Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 1 of 78 PageID #: 24161
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
` CIVIL NO. 1:22-CV-61
`
`
` (KLEEH)
`
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`Plaintiff/Counter-Defendant,
`
`
`v.
`
`
`
`
`
`
`
`
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`Defendant/Counter-Claimant.
`
`
`ORDER ON CLAIM CONSTRUCTION
`
`INTRODUCTION
`The patents now before the Court with terms requiring
`construction are: U.S. Patent No. 11,084,865 (“the ‘865 patent”
`or the “Formulation Patent”) (Dkt. 146, ‘865 patent); U.S. Patent
`Nos. 10,888,601 (“the ‘601 patent”) and 11,253,572 (“the ‘572
`patent”) (collectively, the “Dosing Patents”) (Dkt. 146, ‘601
`patent; Dkt. 146, ‘572 patent); and U.S. Patent No. 11,104,715
`(“the ‘715 patent” or “the Manufacturing Patent”) (Dkt. 146, ‘715
`patent).1
`
`
`
`
`
`
`
`
`1 Regeneron initially asserted U.S. Patent Nos. 11,053,280, and 11,299,532,
`(Dkt. 146, MOB at 3, n.3), but has since withdrawn these from the first stage
`of the litigation.
`
`

`

`
`
`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 2 of 78 PageID #: 24162
`REGENERON V. MYLAN
`
`1:22-CV-61
`
`ORDER ON CLAIM CONSTRUCTION
`
`This Court has examined the disputes over the construction of
`these claim terms and, on January 24, 2023, held a hearing pursuant
`to Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996).
`GENERAL CONCLUSIONS OF LAW
`Claim construction is the process by which the Court gives
`legal effect to the meaning of the claims of the asserted patents.
`See Teva Pharm. USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 321-22
`(2015). “It is not an obligatory exercise in redundancy” and is
`not required where a term’s meaning is apparent from the claim
`language itself or its scope is not disputed. U.S. Surgical Corp.
`v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997). “[S]ome
`line-drawing problems . . . [are] properly left to the trier of
`fact.” Acumed LLC v. Stryker Corp., 483 F.3d 800, 806 (Fed. Cir.
`2007).
`The Federal Circuit’s leading authority on how to construe
`claims, Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en
`banc), explains that “the claims of a patent define the invention.”
`Id. at 1312 (quotation marks omitted). “[T]he claims themselves
`provide substantial guidance as to the meaning of particular claim
`terms” and “the context in which a term is used in the asserted
`claim can be highly instructive.” Id. at 1314. This is true for
`both the claim containing the disputed term itself, as well as all
`other claims in the patent—whether asserted or unasserted. Id.
`
`
`
`2
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`REGENERON V. MYLAN
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`1:22-CV-61
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`ORDER ON CLAIM CONSTRUCTION
`
`Indeed, “an independent claim is broader than a claim that depends
`from it, so if a dependent claim reads on a particular embodiment
`of the claimed invention, the corresponding independent claim must
`cover that embodiment as well.” Littelfuse, Inc. v. Mersen USA EP
`Corp., 29 F.4th 1376, 1380 (Fed. Cir. 2022); see Phillips, 415
`F.3d at 1314 (“Differences among claims can also be a useful guide
`in understanding the meaning of particular claim terms.”).2
`Together with the claim language, “the specification ‘is
`always highly relevant to the claim construction analysis.
`Usually, it is dispositive; it is the single best guide to the
`meaning of a disputed term.’” Phillips, 415 F.3d at 1315. The
`specification may define claim terms “expressly,” or it may define
`them “by implication,” i.e., “such that the meaning may be found
`in or ascertained by a reading of the patent.” Id. at 1321
`(quotation marks omitted). But while the specification serves as
`a resource to understand the words used in the claims, courts must
`avoid the “cardinal sin[]” of importing language from the
`specification into the claims. Id. at 1320. Indeed, even if every
`example described in the specification contains a particular
`element, such uniformity is not enough to justify importing that
`
`
`2 An “independent” claim is a standalone claim that contains all the
`limitations that define an invention, whereas a “dependent” claim refers back
`to, and incorporates by dependency, a previous independent claim and further
`limits the claim. See generally 37 C.F.R. § 1.75.
`3
`
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`

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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 4 of 78 PageID #: 24164
`REGENERON V. MYLAN
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`1:22-CV-61
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`ORDER ON CLAIM CONSTRUCTION
`
`element into claims whose plain language does not expressly require
`it. See id. at 1323; Liebel-Flarsheim Co. v. Medrad, Inc., 358
`F.3d 898, 906-07 (Fed. Cir. 2004); AstraZeneca AB v. Mylan Pharm.
`Inc., 2022 WL 17178691, at *5-6 (N.D. W. Va. Nov. 23, 2022)
`(“Dependent claims . . . refer to at least one other claim, include
`all of the limitations of the claim to which they refer, and
`specify a further limitation on that claim.”).
`“[A] court ‘should also consider the patent’s prosecution
`history.’” Phillips, 415 F.3d at 1317. “Yet because the
`prosecution history represents an ongoing negotiation between the
`PTO and the applicant, rather than the final product of that
`negotiation, it often lacks the clarity of the specification and
`thus is less useful for claim construction purposes.” Id. To
`find disavowal of the ordinary meaning of a claim term in view of
`the specification based on statements in the prosecution history,
`the Federal Circuit requires that the alleged disavowing actions
`or statements made during prosecution be “both clear and
`unmistakable.” CUPP Comput. AS v. Trend Micro Inc., 53 F.4th 1376,
`1382 (Fed. Cir. 2022).
`
`Where the court “reviews only evidence intrinsic to the patent
`(the patent claims and specifications, along with the patent’s
`prosecution history), the judge’s determination will amount solely
`to a determination of law.” Teva, 574 U.S. at 331. However, in
`
`
`
`4
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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 5 of 78 PageID #: 24165
`REGENERON V. MYLAN
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`1:22-CV-61
`
`ORDER ON CLAIM CONSTRUCTION
`
`situations where the patent does not provide the meaning for a
`claim term, a “court will need to look beyond the patent’s
`intrinsic evidence and to consult extrinsic evidence in order to
`understand, for example, the background science or the meaning of
`a term in the relevant art during the relevant time period.” Id.
`In those circumstances, the court may “make subsidiary factual
`findings about that extrinsic evidence.” Id. at 332. But
`extrinsic evidence cannot be used to “contradict claim meaning
`that is unambiguous in light of the intrinsic evidence.” Phillips,
`415 F.3d at 1324. “[A] court should discount any expert testimony
`that is clearly at odds with the claim construction mandated by
`the claims themselves, the written description, and the
`prosecution history, in other words, with the written record of
`the patent.” Genuine Enabling Tech. LLC v. Nintendo Co., 29 F.4th
`1365, 1373 (Fed. Cir. 2022) (quoting Phillips, 415 F.3d at
`1318); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1584
`(Fed. Cir. 1996) (“[E]xpert testimony ... may not be used to vary
`or contradict the claim language. Nor may it contradict the import
`of other parts of the specification.” (citation omitted)); Omega
`Eng’g, Inc, v. Raytek Corp., 334 F.3d 1314, 1332 (Fed. Cir.
`2003) (“Yet, Omega submits its expert declarations not to shed
`light on this field of art, but to rewrite the patent’s
`specification and explicitly provide for the laser splitting
`
`
`
`5
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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 6 of 78 PageID #: 24166
`REGENERON V. MYLAN
`
`1:22-CV-61
`
`ORDER ON CLAIM CONSTRUCTION
`
`device, lenses, and prisms to strike the center of the energy zone.
`That we cannot accept.”). Accordingly, “where the patent documents
`are unambiguous, expert testimony regarding the meaning of a claim
`is entitled to no weight.” Vitronics, 90 F.3d at 1584.
`DISPUTED TERMS
`A. The Formulation Patent (The ‘865 Patent)
`
`a. “Organic Co-Solvent”
`
`The parties agree that a plain and ordinary meaning applies
`to the term “organic co-solvent.” (See, e.g., Dkt. 124, ROB at 3;
`Dkt. 146, MOB at 9). The specification of the ‘865 patent is clear
`that “all technical and scientific terms used herein have the same
`meaning as commonly understood by one of ordinary skill in the art
`to which this invention belongs.” (Dkt. 146, ‘865 patent at 8:23-
`26).
`The scientific literature explains why there is a need for
`co-solvents:
`Frequently a solute is more soluble in
`mixtures of solvents than in one solvent
`alone. This phenomenon is known as
`cosolvency, and the solvents that, in
`combination, increase the solubility of the
`solute are called cosolvents.
`
`(Dkt. 146, Ex. 50 at 225 (emphasis in original)).
`Mylan’s expert, who undisputedly is one of ordinary skill in
`the art, provided the meaning of organic co-solvent to those of
`ordinary skill: the term “solvent” is well-known in the art (and
`6
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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 7 of 78 PageID #: 24167
`REGENERON V. MYLAN
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`1:22-CV-61
`
`ORDER ON CLAIM CONSTRUCTION
`
`commonly defined) as a pharmaceutical excipient (i.e., an
`ingredient) “[u]sed to dissolve another substance in preparation
`of a solution.” (Dkt. 146, MacMichael Decl. ¶ 52) (internal
`citations omitted). Dr. MacMichael cites to multiple literature
`sources from the pharmaceutical formulation art to support this
`common understanding of a person of ordinary skill in the art.
`(Id. ¶¶ 40-44; see Dkt. 269-1, MYL PPP at slides 9-14).3
`Dr. MacMichael explains that a person of ordinary skill in
`the art also knows that a co-solvent is a pharmaceutical excipient
`used in conjunction with a primary solvent to increase the
`solubility of the substance in question. (Dkt. 146, MacMichael
`Decl. ¶¶ 52-53; Dkt. 269-1, MYL PPP at slide 15 (“A co-solvent, by
`definition, changes the overall behavior of the -- of the combined
`mixtures of the two solvents.”)). More specifically, the co-
`solvent works in conjunction with a primary solvent (e.g., water)
`to better dissolve the drug substance. (Dkt. 146, MacMichael Decl.
`¶ 19). In the ‘865 patent, the drug substance is the specific
`
`
`3 (See also Dkt. 146, Ex. 44 at 125 (to prepare solutions, “…one or more solvents
`are used to dissolve the drug substance”); Dkt. 146, Ex. 49 at 211 (solvent is
`“the dispersing medium” that dissolves the solute); id. at 229 (“A common way
`to increase drug solubility is through the use of a water miscible organic
`solvent…. Addition of a cosolvent … thereby improv[es] solubility”); Dkt. 146,
`Ex. 52 at 1014 (“injectable formulations currently on the market… utilize one
`or more cosolvents to solubilize the active constituents…. The use of water-
`miscible cosolvents is by far the most versatile means of increasing the
`solubility of drugs”); Dkt. 146, Ex. 53 at 912 (“Cosolvents are used to increase
`the solubility of the poorly soluble drug in water… Water-miscible cosolvents
`operate on the principle of lowering the dielectric constant property of water,
`thereby increasing the aqueous solubility of poorly water-soluble drugs.”)).
`7
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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 8 of 78 PageID #: 24168
`REGENERON V. MYLAN
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`1:22-CV-61
`
`ORDER ON CLAIM CONSTRUCTION
`
`VEGF antagonist fusion protein required by the claims. (Id. ¶
`54; see also Dkt. 269-1, MYL PPP at slide 8). Dr. MacMichael thus
`concludes that a person of ordinary skill in the art would
`understand the phrase “organic co-solvent” in claim 1 to have its
`plain and ordinary meaning: an organic substance added to a primary
`solvent to increase the solubility of [another substance]. (See,
`e.g., Dkt. 146, MacMichael Decl. ¶¶ 55, 57).
`Regeneron argues that “organic co-solvent” should be given
`its plain and ordinary meaning, but does not give the Court a
`different plain and ordinary meaning construction for the term
`“organic co-solvent.” (Dkt. 146, MOB at 11; Dkt. 173, MRB at 3).
`This Court “rejects[] at the outset[] the notion that the
`disputed claim terms … 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). Regeneron “cannot avoid defining its own claim
`terms by asserting that its claims have a plain meaning,” and
`effectively appoint itself “arbiter of whether its [own] claims
`are clear and unambiguous.” Liebel-Flarsheim Co. v. Medrad Inc.,
`No. 1:04-CV-607, 2006 WL 335846, at *6 (S.D. Ohio Feb. 14, 2006)
`(quoting Moore U.S.A., Inc. v. Standard Register Co., 2000 WL
`876884, at *3 (W.D.N.Y. 2000)) (internal quotations omitted).
`
`
`
`8
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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 9 of 78 PageID #: 24169
`REGENERON V. MYLAN
`
`1:22-CV-61
`
`ORDER ON CLAIM CONSTRUCTION
`
`Regeneron proposes that the Court just “acknowledge[e]” that
`“polysorbate is an organic co-solvent,” and need not “consider
`what additional substances this [organic co-solvent] claim term
`encompasses.” (Dkt. No. 124, ROB at 6). That is not the proper
`course of action.
`First, it has long-been established that “claims are not
`construed ‘to cover’ or ‘not to cover’ the accused device.” SRI
`Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1118 (Fed.
`Cir. 1985); see also NeoMagic Corp. v. Trident Microsys., Inc.,
`287 F.3d 1062, 1074 (Fed. Cir. 2002) (same). Second, it will not
`“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). Mylan challenges the ‘865 patent claims on both non-
`infringement and invalidity. (See, e.g., Dkt. 47, Answer at
`Counterclaim ¶¶ 156-57; see also Dkt. 269-1, MYL PPP at slides 22-
`23 (illustrating the inapplicability of Regeneron’s proposal to
`the prior art)). Claims must be construed similarly for
`infringement
`and
`invalidity.
`
`v.
`Inc.
`Amazon.com,
`Barnesandnoble.com, Inc., 239 F.3d 1343, 1351 (Fed. Cir. 2001);
`W.L. Gore Assocs., Inc. v. Garlock, Inc., 842 F.2d 1275, 1279 (Fed.
`Cir. 1988). The term “organic co-solvent” needs a single clear
`
`
`
`9
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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 10 of 78 PageID #:
`24170
`REGENERON V. MYLAN
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`1:22-CV-61
`
`ORDER ON CLAIM CONSTRUCTION
`
`construction that will apply for both analyses. Only Mylan’s claim
`construction proposal serves that purpose.
`Since Dr. MacMichael’s description of an “organic co-solvent”
`is unrebutted, it is adopted as the plain and ordinary meaning of
`“organic co-solvent.”
`The intrinsic record, and the role of polysorbates
`
`Regeneron did not provide an actual construction to assist
`the Court to clarify the meaning of “organic co-solvent” to one of
`ordinary skill, but Regeneron does ask the Court to confirm that
`various ingredients must always qualify as the claimed “organic
`co-solvent,” namely “polysorbate 20, polysorbate 80, polyethylene
`glycol, or propylene glycol, or a combination thereof.” (Dkt.
`124, ROB at 5). Regeneron accuses Mylan of wanting to preclude
`them from being categorized as organic co-solvents. (Dkt. 124, ROB
`at 5; Dkt. 174, RRB at 6).
`Mylan does not dispute that there are some formulations where
`a polysorbate ingredient may act as a co-solvent. The
`specification does label some formulations’ polysorbate as a “co-
`solvent.” (See, e.g., Dkt, 146, MacMichael Decl. ¶ 59
`(acknowledging that polysorbate may be used as a co-solvent in
`certain embodiments of the ‘865 patent)). But deciding whether a
`particular ingredient in a particular formulation qualifies as an
`“organic co-solvent” under the claims is premature—that analysis
`
`
`
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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 11 of 78 PageID #:
`24171
`REGENERON V. MYLAN
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`1:22-CV-61
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`ORDER ON CLAIM CONSTRUCTION
`
`occurs after claim construction, and during the infringement and
`invalidity part of the case. (Dkt. 173, MRB at 2-3; Hearing Tr.
`at 38:19-40:7). Mylan objects to permanently pre-judging all
`polysorbates as always organic co-solvents, irrespective of
`formulation purpose or amounts, during claim construction. (Dkt.
`146, MOB at 9-10; Dkt. 124, MRB at 4; Hearing Tr. at 57:22-60:2).
`Regeneron responds that the meaning of co-solvent cannot
`consider whether a given ingredient is serving a function, role or
`purpose within the formulation, citing Ecolab, Inc. v.
`Environchem, Inc., 264 F.3d 1358, 1367 (Fed. Cir. 2001) and
`GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., 744 F.3d 725, 731
`(Fed. Cir. 2014). (Dkt. 174, RRB at 8-11; Hearing Tr. at 21:8-
`22:16; Dkt. 268, REG PPP at slide 21).
`In Ecolab, the district court construed the term
`“substantially uniform” to require that the claimed alkaline
`detergent produce a “homogenous cleaning solution … over the life
`of the cast.” Ecolab, 264 F.3d at 1364-65. The Federal Circuit
`disagreed that this latter requirement—staying homogenous over the
`life of the cast—was required by the “substantially uniform” claim
`language. Id. at 1367. The Federal Circuit did agree though that
`while “there is no claimed functional requirement as to forming a
`homogeneous wash solution throughout the cast life,” the detergent
`solution did have to “contain components capable of ‘ware and hard
`
`
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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 12 of 78 PageID #:
`24172
`REGENERON V. MYLAN
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`1:22-CV-61
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`ORDER ON CLAIM CONSTRUCTION
`
`surface washing.’” Id. at 1366. Thus, Ecolab does not preclude
`ensuring that the meaning of “co-solvent” describes what a solvent
`is supposed to do, e.g., help dissolve something.
`The parties vigorously contested the significance of
`GlaxoSmithKline at the hearing. (Hearing Tr. at 22:4-23:18, 54:11-
`55:11). GlaxoSmithKline involved a Section 112 written
`description challenge; the Federal Circuit considered this
`question “without resolving the claim-construction dispute.” 744
`F.3d at 726 (emphasis added). GlaxoSmithKline’s claims were to
`the drug dutasteride, and “any ‘pharmaceutically acceptable
`solvate thereof,’” with solvate referring to a “crystalline”
`structural arrangement of the atoms of the drug compound. Id. at
`726-27 (emphasis in original). When the Federal Circuit explained
`that “solvate” lacked a functional component, it was in the context
`of differentiating prior written description cases where patentees
`claimed a functional result without a sufficiently supportive
`specification. Id. at 730-31 (reciting cases involving claims to
`plasmids with a DNA coding sequence broadly defined by its
`function; claims to all genetic material capable of encoding
`insulin; claims to an antibody’s ability to bind to an antigen,
`etc.). Even so, when the Federal Circuit discussed the
`GlaxoSmithKline patent’s written description, it noted that a
`solvate must “originate[] in a ‘solution,’ which is a mixture of
`
`
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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 13 of 78 PageID #:
`24173
`REGENERON V. MYLAN
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`1:22-CV-61
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`ORDER ON CLAIM CONSTRUCTION
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`two substances: a ‘solute’ dissolved in a ‘solvent.’” Id. at
`727. GlaxoSmithKline’s description of a solvent as something that
`dissolves something else is what Dr. MacMichael explained
`“[p]ersons of skill in the art widely understand”: co-solvents
`are “used to dissolve another substance.” (Dkt, 146, MacMichael
`Decl. ¶ 20) (emphasis added); see also id. at ¶ 41 (citing Dkt.
`146, Ex. 44; Dkt. 146, Ex. 49; Dkt. 146, Ex. 50; Dkt. 146, Ex. 51;
`Dkt. 146, Ex. 52).
`The function that an ingredient plays in a formulation is not
`an idle issue. Water is a universally recognized solvent, but in
`some contexts, does not work as a solvent (e.g., it cannot dissolve
`sand). (Hearing Tr. at 58:4-14; Dkt 146, Ex. 49 at 211 (noting
`mixing sand and water only produces a suspension, not a solution)).
`Polysorbates may in some circumstances—including for some of
`Regeneron’s specification examples or dependent claims—qualify as
`a co-solvent. But the scientific literature recognizes
`polysorbate’s role in a pharmaceutical formulation as a
`“surfactant.” (Dkt. 173, MRB at 4-6; Hearing Tr. at 45:2-46:15;
`Dkt. 269-1, MYL PPP at slides 10, 14; MOB Ex. 53 at 11 (“Surface
`active agents: polysorbate 80…”)). The terms surfactants and “co-
`solvents” also are not used interchangeably. AstraZeneca, 384
`F.3d at 1338-41 (specification recognized that surfactants and co-
`solvents were different categories of solubilizers); see also Dkt.
`
`
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`24174
`REGENERON V. MYLAN
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`1:22-CV-61
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`ORDER ON CLAIM CONSTRUCTION
`
`146, Ex. 53 at 917 (three different categories of solubilizers:
`cosolvents, surface active agents, and complexing agents). Even
`in this litigation, for other claims, Regeneron calls polysorbate
`a surfactant.4
`At oral argument, Regeneron presented a Venn Diagram
`proposing that the relationship between organic co-solvent and
`polysorbate looked like this:
`
`
`
`
`(Dkt. 268, RGN PPP at slide 17). The evidence of record suggests
`this is more accurate:
`
`
`4 Regeneron continues to assert, e.g., claim 7 of the ‘572 Dosing Patent, which
`requires a regimen that uses aflibercept “formulated with a nonionic
`surfactant.” (Dkt. 146, ‘572 patent at claim 7). In its pleadings, Regeneron
`alleges that Mylan infringes the ‘572 patent claims. (Dkt. 1, Compl. at 32-
`34, ¶¶ 223-232). Regeneron and its expert assert that the same polysorbate
`Regeneron wants to call a “co-solvent” for the purpose of the ‘865 patent also
`meets the “formulated with a nonionic surfactant” element of the ‘572 Dosing
`Patent’s formulation claims. Regeneron’s infringement contentions and expert
`report regarding infringement are not currently part of the claim construction
`record, since Regeneron submitted them after the Markman briefing and/or
`hearing; Mylan is willing to file the relevant evidence if needed by the Court.
`14
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`24175
`REGENERON V. MYLAN
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`1:22-CV-61
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`ORDER ON CLAIM CONSTRUCTION
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`
`
`
`(Hearing Tr. at 58:15-60:2). The parties plainly dispute whether,
`for any given formulation, polysorbate always qualifies as an
`organic co-solvent; a surfactant; or both. Since Regeneron’s
`contentions accuse polysorbate of being a co-solvent for this
`patent, and a surfactant for another patent, it is hardly
`surprising that Mylan’s invalidity contentions likewise identify
`prior art formulations with polysorbates could satisfy the ‘865
`patent’s co-solvent element. (Hearing Tr. at 16:16-17:18, 52:8-
`53:11; Dkt. 268, RGN PPP at slides 19-20). This also indicates
`that the parties’ dispute is more of an infringement/invalidity
`dispute, not a claim construction dispute, the latter of which
`must stay focused on what “organic co-solvent” means to one of
`ordinary skill, having reviewed the intrinsic evidence.
`Regeneron’s other specification-related arguments also do not
`justify changing the plain and ordinary meaning of “organic co-
`solvent” to mandate including all polysorbates.
`Regeneron could have used lexicography in the specification
`to change the plain and ordinary meaning to mandate that organic
`
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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 16 of 78 PageID #:
`24176
`REGENERON V. MYLAN
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`1:22-CV-61
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`ORDER ON CLAIM CONSTRUCTION
`
`co-solvents means polysorbate. Phillips, 415 F.3d at 1312–17.
`But the standard for lexicography is “exacting.” Hill-Rom Servs.,
`Inc. v. Stryker Corp., 755 F.3d 1367, 1371 (Fed. Cir. 2014).
`Regeneron admits it did not use lexicography here. (See, e.g.,
`Dkt. 174, RRB at 1; Hearing Tr. at 73:18-23, 9:23-10:15).
`Patentees can disavow claim scope if the specification “describes
`a feature of the invention” and “criticizes other products” that
`“lack the same feature.” AstraZeneca, 384 F.3d at 1340. But there
`must be a clear “demonstrat[ion of] an intent to deviate from the
`ordinary and accustomed meaning of a claim term through expressions
`of manifest exclusion or restriction.” Intellectual Ventures I LLC
`v. T-Mobile USA, Inc., 902 F.3d 1372, 1378-79 (Fed. Cir. 2018)
`(cleaned up)). Regeneron does not contend disavowal applies. (See
`e.g., Dkt. 174, RRB at 13-14).
`Regeneron suggested that its specification defined “co-
`solvents” by implication to require polysorbate. (Hearing Tr. at
`9:17-10:20). Regeneron insists that “the specification repeatedly
`confirms that substances like polysorbate are organic co-
`solvents,” in a “repeated and unequivocal” way. (Dkt. 124, ROB at
`5 (emphasis added), 6; see also Dkt. 174, RRB at 6).
`The specification carefully avoids being so absolute. The
`specification
`repeatedly
`qualifies
`its
`polysorbate
`and
`polyethylene glycol descriptions. For example, in column 2, the
`
`
`
`16
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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 17 of 78 PageID #:
`24177
`REGENERON V. MYLAN
`
`1:22-CV-61
`
`ORDER ON CLAIM CONSTRUCTION
`
`specification states that “the organic co-solvent may be
`polysorbate… polyethylene glycol … or a combination thereof,” not
`‘is” or “must include” one or more of these ingredients. (Dkt.
`146, ‘865 patent at 2:39-42) (emphasis added). Similarly, when
`column 2 states that the “organic co-solvent is polysorbate and/or
`PEG,” and gives examples of preferred formulations, the
`immediately preceding text qualifies all of them as reflective of
`“various embodiments.” (Id. at 2:49-50) (emphasis added). The
`same holds true for the formulations with polysorbate in column 3
`onwards, which are specific formulation recipes described as
`“specific preferred embodiment[s]” or “examples.” (Id. at 3:1-
`10; id. at 3:28-29 (“In another embodiment, the organic co-solvent
`is selected from one or more of polysorbate…) (emphasis added);
`id. at 7:2-5 (“An example of a pharmaceutically acceptable liquid
`formulation comprises … an organic co-solvent such as
`polysorbate…”); see generally cols. 3-4 (describing formulations
`with polysorbate as embodiments)). The ‘865 patent claims also
`avoid such absolutes, such as by stating “wherein said organic co-
`solvent comprises polysorbate.” (Id. at claims 2-5; Dkt. 269-1,
`MYL PPP at slide 5); CIAS, Inc. v. All. Gaming Corp., 504 F.3d
`1356, 1360-61 (Fed. Cir. 2007) (noting that “comprising” just means
`“including”).
`
`
`
`17
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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 18 of 78 PageID #:
`24178
`REGENERON V. MYLAN
`
`1:22-CV-61
`
`ORDER ON CLAIM CONSTRUCTION
`
`But even assuming the desirability of defining “organic co-
`solvent” by implication, the ‘865 patent’s specification
`forecloses that option, reiterating that “the terminology used
`herein is for the purpose of describing particular embodiments
`only; [it] is not intended to be limiting.” (Dkt. 146, ‘865 patent
`at 8:8-13) (emphasis added). The specification emphasizes that
`the “scope of the present invention will be limited only to the
`appended claims.” (Id. at 8:13-14 (emphasis added); id. at 5:32-
`38 (stating that examples and embodiments were non-limiting, and
`that “the scope of the present invention will be limited only by
`the appended claims”)). Regeneron thus asks the Court for a claim
`construction to change its claims’ parameters based on its
`particular embodiments, despite its specification reiterating not
`once, but twice, to not do that. Regeneron’s approach thus
`conflicts with the specification.
`Regeneron alternatively speculates that if proof of an
`ingredient’s “functional” behavior is needed to qualify as a co-
`solvent, this causes all of the claims to exclude preferred
`embodiments. (Dkt. 124, ROB at 7; Dkt. 174, RRB at 8-9). The
`briefing citations and excerpt of Dr. MacMichael’s testimony that
`Regeneron provided at oral argument on claims 2-5 does not support
`the premise. (Hearing Tr. at 55:12-56:13; Dkt. 268, RGN PPP at
`slide 27).
`
`
`
`18
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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 19 of 78 PageID #:
`24179
`REGENERON V. MYLAN
`
`1:22-CV-61
`
`ORDER ON CLAIM CONSTRUCTION
`
`The ‘865 patent has 64 claims. While claim 1 requires a co-
`solvent, claim 51 does not, even though claim 51 does expressly
`require using polysorbate in the formulation. (Dkt. 146, ‘865
`patent at claim 51 (“ophthalmic formulation comprising: (a) 40
`mg/ml of a glycosylated VEGF antagonist fusion protein” from “SEQ
`ID NO:4; (b) 0.03% to 0.1% polysorbate” and other excipients)
`(emphasis added)). Claim 51 corresponds to embodiments, e.g.,
`those in column. 2, lines 53 through 57; in Example 3 (40 mg/mL
`formulation, fusion protein, 0.03% polysorbate 20, and other
`excipients); and in Example 4 (40 mg/mL formulation, fusion
`protein, 0.03% polysorbate 20, and other excipients). Example 2
`of the ‘865 patent also is an embodiment of claim 1. (Hearing Tr.
`at 42:25-43:6). Regeneron thus does have claims that cover its
`polysorbate embodiments; and its non-polysorbate embodiments.
`While courts should consider whether a claim construction would
`exclude all embodiments, “where the patent describes multiple
`embodiments, every claim does not need to cover every embodiment.”
`Pacing Techs., LLC v. Garmin Int’l, Inc., 778 F.3d 1021, 1026 (Fed.
`Cir. 2015).
`Thus, in view of the intrinsic record, “organic co-solvent”
`cannot be construed to require covering all polysorbates in all
`circumstances. See Conoco, Inc. v. Energy & Env’t Int’l., L.C.,
`460 F.3d 1349, 1358 (Fed. Cir. 2006) (finding a specification that
`
`
`
`19
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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 20 of 78 PageID #:
`24180
`REGENERON V. MYLAN
`
`1:22-CV-61
`
`ORDER ON CLAIM CONSTRUCTION
`
`stated an amount of alcohol “may vary widely but it usually forms
`between about 0 and 70 weight percent of the suspending material”
`did not limit the claims to between 0 and 70 percent).
`Given the above, the Court adopts Mylan’s definition of “co-
`solvent” to have its plain and ordinary meaning to a person of
`ordinary skill in the art: it is an organic substance added to
`the primary solvent to increase the solubility of the solute, here
`a VEGF antagonist. The Court will decide the question of whether
`a specific formulation with polysorbate 20, polysorbate 80,
`polyethylene glycol, or propylene glycol satisfies the “organic
`co-solvent” claim language during the infringement and invalidity
`part of this case.
`b. “Present in Native Conformation”
`
`The parties generally agree that the “native” protein for
`purposes of the claims here is the original, intact, aflibercept
`fusion protein, standing alone as a single molecule. (Hearing Tr.
`at 29:15-17 (Regeneron stating “you have something present in the
`native conformation. That’s the aflibercept by itself.”); id. at
`61:22-24 (Mylan stating “native conformation, Your Honor, is a
`reference to the protein in its original form and structure,
`without any degradation.”)).
`Proteins are complex biologic molecules. The specification
`recognizes that the nature of proteins’ structures present
`
`
`
`20
`
`

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`Case 1:22-cv-00061-TSK-JPM Document 427 Filed 04/19/23 Page 21 of 78 PageID #:
`24181
`REGENERON V. MYLAN
`
`1:22-CV-61
`
`ORDER ON CLAIM CONSTRUCTION
`
`pharmaceutical formulators with unique issues. Proteins can
`degrade
`chemically,
`through
`“deamination”
`reactions,
`“aggregation,” by “clipping of the peptide backbone,” and by
`“oxidation of methionine residues.” (Dkt. 146, ‘865 patent at
`5:56-58). Proteins can degrade physically, through “many
`phenomena,
`including,
`for
`example,
`aggregation
`and/or
`precipitation.” (Id. at 5:58:60). If aflibercept is chemically
`changed, it is no longer aflibercept; if it is aggregated or
`precipitated, it also will no longer be a “single aflibercept
`molecule by itself.” (Hearing Tr. at 28:25 – 30:7).
`Plain and ordinary meaning
`
`Dr. MacMichael, consistent with the specification, explained
`that the “plain and ordinary meaning of the term ‘[present in]
`native conformation’ requires the VEGF antagonist fusion protein
`to be present in a form that does not exhibit chemical or physical
`instability. A POSA would understand that aflibercept ‘[present
`in] nativ