IPR2017-01446
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioners,
`
`v.
`
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`________________
`
`Case IPR2017-01446
`U.S. Patent No. 7,049,328
`
`Title: USE FOR DEFERIPRONE
`________________
`
`
`PATENT OWNER’S MOTION TO EXCLUDE
`PETITIONER’S EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(c)
`
`
`
`

`

`
`INTRODUCTION ........................................................................................... 1 
`I. 
`LEGAL STANDARDS ................................................................................... 1 
`II. 
`III.  ARGUMENT ................................................................................................... 1 
`A. 
`Certain Portions of Exhibit 1002 Should be Excluded ......................... 1 
`1. 
`¶¶ 63-85 should be excluded under FRE 702 and 703 ............... 1 
`2. 
`¶¶ 26-28, 30, 33, 34, 36, 37, 40, 55, 56, 60, 64, 66, 67, 72, 74-
`76, 80, and 82-85 should be excluded under FRE 702, 703, 705,
`403; Guide, 77 Fed. Reg. at 48,763; 37 C.F.R. § 42.65 ............. 3 
`¶¶ 30, 31, 37-40, 63-65, 68-71, and 80-81 should be excluded
`under FRE 402 ............................................................................ 4 
`Exhibits 1005, 1006, 1022, 1024, 1026, and 1030 Should be Excluded
`Under FRE 402 ...................................................................................... 4 
`Exhibits 1028, 1029, 1031, and 1033-1035 Should be Excluded Under
`FRE 401-403 ......................................................................................... 5 
`Exhibits 1037, 1038, 1040-1043, 1045, and 1047-1049 Should be
`Excluded Under FRE 401-403, 801-802, and 901 ................................ 5 
`Exhibits 1037, 1038, 1040-1043, 1045, and 1047-1049 are
`1. 
`irrelevant and unfairly prejudicial under FRE 401-403 .............. 6 
`Exhibits 1038, 1040-1043, and 1045 are inadmissible hearsay
`under FRE 801 and 802 .............................................................. 7 
`Exhibits 1037, 1038, 1040-1043, 1045, and 1047-1049 are
`inadmissible under FRE 901 ....................................................... 8 
`Exhibits 1052-1054 and 1056 Should be Excluded Under FRE 401-
`403 ......................................................................................................... 9 
`Certain Portions of Exhibit 1060 Should be Excluded ....................... 10 
`1. 
`¶¶ 19-50 should be excluded under FRE 702 and 703 ............. 10 
`
`D. 
`
`3. 
`
`2. 
`
`3. 
`
`B. 
`
`C. 
`
`E. 
`
`F. 
`
`Table of Contents
`
`IPR2017-01446
`
`
`i
`
`

`

`
`
`G. 
`H. 
`
`2. 
`
`3. 
`
`¶¶ 5, 14-16, 18, 20, 21-23, 36, 38-41, and 45-46 should be
`excluded under FRE 702, 703, 705, 403; Guide, 77 Fed. Reg. at
`48,763; 37 C.F.R. § 42.65 ......................................................... 10 
`¶¶ 14, 25, 28, and 44-45 and footnotes 1, 3, and 8 should be
`excluded under FRE 401 and 402 ............................................. 11 
`Exhibits 1063-1066 Should be Excluded Under FRE 401-403 .......... 12 
`Exhibit 1065 and Corresponding ¶ 25 of Exhibit 1060 Should be
`Excluded Under FRE 401, 402, and 901 ............................................. 12 
`IV.  CONCLUSION .............................................................................................. 15 
`
`
`
`
`
`
`
`
`ii
`
`

`

`
`
`Table of Authorities
`
`Page(s)
`
`
`Cases
`
`Legend3D, Inc. v. Prime Focus Creative Servs. Can. Inc.,
`IPR2016-00806, Paper 73 (PTAB Sept. 18, 2017) ......................................... 1
`
`
`Neste Oil OYJ v REG Synthetic Fuels, LLC,
`IPR2013-00578, Paper 53 (PTAB Mar. 12, 2015) .................................. 13, 14
`
`
`Riverbed Tech., Inc. v. Realtime Data LLC,
`IPR2016-00978, Paper 67 (PTAB Oct. 30, 2017) ............................... 9, 14, 15
`
`
`TRW Auto. U.S. LLC v Magna Elecs. Inc.,
`IPR2014-01347, Paper 25 (PTAB Jan. 6, 2016) ....................................... 9, 14
`
`
`Statutes & Regulations
`
`37 C.F.R. § 42.62 ....................................................................................................... 1
`
`37 C.F.R. § 42.64(c) ................................................................................................... 1
`
`37 C.F.R. § 42.65 ....................................................................................... 3, 4, 10, 11
`
`Rules
`
`77 Fed. Reg. 48,756-48,773 (Aug. 14, 2012) ........................................ 1, 3, 4, 10, 11
`
`FRE 401 .......................................................................................5, 6, 7, 9, 11, 12, 13
`
`FRE 402 .........................................................................................4, 5, 6, 7, 9, 12, 13
`
`FRE 403 .............................................................................. 3, 4, 5, 6, 7, 9, 10, 11, 12
`
`FRE 702 ................................................................................................. 2, 3, 4, 10, 11
`
`FRE 703 ................................................................................................. 2, 3, 4, 10, 11
`
`FRE 705 ..................................................................................................... 3, 4, 10, 11
`
`
`
`
`iii
`
`

`

`
`
`FRE 801 ............................................................................................................. 5, 7, 8
`FRE 801 ............................................................................................................. 5, 7, 8
`
`FRE 802 ............................................................................................................. 5, 7, 8
`FRE 802 ............................................................................................................. 5, 7, 8
`
`FRE 901 ..................................................................................................... 5, 8, 12, 13
`FRE 901 ..................................................................................................... 5, 8,12,13
`
`FRE 902 ................................................................................................................... 13
`
`
`
`FRE 902 ................................................................................................................... 13
`
`
`
`
`
`iv
`
`iV
`
`

`

`IPR2017-01446
`
`
`I.
`
`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.64(c) and the scheduling order governing this
`
`proceeding (Paper 8), Patent Owner Apotex Technologies, Inc. (“Apotex”)
`
`respectfully moves to exclude certain evidence presented in support of Petitioner
`
`Taro Pharmaceuticals U.S.A., Inc.’s (“Taro”) Petition for Inter Partes Review of
`
`U.S. Patent 7,049,328 (“Taro’s Petition,” Paper 2) and Petitioner’s Reply (“Taro’s
`
`Reply,” Paper 41).
`
`II. LEGAL STANDARDS
`A motion to exclude rests on the admissibility of evidence under the Federal
`
`Rules of Evidence (“FRE”). Legend3D, Inc. v. Prime Focus Creative Servs. Can.
`
`Inc., IPR2016-00806, Paper 73 at 8-9 (PTAB Sept. 18, 2017); see 37 C.F.R.
`
`§§ 42.62, 42.64; Office Patent Trial Practice Guide (the “Guide”), 77 Fed. Reg.
`
`48,756-48,773 at 48,758 (Aug. 14, 2012) (“Admissibility of evidence is generally
`
`governed by the Federal Rules of Evidence.”) As stated in the Guide, parties may
`
`submit motions to exclude evidence “believed to be inadmissible.” Guide, 77 Fed.
`
`Reg. at 48,758. A motion to exclude “must explain why the evidence is not
`
`admissible (e.g., relevance or hearsay).” Id.; see also 37 C.F.R. § 42.64(c).
`
`III. ARGUMENT
`A. Certain Portions of Exhibit 1002 Should be Excluded
`1.
`¶¶ 63-85 should be excluded under FRE 702 and 703
`Apotex timely objected (Paper 12 at 1) to ¶¶ 63-85 of Ex. 1002 as containing
`
`1
`
`

`

`
`
`testimony on a topic which Dr. Mehta is not qualified to opine. (FRE 702 and
`
`703.) Under Rule 702, an expert witness must have “knowledge, skill, experience,
`
`training, or education” relevant to the evidence or facts at issue and his or her
`
`testimony must be based on sufficient facts or data and be the product of reliable
`
`principles and methods. (FRE 702.)
`
`Here, the claims at issue are directed to the administration of deferiprone to
`
`treat iron-induced cardiac disease in a patient with iron overload. (Ex. 1001 at
`
`Abstract; id. at col. 1, ll. 9-15.) In his declaration, Dr. Mehta offered opinions on,
`
`among other things, anticipation, obviousness and secondary considerations related
`
`to the asserted claims. (Ex. 1002 at ¶¶ 63-85.) However, Dr. Mehta confirmed
`
`during cross examination that he lacks the relevant expertise, i.e., using deferiprone
`
`to treat iron-induced cardiac disease in iron overload patents, to offer these
`
`opinions. (See, e.g., Ex. 2024.) For example, Dr. Mehta testified that since 1993
`
`he has “not directly prescribed deferiprone.” (Id. at 36:34 to 37:7, 41:3-24.) Dr.
`
`Mehta also testified that since 1995 the majority of his publications have been
`
`related to bone marrow transplantation and stem cell transplantation. (Id. at 43:15-
`
`19.) Indeed, since 2000, Dr. Mehta has been a Professor of Medicine and Director
`
`of the Hematopoietic Stem Cell Transplant Program at the Northwestern
`
`University Feinberg School of Medicine, and his work has focused on “the use of
`
`bone marrow and stem cell transplantation for all types of hematologic
`
`
`
`2
`
`

`

`
`
`malignancies and bone marrow failure syndromes including aplastic anemia [and]
`
`focusing also on multiple myeloma . . . .” (Id. at 47:3-18.) Accordingly, Dr.
`
`Mehta does not have the relevant expertise or experience in the issues central to
`
`this proceeding. Because he is unqualified, Dr. Mehta’s opinions expressed in
`
`¶¶ 63-85 of Ex. 1002 are unreliable and should be excluded under FRE 702.
`
`2.
`
`¶¶ 26-28, 30, 33, 34, 36, 37, 40, 55, 56, 60, 64, 66, 67, 72, 74-
`76, 80, and 82-85 should be excluded under FRE 702, 703,
`705, 403; Guide, 77 Fed. Reg. at 48,763; 37 C.F.R. § 42.65
`Apotex also timely objected (Paper 12 at 1) to ¶¶ 26-28, 30, 33, 34, 36, 37,
`
`40, 55, 56, 60, 64, 66, 67, 72, 74-76, 80, and 82-85 of Ex. 1002 as not being based
`
`on sufficient facts or data, the product of reliable principles and methods, and/or
`
`reliable application of the principles of methods and facts. (FRE 702, 703, 705,
`
`403; Guide, 77 Fed. Reg. at 48,763; 37 C.F.R. § 42.65.)
`
`Dr. Mehta makes assertions in ¶¶ 26-28, 30, 33, 34, 36, 37, 40, 55, 56, 60,
`
`64, 66, 67, 72, 74-76, 80, and 82-85 of his declaration (Ex. 1002) without citing
`
`any underlying facts or data to support these statements. For example, in ¶¶ 26-27,
`
`Dr. Mehta provides background information on thalassemia and red blood cells (¶
`
`26) and iron overload as a result of treating thalassemia (¶ 27). (Ex. 1002 at ¶¶ 26-
`
`27.) However, Dr. Mehta fails to provide even a single citation in either of these
`
`paragraphs. (Id.) Likewise, in ¶ 33, Dr. Mehta discusses the side effects of
`
`subcutaneous infusions of desferrioxamine, but again fails to cite any authority for
`
`
`
`3
`
`

`

`
`
`his statements. (Id. at ¶ 33) And, in ¶ 80, Dr. Mehta states “it was known in the art
`
`that most therapeutic agents for most diseases are given in combination with
`
`excipients.” (Id. at ¶ 80) However, once again, Dr. Mehta provides no support for
`
`this assertion. (Id.) These examples typify the lack of underlying support for
`
`many of Dr. Mehta’s assertion. Accordingly, ¶¶ 26-28, 30, 33, 34, 36, 37, 40, 55,
`
`56, 60, 64, 66, 67, 72, 74-76, 80, and 82-85 of Ex. 1002 should be excluded under
`
`FRE 702, 703, 705, 403; Guide, 77 Fed. Reg. at 48,763; and, 37 C.F.R. § 42.65.
`
`3.
`
`¶¶ 30, 31, 37-40, 63-65, 68-71, and 80-81 should be excluded
`under FRE 402
`Apotex timely objected (Paper 12 at 1) to ¶¶ 30, 31, 37-40, 63-65, 68-71,
`
`and 80-81 of Ex. 1002 as irrelevant. (FRE 402.) Specifically, these paragraphs
`
`(with the exception of ¶ 30) were not directly cited in Taro’s Petition. Thus, the
`
`relevance of these paragraphs to the arguments in Taro’s Petition is unknown.
`
`Further, ¶ 30 of Ex. 1002 is irrelevant because it cites to Ex. 1028, which is not
`
`cited in Taro’s Petition. Accordingly, ¶¶ 30, 31, 37-40, 63-65, 68-71, and 80-81 of
`
`Ex. 1002 should be excluded under FRE 402.
`
`B.
`
`Exhibits 1005, 1006, 1022, 1024, 1026, and 1030 Should be
`Excluded Under FRE 402
`Exhibits 1005, 1006, 1022, 1024, 1026, and 1030 were included in the
`
`obviousness analysis in Taro’s Petition and in Dr. Mehta’s declaration (Ex. 1002).
`
`(See Taro’s Petition at 7, 8, 15-18, 34, and 46-48; see also Ex. 1002 at ¶ 83.)
`
`
`
`4
`
`

`

`
`
`Apotex timely objected (Paper 12 at 2) to these Exhibits as irrelevant, and thus
`
`inadmissible, under FRE 402.
`
`Specifically, Taro’s Petition and Dr. Mehta’s declaration (Ex. 1002) failed to
`
`identify any combination of references in the obviousness analysis. Thus, the
`
`relevance of Exs. 1005, 1006, 1022, 1024, 1026, and 1030 to the obviousness
`
`analysis is unknown. Accordingly, Exs. 1005, 1006, 1022, 1024, 1026, and 1030
`
`should be excluded under FRE 402.
`
`C. Exhibits 1028, 1029, 1031, and 1033-1035 Should be Excluded
`Under FRE 401-403
`Apotex timely objected (Paper 12 at 2) to Exs. 1028, 1029, 1031, and 1033-
`
`1035 because these exhibits were never cited in Taro’s Petition. Rather, Exs. 1028,
`
`1031, and 1033-1035 were only cited in the Dr. Mehta’s declaration. (See Ex.
`
`1002 at ¶¶ 8, 9, 30, and footnote(s) (“Fn”) 3.) What is more, Ex. 1029 was not
`
`cited in either Taro’s Petition or the Dr. Mehta’s declaration (Ex. 1002).
`
`Accordingly, because Taro did not rely on these Exhibits in its Petition, there is no
`
`relevance or probative value to Exs. 1028, 1029, 1031, and 1033-1035 and they
`
`should be excluded under FRE 401-403.
`
`D. Exhibits 1037, 1038, 1040-1043, 1045, and 1047-1049 Should be
`Excluded Under FRE 401-403, 801-802, and 901
`Apotex timely objected (Paper 43 at 1) to Exs. 1037, 1038, 1040-1043,
`
`1045, and 1047-1049 under FRE 401-403, 801-802, and 901 because these
`
`
`
`5
`
`

`

`
`
`exhibits: (i) do not contain evidence that is contradictory to any position advanced
`
`by Apotex in this proceeding (i.e., lack relevance and probative value), (ii) are
`
`hearsay, and (iii) lack authentication.
`
`1.
`
`Exhibits 1037, 1038, 1040-1043, 1045, and 1047-1049 are
`irrelevant and unfairly prejudicial under FRE 401-403
`Exhibits 1037, 1038, 1040-1043, 1045, and 1047-1049 are not relevant.
`
`Petitioner introduced these Exhibits in its Reply in an attempt to show that Patent
`
`Owner has made statements inconsistent with its arguments in this proceeding.
`
`(See e.g., Taro’s Reply at 4, 6, 7, 11-13, 15, and 21-22.) As Apotex previously
`
`explained, however, none of these documents contains inconsistent statements.
`
`(See Paper 30.) These Exhibits are thus not relevant and should be excluded.
`
`(FRE 401 and 402.) Further, any probative value that these Exhibits might have is
`
`substantially outweighed by the confusion of the issues. (FRE 403.) For example,
`
`in instituting these proceedings the PTAB adopted a preliminary claim
`
`construction that differs from that of the District Court in a related litigation. Thus,
`
`statements by Apotex’s witnesses or experts in the District Court proceedings (see
`
`Ex. 1042 (Nov. 8, 2017 deposition transcript of Dr. Michael Spino), Ex. 1043
`
`(Nov. 7, 2017 deposition transcript of Dr. Fernando Tricta), and Ex. 1045
`
`(Opening Expert Report of Dudley J. Pennell, M.D.)) are wholly consistent with
`
`the District Court’s claim construction, but have no probative value should the
`
`PTAB maintain its preliminary construction adopted in instituting these
`
`
`
`6
`
`

`

`
`
`proceedings. Consequently, reliance on these statements has the potential to cause
`
`confusion and prejudice, and are misleading to a finder of fact. Accordingly, Exs.
`
`1037, 1038, 1040-1043, 1045, and 1047-1049 should be excluded, whether for
`
`relevance under FRE 401/402 or confusion under FRE 403.
`
`2.
`
`Exhibits 1038, 1040-1043, and 1045 are inadmissible
`hearsay under FRE 801 and 802
`Exhibits 1038, 1040-1043, and 1045 are inadmissible hearsay because
`
`Petitioner offers them to prove the truth of the matter asserted and they do not fall
`
`within any hearsay exception. (FRE 801 and 802.) Specifically, Exs. 1038, 1040,
`
`and 1041 include: (i) an email from Michael Spino to Fernando Tricta on October
`
`7, 1999; (ii) an email exchange among Michael Spino, Fernando Tricta, and John
`
`Furedy between January 16, 2000 and April 3, 2000; and, (iii) an email exchange
`
`among Fernando Tricta, Michael Spino, and Sheila Mandell between December
`
`31, 1999 and January 1, 2000, respectively. Each of these Exhibits is hearsay
`
`because: they embody statements, not made in this proceeding, and are offered by
`
`Petitioner as proof of the matter asserted, i.e., that Patent Owner publicly
`
`discredited subsequent Olivieri publications. (See Taro’s Reply at 22.)
`
`Exhibits 1042 and 1043 are likewise hearsay under FRE 801. Ex. 1042 is
`
`the November 8, 2017 deposition transcript of Dr. Michael Spino and Ex. 1043 is
`
`the November 7, 2017 deposition transcript of Dr. Fernando Tricta. Each of these
`
`Exhibits is hearsay because: they embody statements, not made in this IPR
`
`
`
`7
`
`

`

`
`
`proceeding (i.e., both transcripts are from the related district court litigation), and
`
`are offered by Petitioner as proof of the matter asserted, i.e., that the cardio-
`
`protective effect of deferiprone is inherent (see Taro’s Reply at 6-7); that
`
`deferiprone may be more effective than deferoxamine in terms of heart signal and
`
`improving function (id. at 12); and, that deferiprone is going to reduce iron and
`
`decrease heart disease associated with iron overload (id. at 13).
`
`Ex. 1045 is similarly hearsay under FRE 801. Ex. 1045 is the Opening
`
`Expert Report of Dudley J. Pennell, M.D., submitted during the related district
`
`court litigation and pertaining patent infringement by Taro. This Exhibit is hearsay
`
`because: it embodies statements, not made in this IPR proceeding, and is offered
`
`by Petitioner as proof of the matter asserted, i.e., that T2* is related to T2. (Taro’s
`
`Reply at 11.)
`
`Because Petitioner has offered no exception allowing Exs. 1038, 1040-1043
`
`and 1045 into evidence, these exhibits should be excluded. (FRE 801/802.)
`
`3.
`
`Exhibits 1037, 1038, 1040-1043, 1045, and 1047-1049 are
`inadmissible under FRE 901
`Exhibits 1037, 1038, 1040-1043, 1045, and 1047-1049 should also be
`
`excluded under FRE 901 as unauthenticated. In order to satisfy the authentication
`
`requirement of FRE Rule 901(a), a proponent of an item of evidence “must
`
`produce evidence sufficient to support a finding that the item is what the proponent
`
`claims it is.” Here, Taro offered no evidence in its Reply to support a finding that
`
`
`
`8
`
`

`

`
`
`Exhibits 1037, 1038, 1040-1043, 1045, and 1047-1049 are what Taro claims them
`
`to be. (See generally Taro’s Reply.) Nor did Taro submit any supplemental
`
`evidence sufficient to authenticate Exhibits 1037, 1038, 1040-1043, 1045, and
`
`1047-1049. Thus, Exhibits 1037, 1038, 1040-1043, 1045, and 1047-1049 should
`
`be excluded because their authenticity has not been established by any statement or
`
`affidavit from someone with first-hand knowledge. See, e.g., TRW Auto. U.S. LLC
`
`v. Magna Elecs. Inc., IPR2014-01347, Paper 25 at 5-12 (PTAB Jan. 6, 2016)
`
`(excluding exhibit for lacking authentication); see also Riverbed Tech., Inc. v.
`
`Realtime Data LLC, IPR2016-00978, Paper 67 at 40-41 (PTAB October 30, 2017)
`
`(same).
`
`E.
`
`Exhibits 1052-1054 and 1056 Should be Excluded Under FRE
`401-403
`Apotex timely objected (Paper 43 at 3) to the relevance and probative value
`
`of Exs. 1052-1054 and 1056 because these Exhibits were never cited in Taro’s
`
`Reply or the Expert Declaration of Dr. Jayesh Mehta in Support of Petitioner’s
`
`Reply (“Mehta Decl. in Support of Taro’s Reply,” Ex. 1060). Indeed, because
`
`these Exhibits were never cited by Petitioner, their relevance to this proceeding is
`
`unclear. Likewise, because these Exhibits were not cited in Petitioner’s papers,
`
`they do nothing more than cause confusion and waste the Board’s time. (FRE
`
`403.) Accordingly, the Board should exclude Exs. 1052-1054 and 1056, whether
`
`for relevance under FRE 401/402 or confusion and waste of time under FRE 403.
`
`
`
`9
`
`

`

`
`
`F. Certain Portions of Exhibit 1060 Should be Excluded
`1.
`¶¶ 19-50 should be excluded under FRE 702 and 703
`Apotex timely objected (Paper 43 at 2) to ¶¶ 19-50 of Ex. 1060 under FRE
`
`702 and 703. Specifically, Apotex objects to these paragraphs as containing
`
`testimony on a topic which Dr. Mehta is not qualified to opine. (FRE 702 and
`
`703.) As explained above, the claims at issue are directed to the administration of
`
`deferiprone to treat iron-induced cardiac disease in a patient with iron overload.
`
`(Ex. 1001 at Abstract; id. at col. 1, ll. 9-15.) In the Mehta Decl. in Support of
`
`Taro’s Reply, Dr. Mehta offered opinions on, among other things, anticipation,
`
`obviousness and secondary considerations related to the asserted claims. (Ex. 1060
`
`at ¶¶ 19-50.) However, as discussed supra (§ III.A.1), Dr. Mehta lacks the relevant
`
`expertise, i.e., using deferiprone to treat iron-induced cardiac disease in iron
`
`overload patents, to offer these opinions. Accordingly, ¶¶ 19-50 of Ex. 1060
`
`should be excluded under FRE 702 and 703.
`
`2.
`
`¶¶ 5, 14-16, 18, 20, 21-23, 36, 38-41, and 45-46 should be
`excluded under FRE 702, 703, 705, 403; Guide, 77 Fed. Reg.
`at 48,763; 37 C.F.R. § 42.65
`Apotex also timely objected (Paper 43 at 2) to ¶¶ 5, 14-16, 18, 20, 21-23, 36,
`
`38-41, and 45-46 of Ex. 1060 as not based on sufficient facts or data, the product
`
`of reliable principles and methods, and/or reliable application of the principles of
`
`methods and facts. (See FRE 702, 703, 705, 403; Guide, 77 Fed. Reg. at 48,763;
`
`37 C.F.R. § 42.65.)
`
`
`
`10
`
`

`

`
`
`Dr. Mehta’s assertions in ¶¶ 5, 14-16, 18, 20, 21-23, 36, 38-41, 45, and 46 of
`
`his declaration (Ex. 1060) are conclusory statements that are unsupported by any
`
`citations to underlying facts or data. For example, in ¶ 36 Dr. Mehta makes
`
`assertions as to why a POSA would have understood that Olivieri 1995 discloses
`
`the treatment of blood transfusion-dependent patients who had an iron overload
`
`condition of the heart. (Ex. 1060.) However, Dr. Mehta fails to provide even a
`
`single citation in this paragraph. (Id.) Likewise, in ¶ 38, Dr. Mehta makes
`
`numerous statements concerning Hoffbrand 1998, e.g., “[a]bsent successful
`
`chelation therapy, this patient would have died far sooner than 26 months
`
`following this initial MUGA scan,” without citing any evidence for his
`
`conclusions. (Id.) Similar statements in ¶¶ 39 and 40 are again made without any
`
`support. (Id.) These examples typify the lack of underlying support for many of
`
`Dr. Mehta’s assertions. Accordingly, ¶¶ 5, 14-16, 18, 20, 21-23, 36, 38-41, and
`
`45-46 of Ex. 1060 should be excluded under FRE 702, 703, 705, 403; Guide, 77
`
`Fed. Reg. at 48,763; and, 37 C.F.R. § 42.65.
`
`3.
`
`¶¶ 14, 25, 28, and 44-45 and footnotes 1, 3, and 8 should be
`excluded under FRE 401 and 402
`Apotex timely objected (Paper 43 at 2) to ¶¶ 14, 25, 28, and 44-45 and Fn 1,
`
`3, and 8 of Ex. 1060 as irrelevant. (FRE 401.) Specifically, ¶¶ 44-45 of Ex. 1060
`
`were not directly cited in Taro’s Reply. Thus, the relevance of these paragraphs to
`
`the arguments set forth by Taro in its Reply is unknown. Further, Fn 1 and
`
`
`
`11
`
`

`

`
`
`portions of ¶ 14 of Ex. 1060 are irrelevant because they contain cites to Exhibit
`
`1066, which is not cited in Taro’s Reply. Likewise, Fn 3 and portions of ¶ 25 of
`
`Ex. 1060 are irrelevant because they contain cites to Ex. 1065, which is not cited in
`
`Taro’s Reply. And, Fn 8 and portions of ¶ 28 of Ex. 1060 are irrelevant because
`
`they contain cites to Exs. 1063-1064, which are not cited in Taro’s Reply.
`
`Accordingly, ¶¶ 14, 25, 28, and 44-45 and Fn 1, 3, and 8 of Ex. 1060 should be
`
`excluded under FRE 401/402.
`
`G. Exhibits 1063-1066 Should be Excluded Under FRE 401-403
`Patent Owner timely objected (Paper 43 at 3) to the relevance and probative
`
`value of Exs. 1063-1066 because they were never cited in Taro’s Reply. Rather,
`
`they were only cited in the Mehta Decl. in Support of Taro’s Reply. (See Ex. 1060
`
`at Fn 1, 3, 8, ¶¶ 14, 25, 28.) Accordingly, because Petitioner did not rely on these
`
`documents in its Reply, there is no relevance or probative value to these Exhibits
`
`and they should be excluded under FRE 401-403.
`
`H. Exhibit 1065 and Corresponding ¶ 25 of Exhibit 1060 Should be
`Excluded Under FRE 401, 402, and 901
`Exhibit 1065 purports to be a website that Dr. Mehta relies on to assert that
`
`T2 relaxation time (“TRT”) and T2* relaxation time are closely related MRI
`
`techniques. (Ex. 1060 at ¶ 25.) Paragraph 25 of Ex. 1060 relies on Ex. 1065.
`
`Apotex timely objected (Paper 43 at 3) to Ex. 1065 and ¶ 25 of Ex. 1060 on
`
`numerous grounds, including FRE 401, 402, and 901.
`
`
`
`12
`
`

`

`
`
`Dr. Mehta relies on Ex. 1065 to assert that T2 relaxation time (“TRT”) and
`
`T2* relaxation time are closely related MRI techniques. (Ex. 1060 at ¶ 25.)
`
`However, there is no evidence that Ex. 1065 is relevant to the state of the art as of
`
`the ’328 patent’s priority date, June 2000. In fact, Ex. 1065 is dated June 13, 2018
`
`and has a copyright date of 2018. (See Ex. 1065.) Thus, Ex. 1065 has no bearing
`
`on how a POSA would view the accuracy of MRI TRT during the relevant time
`
`period (i.e., June 2000 and prior) and is irrelevant under FRE 401. Ex. 1065
`
`should thus be excluded. (FRE 401/402.)
`
`Exhibit 1065 should also be excluded under FRE 901 for lack of
`
`authentication. Ex. 1065 is a printout of a webpage ostensibly accessed by Taro’s
`
`declarant, Dr. Mehta, on June 13, 2018. (See Ex. 1060 at Fn 3.) Websites,
`
`however, are not self-authenticating. (FRE 902.) As Rule 901(a) states: “To
`
`satisfy the requirement of authenticating or identifying an item of evidence, the
`
`proponent must produce evidence sufficient to support a finding that the item is
`
`what the proponent claims it is.” (FRE 901(a).) Further, the Board has required
`
`that “‘[t]o authenticate printouts from a website, the party proffering the evidence
`
`must produce some statement or affidavit from someone with knowledge of the
`
`website . . . for example a web master or some else with personal knowledge
`
`would be sufficient.’” Neste Oil OYJ v. REG Synthetic Fuels, LLC, IPR2013-
`
`00578, Paper 53 at 4 (PTAB March 12, 2015) (citing EMC Corp. v. Personalweb
`
`
`
`13
`
`

`

`
`
`Techs., LLC, IPR2013-00084, Paper 64 (PTAB May 15, 2014)).
`
`Here, it is Taro’s burden to proffer evidence sufficient to support a finding
`
`that Ex. 1065 is what Taro (and its expert) claims it to be. Taro has provided no
`
`evidence whatsoever to that effect. In fact, Ex. 1065 is not directly cited or
`
`discussed in Taro’s Reply. (See generally Taro’s Reply.) Instead, the only
`
`identifying information provided by Taro is in a footnote in the Dr. Mehta’s
`
`declaration stating that: “I downloaded Ex. 1065 from http://mriquestions.com/t2-
`
`vs-t2.html (a web page entitled “Questions and Answers on MRI: T2 vs T2*, What
`
`is the difference between T2 and T2*?”) on June 13, 2018.” (See Ex. 1060 at Fn
`
`3.) Notably, Dr. Mehta does not cite any evidence, or first-hand knowledge, to
`
`support the authenticity of Ex. 1065. Further, Taro did not serve any supplemental
`
`evidence that Ex. 1065 is what Taro claims it is. Accordingly, Exhibit 1065 should
`
`be excluded because Taro failed to authenticate it with any type of statement or
`
`affidavit from someone with knowledge of the website. See, e.g., TRW, IPR2014-
`
`01347, Paper 25 at 5-12 (excluding exhibit for lacking authentication); see also
`
`Riverbed Tech., IPR2016-00978, Paper 67 at 40-41 (same); Neste Oil, IPR2013-
`
`00578, Paper 53 at 4 (same).
`
`Finally, ¶ 25 of Dr. Mehta’s declaration (Ex. 1060) cites Ex. 1065 to support
`
`the allegation that Olivieri Abstract 1995 anticipates the challenged claims.
`
`Because Ex. 1065 has not been authenticated and is irrelevant to this proceeding,
`
`
`
`14
`
`

`

`
`
`as discussed above, ¶ 25 of Ex. 1060 should be likewise be excluded for the same
`
`reasons. See Riverbed Tech., IPR2016-00978, Paper 67 at 41 (excluding those
`
`portions of paragraphs in an expert’s declaration that expressly relied on an exhibit
`
`excluded for lack of authentication).
`
`IV. CONCLUSION
`For the foregoing reasons, Patent Owner respectfully asks that the Board
`
`exclude the entirety of Exhibits 1005, 1006, 1022, 1024, 1026, 1028, 1029-1031,
`
`1033-1035, 1037, 1038, 1040-1043, 1045, 1047-1049, 1052-1054, 1056, 1063-
`
`1066, and certain portions of Exhibits 1002 and 1060.
`
`
`
`
`
`
`
`Respectfully submitted,
`
`Date: June 28, 2018
`
`By: /s/ W. Blake Coblentz
`
`
`
`
`
`
`W. Blake Coblentz
`
`
`
`
`
`
` Reg. No. 57,104
`
`
`
`
`
`
`COZEN O’CONNOR
` 1200 Nineteenth Street, N.W.
` Washington, D.C. 20036
` Tel. (202) 912-4837
`
`
`
`
`15
`
`

`

`IPR2017-01446
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on June 28, 2018, I caused a true and correct copy of
`
`Patent Owner’s Motion to Exclude Petitioner’s Evidence Pursuant to 37
`
`C.F.R. § 42.64(c) to be served via electronic mail on the following attorneys of
`
`record:
`
`Huiya Wu
`Sarah Fink
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`HWu@goodwin.law.com
`SFink@goodwinlaw.com
`
`
`
`
`
`
`
`Date: June 28, 2018
`
`
`
`
`
`
`
`/s/ W. Blake Coblentz
`W. Blake Coblentz
`Reg. No. 57,104
`COZEN O’CONNOR
`1200 Nineteenth Street, N.W.
`Washington, DC 20036
`(202) 912-4837
`
`