GOV
`571 272-7822
`
`Paper 22
`Date: January 11, 2023
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`V.
`
`REGENERON PHARMACEUTICALS, INC.,
`
`Patent Owner.
`
`
`
`IPR2022-01226
`Patent 10,888,601 B2
`
`
`Before JOHN G. NEW, SUSANL. C. MITCHELL, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`NEW,Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`3S US.C. $ 314
`
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`IPR2022-01226
`Patent 10,888,601 B2
`
`I. INTRODUCTION
`
`Petitioner Mylan Pharmaceuticals Inc. (“Petitioner”) hasfiled a
`
`Petition (Paper 2, “Pet.”) seeking inter partes review of claims 1—9, 34-39,
`
`41-43, and 45 of US Patent 10,888,601 B2 (Ex. 1001, the “’601 patent”).
`
`Patent Owner Regeneron Pharmaceuticals, Inc. (“Patent Owner”) timely
`
`filed a Preliminary Response. Paper 13 (“Prelim. Resp.”). With our
`
`authorization (see Paper 16 at 1), Petitioner filed a Reply to the Preliminary
`
`Response (Paper 17 (“Reply’’)), and Patent Ownerfiled a Sur-Reply. Paper
`
`19 (“Sur-Reply”).
`
`Under 35 U.S.C. § 314, the Board “maynot authorize an inter partes
`
`review to be instituted unless ... the information presented in the petition
`
`... and any response ... showsthat there is a reasonable likelihood that the
`
`petitioner would prevail with respect to at least 1 of the claims challenged in
`
`the petition.” Upon consideration of the Petition, Preliminary Response,
`
`Reply, Sur-Reply, and the evidence of record, we determine that the
`
`evidence presented demonstrates a reasonable likelihood that Petitioner
`
`would prevail in establishing the unpatentability of at least one challenged
`
`claim of the °601 patent.
`
`A,
`
`Real Parties-in-Interest
`
`Il. BACKGROUND
`
`Petitioner identifies Viatris Inc., Mylan Inc., Mylan Pharmaceuticals
`
`Inc., Momenta Pharmaceuticals, Inc., Janssen Research & Development
`
`LLC,and Johnson & Johnson as the real parties-in-interest. Paper 11 at 1.
`
`Patent Owneridentifies Regeneron Pharmaceuticals, Inc. as the real party-
`
`in-interest. Paper 5 at 1.
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`IPR2022-01226
`Patent 10,888,601 B2
`
`B.
`
`Related Matters
`
`Petitioner and Patent Owner identify Mylan Pharms. Inc. y.
`
`Regeneron Pharms., Inc., [PR2021-00880, IPR2021-00881, IPR2022-01225
`
`(PTAB), and Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 1:22-cv-
`
`00061-TSK (N.D.W.Va.) as related matters. Paper 5 at 1; Paper 11 at 1.
`
`Patent Owneralso identifies Chengdu Kanghong Biotechnology Co.v.
`
`Regeneron Pharms., Inc., PGR2021-00035 (PTAB)(proceeding terminated).
`
`Paper 5 at 2-3. Petitioner further identifies the following as judicial or
`
`administrative matters that could affect, or be affected by, a decision in this
`
`inter partes review: Apotex Inc. v. Regeneron Pharmaceuticals, Inc.,
`
`No. IPR2022-01524 (PTAB), United States v. Regeneron Pharms., Inc.,
`
`No. 1:20-cv-11217-FDS (D. Mass.), and Horizon Healthcare Servs., Inc. v.
`
`Regeneron Pharms., Inc., No. 1:22-cv-10493-FDS (D. Mass.). Paper 11 at
`
`1-2.
`
`Petitioner also identifies additional patents and patent applications that
`
`claim priority to the 601 patent, namely: US 9,254,338 B2; US 9,669,069
`
`B2; US 10,857,205 B2; US 10,828,345 B2; US 10,888,601 B2; and US
`
`11,253,572 B2; and US Appl. Ser. Nos. 17/072,417; 17/112,063;
`
`17/112,404; 17/350,958; and 17/740,744. Paper 11 at 2.
`
`Of particular relevance to our decision in this proceeding is the Final
`
`Written Decision entered in IPR2021-00881 on November9, 2022. See IPR
`
`2021-00881, Paper 94 (the “-00881 Decision” Ex. 3001). In the -00881
`
`Decision, the panel found that the challenged claims were unpatentable on at
`
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`IPR2022-01226
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`least one of the same groundsasserted against the challenged claimsin the
`
`present Petition. See generally Ex. 3001.
`
`C.
`
`The Asserted Grounds of Unpatentability
`
`Petitioner contends that claims 1—9, 34-39, 41—43, and 45 of the ’601
`
`patent are unpatentable, based upon the following grounds:
`
`
`
`
`
`1-9, 34-39, 41-
`43,45
`
`1-9, 34-39, 41-
`43,45
`
`102
`
`102
`
`Regeneron 2008+
`
`' The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
`Stat. 284 (2011), amended 35 U.S.C. §§ 102 and 103, effective March 16,
`2013. Because the application from which the ’601 patent issued has an
`effective filing date after that date, the AIA versions of §§ 102 and 103
`apply.
`2 J.A. Dixonet al., VEGF Trap-Eye for the Treatment ofNeovascular Age-
`Related Macular Degeneration, 18(10) EXPERT OPIN. INVESTIG. DRUGS
`1573-80 (2009) (“Dixon”) Ex. 1006.
`3 Adis R&D Profile, Aflibercept: AVE 0005, AVE 005, AVE0005, VEGF
`Trap — Regeneron, VEGF Trap (RIR2), VEGF Trap-Eye, 9(4) DRUGS R D
`261-269 (2008) (“Adis”) Ex. 1007.
`* Press Release, Regeneron and Bayer HealthCare Announce Encouraging
`32-Week Follow-Up Resultsfrom a Phase 2 Study of VEGF Trap-Eye in
`Age-Related Macular Degeneration, April 28, 2008 (“Regeneron 2008”)
`Ex. 1012.
`
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`IPR2022-01226
`Patent 10,888,601 B2
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`1-9, 34-39, 41
`
`102
`
`NCT-795°
`
`
`
`
`
`4
`
`5
`
`6
`
`7
`
`
`
`
`1, 3-11, 13, 14,
`16-24, 26
`
`
`
`1, 3-11, 13, 14,
`16-24, 26
`
`1, 3-11, 13, 14,
`16—24, 26
`
`103
`
`103
`
`103
`
`Dixon alone or in view of
`Papadopoulos? and/or
`Wiegand’
`
`Dixon in combination
`with Rosenfeld-2006°,
`and if necessary,
`Papadopoulospatent
`and/or Wiegand
`
`Dixon in combination
`with Heimann-2007, and
`if necessary,
`Papadopoulos and/or
`Wiegand
`
`> ClinicalTrials.gov (archive), Vascular Endothelial Growth Factor
`(VEGF) Trap-Eye: Investigation ofEfficacy and Safety in Wet Age-Related
`Macular Degeneration (AMD) (VIEW1), available at:
`https://clinicaltrials.gov/ct2/history/NCT00509795?A=8&B=9&C=merged
`#StudyPageTop(last visited December 21, 2022) Ex. 1014.
`° Papadopouloset al. (US 7,374,758 B2, May 20, 2008) (“Papadopoulos”)
`Ex. 1010.
`
`7 Wiegandet al. (US 7,531,173 B2, May 12, 2009) (“Wiegand”) Ex. 1008.
`§ PJ. Rosenfeld et al., Ranibizumab for Neovascular Age-Related Macular
`Degeneration, 355 (14) N. ENGL. J. MED. 1419-31; Suppl. App’x 1-17
`(2006) (“Rosenfeld”) Ex. 1058.
`
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`IPR2022-01226
`Patent 10,888,601 B2
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`Petitioner also relies upon the Declarations of Dr. Thomas A. Albini
`
`(the “Albini Declaration,” Ex. 1002) and Dr. Mary Gerritsen (the “Gerritsen
`
`Declaration,” Ex. 1003).
`
`D.
`
`The 601 Patent
`
`The ’601 patent is directed to methodsfor treating angiogenic eye
`
`disorders by sequentially administering multiple doses of a vascular
`
`epithelial growth factor (“VEGF”) antagonist to a patient. Ex. 1001, Abstr.
`
`These methods include the administration of multiple doses of a VEGF
`
`antagonist to a patient at a frequency of once every 8 or more weeks,and are
`
`useful for the treatment of angiogenic eye disorders such as, inter alia, age
`
`related macular degeneration.
`
`/d.
`
`In an exemplary embodiment, a single “initial dose” of VEGF
`
`antagonist (“VEGFT”’) is administered at the beginning of the treatment
`
`regimen(1.e., at “week 0°’), two “secondary doses” are administered at
`
`weeks 4 and 8, respectively, and at least six “tertiary doses” are administered
`
`once every 8 weeksthereafter, 1.e., at weeks 16, 24, 32, 40, 48, 56, etc.).
`
`Ex. 1001 cols. 2-3, Il. 63-2.
`
`EF.
`
`Representative Claim
`
`Independentclaim 34 is representative of the challenged claims, and
`
`recites:
`
`34. A method for treating an angiogenic eye disorderin a patient in
`need thereof, said method comprising administering to the patient an
`effective sequential dosing regimen ofa single initial dose of a VEGF
`antagonist, followed by one or more secondary doses of the VEGF
`
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`IPR2022-01226
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`antagonist, followed by one or moretertiary doses of the VEGF
`antagonist;
`
`wherein each secondary dose is administered 4 weeksafter the
`immediately preceding dose; and
`
`wherein the VEGF antagonist is a receptor-based chimeric
`molecule comprising an immunoglobin-like (Ig) domain
`2 of a first VEGF receptor which is VEGFR1 andan Ig
`domain 3 of a second VEGF receptor which is VEGFR2,
`and a multimerizing component
`
`wherein eachtertiary dose is administered at least 8 weeks after
`the immediately preceding dose;
`
`wherein the VEGF antagonist is a receptor-based chimeric
`molecule comprising an immunoglobin-like (Ig) domain
`2 of a first VEGF receptor which is VEGFR1 andan Ig
`domain 3 of a second VEGF receptor which is VEGFR2,
`and a multimerizing component.
`
`Ex. 1001, col. 24, Il. 4-19.
`
`FF.
`
`Priority History of the ’601 Patent
`
`The °601 patent issued from U.S. Application Ser. No. 16/397,267
`
`(the “’267 application”) filed on April 29, 2019, and claimsthe priority
`
`benefit of, inter alia, US Provisional Application Ser. No. 61/432,245,
`
`which wasfiled on Jan. 13, 2011. Ex. 1001, code (60).
`
`The claims of the *601 patent, including challenged claims 1-9, 34—
`
`39, 41-43, and 45 were allowed on November12, 2020, and the patent
`
`issued on January 12, 2021. Ex. 1017, 5591; Ex. 1001, code (45).
`
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`IPR2022-01226
`Patent 10,888,601 B2
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`A.
`
`Claim Construction
`
`IH. ANALYSIS
`
`The Board applies the same claim construction standard that would be
`
`used to construe the claim in a civil action under 35 U.S.C. § 282(b). See
`
`37 C.F.R. § 100(b) (2020). Under that standard, claim terms “are generally
`
`given their ordinary and customary meaning”as understood by a person of
`
`ordinary skill in the art at the time of the invention. Phillips v. AWH Corp.,
`
`A415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc). “In determining the
`
`meaning of the disputed claim limitation, we look principally to the intrinsic
`
`evidence of record, examining the claim languageitself, the written
`
`description, and the prosecution history, if in evidence.” DePuy Spine, Inc.
`
`v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006)
`
`(citing Phillips, 415 F.3d at 1312-17). Extrinsic evidenceis “less significant
`
`than the intrinsic record in determining ‘the legally operative meaning of
`
`claim language.’” Phillips, 415 F.3d at 1317 (quoting C_R. Bard, Inc. v. U.S.
`
`Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004)).
`
`Petitioner initially argues that the language of the preamble reciting “a
`
`methodfor treating”is not limiting upon the claims. Pet. 15—22. Petitioner
`
`additionally proposes constructions for the claim terms“initial dose,”
`
`“secondary dose,” and “tertiary dose.” /d. at 22—23. Finally, Petitioner
`
`argues that the limitation reciting “wherein exclusion criteria for the patient
`
`includeall of....” (the “exclusion criteria”) of claims 9 and 36 are not
`
`entitled to patentable weight under the printed matter doctrine. /d. at 23-25.
`
`In its Preliminary Response, Patent Owner does not expressly contest
`
`Petitioner’s construction of the preamble or the claim terms“initial dose,”
`
`“secondary dose,” and “tertiary dose.” In a footnote, Patent Ownerstates
`
`8
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`IPR2022-01226
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`that it disagrees with Petitioner’s position concerning the exclusion criteria,
`
`which it argues define the scope of claims 9 and 36 andare entitled to
`
`patentable weight. Prelim Resp. 14—15 n.16. Patent Ownerstatesthat, if
`
`trial is instituted in this proceeding,it reserves the right to address the
`
`exclusion criteria, and claim construction more generally, but that it does not
`
`believe that it is necessary for the Board to decide claim construction inits
`
`Decision to Institute.
`
`Weaddress each of these argumentsin turn.
`
`L
`
`Preamble
`
`Petitioner argues the preamble is not limiting upon the claims.
`
`Pet. 15-16. Petitioner arguesthat: (1) the preamble is merely a statement of
`
`intended purpose and, therefore, not a limitation; and (2) the preamble
`
`provides no antecedent basis for any other claim element. /d. at 15-16, 18.
`
`Alternatively, argues Petitioner, if the preamble 1s limiting, it should be
`
`given its plain and ordinary meaning, which does not require any specific
`
`efficacy requirement.
`
`/d. at 18-22.
`
`These same arguments were argued and addressedin the previous
`
`-00881 Decision. See Ex. 3001, 12-23. In the -00881 Decision, challenged
`
`claim | of US 9,254,338 B2 (the “°338 patent’) recited preamble language
`
`identical to that recited in claim 34 of the ’601 patent, viz., “a method for
`
`treating an angiogenic eye disorderin a patient.” See Ex. 1001 col. 21,
`
`Il. 40-41; Ex. 3001, 7. The Board found that this preamble waslimiting
`
`upon the remainderof the claim. Ex. 3001, 18. Specifically, the Board
`
`found that:
`
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`IPR2022-01226
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`Here, the claims are directed to methods of administering,1.e.,
`using, a VEGFantagonist for an intended purposeof “treating an
`angiogenic eye disorder
`in a patient.” The Specification
`repeatedly characterizes
`the method as one
`for
`treating
`angiogenic eye disorders in patients. Apart from the preamble,
`the independent claims do not elsewhere recite or indicate any
`other use for the method steps comprising the administration of
`a VEGFantagonist. Thus, we determine that the preamble sets
`forth the essence of the invention—treating an angiogenic eye
`disorderin a patient.
`
`Additionally, we find that the preamble provides antecedent
`basis for claim terms “the patient” recited in the body of each
`independent claim, and “angiogenic eye disorders” recited in
`dependent claims 6, 7, 18, and 20. Indeed, without the preamble,
`it would be unclear
`to whom the doses of VEGF are
`administered.
`
`... in view of the evidence of record, namely, the claim
`Thus,
`language and the written description of the ’338 patent, we find
`that the preambles of method claims | and 14 are limiting insofar
`as they require “treating an angiogenic eye disorderin a patient.”
`
`Ex. 3001, 17—18 (citations omitted). We adopt this same reasoning here and
`
`find, for the purposesof this Decision, that the preamble of claim 34 reciting
`
`“Ta] method for treating an angiogenic eye disorderin a patient”is limiting
`
`uponthe claims.
`
`2.
`
`“Initial dose.” “Secondary Dose,” and “Tertiary Dose”
`
`Petitioner next contends that a person of ordinary skill in the art would
`
`understand each of these claim terms as expressly defined in the ’601
`
`patent’s Specification. Pet. 22. The Specification defines the claim terms as
`
`follows:
`
`“secondary doses,” and “tertiary doses,”
`The terms“initial dose,”
`refer to the temporal sequence of administration of the VEGF
`
`99 ¢¢
`
`10
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`the dose which is
`the “initial dose” is
`antagonist Thus,
`administered at the beginning of the treatment regimen (also
`referred to as the “baseline dose’) ; the “secondary doses”are the
`doses which are administered after the
`initial dose; and the
`“tertiary doses” are the doses which are administered after the
`secondary doses. The initial, secondary, and tertiary doses may
`all contain the same amount of dosing regimens, but will
`generally differ from one another in terms of frequency of
`administration.
`
`Ex. 1001 col. 3 Il. 42-52. Petitioner also notes that the Specification further
`
`explains that “the immediately preceding dose” means“in a sequence of
`
`multiple administrations, the dose of VEGF antagonist whichis
`
`administered to a patient prior to the administration of the very next dose in
`
`the sequence with no intervening doses.” Pet. 22 (citing Ex.1001 col. 3,
`
`Il. 62-67; Ex.1002, 9] 42-52).
`
`For the purposes of this Decision, we adoptPetitioner’s proposed
`99 ¢¢
`
`construction of the claim terms“initial dose,”
`
`“secondary dose,” and
`
`“tertiary dose.” Petitioner proposes adoption of the definitions expressly set
`
`forth in the Specification of the ’601 patent, viz., that the initial dose is the
`
`dose “administered at the beginning of the treatment regimen,” and is
`
`followed by the secondary doses “secondary doses”are “administered after
`
`the initial dose,” and the tertiary doses are “administered after the secondary
`
`doses” and maybe distinguished from the secondary doses “in terms of
`
`frequency of administration.” Ex. 1001 col. 3, Il. 36-44.
`
`3.
`
`The exclusion criteria
`
`The exclusion criteria limitation of challenged claims 9 and 36 recite
`
`“wherein exclusion criteria for the patient include (1) active intraocular
`
`11
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`inflammation; (2) active ocular or periocular infection.” See, e.g., Ex. 1001
`
`col. 21, Il. 65-67. Petitioner argues that these “exclusion criteria” are
`
`entitled to no patentable weight underthe printed matter doctrine. Pet. 23.
`
`Pointing to the two-part analysis set forth in Praxair Distrib., Inc. v.
`
`Mallinckrodt Hosp. Prods. IP Ltd., 890 F.3d 1024, 1032 (Fed. Cir. 2018),
`
`Petitioner first argues that the exclusioncriteria(1.e., preexisting conditions)
`
`represent informational content regarding the patient. Pet. 24. Petitioner
`
`argues that the challenged claimsrecite no active step of applying (or
`
`assessing the patient for) the exclusion criteria and consequently is
`
`“informational content” constituting a “mental step/printed material
`
`element.” /d. Petitioner asserts that, even if application of the “exclusion
`
`criteria” could be inferred, the challenged claims do notdictate that any
`
`procedural step be taken, or that any alteration be madeto the claimed
`
`dosing regimen.
`
`/d.
`
`Turning to the second step of the Praxair analysis, Petitioner contends
`
`that there is no functional relationship between the exclusion criteria and the
`
`rest of the claim (1.e., the operative steps of administering a VEGF
`
`antagonist to treat an angiogenic eye disorder). Pet. 24—25. Specifically,
`
`Petitioner argues that neither the presence nor absence of any exclusion
`
`criteria dictate any changesto the actual claimed dosing steps—i.e., the
`
`operative steps remain the same.
`
`/d. Therefore, argues Petitioner, because
`
`the “exclusion criteria” are “directed to mental steps”that “attempt to
`
`capture informational content,” and lack a functional relationship to the
`
`other steps of the claimed treatment method, the exclusion criteria should be
`
`“considered printed matter lacking patentable weight.” /d. (quoting Praxair,
`
`890 F.3d at 1033).
`
`12
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`Weare persuaded, for the purpose of this Decision, that Petitioner’s
`
`argument that the exclusion criteria limitations of claims 9 and 36 are non-
`
`limiting upon the claims under the printed matter doctrine has merit. In
`
`Praxair, our reviewing court has held that the printed matter doctrine does
`
`not apply only to literal printed matter, but, rather, 1s applicable when a
`
`claim limitation “claims the content of information.” Praxair, 890 F.3d at
`
`1032 (quoting Jn re DiStefano, 808 F.3d 845, 848 (Fed. Cir. 2015)). “Claim
`
`limitations directed to the content of information and lacking a requisite
`
`functional relationship are not entitled to patentable weight because such
`
`information is not patent eligible subject matter under 35 U.S.C. § 101.” /d.
`
`(citing AstraZeneca LP y. Apotex, Inc., 633 F.3d 1042, 1064 (Fed. Cir.
`
`2010)).
`
`If a claim limitation is directed to printed matter, the next step in the
`
`Praxair analysis is to determine whether the printed matter is functionally
`
`related to its “substrate,” 1.e., whether the printed material is “interrelated
`
`with the rest of the claim.” Praxair, 890 F.3d at 1032. Printed matter thatis
`
`functionally related to its substrate is given patentable weight.
`
`/d. (citing
`
`DiStefano, 808 F.3d at 850). However, “[w]here the printed matter 1s not
`
`functionally related to the substrate, the printed matter will not distinguish
`
`the invention from the prior art in terms of patentability.” /d. (quoting /n re
`
`Neai, 367 F.3d 1336, 1339 (Fed. Cir. 2004).
`
`In the case presently before us, there is little question that the
`
`exclusion criteria are directed to informational content. Specifically, the
`
`limitation in question expressly states that the “exclusion criteria for the
`
`patient includeall of: (1) active intraocular inflammation; (2) active ocular
`
`or periocular infection; (3) any ocular or periocular infection within the last
`
`13
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`2 weeks.” Thislist of conditions relays direct information to the practitioner
`
`of the patent as to the nature of the exclusion criteria, much in the mannerof
`
`the listing of contraindications included with the packaging of any other
`
`drug. The exclusion criteria are certainly analogousto claim | in Praxair, in
`
`whichthe practitioner of the claimed “method of providing pharmaceutically
`
`acceptable nitric oxide gas” included providing information [to the medical
`
`provider]
`
`[T]hat, in patients with preexisting left ventricular dysfunction,
`inhaled nitric oxide may increase pulmonary capillary wedge
`pressure (PCWP), leading to pulmonary edema, the information
`of (11) being sufficient to cause a medical provider considering
`inhaled nitric oxide treatment for a plurality of neonatal patients
`who(a) are suffering from a condition for which inhaled nitric
`oxide is indicated, and (b) have pre-existing left ventricular
`dysfunction,to elect to avoid treating one or moreofthe plurality
`of patients with inhaled nitric oxide in order to avoid putting the
`one or more patients at risk of pulmonary edema.
`
`Praxair, 890 F.3d at 1028-29. These limitations of claim 1 of Praxair
`
`(quoted above) and the exclusion criteria of the present challenged claims 9
`
`and 36 both provide information to the practitioner of the respective claimed
`
`methods concerning criteria to assess risks that may be incurred when
`
`practicing the method with a patient.
`
`However, we do notfind that the exclusion criteria of the challenged
`
`claims are functionally related to the rest of the claim. The claims do not
`
`expressly recite any positive step to be performed (or a negative step not to
`
`be performed) should a patient meet the exclusion criteria. An individual
`
`practicing the method of the challenged claims would be free to ignore the
`
`conditions of the exclusionary criteria andstill be practicing the claimed
`
`method. Granted, the outcomefor the patient in either case might well be
`
`14
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`Biocon Exhibit 1058 - Page 14
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`Biocon Exhibit 1058 - Page 14
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`IPR2022-01226
`Patent 10,888,601 B2
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`unfortunate, but there are no positive or negative limitations in the
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`challenged claimsthat require a person of ordinary skill in the art to act, or
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`not act, in a certain way to practice the claimed method. As such, the
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`information provided by the exclusionary criteria can be considered to be
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`optional information,in that there is no direction to the practitioner to
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`perform, or not perform, any specific step based upon the provided criteria.
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`Thus, the exclusionary criteria are strictly informational, without requiring
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`the practitioner to act, or refrain from acting, in a specified manner, and not
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`functionally related to the practice of the claimed method.
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`Weconsequently find, for the purpose of this Decision, that the
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`exclusion criteria are not limiting upon challenged claims 9 and 36 underthe
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`printed matter doctrine. The parties may wish to further develop their
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`respective arguments uponthis issueattrial.
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`B.
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`A Person of Ordinary Skill in the Art
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`Petitioner contendsthat a person of ordinary skill in the art would
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`have:
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`(1) knowledge regarding the diagnosis and treatment of angiogenic
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`eye disorders, including the administration of therapies to treat said
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`disorders; and (2) the ability to understand results and findings presented or
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`published byothers in the field. Pet. 25—26. Petitioner asserts that such a
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`person would typically have an advanced degree, such as an M.D. or Ph.D.
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`(or equivalent, or less education but considerable professional experience in
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`the medical, biotechnological, or pharmaceutical field), with practical
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`academic or medical experience in (i) developing treatments for angiogenic
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`eye disorders, including through the use of VEGF antagonists, or (11) treating
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`15
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`Biocon Exhibit 1058 - Page 15
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`IPR2022-01226
`Patent 10,888,601 B2
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`of same, including through the use of VEGF antagonists.
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`/d. at 26 (citing
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`Ex. 1002 4] 27-29; Ex. 1003 9] 21-25).
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`Patent Owner doesnot expressly contest this definition of a person of
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`ordinary skill in the art in its Preliminary Response. For the purposesofthis
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`decision, because wefind Petitioner’s definition to be consistent with the
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`level of skill in the art (see, e.g., Exs. 1006, 1020), and in the absence of a
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`different proposed definition of the level of skill in the art by Patent Owner,
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`we consequently adopt Petitioner’s definition.
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`C.
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`Ground 1: Anticipation under 35 U.S.C. $ 102 of claims by Dixon
`(Ex. 1006)
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`Claims 1, 3-11, 13, 14, 16—24, and 26 of the ’601 patent are
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`challenged as unpatentable under 35 U.S.C. § 102 as being anticipated by
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`Dixon. Pet. 43-50.
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`In the -00881 Decision we determined that claim 1 of the ?338 patent
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`was unpatentable under 35 U.S.C. § 102 as anticipated by Dixon. For the
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`convenience of the reader, we present a claim chart comparing independent
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`claim 34 of the present challenged claims and claim 1 of the ’338 patent in
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`the -00881 Decision:
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`
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`34. A methodfor treating an
`angiogenic eye disorder in a
`patient in needthereof,
`
`1. A methodfor treating an
`angiogenic eye disorder in a
`patient,
`
`patient
`
`said method comprising
`said method comprising
`administering to the patient an|sequentially administering to the
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`16
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`Biocon Exhibit 1058 - Page 16
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`Biocon Exhibit 1058 - Page 16
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`IPR2022-01226
`Patent 10,888,601 B2
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`effective sequential dosing
`regimen
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`a single initial dose of a VEGF
`antagonist,
`
`of a single initial dose of a
`VEGFantagonist,
`followed by one or more
`secondary doses of the VEGF
`antagonist,
`
`followed by one or more
`secondary doses of the VEGF
`antagonist,
`followed by one or moretertiary
`doses of the VEGFantagonist;
`
`of SEQ ID NO:2.
`
`followed by one or moretertiary
`doses of the VEGF antagonist
`
`wherein each secondary dose is|wherein each secondary doseis
`administered 4 weeksafter the|administered 2 to 4 weeksafter
`immediately preceding dose;
`the immediately preceding dose;
`and
`and
`
`wherein each tertiary dose is
`wherein each tertiary dose is
`administered at least 8 weeks
`administered at least 8 weeks
`after the immediately preceding|after the immediately preceding
`dose
`dose;
`
`wherein the VEGF antagonist is|wherein the VEGF antagonist is
`a receptor-based chimeric
`a VEGFreceptor-based chimeric
`molecule comprising an
`molecule comprising (1) a
`immunoglobin-like (Ig) domain|VEGFR1 component comprising
`2 of a first VEGF receptor which} amino acids 27 to 129 of SEQ ID
`is VEGFRI1 and an Ig domain 3|NO:2; (2) a VEGFR2 component
`of a second VEGFreceptor
`comprising amino acids 130-231
`which is VEGFR2, and a
`of SEQ ID NO:2; and (3) a
`multimerizing component.
`multimerization component
`comprising amino acids 232—457
`
`As should be readily apparent to the reader, challenged claim 34 of
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`the present Petition and claim 1 of the ?338 patent are substantially identical:
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`the preamble adding only that the method is to be administered to a patient
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`Biocon Exhibit 1058 - Page 17
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`IPR2022-01226
`Patent 10,888,601 B2
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`“in need thereof” and the first limitation additionally reciting that the
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`administration of primary, secondary, and tertiary dosesis “an effective
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`sequential dosing regimen.” With respect to the former, Dixon discloses the
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`VIEW 1/VIEW2clinical trials in which the claimed composition is
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`administered to approximately “1200 patients with neovascular [Age-related
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`macular degeneration (“AMD”’)] in the US and Canada.” Ex. 1006, 1575.
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`AMD is an angiogenic eye disorder.
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`/d. at 1573. We consequently find that
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`patients with AMD would constitute patients whoare in needof treatment
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`for an angiogenic eye disorder.
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`With respect to the limitation reciting “an effective sequential dosing
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`regimen,” wefind that a person of ordinary skill in the art would understand
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`that a sequence of primary, secondary, and tertiary doses would constitute a
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`sequence of doses, as taught by Dixon, and that Dixon teaches that
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`sequenced dosing of 0.5 mg—2.0 mg of the claimed compoundreceived
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`effective benefit from the treatment. See Ex. 1006, 1575.
`
`Thefinal limitation of challenged claim 34 is broader than claim 1 of
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`the ’338 patent in the -00881 Decision in that it does not require a specific
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`SEQ ID of amino acidsfor either of the VEGFR1 and VEGFR2 components
`
`of the receptor-based chimeric molecule. Challenged claim 34 merely
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`requires:
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`(1) an immunoglobin-like (“Ig”) domain 2 of a first VEGF
`
`receptor which is VEGFR1; (2) an Ig domain 3 of a second VEGFreceptor
`
`which is VEGFR2; and (3) a multimerizing component. Nevertheless, the
`
`specific sequencesrecited in claim | of the °338 patent fall squarely within
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`the broader genusrecited in challenged claim 34 of the ’601 patent.
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`Furthermore, Dixon disclosesthat “[s]tructurally, VEGF Trap-Eye is a
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`fusion protein of key binding domains of human VEGFR-1 and -2 combined
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`Biocon Exhibit 1058 - Page 18
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`IPR2022-01226
`Patent 10,888,601 B2
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`with a human IgG Fe fragment (Figure 1).” Ex. 1006, 1575. Figure 1 of
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`Dixon1s reproduced below:
`
`SASSAA
`
`Figure 1 of Dixon is a schematic diagram of VEGF Trap-Evye, a
`
`fusion protein of binding domains of VEGFreceptors-1 and -2
`
`attached to the Fc fragment of human IgG.
`
`
`Because, in the -00881 Decision, we concluded that claim | of the
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`°338 patent is anticipated by Dixon, we incorporate here by reference our
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`reasoning in the -00881 Decision with respect to the corresponding
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`limitations of challenged claim 34 of the ’601 patent. See -00881 Decision,
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`26-46. We therefore conclude that Petitioner has demonstrated a reasonable
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`likelihood of prevailing at trial in demonstrating that claim 34 of the ’601 is
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`unpatentable as being anticipated by Dixon.
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`Furthermore, because we have determinedthat Petitioner has shown a
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`reasonablelikelihood of prevailing at trial in demonstrating that at least one
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`claim is unpatentable on at least one of the stated Grounds, weinstitute an
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`inter partes review ofall challenged claims of the ’601 patent, based onall
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`of the grounds identified in the Petition. See SAS Inst., Inc. v. Jancu, 138 S.
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`19
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`Biocon Exhibit 1058 - Page 19
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`Biocon Exhibit 1058 - Page 19
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`IPR2022-01226
`Patent 10,888,601 B2
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`Ct. 1348, 1359-60 (2018); PGS Geophysical AS v. lancu, 891 F.3d 1354,
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`1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no
`
`institution choice respecting a petition, embracing all challenges included in
`
`the petition”).
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`D.
`
`L.
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`Discretionary DenialofInstitution under 35 U.S.C. $ 314(a)
`
`General Plastic analysis
`
`Patent Ownerurgesus to exercise our discretion to deny institution of
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`trial under 35 U.S.C. §314(a) under the analysis set forth in General Plastic
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`Indus. Co. v. Canon Kabushiki Kasha, 1PR2016-01357, 2017 WL 3917706
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`(PTABSept. 6, 2017) (precedential). Prelim. Resp. 25. Under General
`
`Plastic, when exercising our discretion to deny institution, we may consider
`
`a numberoffactors:
`
`1. whether the samepetitioner previously filed a petition
`directed to the same claims of the same patent;
`
`2. whetherat the time offiling of the first petition the petitioner
`knew of the prior art asserted in the second petition or should
`have knownofit;
`
`3. whetherat the timeoffiling of the secondpetition the
`petitioner already received the patent owner’s preliminary
`response to the first petition or received the Board’s decision
`on whether to institute review in thefirst petition;
`
`4. the length of time that elapsed between the time the petitioner
`learned of the prior art asserted in the second petition and the
`filing of the secondpetition;
`
`5. whether the petitioner provides adequate explanation for the
`time elapsed betweenthefilings of multiple petitions directed
`to the same claimsof the same patent;
`
`6. the finite resources of the Board; and
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`IPR2022-01226
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`7. the requirement under 35 U.S.C. § 316(a)(11) to issue a final
`determination not later than 1 year after the date on which the
`Director notices institution of review.
`
`General Plastic, Paper 19 at 9-10. The purposeof the analysis thus
`
`established in General Plastic is to deny a Petitioner s