UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner
`
`____________
`
`Case IPR2021-00880
`Patent No. 9,669,069 B2
`____________
`
`PRELIMINARY RESPONSE OF PATENT OWNER
`REGENERON PHARMACEUTICALS, INC.
`
`US 169984423v25
`
`

`

`TABLE OF CONTENTS
`
`Page No.
`
`I.
`II.
`
`III.
`
`IV.
`
`INTRODUCTION ........................................................................................... 1
`THE PETITION SHOULD BE REJECTED FOR CIRCUMVENTING
`THE WORD LIMIT AND OBFUSCATING ITS GROUNDS ...................... 4
`A.
`The Petition Violates the Word Limit ................................................... 4
`B.
`The Petition Fails the Particularity Requirement .................................. 5
`C.
`Janssen Pharmaceuticals, Inc. Is a Real Party-in-Interest ..................... 9
`THE BOARD SHOULD DENY INSTITUTION UNDER
`35 U.S.C. § 325(D) ....................................................................................... 10
`A.
`The Examiner Considered the Same or Substantially the Same Art
`(Becton, Dickinson Factors (a), (b), and (d)) ...................................... 10
`1.
`Dixon ......................................................................................... 10
`2.
`Heier-2009 ................................................................................ 11
`3.
`Regeneron (30-April-2009) ...................................................... 13
`4.
`Mitchell ..................................................................................... 14
`5.
`’758 Patent and Dix................................................................... 14
`Petitioner Fails to Argue that the Examiner Erred in a Manner
`Material to Patentability (Becton, Dickinson Factors (c), (e), and
`(f)) ........................................................................................................ 16
`THE BOARD SHOULD DENY INSTITUTION BECAUSE
`PETITIONER FAILS TO MAKE ITS THRESHOLD SHOWING THAT
`AT LEAST ONE CHALLENGED CLAIM IS UNPATENTABLE ............ 17
`A.
`Grounds 1-5: Petitioner Fails to Establish the “Assessed by a
`Physician” Limitation Is Anticipated or Obvious ............................... 18
`
`B.
`
`i
`
`US 169984423v25
`
`

`

`1.
`
`2.
`
`3.
`
`4.
`
`B.
`
`Claim Construction ................................................................... 18
`a.
`“Based On Visual and/or Anatomical Outcomes as
`Assessed by a Physician or Other Qualified Medical
`Professional” ................................................................... 20
`Grounds 1-4: Petitioner Fails to Establish that Heier-2009,
`Dixon or Regeneron (30-April-2009) Inherently or
`Expressly Discloses the “Assessed by a Physician or Other
`Qualified Medical Professional” Limitation (All Challenged
`Claims) ...................................................................................... 24
`a.
`Heier-2009 (Ground 1) ................................................... 24
`b.
`Dixon (Ground 2 and 4) .................................................. 27
`c.
`Regeneron (30-April-2009) (Ground 3) ......................... 29
`Under Petitioner’s Definition of the POSA, Petitioner Fails
`to Show that Heier-2009, Dixon, or Regeneron (30-April-
`2009) Is Enabled ....................................................................... 29
`Ground 5: Petitioner Fails to Satisfy Its Burden that the
`“Assessed by a Physician or Other Qualified Medical
`Professional” Is Obvious (All Challenged Claims) .................. 31
`Grounds 1-4 (§ 102 Anticipation): Petitioner Fails to Establish that
`the Disclosure of “VEGF Trap-Eye” in Heier-2009, Dixon, or
`Regeneron (30-April-2009) Anticipates the Recited Amino Acid or
`Nucleic Acid Sequences ...................................................................... 31
`1.
`Petitioner Fails to Establish that “VEGF Trap-Eye” Was
`Known in the Art to Correspond to SEQ ID NO: 2 (Claims
`1 and 8-11) ................................................................................ 32
`a.
`Petitioner and Its Expert Repeatedly Equate
`“Aflibercept” with All Variations of “VEGF Trap” ...... 34
`Petitioner Fails to Address Uncertainty in the Art as
`to the Amino Acid Sequence of “VEGF Trap-Eye” ...... 38
`
`b.
`
`ii
`
`US 169984423v25
`
`

`

`Petitioner Fails to Establish that “VEGF Trap-Eye” Was
`Known in the Art to Be Encoded by SEQ ID NO: 1 (Claim
`12) ............................................................................................. 40
`Ground 4: Petitioner Fails to Demonstrate that There Is a
`Reasonable Likelihood that at Least One of the Challenged Clams
`Is Anticipated or Rendered Obvious by VIEW1/2 as Disclosed in
`Dixon ................................................................................................... 41
`1.
`Petitioner Fails to Establish that the 8-Week Dosing Arm of
`the VIEW Clinical Trial Anticipates the Claimed PRN
`Dosing Regimen (All Challenged Claims) ............................... 42
`Petitioner Fails to Establish that the 8-Week Dosing Arm of
`the VIEW Clinical Trial Renders Obvious the Claimed PRN
`Dosing Regimen (All Challenged Claims) ............................... 45
`Ground 5: Petitioner Fails to Demonstrate that There Is a
`Reasonable Likelihood that at Least One of the Challenged Clams
`Is Rendered Obvious ........................................................................... 47
`Petitioner’s Argument Against Objective Evidence Should Be
`Rejected ............................................................................................... 52
`CONCLUSION .............................................................................................. 57
`
`C.
`
`D.
`
`E.
`
`2.
`
`2.
`
`V.
`
`iii
`
`US 169984423v25
`
`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`ABS Global, Inc. v. Cytonome/ST, LLC,
`IPR2021-00306, Paper 13 (Jun. 7, 2021) ...................................................... 11, 16
`Adaptics Ltd. v. Perfect Co.,
`IPR2018-01596, Paper 20 (Mar. 6, 2019) .............................................................. 5
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Gerate GmbH,
`IPR2019-01469, 2020 WL 740292 (Feb. 13, 2020) ............................................16
`Advanced Display Sys., Inc. v. Kent State Univ.,
`212 F.3d 1272 (Fed. Cir. 2000) ............................................................................42
`Amgen, Inc. v. Alexion Pharms., Inc.,
`IPR2019-00739, Paper 15 (Aug. 30, 2019) ..........................................................41
`Apple, Inc. v. ITC,
`725 F.3d 1356 (Fed. Cir. 2013) ............................................................................52
`AstraZeneca AB v. Aurobindo Pharma Ltd.,
`232 F. Supp. 3d 636 (D. Del. 2017) .....................................................................46
`Belden Inc. v. Berk–Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) ............................................................................51
`Boragen, Inc. v. Syngenta Participations AG,
`IPR2020-00124, 2020 WL 2206972 (May 5, 2020) ............................................14
`C R Bard Inc. v. AngioDynamics, Inc.,
`979 F.3d 1372 (Fed. Cir. 2020) ............................................................................23
`Cisco Sys., Inc. v. C-Cation Techs., LLC,
`IPR2014-00454, Paper 12 (Aug. 29, 2014) ..........................................................26
`Continental Can Co. USA v. Monsanto Co.,
`948 F.2d 1264 (Fed. Cir. 1991) ............................................................................33
`Dropworks, Inc. v. Univ. of Chi.,
`IPR2021-00100, Paper 9 (May 14, 2021) ............................................................15
`EIK Eng’g Sdn. Bhd. v. Wilco Marsh Buggies & Draglines, Inc.,
`IPR2020-00344, Paper 7 (June 23, 2020),
`reh’g denied, IPR2020-00344, Paper 12 (Mar. 4, 2021)....................................... 9
`i
`
`US 169984423v25
`
`

`

`Elan Pharms., Inc. v. Mayo Found. for Med. Educ. & Rsch.,
`346 F.3d 1051 (Fed. Cir. 2003) ............................................................................29
`Evergreen Theragnostics, Inc. v. Advanced Accelerator Applications SA,
`PGR2021-00003, Paper 10 (Apr. 15, 2021) .................................................. 12, 14
`Forest Lab’ys, LLC v. Sigmapharm Lab’ys, LLC,
`918 F.3d 928 (Fed. Cir. 2019) ..............................................................................48
`Gardner Denver, Inc. v. Utex Indus., Inc.,
`IPR2020-00333, 2020 WL 4529832 (Aug. 5, 2020) ......................... 12, 14, 15, 16
`Henny Penny Corp. v. Frymaster LLC,
`938 F.3d 1324 (Fed. Cir. 2019) ............................................................................46
`Hoffer v. Microsoft Corp.,
`405 F.3d 1326 (Fed. Cir. 2005) ............................................................................21
`In re Morsa,
`713 F.3d 104 (Fed. Cir. 2013) ..............................................................................29
`Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ............................................................................45
`King Pharms., Inc. v. Eon Labs, Inc.,
` 616 F.3d 1267 (Fed. Cir. 2010) ................................................................... passim
`KSR Int'l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) .............................................................................................48
`Luye Pharma Grp. Ltd. v. Alkermes Pharma Ir. Ltd.,
`IPR2016-01096, Paper 74 (Nov. 28, 2017) ..........................................................52
`Merck Sharp & Dohme Corp. v. Wyeth LLC,
`IPR2017-01211, Paper 9 (Oct. 20, 2017) .............................................................26
`Microsoft Corp. v. Bradium Techs. LLC,
`IPR2015-01435, Paper 15 (Dec. 23, 2015) ..........................................................25
`NXP USA, Inc. v. Impinj, Inc.,
`IPR2020-00519, 2020 WL 4805424 (Aug. 17, 2020) ....................... 12, 14, 15, 16
`Pers. Web Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ..............................................................................51
`Philip Morris Prods., S.A. v. Rai Strategic Holdings, Inc.,
`IPR2020-00921, 2020 WL 6750120 (Nov. 16, 2020) ..........................................11
`
`ii
`
`US 169984423v25
`
`

`

`Pi-Net Int’l, Inc. v. JPMorgan Chase & Co.,
`600 F. App’x 774 (Fed. Cir. 2015) ......................................................................... 5
`Rohm & Haas Co. v. Brotech Corp.,
`127 F.3d 1089 (Fed. Cir. 1997) ............................................................................26
`Samsung Elecs. Co. v. Elm 3DS Innovations, LLC,
`925 F.3d 1373 (Fed. Cir. 2019) ............................................................................19
`Schering v. Amgen,
`222 F.3d 1347 (Fed. Cir. 2000) ............................................................................37
`Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co.,
`868 F.3d 1013 (Fed. Cir. 2017) ..................................................................... 19, 20
`Smiths Indus. Med. Sys., Inc. v. Vital Signs, Inc.,
`183 F.3d 1347 (Fed. Cir. 1999) ............................................................................48
`Sony Interactive Ent. LLC v. Terminal Reality, Inc.,
`IPR2020-00711, 2020 WL 6065188 (Oct. 13, 2020) ...........................................17
`Vanda Pharms. Inc. v. W.-Ward Pharms. Int’l Ltd.,
`887 F.3d 1117 (Fed. Cir. 2018) ............................................................................23
`Verdegaal Bros. v. Union Oil Co. of Cal.,
`814 F.2d 628 (Fed. Cir. 1987) ..............................................................................43
`Statutes
`35 U.S.C. § 312(a)(3) .................................................................................... 2, 3, 5, 6
`35 U.S.C. § 314 ........................................................................................................18
`35 U.S.C. § 314(a) ........................................................................................... passim
`35 U.S.C. § 315 ........................................................................................................18
`35 U.S.C. § 325(d) ........................................................................................ 2, 10, 17
`Other Authorities
`77 Fed. Reg. 48756 (August 14, 2012) ...................................................................... 6
`77 Fed. Reg. 48763 (August 14, 2012) ...................................................................... 6
`Trial Practice Guide (November 2019) ..................................................................... 5
`Regulations
`37 C.F.R. § 42.24(a)(1)(i) .......................................................................................... 4
`
`iii
`
`US 169984423v25
`
`

`

`TABLE OF EXHIBITS
`
`Description
`
`Ex. No.
`Exhibit Number Unused
`2001
`Exhibit Number Unused
`2002
`Lucentis (ranibzumab injection) label, revised June 2010
`2003
`2004 Ex. (a)(1)(a) to Tender Offer Statement to Momenta, filed with SEC on
`September 2, 2020
`2005 Press Release, Johnson & Johnson, Johnson & Johnson to Acquire
`Momenta Pharmaceuticals, Inc., Expanding Janssen’s Leadership in
`Novel Treatments for Autoimmune Diseases, dated August 19, 2020
`2006 Press Release, Johnson & Johnson, Johnson & Johnson Completes
`Acquisition of Momenta Pharmaceuticals, Inc, dated October 1, 2020
`2007 Press Release, THOMAS REUTERS INTEGRITY “VEGF Trap-Eye
`final phase II results in age-related macular degeneration presented at
`2008 Retina Society Meeting” (September 2008)
`Information from ClinicalTrials.gov archive on the VIEW 2 study
`(NCT00637377) “VEGF Trap-Eye: Investigation of Efficacy and Safety
`in Wet AMD (VIEW 2)” versions available and updated on 17 March
`2008.
`2009 U.S. Patent App. No. 2006/0058234
`2010
`Excerpts from J.M. Berg et al., Biochemistry (5th Ed. 2002)
`2011 M.W. Stewart & P.J. Rosenfeld, Predicted Biological Activity of
`Intravitreal VEGF Trap¸ Br. J. Opthamol 92:667-68 (2008)
`2012 P. Iacono et al., Antivascular Endothelial Growth Factor in Diabetic
`Retinopathy, Dev. Opthamol. 46:39-53 (2010)
`2013 D.V. Do et al., An Exploratory Study of the Safety, Tolerability and
`Bioactivity of a Single Intravitreal Injection of Vascular Endothelial
`Growth Factor Trap-Eye in Patients With Diabetic Macular Oedema,
`Br. J. Opthamol 93:144-49 (2009)
`J.W. Moroney et al., Aflibercept in Epithelial Ovarian Carcinoma,
`Future Oncol 5(5):591-600 (2009)
`2015 U.S. Patent Publication 2010/0160233 A1 to Bissery et al., published
`June 24, 2010
`2016 T. Hachiya et al., Increase in respiratory cost at high growth
`temperature is attributed to high protein turnover cost in Petunia x
`hybrida petals, Plant, Cell, and Environment, 30:1269-1283 (2007)
`
`2008
`
`2014
`
`iv
`
`US 169984423v25
`
`

`

`2018
`
`2017 M. Piques et al., Ribosome and transcript copy numbers, polysome
`occupancy and enzyme dynamics in Arabidoposis, Molecular Systems
`Biology 5: Article number 314 (2009)
`Jaffe et al., Differential Response to Anti-VEGF Regimens in Age-
`Related Macular Degeneration Patients with Early Persistent Retinal
`Fluid, Ophthalmology 2016;123:1856-1864 (2016)
`Eylea (aflibercept) Injection label, revised May 2016
`2019
`2020 A Study Investigating the Safety and Efficacy of Lampalizumab
`Intravitreal Injections in Participants With Geographic Atrophy
`Secondary to Age-Related Macular Degeneration (SPECTRI),
`NCT02247531, ClinicalTrials.gov (August 2, 2021),
`https://clinicaltrials.gov/ct2/show/NCT02247531?term=lampalizumab&
`phase=2&draw=2&rank=2
`2021 A Study Investigating the Efficacy and Safety of Lampalizumab
`Intravitreal Injections in Participants With Geographic Atrophy
`Secondary to Age-Related Macular Degeneration (CHROMA),
`NCT02247479, ClinicalTrials.gov (August 2, 2021),
`https://clinicaltrials.gov/ct2/show/NCT02247479?term=lampalizumab&
`phase=2&draw=2&rank=3
`2022 Efficacy and Safety Trial of Conbercept Intravitreal Injection for
`Neovascular AMD(PANDA-2), NCT03630952, ClinicalTrials.gov
`(August 2, 2021),
`https://clinicaltrials.gov/ct2/show/NCT03630952?term=NCT03630952
`&draw=2&rank=1
`2023 Efficacy and Safety Trial of Conbercept Intravitreal Injection for
`Neovascular AMD(PANDA-1), NCT03577899, ClinicalTrials.gov
`(August 2, 2021),
`https://clinicaltrials.gov/ct2/show/NCT03577899?term=NCT03577899
`&draw=2&rank=1
`2024 A Phase 3 Safety and Efficacy Study of Fovista® (E10030)
`Intravitreous Administration in Combination With Lucentis® Compared
`to Lucentis® Monotherapy, NCT01944839, ClinicalTrials.gov (August
`2, 2021),
`https://clinicaltrials.gov/ct2/show/NCT01944839?term=fovista&phase=
`2&draw=2&rank=1
`
`v
`
`US 169984423v25
`
`

`

`2025 A Phase 3 Safety and Efficacy Study of Fovista® (E10030)
`Intravitreous Administration in Combination With Lucentis® Compared
`to Lucentis® Monotherapy, ClinicalTrials.gov (August 2, 2021),
`https://clinicaltrials.gov/ct2/show/NCT01940900?term=fovista&phase=
`2&draw=2&rank=2
`2026 S. Elvidge, Opthotech’s Fovista crashes out in wet AMD,
`BIOPHARMADIVE (Aug. 14, 2017), available at,
`https://www.biopharmadive.com/news/opthotech-fovista-phase-3-
`failure-setback-novartis/449248/
`2027 X. Li et al., Safety and Efficacy of Conbercept in Neovascular Age-
`Related Macular Degeneration: Results from a 12-Month Randomized
`Phase 2 Study: AURORA Study, Ophthalmology 2014:121:1740-1747
`(2014)
`2028 Regeneron Pharmaceuticals Inc., “VEGF Trap-Eye CLEAR-IT 2 Final
`Primary Endpoint Results” presented at the 2007 Retina Society
`Conference in Boston, Massachusetts (September 30, 2007)
`2029 Bhisitkul, Robert B. and Stewart, Jay M., Alternative anti-VEGF
`treatment regimens in exudative age-related macular degeneration,
`Expert Rev. Ophthalmol., Vol. 5, No. 6 (2010).
`2030 Park, Young Gun et al., New Approach to Anti-VEGF Agents for Age-
`Related Macular Degeneration, Journal of Ophthalmology (2012).
`2031 Spaide, Richard, Ranibizumab According to Need: A Treatment for Age-
`related Macular Degeneration, American Journal of Ophthalmology
`(April 2007)
`2032 Boyer, David S., A Phase IIIb Study to Evaluate the Safety of
`Ranibizumab in Subjects with Neovascular Age-related Macular
`Degeneration, Ophthalmology, Vol. 116, No. 9 (Sept. 2009)
`Lucentis (ranibzumab injection) label, revised March 2018
`2033
`2034 U.S. Patent No. 7,303,746
`2035 U.S. Patent No. 7,521,049
`2036 U.S. Patent No. 7,303,747
`2037 U.S. Patent No. 7,306,799
`2038 Macugen (pegaptanib sodium injection) label submitted with NDA 21-
`756
`2039 Press Release, Regeneron, Regeneron Reports Fourth Quarter and Full
`Year 2012 Financial and Operating Results, dated February 14, 2013
`2040 Press Release, Regeneron, Regeneron Reports Fourth Quarter and Full
`Year 2019 Financial and Operating Results, dated February 6, 2030
`
`vi
`
`US 169984423v25
`
`

`

`2041 Press Release, Regeneron, Regeneron and Bayer Report Positive Results
`for VEGF Trap-Eye in Phase 3 Study in Central Retinal Vein Occlusion
`(CRVO) and in Phase 2 Study in Diabetic Macular Edema (DME),
`dated December 20, 2010
`J.P. Levine et al., Macular Hemorrhage in Neovascular Age-related
`Macular Degeneration After Stabilization With Antiangiogenic Therapy,
`Retina 29(8):1074-79 (2009)
`
`2042
`
`vii
`
`US 169984423v25
`
`

`

`Regeneron Pharmaceuticals, Inc. (“Patent Owner” or “Regeneron”) submits
`
`this preliminary response pursuant to 35 U.S.C. § 313 and 37 C.F.R. § 42.107 to
`
`Mylan Pharmaceuticals Inc.’s (“Petitioner’s” or “MPI’s”) request for inter partes
`
`review (“IPR”) of claims 1 and 8-12 (“Challenged Claims”) of U.S. Patent No.
`
`9,669,069 (“the ’069 Patent,” Ex. 1001).
`
`I.
`
`INTRODUCTION
`Petitioner, who is developing a biosimilar of EYLEA® for the treatment of
`
`angiogenic eye disorders, files this challenge to try to invalidate Regeneron’s ’069
`
`Patent, which covers an alternate approved dosing regimen for EYLEA®.
`
`Before the development of EYLEA®, the standard of care for treatment of
`
`angiogenic eye disorders was monthly intravitreal injections of ranibizumab
`
`(Lucentis®), an antibody fragment that binds Vascular Endothelial Growth Factor
`
`(“VEGF”), or monthly off-label use of bevacizumab (Avastin®), an anti-VEGF
`
`antibody. The great burden of monthly injections led to several attempts to
`
`increase intervals between injections. Ex. 1018, 1 and 9. However, existing
`
`VEGF inhibitors were not effective at maintaining vision through fixed quarterly
`
`or “as needed” (pro re nata) dosing regimens. Ex. 1001, 1:55-59; Ex. 2003, 5.
`
`Regeneron sought to develop a therapy that would finally improve and
`
`maintain visual acuity with extended time between injections. The ’069 Patent
`
`discloses and claims the administration of a specific VEGF antagonist using a
`
`dosing regimen that includes a single initial dose of the VEGF antagonist,
`
`US 169984423v25
`
`1
`
`

`

`followed by one or more secondary doses of the VEGF antagonist, followed by
`
`one or more tertiary doses of the VEGF antagonist, where the tertiary doses are
`
`“administered on an as-needed/pro re nata (PRN) basis, based on visual and/or
`
`anatomical outcomes as assessed by a physician or other qualified medical
`
`professional.”
`
`As set forth herein and in the accompanying exhibits, the Petition should be
`
`denied for at least the following independent reasons:
`
`First, Petitioner flouts the Board’s rules by circumventing word count limits
`
`and by disregarding the particularity requirement of 35 U.S.C. § 312(a)(3),
`
`presenting “catch-all” obviousness arguments that do not differentiate between six
`
`references and nine obviousness theories.
`
`Second, Petitioner bases its challenges on the same or substantially the
`
`same prior art that was previously before the U.S. Patent & Trademark Office
`
`(“Office”) and was considered by the Examiner, yet Petitioner does not allege that
`
`the Examiner erred in a manner material to the patentability of the Challenged
`
`Claims, warranting discretionary denial under 35 U.S.C. §§ 325(d) and 314(a).
`
`Third, Petitioner makes no effort to show that the art relied upon in any of
`
`its Grounds discloses, expressly or inherently, that the PRN dosing of the claimed
`
`VEGF Trap fusion protein be administered “based on visual and/or anatomical
`
`outcomes as assessed by a physician or other qualified medical professional.”
`
`Instead, Petitioner argues — unconvincingly — that this limitation is a “mental
`
`US 169984423v25
`
`2
`
`

`

`step” that should be afforded no patentable weight. Because Petitioner’s claim
`
`construction position lacks merit and it has utterly failed to show this limitation in
`
`its cited art, it has not met its threshold burden under 35 U.S.C. §§ 314(a) and
`
`312(a)(3), and the Board should deny institution for this reason alone.
`
`Fourth, Petitioner’s anticipation challenges also fail because Petitioner does
`
`not demonstrate that the claims’ required nucleic acid or amino acid sequence was
`
`expressly or inherently disclosed in its cited references. Petitioner’s anticipation
`
`position depends on its unsupported theory that the alleged prior art inherently
`
`discloses aflibercept and its amino acid and nucleic acid sequences through
`
`reference to “VEGF Trap-Eye.” But Petitioner relies on inference to make a
`
`connection between “VEGF Trap-Eye” and “aflibercept” that the prior art does
`
`not support, and the Federal Circuit has repeatedly held that such mere
`
`possibilities or probabilities are insufficient for anticipation.
`
`Fifth, Petitioner’s Ground 4 anticipation and obviousness challenges
`
`additionally fail because its cited art fails to disclose a “tertiary dose” that “is
`
`administered on an as-needed/pro re nata PRN basis” and, further, Petitioner fails
`
`to show that the person of ordinary skill in the art (“POSA”) would have been
`
`motivated to modify a fixed 8-week tertiary dosing regimen to become a PRN
`
`tertiary dosing regimen, as required by each of the Challenged Claims.
`
`Finally, Petitioner’s Ground 5 obviousness challenge additionally should be
`
`rejected because Petitioner fails to show that the POSA would have been
`
`US 169984423v25
`
`3
`
`

`

`motivated to reduce the four monthly loading doses1 in Regeneron’s Phase 2
`
`clinical trials to three monthly loading doses, and further fails to address that the
`
`clinical trial results and the art as a whole would caution against such a
`
`modification.
`
`For these reasons, as explained further below, Regeneron respectfully
`
`requests that the Board deny institution of the Petition.
`
`II.
`
`THE PETITION SHOULD BE REJECTED FOR CIRCUMVENTING
`THE WORD LIMIT AND OBFUSCATING ITS GROUNDS
`A.
`The Petition Violates the Word Limit
`The Petition exceeds the 14,000-word limit (37 C.F.R. § 42.24(a)(1)(i)).
`
`Despite certifying that the word count for its petition is 13,951 words (Pet., Cert.
`
`of Compliance), the Petition’s word count includes only the typed words of the
`
`Petition. The word count ignores words in images of text from the ’069 Patent
`
`specification, including a lengthy passage of text on which Petitioner
`
`substantively relies for its arguments. See e.g., Pet., 14-15. In total, Petitioner
`
`fails to account for 186 words in text images in the Petition which, when included,
`
`results in a word count of 14,137 words. Thus, Petitioner disregards the Board’s
`
`rules, as further evidenced by Petitioner’s use of the same tactic in its Petition
`
`filed in IPR2021-00881. Paper 1. This is a reason to deny institution. Trial
`
`1 The recited initial and secondary doses are also referred to as “loading doses” and
`
`the recited tertiary doses are also referred to as “maintenance doses” herein.
`
`US 169984423v25
`
`4
`
`

`

`Practice Guide (November 2019) at 40 (“Excessive words in figures, drawings, or
`
`images, deleting spacing between words, or using excessive acronyms or
`
`abbreviations for word phrases, in order to circumvent the rules on word count,
`
`may lead to a party’s brief not being considered.”); see Pi-Net Int’l, Inc. v.
`
`JPMorgan Chase & Co., 600 F. App’x 774 (Fed. Cir. 2015) (denying request to
`
`file a corrected brief and dismissing appeal because appellant violated word
`
`count).
`
`The proper remedy here is to deny institution, thereby allowing Petitioner to
`
`refile a petition that properly conforms with the Board’s word count rules. No
`
`time bar precludes Petitioner from refiling a petition challenging the ’069 Patent.
`
`The Petition Fails the Particularity Requirement
`B.
`Despite exceeding the allowed word count, Petitioner still has not managed
`
`to state, with particularity, the grounds on which the challenge to each claim is
`
`based. Accordingly, the Petition presents an inefficient use of the Board’s time
`
`and resources, as well as procedural unfairness to Regeneron.
`
`A petition “may be considered only if . . . the petition identifies, in writing
`
`and with particularity, each claim challenged, the grounds on which the challenge
`
`to each claim is based, and the evidence that supports the grounds for the
`
`challenge to each claim.” 35 U.S.C. § 312(a)(3); see also Adaptics Ltd. v. Perfect
`
`Co., IPR2018-01596, Paper 20 at 15-24 (Mar. 6, 2019) (informative). “[T]he
`
`Board may consider whether a lack of particularity as to one or more of the
`
`US 169984423v25
`
`5
`
`

`

`asserted grounds justifies denial of an entire petition.” Id. at 17. Furthermore, the
`
`Office Patent Trial Practice Guide advises practitioners to “focus on concise, well-
`
`organized, easy-to-follow arguments supported by readily identifiable evidence of
`
`record.” 77 Fed. Reg. 48756, 48763 (August 14, 2012).
`
`Here, Petitioner has not satisfied the particularity requirements under
`
`§ 312(a)(3) for at least Ground 5 because the Petition suffers from the same
`
`deficiencies identified by the Board in Adaptics. Specifically, Ground 5 is a
`
`“catch-all” ground that alleges that the Challenged Claims are obvious over six
`
`references under at least seven and as many as nine different theories:
`
`1. Heier-2009 + Mitchell;
`
`2. Heier-2009 + Mitchell + the ’758 Patent;
`
`3. Heier-2009 + Mitchell + Dix;
`
`4. Heier-2009 + Dixon;
`
`5. Heier-2009 + Dixon + the ’758 Patent;
`
`6. Heier-2009 + Dixon + Dix;
`
`7. Heier-2009 + Lalwani;
`
`8. Heier-2009 + Lalwani + the ’758 Patent; and
`
`9. Heier-2009 + Lalwani + Dix.
`
`See Pet., 60-61 n.22.
`
`Importantly, Petitioner fails to explain why each of these combinations is
`
`necessary. Id. at 60-67. Rather, as in Adaptics, Petitioner impermissibly assumes
`
`US 169984423v25
`
`6
`
`

`

`that Heier-2009 does not disclose one or more claim limitations and leaves it to
`
`the Board and Regeneron to fill in the gaps of its Petition. Petitioner also does not
`
`explain the differences between at least independent claim 1 and the alleged
`
`primary reference, Heier-2009, much less the other secondary or tertiary
`
`references, or the differences between each of the various secondary references
`
`(Mitchell, Dixon, Lalwani) or between each of the various tertiary references
`
`(the ’758 Patent and Dixon). Id. at 63-66. Consequently, as in Adaptics,
`
`Petitioner turns the Petition into an empty invitation to the Board and Regeneron
`
`to ascertain what evidence purportedly supports the full breadth of Petitioner’s
`
`contentions.
`
`Beyond its failure to identify how each combination maps to the claim
`
`limitations or the differences between each combination, Petitioner does not
`
`articulate any specific motivation to combine or modify at least: (1) Heier-2009
`
`with Lalwani, (2) the Heier-2009 and Mitchell combination with either of the two
`
`tertiary references, or (3) the Heier-2009 and Dixon combination with either of the
`
`two tertiary references. Again, this lack of particularization leaves Regeneron and
`
`the Board to search the record for the evidence that would support Petitioner’s
`
`theories.
`
`Compounding Petitioner’s lack of specificity as to the distinct combinations
`
`comprising Ground 5, Petitioner uses its cited references inconsistently. Three of
`
`the seven obviousness theories Petitioner sets out in Ground 5 involve combining
`
`US 169984423v25
`
`7
`
`

`

`Heier-2009 (Ex. 1020) with Dixon (Ex. 1006), even though these two references
`
`are characterized elsewhere in the Petition as alternative references. Compare
`
`Pet., 60-67 (Ground 5) (arguing Heier-2009 and Dixon must be combined) with
`
`Pet., 45-50 (Grounds 1 & 2) (arguing Heier-2009 and Dixon both independently
`
`anticipate). Specifically, Petitioner argues that each of Heier-2009 and Dixon
`
`represent alternative disclosures anticipating claim 1. Id. at 46 (“[E]ach of Heier-
`
`2009 and Dixon disclose every element of independent claim 1.”); see also, id. at
`
`61-62 n.23 (“[B]oth Heier-2009 and Dixon are directed toward and expressly
`
`disclose VEGF Trap-Eye.”). Yet, in Ground 5, Petitioner asserts Heier-2009 and
`
`Dixon in combination disclose all the elements of claim 1. Id. at 62-66 (“A
`
`skilled artisan naturally would have been motivated to combine the successful
`
`PRN regimen of CLEAR-IT-2 from Heier-2009 with the widely used loading
`
`regimen of three monthly doses disclosed in Mitchell and Dixon—to arrive at a
`
`regimen falling squarely within Challenged Claim 1.”); see also, id. at 68-69
`
`(“Heier-2009 plus Dixon”).
`
`This inconsistency as to whether Heier-2009 and Dixon are alternative
`
`references anticipating the Challenged Claims or are cumulative references that
`
`render the Challenged Claims obvious in combination makes Petitioner’s
`
`arguments impermissibly ambiguous and difficult to understand. The Board has
`
`previously deemed similar confusing and inconsistent arguments to lack
`
`particularity and has exercised its discretion to deny the entire Petition under these
`
`US 169984423v25
`
`8
`
`

`

`circumstances. See, e.g., EIK Eng’g Sdn. Bhd. v. Wilco Marsh Buggies &
`
`Draglines, Inc., IPR2020-00344, Paper 7 at 2 (June 23, 2020), reh’g denied,
`
`IPR2020-00344, Paper 12 (Mar. 4, 2021).
`
`For at least the above reasons, Petitioner has not satisfied the requirement to
`
`state, with particularity, the grounds on which the challenge to each claim is
`
`based. Accordingly, the Petition presents procedural unfairness to Regeneron, as
`
`well as an inefficient use of the Board’s time and resources. Consequently,
`
`Regeneron respectfully requests denial of the petition under 35 U.S.C. § 314(a).
`
`Janssen Pharmaceuticals, Inc. Is a Real Party-in-Interest
`C.
`Petitioner also fails to identify the correct RPIs in its Petition. Petitioner
`
`identifies Viatris Inc., Mylan Inc., Mylan Pharmaceuticals Inc., Momenta
`
`Pharmaceuticals, Inc., and Johnson & Johnson as real parties-in-interest to the
`
`instant Petition. Pet., 4-5. Petitioner stated “[n]o other parties exercised or could
`
`have