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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
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`v.
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`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
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`Patent No. 11,253,572
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`_______________
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`Inter Partes Review No. IPR2023-00884
`____________________________________________________________
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`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`SUBMITTED WITH THE PETITION FOR INTER PARTES REVIEW
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`IPR2023-00884
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`Regeneron Pharmaceuticals, Inc. (“Regeneron” or “Patent Owner”) hereby
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`objects to the following evidence that was submitted by Samsung Bioepis Co.,
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`Ltd., (“Samsung” or “Petitioner”) with the Petition (“Pet.,” Paper 2) in the above-
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`captioned proceeding.
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`A. Exhibit 1002 (Expert Declaration of Dr. Edward Chaum in
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`Support of Petition for Inter Partes Review of Patent No.
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`11,253,572, dated April 27, 2023 (“Chaum Decl.”))
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`Patent Owner objects to Exhibit 1002 under
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`• FRE 402-403. The declaration is irrelevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including because Paragraphs 31 and 177 are not
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`cited in the Petition.
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`• FRE 801-804. The declaration constitutes hearsay to the extent that the
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`declarant has not yet been made available for deposition.
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`• FRE 106 and/or FRE 1006.
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`o The declaration relies on excerpts of documents identified below. In
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`fairness, the full document ought to be considered at the same time.
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`o For example, at least Paragraphs 51, 54, 109, and 111-13, rely on
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`incomplete evidence or improper summary and/or improperly cherry-
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`picking selective passages of a reference, while ignoring other
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`passages in the same reference.
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`• FRE 901.
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`o The declaration relies on the unauthenticated evidence identified
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`below.
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`o Paragraph 180 relies on unauthenticated evidence. It is not clear
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`where the image came from, how it was compiled, or what methods,
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`materials, or metrics were used to arrive at the information in the
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`image.
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`B. Exhibit 1005 (Press Release, “Enrollment Completed in
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`Regeneron and Bayer Healthcare Phase 3 Studies of VEGF Trap-
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`Eye in Neovascular Age-Related Macular Degeneration (Wet
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`AMD) (September 14, 2009),” available at:
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`https://newsroom.regeneron.com/news-releases/newsrelease-
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`details/enrollment-completed-regeneron-and-bayer-
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`healthcarephase-3 (“2009 Press Release”))
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`Patent Owner objects to Exhibit 1005 under
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`• FRE 402 and 403. The exhibit is irrelevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including to the extent Petitioner relies on this
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`exhibit to show the results of a dosing regimen that it does not disclose.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit. It
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`is not clear where the exhibit came from or how it was compiled.
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`C. Exhibit 1006 (Press Release, “Regeneron and Bayer Report
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`Positive Results for VEGF Trap-Eye in Phase 3 Study in Central
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`Retinal Vein Occlusion (CRVO) and in Phase 2 Study in Diabetic
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`Macular Edema (DME),” Exhibit 99.1 to Regeneron 8-K filed on
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`December 20, 2010, available at:
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`https://yahoo.brand.edgaronline.com/displayfilinginfo.aspx?Filing
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`ID=7617341643623571&type=sect&TabIndex=2&companyid=503
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`6&ppu=%252fdef% E2%80%A6 (“December 2010 Press
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`Release”)
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`Patent Owner objects to Exhibit 1006 under
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`• FRE 402 and 403. The exhibit is irrelevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including because Petitioner relies on it as prior
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`art to the challenged patent, but it is not prior art.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit.
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`• FRE 802. The exhibit is offered for the truth of its content without
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`satisfying any of the hearsay exceptions, including because Petitioner relies
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`on the reference itself for the date of publication online.
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`D. Exhibit 1007 (Press Release, “Bayer and Regeneron Report
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`Positive Top-Line Results of Two Phase 3 Studies with VEGF
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`Trap-Eye in Wet Age-related Macular Degeneration,” Exhibit
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`99.1 to Regeneron 8-K filed on November 22, 2010, available at:
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`https://yahoo.brand.edgaronline.com/displayfilinginfo.aspx?Filing
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`ID=7572010861126486&type=sect&TabIndex=2&companyid=503
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`6&ppu=%252fdef%E2%80%A6 (“November 2010 Press
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`Release”))
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`Patent Owner objects to Exhibit 1007 under
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`• FRE 402 and 403. The exhibit is irrelevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including because Petitioner relies on it as prior
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`art to the challenged patent, but it is not prior art.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit.
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`• FRE 802. The exhibit is offered for the truth of its content without
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`satisfying any of the hearsay exceptions, including because Petitioner relies
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`on the reference itself for the date of publication online.
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`E. Exhibit 1009 (Dixon JA, Oliver SC, Olson JL, Mandava N. VEGF
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`Trap-Eye for the treatment of neovascular age-related macular
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`degeneration. Expert Opin Investig Drugs. 2009;18(10):1573-
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`1580. (“Dixon”))
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`Patent Owner objects to Exhibit 1009 under
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`• FRE 402 and 403. The exhibit is irrelevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including because Petitioner relies on this exhibit
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`to show the results of a dosing regimen that it does not disclose.
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`F. Exhibit 1010 (Major JC et al., “DA VINCI: DME and VEGF
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`Trap-Eye: INvestigationof Clinical Impact: Phase 2 Study in
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`Patients With Diabetic Macular Edema (DME), ARVO Annual
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`Meeting Abstract (April 2010), Vol. 51, Issue 13, available at:
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`https://iovs.arvojournals.org/article.aspx?articleid=2375028
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`(“2010 ARVO Abstract”))
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`Patent Owner objects to Exhibit 1010 under
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`• FRE 402 and 403. The exhibit is irrelevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including because Petitioner relies on it as prior
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`art to the challenged patent, but it is not prior art.
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`G. Exhibit 1016 (Hecht, “Opthalmic Preparations,” Remington: The
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`Science and Practice of Pharmacy, Volume II, 19th edition,
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`Chapter 89 (1995). (“Hecht”))
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`Patent Owner objects to exhibit 1016 under
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`• FRE 106 and/or FRE 1006. The Exhibit appears to be an excerpt. In
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`fairness, the full document ought to be considered at the same time.
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`H. Exhibit 1017 (WO 2006/047325 Al (“Shams”))
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`Patent Owner objects to Exhibit 1017 under
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`• FRE 802. The exhibit is offered for the truth of its content without
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`satisfying any of the hearsay exceptions.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit. It
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`is not clear where the exhibit came from or how it was compiled.
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`I. Exhibit 1018 (Elman MJ, et al., Randomized trial evaluating
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`ranibizumab plus prompt or deferred laser or triamcinolone plus
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`prompt laser for diabetic macular edema. Ophthalmology. 2010
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`Jun;117(6):1064-1077.e35. (“Elman 2010”))
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`Patent Owner objects to Exhibit 1018 under
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`• FRE 402 and 403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder.
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`• FRE 802. The exhibit is offered for the truth of its content without
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`satisfying any of the hearsay exceptions.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit. It
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`is not clear where the exhibit came from or how it was compiled.
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`J. Exhibit 1019 (Elman MJ, et al., Randomized trial evaluating
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`ranibizumab plus prompt or deferred laser or triamcinolone plus
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`prompt laser for diabetic macular edema. Ophthalmology. 2010
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`Jun;117(6):1064-1077.e35, published April 28 2010, available at
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`https://www.aaojournal.org/article/S0161-6420(10)00243-
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`5/fulltext (“Elman AAO Website))
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`Patent Owner objects to Exhibit 1019 under
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`• FRE 802. The exhibit is offered for the truth of its content without
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`satisfying any of the hearsay exceptions.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit. It
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`is not clear where the exhibit came from, how it was compiled, or what
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`methods, materials, or metrics were used to arrive at the information in the
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`document.
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`K. Exhibit 1020 (Authenticating Affidavit and the July 13, 2010 Web
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`Archive of the CATT Patient Eligibility Criteria, available at
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`https://web.archive.org/web/20100713035617/http://www.med.upe
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`nn.edu/cpob/studies/documents/CATTEligibilityCriteria_000.pdf,
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`attached as Exhibit B (“CATT Study”))
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`Patent Owner objects to Exhibit 1020 under
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`• FRE 402 and 403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including because Petitioner has not shown it was
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`publicly accessible as of the priority date of the challenged claims of the
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`’572 patent (January 13, 2011).
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`• FRE 802. The exhibit is offered for the truth of its content without
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`satisfying any of the hearsay exceptions.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit.
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`L. Exhibit 1021 (Regillo CD, Brown DM, Abraham P, et al.
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`Randomized, double-masked, sham-controlled trial of
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`ranibizumab for neovascular age-related macular degeneration:
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`PIER Study year 1. Am J Ophthalmol. 2008;145(2):239-248.
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`(“PIER Study”))
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`Patent Owner objects to Exhibit 1021 under
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit. It is
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`not clear where the exhibit came from or how it was compiled.
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`M. Exhibit 1022 (Comparison of Age-related Macular Degeneration
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`Treatments Trials: Lucentis-Avastin Trial (NCT00593450),
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`available at: https://clinicaltrials.gov/ct2/show/NCT00593450
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`(“NCT-450”))
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`Patent Owner objects to Exhibit 1022 under
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`• FRE 802. The exhibit is offered for the truth of its content without
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`satisfying any of the hearsay exceptions.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit. It
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`is not clear where the exhibit came from, how it was compiled, or what
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`methods, materials, or metrics were used to arrive at the information in the
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`document.
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`N. Exhibit 1023 (Regillo CD, Brown DM, Abraham P, et al.
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`Randomized, double-masked, sham-controlled trial of
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`ranibizumab for neovascular age-related macular degeneration:
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`PIER Study year 1. Am J Ophthalmol. 2008;145(2):239-248,
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`published December 3, 2007, available at
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`https://www.ajo.com/article/S0002-9394(07)00881-1/fulltext
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`(“PIER AJO Website”))
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`Patent Owner objects to Exhibit 1023 under
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit. It
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`is not clear where the exhibit came from, how it was compiled, or what
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`methods, materials, or metrics were used to arrive at the information in the
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`document.
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`O. Exhibit 1024 (History of Changes for Study: A Study of rhuFab
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`V2 (Ranibizumab) in Subjects With Subfoveal Choroidal
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`Neovascularization Secondary to Age-Related Macular
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`Degeneration (AMD) (NCT00090623), available at:
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`https://clinicaltrials.gov/ct2/history/NCT00090623?V_1=View#Stu
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`dyPageTop. (“NCT-623”))
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`Patent Owner objects to Exhibit 1024 under
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit. It
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`is not clear where the exhibit came from, how it was compiled, or what
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`methods, materials, or metrics were used to arrive at the information in the
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`document.
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`P. Exhibit 1025 (ClinicalTrials.gov Background, available at:
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`https://clinicaltrials.gov/ct2/about-site/background
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`(“ClinicalTrials.gov Background”))
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`Patent Owner objects to Exhibit 1025 under
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit. It
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`is not clear where the exhibit came from, how it was compiled, or what
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`methods, materials, or metrics were used to arrive at the information in the
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`document.
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`Q. Exhibit 1026 (ClinicalTrials.gov About the Results Database,
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`available at: https://clinicaltrials.gov/ct2/about-site/results
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`(“ClinicalTrials.gov About the Results Database”))
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`Patent Owner objects to Exhibit 1026 under
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit. It
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`is not clear where the exhibit came from, how it was compiled, or what
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`methods, materials, or metrics were used to arrive at the information in the
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`document.
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`R. Exhibit 1027 (Press Release, “Regeneron Reports Positive Phase 1
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`Data for the VEGF TRAP in Age-Related Macular
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`Degeneration,” Exhibit 99(a) to Regeneron 8-K filed on May 2,
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`2006, available at:
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`https://yahoo.brand.edgaronline.com/displayfilinginfo.aspx?Filing
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`ID=4380124-5423-
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`15279&type=sect&TabIndex=2&companyid=5036&ppu=%252fd
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`ef%E2%80%A6 (“May 2006 Press Release”))
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`Patent Owner objects to Exhibit 1027 under
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`• FRE 402 and 403. The exhibit is irrelevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including because Petitioner relies on this exhibit
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`to show the results of a dosing regimen that it does not disclose.
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`• FRE 802. The exhibit is offered for the truth of its content without
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`satisfying any of the hearsay exceptions.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit. It
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`is not clear where the exhibit came from, how it was compiled, or what
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`methods, materials, or metrics were used to arrive at the information in the
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`document.
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`S. Exhibit 1030 (Do DV et al., “Results of a Phase I Study of
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`Intravitreal VEGF Trap in Subjects With Diabetic Macular
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`Edema: The CLEAR-IT DME Study,” ARVO Annual Meeting
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`Abstract (May 2007), Vol. 48, Issue 3, available at:
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`https://iovs.arvojournals.org/article.aspx?articleid=2384099
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`(“2007 ARVO Abstract”))
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`Patent Owner objects to Exhibit 1030 under
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`• FRE 402 and 403. The exhibit is irrelevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including because Petitioner relies on this exhibit
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`to show the results of a dosing regimen that it does not disclose.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit. It
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`is not clear where the exhibit came from, how it was compiled, or what
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`methods, materials, or metrics were used to arrive at the information in the
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`document.
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`• FRE 106 and/or FRE 1006. The Exhibit appears to be an excerpt. In
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`fairness, the full document ought to be considered at the same time.
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`T. Exhibit 1031 (Do DV et al., The DA VINCI Study: phase 2
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`primary results of VEGF Trap-Eye in patients with diabetic
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`macular edema. Ophthalmology. 2011 Sep;118(9):1819-26
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`(published online on May 5, 2011). (“Do 2011”))
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`Patent Owner objects to Exhibit 1031 under
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`• FRE 402 and 403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder because it was not published before the priority
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`date of the challenged claims of the ’572 patent (January 13, 2011).
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`U. Exhibit 1032 (Randolph and Jones, “Surfactant-Protein
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`Interactions,” Rational Design of Stable Protein Formulations,
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`edited by Carpenter and Manning, vol. 13, 2002 (“Randolph”))
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`Patent Owner objects to Exhibit 1032 under
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`• FRE 802. The exhibit is offered for the truth of its content without
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`satisfying any of the hearsay exceptions.
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`V. Exhibit 1034 (Lucentis ® Original Approved Labeling (2006),
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`available at:
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`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125156
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`s0000_Lucentis_Prntlbl.pdf)
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`Patent Owner objects to Exhibit 1034 under
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`• FRE 402 and 403. The undated exhibit is not relevant, and its probative
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`value is substantially outweighed by the danger of confusion of the issues
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`and misleading the fact finder to the extent it is not shown to be published
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`before the priority date of the challenged claims of the ’572 patent (January
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`13, 2011).
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`• FRE 901. Petitioner has not demonstrated the authenticity of the document.
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`It is not clear where the exhibit came from or how it was compiled.
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`W. Exhibit 1038 (Heier JS, et al., Intravitreal aflibercept (VEGF
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`trap-eye) in wet agerelated macular degeneration. Ophthalmology
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`2012;119(12):2537-2548. (“Heier 2012”))
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`Patent Owner objects to Exhibit 1038 under
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`• FRE 402 and 403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder because it was not published before the priority
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`date of the challenged claims of the ’572 patent (January 13, 2011).
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`• FRE 802. The exhibit is offered for the truth of its content without
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`satisfying any of the hearsay exceptions.
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`X. Exhibit 1039 (Heier JS, et al., CLEAR-IT 2 Investigators. The 1-
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`year results of CLEAR-IT 2, a phase 2 study of vascular
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`endothelial growth factor trapeye dosed as-needed after 12-week
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`fixed dosing. Ophthalmology. 2011 Jun;118(6):1098-106. (“Heier
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`2011”))
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`Patent Owner objects to Exhibit 1039 under
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`• FRE 802. The exhibit is offered for the truth of its content without
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`satisfying any of the hearsay exceptions.
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`Y. Exhibit 1040 (Pai A, El Shafei MM, Mohammed OA, Al Hashimi
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`M., Current concepts in intravitreal drug therapy for diabetic
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`retinopathy. Saudi J Ophthalmol. 2010 Oct;24(4):143-9. (“Pai
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`2010”))
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`Patent Owner objects to Exhibit 1040 under
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`• FRE 802. The exhibit is offered for the truth of its content without
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`satisfying any of the hearsay exceptions.
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`Z. Exhibit 1041 (U.S. Patent App. Pub. US 2007/0190058A1 (“Shams
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`US App. Pub.”))
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`Patent Owner objects to Exhibit 1041 under
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`• FRE 402 and 403. The exhibit is irrelevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including because it is not cited in the Petition.
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`AA.
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`Exhibit 1043 (WO 2012/097019A1 (“Yancopoulos PCT
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`Application”))
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`Patent Owner objects to Exhibit 1043 under
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`• FRE 402 and 403. The exhibit is irrelevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including because it is not cited in the Petition.
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`BB.
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`Exhibit 1044 (U.S. Dep’t Health & Human Servs., Nat’l
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`Inst. Health, Nat’l Eye Inst.,“Diabetic Retinopathy: What You
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`Should Know (Sept. 2015),” available at:
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`https://www.nei.nih.gov/sites/default/files/healthpdfs/Diabetic_Ret
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`inopathy_What_You_Should_Know.pdf (“NIHDR”))
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`Patent Owner objects to Exhibit 1044 under
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`• FRE 402 and 403. The exhibit is irrelevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including because it is not cited in the Petition,
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`and including because it was not published before the priority date of the
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`challenged claims of the ’572 patent (January 13, 2011).
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`• FRE 802. The exhibit is offered for the truth of its content without
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`satisfying any of the hearsay exceptions.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the document.
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`It is not clear where the exhibit came from or how it was compiled.
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`CC.
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`Exhibit 1045 (U.S. Dep’t Health & Human Servs., Nat’l
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`Inst. Health, Nat’l Eye Inst.,“Age-Related Macular Degeneration:
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`What You Should Know (Sept.2015),” available at
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`https://www.nei.nih.gov/sites/default/files/healthpdfs/WYSK_AM
`
`D_English_Sept2015_PRINT.pdf (“NIH AMD”))
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`Patent Owner objects to Exhibit 1045 under
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`• FRE 402 and 403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including because it was not published before the
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`priority date of the challenged claims of the ’572 patent (January 13, 2011).
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`• FRE 802. The exhibit is offered for the truth of its content without
`
`satisfying any of the hearsay exceptions.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the document.
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`It is not clear where the exhibit came from or how it was compiled.
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`DD.
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`Exhibit 1046 (Halpern MT, Schmier JK, Covert D,
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`Venkataraman K. Resource utilization and costs of age-related
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`macular degeneration. Health Care Financ Rev. 2006;27(3):37-47.
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`(“Halpern 2006”))
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`Patent Owner objects to Exhibit 1046 under
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`• FRE 402 and 403. The exhibit is irrelevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including because it is not cited in the Petition.
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`• FRE 802. The exhibit is offered for the truth of its content without
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`satisfying any of the hearsay exceptions.
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`EE.
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`Exhibit 1047 (Rudge JS, Holash J, Hylton D, et al. VEGF
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`Trap complex formation measures production rates of VEGF,
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`providing a biomarker for predicting efficacious angiogenic
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`blockade. Proc Natl Acad Sci U S A. 2007;104(47):18363-18370.
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`(“Rudge 2007”))
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`Patent Owner objects to Exhibit 1047 under
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`• FRE 402 and 403. The exhibit is irrelevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the fact finder, including because it is not cited in the Petition.
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`FF.
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`Exhibit 1048 (Li E, Donati S, Lindsley KB, Krzystolik MG,
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`Virgili G. Treatment regimens for administration of anti-vascular
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`endothelial growth factor agents for neovascular age-related
`
`macular degeneration. Cochrane Database Syst Rev.
`
`2020;5(5):CD012208. (“Li 2020”))
`
`Patent Owner objects to Exhibit 1048 under
`
`• FRE 402 and 403. The exhibit is irrelevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and
`
`misleading the fact finder, including because it is not cited in the Petition,
`
`and including because it was not published before the priority date of the
`
`challenged claims of the ’572 patent (January 13, 2011).
`
`• FRE 802. The exhibit is offered for the truth of its content without
`
`satisfying any of the hearsay exceptions.
`
`19
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`IPR2023-00884
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`
`
`GG.
`
`Exhibit 1049 (Brown DM, Michels M, Kaiser PK, et al.
`
`Ranibizumab versus verteporfin photodynamic therapy for
`
`neovascular age-related macular degeneration: Two-year results
`
`of the ANCHOR study. Ophthalmology.2009;116(1):57-65.e5.
`
`(“Brown 2009”))
`
`Patent Owner objects to Exhibit 1049 under
`
`• FRE 403. The exhibit is irrelevant, and its probative value is substantially
`
`outweighed by the danger of confusion of the issues and misleading the fact
`
`finder, including because it is not cited in the Petition.
`
`• FRE 802. The exhibit is offered for the truth of its content without
`
`satisfying any of the hearsay exceptions.
`
`HH.
`
`Exhibit 1050 (Martin DF, Maguire MG, Fine SL, Ying GS,
`
`Jaffe GJ, Grunwald JE, et al, Comparison of Age-Related
`
`Macular Degeneration Treatments Trial (CATT) Research
`
`Group. Ranibizumab and bevacizumab for treatment of
`
`neovascular age-related macular degeneration: two-year results.
`
`Ophthalmology 2012; 119(7):1388-98 (“Martin”))
`
`Patent Owner objects to Exhibit 1050 under
`
`• FRE 403. The exhibit is irrelevant, and its probative value is substantially
`
`outweighed by the danger of confusion of the issues and misleading the fact
`
`20
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`IPR2023-00884
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`
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`finder, including because it is not cited in the Petition, and including because
`
`its probative value is substantially outweighed by the danger of confusion of
`
`the issues and misleading the fact finder because it was not published before
`
`the priority date of the challenged claims of the ’572 patent (January 13,
`
`2011).
`
`• FRE 802. The exhibit is offered for the truth of its content without
`
`satisfying any of the hearsay exceptions.
`
`II. Exhibit 1051 (Chakravarthy U, Harding SP, Rogers CA, Downes
`
`SM, Lotery AJ, Wordsworth S, et al, Inhibition of VEGF in Age-
`
`related choroidal Neovascularization (IVAN) Study Investigators.
`
`Ranibizumab versus bevacizumab to treat neovascular age-
`
`related macular degeneration: one-year findings from the IVAN
`
`randomized trial. Ophthalmology 2012; 119(7):1399-411
`
`(“Chakravarthy 2012”)
`
`Patent Owner objects to Exhibit 1051 under
`
`• FRE 403. The exhibit is irrelevant, and its probative value is substantially
`
`outweighed by the danger of confusion of the issues and misleading the fact
`
`finder, including because it is not cited in the Petition, including because it
`
`was not published before the priority date of the challenged claims of the
`
`’572 patent (January 13, 2011).
`
`21
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`IPR2023-00884
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`
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`• FRE 802. The exhibit is offered for the truth of its content without
`
`satisfying any of the hearsay exceptions.
`
`JJ. Exhibit 1052 (Rosenfeld PJ, Brown DM, Heier JS, Boyer DS,
`
`Kaiser PK, Chung CY, et al. Ranibizumab for neovascular age-
`
`related macular degeneration. New England Journal of Medicine
`
`2006; 355(14):1419-31 (“Rosenfeld 2006”))
`
`Patent Owner objects to Exhibit 1052 under
`
`• FRE 403. The exhibit is irrelevant, and its probative value is substantially
`
`outweighed by the danger of confusion of the issues and misleading the fact
`
`finder, including because it is not cited in the Petition.
`
`• FRE 802. The exhibit is offered for the truth of its content without
`
`satisfying any of the hearsay exceptions.
`
`KK.
`
`Exhibit 1053 (Heimann, H. (2007). Chapter 5 Intravitreal
`
`Injections: Techniques and Sequelae. In: Holz, F.G., Spaide, R.F.
`
`(eds) Medical Retina. Essentials in Ophthalmology. Springer,
`
`Berlin, Heidelberg. (“Heimann 2007”))
`
`Patent Owner objects to Exhibit 1053 under
`
`• FRE 403. The exhibit is irrelevant, and its probative value is substantially
`
`outweighed by the danger of confusion of the issues and misleading the fact
`
`finder, including because it is not cited in the Petition.
`
`22
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`IPR2023-00884
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`
`
`
`
`• FRE 802. The exhibit is offered for the truth of its content without
`
`satisfying any of the hearsay exceptions.
`
`LL.
`
`Exhibit 1054 (Jager RD, Aiello LP, Patel SC, Cunningham
`
`ET Jr. Risks of intravitreous injection: a comprehensive review.
`
`Retina. 2004;24(5):676-698. (“Jager 2004”))
`
`Patent Owner objects to Exhibit 1054 under
`
`• FRE 403. The exhibit is irrelevant, and its probative value is substantially
`
`outweighed by the danger of confusion of the issues and misleading the fact
`
`finder, including because it is not cited in the Petition.
`
`• FRE 802. The exhibit is offered for the truth of its content without
`
`satisfying any of the hearsay exceptions.
`
`MM.
`
`Exhibit 1056 (Pilot Study of Intravitreal Injection of
`
`Ranibizumab for Macular Telangiectasia With
`
`Neovascularization (NCT00685854) (May 24, 2008), available at:
`
`https://clinicaltrials.gov/ct2/history/NCT00685854?V_1=View#Stu
`
`dyPageTop (“MACTEL Study”))
`
`Patent Owner objects to Exhibit 1056 under
`
`• FRE 403. The exhibit is irrelevant, and its probative value is substantially
`
`outweighed by the danger of confusion of the issues and misleading the fact
`
`finder, including because it is not cited in the Petition.
`
`23
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`IPR2023-00884
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`
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit. It
`
`is not clear where the exhibit came from or how it was compiled.
`
`NN.
`
`Exhibit 1057 (Authenticating Affidavit and the November 7,
`
`2008 Web Archive of Ranibizumab Injections to Treat Macular
`
`Telangiectasia Without New Blood Vessel Growth
`
`(NCT00685854), available at
`
`https://web.archive.org/web/20081107014243/https://clinicaltrials.
`
`gov/ct2/show/NCT00685854, attached as Exhibit A (“MACTEL
`
`Study Wayback Machine”))
`
`Patent Owner objects to Exhibit 1057 under
`
`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit.
`
`OO.
`
`Exhibit 1058 (Using the Wayback Machine, available at:
`
`https://help.archive.org/help/using-the-wayback-machine/)
`
`Patent Owner objects to Exhibit 1058 under
`
`• FRE 403. The exhibit is irrelevant, and its probative value is substantially
`
`outweighed by the danger of confusion of the issues and misleading the fact
`
`finder, including because it is not cited in the Petition.
`
`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit. It
`
`is not clear where the exhibit came from or how it was compiled.
`
`24
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`IPR2023-00884
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`
`
`
`
`PP.
`
`Exhibit 1059 (Eylea Label 2011 available at:
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/12538
`
`7lbl.pdf)
`
`Patent Owner objects to Exhibit 1059 under
`
`• FRE 403. The exhibit is irrelevant, and its probative value is substantially
`
`outweighed by the danger of confusion of the issues and misleading the fact
`
`finder, including because it is not cited in the Petition.
`
`• FRE 901. Petitioner has not demonstrated the authenticity of the document.
`
`It is not clear where the exhibit came from or how it was compiled.
`
`QQ.
`
`Exhibit 1060 (Glenn J. Jaffe, Paul Ashton, P. Andrew
`
`Pearson, Intraocular Drug Delivery (2006) (“Jaffe”))
`
`Patent Owner objects to Exhibit 1060 under
`
`• FRE 402 and 403. The exhibit is not relevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and
`
`misleading the fact finder, including because it is not cited in the Petition.
`
`• FRE 802. The exhibit is offered for the truth of its content without
`
`satisfying any of the hearsay exceptions.
`
`RR.
`
`Exhibit 1061 (Steps for a Safe Intravitreal Injection
`
`Technique (2009), available at:
`
`25
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`IPR2023-00884
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`
`
`
`
`https://www.retinalphysician.com/issues/2009/July aug/steps-for-
`
`asafe-intravitreal-injection-technique)
`
`Patent Owner objects to Exhibit 1061 under
`
`• FRE 403. The exhibit is irrelevant, and its probative value is substantially
`
`outweighed by the danger of confusion of the issues and misleading the fact
`
`finder, including because it is not cited in the Petition.
`
`
`To the extent the exhibits are admitted, their scope should be restricted to the
`
`purpose for which they were originally submitted. FRE 105. Should Samsung rely
`
`on an exhibit for a different purpose than the one for which it has been offered,
`
`Regeneron reserves the right to make additional objections.
`
`
`
`In accordance with 37 C.F.R. § 42.64(b)(1), these objections are being
`
`timely filed and served within ten (10) business days of the institution of the trial
`
`by the Patent and Trial Appeal Board (“Board”), which is reflected in the Board’s
`
`Institution Decision dated November 17, 2023 (Paper 13).
`
`26
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`IPR2023-00884
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`
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`Dated: December 4, 2023
`
`
`
`
`
`Respectfully submitted,
`
`
`By /Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`MORRISION & FOERSTER LLP
`425 Market Street
`San Francisco, California 94105
`Tel: (415) 268-6053
`ABrausa@mofo.com
`
`Attorney for Patent Owner
`
`27
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`
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`IPR2023-00884
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`
`
`
`
`Certificate of Service (37 C.F.R. § 42.6(e)(4))
`
`
`
`I hereby certify that the attached PATENT OWNER’S OBJECTIONS TO
`
`EVIDENCE SUBMITTED WITH THE PETITION FOR INTER PARTES
`
`REVIEW was served as of the below date on the Petitioner via e-mail (by
`
`agreement) to the following counsel of record.
`
`Raymond N. Nimrod (Reg. No. 31,987)
`Matthew A. Traupman (Reg. No. 50,832)
`Landon Andrew Smith (Reg. No. 79,248)
`QUINN EMANUEL URQUHART
`& SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Email: raynimrod@quinnemanuel.com
`Email: matthewtraupman@quinnemanuel.com
`Email: landonsmith@quinnemanuel.com
`Email: qe-samsungbioepis@quinnemanuel.com
`
`
`Dated: December 4, 2023
`
`/Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`
`
`
`28
`
`
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