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`Case IPR2017-01434
`US Patent No. 5,886,035
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
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`MICRO LABS LIMITED AND MICRO LABS USA INC.
`Petitioners,
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`v.
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`SANTEN PHARMACEUTICAL CO., LTD. AND ASAHI GLASS CO., LTD.
`Patent Owners.
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`____________
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`Case IPR2017-01434
`U.S. Patent No. 5,886,035
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`____________
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`PATENT OWNERS' MOTION TO EXCLUDE
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`Case IPR2017-01434
`US Patent No. 5,886,035
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`TABLE OF CONTENTS
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`I. INTRODUCTION ............................................................................................... 3
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`II. ARGUMENT ....................................................................................................... 3
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`A. ¶¶ 10-70, 75-88, 91-98 of Ex. 1031 (Supplemental Declaration
`of Dr. deLong) and ¶¶ 23-28, 31-33, 36-41, 48-53, 55-62, 67-73 of
`Ex. 1032 (Supplemental Declaration of Dr. Rose) Should Be Excluded
`As Improper Incorporation By Reference .............................................................. 3
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`B. Exhibits and Portions of the deLong and Rose Declarations
`(Exs. 1031 and 1032) Not Cited or Discussed in the Petition or Reply
`Should Be Excluded ..............................................................................................10
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`C. Dr. deLong's and Dr. Rose's Testimony Relating to the Exhibits
`Identified in Section B Above Should Be Excluded on the Same
`Grounds Set Forth with Respect to the Specific Exhibits.....................................13
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`D. Dr. Rose's Redirect Deposition Testimony, Improperly Elicited
`Through Leading Questions, Should be Excluded ...............................................13
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`III. CONCLUSION ..............................................................................................14
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`US Patent No. 5,886,035
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`INTRODUCTION
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`Pursuant to 37 C.F.R. § 42.64 and the Scheduling Order governing this
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`I.
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`proceeding (Paper No. 12), Patent Owners Santen Pharmaceutical Co., Ltd.
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`("Santen") and Asahi Glass Co., Ltd. ("AGC") (together, "Patent Owners")
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`respectfully move to exclude at least the following evidence submitted by
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`Petitioners Micro Labs Limited and Micro Labs USA Inc. (together, "Petitioners")
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`in connection with the present Inter Partes Review proceeding concerning U.S.
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`Patent No. 5,886,035 ("the '035 Patent"): (1) ¶¶ 6-8, 10-71, 75-98 of Ex. 1031; (2)
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`¶¶ 20-33, 36-41, 48-73 of Ex. 1032; (3) Exs. 1033-1035, 1037-1038, 1040-1043,
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`1045-1060; (4) testimony in ¶¶ 16, 39, 43, 49, 50, 55, 57, 59, 69, 81, 82, 83, 85,
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`and 86 of Ex. 1031 relating to Exs. 1040 and 1045-1060; (5) testimony in ¶¶ 24,
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`26, 27, 41, 44, 47, 49, 56, 57, 59, and 60 of Ex. 1032 relating to Exs. 1033-1035,
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`1037-1038, and 1040-1043; and (6) testimony at 117:23-118:23 of Ex. 2062.
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`II. ARGUMENT
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`A.
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`¶¶ 10-70, 75-88, 91-98 of Ex. 1031 (Supplemental Declaration of
`Dr. deLong) and ¶¶ 23-28, 31-33, 36-41, 48-53, 55-62, 67-73 of Ex.
`1032 (Supplemental Declaration of Dr. Rose) Should Be Excluded
`As Improper Incorporation By Reference
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`In a transparent and improper attempt to supplement their deficient Petition,
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`while avoiding the word-count limits for their Reply, Petitioners incorporate by
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`reference into the Reply wide swaths of arguments and discussions found only in
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`US Patent No. 5,886,035
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`the Supplemental Declarations of Dr. deLong (Ex. 1031) ("deLong Declaration")
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`and Dr. Rose (Ex. 1032) ("Rose Declaration"). Paper 27 at 1-2 (Patents Owners'
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`timely objections). Such incorporation by reference is improper. See 37 C.F.R. §
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`42.6(a)(3) ("Arguments must not be incorporated by reference from one document
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`into another document."); 37 C.F.R. § 42.104(b)(5) ("The Board may exclude or
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`give no weight to the evidence where a party has failed to state its relevance or to
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`identify specific portions of the evidence that support the challenge."); 37 C.F.R. §
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`42.61(a) ("Evidence that is not taken, sought, or filed in accordance with this
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`subpart is not admissible."); Cisco Sys., Inc. v. C-Cation Techs., LLC, IPR2014-
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`00454, Paper 12 at 7-10 (PTAB Aug. 29, 2014) (informative) (explaining that Rule
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`42.6(a)(3) prohibits incorporating by reference arguments from supporting
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`declarations).
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`Notably, the deLong and Rose Declarations total 102 pages compared to
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`Petitioners' 23-page Reply. The Board should not condone Petitioners' plain
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`attempt to circumvent the word limit through improper incorporation of arguments
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`from the Supplemental Declarations. See 37 C.F.R. § 42.24(c); Conopco, Inc. v.
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`Procter & Gamble Co., IPR2013-00510, Paper 9 at 8 (PTAB Feb. 12, 2014) ("We
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`decline to consider information presented in a supporting declaration, but not
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`discussed in a petition, because among other reasons, doing so would encourage
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`the use of declarations to circumvent the page limits that apply to petitions.").
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`For the foregoing reasons and the reasons set forth below, at least ¶¶ 10-70,
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`75-88, and 91-98 of the deLong Declaration and ¶¶ 23-28, 31-33, 36-41, 48-53, 55-
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`62, and 67-73 of the Rose Declaration should be excluded under 37 C.F.R. §
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`42.6(a)(3), 37 C.F.R. § 42.104(b)(5), and 37 C.F.R. § 42.61(a).1
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`1.
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`¶¶ 10-16, 75 of the deLong Declaration (Ex. 1031); ¶¶ 48-53 of
`the Rose Declaration (Ex. 1032)
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`At page 2 of the Reply, Petitioners contend that "Klimko's data shows that
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`compound C has longer-lasting efficacy than the comparison compounds A, B and
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`D." Petitioners' purported support for their argument is limited to two short
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`paragraphs directly following that statement. Reply at 3. Petitioners, however,
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`seek to improperly supplement their Reply by citing to 8 paragraphs of the deLong
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`Declaration (¶¶ 10-16, 75)—spanning 8 pages—and 6 paragraphs of the Rose
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`Declaration (¶¶ 48-53)—spanning 4 pages—which contain numerous arguments
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`and discussions not found in the Reply.
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`1 Patent Owners submit that given the pervasiveness of Petitioners' improper
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`incorporation by reference of arguments from the Declarations into the Reply, the
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`Board should disregard Petitioners' Reply and Supporting Declarations in their
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`entirety. As the Office Patent Trial Practice Guide states: "[T]he Board will not
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`attempt to sort proper from improper portions of the reply." 77 Fed. Reg. 48,767
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`(Aug. 14, 2012).
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`2.
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`¶¶ 30-45 of the deLong Declaration (Ex. 1031); ¶¶ 26-27, 31-
`33, 36-41of the Rose Declaration (Ex. 1032)
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`Petitioners' argument at page 8 of the Reply regarding the undesirable initial
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`increase in IOP explicitly incorporates what "Dr. deLong explains in his
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`declaration." (Emphasis added). Rather than provide their arguments in the
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`Reply as the Rules require, Petitioners incorporate by reference 6 paragraphs from
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`the deLong Declaration (¶¶ 30-35)—spanning 5 pages—containing numerous
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`arguments not found in the Reply. In the subsequent paragraph, Petitioners again
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`seek to improperly supplement their Reply by citing to ¶¶ 30-35 of the deLong
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`Declaration, as well as ¶¶ 36-41 of the Rose Declaration. Reply at 9. At page 10
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`of the Reply, Petitioners again explicitly incorporate arguments "explained by Drs.
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`deLong and Rose." (Emphasis added). Petitioners cite to 10 paragraphs of the
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`deLong Declaration (¶¶ 30-39) spanning 8 pages and 6 paragraphs of the Rose
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`Declaration (¶¶ 36-41) spanning 5 pages. Finally, at pages 12-13 of the Reply,
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`Petitioners improperly incorporate arguments from ¶¶ 40-45 of the deLong
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`Declaration and ¶¶ 26-27, 31-33, and 41 of the Rose Declaration.
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`3.
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`¶¶ 46-70 and 76 of the deLong Declaration (Ex. 1031)
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`At page 14 of the Reply, Petitioners argue in conclusory fashion that "[t]he
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`POSA would have reasonably expected this modification to successfully result in a
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`compound with an improved therapeutic profile." In a particularly egregious
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`attempt to back-fill gaps in their flawed and deficient Petition, Petitioners follow
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`that statement with a citation to 26 paragraphs of the deLong Declaration (¶¶ 46-
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`70, 76) spanning 21 pages. As detailed below in points 4 and 5, Petitioners also
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`seek to improperly incorporate by reference many of the same paragraphs into
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`other parts of the Reply in a continued effort to supplement their deficient Petition.
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`Notably, the arguments and discussions set forth in ¶¶ 46, 68-70, and 76 are neither
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`cited nor discussed in any other part of the Reply.
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`4.
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`¶¶ 48-61 of the deLong Declaration (Ex. 1031)
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`At page 15 of the Reply, Petitioners again incorporate by reference what Dr.
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`deLong explains in his declaration about how fluorine's unique properties
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`purportedly "make it a desirable substitute for the C-15 hydroxyl group." Instead
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`of providing arguments in their Reply as the Rules require, Petitioners cite 14
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`paragraphs of the deLong Declaration (¶¶ 48-61)—spanning 12 pages—in an effort
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`to improperly supplement their Reply with a wide array of arguments and
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`discussions not found in the Reply.
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`Petitioners go on to make the following general statement: "This is due to
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`teachings in the prior art that difluorination at the C-15 position would mimic the
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`tehrahedral geometry of the carbon C-15 of the parent compound (with its
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`hydroxyl group), and would also confer greater resistance to metabolic degradation
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`and improved membrane penetration through elimination of the hydroxyl group."
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`Id. at 15. Petitioners follow that conclusory statement with citation to 7 paragraphs
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`of the deLong Declaration (¶¶ 50, 55-60) spanning 7 pages in an effort to introduce
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`arguments not found in the Reply.
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`5.
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`¶¶ 50, 56-59, 62-67 of the deLong Declaration (Ex. 1031)
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`At pages 17-18 of the Reply, Petitioners make 3 general statements in
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`support of their argument that Ueno Japan is purportedly relevant prior art. As
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`purported support for those 3 statements, Petitioners cite to 11 paragraphs from the
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`deLong Declaration (¶¶ 50, 56-59, 62-67)—spanning 10 pages—containing
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`numerous arguments and discussions not found in the Reply.
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`6.
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`¶¶ 77-88, 92 of the deLong Declaration (Ex. 1031); ¶¶ 67-73 of
`the Rose Declaration (Ex. 1032)
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`At pages 19-20 of the Reply, Petitioners argue in approximately 1 and a half
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`pages that tafluprost has purportedly not achieved commercial success. Petitioners
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`seek to improperly supplement their Reply with 13 paragraphs of the deLong
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`Declaration (¶¶ 77-88, 92)—spanning 9 pages—and 7 paragraphs of the Rose
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`Declaration (¶¶ 67-73)—spanning 4 pages—containing numerous arguments and
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`information not found in the Reply.
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`¶¶ 17-39 and ¶¶ 47-57 of the deLong Declaration (Ex. 1031)
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`7.
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`At page 20 of the Reply, Petitioners make the following conclusory
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`statement: "PO's assertion that there are 'unexpected results' is directly
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`contradicted by the prior art, including Kishi, Bezuglov 1982 and/or Bezuglov
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`1986, and Ueno Japan and also the common sense knowledge of the POSA."
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`Petitioners follow that conclusory statement with citation to 23 paragraphs of the
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`deLong Declaration (¶¶ 17-39) spanning 16 pages. In addition, as purported
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`support for the conclusory statement that "difluorination at the C-15 position of
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`compound C would be expected to improve the therapeutic profile of compound C
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`by maintaining IOP-lowering activity while reducing side effects," (id. at 20-21)
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`Petitioners cite to 11 paragraphs of the deLong Declaration (¶¶ 47-57) spanning 10
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`pages.
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`8.
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`¶¶ 91-93 of the deLong Declaration (Ex. 1031); ¶¶ 55-62 of the
`Rose Declaration (Ex. 1032)
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`At page 21 of the Reply, Petitioners argue in a single 10-line paragraph that
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`tafluprost purportedly did not fulfill any long-felt unmet need. Petitioners
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`improperly seek to supplement their Reply with arguments and discussions from 3
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`paragraphs of the deLong Declaration (¶¶ 91-93) spanning 3 pages and 8
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`paragraphs of the Rose Declaration (¶¶ 55-62) spanning 5 pages.
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`9.
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`¶¶ 92-98 of the deLong Declaration (Ex. 1031); ¶¶ 23-28 of the
`Rose Declaration
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`At pages 21-22 of the Reply, Petitioners argue in a single paragraph that
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`there has purportedly been no failure of others. Petitioners seek to improperly
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`supplement their Reply with arguments and discussions from ¶¶ 92-98 of the
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`deLong Declaration and ¶¶ 23-28 of the Rose Declaration that are not found in the
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`Reply.
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`10.
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`¶¶ 94-98 of the deLong Declaration (Ex. 1031); ¶¶ 23-28 of the
`Rose Declaration (Ex. 1032)
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`At pages 22-23 of the Reply, Petitioners argue that Patent Owners'
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`secondary considerations evidence is purportedly not commensurate in scope with
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`the claims. Petitioners seek to improperly supplement their Reply with arguments
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`and discussions from 5 paragraphs of the DeLong Declaration (¶¶ 94-98) spanning
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`4 pages and 6 paragraphs of the Rose Declaration (¶¶ 23-28) spanning 5 pages.
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`*
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`Petitioners' blatant (and pervasive) incorporation by reference is prohibited
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`under 37 C.F.R. § 42.6(a)(3), 37 C.F.R. § 42.104(b)(5), and 37 C.F.R. § 42.61(a).
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`Patent Owners respectfully request that at least the foregoing paragraphs of Ex.
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`1031 and Ex. 1032 be excluded.
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`B.
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`Exhibits and Portions of the deLong and Rose Declarations (Exs.
`1031 and 1032) Not Cited or Discussed in the Petition or Reply
`Should Be Excluded
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`The Exhibits and portions of the deLong and Rose Declarations (Exs. 1031
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`and 1032) identified below should be excluded as irrelevant and unfairly
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`prejudicial because they are not cited or discussed in Petitioners' Petition or Reply.2
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`Paper 27 at 1-14 (Patents Owners' timely objections). Materials not discussed in a
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`substantive paper are irrelevant and their consideration would be unfairly
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`prejudicial. FRE 401-403.
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`1.
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`¶¶ 6-8, 71, and 89-90 of Ex. 1031 (Supplemental Declaration of
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`Mitchell A. deLong, Ph.D.)
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`2.
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`¶¶ 20-22, 29-30, and 63-66 of Ex. 1032 (Supplemental
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`Declaration of Aron D. Rose, M.D.)
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`3.
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`4.
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`5.
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`6.
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`7.
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`8.
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`Ex. 1033 (article from the American Journal of Ophthalmology)
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`Ex. 1034 (article from British Journal of Ophthalmology)
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`Ex. 1035 (U.S. Patent No. 5,296,504)
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`Ex. 1037 (article from Primary Care Optometry News)
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`Ex. 1038 (article from the Survey of Ophthalmology)
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`Ex. 1040 (article from The Journal of the American Academy
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`of Ophthalmology)
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`2 Patents Owners only seek to exclude portions of the deLong and Rose
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`Declarations that contain substantive arguments and information that should have
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`been discussed in the Reply. Patent Owners are not seeking to exclude portions of
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`the Declarations that relate solely to background information, e.g., qualifications of
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`the experts and their scope of work.
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`9.
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`Ex. 1041 (article from the British Journal of Ophthalmology)
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`10. Ex. 1042 (article from the Clinical Ophthalmology)
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`11. Ex. 1043 (article from Advances in Therapy)
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`12. Ex. 1045 (article from Drug Evaluation)
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`13. Ex. 1046 (article from the Journal of Ocular Pharmacology and
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`Therapeutics)
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`14. Ex. 1047 (article from the Journal of Medicinal Chemistry)
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`15. Ex. 1048 (article from the Journal of Medicinal Chemistry)
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`16. Ex. 1049 (article from Experimental Eye Research)
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`17. Ex. 1050 (article from Tetrahedron)
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`18. Ex. 1051 (deLong lecture notes)
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`19. Ex. 1052 (Latanoprost Drug Bank Profile)
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`20. Ex. 1053 (Santen Annual Report 2013)
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`21. Ex. 1054 (Santen Data Book Year Ended March 31, 2016)
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`22. Ex. 1055 (GlobalData)
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`23. Ex. 1056 (Aerie Pharmaceuticals Form 8-K)
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`24. Ex. 1057 (Aerie Pharmaceuticals Form 8-K)
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`25. Ex. 1058 (Santen Data Book Year Ended March 31, 2015)
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`26. Ex. 1059 (Santen Data Book Year Ended March 31, 2017)
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`27. Ex. 1060 (Santen Annual Report 2014)
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`C. Dr. deLong's and Dr. Rose's Testimony Relating to the Exhibits
`Identified in Section B Above Should Be Excluded on the Same
`Grounds Set Forth with Respect to the Specific Exhibits
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`Testimony from the Supplemental Declaration of Mitchell A. deLong, Ph.D.
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`(Ex. 1031) relating to Exhibits 1040 and 1045-1060 is inadmissible for the grounds
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`set forth above with respect to the specific exhibits. Paper 27 at 2 (Patent Owners'
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`timely objections). Specifically, Dr. deLong's testimony relating to the
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`aforementioned exhibits in at least ¶¶ 16, 39, 43, 49, 50, 55, 57, 59, 69, 81, 82, 83,
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`85, and 86 of Ex. 1031 should be excluded.
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`Testimony from the Supplemental Declaration of Aron D. Rose, M.D. (Ex.
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`1032) relating to Exhibits 1033-1035, 1037-1038, and 1040-1043 is inadmissible
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`for the grounds set forth above with respect to the specific exhibits. Paper 27 at 2
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`(Patent Owners' timely objections). Specifically, Dr. Rose's testimony relating to
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`the aforementioned exhibits in at least ¶¶ 24, 26, 27, 41, 44, 47, 49, 56, 57, 59, and
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`60 of Ex. 1032 should be excluded.
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`D. Dr. Rose's Redirect Deposition Testimony, Improperly Elicited
`Through Leading Questions, Should be Excluded
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`Petitioners' improperly elicited testimony at 117:23-118:23 of the June 16,
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`2018 Deposition of Aron D. Rose (Ex. 2062) should be excluded under FRE 611.
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`Specifically, during redirect examination, Petitioners posed leading questions to
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`Dr. Rose—their own expert witness—in seeking testimony on Ex. 1033: "Now,
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`the paragraph does not say that the two patients or any patients complained of
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`hyperemia; correct?" (Id. at 117:23-25); "Now, this paragraph does not say that the
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`two patients were excluded from the study due to hyperemia; correct?" (Id. at
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`118:6-8). Despite Patent Owners' timely objections to these questions (id. at
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`118:2-3, 11-23), Petitioners did not correct the format of their questions. Instead,
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`Petitioners instructed Dr. Rose to answer the questions as posed. Because FRE
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`611(c) does not permit Petitioners to pose leading questions on direct/redirect
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`examination of their own expert witness ("[l]eading questions should not be used
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`on direct examination except as necessary to develop the witness's testimony"), Dr.
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`Rose's improperly elicited redirect testimony in Ex. 2062, 117:23-118:23, should
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`be excluded.
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`III. CONCLUSION
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`For the reasons stated above, Patent Owners respectfully request that the
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`Board grant the relief sought through the present motion. In particular, Patent
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`Owners respectfully submit that the Board should disregard Petitioners' Reply and
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`Supplemental Declarations in their entirety, and/or exclude at least the following
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`evidence: (1) ¶¶ 6-8, 10-71, 75-98 of Ex. 1031; (2) ¶¶ 20-33, 36-41, 48-73 of Ex.
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`1032; (3) Exs. 1033-1035, 1037-1038, 1040-1043, 1045-1060; (4) testimony in ¶¶
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`16, 39, 43, 49, 50, 55, 57, 59, 69, 81, 82, 83, 85, and 86 of Ex. 1031 relating to
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`Exs. 1040 and 1045-1060; and (5) testimony in ¶¶ 24, 26, 27, 41, 44, 47, 49, 56,
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`57, 59, and 60 of Ex. 1032 relating to Exs. 1033-1035, 1037-1038, and 1040-1043.
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`Patent Owners respectfully submit that the Board should also exclude 117:23-
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`118:23 of Ex. 2062.
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`Dated: July 26, 2018
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`/ Arlene Chow /
`Arlene L. Chow
`Registration No. 47,489
`Eric J. Lobenfeld
`(pro hac vice)
`Ernest Yakob
`Registration No. 45,893
`Hogan Lovells US LLP
`875 Third Avenue
`New York, New York 10022
`Telephone: (212) 918-3000
`Fax: (212) 918-3100
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`Counsel for Patent Owners
`Santen Pharmaceutical Co., Ltd.
`and Asahi Glass Co., Ltd.
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent Owners'
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`Motion to Exclude was served on July 26, 2018, by filing this document through
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`the Patent Trial and Appeal Board End to End System as well as delivering a copy
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`via electronic mail upon the following attorneys of record for the Petitioners:
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`Cedric C.Y. Tan, Reg. No. 56,082
`H. Keeto Sabharwal (pro hac vice)
`Yun Wei, Reg. No. 70,744
`Alton L. Hare, Reg. No. 68, 638
`PILLSBURY WINTHROP SHAW PITTMAN LLP
`1200 Seventeenth Street, NW
`Washington, DC 20036
`Tel.: (202) 663-8000
`Fax.: (202) 663-8007
`Email: cedric.tan@pillsburylaw.com
`Email: keeto.sabharwal@pillsburylaw.com
`Email: sophie.wei@pillsburylaw.com
`Email: alton.hare@pillsburylaw.com
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`Sean M. Weinman, Reg. No. 69,515
`PILLSBURY WINTHROP SHAW PITTMAN LLP
`1650 Tysons Boulevard, 14th Floor
`McLean, VA 22102
`Tel.: (703) 770-7511
`Fax.: (703) 770-4856
`Email: sean.weinman@pillsburylaw.com
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`MicroLabsIPR@pillsburylaw.com
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`Case IPR2017-01434
`US Patent No. 5,886,035
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`/ Arlene Chow /
`Arlene L. Chow
`Registration No. 47,489
`Hogan Lovells US LLP
`875 Third Avenue
`New York, New York 10022
`Telephone: (212) 918-3000
`Fax: (212) 918-3100
`
`Counsel for Patent Owners
`Santen Pharmaceutical Co., Ltd.
`and Asahi Glass Co., Ltd.
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`
`Dated: July 26, 2018
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`17
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