Trials@uspto.gov
`571-272-7822
`
`Paper 77
`Date: February 18, 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.
`
`IPR2018-01422 (Patent 9,340,614 B2)
`IPR2018-01423 (Patent 9,266,951 B2)
` IPR2018-01425 (Patent 9,890,210 B2)1
`
`
`
`
`
`
`
`
`
`Before JENNIFER MEYER CHAGNON, JAMES A. WORTH, and
`RICHARD J. SMITH, Administrative Patent Judges.
`Per Curiam
`
`
`
`JUDGMENT
`Final Written Decision
`Determining All 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.
`
`
`
`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`
`INTRODUCTION
`I.
`This is a Final Written Decision addressing three inter partes reviews
`challenging claims 1–7 and 15–20 of U.S. Patent No. 9,340,614 B2 (“the
`’614 patent”) (IPR2018-01422), claims 1–6 and 14–19 of U.S. Patent No.
`9,266,951 B2 (“the ’951 patent”) (IPR2018-01423), and claims 1–15 of U.S.
`Patent No. 9,890,210 B2 (“the ’210 patent”) (IPR2018-01425).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 demonstrated
`by a preponderance of the evidence that all 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 ’614 patent, the ’951 patent, and the ’210 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 ’614 patent, the ’951 patent, and the ’210
`patent are referred to collectively as the “challenged patents.”
`IPR2018-01422 (“1422 IPR”), IPR2018-01423 (“1423 IPR”), and
`IPR2018-01425 (“1425 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 IPR2018-01422. Similar Papers and Exhibits were filed in each
`of the three inter partes reviews.
`
`2
`
`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`
`We entered our three Decisions on Institution (Paper 14, “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 24, “PO Resp.”), Petitioner filed a substantially similar
`Reply (Paper 39, “Reply”), and Patent Owner filed a substantially similar
`Sur-reply (Paper 51, “Sur-reply”).
`In each of the three inter partes reviews, Patent Owner filed a
`substantially similar Motion to Strike (Paper 45, “Mot. Strike”) and
`Petitioner filed a substantially similar Opposition to the Motion to Strike
`(Paper 47). In each of the three inter partes reviews, Patent Owner also filed
`a substantially similar Motion to Exclude (Paper 58, “Mot. Excl.”),
`Petitioner filed a substantially similar Opposition to the Motion to Exclude
`(Paper 60, “Opp. Excl.”), and Patent Owner filed a substantially similar
`Reply to Petitioner’s Opposition to the Motion to Exclude (Paper 61).
`Petitioner and Patent Owner requested an oral hearing. Papers 52, 53.
`A combined5 oral hearing was granted, and scheduled for November 22,
`2019. Paper 59.
`On November 21, 2019, Patent Owner filed the following documents,
`in each of the three inter partes reviews, regarding our denial of its request
`
`
`4 IPR2018-01422 and IPR2018-01423 were instituted on February 19, 2019,
`and IPR2018-01425 was instituted on February 25, 2019. See also 1423 IPR
`Paper 14; 1425 IPR Paper 14.
`5 In addition to the three inter partes reviews addressed in this Decision, the
`oral hearing included IPR2018-01424, IPR2018-01426, and
`IPR2018-01427. Those cases are addressed in a separate decision.
`
`3
`
`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`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 69);6
`Patent Owner’s Petition to Expedite Under 37 C.F.R. § 1.182
`(Paper 68); and
`Patent Owner’s Petition Under 37 C.F.R. § 1.181(a)(3) Invoking
`the Supervisory Authority of the Director (Paper 67).
`No decision was reached on Patent Owner’s filings (Papers 67, 68,
`69) prior to the hearing scheduled for the following day. Accordingly, we
`held a combined oral hearing on November 22, 2019, and the transcript of
`that hearing has been entered into the record. Paper 71 (“Tr.”). Patent
`Owner’s request for rehearing (Paper 69) was denied on February 18, 2020.
`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 as issue. Id. at
`1374. Because Patent Owner argued a presumption of nexus with respect to
`its proffered evidence of objective indicia of nonobviousness, 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 72. Petitioner filed a substantially similar
`supplemental brief and responsive brief (Paper 73, “Pet. Supp. Br.,”
`
`
`6 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 77.
`
`4
`
`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`Paper 76, “Pet. Supp. Rep. Br.”), and Patent Owner filed a substantially
`similar supplemental brief and responsive brief (Paper 74, “PO Supp. Br.,”
`Paper 75, “PO Supp. Rep. Br.”) 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. 59.
`Patent Owner identifies Teva Pharmaceuticals International GmbH
`and Teva Pharmaceuticals USA, Inc. as the real parties-in-interest. Paper 5,
`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. 59. According to Petitioner, the
`first DJ action seeks a declaration that Petitioner’s investigational drug
`galcanezumab will infringe U.S. Patent Nos. 8,586,045; 8,597,649;
`9,346,881; the ’951 patent; and the ’614 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 U.S. Patent Nos. 9,884,907 and 9,884,908 (“the second DJ action”).
`Id. Petitioner states that Patent Owner thereafter filed an amended
`complaint in the second DJ action to incorporate the ’210 patent and U.S.
`Patent No. 9,890,211. Id.
`According to Petitioner, all of the patents in the first DJ action and the
`second DJ action purport to claim priority to the same provisional
`application, and that two applications (15/883,218 and 15/956,580) based on
`
`5
`
`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`the same provisional application are pending before the United States Patent
`and Trademark Office. Id.
`Patent Owner identifies the first DJ action, the second DJ action, the
`three inter partes reviews, and six other inter partes reviews styled Eli Lilly
`and Co. v. Teva Pharmaceuticals International GmbH, IPR2018-01424,
`IPR2018-01426, IPR2018-01427, IPR2018-01710, IPR2018-01711, and
`IPR2018-01712. Papers 5, 7. Patent Owner also identifies U.S. Patent Nos.
`9,365,648; 9,328,168; 9,115,194; 8,734,802; 8,007,794, in addition to the
`patents and patent applications identified by Petitioner. Paper 5. Patent
`Owner also identifies a litigation styled Teva Pharmaceuticals International
`GmbH v. Eli Lilly and Co., Civ. No. 1-18-cv-12029 (D. Mass.). Paper 7.
`D. The Challenged Patents7
`The ’614 patent is titled “Antagonist Antibodies Directed Against
`Calcitonin Gene-Related Peptide[8] and Methods Using Same” and “relates
`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) and hot flushes.” Ex. 1001, code (54), 1:36–39.
`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 1:43–45. In humans, two forms of CGRP
`with similar activities (α-CGRP and β-CGRP) exist and exhibit differential
`
`
`7 The challenged patents are direct or indirect continuations of U.S. Patent
`Application No. 14/719,015 (now U.S. Patent No. 9,328,168) and share a
`common specification. Ex. 1001, code (60); 1423 IPR Ex. 1001, code (60);
`1425 IPR Ex. 1001, code (60). We refer to the ’614 patent in this Decision
`unless otherwise indicated.
`8 Calcitonin Gene-Related Peptide is abbreviated throughout as CGRP. See
`Ex. 1001, 1:43.
`
`6
`
`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`distribution. Id. at 1:45–48. At least two CGRP receptor subtypes may also
`account for differential activities. Id. at 1:48–49. 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 1:49–53.
`CGRP-mediated vasodilation is 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 1:53–56. CGRP has been noted for its possible connection to
`vasomotor symptoms. Id. at 1:57–58. Vasomotor symptoms include hot
`flushes and night sweats. Id. at 1:60–61. 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 2:21–24.
`According to the Specification, the precise pathophysiology of
`migraine is not yet well understood. Id. at 3:35–36. Dilation of blood
`vessels is associated with and exacerbates the pain symptoms of migraine.
`Id. at 3:41–42. The variety of pharmacologic interventions that have been
`used to treat migraine and the variability in responses among patients
`indicate that migraine is a diverse disorder. Id. at 3:8–10. 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 3:11–26. Some patients respond well to sumatriptan,
`which is a 5HT1 receptor agonist, which also inhibits release of CGRP;
`others are relatively resistant to its effects. See id. at 2:33–35, 3:27–32,
`4:23–25.
`
`7
`
`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`
`Embodiments described in ’614 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 3:55–4:5. Other embodiments of the
`’614 patent are also 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 4:6–
`46. 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 4:59–5:53, 8:18–23. Other
`embodiments are directed to a polypeptide which may or may not be an
`antibody. See id. at 7:7–8:17. 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 8:30–60. Other embodiments are
`directed to methods of making the same. See id. at 9:4–19.
`The Specification describes an experiment involving antibody G1 Fab
`fragment, and states that “human amylin . . . did not compete with binding of
`G1 Fab to human α-CGRP,” and that “[t]hese data demonstrate that G1
`targets a C-terminal epitope of CGRP and that both the identity of the most
`terminal residue (F37) and its amidation is important for binding.” Id. at
`65:45–66:40.
`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 10:24–26. Table 6 provides data on
`
`8
`
`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`binding affinity for G1 variants. See id. at cols. 60–65. Another table (cols.
`71–101) lists additional antibody sequences.
`E. Illustrative Claims
`Claim 1 of the ’614 patent, the only independent claim, is illustrative
`and reproduced below:
`1. A human or humanized monoclonal anti-CGRP antagonist
`antibody that preferentially binds to human α-CGRP as
`compared to amylin.
`Ex. 1001, 101:32–34.
`Claims 2–7 and 15–20 depend, directly or indirectly, from claim 1.
`Id. at 101:35–56, 102:53–103:3.
`Claim 1 of the ’951 patent, the only independent claim, is illustrative
`and reproduced below:
`1. A human or humanized monoclonal anti-CGRP antagonist
`antibody that (1) binds human α-CGRP and (2) inhibits cyclic
`adenosine monophosphate (cAMP) activation in cells.
`1423 IPR Ex. 1001, 99:21–23.
`Claims 2–6 and 14–19 depend, directly or indirectly, from claim 1.
`Id. at 99:24–41, 100:38–55.
`Claim 1 of the ’210 patent, the only independent claim, is illustrative
`and reproduced below:
`1. 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;
`
`9
`
`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 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.
`1425 IPR Ex. 1001, 103:35–46.
`Claims 2–15 depend, directly or indirectly, from claim 1. Id. at
`103:47–104:60.
`F. The Asserted Prior Art and Declaration Evidence
`
`Petitioner’s asserted grounds of unpatentability rely on the following
`references:
`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.
`S.J. Wimalawansa, Calcitonin Gene-Related Peptide and its
`Receptors: Molecular Genetics, Physiology, Pathophysiology,
`and Therapeutic Potentials, 17 ENDOCRINE REVIEWS 5, 533–85
`(1996) (“Wimalawansa”). Ex. 1096.
`Queen et al., US 6,180,370 B1, issued Jan. 30, 2001 (“Queen”).
`Ex. 1023.
`Doods et al., Pharmacological Profile of BIBN4096BS, the first
`selective small molecule CGRP antagonist, 129 BR. J.
`PHARMACOL. 420–23 (2000) (“Doods”). Ex. 1024.
`Petitioner relies on the Declaration of Dr. Andrew C. Charles, M.D.
`dated August 7, 2018 (Ex. 1008, “First Charles Declaration”9), the
`Declaration of Dr. Alain P. Vasserot, Ph.D. (Ex. 1009, “Vasserot
`
`
`9 The First Charles Declaration is Ex. 1004 in the 1423 IPR, and Ex. 1010 in
`the 1425 IPR.
`
`10
`
`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`Declaration”10), the Declaration of Dr. Andrew C. Charles, M.D. dated
`September 9, 2019 (Ex. 1306, “Second Charles Declaration”11), and the
`Declaration of Dr. Joseph P. Balthasar, Ph.D. (Ex. 1305, “Balthasar
`Declaration”12).
`Patent Owner relies on the Declaration of Dr. Michael Ferrari, M.D.,
`Ph.D. (Ex. 2212, “Ferrari Declaration”13), the Declaration of Dr. Ian M.
`Tomlinson, M.A., Ph.D. (Ex. 2224, “Tomlinson Declaration”14), the
`Declaration of Steven M. Foord, Ph.D. (Ex. 2230, “Foord Declaration”15),
`the Declaration of Alan M. Rapoport, M.D. (Ex. 2235, “Rapoport
`Declaration”16), and the Declaration of Robert D. Stoner, Ph.D. (Ex. 2241,
`“Stoner Declaration”17).
`G. The Asserted Grounds of Unpatentability
`Petitioner asserts that the challenged claims would have been
`unpatentable on the following grounds:
`
`
`10 The Vasserot Declaration is Ex. 1005 in the 1423 IPR, and Ex. 1011 in the
`1425 IPR.
`11 The Second Charles Declaration is Ex. 1322 in the 1423 IPR, and
`Ex. 1326 in the 1425 IPR.
`12 The Balthasar Declaration is Ex. 1321 in the 1423 IPR, and Ex. 1325 in
`the 1425 IPR.
`13 The Ferrari Declaration is Ex. 2211 in the 1423 IPR, and Ex. 2213 in the
`1425 IPR.
`14 The Tomlinson Declaration is Ex. 2223 in the 1423 IPR, and Ex. 2225 in
`the 1425 IPR.
`15 The Foord Declaration is Ex. 2229 in the 1423 IPR, and Ex. 2231 in the
`1425 IPR.
`16 The Rapoport Declaration is Ex. 2234 in the 1423 IPR, and Ex. 2236 in
`the 1425 IPR.
`17 The Stoner Declaration is Ex. 2240 in the 1423 IPR, and Ex. 2242 in the
`1425 IPR.
`
`11
`
`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`
`35 U.S.C. §
`103(a)
`
`103(a)
`
`103(a)
`
`Claim(s) Challenged
`IPR2018-01422
`1–7, 15–20
`IPR2018-01423
`1–6, 14–19
`IPR2018-01425
`1–15
`
`Reference(s)/Basis
`Tan, Wimalawansa, Queen
`Tan, Wimalawansa, Queen,
`Doods
`Tan, Wimalawansa, 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. 21 (citing Ex. 1009 ¶¶ 64–66;
`Ex. 1008 ¶¶ 79–81). Patent Owner advanced its own proposed definition of
`a person of skill in the art in its Preliminary Response. Prelim. Resp. 29.
`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
`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
`
`12
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`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`neurology, and several years of experience studying CGRP or treating
`patients with a CGRP-related disease, such as migraine headaches. See id.
`Petitioner does not contest this definition of a person of ordinary skill
`in the art. See generally Reply. Patent Owner expressly adopts this
`definition of a person of ordinary skill in the art. PO Resp. 2 n.3.
`Accordingly, for purposes of this Final Written Decision, we adopt and
`apply 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. 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. 1008,
`Appendix A; Ex. 1009, Appendix A; Ex. 1305, 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)).
`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.18 37 C.F.R. § 42.100(b)
`
`
`18 The claim construction standard to be employed in inter partes reviews
`has changed for proceedings in which the petition was filed on or after
`
`13
`
`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`(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 on
`August 8, 2018. Paper 4. 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 the following terms: “anti-CGRP
`antagonist antibody” and “humanized antibody,” citing to the Specification
`of the ’614 patent.19 Pet. 21–23. Patent Owner stated in its Preliminary
`Response that “for purposes of this proceeding, the Board should construe
`the ’614 patent claims according to their plain and customary meaning,” but
`
`
`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)).
`19 Petitioner also requested construction of the term “specific binding” in the
`1425 IPR. Pet. 21–22. We determined in our Institution Decision that “it is
`not necessary to construe the term ‘specific binding’ on this record and at
`this stage of the proceeding.” 1425 IPR Inst. Dec. 11. Neither party pursued
`construction after our Institution Decision, and we decide that it is not
`necessary to construe the term “specific binding” for purposes of this Final
`Written Decision.
`
`14
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`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`did not address claim construction further in its Patent Owner Response or
`Sur-reply. See Prelim. Resp. 28; see generally PO Resp., Sur-reply.
`Petitioner argues that the ’614 patent expressly defines “antibody” to
`encompass “not only intact polyclonal or monoclonal antibodies, but also
`fragments thereof (such as Fab, Fab’, F(ab’)2, Fv).” Pet. 22 (citing Ex. 1001,
`12:40–46, 26:30–40; Ex. 1008 ¶ 104; Ex. 1009 ¶ 67). The Specification of
`the ’614 patent states:
`An “antibody” is an immunoglobulin molecule capable of
`specific binding
`to a
`target, such as a carbohydrate,
`polynucleotide, lipid, polypeptide, etc., through at least one
`antigen recognition site, located in the variable region of the
`immunoglobulin molecule. As used herein,
`the
`term
`encompasses not only
`intact polyclonal or monoclonal
`antibodies, but also fragments thereof (such as Fab, Fab', F(ab')2,
`Fv), single chain (ScFv), mutants thereof, fusion proteins
`comprising an antibody portion (such as domain antibodies), and
`any other modified configuration of the immunoglobulin
`molecule that comprises an antigen recognition site. An antibody
`includes an antibody of any class, such as IgG, IgA, or IgM (or
`sub-class thereof), and the antibody need not be of any particular
`class.
`Ex. 1001, 12:36–49; see also id. at 26:30–51. We agree with Petitioner that
`this constitutes an express definition of the term “antibody” and we so
`construe the term. Paulsen, 30 F.3d at 1480. We agree with Petitioner that
`the defined term “antibody” includes antibody fragments. Ex. 1001,
`12:36–49.
`Petitioner argues that the ’614 patent expressly defines “humanized”
`antibodies in the same manner, i.e., encompassing “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) . . . .” Pet. 22–23
`
`15
`
`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`(citing Ex. 1001, 14:26–34; Ex. 1008 ¶ 104; Ex. 1009 ¶ 68). The
`Specification of the ’614 patent states:
`As 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.
`Ex. 1001, 13:16–21; see also id. at 26:30–51. We agree with Petitioner that
`this constitutes an express definition of the term “humanized antibody” and
`we so construe the term. Paulsen, 30 F.3d at 1480. We agree with
`Petitioner that “humanized antibody” includes antibody fragments.
`Ex. 1001, 13:16–21.
`We adopt and apply the foregoing constructions for purposes of this
`Final Written Decision. We determine that no other term requires express
`construction. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795,
`803 (Fed. Cir. 1999) (only those terms need be construed that are in
`controversy, and only to the extent necessary to resolve the controversy).
`However, we provide the following additional discussion regarding
`interpretation of the challenged claims.
`The antibody of the challenged claims is a human or humanized
`monoclonal anti-CGRP antagonist antibody that has certain properties, such
`as (in the ’614 patent) “preferentially bind[ing] to human α-CGRP as
`compared to amylin.” Ex. 1001, 101:32–34. The terms “human” and
`“humanized” as applied to antibodies are defined in the Specification by the
`structure of the antibody (e.g. amino acid sequence). Id. at 13:16–14:9.
`Accordingly, we do not construe the claim terms “human” or “humanized”
`as incorporating a use of the antibody into the claims, such as use in
`
`16
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`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`humans.20 See Senju Pharm. Co. v. Lupin, 780 F.3d 1337, 1346 (Fed. Cir.
`2015) (“In composition claims 12–16 . . . there is no limitation denoting the
`function of the composition and we decline to import this limitation into the
`claims.”) (citing Phillips v. AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir.
`2005) (stating that the Federal Circuit has repeatedly warned against
`confining the claims to particular embodiments in the written description)).
`Similarly, we do not construe the claimed antibody as reciting any use
`of the antibody, such as for treatment or prevention of a disease, disorder, or
`symptom. See, e.g., ParkerVision, Inc. v. Qualcomm Inc., 903 F.3d 1354,
`1361 (Fed. Cir. 2018) (“We explained long ago that ‘[a]pparatus claims
`cover what a device is, not what a device does.’”) (quoting Hewlett-Packard
`Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990)).
`Patent Owner argues that “the utility of the claimed antibody must be
`considered here, namely ‘preventing or treating CGRP associated disorders
`such as vasomotor symptoms, including headaches (e.g., migraine, cluster
`headache, and tension headache) and hot flushes.’” PO Resp. 13–14 (citing
`Ex. 1001, Abstract).21 Patent Owner bases this argument on Otsuka
`Pharmaceutical Co. v. Sandoz Inc., 678 F.3d 1280, 1291 (Fed. Cir. 2012).
`Otsuka involved an obviousness challenge in which “the parties’ arguments
`
`
`20 The record reflects that humanized antibodies were administered to
`animals as of November 2005. See Ex. 2128, 1, 5 (discussing the humanized
`monoclonal antibody bevacizumab (Avastin®) and stating that “[t]he safety
`and pharmacokinetics of bevacizumab were evaluated in young adult
`cynomolgus monkeys”).
`21 Immediately after this statement, Patent Owner states that “Lilly agrees.”
`PO Resp. 14 (citing Pet. 4). The Petition at page 4 is a description of the
`’614 patent and is not an agreement by Petitioner that the utility of the
`claimed antibody must be considered. See Pet. 4.
`
`17
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`

`

`IPR2018-01422 (Patent 9,340,614 B2); IPR2018-01423 (Patent 9,266,951
`B2); IPR2018-01425 (Patent 9,890,210 B2)
`
`focus on selecting and modifying particular prior art compounds, designated
`as lead compounds.” Id. Here, the parties’ arguments do not focus on
`selecting and modifying particular prior art compounds. Moreover, in a lead
`compound analysis as was at issue in Otsuka, “whether a chemist would
`have selected a prior art compound as a lead . . . is guided by evidence of the
`compound’s pertinent properties.” Id. at 1292 (citing cases). Thus, the
`pertinent properties in the lead compound analysis of Otsuka are those of a
`prior art compound, not properties that are read into the claims. See
`ParkerVision, 903 F.3d at 1361.
`We also reject Patent Owner’s argument that Petitioner has read
`“safety and efficacy requirements into the claims” based on arguments in the
`Petition. Sur-reply 3–5. Patent Owner relies on Phigenix v. ImmunoGen,
`IPR2014-00676, Paper 39 at 16 (PTAB Oct. 27, 2017), that addressed a
`particular rationale that the patent challenger advanced for combining the
`teachings of the prior art. Id. Phigenix does not stand for the proposition
`that limitations can be read into claims based on arguments by a party that is
`not the owner of the patent. Here, the challenged claims do not recite any
`safety or efficacy requirements, and we decline to incorporate such
`limitations into the challenged claims. However,