UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner
`
`
`
`Case IPR2021-00881
`Patent 9,254,338 B2
`
`
`
`PETITIONER’S OBJECTIONS TO
`ADMISSIBILITY OF EVIDENCE SUBMITTED BY PATENT OWNER
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner
`
`
`
`Case IPR2021-00881
`Patent 9,254,338 B2
`
`
`
`PETITIONER’S OBJECTIONS TO
`ADMISSIBILITY OF EVIDENCE SUBMITTED BY PATENT OWNER
`
`
`
`
`Case No. IPR2021-00881
`
`Pursuant to 37 C.F.R. § 42.64(b), Petitioner Mylan Pharmaceuticals Inc.
`
`(“Petitioner”), hereby objects as follows to the admissibility of evidence filed by
`
`Patent Owner Regeneron Pharmaceuticals, Inc. (“Regeneron” or “Patent Owner”),
`
`in conjunction with the Patent Owner Preliminary Response, filed on August 16,
`
`2021, and Patent Owner Consolidated Sur-Reply, filed on October 6, 2021.
`
`In this paper, a reference to “FRE” means the Federal Rules of Evidence, a
`
`reference to “CFR” means the Code of Federal Regulations, and “’338 patent”
`
`means U.S. Patent No. 9,254,338. All objections under FRE 802 (hearsay) apply to
`
`the extent Patent Owner relies on the exhibits identified in connection with that
`
`objection for the truth of the matter asserted therein.
`
`Exhibit descriptions provided in this table are Patent Owner’s exhibit list and
`
`are used for identification purposes only. The use of the description does not indicate
`
`that Petitioner agrees with the descriptions or characterizations of the documents.
`
`Ex. No.
`
`Description
`
`Objections
`
`2001 Expert Declaration of Dr. Diana V. Do, M.D.
`
`2002 Curriculum Vitae of Dr. Diana Do
`
`A, C, D, E, F, G, H,
`M, N, O, Q, S, T
`
`A, B, C, D, E, F, G,
`H, I, M, N, O, T
`
`2003 Lucentis (ranibzumab injection) label, revised
`June 2010
`
`A, C, D, E, F, G, H,
`M, N, O
`
`2004 Ex. (a)(1)(a) to Tender Offer Statement to
`Momenta, filed with SEC on September 2, 2020
`
`A, B, C, D, E, F, G,
`H, I, M, N, O, T
`
`2005 Press Release, Johnson & Johnson, Johnson &
`
`A, B, C, D, E, F, G,
`
`
`
`Ex. No.
`
`Description
`
`Johnson to Acquire Momenta
`Pharmaceuticals, Inc., Expanding Janssen’s
`Leadership in Novel Treatments for
`Autoimmune Diseases, dated August 19, 2020
`
`Case No. IPR2021-00881
`
`Objections
`
`H, M, N, O, T
`
`2006 Press Release, Johnson & Johnson, Johnson &
`Johnson Completes Acquisition of Momenta
`Pharmaceuticals, Inc, dated October 1, 2020
`
`A, B, C, D, E, F, G,
`H, M, N, O, T
`
`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)
`
`A, B, C, D, E, F, G,
`H, M, N, O, T
`
`2010 Excerpts from J.M. Berg et al., Biochemistry (5th
`Ed. 2002)
`
`A, C, D, E, F, G, H,
`I, M, N, O
`
`2012 P. Iacono et al., Antivascular Endothelial
`Growth Factor in Diabetic Retinopathy, Dev.
`Opthamol. 46:39-53 (2010)
`
`2014
`
`J.W. Moroney et al., Aflibercept in
`Epithelial Ovarian Carcinoma, Future
`Oncol 5(5):591-600 (2009)
`
`A, C, D, E, F, G, H,
`M, N, O
`
`A, C, D, E, F, G, H,
`M, N, O
`
`2015 U.S. Patent Publication 2010/0160233 A1 to
`Bissery et al., published June 24, 2010
`
`A, C, D, E, F, G, H,
`K, M, N, O
`
`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)
`
`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)
`
`A, C, D, E, F, G, H,
`M, N, O
`
`A, C, D, E, F, G, H,
`M, N, O
`
`2
`
`
`
`Case No. IPR2021-00881
`
`Ex. No.
`
`2018
`
`Description
`
`Objections
`
`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)
`
`A, C, D, E, F, G, H,
`M, N, O
`
`2019 Eylea (aflibercept) Injection label, revised May
`2016
`
`A, C, D, E, F, G, H,
`M, N, O
`
`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
`
`A, B, C, D, E, F,
`G, H, M, N, O, T
`
`A, B, C, D, E, F,
`G, H, M, N, O, T
`
`A, B, C, D, E, F,
`G, H, M, N, O, T
`
`2023 Efficacy and Safety Trial of Conbercept
`Intravitreal Injection for Neovascular
`
`A, B, C, D, E, F,
`G, H, M, N, O, T
`
`3
`
`
`
`Ex. No.
`
`Description
`
`Objections
`
`Case No. IPR2021-00881
`
`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
`
`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/opthotec
`h-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)
`
`A, B, C, D, E, F,
`G, H, M, N, O, T
`
`A, B, C, D, E, F,
`G, H, M, N, O, T
`
`A, B, C, D, E, F, G,
`H, M, N, O
`
`A, C, D, E, F, G, H,
`M, N, O
`
`2029 Bhisitkul, Robert B. and Stewart, Jay M.,
`Alternative anti-VEGF treatment regimens in
`exudative age-related macular degeneration,
`
`A, C, D, E, F, G, H,
`M, N, O
`
`4
`
`
`
`Case No. IPR2021-00881
`
`Ex. No.
`
`Description
`
`Objections
`
`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).
`
`A, C, D, E, F, G, H,
`M, N, O
`
`2033 Lucentis (ranibzumab injection) label, revised
`March 2018
`
`A, C, D, E, F, G, H,
`M, N, O
`
`2038 Macugen (pegaptanib sodium injection) label
`submitted with NDA 21- 756
`
`A, C, D, E, F, G, H,
`M, N, O
`
`2039 Press Release, Regeneron, Regeneron Reports
`Fourth Quarter and Full Year 2012 Financial
`and Operating Results, dated February 14, 2013
`
`A, B, C, D, E, F, G,
`H, M, N, O, T
`
`2040 Press Release, Regeneron, Regeneron Reports
`Fourth Quarter and Full Year 2019 Financial
`and Operating Results, dated February 6, 2030
`
`A, B, C, D, E, F, G,
`H, M, N, O, T
`
`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
`
`A, B, C, D, E, F, G,
`H, M, N, O, T
`
`2042
`
`J.P. Levine et al., Macular Hemorrhage in
`Neovascular Age-related Macular Degeneration
`After Stabilization With Antiangiogenic Therapy,
`Retina 29(8):1074-79 (2009)
`
`A, C, D, E, F, G, H,
`M, N, O
`
`2043 Press Release, Thomson Reuters Links
`Discovery and Literature Citation Databases,
`dated January 4, 2010
`
`A, B, C, D, E, F, G,
`H, M, N, O, T
`
`
`
`5
`
`
`
`Case No. IPR2021-00881
`
`Objection Key:
`
`
`
`A:
`B:
`
`C:
`
`D:
`
`E:
`
`F:
`
`G:
`
`H:
`
`I:
`
`J:
`
`K:
`
`L:
`
`M:
`
`N:
`
`O:
`
`FRE 802 (hearsay)
`FRE 901 (lacking authentication)
`
` FRE 402 (relevance) the document is not relevant to any issue in this
`IPR proceeding because the purported date of the document is after the
`filing date of the ’338 patent or the prior art status is not clear
`
` FRE 402 (relevance) to the extent the document is relied upon for
`secondary considerations of nonobviousness, there is no nexus to the
`claimed compositions and methods
`
` FRE 403 (confusing, waste of time) the document is not relevant to any
`issue in this IPR proceeding because the purported date of the document
`is after the filing date of the ’338 patent or the prior art status is not
`clear
`
`FRE 403 (confusing, waste of time) to the extent the document is relied
`upon for secondary considerations of nonobviousness, there is no nexus
`to the claimed compositions and methods
`
` FRE 702 (improper expert testimony) expert testimony that relies on the
`document is not based on sufficient facts or data and/or is not the product
`of reliable principles and methods
`
` FRE 703 (bases of expert opinion) expert testimony that relies on the
`document is unreliable because the document is not of a type
`reasonably relied upon by experts in the field
`
`FRE 106 (completeness) the document is incomplete and includes
`only a select portion of a larger document that in fairness should be
`considered along with this document
`
`FRE 701, 702 (improper expert testimony) improper expert testimony
`by a lay witness
`
`FRE 1001-1003 (best evidence)
`
`FRE 403, 901 (improper compilation)
`
`FRE 403 (cumulative)
`
`FRE 402 (relevance) the document is not relevant to any issue in the
`IPR proceeding
`FRE 403 (confusing, waste of time) the document is not relevant to
`any issue in the IPR proceeding
`
`P:
`
`No exhibit filed
`
`6
`
`
`
`Case No. IPR2021-00881
`
`Expert testimony fails to identify with particularity the underlying
`facts or data on which the opinion is based violating 37 C.F.R.
`§ 42.65(a)
`FRE 602 (lack of personal knowledge)
`FRE 702/703 to the extent that the expert declarant relies on an
`exhibit objected to under grounds G and H, the testimony is (i) not
`based on sufficient facts or data and/or is not the product of reliable
`principles and methods and/or is (ii) is unreliable because the exhibit
`is not of a type reasonably relied upon by experts in the field
`FRE 1006 (improper summary)
`
`Q:
`
`R:
`S:
`
`T:
`
`
`
`7
`
`
`
`Dated: November 26, 2021
`
`
`
`
`
`
`
`
`
`
`Case No. IPR2021-00881
`
`Respectfully Submitted,
`
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`
`/Paul J. Molino/
`Paul J. Molino
`Registration No. 45,350
`6 West Hubbard Street
`Chicago, IL 60654
`Telephone:
`(312) 222-6300
`Facsimile:
`(312) 843-6260
`paul@rmmslegal.com
`
`
`Counsel for Petitioner
`
`8
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a true and correct copy of the foregoing
`
`Petitioner’s Objections to Admissibility of Evidence Submitted by Patent Owner
`
`was served on November 26, 2021, via electronic mail by agreement of the parties,
`
`to the following counsel for record of Patent Owners:
`
`Deborah E. Fishman (Reg. No. 48,621)
`David A. Caine (Reg. No. 52,683)
`Arnold & Porter Kaye Scholer LLP
`3000 El Camino Real
`Five Palo Alto Square, Suite 500
`Palo Alto, California 94306-3807
`Telephone: 650.319.4519
`Telephone: 650.319.4710
`Facsimile: 650.319.4573
`Deborah.Fishman@arnoldporter.com
`David.Caine@arnoldporter.com
`RegeneronEyleaIPRs@arnoldporter.com
`
`Daniel Reisner
`Matthew M. Wilk
`Arnold & Porter Kaye Scholer LLP
`250 West 55th Street
`New York, New York 10019-9710
`Telephone: 212.836.8000
`Fax: 212.836.8689
`Daniel.Reisner@arnoldporter.com
`Matthew.Wilk@arnoldporter.com
`
`Dated: November 26, 2021
`
`
`
`
`9
`
`Alice S. Ho (Lim. Rec. No. L1162)
`Victoria Reines
`Jeremy Cobb
`Arnold & Porter Kaye Scholer LLP
`601 Massachusetts Ave., N.W.
`Washington D.C. 20001
`Tel: 202.942.5000
`Fax: 202.942.5999
`Alice.Ho@arnoldporter.com
`Victoria.Reines@arnoldporter.com
`Jeremy.Cobb@arnoldporter.com
`
`
`Respectfully Submitted,
`
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`
`/Paul J. Molino/
`
`
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