d 1356 (Fed. Cir. 2007) .................................................................................................. 4
`
`Cont’l Circuits LLC v. Intel Corp.,
`915 F.3d 788 (Fed. Cir. 2019) .................................................................................................... 5
`
`Dippin’ Dots, Inc. v. Mosey,
`476 F.3d 1337 (Fed. Cir. 2007) .......................................................................................... 25, 29
`
`Embrex, Inc. v. Serv. Eng’g Corp.,
`216 F.3d 1343 (Fed. Cir. 2000) .......................................................................................... 25, 28
`
`Finjan LLC v. ESET, LLC,
`51 F.4th 1377 (Fed. Cir. 2022) ................................................................................................. 22
`
`Hill-Rom Servs., Inc. v. Stryker Corp.,
`755 F.3d 1367 (Fed. Cir. 2014) .................................................................................................. 5
`
`Housey Pharms., Inc. v. AstraZeneca UK Ltd.,
`366 F.3d 1348 (Fed. Cir. 2004) .................................................................................... 2, 6, 8, 10
`
`In re Ngai,
`367 F.3d 1336 (Fed. Cir. 2004) ................................................................................................ 19
`
`iii
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 5 of 40 PageID #: 47516
`
`In re: Copaxone Consol. Cases,
`906 F.3d 1013 (Fed. Cir. 2018) ......................................................................................... passim
`
`Intellectual Ventures I LLC v. T-Mobile USA, Inc.,
`902 F.3d 1372 (Fed. Cir. 2018) .............................................................................................. 5, 8
`
`Invitrogen Corp. v. Biocrest Mfg., LP,
`327 F.3d 1364 (Fed. Cir. 2003) ................................................................................................ 29
`
`King Pharms., Inc. v. Eon Labs, Inc.,
`616 F.3d 1267 (Fed. Cir. 2010) .......................................................................................... 18, 19
`
`Liebel-Flarsheim Co. v. Medrad, Inc.
`358 F.3d 898 (Fed. Cir. 2004) .................................................................................................... 5
`
`Minton v. Nat’l Ass’n of Sec. Dealers, Inc.,
`336 F.3d 1373 (Fed. Cir. 2003) ................................................................................................ 13
`
`Moore U.S.A. Inc. v. Standard Reg. Co.,
`2000 WL 876884 (W.D.N.Y. May 26, 2000) ............................................................................. 1
`
`NeoMagic Corp. v. Trident Microsystems, Inc.,
`287 F.3d 1062 (Fed. Cir. 2002) .................................................................................................. 3
`
`Novartis Pharms. Corp. v. Abbott Lab’ys,
`375 F.3d 1328 (Fed. Cir. 2004) .............................................................................................. 6, 7
`
`Nuvo Pharm. (Ireland) Designated Activity Co. v. Dr. Reddy’s Labs. Inc.,
`923 F.3d 1368 (Fed. Cir. 2019) .............................................................................................. 4, 9
`
`On Demand Mach. Corp. v. Ingram Indus.,
`442 F.3d 1331 (Fed. Cir. 2006) ............................................................................................ 4, 13
`
`Ortho-McNeil Pharm., Inc. v. Mylan Lab’ys, Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) ................................................................................................ 15
`
`Phillips v. AWH Corp.,
`415 F.3d at 1303 (Fed. Cir. 2005) ........................................................................................... 2, 4
`
`Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
`843 F.3d 1315 (Fed. Cir. 2016) ................................................................................................ 15
`
`Power Mosfet Techs., LLC v. Siemens AG,
`378 F.3d 1396 (Fed. Cir. 2004) ................................................................................................ 25
`
`PPG Indus. v. Guardian Indus. Corp.,
`156 F.3d 1351 (Fed. Cir. 1998) .................................................................................................. 4
`
`iv
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 6 of 40 PageID #: 47517
`
`Praxair Distrib., Inc. v. Mallinckrodt Hosp. Prods. IP Ltd.,
`890 F.3d 1024 (Fed. Cir. 2018) .......................................................................................... 19, 20
`
`Profectus Tech. LLC v. Huawei Techs. Co.,
`823 F.3d 1375 (Fed. Cir. 2016) .................................................................................................. 6
`
`Prometheus Lab’ys Inc. v. Roxane Lab’ys, Inc.,
`No. 11-1241, 2013 WL 5333033 (D.N.J. Sept. 23, 2013) ........................................................ 13
`
`Raytheon Co. v. Sony Corp.,
`727 F. App'x 662 (Fed. Cir. 2018) ...................................................................................... 25, 26
`
`Rhine v. Casio, Inc.,
`183 F.3d 1342 (Fed. Cir. 1999) ............................................................................................ 4, 10
`
`Seabed Geosolutions (US) Inc. v. Magseis FF LLC,
`8 F.4th 1285 (Fed. Cir. 2021) ................................................................................................... 17
`
`SRI Int’l v. Matsushita Elec. Corp. of Am.,
`775 F.2d 1107 (Fed. Cir. 1985) .............................................................................................. 2, 3
`
`Tate Access Floors, Inc. v. Interface Architectural Res., Inc.,
`279 F.3d 1357 (Fed. Cir. 2002) .................................................................................................. 5
`
`Teleflex, Inc. v. Ficosa N. Am. Corp.
` 299 F.3d 1313 (Fed. Cir. 2002) ................................................................................................. 5
`
`Trader Techs. Int’l, Inc. v. eSpeed, Inc.,
`595 F.3d 1340 (Fed. Cir. 2010) ................................................................................................ 26
`
`U.S. Surgical Corp. v. Ethicon, Inc.,
`103 F.3d 1554 (Fed. Cir. 1997) .............................................................................................. 2, 3
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) .................................................................................................. 20
`
`XpertUniverse, Inc. v. Cisco Sys., Inc.,
`No. 09-157-RGA, 2012 WL 1416776 (D. Del. Apr. 20, 2012) .................................................. 2
`
`Z4 Techs., Inc. v. Microsoft Corp.,
`507 F.3d 1340 (Fed. Cir. 2007) .................................................................................................. 9
`
`Statutes 
`
`35 U.S.C. § 112 ............................................................................................................................... 9
`
`Other Authorities 
`
`Webster’s Third New International Dictionary 514 (1993) ........................................................... 6
`
`v
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 7 of 40 PageID #: 47518
`Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 7 of 40 PagelD #: 47518
`
`<a
`
`(“865 patent”)
`
`Certified U.S. Patent No. 11,253,572 (RGN-EYLEA-MYLAN-00036361-87)
`(“572 patent”)
`
`Certified U.S. Patent No. 10,888,601 (RGN-EYLEA-MYLAN-00017798-820)
`(“601 patent”)
`
`Certified U.S. Patent No. 11,053,280 (RGN-EYLEA-MYLAN-00028420-607)
`(“280 patent”)
`
`Table of Exhibits Cited in Responsive Brief Certified U.S. Patent No. 11,084,865 (RGN-EYLEA-MYLAN-00028406-419)
`
`U.S. Provisional Patent Application No. 62/944,635
`
`Certified U.S. Patent No. 11,104,715 (RGN-EYLEA-MYLAN-00036163-360)
`(“715 patent”)
`
`WO 2007/0077217 from Certified File History of U.S. Patent No. 11,053,280
`(RGN-EYLEA-MYLAN-00024664-93)
`
`Loyd V.Allen, Jr. et al., Dosage Form Design: Pharmaceutical and
`Formulation Considerations, in ANSEL’S PHARMACEUTICAL DOSAGE FORMS
`AND DruG DELIVERY SYSTEMS92 (8th ed. 2005) (“Ansel’s 2005”)
`
`Florian Krattenmacher, Beyond Chemically Defined—Characterization of
`Chemically Defined Cell Culture Mediumfor the Cultivation of CHO
`Cells(Dec. 2019) (Doctoral thesis, Bielefeld University) from Certified File
`History of U.S. Patent No. 11,053,280 (RGN-EYLEA-MYLAN-00027425-
`634) (“Krattenmacher’’)
`
`AparnaS. Kolhekar et al., Peptidyiglycine a-Hydroxylating Monooxygenase:
`Active Site Residues, Disulfide Linkages, and a Two-Domain Modelofthe
`Catalytic Core, 38 BIOCHEMISTRY 10901 (1997) from Certified File History of
`U.S. Patent No. 11,053,280 (RGN-EYLEA-MYLAN-00025113-21)
`
`Jennie P. Matheret al., Culture of Testicular Cells in Hormone-Supplemented
`Serum-Free Medium, 383 ANNALS N.Y. ACAD. Sci. 44 (1982) from Certified
`File History of U.S. Patent No. 11,053,280 (RGN-EYLEA-MYLAN-
`00025 122-46)
`
`WO 2018/094316 from Certified File History of U.S. Patent No. 11,053,280
`(RGN-EYLEA-MYLAN-00025379-463)
`
`
`
`Exhibit
`
`10
`
`12
`
`22
`
`23
`
`45
`
`65
`
`66
`
`67
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 8 of 40 PageID #: 47519
`Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 8 of 40 PagelD #: 47519
`
`(RGN-EYLEA-MYLAN-00025939-94) WO 2016/156476 from Certified File History of U.S. Patent No. 11,053,280
`
`WO 02/101019 from Certified File History of U.S. Patent No. 11,053,280
`
`(RGN-EYLEA-MYLAN-00025995-6097)
`
`WO2014/145098 from Certified File History of U.S. Patent No. 11,053,280
`(RGN-EYLEA-MYLAN-00026920-7029)
`
`Frank V. Ritaccoet al., Ce// Culture Mediafor Recombinant Protein
`Expression in Chinese Hamster Ovary (CHO) Cells: History, Key
`Components, and Optimization Strategies, 34 BIOTECH. PROGRESS 1407
`(2018) from Certified File History of U.S. Patent No. 11,053,280 (RGN-
`EYLEA-MYLAN-00026920-7029)
`
`Excerpt from 9/29/2021 Request for Prioritized Examination from Certified
`File History of U.S. Patent No. 11,299,532 (RGN-EYLEA-MYLAN-
`00043450-736)
`
`3/11/2021 Non-Final Rejection from Certified File History of U.S. Patent No.
`11,299,532 (RGN-EYLEA-MYLAN-00043826-33)
`
`12/16/2021 Response to Non-Final Office Action from Certified File History
`of U.S. Patent No. 11,299,532 (RGN-EYLEA-MYLAN-00043900-10)
`
`Excerpts from Mylan BLA No. 761274, WBP231 Cell Culture in 2000L
`Bioreactor (MYL-AFL-BLA0008640-41; MYL-AFL-BLA0008655-56)
`(CONFIDENTIAL)
`
`Mylan BLA No. 761274, Section 3.2.S.2.3 Control of Materials (MYL-AFL-
`BLA0013581-627) (CONFIDENTIAL)
`
`
`
`Exhibit
`
`68
`
`69
`
`70
`
`71
`
`72
`
`73
`
`74
`
`75
`
`76
`
`Table of Abbreviations
`
`Initial Patents|U.S. Patent Nos. 10,888,601, 11,053,280, 11,084,865, 11,104,715, 11,253,572
`
`and 11,299,532 (see Dkt. No. 88) MacMichael|Declaration of Gregory MacMichael, Ph.D. in Support of Defendant’s Claim
`
`Construction Brief, dated November 29, 2022 (Dkt. No. 122)
`
`Vii
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 9 of 40 PageID #: 47520
`Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 9 of 40 PagelD #: 47520
`
`
`
`Jungbauer
`
`Tustian
`
`Patents
`
`Dosing
`Patents
`
`601 patent
`
`280 patent
`
`865 patent
`
`715 patent
`
`572 patent
`
`532 patent
`
`635
`application
`
`in Support of Defendant’s Claim
`Construction Brief, dated November 29, 2022 (Dkt. No. 122)
`
`U.S. Patent Nos. 11,053,280, 11,104,715, and 11,299,532
`
`U.S. Patent Nos. 10,888,601 and 11,253,572
`
`USS.Patent No. 10,888,601
`
`USS. Patent No. 11,053,280
`
`USS. Patent No. 11,084,865
`
`USS. Patent No. 11,104,715
`
`USS. Patent No. 11,253,572
`
` Declaration of Alois Jungbauer, Ph.D.
`
`U.S. Patent No. 11,299,532
`
`U.S. Provisional Patent Application No. 62/944,635
`
`vill
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 10 of 40 PageID #:
`47521
`
`Defendant Mylan Pharmaceuticals Inc. (“Mylan”) respectfully submits its Responsive
`
`Claim Construction Brief regarding the Initial Patents selected by Regeneron.
`
`I.
`
`INTRODUCTION.
`
`Regeneron engaged in the exact gamesmanship and violations of claim construction tenets
`
`that Mylan forewarned. (Dkt. No. 122, 1-4). First, for Mylan’s proposed terms, Regeneron “offers
`
`[this Court] no alternative [plain and ordinary meaning] definition[s] and all it does is criticize
`
`[Mylan’s] construction[s].” (Id., 2, quoting C.J. Connolly (emphasis added)). Second, Regeneron
`
`misdirects the Court to its infringement contentions, presenting proposals that are unabashedly
`
`focused on construing claims in view of Mylan’s accused product instead of the intrinsic record.
`
`Yet, “[b]oth infringement and invalidity are at issue,” and therefore, Regeneron’s approach is not
`
`only improper but also ignores the elementary principle of patent law that “claims must be
`
`interpreted and given the same meaning for purposes of both validity and infringement analyses”:
`
`[A]n infringement analysis involves two steps: the claim scope is first determined,
`and then the properly construed claim is compared with the accused device.… [T]he
`first step of an invalidity analysis … is no different from that of an infringement
`analysis. “It is elementary in patent law that, in determining whether a patent is
`valid and, if valid, infringed, the first step is to determine the meaning and scope of
`each claim in suit. A claim must be construed before determining its validity just
`as it is first construed before deciding infringement.”
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1351 (Fed. Cir. 2001) (emphasis
`
`added) (citations omitted); Moore U.S.A., Inc. v. Standard Reg. Co., 2000 WL 876884, at *3
`
`(W.D.N.Y. May 26, 2000) (“Although [plaintiff] may believe that [its] claims are clear and
`
`unambiguous, [defendant] may reasonably require construction of the claims.”).
`
`Regeneron’s non-constructions flout widely accepted claim construction tenets and further
`
`the ongoing prejudice to Mylan under the Regeneron-demanded schedule. Altogether, Regeneron
`
`seeks to skip “the first step” in assessing infringement and validity with non-construction proposals
`
`that do not even identify the meaning or scope of each disputed claim term. On the Tustian Patents,
`
`1
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 11 of 40 PageID #:
`47522
`
`Regeneron pays lip service to the express definition in the specification, then openly seeks a
`
`construction that throws that definition out the window and would read undefined compositions
`
`into the term “chemically defined media.” Mylan’s proposed constructions should govern.
`
`II.
`
`RESPONSIVE ARGUMENT: THE 865 PATENT CLAIM TERMS.
`
`A.
`
`“Organic Co-Solvent”
`
`Regeneron does not once inform the Court how a Formulation-POSA would understand
`
`“organic co-solvent” within the context of the 865 patent claims, failing to either “resol[ve the]
`
`disputed meanings and technical scope [of the claims]” or “clarify…what the patentee covered by
`
`the claims.” U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997). This
`
`alone should prompt the Court to adopt Mylan’s proposal, i.e., the only proposed construction that
`
`sets forth the “ordinary and customary meaning amongst artisans of ordinary skill in the relevant
`
`art at the time of the invention.” Housey Pharms., Inc. v. AstraZeneca UK Ltd., 366 F.3d 1348,
`
`1352 (Fed. Cir. 2004); Phillips v. AWH Corp., 415 F.3d at 1303, 1313 (Fed. Cir. 2005) (en banc).
`
`Courts routinely “reject[], at the outset, the notion that the disputed claim terms require no
`
`construction, or can be construed simply by reference, without explanation, to the ‘plain and
`
`ordinary meaning.’” Baxter Healthcare Corp. v. Mylan Lab’ys Ltd., 346 F. Supp. 3d 643, 653
`
`(D.N.J. 2016); XpertUniverse, Inc. v. Cisco Sys., Inc., No. 09-157-RGA, 2012 WL 1416776, at *1
`
`(D. Del. Apr. 20, 2012) (rejecting constructions that “[do not] clarify what the patentee covered
`
`by the claims”). Rather than give this Court the requisite “plain and ordinary meaning,” Regeneron
`
`pre-litigates infringement, focusing entirely on one embodiment it claims should be included in an
`
`otherwise undefined term.1 But doing so ignores assertions that these “organic co-solvent” claims
`
`
`1 Regeneron’s attempt to argue its infringement case in a claim construction brief is improper. SRI
`Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1118 (Fed. Cir. 1985) (en banc) (“[C]laims
`are not construed ‘to cover’ or ‘not to cover’ the accused device. That procedure would make
`infringement a matter of judicial whim. It is only after the claims have been construed without
`
`2
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 611 Filed 09/01/23 Page 12 of 40 PageID #:
`47523
`
`are not infringed and invalid. (Dkt. No. 47, 36-37). Bottom line, the claims must be construed,
`
`objectively, from the perspective of a Formulation-POSA to resolve the full scope of the parties’
`
`disputes. Amazon.com, 239 F.3d at 1351. Regeneron wants to avoid that legal prerequisite.
`
`Regeneron’s arguments—to the extent they can be nailed down—would expand claims’
`
`scope well beyond a Formulation-POSA’s understanding, and eviscerate the notice function.
`
`Mylan’s construction reflects the plain and ordinary meaning in view of the intrinsic record.
`
`1.
`
`Regeneron fails to assist the Court in construing the claim term.
`
`No Definition. Regeneron admits that a “core purpose of claim construction” is “‘to
`
`clarify’ claim scope” “so that ‘the finder of fact has an understandable interpretation of [what]
`
`claim scope to apply.” (Dkt. No. 124, 8 (citing U.S. Surgical, 103 F.3d at 1568 and Avid Tech.,
`
`Inc. v. Harmonic, Inc., 812 F.3d 1040, 1050 (Fed. Cir. 2016)). But, Regeneron then fails to give
`
`the Court a definition that can be used to assess both non-infringement and invalidity issues.
`
`Legal Error. In place of an actual “organic co-solvent” definition, Regeneron urges the
`
`Court to just find that “polysorbate[s] are ‘organic co-solvents,’” mainly “because Mylan’s product
`
`undisputedly uses polysorbate 20.” (Dkt. No. 124, 5-6). First, as Mylan previously explained,
`
`(Dkt. No. 122, 11), Regeneron’s request defies “well settled” precedent “that claims may not be
`
`construed by reference to the accused device.” NeoMagic Corp. v. Trident Microsystems, Inc.,
`
`287 F.3d 1062, 1074 (Fed. Cir. 2002). The Federal Circuit has reiterated that “[a] claim is
`
`construed in the light of [the intrinsic evidence], not in light of the accused device.” SRI Int’l, 775
`
`F.2d at 1118. And, courts cannot, “under the rubric of claim construction,” give “a claim whatever
`
`
`reference to the accused device that the claims, as so construed, are applied to the accused device
`to determine infringement.”). Regeneron’s accusation demands a response: Mylan does not use
`an “organic co-solvent.” Faced with that reality, Regeneron asks this Court to rewrite the 865
`patent claims to capture an otherwise non-infringing formulation.
`
`3
`
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`additional precision or specificity is necessary to facilitate a comparison between the claim and
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`the accused product.” PPG Indus. v. Guardian Indus., 156 F.3d 1351, 1355 (Fed. Cir. 1998).
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`Second, Regeneron asks this Court to not give meaning to the full claim term: “there is no
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`need for the Court to consider what additional substances this claim term encompasses.” (Dkt.
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`No. 124, 6). The Federal Circuit rejects this approach as well. The “interpretation to be given a
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`term can only be determined and confirmed with a full understanding of what the inventors
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`actually invented and intended to envelop with the claim.” Phillips, 415 F.3d at 1316 (emphasis
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`added). This “full understanding” is essential because “claims cannot be of broader scope than the
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`invention that is set forth in the specification,” lest they be construed invalid. On Demand Mach.
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`Corp. v. Ingram Indus., 442 F.3d 1331, 1340 (Fed. Cir. 2006); Nuvo Pharms. (Ireland) Designated
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`Activity Co. v. Dr. Reddy’s Lab’ys. Inc., 923 F.3d 1368, 1382-84 (Fed. Cir. 2019); Rhine v. Casio,
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`Inc., 183 F.3d 1342, 1345 (Fed. Cir. 1999) (constructions rendering claims invalid or meaningless
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`should be avoided). Since adopting Regeneron’s proposal invites legal error, it should be rejected.
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`2.
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`Neither the claims nor the specification establishes that the “organic
`co-solvent” is polysorbate.
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`Regeneron tries to bolster its theory by arguing “[t]he dependent claims” state that “the
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`‘organic co-solvent’ is ‘polysorbate.’” (Dkt. No. 124, 5). This is not accurate, no matter how
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`carefully Regeneron places its quotation marks. Instead, the claims clearly require an “ophthalmic
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`formulation” comprising an “organic co-solvent … wherein said organic co-solvent comprises …
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`polysorbate.” CIAS, Inc. v. All. Gaming Corp., 504 F.3d 1356, 1360–61 (Fed. Cir. 2007)
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`(“comprising” means “including”). The claims never say the “organic co-solvent is polysorbate,”
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`and for good reason: polysorbate is actually a surfactant. (MacMichael ¶44). Overall, the claims
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`are clear regarding “organic co-solvent,” and thus, as a matter of “[f]airness and the public notice
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`function,” the Court should “bind” Regeneron to the full breadth of its claim language. Tate Access
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`4
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`Floors, Inc. v. Interface Architectural Res., Inc., 279 F.3d 1357, 1367 (Fed. Cir. 2002). But even
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`assuming the dependent claims let the organic co-solvent include a polysorbate surfactant, that
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`doesn’t answer the question of what the term “organic co-solvent” means to a Formulation-POSA.
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`The specification also does not “state clearly” that “polysorbate is an organic co-solvent”
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`(Dkt. No. 124, 6 (emphasis added)) and its disclosure of certain embodiments where “the organic
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`co-solvent may be polysorbate” is not enough. (Ex.5, 2:39-40, 49-50 (“[i]n various embodiments,
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`the organic co-solvent is polysorbate and/or PEG”)). “Even when the specification describes only
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`a single embodiment, the claims of the patent will not be read restrictively unless the patentee has
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`demonstrated a clear intention to limit the claim scope using ‘words or expressions of manifest
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`exclusion or restriction.’” Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir.
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`2004) (quoting Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002)).2
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`Regeneron cannot—nor has it even tried to3—“demonstrate[] an intent to deviate from the ordinary
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`and accustomed meaning of [polysorbate, which is universally defined as a surfactant,] through
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`expressions of manifest exclusion or restriction.” Intellectual Ventures I LLC v. T-Mobile USA,
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`Inc., 902 F.3d 1372, 1378-79 (Fed. Cir. 2018). Consequently, none of the claim construction cases
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`that could give “organic co-solvent” or “polysorbate” a non-ordinary meaning apply here.
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`Regeneron also failed to meet (or even address) the “exacting” standard for lexicography.
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`Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1371 (Fed. Cir. 2014). “To act as its own
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`lexicographer, [Regeneron] must clearly set forth a definition of the disputed claim term other than
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`its plain and ordinary meaning’ and must ‘clearly express an intent to redefine the term.” Id. It
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`did not. In sum, Regeneron has not proved “organic co-solvent” should be redefined to mean
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`2 See also Cont’l Circuits LLC v. Intel Corp., 915 F.3d 788, 797 (Fed. Cir. 2019).
`3 This is because Regeneron does not advocate a construction; it only criticizes Mylan’s.
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`something different than what a Formulation-POSA understands.
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`3.
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`Regeneron misstates the parties’ dispute and Mylan’s construction.
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`To artificially advance its argument, Regeneron oversimplifies the parties’ dispute as
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`merely whether polysorbate is an organic co-solvent. (Dkt. No. 124, 5). That is neither the issue,
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`nor the relevant inquiry. The disputed term is “organic co-solvent.” The appropriate inquiry is
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`“how a Formulation-POSA understands that term within the context of the 865 patent claims.”
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`Only Mylan provides an answer: an organic substance added to a primary solvent to increase the
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`solubility of said VEGF antagonist. (Dkt. No. 122, 10-11). Mylan’s construction also adheres to
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`a meaning the Federal Circuit adopted: “[a] co-solvent is a ‘solvent that in conjunction with
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`another solvent can dissolve a solute.’” Novartis Pharms. Corp. v. Abbott Lab’ys, 375 F.3d 1328,
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`1335 (Fed. Cir. 2004) (quoting Webster’s Third New International Dictionary 514 (1993)).
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`Regeneron complains Mylan’s construction improperly relies on extrinsic evidence. Not
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`so. Mylan’s construction is informed by a Formulation-POSA’s knowledge, as confirmed by
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`pharmaceutical treatises, and thus, meets the “‘heavy presumption’ that the language in the claim
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`‘carries its ordinary and customary meaning.’” Housey, 366 F.3d at 1352; (Ex.44, 125 (“in the
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`preparation of solutions, one or more solvents are used to dissolve the drug substance”), 129
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`(defining “solvent” as “[a pharmaceutical ingredient u]sed to dissolve another substance in
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`preparation of a solution”); MacMichael ¶41). “Extrinsic evidence may not be used ‘to contradict
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`claim meaning that is unambiguous in light of the intrinsic evidence.’” Profectus Tech. LLC v.
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`Huawei Techs. Co., 823 F.3d 1375, 1380 (Fed. Cir. 2016) (emphasis added) (citation omitted).
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`Mylan’s approach neither contradicts the intrinsic record nor relies on contradictory extrinsic
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`evidence. Mylan also does not exclude embodiments. Instead, Mylan’s construction reflects the
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`proper use of extrinsic evidence—i.e., to ascertain “relevant scientific principles, the meaning of
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`technical terms, and the state of the art.” Phillips, 415 F.3d at 1314.
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`6
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`Mylan’s Proposal Does Not Exclude Embodiments. Regeneron also mischaracterizes
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`Mylan’s construction by arguing that “despite being specifically listed as ‘organic co-solvents’ in
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`the claims and specification, [polysorbates] somehow could be excluded [under Mylan’s
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`construction] from the scope of that term.” (Dkt. No. 124, 5). That is not Mylan’s position, nor is
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`it a correct application of Mylan’s construction. As previously explained, the claims provide a
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`“list of excipients that may be used as an ‘organic co-solvent’ in the claimed formulation, e.g.,
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`polysorbate.” (Dkt. No. 122, 9). In other words, Mylan does not dispute that in some
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`circumstances, polysorbates “may be” (and conversely, may not be) co-solvents—which is exactly
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`how the claims and specification describe the use of polysorbates. (E.g., Ex.5, 2:39-41 (“the
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`organic co-solvent may be polysorbate, for example, polysorbate 20”)). Mylan’s proposal thus
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`does not exclude embodiments. Instead, as a Formulation-POSA reading the claims understands,
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`Mylan’s constructio