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`UNITED STATES DISTRICT COURT
`DISTRICT OF MASSACHUSETTS
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`MEMORANDUM AND ORDER ON CLAIM CONSTRUCTION
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`BURROUGHS, D.J.
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`In this patent infringement suit, Teva Pharmaceuticals International GmbH and Teva
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`Pharmaceuticals USA, Inc. (collectively, “Teva”) allege that Eli Lilly and Company (“Lilly”) has
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`infringed claims in nine patents owned by Teva related to a product marketed under the brand
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`name Ajovy, which contains the active ingredient fremanezumab and is used to treat migraines.
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`[ECF No. 1]. Lilly has brought counterclaims against Teva, seeking declaratory judgments that
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`its product marketed under the brand name Emgality, which contains the active ingredient
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`galcanezumab and is also used to treat migraines, does not infringe Teva’s patents and that
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`Teva’s patents are invalid. [ECF No. 17]. The parties briefed claim construction for six disputed
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`terms, [ECF Nos. 65, 66, 77, 79, 89, 90], and the Court conducted a hearing on December 15,
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`2020, at which the parties presented their proposed constructions, [ECF No. 88]. The Court
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`construes the terms as set forth below.
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`Civil Action No. 18-cv-12029-ADB
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`*************
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`*
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`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and TEVA
`PHARMACEUTICALS USA, INC.,
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` Plaintiffs and Defendants-in-
`Counterclaim,
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`v.
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`ELI LILLY AND COMPANY,
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`Defendant and Plaintiff-in-
`Counterclaim.
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 2 of 33
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`I.
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`LEGAL STANDARD
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`A.
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`Claim Construction
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`Claim construction is the first stage of a patent infringement analysis and requires the
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`Court to determine “the scope and meaning of the patent claims asserted.” Clearstream
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`Wastewater Sys., Inc. v. Hydro-Action, Inc., 206 F.3d 1440, 1444 (Fed. Cir. 2000). Claim
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`construction is a question of law for the Court, Markman v. Westview Instruments, Inc., 517
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`U.S. 370, 372 (1996), to be resolved with an eye toward the fact that the Court’s adopted
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`construction “becomes the basis of the jury instructions, should the case go to trial” on the issue
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`of infringement, AFG Indus., Inc. v. Cardinal IG Co., 239 F.3d 1239, 1247 (Fed. Cir. 2001).
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`“[T]he claims of a patent define the invention to which the patentee is entitled the right to
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`exclude.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (citation and internal
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`quotation marks omitted). “[T]he words of a claim are generally given their ordinary and
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`customary meaning,” which “is the meaning that the term would have to a person of ordinary
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`skill in the art in question at the time of the invention.” Id. at 1312–13 (internal quotation marks
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`omitted). Certain terms “may be readily apparent even to lay judges, and claim construction in
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`such cases involves little more than the application of the widely accepted meaning of commonly
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`understood words.” Id. at 1314.
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`“There are only two exceptions to this general rule: 1) when a patentee sets out a
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`definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope of a
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`claim term either in the specification or during prosecution.” Thorner v. Sony Comput. Ent. Am.
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`LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). “To act as [his] own lexicographer, a patentee must
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`clearly set forth a definition of the disputed claim term other than its plain and ordinary
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`meaning.” Id. (citation and internal quotation marks omitted). Similarly, to disavow the scope
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`2
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 3 of 33
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`of a claim term, “[t]he patentee may demonstrate intent to deviate from the ordinary and
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`accustomed meaning of a claim term by including in the specification expressions of manifest
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`exclusion or restriction, representing a clear disavowal of claim scope.” Id. at 1366 (citation and
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`internal quotation marks omitted).
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`“It is well-settled that, in interpreting an asserted claim, the court should look first to the
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`intrinsic evidence of record, i.e., the patent itself, including the claims, the specification and, if in
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`evidence, the prosecution history.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582
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`(Fed. Cir. 1996); see also Allergan Sales, LLC v. Sandoz, Inc., 935 F.3d 1370, 1373 (Fed. Cir.
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`2019). “First, we look to the words of the claims themselves, both asserted and nonasserted, to
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`define the scope of the patented invention.” Vitronics, 90 F.3d at 1582. “[S]econd, it is always
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`necessary to review the specification to determine whether the inventor has used any terms in a
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`manner inconsistent with their ordinary meaning.” Id. “The specification acts as a dictionary
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`when it expressly defines terms used in the claims or when it defines terms by implication.” Id.
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`For this reason, the specification “is always highly relevant to the claim construction analysis,”
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`and “[u]sually, it is dispositive; it is the single best guide to the meaning of a disputed term.” Id.
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`“Third, the court may also consider the prosecution history of the patent, if in evidence.” Id.
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`The prosecution history is relevant because
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`[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.
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`Phillips, 415 F.3d at 1317.
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`“In most situations, an analysis of the intrinsic evidence alone will resolve any ambiguity
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`in a disputed claim term. In such circumstances, it is improper to rely on extrinsic evidence.”
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`Vitronics, 90 F.3d at 1583. However, “[w]hen the intrinsic evidence is silent as to the plain
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`3
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 4 of 33
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`meaning of a term, it is entirely appropriate for the district court to look to dictionaries or other
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`extrinsic sources for context—to aid in arriving at the plain meaning of a claim term.”
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`Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d 1379, 1382 (Fed. Cir. 2008).
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`“[E]xtrinsic evidence may be useful to the court, but it is unlikely to result in a reliable
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`interpretation of patent claim scope unless considered in the context of the intrinsic evidence.”
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`Phillips, 415 F.3d at 1319.
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`B.
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`Indefiniteness
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`Patent law speaks to indefiniteness by requiring that “[t]he specification . . . conclude
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`with one or more claims particularly pointing out and distinctly claiming the subject matter
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`which the applicant regards as his invention.” 35 U.S.C. § 112. The Supreme Court has held
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`that “a patent is invalid for indefiniteness if its claims, read in light of the specification
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`delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those
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`skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 572
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`U.S. 898, 901 (2014). The requirement is aimed at providing the public with clear notice about
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`what is being claimed. Id. at 911.
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`“Indefiniteness is a matter of claim construction, and the same principles that generally
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`govern claim construction are applicable to determining whether allegedly indefinite claim
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`language is subject to construction.” Praxair, Inc. v. ATMI, Inc., 543 F.3d 1306, 1319 (Fed. Cir.
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`2008). “Of course, claims are not indefinite merely because they present a difficult task of claim
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`construction.” Halliburton Energy Servs. v. M-I LLC, 514 F.3d 1244, 1249 (Fed. Cir. 2008).
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`“Instead, ‘[i]f the meaning of the claim is discernible, even though the task may be formidable
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`and the conclusion may be one over which reasonable persons will disagree, we have held the
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`claim sufficiently clear to avoid invalidity on indefiniteness grounds.’” Id. (alteration in
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`4
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 5 of 33
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`original) (quoting Exxon Research & Eng’g Co. v. United States, 265 F.3d 1371, 1375 (Fed. Cir.
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`2001)). On the other hand, “[i]t cannot be sufficient that a court can ascribe some meaning to a
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`patent’s claims; the definiteness inquiry trains on the understanding of a skilled artisan at the
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`time of the patent application, not that of a court viewing matters post hoc.” Nautilus, 572 U.S.
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`at 911. “[A]n accused infringer [must] show[] by clear and convincing evidence that a skilled
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`artisan could not discern the boundaries of the claim based on the claim language, the
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`specification, and the prosecution history, as well as her knowledge of the relevant art area.”
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`Halliburton, 514 F.3d at 1249–50.
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`II.
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`DISCUSSION
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`The terms submitted for claim construction are found across nine patents: U.S. Patent
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`Nos. 8,586,045 (“the ’045 patent”); 8,597,649 (“the ’649 patent”); 9,266,951 (“the ’951 patent”);
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`9,340,614 (“the ’614 patent”); 9,346,881 (“the ’881 patent”); 9,884,907 (“the ’907 patent”);
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`9,884,908 (“the ’908 patent”); 9,890,210 (“the ’210 patent”); and 9,890,211 (“the ’211 patent”).
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`[ECF No. 65 at 7, 8 n.3; ECF No. 66 at 6]. Six of the patents claim as inventive anti-Calcitonin
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`Gene-Related Peptide (“CGRP”) antibodies (composition patents), while three patents claim
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`methods of treating migraines by using the anti-CGRP antibodies (method of treatment patents).
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`[ECF No. 65 at 8].1 Since all of the patents share a common specification, for the purposes of
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`claim construction the parties primarily focus on the ’045 patent. [ECF No. 59-1 at 2 nn.1–2].
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`The parties present six disputed claim terms for construction: (1) “anti-CGRP antagonist
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`antibody” or “anti-Calcitonin Gene-Related Peptide (CGRP) antagonist antibody”;
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`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].
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`5
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 6 of 33
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`(2) “humanized . . . antibody”; (3) “specific binding” or “preferentially binds”; (4) “human IgG
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`heavy chain”; (5) “or” (as used in a specific phrase); and (6) “treating.” [ECF No. 59-1 at 2–6].2
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`In addition, the parties present an agreed-upon construction for two claim terms: “antibody” and
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`“effective amount.” [Id. at 6].
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`A.
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`“Anti-CGRP antagonist antibody” or “anti-Calcitonin Gene-Related Peptide
`(CGRP) antagonist antibody”
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`Patent (Claims)
`All patents-in-suit
`(all asserted claims)
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`Teva’s Proposed Construction
`No construction needed in light of the
`specification.
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`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”
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`Lilly’s Proposed Construction
`Indefinite.
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`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”
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`This term is used in all asserted claims of each of the nine patents in dispute. [ECF No.
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`59-1 at 2]. Lilly primarily argues that the term is indefinite. [ECF No. 66 at 13]. Lilly asserts in
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`the alternative that the term requires construction because the definition provided in the
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`specification contains terms that should be further defined. [Id. at 12]. Teva counters that the
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`term is not indefinite and that Lilly’s experts testified during the inter partes review process that
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`the term would have been “well known” to a person of ordinary skill in the art (“POSITA”).
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`[ECF No. 65 at 15]. In addition, Teva argues that this term is clearly defined in the specification
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`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].
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`6
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 7 of 33
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`and that Lilly is impermissibly adding language from more general descriptions of CGRP—
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`rather than anti-CGRP antagonist antibodies—in its proposed claim construction. [Id. at 17].
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`1.
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`Indefiniteness Challenge
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`The Court begins with Lilly’s indefiniteness challenge. See Enzo Biochem, Inc. v.
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`Applera Corp., 599 F.3d 1325, 1332 (Fed. Cir. 2010) (“If a claim is indefinite, the claim, by
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`definition, cannot be construed.”).
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`The term “anti-CGRP antagonist antibody” is used in all claims of the patents, for
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`example, in Claim 1 of the ’045 patent: “A method for reducing incidence of or treating at least
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`one vasomotor symptom in an individual, comprising administering to the individual an effective
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`amount of an anti-CGRP antagonist antibody, wherein said anti-CGRP antagonist antibody is a
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`human monoclonal antibody or a humanized monoclonal antibody.” [ECF No. 67-1 at 70
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`(99:1–7)]. The term is defined in the specification as
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`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.
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`[Id. at 27 (13:63–14:4)]. Lilly claims that the term is indefinite because the specification does
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`not identify a single test or associated test results to identify which antibodies meet the term’s
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`definition and properties, specifically the inhibition of CGRP biological activity and/or
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`downstream pathways. [ECF No. 66 at 12; ECF No. 68 ¶¶ 34–59 (Garcia declaration)]. Teva
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`argues compellingly that the specification provides sufficient information to allow a POSITA to
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`7
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 8 of 33
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`understand how to identify and assess an anti-CGRP antagonist antibody’s activity. [ECF No. 65
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`at 18–19; ECF No. 70 ¶¶ 25–33 (Ravetch declaration)].
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`Although claim terms must provide a POSITA with reasonable certainty about the scope
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`of an invention, that certainty “does not require ‘absolute or mathematical precision.’” BASF
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`Corp. v. Johnson Matthey Inc., 875 F.3d 1360, 1365 (Fed. Cir. 2017) (quoting Biosig
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`Instruments, Inc. v. Nautilus, Inc., 783 F.3d 1374, 1381 (Fed. Cir. 2015)). “A term is not
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`indefinite . . . merely because of the possibility of variations in experimental conditions.”
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`Oxford Immunotec Ltd. v. Qiagen, Inc., 255 F. Supp. 3d 263, 272 (D. Mass. 2017) (citing Enzo
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`Biochem, 599 F.3d at 1335–36).
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`In one case cited by Lilly, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Federal
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`Circuit found a claim reciting “molecular weight” indefinite where the claim and specification
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`did not define the term and there were three different types of molecular weight (Mp, Mw, and
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`Mn) as well as different ways to measure each type, which could produce different results. 789
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`F.3d 1335, 1341 (Fed. Cir. 2015). In contrast, in a second case cited by Lilly, not providing any
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`information about methods to measure or test a property or characteristic disclosed in a patent
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`rendered a claim indefinite. Dow Chem. Co. v. Nova Chems. Corp. (Can.), 803 F.3d 620, 634
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`(Fed. Cir. 2015) (“Neither the patent claims nor the specification here discusses the four methods
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`or provides any guidance as to which method should be used or even whether the possible
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`universe of methods is limited to these four methods.”). Neither of these extremes is evident in
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`the patents at issue in this case.
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`Here, although the claim itself does not reference inhibition, the specification’s definition
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`of an anti-CGRP antagonist antibody describes inhibition as the ability to “block, antagonize,
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`suppress or reduce (including significantly).” [ECF No. 67-1 at 27 (13:66–14:1)]. The
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`8
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 9 of 33
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`specification suggests six different tests, or assays, for measuring this ability, as well as an
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`antibody’s binding affinity. [ECF No. 65 at 19 (citing specification references to tests)]; see,
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`e.g., [ECF No. 67-1 at 34 (27:3–19) (discussing assay and method to test binding affinity of
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`antibodies); id. at 47 (53:36–54:64) (discussing test to measure downstream activity and test
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`results)]. In addition, the specification provides results for the assays. See, e.g., [id. at 47
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`(53:36–54:64); id. at 48 (55:26–57:12)]. Both parties agree that a POSITA would understand
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`that these different tests are measuring different aspects of those binding and inhibition
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`properties under different conditions. [ECF No. 79 at 11–12; ECF No. 70 ¶ 33 (noting that a
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`POSITA would understand that in vitro assay results would differ from in vivo assay results);
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`ECF No. 68 ¶ 36 (acknowledging that a POSITA would understand that different types of tests
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`will produce different results)]. As a result, the Court does not credit Lilly’s contention that a
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`POSITA would be confused by these varying results. Where one of the disclosed assays
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`demonstrates an antibody’s binding and inhibition of specified activities and/or downstream
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`pathways, that antibody meets the definition of an anti-CGRP antagonist antibody.
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`The Court is also not persuaded by Lilly’s arguments that the patent must disclose precise
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`parameters or amounts for these activities. The specification provides a range of possible levels
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`of binding affinity and inhibition relative to the assays necessary for an antibody to qualify as an
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`anti-CGRP antagonist antibody. See, e.g., [ECF No. 67-1 at 46 (51:1–52:26) (listing results
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`related to binding and antagonist activity from two different assays)]; see also [ECF No. 70
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`¶¶ 29–31 (discussing specification’s description of ranges produced by different assays)]. This
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`provides sufficient notice of the scope of the claimed invention, even if the exact extent of an
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`antibody’s binding and inhibition properties is not provided to a mathematical certainty. See
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`9
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 10 of 33
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`BASF, 875 F.3d at 1365. Accordingly, Lilly has failed to demonstrate by clear and convincing
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`evidence that the term is indefinite. See Halliburton, 514 F.3d at 1249–50.
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`2.
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`Claim Construction
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`Teva’s proposed construction mirrors a definition for the claim term that is set out in the
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`specification. Compare [ECF No. 59-1 at 2], with [ECF No. 67-1 at 27 (13:62–14:4)]. In
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`contrast, Lilly’s proposed construction deviates from the specification’s definition for the term
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`and the claims’ use of the term by adding definitions of other terms from the specification. See
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`[ECF No. 59-1 at 2].
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`“When a patentee explicitly defines a claim term in the patent specification, the
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`patentee’s definition controls.” Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363,
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`1380 (Fed. Cir. 2009); see Vitronics, 90 F.3d at 1582 (“The specification acts as a dictionary
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`when it expressly defines terms used in the claims or when it defines terms by implication.”).
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`This is true even when the patentee’s definition is different than the term’s ordinary meaning.
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`Honeywell Int’l, Inc. v. Universal Avionics Sys. Corp., 493 F.3d 1358, 1361 (Fed. Cir. 2007).
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`As a result, the Federal Circuit will affirm a construction that “is consistent with the definition
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`provided by the patentee in the patents’ specifications.” Mexichem Amanco Holding S.A. de
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`C.V. v. Honeywell Int’l Inc., 702 F. App’x 993, 994 (Fed. Cir. 2017).
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`As noted above, Teva expressly defined the term at issue in the specification. In addition,
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`the specification consistently uses the term as it is defined:
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`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.
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`[ECF No. 67-1 at 33 (25:45–50)]; see also [id. at 36 (31:31–41); id. at 37 (34:21–30)].
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`10
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 11 of 33
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`Lilly argues that adding a reference to CGRP “from any mammalian species” to the
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`construction of “anti-CGRP antagonist antibody” is consistent with the specification’s definition
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`of “CGRP.” [ECF No. 66 at 17]. The specification does define CGRP to “include[] all
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`mammalian species of native sequence CGRP, e.g., human, canine, feline, equine, and bovine.”
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`[ECF No. 67-1 at 27 (13:59–61)]. Read with the claims from the nine patents, however,
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`anti-CGRP antagonist antibodies are consistently narrowed by referencing “human” or
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`“humanized.” See, e.g., [id. at 70 (99:2–7 (’045 patent, Claim 1, describing a method to treat
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`headaches and referring to an anti-CGRP antagonist antibody that “is a human monoclonal
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`antibody or a humanized monoclonal antibody”); ECF No. 67-2 at 71 (101:38–41) (’649 patent,
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`Claim 1, describing “[a]n isolated human or humanized anti-CGRP antagonist antibody”); ECF
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`No. 67-3 at 73 (99:21–23) (’951 patent, Claim 1, describing “[a] human or humanized
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`monoclonal anti-CGRP antagonist antibody”)]. Lilly’s proposed construction is, therefore, not
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`supported by the claims.
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`Because the specification sets out an express definition and Teva’s proposed construction
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`mirrors that definition, the Court adopts Teva’s proposed construction for “anti-CGRP antagonist
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`antibody” or “anti-Calcitonin Gene-Related Peptide (CGRP) antagonist antibody” and construes
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`the term as “an antibody that is able to bind to CGRP and inhibit CGRP biological activity
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`and/or downstream pathway(s) mediated by CGRP signaling.” See Martek, 579 F.3d at
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`1380.
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`11
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 12 of 33
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`B.
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`“Humanized . . . antibody”
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`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
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`2]. Teva states that Lilly’s proposed construction omits a sentence from the specification so as to
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`make the term appear indefinite. [ECF No. 65 at 21]. Lilly claims that its proposed construction
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`eliminates superfluous language, [ECF No. 66 at 21], but primarily focuses on its indefiniteness
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`argument, contending that the term’s discussion of containing a “minimal sequence” does not
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`provide a POSITA with enough information to understand the term, [id. at 18].
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`1.
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`Indefiniteness Challenge
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`The term is used in all claims of the patents, for example in Claim 1 of the ’045 patent:
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`“wherein said anti-CGRP antagonist antibody is a human monoclonal antibody or a humanized
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`12
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`
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 13 of 33
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`monoclonal antibody.” [ECF No. 67-1 at 70 (99:5–7)]. The specification defines “humanized
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`antibody” as follows:
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`[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
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`different ways that an antibody may be humanized. [Id. at 26–27 (12:66–13:25) (“For the most
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`part, humanized antibodies are human immunoglobulins (recipient antibody) in which residues
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`from a complementarity determining region (CDR) of the recipient are replaced by residues from
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`a CDR of a non-human species . . . . In some instances . . . .”)].
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`Claims “must provide objective boundaries” when measurements are involved—
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`including less precise terms of degree, like “minimal.” Dow Chem., 803 F.3d at 630 (quoting
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`Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1371 (Fed. Cir. 2014)); see Berkheimer v.
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`HP Inc., 881 F.3d 1360, 1364 (Fed. Cir. 2018) (applying objective boundaries requirement to
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`terms of degree). “Because language is limited,” however, the Federal Circuit “ha[s] rejected the
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`proposition that claims involving terms of degree are inherently indefinite. Thus, ‘a patentee
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`need not define his invention with mathematical precision in order to comply with the
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`definiteness requirement.’” Sonix Tech. Co. v. Publ’ns Int’l, Ltd., 844 F.3d 1370, 1377 (Fed.
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`Cir. 2017) (quoting Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1384 (Fed. Cir.
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`2005)). “Indeed, ‘[c]laim language employing terms of degree has long been found definite
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`where it provided enough certainty to one of skill in the art when read in the context of the
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`invention.’” Id. (quoting Interval Licensing, 766 F.3d at 1370); see Enzo Biochem, 599 F.3d at
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`1335 (“Because the intrinsic evidence here provides ‘a general guideline and examples sufficient
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`to enable a person of ordinary skill in the art to determine [the scope of the claims],’ the claims
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 14 of 33
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`are not indefinite even though the construction of the term ‘not interfering substantially’ defines
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`the term without reference to a precise numerical measurement.” (citation omitted) (quoting In
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`re Marosi, 710 F.2d 799, 803 (Fed. Cir. 1983))); One-E-Way, Inc. v. ITC, 859 F.3d 1059, 1067
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`(Fed. Cir. 2017) (“While we note that ‘virtually’ is a term of degree, one that slightly expands the
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`scope of the term ‘free from interference,’ the inclusion of ‘virtually’ in these claims does not
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`render them indefinite.”).
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`Lilly cites Berkheimer v. HP Inc., 881 F.3d at 1363–64, for the proposition that a
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`specification’s reference to a “minimal” condition is indefinite, however in Berkheimer, the
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`specification used “minimal,” “reducing,” and “eliminating” to refer to “redundancy.” The court
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`found that, because there were various levels of redundancy described and no mention of a
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`“point of comparison” to understand “minimal” in comparison to “reduced” or “eliminated”
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`redundancies, the term was indefinite. Id. In contrast, in Sonix Technology Co. v. Publications
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`International, Ltd., the Federal Circuit found that the specification’s use of examples to describe
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`the term “visually negligible” did not render the term indefinite but instead provided guidance to
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`enable a POSITA “to underst[and] the term with reasonable certainty.” 844 F.3d at 1379.
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`Here, the specification provides examples of various ways to make humanized antibodies
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`with minimal sequences from non-human sources. See, e.g., [ECF No. 67-1 at 34–35 (29:65–
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`30:3) (describing antibodies with rodent variable regions and complementarity determining
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`regions (“CDRs”) fused to human constant domains)); id. at 35 (29:7–10) (describing antibodies
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`with “rodent CDRs grafted into a human supporting framework region (FR) prior to fusion with
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`an appropriate human antibody constant domain”)]. Teva notes that the specification’s definition
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`of a “human antibody” would guide a POSITA to find the line between human and humanized
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`antibodies because the specification states that human antibodies must contain “at least one
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 15 of 33
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`human heavy chain polypeptide or at least one human light chain polypeptide.” [ECF No. 79 at
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`16 (citing ECF No. 67-1 at 27 (13:30–34)]. In contrast, as Teva’s expert explained,
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`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.
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`[ECF No. 70 ¶ 37].
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`In addition, the “minimal sequence” reference is a matter of objective degree and the
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`patent provides examples to guide a POSITA in determining what “minimal” means. See
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`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
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`context of the patent, therefore, a POSITA would be able to understand the term “humanized
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`antibody” with “enough certainty.” Sonix, 844 F.3d at 1377. Thus, the Court finds that Lilly has
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`failed to demonstrate by clear and convincing evidence that the term is indefinite. See
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`Halliburton, 514 F.3d at 1249–50.
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`2.
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`Claim Construction
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`Lilly argues that Teva’s proposed construction impermissibly adds limiting language
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`from a sentence providing an example of a humanized antibody, which Lilly describes as an
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`embodiment. [ECF No. 66 at 21]. Teva correctly notes, however, that examples of terms being
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`defined in the “definitions” section of the specification are not the invention itself (and therefore
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`not an embodiment of the invention). [ECF No. 79 at 17–18]. In other words, Teva is not
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`claiming humanized antibodies broadly in these patents, but is instead claiming humanized
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`antibodies that possess the characteristics set forth in the patents’ claims. The definitions section
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`Case 1:18-cv-12029-ADB Document 101 Filed 02/24/21 Page 16 of 33
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`of the specification merely provides examples of defined terms, not embodiments of the
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`invention disclosed in the claims. See Durel Corp. v. Osram Sylvania, Inc., 256 F.3d 1298, 1304
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`(Fed. Cir. 2001) (looking to examples that immediately followed definition in specification to
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`construe claim term).
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`As discussed supra, Section II.A.2, “[w]hen a patentee explicitly defines a claim term in
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`the patent specification, the patentee’s definition controls.” Martek, 579 F.3d at 1380. Because
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`“humanized antibody” is defined in the specification, that definition controls. See id. Teva has
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`stated that it would not object to the Court adopting the full paragraph from the specification that
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`defines “humanized antibody” and provides examples, rather than the one sentence Lilly
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`proposes or the two sentences Teva initially proposed. [ECF No. 79 at 17 n.9]. The Court will
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`adopt Lilly’s construction, which is the specification’s most precise definition of “humanized
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`antibody,” with the caveat that Teva will be allowed to reference the examples of humanized
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`antibodies provided in the specification to further explain the term to the jury. The Court
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`therefore construes “humanized antibody” to mean “a form of non-human (e.g. murine)
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`anti