Trials@uspto.gov
`571-272-7822
`
`Paper 69
`Date: March 31, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ELI LILLY AND COMPANY,
`Petitioner,
`v.
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH,
`Patent Owner.
`
`IPR2018-01710 (Patent 8,586,045 B2)
`IPR2018-01711 (Patent 9,884,907 B2)
` IPR2018-01712 (Patent 9,884,908 B2)1
`
`
`
`
`
`
`
`
`
`Before JENNIFER MEYER CHAGNON, JAMES A. WORTH, and
`RICHARD J. SMITH, Administrative Patent Judges.
`
`Per Curiam
`
`
`
`
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
`
`
`1 The proceedings have not been consolidated. The parties are not
`authorized to use a combined caption unless an identical paper is being
`entered into each proceeding and the paper contains a footnote indicating the
`same.
`
`
`
`

`

`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`
`I.
`INTRODUCTION
`This is a Final Written Decision addressing three inter partes reviews
`challenging claims 1, 3, 4, 8–17, 19, 20, and 24–31 of U.S. Patent No.
`8,586,045 B2 (“the ’045 patent”) (IPR2018-01710), claims 1–18 of U.S.
`Patent No. 9,884,907 B2 (“the ’907 patent”) (IPR2018-01711), and claims
`1–18 of U.S. Patent No. 9,884,908 B2 (“the ’908 patent”) (IPR2018-
`01712).2 We have jurisdiction under 35 U.S.C. § 6(b). This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a). Having reviewed the
`arguments of the parties and the supporting evidence, we find that Petitioner
`has failed to demonstrate by a preponderance of the evidence that any of the
`challenged claims are unpatentable.
`A. Procedural History
`Eli Lilly and Company (“Petitioner” or “Lilly”) filed three Petitions
`(Paper 1,3 “Pet.”) requesting an inter partes review of the respective
`challenged claims of the ’045 patent, the ’907 patent, and the ’908 patent.
`Teva Pharmaceuticals International GmbH (“Patent Owner” or “Teva”) filed
`a Preliminary Response to each of the Petitions. Paper 8 (“Prelim. Resp.”).
`
`
`2 All of the respective challenged claims are referred to collectively as the
`“challenged claims,” and the ’045 patent, the ’907 patent, and the ’908
`patent are referred to collectively as the “challenged patents.”
`IPR2018-01710 (“1710 IPR”), IPR2018-01711 (“1711 IPR”), and
`IPR2018-01712 (“1712 IPR”) are referred to herein as “the three inter partes
`reviews.”
`3 Unless this Decision otherwise indicates, all citations are to the Papers and
`Exhibits in IPR2018-01710. Similar Papers and Exhibits were filed in each
`of the three inter partes reviews.
`
`2
`
`

`

`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`
`We entered our three Decisions on Institution (Paper 12, “Inst. Dec.”
`or “Institution Decision”),4 instituting inter partes review of all challenged
`claims under the only ground asserted in each of the three petitions. In each
`of the three inter partes reviews, Patent Owner filed a substantially similar
`Response (Paper 21, “PO Resp.”), Petitioner filed a substantially similar
`Reply (Paper 32, “Reply”), and Patent Owner filed a substantially similar
`Sur-reply (Paper 43, “Sur-reply”).
`In each of the three inter partes reviews, Patent Owner filed a
`substantially similar Motion to Strike (Paper 38, “Mot. Strike”) and
`Petitioner filed a substantially similar Opposition to the Motion to Strike
`(Paper 40, “Opp. Strike”). In each of the three inter partes reviews, Patent
`Owner also filed a substantially similar Motion to Exclude (Paper 51, “Mot.
`Excl.”), Petitioner filed a substantially similar Opposition to the Motion to
`Exclude (Paper 52, “Opp. Excl.”), and Patent Owner filed a substantially
`similar Reply to Petitioner’s Opposition to the Motion to Exclude
`(Paper 57).
`On November 21, 2019, Patent Owner filed the following documents,
`in each of the three inter partes reviews, regarding our denial of its request
`to file a motion to stay based on the Federal Circuit decision in Arthrex, Inc.
`v. Smith & Nephew, Inc., 941 F.3d 1320 (Fed. Cir. 2019) (“Arthrex”):
`Patent Owner’s Request for Rehearing Pursuant to 37 C.F.R.
`§ 42.71(d) on Denial of Authorization to File a Motion to Stay
`and Supplemental Brief Addressing Arthrex (Paper 49);5
`
`
`4 The three inter partes reviews were instituted on April 3, 2019. See also
`1711 IPR Paper 12; 1712 IPR Paper 11.
`5 Patent Owner also requested Precedential Opinion Panel (POP) review of
`the requests for rehearing. See Ex. 3002 (e-mail dated November 21, 2019).
`That request was denied on February 13, 2020. Paper 65.
`
`3
`
`

`

`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`
`Patent Owner’s Petition to Expedite Under 37 C.F.R. § 1.182
`(Paper 48); and
`Patent Owner’s Petition Under 37 C.F.R. § 1.181(a)(3) Invoking
`the Supervisory Authority of the Director (Paper 47).
`Patent Owner’s Petition invoking the supervisory authority of the
`Director (Paper 47) was denied on February 18, 2020. Paper 66. Patent
`Owner’s request for rehearing (Paper 49) also was denied on February 18,
`2020. Paper 67.
`We held a combined6 oral hearing on January 8, 2020, and the
`transcript of that hearing has been entered into the record. Paper 68 (“Tr.”).
`On December 18, 2019, the U.S. Court of Appeals for the Federal
`Circuit issued an opinion in Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366
`(Fed. Cir. 2019). In Fox Factory, the court “address[ed] the Board’s
`application of the presumption of nexus” to certain claims at issue. Id. at
`1374. Because Patent Owner argued a presumption of nexus with respect to
`its proffered evidence of objective indicia of nonobviousness,7 we
`authorized both of the parties to file, in each of the three inter partes
`reviews, a supplemental brief, and a brief responsive to the other party’s
`supplemental brief, addressing the application, if any, of Fox Factory to the
`three inter partes reviews. Paper 60. Petitioner filed a substantially similar
`supplemental brief and responsive brief (Paper 62, Paper 63), and Patent
`
`
`6 The hearing included the three inter partes reviews addressed in this
`Decision.
`7 Because we determine that Petitioner has failed to establish by a
`preponderance of the evidence that a person of ordinary skill in the art would
`have had a reasonable expectation of success in achieving the invention of
`the independent claims of the challenged patents (see infra Section
`II.D.4.b)), we need not rely on Patent Owner’s evidence of objective indicia
`of nonobviousness for purposes of this Final Written Decision.
`
`4
`
`

`

`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`Owner filed a substantially similar supplemental brief and responsive brief
`(Paper 61, Paper 64) in each of the three inter partes reviews.
`B. Real Parties-in-Interest
`Petitioner identifies Eli Lilly and Company as the real party-in-
`interest. Pet. 66.
`Patent Owner identifies Teva Pharmaceuticals International GmbH
`and Teva Pharmaceuticals USA, Inc. as the real parties-in-interest. Paper 6,
`2.
`
`C. Related Matters
`Petitioner identifies a declaratory judgment action filed by Patent
`Owner on October 24, 2017, in the District Court for the District of
`Massachusetts (“the first DJ action”). Pet. 66. According to Petitioner, the
`first DJ action seeks a declaration that Petitioner’s investigational drug
`galcanezumab will infringe U.S. Patent Nos. 8,597,649; 9,266,951;
`9,340,614; 9,346,881; and the ’045 patent, and Patent Owner filed an
`amended complaint in the first DJ action on January 16, 2018. Id. Petitioner
`also identifies a declaratory judgment action filed by Patent Owner on
`February 6, 2018, seeking a declaration that Petitioner’s product will
`infringe the ’907 patent and ’908 patent (“the second DJ action”). Id.
`Petitioner states that Patent Owner thereafter filed an amended complaint in
`the second DJ action to incorporate U.S. Patent Nos. 9,890,210 and
`9,890,211. Id.
`According to Petitioner, the court dismissed Patent Owner’s amended
`complaints in the first DJ action and the second DJ action, and Patent Owner
`filed a third action for infringement of the same patents on September 27,
`2018. Id. Petitioner asserts that those patents purport to claim priority to the
`
`5
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`

`

`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`same provisional application as the ’045 patent, and that two applications
`(15/883,218 and 15/956,580) based on the same provisional application are
`pending before the United States Patent and Trademark Office. Id.
`Patent Owner identifies the first DJ action and the second DJ action,
`as well as a litigation styled Teva Pharmaceuticals International GmbH v.
`Eli Lilly & Co., Civ. No. 1-18-cv-12029 (D. Mass.). Paper 6. Patent Owner
`also identifies U.S. Patent Nos. 9,365,648; 9,328,168; 9,115,194; 8,734,802;
`and 8,007,794, as related to the challenged patents, in addition to the patents
`and patent applications identified by Petitioner. Id.
`The parties also identify six related inter partes review proceedings.
`Pet. 67; Paper 6; see IPR2018-01422, IPR2018-01423, IPR2018-01424,
`IPR2018-01425, IPR2018-01426, and IPR2018-01427. Final Written
`Decisions issued in these six related inter partes review proceedings on
`February 18, 2020.8 See, e.g., Eli Lilly & Co. v. Teva Pharms. Int’l GmbH,
`IPR2018-01422, Paper 80 (PTAB Feb. 18, 2020); Eli Lilly & Co. v. Teva
`Pharms. Int’l GmbH, IPR2018-01424, Paper 78 (PTAB Feb. 18, 2020).
`D. The Challenged Patents9
`The ’045 patent is titled “Methods of Using Anti-CGRP[10] Antagonist
`Antibodies” and “relates to the use of anti-CGRP antagonist antibodies for
`
`
`8 In those decisions, claims directed to human or humanized monoclonal
`anti-CGRP antagonist antibodies were held unpatentable as obvious.
`9 The challenged patents are direct or indirect continuations of U.S. Patent
`Application No. 12/093,638 (now U.S. Patent No. 8,007,794) and share a
`common specification. Ex. 1001, code (60); 1711 IPR Ex. 1001, code (60);
`1712 IPR Ex. 1001, code (60). We refer to the ’045 patent in this Decision
`unless otherwise indicated.
`10 Calcitonin Gene-Related Peptide is abbreviated throughout as CGRP. See
`Ex. 1001, 1:25.
`
`6
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`

`

`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`the prevention, amelioration, or treatment of vasomotor symptoms, such as
`CGRP related headaches (e.g., migraine) and hot flushes.” Ex. 1001, code
`(54), 1:18–21.
`According to the Specification, CGRP is a 37 amino acid
`neuropeptide, which belongs to a family of peptides that includes calcitonin,
`adrenomedullin and amylin. Id. at 1:25–27. In humans, two forms of CGRP
`with similar activities (α-CGRP and β-CGRP) exist and exhibit differential
`distribution. Id. at 1:27–30. At least two CGRP receptor subtypes may also
`account for differential activities. Id. at 1:30–31. CGRP 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. Id. at 1:31–35.
`CGRP-mediated vasodilatation is also associated with neurogenic
`inflammation, as part of a cascade of events that results in extravasation of
`plasma and vasodilation of the microvasculature and is present in migraine.
`Id. at 1:35–38. CGRP has been noted for its possible connection to
`vasomotor symptoms. Id. at 1:39–40. Vasomotor symptoms include hot
`flushes and night sweats. Id. at 1:42–43. CGRP is a potent vasodilator that
`has been implicated in the pathology of other vasomotor symptoms, such as
`all forms of vascular headache, including migraines (with or without aura)
`and cluster headache. Id. at 2:3–6.
`According to the Specification, the precise pathophysiology of
`migraine is not yet well understood. Id. at 3:17–18. Dilation of blood
`vessels is associated with and exacerbates the pain symptoms of migraine.
`Id. at 3:23–24. The variety of pharmacologic interventions that have been
`used to treat migraine and the variability in responses among patients
`
`7
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`

`

`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`indicate that migraine is a diverse disorder. Id. at 2:57–59. Different classes
`of drugs have been used in treatment (and some patients, usually those with
`milder symptoms, are able to control their symptoms with non-prescription
`remedies). See id. at 2:60–3:8. Some patients respond well to sumatriptan,
`which is a 5HT1 receptor agonist, which also inhibits release of CGRP;
`others are relatively resistant to sumatriptan’s effects. See id. at 2:14–16,
`3:8–13, 4:4–6.
`Embodiments described in the ’045 patent are directed, inter alia, to
`methods of treating or preventing a vasomotor symptom, migraine headache,
`or cluster headache in an individual using an effective amount of an
`anti-CGRP antagonist antibody. See id. at 3:37–54. Other embodiments of
`the ’045 patent are directed to methods of ameliorating, controlling,
`reducing incidence of, or delaying the development or progression of a
`migraine headache or cluster headache, using an effective amount of an
`anti-CGRP antagonist antibody with or without additional agents. See id. at
`3:55–4:36. In various embodiments, the antibody is a human antibody or
`humanized antibody, the antibody recognizes a human CGRP, or the
`antibody comprises modified regions. See id. at 4:40–5:34, 7:64–66. Other
`embodiments are directed to a polypeptide, which may or may not be an
`antibody. See id. at 6:56–7:63. Other embodiments are directed to a
`polynucleotide encoding a fragment or region of the antibody or its variants,
`or to expression and cloning vectors and host cells comprising any of the
`disclosed polynucleotides. See id. at 8:9–38. Other embodiments are
`directed to methods of making the same. See id. at 8:49–64.
`The ’045 patent includes a Table 4 showing amino acid sequences of
`different variants of human α-CGRP and related peptides. Id. at 50:55–58;
`
`8
`
`

`

`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`cols. 52–53 (Table 4). Table 4 identifies CGRP 1–37 (WT) as SEQ ID
`NO:15 and CGRP human β (1–37) as SEQ ID NO:43. See id.
`Figure 5 (not reproduced here) shows the amino acid sequence of the
`heavy chain variable region (SEQ ID NO:1) and light chain variable region
`(SEQ ID NO:2) of antibody G1. Id. at 10:4–6. Table 6 provides data on
`binding affinity for G1 variants. See id. at cols. 60–65. Another table (cols.
`72–97) lists additional antibody sequences.
`E. Illustrative Claims
`Claims 1 and 17, the only independent claims of the ’045 patent, are
`reproduced below:
`1. 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.
`Ex. 1001, 99:2–7.
`17. A method for reducing incidence of or treating headache in
`a human, comprising administering to the human 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.
`Id. at 100:3–7.
`Claims 3, 4, and 8–16 of the ’045 patent depend directly from claim 1,
`and claims 19, 20, and 24–31 of the ’045 patent depend directly from claim
`17. Id. at 99:17–25; 99:38–100:2; 100:17–24, 37–59.
`
`9
`
`

`

`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`
`Claim 1, the only independent claim of the ’907 patent, is reproduced
`below:
`1. A method for treating headache in an individual, 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 region; and
`two light chains, each light chain comprising three CDRs and
`four framework regions;
`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.
`1711 IPR Ex. 1001, 103:21–35.
`Claims 2–18 of the ’907 patent depend directly or indirectly from
`claim 1. Id. at 103:36–104:49.
`Claim 1, the only independent claim of the ’908 patent, is reproduced
`below:
`1. A method for treating headache in an individual, 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 region; and
`two light chains, each light chain comprising three CDRs and
`four framework regions;
`
`10
`
`

`

`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`
`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 measured by surface plasmon resonance
`at 37° C.
`1712 IPR Ex. 1001, 99:55–100:58.
`Claims 2–18 of the ’908 patent depend directly or indirectly from
`claim 1. Id. at 100:59–102:18.
`F. The Asserted Prior Art and Declaration Evidence
`Petitioner’s asserted grounds of unpatentability rely on the following
`references:
`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) (“Olesen”). Ex. 1025.
`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 monoclonal antibody
`and its Fab' fragment, 89 CLINICAL SCI. 6, 565–73 (1995)
`(“Tan”). Ex. 1022.
`Queen et al., US 6,180,370 B1, issued Jan. 30, 2001 (“Queen”).
`Ex. 1023.
`Petitioner relies on the Declaration of Dr. Andrew C. Charles, M.D.
`dated September 27, 2018 (Ex. 1014, “First Charles Declaration”11), the
`Declaration of Dr. Alain P. Vasserot, Ph.D. (Ex. 1015, “Vasserot
`Declaration”12), the Declaration of Dr. Andrew C. Charles, M.D. dated
`
`
`11 The First Charles Declaration is Ex. 1016 in the 1711 IPR, and Ex. 1018
`in the 1712 IPR.
`12 The Vasserot Declaration is Ex. 1017 in the 1711 IPR, and Ex. 1236 in the
`1712 IPR.
`
`11
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`

`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`September 30, 2019 (Ex. 1338, “Second Charles Declaration”13), and the
`Declaration of Dr. Joseph P. Balthasar, Ph.D. (Ex. 1337, “Balthasar
`Declaration”14).
`Patent Owner relies on the Declaration of Dr. Michael Ferrari, M.D.,
`Ph.D. (Ex. 2268, “Ferrari Declaration”15), the Declaration of Dr. Ian M.
`Tomlinson, M.A., Ph.D. (Ex. 2271, “Tomlinson Declaration”16), the
`Declaration of Steven M. Foord, Ph.D. (Ex. 2265, “Foord Declaration”17),
`the Declaration of Alan M. Rapoport, M.D. (Ex. 2262, “Rapoport
`Declaration”18), the Declaration of Robert D. Stoner, Ph.D. (Ex. 2274,
`“Stoner Declaration”19), and the Declaration of Jaume Pons, Ph.D.
`(Ex. 2331, “Pons Declaration”20).
`
`
`13 The Second Charles Declaration is Ex. 1340 in the 1711 IPR, and
`Ex. 1342 in the 1712 IPR.
`14 The Balthasar Declaration is Ex. 1339 in the 1711 IPR, and Ex. 1341 in
`the 1712 IPR.
`15 The Ferrari Declaration is Ex. 2269 in the 1711 IPR, and Ex. 2270 in the
`1712 IPR.
`16 The Tomlinson Declaration is Ex. 2272 in the 1711 IPR, and Ex. 2273 in
`the 1712 IPR.
`17 The Foord Declaration is Ex. 2266 in the 1711 IPR, and Ex. 2267 in the
`1712 IPR.
`18 The Rapoport Declaration is Ex. 2263 in the 1711 IPR, and Ex. 2264 in
`the 1712 IPR.
`19 The Stoner Declaration is Ex. 2275 in the 1711 IPR, and Ex. 2276 in the
`1712 IPR.
`20 The Pons Declaration is Ex. 2332 in the 1711 IPR, and Ex. 2333 in the
`1712 IPR.
`
`12
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`

`

`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`
`Reference(s)/Basis
`
`103(a)
`
`Olesen, Tan, Queen
`
`G. The Asserted Grounds of Unpatentability
`Petitioner asserts that the challenged claims would have been
`unpatentable on the following grounds:
`Claim(s) Challenged
`35 U.S.C. §
`IPR2018-01710
`1, 3, 4, 8–17, 19, 20,
`24–31
`IPR2018-01711
`1–18
`IPR2018-01712
`1–18
`
`103(a)
`
`103(a)
`
`Olesen, Tan, Queen
`
`Olesen, Tan, Queen
`
`
`
`II. DISCUSSION
`A. Level of Ordinary Skill in the Art
`In determining the level of skill in the art, we consider the type of
`problems encountered in the art, the prior art solutions to those problems, the
`rapidity with which innovations are made, the sophistication of the
`technology, and the educational level of active workers in the field. Custom
`Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir.
`1986); Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed.
`Cir. 1983).
`Petitioner advanced a proposed definition of a person of ordinary skill
`in the art (“POSA”) in its Petition. Pet. 18–19 (citing Ex. 1014 ¶¶ 76–78;
`Ex. 1015 ¶¶ 77–79). Patent Owner advanced its own proposed definition of
`a person of skill in the art in its Preliminary Response. Prelim. Resp. 32–33.
`We found in our Institution Decision that we did not discern an
`appreciable difference in the parties’ respective definitions of a person of
`ordinary skill in the art. Inst. Dec. 8. Accordingly, we determined for
`purposes of our Institution Decision that a person of ordinary skill in the art
`
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`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`would have had (1) a Ph.D. in a relevant field, such as immunology,
`biochemistry, or pharmacology, with several years of post-doctoral
`experience in antibody engineering, pharmacokinetics, and
`pharmacodynamics, or (2) an M.D. with a residency or specialty in
`neurology, and several years of experience studying CGRP or treating
`patients with a CGRP-related disease, such as migraine headaches. See id.
`at 8–9.
`The parties do not contest this definition of a person of ordinary skill
`in the art. See generally Reply; PO Resp. 2 n.3. Accordingly, for purposes
`of this Final Written Decision, we maintain the definition of a person of
`ordinary skill in the art as set forth in our Institution Decision, and restated
`above. See Inst. Dec. 8–9. We also find on this record that Dr. Charles,
`Dr. Vasserot, Dr. Balthasar, Dr. Foord, Dr. Ferrari, Dr. Rapoport, and
`Dr. Tomlinson are persons of at least ordinary skill in the art under this
`standard. See curriculum vitaes at Ex. 1014, Appendix A; Ex. 1015,
`Appendix A; Ex. 1337, Appendix A; Ex. 2055; Ex. 2138; Ex. 2142; and
`Ex. 2160.
`We further note that the prior art itself demonstrates the level of skill
`in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d
`1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding
`ordinary skill level are not required “where the prior art itself reflects an
`appropriate level and a need for testimony is not shown”) (quoting Litton
`Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir.
`1985)).
`
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`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`
`B. Claim Construction
`In an inter partes review filed before November 13, 2018, a claim in
`an unexpired patent is given its broadest reasonable construction in light of
`the specification of the patent in which it appears.21 37 C.F.R. § 42.100(b)
`(2018); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016)
`(affirming applicability of broadest reasonable construction standard to inter
`partes review proceedings). The broadest reasonable construction standard
`applies to the three inter partes reviews because the Petitions were filed
`prior to November 13, 2018.22 Under that standard, and absent any special
`definitions, we generally give claim terms their ordinary and customary
`meaning, as would have been understood by one of ordinary skill in the art
`at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249,
`1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set
`forth with reasonable clarity, deliberateness, and precision. See In re
`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`Petitioner requests construction of (1) the terms “reducing incidence
`of or treating,” “anti-CGRP antagonist antibody,” and “humanized
`monoclonal antibody” in the 1710 IPR, (2) the term “effective amount” in all
`
`
`21 The claim construction standard to be employed in inter partes reviews
`has changed for proceedings in which the petition was filed on or after
`November 13, 2018. See Changes to the Claim Construction Standard for
`Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal
`Board, 83 Fed. Reg. 51,340, 51,343 (amending 37 C.F.R. § 42.100(b)
`effective November 13, 2018) (now codified at 37 C.F.R. § 42.100(b)
`(2019)).
`22 The Petition in the 1710 IPR was accorded a filing date of October 4,
`2018. Paper 4. The Petitions in the 1711 IPR and the 1712 IPR were each
`accorded a filing date of October 1, 2018. 1711 IPR Paper 5; 1712 IPR
`Paper 4.
`
`15
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`

`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`three inter partes reviews, and (3) the terms “treating” and “specific
`binding” in the 1711 IPR and the 1712 IPR. See Pet. 19–24; 1711 IPR Pet.
`20–23; 1712 IPR Pet. 21–25. Patent Owner does not advance constructions
`for any claim terms other than those advanced by Petitioner. See generally
`PO Resp.; Sur-reply. We address the parties’ claim construction arguments
`with respect to the identified claim terms in the following sections.
`1. Claim Preambles: “reducing incidence of or treating” and
`“treating”
`Certain of the claim terms for which Petitioner requests construction
`are found in the preambles of the challenged claims. These terms include:
`“reducing incidence of or treating” (in claims 1 and 17 of the ’045 patent)
`and “treating” (in claim 1 of the ’907 patent and claim 1 of the ’908 patent).
`Ex. 1001, 99:2, 100:3; 1711 IPR Ex. 1001, 103:21; 1712 IPR Ex. 1001,
`99:55.
`We determined in our Institution Decision in the 1710 IPR that
`“‘reducing incidence of or treating’ is a statement of intended purpose that
`does not require achieving a result.” Inst. Dec. 11. Similarly, we
`determined in our Institution Decisions in the 1711 IPR and the 1712 IPR
`that “the term ‘treating’ refers to a statement of intended purpose, i.e., to
`achieve a clinical result, without requiring achievement of any clinical
`result.” 1711 IPR Inst. Dec. 11; see also 1712 IPR Inst. Dec. 10 (same).
`The parties do not dispute that the preamble claim language is a statement of
`intended purpose. See Reply 2; 1711 IPR Reply 2; 1712 IPR Reply 2;
`generally PO Resp.; 1711 IPR PO Resp.; 1712 IPR PO Resp.
`The preambles of the challenged claims are thus limiting to the extent
`that they require that the recited method must be performed with the
`intentional purpose of “reducing incidence of or treating” at least one
`
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`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`vasomotor symptom (claim 1, ’045 patent) or headache (claim 17, ’045
`patent); or the with the intentional purpose of “treating” headache (claim 1,
`’907 patent; claim 1, ’908 patent). See Sanofi Mature IP v. Mylan Labs.
`Ltd., 757 F. App’x 988, 993–94 (Fed. Cir. 2019) (instructing the Board on
`remand to treat the preamble “as an additional limitation of” the claim that
`“require[s] ‘increasing survival’” as the “intentional purpose . . . for which
`the [recited] method must be performed” (quoting Jansen v. Rexall
`Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir. 2003))); Jansen, 342 F.3d at
`1333 (in claimed method “for treating or preventing” particular anemia, to
`be performed on “human in need thereof,” the preamble is a “statement of
`intentional purpose for which the method must be performed”); Rapoport v.
`Dement, 254 F.3d 1053, 1058–61 (Fed. Cir. 2001) (in claimed method “for
`treatment of sleep apneas,” comprising administration “to a patient in need
`of such treatment,” the preamble requires that the method (administering a
`certain compound) must be practiced to achieve the purpose stated in the
`preamble). This is consistent with our construction from the Institution
`Decisions that the preambles are a “statement of intended purpose” of the
`recited methods, and we maintain the constructions from the Institution
`Decisions for purposes of this Final Written Decision.
`In discussing claim construction, Patent Owner further contends that
`the claimed method for “reducing incidence of or treating,” as recited in the
`challenged claims of the ’045 patent, “requires a reasonable expectation that
`the method will be therapeutically effective.” PO Resp. 10. Regarding the
`“treating” claim language, Patent Owner also contends that the challenged
`claims of the ’907 and ’908 patents “require at least a reasonable expectation
`that treatment with anti-CGRP antibodies would have a beneficial clinical
`
`17
`
`

`

`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`result in an individual.” See 1711 IPR Sur-reply 3 (citing 1711 IPR PO
`Resp. 10–11 (citing Ex. 2266 ¶ 53; Ex. 2269 ¶¶ 19–20; Ex. 2272 ¶ 18; 1711
`IPR Ex. 1001, 18:4–18); Ex. 2336, 41:19–42:2). Petitioner reiterates that the
`claims do not require actually achieving a clinical result/response. See
`Reply 2–3; 1711 IPR Reply 2. In other words, the parties dispute what is
`required for a showing of a reasonable expectation of success with respect to
`the recited intended purpose of the claimed methods.
`As relevant to the parties’ arguments set forth in the claim
`construction discussion, we determine here that to prove a reasonable
`expectation of success with respect to a limitation that recites achieving a
`particular result as the intended purpose for which a recited method must be
`performed, what is required is not proof that the recited method would
`actually bring about the recited result, but rather proof that a person of
`ordinary skill in the art would have had a reasonable expectation that
`performing the recited method would bring about the recited result. See
`Sanofi v. Watson Labs. Inc., 875 F.3d 636, 647 (Fed. Cir. 2017); see also
`Mylan Labs. Ltd. v. Aventis Pharma S.A., IPR2016-00712, Paper 112 at
`12–14 (PTAB Oct. 22, 2019) (discussing requirements to prove reasonable
`expectation of success of similar claim language). The parties’ specific
`arguments regarding whether Petitioner has shown a reasonable expectation
`of success are addressed below. See infra Section II.D.4.b).
`2. “effective amount”
`The term “effective amount” is recited in all of the independent
`challenged claims, and thus is recited in all of the challenged claims. We
`determined in our Institution Decisions that an “effective amount” means
`“an amount sufficient to effect beneficial or desired results,” including
`
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`IPR2018-01710 (Patent 8,586,045 B2); IPR2018-01711 (Patent 9,884,907
`B2); IPR2018-01712 (Patent 9,884,908 B2)
`
`results of prophylactic or therapeutic use, as those terms are used in the
`challenged patents. See, e.g., Ex. 1001, 18:41–57; Inst. Dec. 11–13.
`Petitioner argues that “effective amount”