Case: 20-1876 Document: 50 Page: 1 Filed: 08/16/2021
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`United States Court of Appeals
`for the Federal Circuit
`______________________
`
`ELI LILLY AND COMPANY,
`Appellant
`
`v.
`
`TEVA PHARMACEUTICALS INTERNATIONAL
`GMBH,
`Appellee
`______________________
`
`2020-1876, 2020-1877, 2020-1878
`______________________
`
`Appeals from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board in Nos. IPR2018-
`01710, IPR2018-01711, IPR2018-01712.
`______________________
`
`Decided: August 16, 2021
`______________________
`
`WILLIAM BARRETT RAICH, Finnegan, Henderson,
`Farabow, Garrett & Dunner, LLP, Washington, DC, ar-
`gued for appellant. Also represented by PIER DEROO, ERIN
`SOMMERS, YIEYIE YANG; SANJAY M. JIVRAJ, MARK STEWART,
`Eli Lilly and Company, Indianapolis, IN.
`
` WILLIAM M. JAY, Goodwin Procter LLP, Washington,
`DC, argued for appellee. Also represented by ELAINE
`BLAIS, EDWINA CLARKE, ALEXANDRA LU, Boston, MA;
`NATASHA ELISE DAUGHTREY, Los Angeles, CA; WILLIAM
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`ELI LILLY AND COMPANY v. TEVA PHARMACEUTICALS
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`MILLIKEN, DEBORAH STERLING, Sterne Kessler Goldstein &
`Fox, PLLC, Washington, DC.
` ______________________
`
`Before LOURIE, BRYSON, and O’MALLEY, Circuit Judges.
`LOURIE, Circuit Judge.
`Eli Lilly and Company (“Lilly”) appeals from a com-
`bined final written decision of the U.S. Patent and Trade-
`mark Office (“PTO”) Patent Trial and Appeal Board
`(“Board”) holding that the claims of U.S. Patents 8,586,045
`(“’045 patent”), 9,884,907 (“’907 patent”), and 9,884,908
`(“’908 patent”) are not unpatentable as obvious. Eli Lilly
`& Co. v. Teva Pharms. Int’l GmbH, Nos. IPR2018-01710,
`IPR2018-01711,
`IPR2018-01712, 2020 WL 1540364
`(P.T.A.B. Mar. 31, 2020) (“Board Decision”). For the rea-
`sons provided below, we affirm.
`BACKGROUND
`I. Patents
`Teva Pharmaceuticals International GmbH (“Teva”)
`owns the ’045, ’907, and ’908 patents (collectively, the “chal-
`lenged patents”) directed to methods of using humanized
`antagonist antibodies that target calcitonin gene-related
`peptide (“CGRP”). CGRP is a 37-amino acid peptide that
`is “a neurotransmitter in the central nervous system, and
`has been shown to be a potent vasodilator in the periphery,
`where CGRP-containing neurons are closely associated
`with blood vessels.” ’045 patent, col. 1 ll. 31–35.
`The challenged patents explain that “CGRP has been
`noted for its possible connection to vasomotor symptoms,”
`id. at col. 1 ll. 39–40, such as “all forms of vascular head-
`ache, including migraines,” id. at col 2 ll. 3–6. Although at
`the time of the challenged patents the pathophysiology of
`migraine was not well understood, dilation of blood vessels
`was associated with and thought to exacerbate the pain
`symptoms of migraine. Id. at col. 3 ll. 14–26. Thus, even
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`ELI LILLY AND COMPANY v. TEVA PHARMACEUTICALS
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`before the challenged patents, the possible connection be-
`tween CGRP as a vasodilator and the pathology of mi-
`graine informed the development of treatments for
`migraine that sought to restrict the activity of CGRP in the
`body. For example:
`Possible CGRP involvement in migraine has
`been the basis for the development and testing of a
`number of compounds that inhibit release of CGRP
`(e.g., sumatriptan), antagonize at the CGRP recep-
`tor
`(e.g., dipeptide derivative BIBN4096BS
`(Boe[]hringer Ingelheim); CGRP (8-37)), or interact
`with one or more of receptor-associated proteins,
`such as, receptor activity membrane protein
`(RAMP) or receptor component protein (RCP), both
`of which affect binding of CGRP to its receptors.
`Id. at col. 2 ll. 14–22.
`The challenged patents are directed to methods of
`treatment using humanized antibodies that antagonize
`CGRP and thus inhibit its activity in the body by targeting
`and binding to the CGRP ligand (as opposed to CGRP re-
`ceptors). The challenged patents’ written description de-
`scribes “anti-CGRP antagonist antibodies and methods of
`using anti-CGRP antagonist antibodies for treating or pre-
`venting vasomotor symptoms, such as headaches, such as
`migraine.” Id. at col. 3 ll. 37–45. The claims at issue are
`directed to methods of treatment comprising the step of ad-
`ministering a humanized anti-CGRP antagonist antibody.1
`Claim 1 in each patent is representative:
`
`
`In contrast with the claims at issue in this case,
`1
`
`which are directed to methods of using anti-CGRP antibod-
`ies in treatment, Teva also owns related patents with
`claims directed to the antibodies themselves. Those claims
`are at issue in Appeal Nos. 2020-1747, 2020-1748, 2020-
`1749, 2020-1750, 2020-1751, and 2020-1752.
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`ELI LILLY AND COMPANY v. TEVA PHARMACEUTICALS
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`1. A method for reducing incidence of or treat-
`ing at least one vasomotor symptom in an individ-
`ual, comprising administering to the individual an
`effective amount of an anti-CGRP antagonist anti-
`body, wherein said anti-CGRP antagonist antibody
`is a human monoclonal antibody or a humanized
`monoclonal antibody.
`’045 patent, col. 99 ll. 2–7.
`1. A method for treating headache in an indi-
`vidual, comprising:
`administering to the individual an effective
`amount of a humanized monoclonal anti-
`Calcitonin Gene-Related Peptide (CGRP)
`antagonist antibody, comprising:
`two human IgG heavy chains, each heavy
`chain comprising three complementarity
`determining regions (CDRs) and four
`framework regions, wherein portions of the
`two heavy chains together form an Fc re-
`gion; and
`two light chains, each light chain compris-
`ing three CDRs and four framework re-
`gions;
`wherein the CDRs impart to the antibody
`specific binding to a CGRP consisting of
`amino acid residues 1 to 37 of SEQ ID
`NO:15 or SEQ ID NO:43.
`’907 patent, col. 103 ll. 21–35.
`1. A method for treating headache in an indi-
`vidual, comprising:
`administering to the individual an effective
`amount of a humanized monoclonal anti-
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`Calcitonin Gene-Related Peptide (CGRP)
`antagonist antibody, comprising:
`two human IgG heavy chains, each heavy
`chain comprising three complementarity
`determining regions (CDRs) and four
`framework regions, wherein portions of the
`two heavy chains together form an Fc re-
`gion; and
`two light chains, each light chain compris-
`ing three CDRs and four framework re-
`gions;
`wherein the CDRs impart to the antibody
`specific binding to a CGRP consisting of
`amino acid residues 1 to 37 of SEQ ID
`NO:15 or SEQ ID NO: 43, and wherein the
`antibody binds to the CGRP with a binding
`affinity (KD) of about 10 nM or less as meas-
`ured by surface plasmon resonance at 37o
`C.
`’908 patent, col. 99 l. 55–col. 100 l. 57. The differences be-
`tween these claims have not been argued as significant to
`these appeals.
`II. IPR Petitions and Prior Art
`Lilly filed petitions for inter partes review of claims 1,
`3, 4, 8–17, 19, 20, and 24–31 of the ’045 patent, claims 1–
`18 of the ’907 patent, and claims 1–18 of the ’908 patent.
`Lilly asserted that each of the challenged claims would
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`ELI LILLY AND COMPANY v. TEVA PHARMACEUTICALS
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`have been obvious over a combination of prior art refer-
`ences that includes Olesen,2 Tan,3 and Queen.4
`Olesen describes a clinical trial proving the efficacy of
`BIBN4096BS (“BIBN”), a nonpeptide CGRP-receptor an-
`tagonist, in the treatment of migraine. In Olesen’s study,
`patients receiving 2.5 mg of BIBN intravenously over a pe-
`riod of 10 minutes had a 66% response rate, with a pain-
`free rate of 44% after two hours and a recurrence rate of
`19%. See Board Decision, 2020 WL 1540364, at *11 (citing
`Olesen). In short, Olesen teaches that BIBN was effective
`and safe in treating acute attacks of migraine. Olesen also
`discusses past studies and discloses that CGRP may have
`a role in initiating and mediating migraine attacks.
`J.A. 3741.
`Tan is a publication describing an in vivo study in rats
`using an anti-CGRP monoclonal antibody for immunob-
`lockade.5 The study investigated the anti-CGRP activity of
`a full-length monoclonal antibody called “MAb C4.19” as
`well as its Fab’ fragment.6 See J.A. 3708–18. Tan describes
`the results of one experiment demonstrating that both the
`
`2 J. Olesen et al., Calcitonin Gene-Related Peptide
`Receptor Antagonist BIBN 4096 BS for the Acute Treatment
`of Migraine, N. ENG. J. MED. 350, 1104–10 (2004).
`3 K.K.C. Tan et al., Calcitonin gene-related peptide
`as an endogenous vasodilator: immunoblockade studies in
`vivo with an anti-calcitonin gene-related peptide monoclo-
`nal antibody and its Fab’ fragment, 89 CLINICAL SCI. 6,
`565–73 (1995).
`
`4 U.S. Patent 6,180,370.
`
`5 Tan defines “immunoblockade” as “the blockade of
`the effects of a biological mediator by inhibition of its bind-
`ing to specific receptors with antibodies directed against
`the mediator.” J.A. 3711.
`
`6 A “Fab’ fragment” is the portion of an antibody that
`binds to the target antigen.
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`full-length antibody and the Fab’ fragment successfully
`achieved immunoblockade by inhibiting the effects of exog-
`enously administered CGRP. See J.A. 3711–12. Tan also
`describes the results of a second experiment analyzing
`whether the antibody and its Fab’ fragment inhibit endog-
`enous CGRP-induced blood flow after a prescribed incuba-
`tion period. J.A. 3714. The results demonstrated that the
`Fab’ fragment effectively blocked skin blood flow after a 30-
`minute incubation period. Id. The full-length antibody did
`not block skin blood flow after a 60-minute incubation, but
`a 2-hour incubation period and higher dose resulted in a
`16% block in skin blood flow. Id. Tan posited that “much
`larger doses and longer distribution times are required for
`successful immunoblockade” with the full-length antibody.
`J.A. 3716.
`Queen “relates generally to the combination of recom-
`binant DNA and monoclonal antibody technologies for de-
`veloping novel therapeutic agents.” J.A. 27230 at col. 1
`ll. 19–21. Specifically, Queen discloses a method of human-
`izing antibodies to address traditional problems associated
`with injecting monoclonal antibodies from donors (e.g.,
`mice) into humans.
`III. Board Decision
`After a combined oral hearing, the Board issued a com-
`bined final written decision in the three IPRs. The Board
`first construed the claims, including the preambles and the
`term “effective amount.” The Board then analyzed the as-
`serted prior art and concluded that Lilly failed to prove
`that the challenged claims in the three patents would have
`been obvious over the stated references.
`For the constructions of the claim preambles, the Board
`noted that “[t]he parties do not dispute that the preamble
`claim language is a statement of intended purpose.” Board
`Decision, 2020 WL 1540364, at *7. The Board thus deter-
`mined that the preambles are “limiting to the extent that
`they require that the recited method must be performed
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`ELI LILLY AND COMPANY v. TEVA PHARMACEUTICALS
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`with the intentional purpose of ‘reducing incidence of or
`treating’ at least one vasomotor symptom . . . or headache.”
`Id. The Board also discussed how the claim construction
`affected Lilly’s burden to demonstrate that a skilled arti-
`san would have had a reasonable expectation of success in
`combining the teachings of the prior art to achieve the
`claimed invention:
`[W]e determine here that to prove a reasonable
`expectation of success with respect to a limitation
`that recites achieving a particular result as the in-
`tended purpose for which a recited method must be
`performed, what is required is not proof that the
`recited method would actually bring about the re-
`cited result, but rather proof that a person of ordi-
`nary skill in the art would have had a reasonable
`expectation that performing the recited method
`would bring about the recited result.
`Id. at *8.
`For the term “effective amount,” the Board determined
`that the written descriptions defined the term to mean “an
`amount sufficient to effect beneficial or desired results.”
`Id. at *10. The Board specifically addressed the relation-
`ship between an “effective amount” under the claims, and
`potential clinical results demonstrating efficacy:
`Although the term “effective amount” may en-
`compass a clinical result, we do not interpret the
`term “effective amount” as requiring a clinical re-
`sult because, as defined in the Specification, the
`term “effective amount” refers only to “beneficial or
`desired results” without the qualifier “clinical.”
`That is, the term “effective amount” requires a ben-
`eficial or desired result, but it need not be a “clini-
`cal” result.
`Id. at *9.
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`After construing the claims, the Board considered the
`evidence pertaining to obviousness. The Board first found
`that Lilly had shown by a preponderance of the evidence
`that the asserted prior art discloses or suggests each and
`every element of the challenged claims. Id. at *18. Next,
`the Board found that a skilled artisan would have been mo-
`tivated to combine the teachings of the prior art:
`[T]here are clearly reasons that a person of or-
`dinary skill in the art would have been motivated
`to combine the teachings of Olesen, Tan, and
`Queen to pursue a method to reduce incidence of or
`treat a vasomotor symptom, such as a migraine
`headache, by administering a human or human-
`ized monoclonal anti-CGRP antagonist antibody.
`Id. at *43. Moreover, the Board found that “any alleged
`safety concerns would not have deterred, discouraged, or
`taught away from pursuing” the patented methods of treat-
`ment. Id.
`After finding a motivation to combine the teachings of
`the prior art, the Board next considered whether a skilled
`artisan would have had a reasonable expectation of suc-
`cess. The Board first addressed Lilly’s arguments based on
`the asserted prior art references, namely, Olesen and Tan.
`Regarding Olesen, the Board found that “the data provided
`by Olesen only relate[] to a small molecule (BIBN) and to
`blocking a CGRP receptor” and “Olesen does not provide a
`reasonable expectation of success of administering an anti-
`CGRP antibody (a different compound) that binds to the
`CGRP ligand rather than the CGRP receptor (a different
`site upstream of the receptor) to treat migraine.” Id. at *44.
`Regarding Tan, the Board found that “Tan did not provide
`data showing that a full length anti-CGRP antibody could
`reach the synaptic cleft, the site of action for immunoblock-
`ade, to thereby achieve inhibition of endogenous CGRP in
`vivo” and “Tan provides no information or data regarding
`the use of a full-length anti-CGRP antibody to reduce
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`ELI LILLY AND COMPANY v. TEVA PHARMACEUTICALS
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`incidence of or treat a vasomotor symptom such as mi-
`graine headache.” Id. at *45–46.
`Having found no reasonable expectation of success
`based on the asserted prior art references, the Board next
`addressed the evidence relied on by each party and its ex-
`perts pertaining to “whether migraine drugs would have
`been required to cross the blood brain barrier (BBB).” Id.
`at *47–59. The Board noted that the blood-brain barrier
`“raised uncertainty, unpredictability, and skepticism in us-
`ing full-length anti-CGRP antibodies to reduce incidence of
`or treat headache such as migraine.” Id. at *57. The Board
`determined that “in 2005, a [skilled artisan] would have
`been aware of the differences of opinion among key opinion
`leaders as to the pathogenesis of migraine and that it was
`largely unresolved.” Id. at *58. Thus, the Board found
`that:
`
`[I]t was unknown as of November 14, 2005,
`whether anti-CGRP antibodies needed to cross the
`blood-brain barrier to reduce incidence of or treat
`headache such as migraine. Although absolute
`predictability in the art is not required to establish
`a reasonable expectation of success, the uncer-
`tainty and unpredictability about this basic
`knowledge and the pathogenesis of migraine head-
`ache, as well as the skepticism around whether
`full-length anti-CGRP antibodies would be effec-
`tive, counsel against finding a reasonable expecta-
`tion of success.
`Id.
`The Board also relied on precedent from this court to
`support its finding that a skilled artisan would not have
`had a reasonable expectation of success. For example, the
`Board cited Honeywell International Inc. v. Mexichem
`Amanco Holdings S.A. DE C.V., 865 F.3d 1348, 1356 (Fed.
`Cir. 2017), for the proposition that “when there is a high
`enough quantum of unpredictability, . . . a proponent of
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`unpatentability may not have met its burden of showing a
`reasonable expectation of success.” Board Decision, 2020
`WL 1540364, at *59. Based on Honeywell, the Board
`stated:
`
`[Lilly] is arguing that a person of ordinary skill
`would have taken the leap from a small molecule
`antagonist such as BIBN to a large molecule anti-
`CGRP antagonist antibody. We determine that
`[Lilly] has not demonstrated that a person of ordi-
`nary skill in the art would have had a reasonable
`expectation of success in using an antibody treat-
`ment in view of the level of unpredictability in
`whether the blood brain barrier would have been
`an obstacle, i.e., the uncertainty in whether anti-
`CGRP antibodies needed to cross the blood-brain
`barrier to reduce incidence of or treat headache
`such as migraine.
`
`Id.
`
`The Board also found that the facts in this case resem-
`bled the fact pattern in Novartis Pharmaceuticals Corp. v.
`West-Ward Pharmaceuticals International Ltd., 923 F.3d
`1051 (Fed. Cir. 2019), where this court held that the as-
`serted art would not have given a skilled artisan a reason-
`able expectation of success. See Board Decision, 2020 WL
`1540364, at *60. The Board found:
`Similar to West-Ward where clinical results
`had been obtained with temsirolimus but not with
`everolimus, clinical results had been obtained with
`BIBN (e.g., Olesen []) but not with anti-CGRP an-
`tagonist antibodies. Indeed, the anti-CGRP anti-
`bodies are pharmacologically different from BIBN
`because anti-CGRP antibodies have different half-
`lives and different sizes than BIBN. . . . Further, as
`above, the mechanisms of migraine and its treat-
`ment were still uncertain in 2005.
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`Id. Thus, the Board concluded that “West-Ward illustrates
`how a jump from one molecule to another may result in a
`lack of a reasonable expectation of success in an area with
`uncertainty.” Id. at *61.
`In summary, the Board found that Lilly failed to prove
`by a preponderance of the evidence that a skilled artisan
`would have had a reasonable expectation of success as to
`any of the challenged claims. Id. at *62–64. Accordingly,
`the Board concluded that Lilly failed to satisfy its burden
`of demonstrating that the challenged claims would have
`been obvious over the combination of Olesen, Tan, and
`Queen. Id. at *64.
`Lilly appealed from the Board’s combined final written
`decision with respect to each of the three challenged pa-
`tents, and we consolidated the appeals. We have jurisdic-
`tion under 28 U.S.C. § 1295(a)(4)(A).
`DISCUSSION
`We review the Board’s legal determinations de novo, In
`re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), but we re-
`view the Board’s factual findings underlying those deter-
`minations for substantial evidence, In re Gartside, 203 F.3d
`1305, 1316 (Fed. Cir. 2000). A finding is supported by sub-
`stantial evidence if a reasonable mind might accept the ev-
`idence as adequate to support the finding. Consol. Edison
`Co. v. NLRB, 305 U.S. 197, 229 (1938).
`While Lilly makes a number of interrelated arguments
`in its briefing, Lilly’s appeal can be broadly broken down
`into two primary challenges. In its first challenge, Lilly
`contends that the Board erred by reading a result into the
`constructions of the preambles and the term “effective
`amount,” which led the Board to erroneously require Lilly
`to prove that a skilled artisan would have expected to
`achieve results that are unclaimed. In its second chal-
`lenge, Lilly contends that even if the preambles are limit-
`ing and the claims thus require administration of an
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`antibody with an expectation of results, the Board erred by
`applying too high a standard when weighing the evidence
`to determine whether a skilled artisan would have had a
`reasonable expectation of success. We address each chal-
`lenge in turn.
`
`I
`We first consider Lilly’s challenge that the Board im-
`properly required proof that a skilled artisan would have
`had a reasonable expectation of achieving a result that was
`not claimed. In considering this challenge, we think it is
`helpful to break down the challenge into two parts. In the
`first part, we discuss the aspects of the challenge that
`sound in claim construction. In the second part, we discuss
`the aspects of the challenge that relate more directly to the
`impact of the Board’s constructions on its analysis of the
`reasonable expectation of success.
`A
`Claim construction is a matter of law that we review de
`novo. See Poly-America, L.P. v. API Indus., Inc., 839 F.3d
`1131, 1135–36 (Fed. Cir. 2016). Because the challenged
`patents are unexpired and the IPR petitions in this case
`were filed before November 13, 2018, the claims are to be
`given their broadest reasonable interpretation. See 37
`C.F.R. § 42.100(b) (2018); Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131, 2142 (2016).
`Lilly challenges the Board’s construction of the claim
`preambles as limiting to the extent that they require that
`the recited methods be performed with an intentional pur-
`pose. According to Lilly, a preamble that contains only a
`statement of purpose cannot as a matter of law be a claim
`limitation. Lilly argues that a proper construction would
`attribute no weight to the claim preambles, and thus ren-
`der them irrelevant to the obviousness analysis. And Lilly
`argues that the Board erred in its construction of the term
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`“effective amount,” which compounded the Board’s errors
`in imposing required results from the preambles.
`Teva responds that Lilly’s argument is based on a false
`dichotomy between limiting preambles as contrasted with
`preambles that are merely statements of intended purpose.
`Teva further argues that the preambles here are limiting
`because they are central to the invention, they provide an-
`tecedent basis for later claim limitations, and they give
`meaning to the substantive claim requirement of adminis-
`tering an “effective amount,” which, Teva argues, the
`Board construed correctly.
`First, we agree with Teva that our case law does not
`support Lilly’s proposed binary distinction between state-
`ments of mere intended purpose on the one hand and lim-
`iting preambles on the other. On the contrary, we have
`stressed that there is no “litmus test” for determining
`whether a preamble is limiting. See Bicon, Inc. v. Strau-
`mann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) (citing Cata-
`lina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,
`808 (Fed. Cir. 2002)). Rather, “[w]hether to treat a pream-
`ble as a claim limitation is determined on the facts of each
`case in light of the claim as a whole and the invention de-
`scribed in the patent.” Storage Tech. Corp. v. Cisco Sys.,
`Inc., 329 F.3d 823, 831 (Fed. Cir. 2003).
`The claims in this case are directed to methods, and
`more specifically to methods of using a composition for a
`specific purpose. Each claim is directed to a method for
`treating or reducing the incidence of vasomotor symptoms,
`and the method comprises a single step of administering
`an effective amount of a composition, namely, a humanized
`anti-CGRP antagonist antibody. This claim format is par-
`ticularly relevant in our consideration of the claim as a
`whole because, while there is no bright-line rule for deter-
`mining whether a preamble is limiting, we have generally
`construed statements of intended purpose in such method
`claims as limiting.
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`To illustrate the significance of methods of using appa-
`ratuses and compositions for specific purposes, we start by
`contrasting them with more general claims directed to ap-
`paratuses or compositions of matter, which are governed
`by the well-established principle that “[a]pparatus claims
`cover what a device is, not what a device does.” Hewlett-
`Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468
`(Fed. Cir 1990). With regard to claims directed to apparat-
`uses or compositions, we have often relied on the proposi-
`tion that “[p]reamble language that merely states the
`purpose or intended use of an invention is generally not
`treated as limiting the scope of the claim.” Bicon, 441 F.3d
`at 952. For example, in Cochlear Bone Anchored Solutions
`AB v. Oticon Med. AB, we held that a statement of intended
`purpose in the preamble—“for rehabilitation of unilateral
`hearing loss”—was not limiting because the claimed appa-
`ratus was fully structurally claimed in the body of the
`claim, and its structure would allow it to function identi-
`cally whether or not used for its stated intended purpose.
`See 958 F.3d 1348, 1355 (Fed. Cir. 2020).
`Even with respect to apparatus or composition claims,
`however, we have, when warranted by the facts, found
`statements of intended purpose to be limiting. For exam-
`ple, in Bicon, we considered a claim in which the preamble
`recited an apparatus and its intended use: “[a]n emergence
`cuff member for use in preserving the interdental papilla
`during the procedure of placing an abutment on a root
`member implanted in the alveolar bone of a patient.” 441
`F.3d at 948. We held that the preamble’s statement of in-
`tended use was limiting because it “recites essential ele-
`ments of the invention pertaining to the structure of the
`abutment that is used with the claimed emergence cuff.”
`Id. at 952. We further noted that the body of the claim
`“refers back to the features of the abutment described in
`the preamble”—i.e., the preamble provided antecedent ba-
`sis for the structural terms in the body of the claim. Id. at
`952–53. Similarly, in Pacing Technologies, LLC v. Garmin
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`International, Inc., we held that a statement of intended
`use—“[a] repetitive motion pacing system for pacing a
`user”—was limiting because the term “user” in the pream-
`ble provided antecedent basis for that term later in the
`body of the claim. 778 F.3d 1021, 1023–24 (Fed. Cir. 2015).
`In contrast to apparatus and composition claims,
`claims to methods of using such apparatuses or composi-
`tions are not directed to what the method “is,” but rather
`they typically rely entirely on what the method “does.” And
`what a method does is usually recited in its preamble. Ac-
`cordingly, our claim construction analysis of statements of
`intended purpose in methods of using apparatuses or com-
`positions has tended to result in a conclusion that such pre-
`amble language is limiting. See, e.g., Boehringer Ingelheim
`Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339,
`1345 (Fed. Cir. 2003); Jansen v. Rexall Sundown, Inc., 342
`F.3d 1329, 1333 (Fed. Cir. 2003); but cf. Bristol-Myers
`Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375–
`76 (Fed. Cir. 2001) (holding preamble language non-limit-
`ing in method of treatment claims containing two steps, the
`second of which was administering a compound).
`For example, in Boehringer Ingelheim Vetmedica, we
`considered a claim directed to “[a] method of growing and
`isolating swine infertility and respiratory syndrome virus,
`ATCC-VR2332.” 320 F.3d at 1344. In holding the pream-
`ble language limiting, we explained that:
`[P]reamble language will limit the claim if it
`recites not merely a context in which the invention
`may be used, but the essence of the invention with-
`out which performance of the recited steps is noth-
`ing but an academic exercise. . . . This principle
`holds true here, as it frequently does for method
`claims: “growing” and “isolating” are not merely
`circumstances in which the method may be useful,
`but instead are the raison d’etre of the claimed
`method itself.
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`Id. at 1345 (emphasis added). Similarly, in Jansen, we
`held that the preamble of a method “for treating or prevent-
`ing macrocytic-megaloblastic anemia” was limiting be-
`cause it “set[] forth the objective of the method, and the
`body of the claim directs that the method be performed on
`someone ‘in need.’” 342 F.3d at 1332–33. We elaborated
`that the preamble “is therefore not merely a statement of
`effect that may or may not be desired or appreciated. Ra-
`ther, it is a statement of the intentional purpose for which
`the method must be performed.” Id. Again, while there is
`no bright-line rule, it is instructive that this court has not
`hesitated to hold preambles limiting when they state an
`intended purpose for methods of using a compound.
`Here, like in Boehringer Ingelheim and Jansen, the
`preambles are not merely statements of effect but rather
`statements of the intentional purpose for which the meth-
`ods must be performed. First and foremost, the treatment
`of vasomotor symptoms such as migraine is central to the
`inventions of the challenged patents. That reality is re-
`flected in the extensive discussions of such treatment in
`every section of the patents’ written description. For ex-
`ample, the Abstract states that the invention “features
`methods for preventing or treating CGRP associated disor-
`ders such as vasomotor symptoms, including headaches.”
`’045 patent at Abstract. The “Field of the Invention” de-
`scribes the invention as relating to “the use of anti-CGRP
`antagonist antibodies for the prevention, amelioration, or
`treatment of vasomotor symptoms, such as CGRP related
`headaches (e.g., migraine).” Id. at col. 1 ll. 15–21. The
`“Background of the Invention” section is largely devoted to
`discussions of the connection between CGRP and vasomo-
`tor symptoms. See id. at col. 1 l. 39–col. 3 l. 29. The “Brief
`Summary of the Invention” describes a number of aspects
`of the invention, all of which are directed to “methods of
`using anti-CGRP antagonist antibodies for treating or pre-
`venting vasomotor symptoms, such as headaches, such as
`migraine.” Id. at col. 3 ll. 38–40; see also id. at col. 3 l. 46–
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`col. 4 l. 3. And the “Detailed Description of the Invention”
`begins by stating that “[t]he invention disclosed herein pro-
`vides methods for treating and/or preventing vasomotor
`symptoms such as headache (e.g., migraine, cluster head-
`ache, chronic headache, and tension headache).” Id. at
`col. 11 ll. 36–39.
`After this heavy emphasis on the treatment of vasomo-
`tor symptoms throughout the written description, the
`claims also reference such treatment, but only in the pre-
`ambles. Thus, the preambles are the portions of the claims
`that embody the essence of the claimed invention—meth-
`ods for treating vasomotor symptoms. Under these circum-
`stances, we reject Lilly’s suggestion that the preambles
`merely state an intended purpose that need not be per-
`formed to practice the