Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 1 of 33
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF MASSACHUSETTS
`
`
`
`
`
`
`
`
`MEMORANDUM AND ORDER ON CLAIM CONSTRUCTION
`
`
`BURROUGHS, D.J.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`In this patent infringement suit, Teva Pharmaceuticals International GmbH and Teva
`
`Pharmaceuticals USA, Inc. (collectively, “Teva”) allege that Eli Lilly and Company (“Lilly”) has
`
`infringed claims in nine patents owned by Teva related to a product marketed under the brand
`
`name Ajovy, which contains the active ingredient fremanezumab and is used to treat migraines.
`
`[ECF No. 1]. Lilly has brought counterclaims against Teva, seeking declaratory judgments that
`
`its product marketed under the brand name Emgality, which contains the active ingredient
`
`galcanezumab and is also used to treat migraines, does not infringe Teva’s patents and that
`
`Teva’s patents are invalid. [ECF No. 17]. The parties briefed claim construction for six disputed
`
`terms, [ECF Nos. 65, 66, 77, 79, 89, 90], and the Court conducted a hearing on December 15,
`
`2020, at which the parties presented their proposed constructions, [ECF No. 88]. The Court
`
`construes the terms as set forth below.
`
`Civil Action No. 18-cv-12029-ADB
`
`*************
`
`
`*
`
`
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and TEVA
`PHARMACEUTICALS USA, INC.,
`
`
`
`
` Plaintiffs and Defendants-in-
`Counterclaim,
`
`
`v.
`
`
`
`
`
`
`
`ELI LILLY AND COMPANY,
`
`
`
`
`Defendant and Plaintiff-in-
`Counterclaim.
`
`
`
`
`
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 2 of 33
`
`I.
`
`LEGAL STANDARD
`
`A.
`
`Claim Construction
`
`Claim construction is the first stage of a patent infringement analysis and requires the
`
`Court to determine “the scope and meaning of the patent claims asserted.” Clearstream
`
`Wastewater Sys., Inc. v. Hydro-Action, Inc., 206 F.3d 1440, 1444 (Fed. Cir. 2000). Claim
`
`construction is a question of law for the Court, Markman v. Westview Instruments, Inc., 517
`
`U.S. 370, 372 (1996), to be resolved with an eye toward the fact that the Court’s adopted
`
`construction “becomes the basis of the jury instructions, should the case go to trial” on the issue
`
`of infringement, AFG Indus., Inc. v. Cardinal IG Co., 239 F.3d 1239, 1247 (Fed. Cir. 2001).
`
`“[T]he claims of a patent define the invention to which the patentee is entitled the right to
`
`exclude.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (citation and internal
`
`quotation marks omitted). “[T]he words of a claim are generally given their ordinary and
`
`customary meaning,” which “is the meaning that the term would have to a person of ordinary
`
`skill in the art in question at the time of the invention.” Id. at 1312–13 (internal quotation marks
`
`omitted). Certain terms “may be readily apparent even to lay judges, and claim construction in
`
`such cases involves little more than the application of the widely accepted meaning of commonly
`
`understood words.” Id. at 1314.
`
`“There are only two exceptions to this general rule: 1) when a patentee sets out a
`
`definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope of a
`
`claim term either in the specification or during prosecution.” Thorner v. Sony Comput. Ent. Am.
`
`LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). “To act as [his] own lexicographer, a patentee must
`
`clearly set forth a definition of the disputed claim term other than its plain and ordinary
`
`meaning.” Id. (citation and internal quotation marks omitted). Similarly, to disavow the scope
`
`2
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 3 of 33
`
`of a claim term, “[t]he patentee may demonstrate intent to deviate from the ordinary and
`
`accustomed meaning of a claim term by including in the specification expressions of manifest
`
`exclusion or restriction, representing a clear disavowal of claim scope.” Id. at 1366 (citation and
`
`internal quotation marks omitted).
`
`“It is well-settled that, in interpreting an asserted claim, the court should look first to the
`
`intrinsic evidence of record, i.e., the patent itself, including the claims, the specification and, if in
`
`evidence, the prosecution history.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582
`
`(Fed. Cir. 1996); see also Allergan Sales, LLC v. Sandoz, Inc., 935 F.3d 1370, 1373 (Fed. Cir.
`
`2019). “First, we look to the words of the claims themselves, both asserted and nonasserted, to
`
`define the scope of the patented invention.” Vitronics, 90 F.3d at 1582. “[S]econd, it is always
`
`necessary to review the specification to determine whether the inventor has used any terms in a
`
`manner inconsistent with their ordinary meaning.” Id. “The specification acts as a dictionary
`
`when it expressly defines terms used in the claims or when it defines terms by implication.” Id.
`
`For this reason, the specification “is always highly relevant to the claim construction analysis,”
`
`and “[u]sually, it is dispositive; it is the single best guide to the meaning of a disputed term.” Id.
`
`“Third, the court may also consider the prosecution history of the patent, if in evidence.” Id.
`
`The prosecution history is relevant because
`
`[it] was created by the patentee in attempting to explain and obtain the patent. . . .
`[T]he prosecution history can often inform the meaning of the claim language by
`demonstrating how the inventor understood the invention and whether the inventor
`limited the invention in the course of prosecution, making the claim scope narrower
`than it would otherwise be.
`
`Phillips, 415 F.3d at 1317.
`
`“In most situations, an analysis of the intrinsic evidence alone will resolve any ambiguity
`
`in a disputed claim term. In such circumstances, it is improper to rely on extrinsic evidence.”
`
`Vitronics, 90 F.3d at 1583. However, “[w]hen the intrinsic evidence is silent as to the plain
`
`3
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 4 of 33
`
`meaning of a term, it is entirely appropriate for the district court to look to dictionaries or other
`
`extrinsic sources for context—to aid in arriving at the plain meaning of a claim term.”
`
`Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d 1379, 1382 (Fed. Cir. 2008).
`
`“[E]xtrinsic evidence may be useful to the court, but it is unlikely to result in a reliable
`
`interpretation of patent claim scope unless considered in the context of the intrinsic evidence.”
`
`Phillips, 415 F.3d at 1319.
`
`B.
`
`Indefiniteness
`
`Patent law speaks to indefiniteness by requiring that “[t]he specification . . . conclude
`
`with one or more claims particularly pointing out and distinctly claiming the subject matter
`
`which the applicant regards as his invention.” 35 U.S.C. § 112. The Supreme Court has held
`
`that “a patent is invalid for indefiniteness if its claims, read in light of the specification
`
`delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those
`
`skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 572
`
`U.S. 898, 901 (2014). The requirement is aimed at providing the public with clear notice about
`
`what is being claimed. Id. at 911.
`
`“Indefiniteness is a matter of claim construction, and the same principles that generally
`
`govern claim construction are applicable to determining whether allegedly indefinite claim
`
`language is subject to construction.” Praxair, Inc. v. ATMI, Inc., 543 F.3d 1306, 1319 (Fed. Cir.
`
`2008). “Of course, claims are not indefinite merely because they present a difficult task of claim
`
`construction.” Halliburton Energy Servs. v. M-I LLC, 514 F.3d 1244, 1249 (Fed. Cir. 2008).
`
`“Instead, ‘[i]f the meaning of the claim is discernible, even though the task may be formidable
`
`and the conclusion may be one over which reasonable persons will disagree, we have held the
`
`claim sufficiently clear to avoid invalidity on indefiniteness grounds.’” Id. (alteration in
`
`4
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 5 of 33
`
`original) (quoting Exxon Research & Eng’g Co. v. United States, 265 F.3d 1371, 1375 (Fed. Cir.
`
`2001)). On the other hand, “[i]t cannot be sufficient that a court can ascribe some meaning to a
`
`patent’s claims; the definiteness inquiry trains on the understanding of a skilled artisan at the
`
`time of the patent application, not that of a court viewing matters post hoc.” Nautilus, 572 U.S.
`
`at 911. “[A]n accused infringer [must] show[] by clear and convincing evidence that a skilled
`
`artisan could not discern the boundaries of the claim based on the claim language, the
`
`specification, and the prosecution history, as well as her knowledge of the relevant art area.”
`
`Halliburton, 514 F.3d at 1249–50.
`
`II.
`
`DISCUSSION
`
`The terms submitted for claim construction are found across nine patents: U.S. Patent
`
`Nos. 8,586,045 (“the ’045 patent”); 8,597,649 (“the ’649 patent”); 9,266,951 (“the ’951 patent”);
`
`9,340,614 (“the ’614 patent”); 9,346,881 (“the ’881 patent”); 9,884,907 (“the ’907 patent”);
`
`9,884,908 (“the ’908 patent”); 9,890,210 (“the ’210 patent”); and 9,890,211 (“the ’211 patent”).
`
`[ECF No. 65 at 7, 8 n.3; ECF No. 66 at 6]. Six of the patents claim as inventive anti-Calcitonin
`
`Gene-Related Peptide (“CGRP”) antibodies (composition patents), while three patents claim
`
`methods of treating migraines by using the anti-CGRP antibodies (method of treatment patents).
`
`[ECF No. 65 at 8].1 Since all of the patents share a common specification, for the purposes of
`
`claim construction the parties primarily focus on the ’045 patent. [ECF No. 59-1 at 2 nn.1–2].
`
`The parties present six disputed claim terms for construction: (1) “anti-CGRP antagonist
`
`antibody” or “anti-Calcitonin Gene-Related Peptide (CGRP) antagonist antibody”;
`
`
`1 Through the inter partes review process, the Patent Trial and Appeals Board found that all
`challenged claims in the composition patents were invalid as obvious, but upheld the validity of
`the challenged claims in the method of treatment patents. [ECF No. 65 at 13]. Both parties are
`appealing the decisions to the Federal Circuit. [Id.; ECF No. 66 at 6 n.3].
`
`5
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 6 of 33
`
`(2) “humanized . . . antibody”; (3) “specific binding” or “preferentially binds”; (4) “human IgG
`
`heavy chain”; (5) “or” (as used in a specific phrase); and (6) “treating.” [ECF No. 59-1 at 2–6].2
`
`In addition, the parties present an agreed-upon construction for two claim terms: “antibody” and
`
`“effective amount.” [Id. at 6].
`
`A.
`
`“Anti-CGRP antagonist antibody” or “anti-Calcitonin Gene-Related Peptide
`(CGRP) antagonist antibody”
`
`Patent (Claims)
`All patents-in-suit
`(all asserted claims)
`
`Teva’s Proposed Construction
`No construction needed in light of the
`specification.
`
`To the extent construction is needed,
`Teva proposes construing the terms as:
`“An antibody that is able to bind to
`CGRP and inhibit CGRP biological
`activity and/or downstream pathway(s)
`mediated by CGRP signaling”
`
`Lilly’s Proposed Construction
`Indefinite.
`
`In the alternative, Lilly proposes
`construing the terms as: “An antibody
`that is able to bind to any form of
`calcitonin gene-related peptide (CGRP)
`(including variants thereof that retain at
`least partial activity) from any
`mammalian species and inhibit CGRP
`biological activity and/or downstream
`pathway(s) mediated by CGRP
`signaling”
`
`
`
`This term is used in all asserted claims of each of the nine patents in dispute. [ECF No.
`
`59-1 at 2]. Lilly primarily argues that the term is indefinite. [ECF No. 66 at 13]. Lilly asserts in
`
`the alternative that the term requires construction because the definition provided in the
`
`specification contains terms that should be further defined. [Id. at 12]. Teva counters that the
`
`term is not indefinite and that Lilly’s experts testified during the inter partes review process that
`
`the term would have been “well known” to a person of ordinary skill in the art (“POSITA”).
`
`[ECF No. 65 at 15]. In addition, Teva argues that this term is clearly defined in the specification
`
`
`2 Terms are presented in the order in which they appear in a chart attached to the parties’ joint
`claim construction statement. [ECF No. 59-1 at 2–6].
`
`6
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 7 of 33
`
`and that Lilly is impermissibly adding language from more general descriptions of CGRP—
`
`rather than anti-CGRP antagonist antibodies—in its proposed claim construction. [Id. at 17].
`
`1.
`
`Indefiniteness Challenge
`
`The Court begins with Lilly’s indefiniteness challenge. See Enzo Biochem, Inc. v.
`
`Applera Corp., 599 F.3d 1325, 1332 (Fed. Cir. 2010) (“If a claim is indefinite, the claim, by
`
`definition, cannot be construed.”).
`
`The term “anti-CGRP antagonist antibody” is used in all claims of the patents, for
`
`example, in Claim 1 of the ’045 patent: “A method for reducing incidence of or treating at least
`
`one vasomotor symptom in an individual, comprising administering to the individual an effective
`
`amount of an anti-CGRP antagonist antibody, wherein said anti-CGRP antagonist antibody is a
`
`human monoclonal antibody or a humanized monoclonal antibody.” [ECF No. 67-1 at 70
`
`(99:1–7)]. The term is defined in the specification as
`
`an antibody that is able to bind to CGRP and inhibit CGRP biological activity
`and/or downstream pathway(s) mediated by CGRP signaling. An anti-CGRP
`antagonist antibody encompasses antibodies that block, antagonize, suppress or
`reduce (including significantly) CGRP biological activity, including downstream
`pathways mediated by CGRP signaling, such as receptor binding and/or elicitation
`of a cellular response to CGRP.
`
`[Id. at 27 (13:63–14:4)]. Lilly claims that the term is indefinite because the specification does
`
`not identify a single test or associated test results to identify which antibodies meet the term’s
`
`definition and properties, specifically the inhibition of CGRP biological activity and/or
`
`downstream pathways. [ECF No. 66 at 12; ECF No. 68 ¶¶ 34–59 (Garcia declaration)]. Teva
`
`argues compellingly that the specification provides sufficient information to allow a POSITA to
`
`7
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 8 of 33
`
`understand how to identify and assess an anti-CGRP antagonist antibody’s activity. [ECF No. 65
`
`at 18–19; ECF No. 70 ¶¶ 25–33 (Ravetch declaration)].
`
`Although claim terms must provide a POSITA with reasonable certainty about the scope
`
`of an invention, that certainty “does not require ‘absolute or mathematical precision.’” BASF
`
`Corp. v. Johnson Matthey Inc., 875 F.3d 1360, 1365 (Fed. Cir. 2017) (quoting Biosig
`
`Instruments, Inc. v. Nautilus, Inc., 783 F.3d 1374, 1381 (Fed. Cir. 2015)). “A term is not
`
`indefinite . . . merely because of the possibility of variations in experimental conditions.”
`
`Oxford Immunotec Ltd. v. Qiagen, Inc., 255 F. Supp. 3d 263, 272 (D. Mass. 2017) (citing Enzo
`
`Biochem, 599 F.3d at 1335–36).
`
`In one case cited by Lilly, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Federal
`
`Circuit found a claim reciting “molecular weight” indefinite where the claim and specification
`
`did not define the term and there were three different types of molecular weight (Mp, Mw, and
`
`Mn) as well as different ways to measure each type, which could produce different results. 789
`
`F.3d 1335, 1341 (Fed. Cir. 2015). In contrast, in a second case cited by Lilly, not providing any
`
`information about methods to measure or test a property or characteristic disclosed in a patent
`
`rendered a claim indefinite. Dow Chem. Co. v. Nova Chems. Corp. (Can.), 803 F.3d 620, 634
`
`(Fed. Cir. 2015) (“Neither the patent claims nor the specification here discusses the four methods
`
`or provides any guidance as to which method should be used or even whether the possible
`
`universe of methods is limited to these four methods.”). Neither of these extremes is evident in
`
`the patents at issue in this case.
`
`Here, although the claim itself does not reference inhibition, the specification’s definition
`
`of an anti-CGRP antagonist antibody describes inhibition as the ability to “block, antagonize,
`
`suppress or reduce (including significantly).” [ECF No. 67-1 at 27 (13:66–14:1)]. The
`
`8
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 9 of 33
`
`specification suggests six different tests, or assays, for measuring this ability, as well as an
`
`antibody’s binding affinity. [ECF No. 65 at 19 (citing specification references to tests)]; see,
`
`e.g., [ECF No. 67-1 at 34 (27:3–19) (discussing assay and method to test binding affinity of
`
`antibodies); id. at 47 (53:36–54:64) (discussing test to measure downstream activity and test
`
`results)]. In addition, the specification provides results for the assays. See, e.g., [id. at 47
`
`(53:36–54:64); id. at 48 (55:26–57:12)]. Both parties agree that a POSITA would understand
`
`that these different tests are measuring different aspects of those binding and inhibition
`
`properties under different conditions. [ECF No. 79 at 11–12; ECF No. 70 ¶ 33 (noting that a
`
`POSITA would understand that in vitro assay results would differ from in vivo assay results);
`
`ECF No. 68 ¶ 36 (acknowledging that a POSITA would understand that different types of tests
`
`will produce different results)]. As a result, the Court does not credit Lilly’s contention that a
`
`POSITA would be confused by these varying results. Where one of the disclosed assays
`
`demonstrates an antibody’s binding and inhibition of specified activities and/or downstream
`
`pathways, that antibody meets the definition of an anti-CGRP antagonist antibody.
`
`The Court is also not persuaded by Lilly’s arguments that the patent must disclose precise
`
`parameters or amounts for these activities. The specification provides a range of possible levels
`
`of binding affinity and inhibition relative to the assays necessary for an antibody to qualify as an
`
`anti-CGRP antagonist antibody. See, e.g., [ECF No. 67-1 at 46 (51:1–52:26) (listing results
`
`related to binding and antagonist activity from two different assays)]; see also [ECF No. 70
`
`¶¶ 29–31 (discussing specification’s description of ranges produced by different assays)]. This
`
`provides sufficient notice of the scope of the claimed invention, even if the exact extent of an
`
`antibody’s binding and inhibition properties is not provided to a mathematical certainty. See
`
`9
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 10 of 33
`
`BASF, 875 F.3d at 1365. Accordingly, Lilly has failed to demonstrate by clear and convincing
`
`evidence that the term is indefinite. See Halliburton, 514 F.3d at 1249–50.
`
`2.
`
`Claim Construction
`
`Teva’s proposed construction mirrors a definition for the claim term that is set out in the
`
`specification. Compare [ECF No. 59-1 at 2], with [ECF No. 67-1 at 27 (13:62–14:4)]. In
`
`contrast, Lilly’s proposed construction deviates from the specification’s definition for the term
`
`and the claims’ use of the term by adding definitions of other terms from the specification. See
`
`[ECF No. 59-1 at 2].
`
`“When a patentee explicitly defines a claim term in the patent specification, the
`
`patentee’s definition controls.” Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363,
`
`1380 (Fed. Cir. 2009); see Vitronics, 90 F.3d at 1582 (“The specification acts as a dictionary
`
`when it expressly defines terms used in the claims or when it defines terms by implication.”).
`
`This is true even when the patentee’s definition is different than the term’s ordinary meaning.
`
`Honeywell Int’l, Inc. v. Universal Avionics Sys. Corp., 493 F.3d 1358, 1361 (Fed. Cir. 2007).
`
`As a result, the Federal Circuit will affirm a construction that “is consistent with the definition
`
`provided by the patentee in the patents’ specifications.” Mexichem Amanco Holding S.A. de
`
`C.V. v. Honeywell Int’l Inc., 702 F. App’x 993, 994 (Fed. Cir. 2017).
`
`As noted above, Teva expressly defined the term at issue in the specification. In addition,
`
`the specification consistently uses the term as it is defined:
`
`The methods of the invention use an anti-CGRP antagonist antibody, which refers
`to any antibody molecule that blocks, suppresses or reduces (including
`significantly) CGRP biological activity, including downstream pathways mediated
`by CGRP signaling, such as receptor binding and/or elicitation of a cellular
`response to CGRP.
`
`[ECF No. 67-1 at 33 (25:45–50)]; see also [id. at 36 (31:31–41); id. at 37 (34:21–30)].
`
`10
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 11 of 33
`
`Lilly argues that adding a reference to CGRP “from any mammalian species” to the
`
`construction of “anti-CGRP antagonist antibody” is consistent with the specification’s definition
`
`of “CGRP.” [ECF No. 66 at 17]. The specification does define CGRP to “include[] all
`
`mammalian species of native sequence CGRP, e.g., human, canine, feline, equine, and bovine.”
`
`[ECF No. 67-1 at 27 (13:59–61)]. Read with the claims from the nine patents, however,
`
`anti-CGRP antagonist antibodies are consistently narrowed by referencing “human” or
`
`“humanized.” See, e.g., [id. at 70 (99:2–7 (’045 patent, Claim 1, describing a method to treat
`
`headaches and referring to an anti-CGRP antagonist antibody that “is a human monoclonal
`
`antibody or a humanized monoclonal antibody”); ECF No. 67-2 at 71 (101:38–41) (’649 patent,
`
`Claim 1, describing “[a]n isolated human or humanized anti-CGRP antagonist antibody”); ECF
`
`No. 67-3 at 73 (99:21–23) (’951 patent, Claim 1, describing “[a] human or humanized
`
`monoclonal anti-CGRP antagonist antibody”)]. Lilly’s proposed construction is, therefore, not
`
`supported by the claims.
`
`Because the specification sets out an express definition and Teva’s proposed construction
`
`mirrors that definition, the Court adopts Teva’s proposed construction for “anti-CGRP antagonist
`
`antibody” or “anti-Calcitonin Gene-Related Peptide (CGRP) antagonist antibody” and construes
`
`the term as “an antibody that is able to bind to CGRP and inhibit CGRP biological activity
`
`and/or downstream pathway(s) mediated by CGRP signaling.” See Martek, 579 F.3d at
`
`1380.
`
`11
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 12 of 33
`
`B.
`
`“Humanized . . . antibody”
`
`Patent (Claims)
`All patents-in-suit
`(all asserted claims)
`
`Lilly’s Proposed Construction
`Indefinite.
`
`In the alternative, Lilly proposes
`construing the term as: “A form of a
`non-human antibody that is a specific
`chimeric immunoglobulin, an
`immunoglobulin chain, or a fragment
`thereof (such as Fv, Fab, Fab', F(ab')2
`or other antigen-binding subsequences
`of antibodies) that contains minimal
`sequence derived from a non-human
`immunoglobulin”
`
`Teva’s Proposed Construction
`No construction needed in light of the
`specification.
`
`To the extent construction is needed,
`Teva proposes construing the term as:
`“A form of a non-human antibody
`that is a specific chimeric
`immunoglobulin, an immunoglobulin
`chain, or a fragment thereof (such as
`Fv, Fab, Fab', F(ab')2 or other antigen-
`binding subsequences of antibodies)
`that contains minimal sequence
`derived from a non-human
`immunoglobulin; humanized
`antibodies are for the most part
`human immunoglobulins in which
`residues from a complementarily
`determining region (CDR) of the
`recipient are replaced by residues
`from a CDR of a non-human species
`such as mouse, rat, or rabbit having
`the desired specificity, affinity, and
`biological activity”
`
`This term is used in all asserted claims of all nine patents in dispute. [ECF No. 59-1 at
`
`2]. Teva states that Lilly’s proposed construction omits a sentence from the specification so as to
`
`make the term appear indefinite. [ECF No. 65 at 21]. Lilly claims that its proposed construction
`
`eliminates superfluous language, [ECF No. 66 at 21], but primarily focuses on its indefiniteness
`
`argument, contending that the term’s discussion of containing a “minimal sequence” does not
`
`provide a POSITA with enough information to understand the term, [id. at 18].
`
`1.
`
`Indefiniteness Challenge
`
`The term is used in all claims of the patents, for example in Claim 1 of the ’045 patent:
`
`“wherein said anti-CGRP antagonist antibody is a human monoclonal antibody or a humanized
`
`12
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 13 of 33
`
`monoclonal antibody.” [ECF No. 67-1 at 70 (99:5–7)]. The specification defines “humanized
`
`antibody” as follows:
`
`[a]s used herein, “humanized” antibodies refer to forms of non-human (e.g. murine)
`antibodies that are specific chimeric immunoglobulins, immunoglobulin chains, or
`fragments thereof (such as Fv, Fab, Fab', F(ab')2 or other antigen-binding
`subsequences of antibodies) that contain minimal sequence derived from non-
`human immunoglobulin.
`
`[Id. at 26 (12:61–66) (emphasis added)]. The specification then goes on to give examples of
`
`different ways that an antibody may be humanized. [Id. at 26–27 (12:66–13:25) (“For the most
`
`part, humanized antibodies are human immunoglobulins (recipient antibody) in which residues
`
`from a complementarity determining region (CDR) of the recipient are replaced by residues from
`
`a CDR of a non-human species . . . . In some instances . . . .”)].
`
`Claims “must provide objective boundaries” when measurements are involved—
`
`including less precise terms of degree, like “minimal.” Dow Chem., 803 F.3d at 630 (quoting
`
`Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1371 (Fed. Cir. 2014)); see Berkheimer v.
`
`HP Inc., 881 F.3d 1360, 1364 (Fed. Cir. 2018) (applying objective boundaries requirement to
`
`terms of degree). “Because language is limited,” however, the Federal Circuit “ha[s] rejected the
`
`proposition that claims involving terms of degree are inherently indefinite. Thus, ‘a patentee
`
`need not define his invention with mathematical precision in order to comply with the
`
`definiteness requirement.’” Sonix Tech. Co. v. Publ’ns Int’l, Ltd., 844 F.3d 1370, 1377 (Fed.
`
`Cir. 2017) (quoting Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1384 (Fed. Cir.
`
`2005)). “Indeed, ‘[c]laim language employing terms of degree has long been found definite
`
`where it provided enough certainty to one of skill in the art when read in the context of the
`
`invention.’” Id. (quoting Interval Licensing, 766 F.3d at 1370); see Enzo Biochem, 599 F.3d at
`
`1335 (“Because the intrinsic evidence here provides ‘a general guideline and examples sufficient
`
`to enable a person of ordinary skill in the art to determine [the scope of the claims],’ the claims
`
`13
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 14 of 33
`
`are not indefinite even though the construction of the term ‘not interfering substantially’ defines
`
`the term without reference to a precise numerical measurement.” (citation omitted) (quoting In
`
`re Marosi, 710 F.2d 799, 803 (Fed. Cir. 1983))); One-E-Way, Inc. v. ITC, 859 F.3d 1059, 1067
`
`(Fed. Cir. 2017) (“While we note that ‘virtually’ is a term of degree, one that slightly expands the
`
`scope of the term ‘free from interference,’ the inclusion of ‘virtually’ in these claims does not
`
`render them indefinite.”).
`
`Lilly cites Berkheimer v. HP Inc., 881 F.3d at 1363–64, for the proposition that a
`
`specification’s reference to a “minimal” condition is indefinite, however in Berkheimer, the
`
`specification used “minimal,” “reducing,” and “eliminating” to refer to “redundancy.” The court
`
`found that, because there were various levels of redundancy described and no mention of a
`
`“point of comparison” to understand “minimal” in comparison to “reduced” or “eliminated”
`
`redundancies, the term was indefinite. Id. In contrast, in Sonix Technology Co. v. Publications
`
`International, Ltd., the Federal Circuit found that the specification’s use of examples to describe
`
`the term “visually negligible” did not render the term indefinite but instead provided guidance to
`
`enable a POSITA “to underst[and] the term with reasonable certainty.” 844 F.3d at 1379.
`
`Here, the specification provides examples of various ways to make humanized antibodies
`
`with minimal sequences from non-human sources. See, e.g., [ECF No. 67-1 at 34–35 (29:65–
`
`30:3) (describing antibodies with rodent variable regions and complementarity determining
`
`regions (“CDRs”) fused to human constant domains)); id. at 35 (29:7–10) (describing antibodies
`
`with “rodent CDRs grafted into a human supporting framework region (FR) prior to fusion with
`
`an appropriate human antibody constant domain”)]. Teva notes that the specification’s definition
`
`of a “human antibody” would guide a POSITA to find the line between human and humanized
`
`antibodies because the specification states that human antibodies must contain “at least one
`
`14
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 15 of 33
`
`human heavy chain polypeptide or at least one human light chain polypeptide.” [ECF No. 79 at
`
`16 (citing ECF No. 67-1 at 27 (13:30–34)]. In contrast, as Teva’s expert explained,
`
`a [POSITA] would read the specification as restricting the non-human portion of a
`humanized antibody to the variable regions of the heavy and light chains, more
`specifically the CDRs and (sometimes) portions of the framework regions. A
`[POSITA] would know that these non-human sequences would necessarily
`represent only a small fraction of the antibody’s overall sequence and would thus
`immediately identify these portions as the “minimal sequence” described in the
`first sentence of the specification’s definition.
`
`[ECF No. 70 ¶ 37].
`
`In addition, the “minimal sequence” reference is a matter of objective degree and the
`
`patent provides examples to guide a POSITA in determining what “minimal” means. See
`
`One-E-Way, 859 F.3d at 1067 (“While we note that ‘virtually’ is a term of degree, one that
`
`slightly expands the scope of the term ‘free from interference,’ the inclusion of ‘virtually’ in
`
`these claims does not render them indefinite.”). With the information provided and in the
`
`context of the patent, therefore, a POSITA would be able to understand the term “humanized
`
`antibody” with “enough certainty.” Sonix, 844 F.3d at 1377. Thus, the Court finds that Lilly has
`
`failed to demonstrate by clear and convincing evidence that the term is indefinite. See
`
`Halliburton, 514 F.3d at 1249–50.
`
`2.
`
`Claim Construction
`
`Lilly argues that Teva’s proposed construction impermissibly adds limiting language
`
`from a sentence providing an example of a humanized antibody, which Lilly describes as an
`
`embodiment. [ECF No. 66 at 21]. Teva correctly notes, however, that examples of terms being
`
`defined in the “definitions” section of the specification are not the invention itself (and therefore
`
`not an embodiment of the invention). [ECF No. 79 at 17–18]. In other words, Teva is not
`
`claiming humanized antibodies broadly in these patents, but is instead claiming humanized
`
`antibodies that possess the characteristics set forth in the patents’ claims. The definitions section
`
`15
`
`

`

`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 16 of 33
`
`of the specification merely provides examples of defined terms, not embodiments of the
`
`invention disclosed in the claims. See Durel Corp. v. Osram Sylvania, Inc., 256 F.3d 1298, 1304
`
`(Fed. Cir. 2001) (looking to examples that immediately followed definition in specification to
`
`construe claim term).
`
`As discussed supra, Section II.A.2, “[w]hen a patentee explicitly defines a claim term in
`
`the patent specification, the patentee’s definition controls.” Martek, 579 F.3d at 1380. Because
`
`“humanized antibody” is defined in the specification, that definition controls. See id. Teva has
`
`stated that it would not object to the Court adopting the full paragraph from the specification that
`
`defines “humanized antibody” and provides examples, rather than the one sentence Lilly
`
`proposes or the two sentences Teva initially proposed. [ECF No. 79 at 17 n.9]. The Court will
`
`adopt Lilly’s construction, which is the specification’s most precise definition of “humanized
`
`antibody,” with the caveat that Teva will be allowed to reference the examples of humanized
`
`antibodies provided in the specification to further explain the term to the jury. The Court
`
`therefore construes “humanized antibody” to mean “a form of non-human (e.g. murine)
`
`anti