Trials@uspto.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, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`NEW, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`Celltrion Exhibit 1013
`Page 1
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`571-272-7822
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` Paper 22
`Date: January 11, 2023
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`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, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`NEW, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
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`I. INTRODUCTION
`Petitioner Mylan Pharmaceuticals Inc. (“Petitioner”) has filed 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 Owner filed a Sur-Reply. Paper
`19 (“Sur-Reply”).
`Under 35 U.S.C. § 314, the Board “may not authorize an inter partes
`review to be instituted unless … the information presented in the petition
`… and any response … shows that 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.
`
`II. BACKGROUND
`Real Parties-in-Interest
`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 Owner identifies Regeneron Pharmaceuticals, Inc. as the real party-
`in-interest. Paper 5 at 1.
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`Related Matters
`B.
`Petitioner and Patent Owner identify Mylan Pharms. Inc. v.
`
`Regeneron Pharms., Inc., IPR2021-00880, 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 Owner also 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 November 9, 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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`least one of the same grounds asserted against the challenged claims in 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:
`
`
`Ground
`
`1
`
`1
`
`3
`
`Claim(s)
`Challenged
`1–9, 34–39, 41–
`43, 45
`1–9, 34–39, 41–
`43, 45
`1–9, 34–39, 41–
`43, 45
`
`35 U.S.C. §
`
`Reference(s)/Basis
`
`1021
`
`102
`
`102
`
`Dixon2
`
`Adis3
`
`Regeneron 20084
`
`
`1 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. Dixon et al., VEGF Trap-Eye for the Treatment of Neovascular 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 (R1R2), VEGF Trap-Eye, 9(4) DRUGS R D
`261–269 (2008) (“Adis”) Ex. 1007.
`4 Press Release, Regeneron and Bayer HealthCare Announce Encouraging
`32-Week Follow-Up Results from a Phase 2 Study of VEGF Trap-Eye in
`Age-Related Macular Degeneration, April 28, 2008 (“Regeneron 2008”)
`Ex. 1012.
`
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`Ground
`
`
`
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`35 U.S.C. §
`
`Reference(s)/Basis
`
`Claim(s)
`Challenged
`1–9, 34–39, 41–
`43, 45
`1, 3–11, 13, 14,
`16–24, 26
`
`1, 3–11, 13, 14,
`16–24, 26
`
`4
`
`5
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`6
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`7
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`
`
`102
`
`103
`
`103
`
`NCT-7955
`
`Dixon alone or in view of
`Papadopoulos6 and/or
`Wiegand7
`Dixon in combination
`with Rosenfeld-20068,
`and if necessary,
`Papadopoulos patent
`and/or Wiegand
`Dixon in combination
`with Heimann-2007, and
`if necessary,
`Papadopoulos and/or
`Wiegand
`
`1, 3–11, 13, 14,
`16–24, 26
`
`103
`
`
`5 ClinicalTrials.gov (archive), Vascular Endothelial Growth Factor
`(VEGF)Trap-Eye: Investigation of Efficacy 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.
`6 Papadopoulos et al. (US 7,374,758 B2, May 20, 2008) (“Papadopoulos”)
`Ex. 1010.
`7 Wiegand et al. (US 7,531,173 B2, May 12, 2009) (“Wiegand”) Ex. 1008.
`8 P.J. 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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`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 methods for 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. Id.
`In an exemplary embodiment, a single “initial dose” of VEGF
`antagonist (“VEGFT”) is administered at the beginning of the treatment
`regimen (i.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 weeks thereafter, i.e., at weeks 16, 24, 32, 40, 48, 56, etc.).
`Ex. 1001 cols. 2–3, ll. 63–2.
`
`E.
`
`Representative Claim
`Independent claim 34 is representative of the challenged claims, and
`recites:
`34. A method for treating an angiogenic eye disorder in a patient in
`need thereof, said method comprising administering to the patient an
`effective sequential dosing regimen of a single initial dose of a VEGF
`antagonist, followed by one or more secondary doses of the VEGF
`
`
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`antagonist, followed by one or more tertiary doses of the VEGF
`antagonist;
`wherein each secondary dose is administered 4 weeks after 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 and an Ig
`domain 3 of a second VEGF receptor which is VEGFR2,
`and a multimerizing component
`wherein each tertiary 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 and an Ig
`domain 3 of a second VEGF receptor which is VEGFR2,
`and a multimerizing component.
`Ex. 1001, col. 24, ll. 4–19.
`
`Priority History of the ’601 Patent
`F.
`The ’601 patent issued from U.S. Application Ser. No. 16/397,267
`
`(the “’267 application”) filed on April 29, 2019, and claims the priority
`benefit of, inter alia, US Provisional Application Ser. No. 61/432,245,
`which was filed 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 November 12, 2020, and the patent
`issued on January 12, 2021. Ex. 1017, 5591; Ex. 1001, code (45).
`
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`III. ANALYSIS
`
`
`
`
`A.
`
`Claim Construction
`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.,
`415 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 language itself, 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 evidence is “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
`method for 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.” Id. at 22–23. Finally, Petitioner
`argues that the limitation reciting “wherein exclusion criteria for the patient
`include all of….” (the “exclusion criteria”) of claims 9 and 36 are not
`entitled to patentable weight under the printed matter doctrine. Id. 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 Owner states
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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 and are entitled to
`patentable weight. Prelim Resp. 14–15 n.16. Patent Owner states that, 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 in its
`Decision to Institute.
`We address each of these arguments in turn.
`
`
`1.
`
`Preamble
`Petitioner argues the preamble is not limiting upon the claims.
`Pet. 15–16. Petitioner argues that: (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. Id. at 15–16, 18.
`Alternatively, argues Petitioner, if the preamble is limiting, it should be
`given its plain and ordinary meaning, which does not require any specific
`efficacy requirement. Id. at 18–22.
`These same arguments were argued and addressed in the previous
`-00881 Decision. See Ex. 3001, 12–23. In the -00881 Decision, challenged
`claim 1 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 disorder in a patient.” See Ex. 1001 col. 21,
`ll. 40–41; Ex. 3001, 7. The Board found that this preamble was limiting
`upon the remainder of the claim. Ex. 3001, 18. Specifically, the Board
`found that:
`
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`Here, the claims are directed to methods of administering, i.e.,
`using, a VEGF antagonist for an intended purpose of “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 VEGF antagonist. Thus, we determine that the preamble sets
`forth the essence of the invention—treating an angiogenic eye
`disorder in 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.
`Thus, … in view of the evidence of record, namely, the claim
`language and the written description of the ’338 patent, we find
`that the preambles of method claims 1 and 14 are limiting insofar
`as they require “treating an angiogenic eye disorder in a patient.”
`Ex. 3001, 17–18 (citations omitted). We adopt this same reasoning here and
`find, for the purposes of this Decision, that the preamble of claim 34 reciting
`“[a] method for treating an angiogenic eye disorder in a patient” is limiting
`upon the 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:
`The terms “initial dose,” “secondary doses,” and “tertiary doses,”
`refer to the temporal sequence of administration of the VEGF
`
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`antagonist Thus, the “initial dose” is the dose which is
`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 ll. 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 which is
`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,
`ll. 62–67; Ex.1002, ¶¶ 42–52).
`
`For the purposes of this Decision, we adopt Petitioner’s proposed
`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 may be distinguished from the secondary doses “in terms of
`frequency of administration.” Ex. 1001 col. 3, ll. 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
`
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`inflammation; (2) active ocular or periocular infection.” See, e.g., Ex. 1001
`col. 21, ll. 65–67. Petitioner argues that these “exclusion criteria” are
`entitled to no patentable weight under the 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 exclusion criteria (i.e., preexisting conditions)
`represent informational content regarding the patient. Pet. 24. Petitioner
`argues that the challenged claims recite 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.” Id. Petitioner asserts that, even if application of the “exclusion
`criteria” could be inferred, the challenged claims do not dictate that any
`procedural step be taken, or that any alteration be made to the claimed
`dosing regimen. Id.
`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 (i.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 changes to the actual claimed dosing steps—i.e., the
`operative steps remain the same. Id. 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.” Id. (quoting Praxair,
`890 F.3d at 1033).
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`We are 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, is applicable when a
`claim limitation “claims the content of information.” Praxair, 890 F.3d at
`1032 (quoting In 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.” Id.
`(citing AstraZeneca LP v. 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,” i.e., whether the printed material is “interrelated
`with the rest of the claim.” Praxair, 890 F.3d at 1032. Printed matter that is
`functionally related to its substrate is given patentable weight. Id. (citing
`DiStefano, 808 F.3d at 850). However, “[w]here the printed matter is not
`functionally related to the substrate, the printed matter will not distinguish
`the invention from the prior art in terms of patentability.” Id. (quoting In re
`Ngai, 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 include all of: (1) active intraocular inflammation; (2) active ocular
`or periocular infection; (3) any ocular or periocular infection within the last
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`2 weeks.” This list of conditions relays direct information to the practitioner
`of the patent as to the nature of the exclusion criteria, much in the manner of
`the listing of contraindications included with the packaging of any other
`drug. The exclusion criteria are certainly analogous to claim 1 in Praxair, in
`which the 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 (ii) 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 more of the 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 not find 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 and still be practicing the claimed
`method. Granted, the outcome for the patient in either case might well be
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`unfortunate, but there are no positive or negative limitations in the
`challenged claims that require a person of ordinary skill in the art to act, or
`not act, in a certain way to practice the claimed method. As such, the
`information provided by the exclusionary criteria can be considered to be
`optional information, in that there is no direction to the practitioner to
`perform, or not perform, any specific step based upon the provided criteria.
`Thus, the exclusionary criteria are strictly informational, without requiring
`the practitioner to act, or refrain from acting, in a specified manner, and not
`functionally related to the practice of the claimed method.
`We consequently find, for the purpose of this Decision, that the
`exclusion criteria are not limiting upon challenged claims 9 and 36 under the
`printed matter doctrine. The parties may wish to further develop their
`respective arguments upon this issue at trial.
`
`A Person of Ordinary Skill in the Art
`B.
`Petitioner contends that a person of ordinary skill in the art would
`
`have: (1) knowledge regarding the diagnosis and treatment of angiogenic
`eye disorders, including the administration of therapies to treat said
`disorders; and (2) the ability to understand results and findings presented or
`published by others in the field. Pet. 25–26. Petitioner asserts that such a
`person would typically have an advanced degree, such as an M.D. or Ph.D.
`(or equivalent, or less education but considerable professional experience in
`the medical, biotechnological, or pharmaceutical field), with practical
`academic or medical experience in (i) developing treatments for angiogenic
`eye disorders, including through the use of VEGF antagonists, or (ii) treating
`
`
`
`15
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`Celltrion Exhibit 1013
`Page 15
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`IPR2022-01226
`Patent 10,888,601 B2
`
`
`of same, including through the use of VEGF antagonists. Id. at 26 (citing
`Ex. 1002 ¶¶ 27–29; Ex. 1003 ¶¶ 21–25).
`Patent Owner does not expressly contest this definition of a person of
`ordinary skill in the art in its Preliminary Response. For the purposes of this
`decision, because we find Petitioner’s definition to be consistent with the
`level of skill in the art (see, e.g., Exs. 1006, 1020), and in the absence of a
`different proposed definition of the level of skill in the art by Patent Owner,
`we consequently adopt Petitioner’s definition.
`
`C. Ground 1: Anticipation under 35 U.S.C. § 102 of claims by Dixon
`(Ex. 1006)
`Claims 1, 3–11, 13, 14, 16–24, and 26 of the ’601 patent are
`challenged as unpatentable under 35 U.S.C. § 102 as being anticipated by
`Dixon. Pet. 43–50.
`In the -00881 Decision we determined that claim 1 of the ’338 patent
`was unpatentable under 35 U.S.C. § 102 as anticipated by Dixon. For the
`convenience of the reader, we present a claim chart comparing independent
`claim 34 of the present challenged claims and claim 1 of the ’338 patent in
`the -00881 Decision:
`IPR2022-01226
`US 10,888,601 B2
`Claim 34
`34. A method for treating an
`angiogenic eye disorder in a
`patient in need thereof,
`said method comprising
`administering to the patient an
`
`IPR2021-00881
`US 9,254,338 B2
`Claim 1 (unpatentable)
`1. A method for treating an
`angiogenic eye disorder in a
`patient,
`said method comprising
`sequentially administering to the
`patient
`
`
`
`16
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`Celltrion Exhibit 1013
`Page 16
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`IPR2022-01226
`Patent 10,888,601 B2
`
`
`
`effective sequential dosing
`regimen
`of a single initial dose of a
`VEGF antagonist,
`followed by one or more
`secondary doses of the VEGF
`antagonist,
`followed by one or more tertiary
`doses of the VEGF antagonist
`wherein each secondary dose is
`administered 4 weeks after the
`immediately preceding dose;
`and
`wherein each tertiary 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 and an Ig domain 3
`of a second VEGF receptor
`which is VEGFR2, and a
`multimerizing component.
`
`a single initial dose of a VEGF
`antagonist,
`followed by one or more
`secondary doses of the VEGF
`antagonist,
`followed by one or more tertiary
`doses of the VEGF antagonist;
`
`wherein each secondary dose is
`administered 2 to 4 weeks after
`the immediately preceding dose;
`and
`wherein each tertiary dose is
`administered at least 8 weeks
`after the immediately preceding
`dose;
`
`wherein the VEGF antagonist is
`a VEGF receptor-based chimeric
`molecule comprising (1) a
`VEGFR1 component comprising
`amino acids 27 to 129 of SEQ ID
`NO:2; (2) a VEGFR2 component
`comprising amino acids 130–231
`of SEQ ID NO:2; and (3) a
`multimerization component
`comprising amino acids 232–457
`of SEQ ID NO:2.
`
`
`
`As should be readily apparent to the reader, challenged claim 34 of
`the present Petition and claim 1 of the ’338 patent are substantially identical:
`the preamble adding only that the method is to be administered to a patient
`
`
`
`17
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`Celltrion Exhibit 1013
`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
`administration of primary, secondary, and tertiary doses is “an effective
`sequential dosing regimen.” With respect to the former, Dixon discloses the
`VIEW 1/VIEW 2 clinical trials in which the claimed composition is
`administered to approximately “1200 patients with neovascular [Age-related
`macular degeneration (“AMD”)] in the US and Canada.” Ex. 1006, 1575.
`AMD is an angiogenic eye disorder. Id. at 1573. We consequently find that
`patients with AMD would constitute patients who are in need of treatment
`for an angiogenic eye disorder.
`With respect to the limitation reciting “an effective sequential dosing
`regimen,” we find that a person of ordinary skill in the art would understand
`that a sequence of primary, secondary, and tertiary doses would constitute a
`sequence of doses, as taught by Dixon, and that Dixon teaches that
`sequenced dosing of 0.5 mg–2.0 mg of the claimed compound received
`effective benefit from the treatment. See Ex. 1006, 1575.
`The final limitation of challenged claim 34 is broader than claim 1 of
`the ’338 patent in the -00881 Decision in that it does not require a specific
`SEQ ID of amino acids for either of the VEGFR1 and VEGFR2 components
`of the receptor-based chimeric molecule. Challenged claim 34 merely
`requires: (1) an immunoglobin-like (“Ig”) domain 2 of a first VEGF
`receptor which is VEGFR1; (2) an Ig domain 3 of a second VEGF receptor
`which is VEGFR2; and (3) a multimerizing component. Nevertheless, the
`specific sequences recited in claim 1 of the ’338 patent fall squarely within
`the broader genus recited in challenged claim 34 of the ’601 patent.
`Furthermore, Dixon discloses that “[s]tructurally, VEGF Trap-Eye is a
`fusion protein of key binding domains of human VEGFR-1 and -2 combined
`18
`
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`Celltrion Exhibit 1013
`Page 18
`
`
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`IPR2022-01226
`Patent 10,888,601 B2
`
`
`with a human IgG Fe fragment (Figure 1).” Ex. 1006, 1575. Figure 1 of
`Dixon is reproduced below:
`
`
`
`
`
`Figure 1 of Dixon is a schematic diagram of VEGF Trap-Eye, a
`fusion protein of binding domains of VEGF receptors-1 and -2
`attached to the Fc fragment of human IgG.
`Because, in the -00881 Decision, we concluded that claim 1 of the
`’338 patent is anticipated by Dixon, we incorporate here by reference our
`reasoning in the -00881 Decision with respect to the corresponding
`limitations of challenged claim 34 of the ’601 patent. See -00881 Decision,
`26–46. We therefore conclude that Petitioner has demonstrated a reasonable
`likelihood of prevailing at trial in demonstrating that claim 34 of the ’601 is
`unpatentable as being anticipated by Dixon.
`Furthermore, because we have determined that Petitioner has shown a
`reasonable likelihood of prevailing at trial in demonstrating that at least one
`claim is unpatentable on at least one of the stated Grounds, we institute an
`inter partes review of all challenged claims of the ’601 patent, based on all
`of the grounds identified in the Petition. See SAS Inst., Inc. v. Iancu, 138 S.
`
`
`
`19
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`Celltrion Exhibit 1013
`Page 19
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`IPR2022-01226
`Patent 10,888,601 B2
`
`
`Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354,
`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”).
`
`D. Discretionary Denial of Institution under 35 U.S.C. § 314(a)
`1. General Plastic analysis
`
`Patent Owner urges us to exercise our discretion to deny institution of
`trial under 35 U.S.C. §314(a) under the analysis set forth in General Plastic
`Indus. Co. v. Canon Kabushiki Kasha, IPR2016-01357, 2017 WL 3917706
`(PTAB Sept. 6, 2017) (precedential). Prelim. Resp. 25. Under General
`Plastic, when exercising our discretion to deny institution, we may consider
`a number of factors:
`1. whether the same petitioner previously filed a petition
`directed to the same claims of the same patent;
`2. whether at the time of filing of the first petition the petitioner
`knew of the prior art asserted in the second petition or should
`have known of it;
`3. whether at the time of filing of the second petition the
`petitioner already received the patent owner’s preliminary
`response to the first petition or received the Board’s decision
`on whether
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