Trials@uspto. gov
`571.272.7822
`
`Paper 9
`Entered: March 10, 2023
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX INC.,
`Petitioner,
`
`V.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`IPR2022-01524
`Patent 11,253,572 B2
`
`Before SUSAN L. C. MITCHELL, ROBERT A. POLLOCK,and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`DECISION
`Denying Institution of /nter Partes Review
`35 US.C. $314
`
`
`571.272.7822
`
`Paper 9
`Entered: March 10, 2023
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX INC.,
`Petitioner,
`
`V.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`IPR2022-01524
`Patent 11,253,572 B2
`
`Before SUSAN L. C. MITCHELL, ROBERT A. POLLOCK,and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`DECISION
`Denying Institution of /nter Partes Review
`35 US.C. $314
`
`
`
`IPR2022-01524
`Patent 11,253,572 B2
`
`I.
`
`INTRODUCTION
`
`Regeneron Pharmaceuticals, Inc. (“Patent Owner’’)is the owner of
`
`U.S. patent 11,253,572 B2 (“the ’572 patent”). Paper5, 1. On September 9,
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`2022, Apotex Inc. (‘Petitioner’) filed a Petition for interpartes review
`
`challenging the patentability of claims 1-14 and 26—30 of the °572 patent
`
`(claims 15—25 are not challenged). Paper 1, 1 (“Pet.”). On December23,
`
`2022, Patent Ownerfiled a Preliminary Responseto the Petition. Paper 7
`
`(“Prelim. Resp.”’). No further briefing was requested or authorized.
`
`Under 37 C.F.R. § 42.4(a), we have authority to determine whetherto
`
`institute trial in an interpartes review. We mayinstitute an interpartes
`
`review if the information presented in the petition filed under 35 U.S.C.
`
`§ 311, and any preliminary responsefiled under § 313, showsthat there is a
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`reasonable likelihood that Petitioner would prevail with respecttoat least
`
`one of the claims challenged in the petition. 35 U.S.C. §314.
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`After reviewing the parties’ submissions, we concludePetitioner does
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`not demonstrate a reasonablelikelihood it would prevail in showing that any
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`challenged claim of the *572 patent is unpatentable under the presented
`
`grounds. Therefore, we denyinstitution of interpartes review.' Our
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`reasoningis discussed below.
`
`A.
`
`REAL PARTIES-IN-INTEREST
`
`Petitionerlists Apotex Inc., Apotex Corp, Apotex Pharmaceutical
`
`Holdings Inc, and Aposherm Delaware Holdings Corp.as real parties-in-
`
`' We note that there are disputed issues in this proceeding under 35 U.S.C.
`§ 325(d) and § 314(a). See Pet. 6-11; Prelim. Resp. 47-57. However,
`because we determineinstitution should be denied on the merits, we do not
`address these matters.
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`Patent 11,253,572 B2
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`interest. Pet. 2. PatentOwneridentifies itself as the only real
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`party-in-interest. Paper5, 1.
`
`B.
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`RELATED MATTERS
`
`Petitioner identifies the following as related matters: IPR2021-00881
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`(concerning U.S. Patent 9,254,338 (“the ’338 patent”); IPR2022-00258 (also
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`concerning the ’338 patent); IPR2022-00298 (also concerning the ’338
`
`patent); IPR2021-00880 (conceming U.S. Patent 9,669,069 (“the ’069
`
`patent)); IPR2022-0257 (also concerning the ’069 patent); IPR2022-00301
`
`(also concerning the °069 patent); [PR2022-01225 (concerning U.S. Patent
`
`10,130,681 (“the 681 patent’’); and IPR2022-01226 (concerning U.S. Patent
`
`10,888,601 (“the ’601 patent’). Pet. 3-4. Petitioner also identifies as related
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`Regeneron Pharms., Inc. v. Mylan Pharms. Inc., No. 1:22-cv-00061-TSK
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`(N.D. W. Va), and PGR2021-00035 (concerning U.S. Patent 10,828,345).
`
`Id. at 5. Inaddition to the above-listed patents, Petitioner identifies U.S.
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`Patent Application Nos. 17/072,417; 17/112,404; 17/112,063; and
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`17/350,958 as related.
`
`/d. Patent Owneridentifies the same matters,
`
`patents, and applications as related. Paper 5, 2—3.
`
`C.
`
` THE’572 PATENT
`
`The ’572 patent issued on February 22, 2022, from U.S. Application
`
`17/352,892, which wasfiled on June 21, 2021. Ex. 1001, codes (45), (21),
`
`(22). The *572 patent ultimately indicates priority to U.S. Provisional
`
`Application 61/432,245, filed on January 13,2011.
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`/d. at code (60), 1:7—29.
`
`Petitioner declines to challenge whether the ’572 patent is entitled such
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`priority. See, e.g., Pet. 1 “Long before the patent’s alleged 2011 priority
`
`date....”).
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`IPR2022-01524
`Patent 11,253,572 B2
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`The *572 patent’s abstract states:
`
`The present invention provides methodsfor treating angiogenic
`eye disorders by sequentially administering multiple doses of a
`VEGFantagonist to a patient. The methods ofthe present
`invention include the administration of multiple doses ofa
`VEGFantagonist to a patient at a frequency of once every 8 or
`more weeks. The methodsofthe present invention are useful
`for the treatment of angiogenic eye disorders such as age related
`macular degeneration, diabetic retinopathy, diabetic macular
`edema,central retinal vein occlusion, branch retinal vein
`occlusion, and corneal neovascularization.
`
`Id. at Abstract.
`
`As background, the ’572 patent statesthat “[r]elease of vascular
`
`endothelial growth factor (VEGF) contributes to increased vascular
`
`permeability in the eye and inappropriate new vessel growth,” and
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`“inhibiting the angiogenic-promoting properties of VEGF appearsto be an
`
`effective strategy for treating angiogenic eye disorders.” /d. at 1:60-65. As
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`further background, the ’572 patent identifies that “FDA-approved
`
`treatments of angiogenic eye disorders such as AMD and CRVOinclude the
`
`administration of an anti-VEGFantibodycalled ranibizumab (Lucentis®,
`
`Genentech, Inc.) ona monthly basis by intravitreal injection.” /d. at 1:66—
`
`2:2. The ’572 patentindicates that its invention is a responseto the need for
`
`“new administration regimes”of “less frequent dosing while maintaining a
`
`high level of efficacy.” /d. at 2:6-9.
`
`In summarizing its invention, the *572 patent states:
`
`The present inventors have surprisingly discovered that
`beneficial therapeutic effects can be achievedin patients
`suffering from angiogenic eye disorders by administering a
`VEGFantagonist to a patient at a frequency of once every 8 or
`more weeks, especially when such doses are preceded by about
`three doses administered to the patient at a frequency of about 2
`
`
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`IPR2022-01524
`Patent 11,253,572 B2
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`to 4 weeks. Thus, according to the methodsofthe present
`invention, each secondary dose of VEGF antagonist is
`administered 2 to 4 weeksafter the immediately preceding
`dose, and eachtertiary dose is administered at least 8 weeks
`after the immediately preceding dose.
`
`Id. at 2:22—33. Relating to this, the °572 patent defines certain terms. For
`
`example, “the VEGF antagonist comprises one or more VEGFreceptor-
`
`based chimeric molecule(s), (also referred to herein as a ‘VEGF-Trap’ or
`
`*“VEGFT’),” and an example of this includes a productcalled “aflibercept,”
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`marketed as “EYLEA”by Regeneron Pharmaceuticals, Inc. and approved by
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`the FDA in November2011 at a dose of 2 mgvia intravitreal injection
`
`every 4 weeks for three months and then every 8 weeks. Jd. at 2:47—67.
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`On the aforementioned FDA-approved dosing regimen, the °572
`
`patent further defines the terms(ultimately used in the claims) “initial dose,
`
`“secondary doses,” and “tertiary doses”as follows:
`
`the “initial dose” is the dose which is administeredat the
`beginning of the treatment regimen (also referred to as the
`“baseline dose’’); the “secondary doses”are the doses which are
`administeredafter the initial dose; and the “tertiary doses”are
`the doses which are administered after the secondary doses.
`
`Id. at 3:51-S8.
`
`The ’572 patent describes a series of Examples detailing clinical trials
`
`conductedto validate the VEGFT drug and the dosing regimen.
`
`/d. at 8:12—
`
`18:3. Example 4 details two “Phase HI Clinical Trials of the Efficacy,
`
`Safety, and Tolerability of Repeated Dosesof Intravitreal VEGFT in
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`Subjects with Neovascular Age-Related Macular Degeneration” (AMD)
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`(Study 1 and Study 2), which followed dosing regimens using 2 mg dosesof
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`aflibercept at the aforementioned initial dose, then two 4-week doses, and
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`then doses every 8-weeks through the end of the 52-week study (the “2Q8”
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`IPR2022-01524
`Patent 11,253,572 B2
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`regimen).
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`/d. at 9:29-14:30. The results of this and other regimens were
`
`compared to subjects administered 0.5 mg ranibizumab every 4 weeks(the
`
`“RQ4”regimen) by assessing patients’ visual acuity based on a Best
`
`Corrected Visual Acuity (BCVA) test, which is based ontheability to
`
`identify letters.
`
`/d. at 9:35—10:7. This disclosure describes the inclusion
`
`criteria and exclusion criteria for the participating patients.
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`/d. at 10:50—
`
`12:22.
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`Results of the Example 4 clinical trials are described in TABLE 1,
`
`which wereproduce below:
`
`TARLE|
`
`
`
`
`VEGPT
`silty
`
`
`
`VEGPT
`ome nantly
`
`;
`
`
`
`
`
`
`4 Sees niteal mrontite dieses
`i
`sued gs She total suomfer af betters read eammectiy anythe Earty Treatment Dxahetic
`
`Ey
`WS & gocsannifiansd
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`Id. at 13:9-27. The’572 patent describes that these results showedthat the
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`VEGFT therapies usually maintained or improved visual acuity in patients
`
`and werenot inferior to the ranibizumab treatment based on similar criteria.
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`Td. at 13:28-38.
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`IPR2022-01524
`Patent 11,253,572 B2
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`As Example 5, the ’572 patent describes a phase 2 clinical trail using
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`the same drug, also administered at 2 mg dosesand, in one arm,at a regimen
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`of three initial doses every four weeks followed by doses every eight weeks,
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`but treating patients with diabetic macular edema (DME).
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`/d. at 14:32—15:5.
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`The *572 patent describes that visual acuity in this trial was maintained or
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`improved for all VEGFT study groups.
`
`/d.
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`The *572 patent concludes with 30 claims, of which claims 1, 15 (not
`
`challenged), 26, and 29 are independent claims. Ex. 1012, 62:12—64:20.
`
`Claim1is illustratrve and reproduced below:
`
`1. A methodoftreating an angiogenic eye disorder in a
`patient in need thereof comprising sequentially administering to
`the patient by intravitreal injection a single initial dose of 2 mg
`of aflibercept, followed by one or more secondary doses of
`2 mg ofaflibercept, followed by one or moretertiary doses of
`2 mg ofaflibercept;
`
`wherein each secondary dose is administered
`approximately 4 weeks following the immediately
`preceding dose; and
`
`wherein eachtertiary dose is administered
`approximately 8 weeks following the immediately
`preceding dose;
`
`wherein the patient achieves a gain in visual acuity
`within 52 weeks following the initial dose.
`
`Ex. 1001, 23:2-14.
`
`Independent claim 26 is similar to claim 1 in reciting the samedrug,at
`
`the same dose, and administered the same way, on the same schedule, but
`
`adds that the methodtreats “age related macular degeneration” (AMD)and
`
`that “the methodis as effective in achieving a gain in visual acuity as
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`monthly administration of 0.5 mg of ranibizumabby intravitreal injection in
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`humansubjects with age-related macular degeneration at 52 weeks
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`IPR2022-01524
`Patent 11,253,572 B2
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`following the initial dose.” Jd. at 24:26—44. Independentclaim 29is also
`
`similar to claim 1, and essentially the same as claim 26, but differs in
`
`requiring effectivenessin “maintaming visual acuity” rather than a gain
`
`therein.
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`/d. at 24:50-67.
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`D.|ASSERTED GROUNDS FOR UNPATENTABILITY
`
`Petitionerasserts the following groundsfor the unpatentability of
`
`claims 1—14 and 26-30 of the 572 patent:
`
`NCT-377° 11,14
`
`1-5, 8-11,
`5
`1-5, =
`2
`8-11, 14
`1-5, 8-11,
`11,14
`
`14, 26-30
`
`, 26-30
`14, 26-30
`
`NCT-795°
`
`* The ’572 patent has an uncontested January 13, 2011, priority date, which
`is before the AIA revisions to 35 U.S.C. §§ 102 and 103 took effect on
`March 16, 2013. 35 U.S.C. § 100 (note). Therefore, pre-AIA §§ 102 and
`103 apply. Our decision is not impacted by which version ofthe statute
`applies.
`3 James A. Dixonet al., VEGF Trap-Eyefor the treatment ofneovascular
`age-related macular degeneration, 18(10) EXPERT OPIN. INVESTIG. DRUGS
`1573-80 (2009) (Ex. 1006, “Dixon’’).
`* Regeneron, News Release: Bayer and Regeneron Dose FirstPatientin
`SecondPhase 3 Studyfor VEGF Trap-Eye in Wet Age-RelatedMacular
`Degeneration -International study to evaluate efficacy and safety in treating
`a leading cause ofblindness 1-3 (May 8, 2008) (Ex. 1009, “Regeneron
`2008”).
`> NIH, U.S. National Library of Medicine, ClinicalTrials. gov archive,
`History ofChangesfor Study: NCT00509795, Vascular Endothelial Growth
`Factor(VEGF) Trap-Eye:Investigation ofEfficacy and Safety in Wet Age-
`RelatedMacular Degeneration(AMD) (VIEW1) (Dec. 20, 2012), accessed
`January 7, 2021, at https://clinicaltrials. gov/ct2/history/NCT00509795?A
`=8&B-9&C=merged#StudyPageTop (Ex. 1010, “NCT-795”).
`° NIH, U.S. National Library of Medicine, ClinicalTrials. gov archive,
`History ofChangesfor Study: NCT00637377, VEGF Trap-Eye:
`
`8
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`Patent 11,253,572 B2
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`|103103
`Regeneron 2008, Hecht
`NCT-795, Hecht
`
`NCT-377, Hecht
`
`See Pet. 12.
`
`In support of these grounds for unpatentability Petitioner submits,
`
`inter alia, the Declaration of Angelo P. Tanna, MD (Ex. 1002). Inthe
`
`absenceof evidenceto the contrary, we find Dr. Tanna competentto testify
`
`on the subject matter of his declaration. See infra Section II.A; see Ex. 1002
`
`4] 3-11, 15-18; Ex. 1003. We understand that Patent Ownerhas not
`
`submitted a similar witness declaration specifically directedto this
`
`proceeding, nor wasit required to do so. Patent Ownerhas, however,
`
`submitted witness declarations from related proceedings before the Board,
`
`including the Declaration of Lucian V. Del Priore, MD, PhD, which was
`
`submitted in related matters IPR2021-00880 and IPR2021-00881 (and notes
`
`that IPR2022-00257, IPR2022-00258, IPR2022-00298, and IPR2022-00301
`
`were joined therewith). See Ex. 2021; see also Prelim. Resp. viii, 37, 40; see
`
`Investigation ofEfficacy and Safety in Wet AMD (VIEW2) (Nov.28, 2014),
`accessed Dec. 29, 2020, at https://clinicaltrials. gov/ct2/history/
`NCT006373772A =1&B=1&C=merged#StudyPageTop (Ex. 1011,
`“NCT-377’).
`7 Grounds S5a—5dlisted here are presented by Petitioneras a single
`“Ground 5”; however, because that ground actually asserts four separate
`challenges for unpatentability premised on separate combinationsofthe
`references of Grounds 1—4 in combination with Hecht, we separate these
`into separate grounds.
`® Gerald Hecht, PhD, OphthalmicPreparations, in 1] REMINGTON: THE
`SCIENCE AND PRACTICE OF PHARMACY, 19" ed., Ch. 89, 1563-76 (Alfonso
`R. Gennaro ed., 1995) (Ex. 1025, “Hecht’’).
`
`9
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`Patent 11,253,572 B2
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`supra Section I.B (Related Matters). In the absence of evidenceto the
`
`contrary, we also find Dr. Del Priore to be competentto testify on the
`
`subject matter of his declaration, which is related to the subject matter of this
`
`proceeding. See Ex. 2021 99 3-10, 16—18; see also infra Section ILA
`
`(identifying the parties’ proposed definition of the ordinarily skilled artisan,
`
`whichis the same as that addressed by Dr. Del Priore).
`
`Il. DISCUSSION
`
`A.
`
`LEVEL OF ORDINARY SKILL IN THE ART
`
`In determining the level of ordinary skill in the art, we consider the
`
`types of problems encounteredin theart, 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 workersin the field.
`
`Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc. , 807 F.2d 955, 962
`
`(Fed. Cir. 1986).
`
`Petitionerstates,
`
`A POSA here 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 understandresults and findings presented or
`published by others in the field, including the publications
`discussed herein. Typically, such a person would have an
`advanceddegree, suchas an M.D. or Ph.D. (or equivalent, or
`less education but considerable professional experience in the
`medical, biotechnological, or pharmaceuticalfield), with
`practical academic or medical experiencein (1) developing
`treatments for angiogenic eye disorders (such as AMD),
`
`10
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`including through the use of VEGF antagonists, or (11) treating
`of same, including through the use of VEGFantagonists.
`Pet. 23 (citing Ex. 1002 § 16).? Patent Ownerneither contests this proposed
`
`definition of the ordinarily skilled artisan noroffers its own. See generally
`
`Prelim. Resp.
`
`For the purposesofthis decision, we acceptPetitioner’s proposed
`
`definition of the person of ordinary skill in the art (or ordinarily skilled
`
`artisan), which appearsto be consistent with the level of skill in the art
`
`reflected in the prior art ofrecord and the disclosure of the *572 patent. See
`
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art
`
`itself [may] reflect[]’ evidence of the ordinary level of skill in the art)
`
`(quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
`
`163 (Fed. Cir. 1985)).
`
`B.|CLAIM CONSTRUCTION
`
`The Boardinterprets claim terms in an interpartes review using the
`
`same claim construction standardthat is used to construe claimsin a civil
`
`action in federal district court. 37 C.F.R. § 42.100(b). In construing claims,
`
`district courts and the Boardhere, by default, give claim terms their ordinary
`
`and customary meaning, which ts “the meaning that the term would have to
`
`a person of ordinary skill in the art in question at the time ofthe invention.”
`
`Phillipsv. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc).
`
`Should claim terms require express construction, sourcesfor claim
`
`interpretation include “the wordsofthe claims themselves, the remainder of
`
`the specification, the prosecution history [1.e., the intrinsic evidence], and
`
`extrinsic evidence concerning relevantscientific principles, the meaning of
`
`’ Petitioner uses “POSA”torefer to the person of ordinary skill in the art.
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`11
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`technical terms, and the state of the art.” /d. at 1314 (quoting /nnova/Pure
`
`Water, Inc. v. Safari Water Filtration Sys., Inc.,381 F.3d 1111, 1116 (Fed.
`
`Cir. 2004)). “[T]he claims themselves [may] provide substantial guidance as
`
`to the meaningofparticular claim terms.” /d. However, the claims “do not
`
`stand alone,” but are part of “‘a fully integrated written instrument’.. .
`
`consisting principally ofa specification that concludes with the claims,” and,
`
`therefore, the claims are “read in view ofthe specification.” /d. at 1315
`
`(quoting Markman v. Westview Instruments, Inc. , 52 F.3d 967, 978-79 (Fed.
`
`Cir. 1995) (en banc)). Any special definition for a claim term must be set
`
`forth in the specification “with reasonableclarity, deliberateness, and
`
`precision.” /nre Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Without
`
`sucha special definition, however, limitations may not be read from the
`
`specification into the claims. /n re Van Geuns, 988 F.2d 1181, 1184 (Fed.
`
`Cir. 1993).
`
`“[WJe need only construe terms ‘that are in controversy, and only to
`
`the extent necessary to resolve the controversy.” Nidec Motor Corp.v.
`
`Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
`
`(quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,200 F.3d 795, 803
`
`(Fed. Cir. 1999)).
`
`Wenow turnto the parties’ positions on claim construction.
`39
`66
`
`1.
`
`“initial dose,”
`
`“secondary doses,” and “tertiary doses”
`
`Oneorall of the terms “initial dose,” “
`
`secondary doses,” and “tertiary
`
`doses,” appearin claims 1, 4,9, 15, 16, 20, 24-27, and 29 (as noted,notall
`
`of these claims are challenged). See Ex. 1001, 23:1—25:5 (claims).
`
`12
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`Petitionerasserts that the °572 patent expressly defines the claim
`99 ¢¢
`
`terms“initial dose,”
`
`“secondary doses,” and “tertiary doses,” in its
`
`Specification, as follows:
`
`99 ¢¢
`
`“secondary doses,” and “tertiary
`The terms“initial dose,”
`doses,” refer to the temporal sequence of administration of the
`VEGFantagonist. Thus, the “initial dose” is the dose whichis
`administered at the beginning ofthe 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. Theinitial, secondary, and tertiary doses may
`all contain the same amount of VEGFantagonist, but will
`generally differ from one anotherin terms of frequency of
`administration. In certain embodiments, however, the amount
`of VEGFantagonist contained in theinitial, secondary and/or
`tertiary doses will vary from one another(e.g., adjusted up or
`downas appropriate) during the course of treatment.
`
`Pet. 16 (quoting Ex. 1001, 3:51—65; citing Ex. 1002 § 62).
`
`Patent Owner“doesnot propose a construction of‘initial dose,’
`
`‘secondary dose[s],’ or “tertiary dose[s]’ that is different than that proposed
`
`by Petitioner,” although it also does not concede Petitioner’s proposalis
`
`correct. Prelim. Resp. 18.
`
`“Whenthe specification explains and defines a term used in the
`
`claims, without ambiguity or incompleteness, there is no need to search
`
`further for the meaning of the term.” M/ultiform Dessicants Inc. v. Medzam
`
`Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998). Weagree with Petitioner’s
`
`unopposedposition that the Specification of the ’572 patent expressly and
`99 ¢¢
`
`unequivocally defines the claim terms “initial dose,”
`
`“secondary doses,” and
`
`“tertiary doses,” as set forth in the quote above, as meaning, respectively,
`
`(1) the dose which is administered at the beginning ofthe treatment
`
`regimen; (2) the doses administeredafterthe initial dose; and (3) the doses
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`administeredafter the secondary doses. We interpret these terms consistent
`
`with the Specification’s definitions.
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`2.
`
`“4 weeks” and “S weeks”after the immediatelypreceding dose
`
`Petitioner contendsthat “[a] skilled artisan would understand the
`
`phrase “‘4 weeks’—asit appears in the Challenged Claims—to be
`
`synonymouswith monthly administration” and ““8 weeks’... . to be
`
`synonymouswith bi- monthly (or every-other-month administration).”
`
`Pet. 17 (citing Ex. 1001, 8:9-11, 15:19-30; Ex. 1002 §] 65-66). Patent
`
`Ownerdoesnot challenge this construction. Prelim. Resp. 18.
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`Wedetermine that express construction of these claim termsis
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`unnecessary for purposes ofrendering this Decision. See Nidec Motor
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`Corp., 868 F.3d at 1017.
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`3.
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`“wherein thepatient achieves/gains”
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`Claim 1 recites as its concluding clause, “wherein thepatient achieves
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`a gain in visual acuity within 52 weeksfollowingthe initial dose.” Ex. 1001,
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`23:13—14 (italics added). Claims 2—4 and 8—10 further define this “gain in
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`visual acuity.” Jd. at 23:15—25, 23:32—38. Independent claim 15 andits
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`dependentclaims 16—26 are not challenged in this proceeding, and, although
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`claim 15 has no gain in visual acuity requirement, claims 16—23 do.
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`/d. at
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`23:53—24:21. Independentclaim 26recites as its concluding clause,
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`“wherein the methodis as effective in achieving a gain in visual acuity as
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`monthly administration of0.5 mg ofranibizumab by intravitreal injectionin
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`human subjects with age-related macular degenerationat 52 weeks
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`followingthe initial dose,” and dependentclaim 28 further defines this “gain
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`in visual acuity.” /d. at 24:40—44, 24:47—49(italics added). Finally,
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`independentclaim 29 recites as its concluding clause, “wherein the method
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`14
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`IPR2022-01524
`Patent 11,253,572 B2
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`is as effective in maintaining visual acuity as monthly administration of0.5
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`mg ofranibizumab by intravitreal injection in human subjects with age-
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`related macular degeneration at 52 weeksfollowingthe initial dose,” and
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`dependentclaim 30further defines this “gain in visual acuity.” Id. at24:63—
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`25:5 (italics added). Collectively we refer to these clauses, particularly of
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`independentclaims 1, 26, and 29, as the “results limitations.”
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`Petitionerasserts that the results limitations merely state the intended
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`results of the otherwise claimed methods of administering aflibercept and, as
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`such, have no patentable weight because they do notalter the steps of the
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`methods. Pet. 17. Petitioner’s position is that the resu/ts limitations should
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`not be treated as limitations.
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`/d. 17—20 (citing Ex. 1002 § 67; Syntex
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`(U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 1378 (Fed. Cir. 2005); Bristol-
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`Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir.
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`2001); In re Copaxone, 2016 WL 873062, at *2 n.1—2 (D. Del. Mar. 7,
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`2016); Endo Pharm. Inc. v. Watson Labs., Inc., 2014 WL 2859349, at *6, *8
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`(E.D. Tex. Jun. 23, 2014)). Petitioner, however, accountsfor the possibility
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`that wefind its position incorrect and alternatively argues under Grounds 1—
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`4 that, if the results limitations are given patentable weight, then the asserted
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`prior art inherently anticipated these limitations. See, e.g., id. at 38-39, 44—
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`45 (citing Ex. 1002 4 148; /n re Montgomery, 677 F.3d 1375, 1382 (Fed.
`
`Cir. 2012)).
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`Patent Ownerarguesthat the results limitations require that the
`
`claimed patients and methodsachieveparticular “endpoints as assessed by
`
`the physician,” and that the resu/ts limitations are ““condition[s] material to
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`patentability,’ and therefore ‘cannot be ignored.’” Prelim. Resp. 18-19
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`(citing Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329 (Fed. Cir. 2005)).
`
`15
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`IPR2022-01524
`Patent 11,253,572 B2
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`Patent Ownerarguesthat “[t]he Visual Acuity [1.e., results] limitations in the
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`Challenged Claims add additional requirements that may be—butare not
`
`necessarily—metupon performanceofthe dosing steps recited earlier in the
`
`claim,” and addsthat the resu/ts limitations requirementsare “not met unless
`
`the patient receiving the dosesdoes,in fact, experience the required gain.”
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`Id. at 20, 25 (italics added).
`
`Thefacts here are similar to those ofLos Angeles Biomedical
`
`Research Institute at Harbor-UCLA Medical Centerv. Eli Lilly & Co. , 849
`
`F.3d 1049 (Fed. Cir. 2017) (“Los Angeles Biomed.”), where claims covered
`
`administering a pharmaceutical according to a certain regimen, to a person
`
`in need of treatment, and included a limitation in the body of the
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`independentclaim to a treatment result of “arresting or regressing” a tissue
`
`fibrosis by the administration of the recited dosage.
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`/d. at 1053-54.
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`Similarly here, as can be seen from claim 1 reproduced aboveat Section I.C
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`(and each challenged independentclaim), the claims are similarly directed to
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`administering a pharmaceutical (aflibercept) to patients in need thereof, ata
`
`specified regimen and dosage, wherearesult of that treatment is expressly
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`recited in the body of the independentclaims. See Ex. 1001, 23:2—14 (claim
`
`1), 24:26—43 (claim 26), 24:50—67 (claim 29).
`
`In Los Angeles Biomed,in an interpartes review the Board construed
`
`the “arresting or regressing” clause to have no limiting role and to merely
`
`state an intendedresult, ultimately finding the claims unpatentable as
`
`obvious.
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`/d. at 1054-57. TheFederal Circuit disagreed and the Board’s
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`decision was vacated and the case was remandedon,inter alia, that issue.
`
`Id. at 1067-68.
`
`16
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`IPR2022-01524
`Patent 11,253,572 B2
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`Relating to the claim construction, the Federal Circuit found that
`
`patentat issue was“clear” that the tissue fibrosis, recited by the claim as
`
`arrested or regressed by the otherwise recited treatment, was not the same as
`
`and did not necessarily accompany the symptom oferectile disfunction
`
`(taught in and the focusof the relied-uponpriorart), although the former
`
`(fibrosis) may frequently result in the latter (disfunction).
`
`/d. at 1059. The
`
`Federal Circuit held that the “arresting or regressing” clause was more than a
`
`mere statementof intended result, but wasalimitation carrying patentable
`
`weight because the phrase wasdrafted as a part of a separate step of the
`
`methodrather than of the preamble, the “arresting or regressing” language
`
`demandedefficacy, and the efficacy waslinked to specific treatment
`
`minimum duration and dosage.
`
`/d. at 1060-61. The patients exhibiting
`
`these two issues were not necessarily the same.
`
`In part because the Board did not considerthe arresting/regressing
`
`result limitation in its unpatentability analysis, the Federal Circuit agreed
`
`with the patent ownerthat the Board’s findings were insufficient.
`
`/d. at
`
`1064, 1067. The Federal Circuit found that that prior art referencerelied
`
`uponin the Board’s decision for teaching the claimed treatment, and also
`
`relied uponto link the condition of fibrosis with the symptom oferectile
`
`dysfunction, did not teach treating a population of patients suffering from
`
`erectile dysfunction on/y because ofa fibrosis condition and, even though
`
`such patients may have hadfibrosis, it was not certain; and further found
`
`that other cited prior art did not make certain a link between fibrosis and
`
`such dysfunction.
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`/d. at 1065-66. This, the Federal Circuit found, was
`
`error.
`
`17
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`
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`IPR2022-01524
`Patent 11,253,572 B2
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`Wefind in agreement with Patent Ownerthat the results limitations of
`
`the challenged claims are limitations and must be given patentable weight
`
`for the same reasonsarresting or regressing a tissuefibrosis was a
`
`limitation in Los Angeles Biomed.
`
`Similarly, here the claimsare directed to expressly required results of
`
`the administration of aflibercept to patients at 2 mg at aninitial dose, in at
`
`least one secondary dose 4 weekslater, and in at least one tertiary dose 8
`
`weekslater. Therefore, we find that in claim 1, “wherein thepatient
`
`achieves a gain in visual acuity within 52 weeksfollowingthe initial dose,”
`
`is a limitation. Further, in claim 26, “wherein the methodis as effective in
`
`achieving a gain in visual acuity as monthly administration of0.5 mg of
`
`ranibizumab by intravitreal injection in human subjects with age-related
`
`macular degeneration at 52 weeksfollowing the initial dose,”is a limitation.
`
`And, in claim 29, “wherein the methodis as effective in maintaining visual
`
`acuity as monthly administration of0.5 mg ofranibizumab by intravitreal
`
`injection in human subjects with age-related macular degeneration at 52
`
`weeksfollowingthe initial dose,”1s a limitation.
`
`4.
`
`“wherein exclusion criteriafor thepatient include both of...”
`
`Claim 14, which depends from claim 1, recites “exclusion criteria for
`
`the patient include both of: (1) active ocular inflammation; and (2) active
`
`ocular or periocular infection.” Ex. 1001, 23:49-53.
`
`Petitionerasserts that this recited subject matter should be entitled to
`
`no patentable weight underthe printed matter doctrine becauseit is directed
`
`only to a mentalstep on the basis of information,1.¢., deciding whetherto
`
`treat a patient based on an instruction, with no functionalrelationship to the
`
`rest of the clatmed method. Pet. 20—23.
`
`18
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`IPR2022-01524
`Patent 11,253,572 B2
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`Patent Ownerarguesthat the printed matter doctrine does not apply
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`and the exclusion criteria should be given patentable weight becauseit
`
`defines the scope ofpatients to be treated and requires an assessmentby the
`
`clinician. Prelim. Resp. 28—30.
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`Wedetermine that express construction of this claim term is
`
`unnecessary for purposes ofrendering this Decision. See Nidec Motor
`
`Corp., 868 F.3d at 1017.
`
`C.
`
`APPLICABLE LEGAL STANDARDS
`
`“In an IPR,the petitioner has the burden from the onset to show with
`
`particularity why the patentit challenges is unpatentable.” Harmonic Inc.v.
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`Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C.
`
`§ 312(a)(3) (requiring interpartes review petitions to identify “with
`
`particularity . .. the evidence that supports the groundsfor the challenge to
`
`each claim’’)). This burden of persuasion nevershifts to Patent Owner. See
`
`Dynamic Drinkware, LLC v. Nat’] Graphics, Inc. , 800 F.3d 1375, 1378
`
`(Fed. Cir. 2015) (discussing the burden ofproofin interpartes review).
`
`An interpartes review may be instituted if the information presented
`
`by Petitioner in the Petition, in view of Patent Owner’s Preliminary
`
`Response and the preliminary record, showsthat there is a reasonable
`
`likelihood that Petitioner would prevail with respect to at least one of the
`
`claims challenged in the Petition. 35 U.S.C. § 314.
`
`“Anticipation requiresthat all of the claim elements and their
`
`limitations are shown inasingle prior art reference.” /n re Skvorecz, 580
`
`F.3d 1262, 1266 (Fed. Cir. 2009). To anticipate “it 1s not enough that the
`
`prior art reference discloses part of the claimed invention, which an ordinary
`
`artisan might supplement to make the whole,or that it includes multiple,
`
`19
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`
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`IPR2022-01524
`Patent 11,253,572 B2
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`distinct teachings that the artisan might somehow combineto achieve the
`
`claimed invention.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359,
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`1371 (Fed. Cir. 2008). “However, a reference can anticipate a claim even if
`
`it “d[oes] not expressly spell out’ all the limitations arranged or combined as
`
`in the claim, if a person ofskill in the art, reading the reference, would ‘at
`
`once envisage’ the claimed arrangement or combination.” Kennametal, Inc.
`
`v. Ingersoll Cutting Tool Co. , 780 F.3d 1376, 1381 (Fed. Cir. 2015) (quoting
`
`In re Petering, 301 F.2d 676, 681 (CCPA 1962)).
`
`A prior art reference without express reference to a claim limitation
`
`may anticipate by inherency. See /n r
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