throbber
Case IPR2016-01096
`Patent No. 6,667,061
`Motion to Exclude Evidence
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA(USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`
`v.
`
`ALKERMES PHARMA IRELAND LTD and
`ALKERMES CONTROLLED THERAPEUTICS, INC.,
`Patent Owners.
`
`Patent No. 6,667,061 to Ramstack et al.
`Issue Date: December 23, 2003
`Title: PREPARATION OF INJECTABLE
`SUSPENSIONS HAVING IMPROVED INJECTABILITY
`____________________________
`Inter Partes Review No. IPR2016-01096
`__________________________________________________________________
`
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
`
`
`Mail Stop: Patent Board
`Patent Trial and Appeal Board
`U.S. Patent And Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`5062864_1.docx
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES ................................................................................... iii
`EXHIBIT LIST ........................................................................................................ iv
`INTRODUCTION ........................................................................................... 1
`I.
`
`II.
`
`ARGUMENT ................................................................................................... 2
`
`A. Exhibits 2034, 2036, 2038-2040 And 2052 And The
`Declarations That Rely On Them Should Be Excluded ........................... 2
`
`1. The CMC Exhibits Should Be Excluded As
`Impermissible Hearsay ....................................................................... 4
`
`2. The CMC Exhibits Should Be Excluded As They Lack
`Authentication .................................................................................... 5
`
`3. The CMC Exhibits Should Be Excluded as Irrelevant
`Under FRE 401/402 ........................................................................... 8
`
`4. The Gehrke Declaration And Portions Of The Berkland
`Declaration Should Be Excluded Under FRE 401/402 ...................10
`
`a.
`
`b.
`
`Gehrke Declaration (Ex.2059) ...............................................10
`
`Berkland Declaration (Ex.2014) ............................................12
`
`B. Exhibit 2049 Should Be Excluded As Hearsay Under FRE 802............12
`
`C. Exhibits 2022-2030, 2035, 2037, 2042 And 2044 Should
`Be Excluded As Irrelevant Under FRE 401/402 ....................................13
`
`D. Exhibits 2020-2021, 2047, And 2056-2058 Are Not Cited
`And Should Be Excluded As Irrelevant Under FRE 401/402 ................14
`
`III. CONCLUSION ..............................................................................................15
`
`
`
`
`
`i
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`TABLE OF AUTHORITIES
`
`
`CASES
`Autoquip, Inc. v. Graco Minn., Inc.,
`IPR2013-00452, Paper 18, at 16 (P.T.A.B. Jan. 14, 2015) .................................. 9
`
`Page(s)
`
`CNET Networks, Inc. v. Etilize, Inc.,
`584 F. Supp. 2d 1260 (N.D. Cal. 2008) ................................................................ 9
`
`EMC Corp. v. Personalweb Techs., LLC,
`IPR2013-00084, Paper 64, at 45-46 (P.T.A.B. May 15, 2014) ............................ 7
`
`Google, Inc. v. Michael Meiresonne,
`IPR2014-01188, Paper 38, at 9-10 (P.T.A.B. Jan. 20, 2016) ......................... 4, 13
`
`In re Homestore.com, Inc. Sec. Litig.,
`347 F. Supp. 2d 769 (C.D. Cal. 2004) .................................................................. 8
`
`Shimano Inc. v. Globeride, Inc.,
`IPR2015-00273, Paper 40, at 26-27 (P.T.A.B. June 16, 2016) ............................ 5
`
`SK Innovation Co. v. Celgard, LLC,
`IPR2014-00680, Paper 57, at 27 (P.T.A.B. Sept. 25, 2015) ............................... 14
`
`St. Luke’s Cataract & Laser Inst., P.A. v. Sanderson,
`No. 8:06-223, WL 1320242 (M.D. Fla. May 12, 2006) ....................................... 8
`
`Standard Innovation Corp. v. Lelo, Inc.,
`IPR2014-00148, Paper 41, at 10 (P.T.A.B Apr. 23, 2015) ................................. 7
`
`TRW Auto. U.S. LLC v. Magna Elecs. Inc.,
`IPR2014-01348, Paper 25, at 5-12 (P.T.A.B. Jan. 15, 2016) ............................... 6
`
`Victaulic Co. v. Tieman,
`499 F.3d 227 (3d Cir. 2007), as amended (Sept. 18, 2007) ............................. 7, 8
`
`
`
`
`
`ii
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`STATUTES, RULES & OTHER AUTHORITIES
`
`37 C.F.R. § 42.62(a) ................................................................................................... 2
`
`37 C.F.R. § 42.64(b)(1) .............................................................................................. 2
`
`37 C.F.R. § 42.64(c) ................................................................................................... 1
`
`FRE 401 ............................................................................................................passim
`
`FRE 402 ............................................................................................................passim
`
`FRE 801 ......................................................................................................... 4, 12, 13
`
`FRE 802 ............................................................................................................passim
`
`FRE 803(6) ............................................................................................................... 13
`
`FRE 901 ............................................................................................................passim
`
`
`
`
`
`iii
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`EXHIBIT LIST
`
`
`1009
`1010
`1011
`1012
`1013
`1014
`
`1015
`1016
`1017
`1018
`1019
`1020
`
`Exhibit # Reference
`U.S. Patent No. 6,667,061 (“the Patent”)
`1001
`1002
`Declaration of Dr. Patrick P. DeLuca
`Curriculum Vitae of Dr. Patrick P. DeLuca
`1003
`1004
`Intentionally Left Blank
`1005
`International Publication No. WO 95/13799 (“Ramstack”)
`1006
`U.S. Pharmacopeia Entry re: CMC, viscosity at 274-75, 1840 (1994)
`1007
`EP Pharmacopoeia Entry re: CMC, at 547-48(3d ed. 1997)
`1008
`Handbook of Pharmaceutical Excipients at 78-81, 135-38, 294-95,
`329-330, 375-78, 420-21, 439-42, 477-80, 481-82 (2nd ed. 1994)
`U.S. Patent No. 5,654,010 (“Johnson”)
`U.S. Patent No. 5,656,299 (“Kino”)
`International Publication No. WO199714408 (“Gustafsson”)
`Intentionally Left Blank
`Intentionally Left Blank
`Herbert A. Lieberman et al. (eds.), Pharmaceutical Dosage Forms:
`Disperse Systems, Vol.2, at 26-35, 40, 43-46, 261, 285-318 (2nd ed.
`rev. expanded 1996)
`U.S. Patent No. 6,495,164 (“the ’164 Patent”)
`Serial No. 10/259,949, Office Action, Apr. 9, 2003
`Serial No. 10/259,949, Applicants’ Resp., May 14, 2003
`Serial No. 09/577,875, Declaration of Mark A. Tracy, May 17, 2002
`Serial No. 10/259,949, Notice of Allowability, July 24, 2003
`Kenneth E. Avis et al. (eds.), 1 (Chs.2, 4, 5) Pharmaceutical Dosage
`Forms:Parenteral Medications 17-25, 115-16, 140-43, 150-51,
`173-75, 190-212 (2nd ed. rev. expanded Marcel Dekker, Inc. 1992)
`Leon Lachman, PhD et al., The Theory and Practice of Industrial
`Pharmacy 642-44, 783-84 (Lea & Febiger 3rd ed. 1986)
`Herbert A. Lieberman et al., Pharmaceutical Dosage Forms:
`Disperse Systems, Vol.1, at 287-313 (2nd ed. rev. expanded 1996)
`Orange Book entries for RISPERDAL®
`Supplemental Declaration of Dr. Patrick P. DeLuca, June 9, 2017
`Intentionally left blank
`
`1021
`
`1022
`
`1023
`1024
`1025
`
`
`
`iv
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`Stedman’s Medical Dictionary (26th ed. 1995)
`1026
`1027
`Decapetyl components sheet
`1028
`International Publication No. WO 97/44039 (“Francois”)
`1029
`Intentionally left blank
`1030
`Nutropin Label (December 1999)
`1031
`Deposition Transcript of Cory J. Berkland, Ph.D., May 26, 2017
`1032 M.A. Macket et al., Tolerability of intramuscular injections of
`testosterone ester in oil vehicle, PubMed-NCBI, 10(4) Hum.
`Reprod. 862-5 (April 1995)
`Intentionally left blank
`USP 23 NF 18, Suspensions, The U.S. Pharmacopeia, The Nat’l
`Formulary, Jan. 1, 1995.
`Intentionally left blank
`Hawley’s Condensed Chemical Dictionary (12th ed. 1993)
`(Ch.19) Organic Chemistry (2nd ed. 1998)
`U.S. Patent No. 5,417,982
`Biochemicals and Reagents for Life Science Research,
`Sigma-Aldrich 1998
`Biochemicals and Reagents for Life Science Research,
`Sigma-Aldrich 1999
`Biochemicals and Reagents for Life Science Research,
`Sigma-Aldrich 2000/2001
`Lupron Label, Center for Drug Evaluation and Research, Application
`No. NDA 19732/S012
`International Publication No. WO 99/013780
`Deposition Transcript of Robson Storey, Ph.D., May 3, 2016
`
`1033
`1034
`
`1035
`1036
`1037
`1038
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`1044
`
`
`
`v
`
`

`

`Case IPR2016-01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`I.
`
`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.64(c) and the Scheduling Order in the
`
`above-captioned proceeding (Paper 15), Petitioners Luye Pharma Group Ltd., Luye
`
`Pharma (USA) Ltd., Shandong Luye Pharmaceutical Co., Ltd., and Nanjing Luye
`
`Pharmaceutical Co., Ltd. (collectively “Luye” or “Petitioners”) move to exclude
`
`certain exhibits from the record on the bases shown in Table 1 and argued further
`
`below.
`
`Evidence
`Ex.2014 (Berkland Decl.)
`¶¶37, 40-41, 47-50, 55,
`58-60, 67, 69, 74, 90, 92,
`121-122, 124, 127, 158
`Exs.2020-2021
`Exs.2022-2030
`Ex.2034
`
`Ex.2035
`Ex.2036
`
`Ex.2037
`Ex.2038
`
`Ex.2039
`
`Ex.2040
`
`
`
`TABLE 1
`
`Objections
`FRE 401/402
`
`Cited In
`Paper 33 at 18, 21-28, 37-38, 61
`
`N/A
`Paper 33 at 55-56
`Paper 33 at 22-24, 26-27
`Ex.2014 ¶¶ 37, 40-41, 47, 55,
`59-60, 67, 69, 74, 90, 92, 127
`Ex.2014 ¶¶ 37, 59, 74, 92
`Paper 33 at 23
`Ex.2014 ¶ 41
`Ex.2014 ¶¶ 38, 51, 66, 125
`Paper 33 at 23
`Ex.2014 ¶ 58
`Paper 33 at 23
`Ex.2014 ¶ 58
`Paper 33, at 23
`
`FRE 401/402
`FRE 401/402
`FRE 802,
`401/402, 901
`
`FRE 401/402
`FRE 802,
`401/402, 901
`FRE 401/402
`FRE 802,
`401/402, 901
`FRE 802,
`401/402, 901
`FRE 802,
`
`
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`Evidence
`
`Ex.2042
`Ex.2044
`Ex.2047
`Ex.2049
`
`Ex.2052
`
`Ex.2056-2058
`Ex.2059
`(Gehrke Declaration)
`
`Objections
`401/402, 901
`FRE 401/402
`FRE 401/402
`FRE 401/402
`FRE 802
`
`FRE 802,
`401/402
`FRE 401/402
`FRE 401/402
`
`Cited In
`Ex.2014 ¶ 58
`Ex.2014 ¶ 38
`Ex.2014 ¶¶ 38, 51, 125
`N/A
`Paper 33 at 1, 61
`Ex.2014 ¶ 158
`Ex.2014 ¶ 47, n.1
`
`N/A
`Paper 33 at 18, 23, 37
`Ex.2014 ¶¶47-48, 50, 121-122, 124
`
`Petitioners timely objected to the above exhibits under 37 C.F.R.
`
`§ 42.64(b)(1) and objected to each exhibit under the respective Federal Rules of
`
`Evidence (“FRE”) pursuant to 37 C.F.R. § 42.62(a). (See Paper 35.) Patent Owners
`
`Alkermes Pharma Ireland Ltd and Alkermes Controlled Therapeutics, Inc.
`
`(collectively “Alkermes” or “Patent Owners”) raised no subsequent questions
`
`regarding Petitioners’ objections and submitted no supplemental evidence or
`
`affidavits to address such rejections.
`
`II. ARGUMENT
`A. Exhibits 2034, 2036, 2038-2040 And 2052 And The
`Declarations That Rely On Them Should Be Excluded
`Exhibits 2034, 2036, 2038-2040, and 2052 (“the CMC Exhibits”) are
`
`catalogs on CMC products and/or documents related to information on suppliers of
`
`such products. Alkermes relies on the CMC Exhibits for its assertion that CMC
`
`2
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`products commercially available at the time of the invention would have produced
`
`viscosities below the claimed range. (Paper 33 at 22-23.) Dr. Gehrke, Alkermes’
`
`expert, testifies to tests he performed on a vehicle that included one of the CMC
`
`products identified in the catalogs to support Alkermes’ argument. (Id. 22-23.)
`
`Dr. Berkland, another Alkermes expert, relies on the CMC Exhibits affirmatively
`
`for his opinion that commercially available CMC products at the time of the
`
`invention would allegedly result in vehicles having viscosities outside of the
`
`claimed range. (Ex.2014 ¶41.) Dr. Berkland also relies on Dr. Gehrke’s testing of
`
`the CMC products in support of his opinion. (Id. ¶¶47-50, Table A, 121-124,
`
`Table B.)
`
`The CMC Exhibits are inadmissible as they are impermissible hearsay
`
`(FRE 802) and lack authentication (FRE 901). Further, none of the CMC Exhibits
`
`makes it more or less probable that the CMC products were actually available at
`
`the time of the invention, and thus, are irrelevant. (FRE 402.) As a result,
`
`Dr. Gehrke's entire declaration and those paragraphs of Dr. Berkland’s declaration
`
`relying on such CMC Exhibits are also irrelevant, and should be excluded under
`
`FRE 402.
`
`3
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`1. The CMC Exhibits Should Be
`Excluded As Impermissible Hearsay
`The CMC Exhibits should be excluded as impermissible hearsay. Hearsay is
`
`an out of court statement offered for the truth of the matter asserted. (FRE 801.)
`
`Hearsay is not admissible. (FRE 802.) Alkermes offers the CMC Exhibits for the
`
`truth of the matter asserted therein, namely, that there were “many possible
`
`viscosities of CMC solutions,” that the use of the CMC products described in the
`
`CMC Exhibits could produce viscosities “that could fall below the claimed range,”
`
`and that those CMC products were available at the time of the invention. (Paper 33
`
`at 22-23.) Each of the CMC Exhibits is an out of court statement made by a third
`
`party. Thus, the CMC Exhibits are hearsay under FRE 801.
`
`The CMC Exhibits are inadmissible under FRE 802 as they do not fall
`
`within any hearsay exception and Alkermes has not put forth any evidence to
`
`suggest otherwise. Exhibits 2036, 2039, and 2052 are all printouts from web pages.
`
`The Board has found this type of evidence inadmissible under FRE 802. Google,
`
`Inc. v. Michael Meiresonne, IPR2014-01188, Paper 38, at 9-10 (P.T.A.B. Jan. 20,
`
`2016). Exhibits 2034 and 2038 are product brochures, and Exhibit 2040 is a safety
`
`data sheet. The Board has found similar materials to be inadmissible hearsay.
`
`4
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`Shimano Inc. v. Globeride, Inc., IPR2015-00273, Paper 40, at 26-27 (P.T.A.B.
`
`June 16, 2016). Thus, the CMC Exhibits should be excluded under FRE 802.
`
`2. The CMC Exhibits Should Be
`Excluded As They Lack Authentication
`The CMC Exhibits, with the exception of Exhibit 2052, should be excluded
`
`from evidence because they lack authentication. 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.” Fed. R. Evid. 901(a). Alkermes and Drs. Gehrke and
`
`Berkland claim that the CMC Exhibits disclose CMC products that were
`
`commercially available at the time of the invention. (Ex.2014 ¶47 n.1, ¶¶55, 58-60,
`
`72; Paper 33 at 22-23 (“As of the time of the invention, a wide variety of grades
`
`and types of CMC were commercially available.”).) But none of the CMC Exhibits
`
`is a document from the time of the invention, and Alkermes has not provided any
`
`additional evidence to support a finding that the documents are what they purport
`
`them to be.
`
`For example, the Ashland catalog (Ex.2038 at 72) has a copyright date of
`
`2012-2016. Similarly, the Spectrum CA193 Safety Data Sheet (Ex.2040) has a
`
`preparation date and revision date of January 22, 2015 (Ex.2040 at 1). Thus,
`
`5
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`Exhibits 2038 and 2040 do not, on their face, bear a date at or before the time of
`
`the invention. Nor has Alkermes provided any additional evidence to show that
`
`Exhibits 2038 and 2040 are from a date at or before the time of invention as they
`
`assert.
`
`With respect to the Aqualon Brochure (Ex.2034), Dr. Berkland asserts that it
`
`is from 1999 (Ex.2014 ¶¶ 47,72). But despite bearing a copyright date of 1999, the
`
`document has a revision date of April 2002 that “[s]upersedes all previous
`
`editions.” (Ex.2034 at 29.) Thus, on its face, Exhibit 2034’s 1999 date is
`
`unreliable. See TRW Auto. U.S. LLC v. Magna Elecs. Inc., IPR2014-01348,
`
`Paper 25, at 5-12 (P.T.A.B. Jan. 15, 2016) (excluding from evidence an article
`
`purported to be published on a date certain but having no corroborative evidence
`
`that it was published on that date).
`
`Similarly, Alkermes’ Sigma-Aldrich specification sheet (Ex.2039) contains
`
`two dates on its face, a revision date of June 2, 1998, and an additional date of
`
`March 1, 2017. Further, the specification sheet that is allegedly from either at or
`
`before the time of invention is absent from the 1998, 1999, and 2000/2001
`
`Sigma-Aldrich catalogs proffered by Petitioners in its response to Exhibit 2039.
`
`(Exs.1039, 1040, 1041.) Thus, the document itself is unreliable as proof that it is a
`
`6
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`specification sheet for a product available at or before the time of invention as
`
`Alkermes asserts.
`
`The Dow brochure (Ex.2036) has the same issue. It bears a copyright date of
`
`1995-2017. Thus, the 1995 date is not reliable to show that it was available as of
`
`that date.
`
`Further to the point, as discussed above, Exhibits 2036, 2039, and 2052 are
`
`all printouts from web pages, which Alkermes relies on for their content. “When
`
`offering a printout of a webpage into evidence to prove the website’s contents, the
`
`proponent of the evidence must authenticate the information from the website
`
`itself, not merely the printout.” Standard Innovation Corp. v. Lelo, Inc.,
`
`IPR2014-00148, Paper 41, at 10 (P.T.A.B Apr. 23, 2015); see also Victaulic Co. v.
`
`Tieman, 499 F.3d 227, 236 (3d Cir. 2007), as amended (Sept. 18, 2007) (citing
`
`United States v. Jackson, 208 F.3d 633, 638 (7th Cir. 2000)). The Board has
`
`explained 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 webmaster or someone else with personal
`
`knowledge would be sufficient.” EMC Corp. v. Personalweb Techs., LLC,
`
`IPR2013-00084, Paper 64, at 45-46 (P.T.A.B. May 15, 2014) (quoting St. Luke’s
`
`7
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`Cataract & Laser Inst., P.A. v. Sanderson, No. 8:06-223, WL 1320242, at *2
`
`(M.D. Fla. May 12, 2006); see also Victaulic, 499 F.3d at 236 (citing with approval
`
`holding in In re Homestore.com, Inc. Sec. Litig., 347 F. Supp. 2d 769, 782-83
`
`(C.D. Cal. 2004) (explaining that printouts of web pages must be authenticated by
`
`a witness)). Alkermes has not provided testimony of any witness with personal
`
`knowledge of the information on the website or associated printouts for any of the
`
`exhibits at issue.
`
`Alkermes has failed to provide any additional information to authenticate
`
`that Exhibits 2034, 2036, 2038, 2039, and 2040 are what Alkermes purports them
`
`to be, i.e., evidence of commercially available products at the time of the
`
`invention. As such, the documents should be excluded for lack of authentication.
`
`3. The CMC Exhibits Should Be
`Excluded as Irrelevant Under FRE 401/402
`As discussed above, Alkermes relies on the CMC Exhibits to show that the
`
`CMC products disclosed therein were commercially available at the time of the
`
`invention and were within the knowledge of a POSA. (Paper 33 at 22-23; Ex.2014
`
`¶55 (“[A]s of the time of the invention, a POSA would have encountered a wide
`
`variety of commercially available grades and
`
`types of CMC . . . [f]or
`
`example . . . one of Alqualon’s available CMC products . . . .”), ¶¶ 57-58 (“[A]
`
`8
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`number of . . . CMCs were commercially available . . . ).) “Evidence is relevant if
`
`it has a tendency to make a fact more or less probable than it would be without the
`
`evidence” and “the fact is of consequence in determining the action.” (FRE 401.)
`
`“Irrelevant evidence is not admissible.” (FRE 402.) In order to be relevant here, the
`
`CMC Exhibits must make some showing that these products were commercially
`
`available and accessible to a POSA at the time of the invention. As explained
`
`above, however, each of the CMC Exhibits relied upon by Alkermes does not bear
`
`a date at or before the time of the invention.
`
`In previously considering this type of issue, the Board has held that where a
`
`“copyright date indicate[d] only the year of the copyright, and not a specific date,”
`
`it would consider the document to have become publicly accessible as of the last
`
`day of the year. Autoquip, Inc. v. Graco Minn., Inc., IPR2013-00452, Paper 18,
`
`at 16 (P.T.A.B. Jan. 14, 2015) (finding the 1998 document to be accessible as of
`
`December 31, 1998); see also CNET Networks, Inc. v. Etilize, Inc., 584 F. Supp. 2d
`
`1260, 1273 (N.D. Cal. 2008) (“based on the purported printed publication itself,
`
`the court finds that a 2001 copyright date does not prove the Liaison CE User
`
`Guide was publicly accessible prior to April 10, 2001”). Using that same approach
`
`here, the CMC Exhibits would only be publicly available as of their latest dates,
`
`9
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`which are all after the critical date. (Exs.2034 (April 2002); 2036 (2017); 2038
`
`(2012-2016); 2039 (3/1/2017); 2040 (1/22/2015).)
`
`Since Alkermes has failed to show that the CMC products disclosed in the
`
`CMC Exhibits were available at or before the time of invention, the viscosities of
`
`vehicles made using those CMC products do not make it any more or less probable
`
`that prior art vehicles would or would not have a viscosity within the claimed
`
`range. As such, the CMC Exhibits are irrelevant under FRE 401 and should be
`
`excluded under FRE 402.
`
`4. The Gehrke Declaration And
`Portions Of The Berkland Declaration
`Should Be Excluded Under FRE 401/402
`For the reasons stated above, the CMC Exhibits should either be excluded as
`
`impermissible hearsay under FRE 802, for lack of authentication under FRE 901 or
`
`as irrelevant under FRE 401/402. Similarly, Dr. Gehrke’s declaration in its entirety
`
`and paragraphs 37, 40-41, 47-50, 55-61, 67, 69, 72, 74, 90, 92, 124, and 127 of
`
`Dr. Berkland’s declaration should be excluded under FRE 401/402 as irrelevant for
`
`relying on the inadmissible CMC Exhibits.
`
`a. Gehrke Declaration (Ex.2059)
`Alkermes instructed Dr. Gehrke to prepare the injection vehicles described
`
`in the prior art Johnson and Gustafsson references using currently available CMCs
`
`10
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`from the manufacturer Ashland. (Exs.2059 ¶¶5-6; 2014 ¶47, n.1.) Dr. Berkland
`
`alleges that Ashland was acquired by Hercules in 2008 and that Hercules was the
`
`manufacturer of the Aqualon-branded CMC, which Dr. Berkland and Alkermes
`
`allege was available “since at least 1999.” (Ex.2014 ¶ 47, n.1.) Alkermes relies on
`
`Dr. Gehrke’s testimony to show that the CMCs available to a POSA at the time of
`
`invention would result in a vehicle having a viscosity outside of the claimed range.
`
`In order to be relevant and admissible, Dr. Gehrke’s tests must be reflective of
`
`commercially available CMCs at the time of the invention. As discussed above,
`
`Alkermes has not authenticated the CMC Exhibits and has not proved their
`
`availability at or before the time of the invention. Further to the point, Dr. Berkland
`
`admitted that he did not know if the CMCs Dr. Gehrke used in his test were
`
`available at the time of the invention. (Exs.1024 ¶43; 1031, at 217:18-218:10; 2059
`
`¶6.) Thus, Dr. Gehrke’s declaration does not make it any more or less probable that
`
`the prior art vehicles would or would not have a viscosity within the claimed range
`
`using CMC products available to a POSA at the time of the invention. As such,
`
`Dr. Gehrke’s declaration is irrelevant in its entirety under FRE 401 and should be
`
`excluded under FRE 402.
`
`11
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`Berkland Declaration (Ex.2014)
`b.
`Similarly, paragraphs 37, 40-41, 47-50, 55-61, 67, 69, 72, 74, 90, 92, 124,
`
`and 127 of Dr. Berkland’s declaration should be excluded as irrelevant under
`
`FRE 401/402. In these paragraphs, Dr. Berkland either relies on the CMC Exhibits
`
`or on Dr. Gehrke’s testimony to show that commercial CMCs available to a POSA
`
`at the time of the invention would produce a viscosity outside of the claimed range.
`
`As discussed above, Dr. Berkland admitted that he did not know if the CMCs
`
`Dr. Gehrke used in his test were available at the time of the invention. (Exs.1024
`
`¶43; 1031, at 217:18-218:10, 2059 ¶6.) Further, the CMC Exhibits have not been
`
`authenticated by Alkermes as being dated at or before the time of the invention.
`
`Thus, the above paragraphs of Dr. Berkland’s declaration should be excluded from
`
`evidence as irrelevant under FRE 401/402 since they do not make it any more or
`
`less probable that the prior art vehicle would or would not have a viscosity within
`
`the claimed range using CMC products available to a POSA at the time of the
`
`invention.
`
`Exhibit 2049 Should Be Excluded As Hearsay Under FRE 802
`B.
`Exhibit 2049 is inadmissible hearsay and should be excluded. Hearsay is an
`
`out of court statement offered for the truth of the matter asserted. (FRE 801.)
`
`Hearsay is not admissible. (FRE 802.) Exhibit 2049 appears to be a press release
`
`12
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`by Johnson & Johnson regarding its fourth-quarter sales for various products
`
`including Risperdal® Consta®. Alkermes offers Exhibit 2049 as evidence for the
`
`truth of the matter it asserts, i.e., sales of Risperdal® Consta®. (Paper 33 at 61.) The
`
`document is an out of court statement. Thus, it is hearsay under FRE 801 and
`
`should be excluded under FRE 802.
`
`Alkermes may argue that the document falls within the business records
`
`exception under FRE 803(6) since it purports to disclose “2016 Fourth-Quarter
`
`Results” for Johnson & Johnson. Alkermes has provided no evidence to support an
`
`assertion that the data provided in the press release is a business record. And even
`
`if Alkermes were to show that the data falls within the hearsay exception under
`
`FRE 803(6), it still must show that the actual press release also falls within an
`
`exception, which it cannot do. See Google, IPR2014-01188, Paper 38, at 9-10
`
`(P.T.A.B. Jan. 20, 2016) (excluding an article as hearsay even though it was relied
`
`upon for an admissible statement against interest by the opposing party contained
`
`within the document).
`
`C. Exhibits 2022-2030, 2035, 2037, 2042 And 2044
`Should Be Excluded As Irrelevant Under FRE 401/402
`Exhibits 2022-2030, 2035, 2037, 2042 and 2044 (“the CMC Properties
`
`Exhibits”) should be excluded as irrelevant under FRE 401/402. Alkermes relies
`
`13
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`on the CMC Properties Exhibits to show that a person of ordinary skill in the art at
`
`the
`
`time of
`
`invention would have allegedly used a
`
`lower viscosity
`
`carboxymethylcellulose (“CMC”) product and would have known of certain
`
`factors that influenced the properties of CMC. In order to be relevant, the CMC
`
`Properties Exhibits must make some showing that a POSA would have known
`
`about the use lower viscosity CMC and the factors influencing its properties at the
`
`time of the invention. As explained above, however, each of the CMC Properties
`
`Exhibits relied upon by Alkermes does not bear a date at or before the time of the
`
`invention. Thus, the CMC Properties Exhibits do not make a fact more or less
`
`probable, and thus, should be excluded as irrelevant.
`
`D. Exhibits 2020-2021, 2047, And 2056-2058 Are Not Cited
`And Should Be Excluded As Irrelevant Under FRE 401/402
`Exhibits 2020-2021, 2047, and 2056-2058 are included in Alkermes’ Exhibit
`
`List, but at no point in this proceeding has Alkermes cited to or relied upon these
`
`exhibits or identified, with any particularity, how these exhibits are relevant to the
`
`proceeding’s issues. Accordingly, Exhibits 2020-2021, 2047, and 2056-2058
`
`should be excluded as irrelevant under FRE 401/402. See SK Innovation Co. v.
`
`Celgard, LLC, IPR2014-00680, Paper 57, at 27 (P.T.A.B. Sept. 25, 2015).
`
`14
`
`

`

`Case IPR2016- 01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`III. CONCLUSION
`For the reasons stated above, Petitioners submit that Exhibits 2020-2030,
`
`2034-2037, 2038-2040, 2042, 2044, 2049, 2052, 2056-2059, and portions of
`
`Exhibit 2014 should be excluded from the record and Patent Owners precluded
`
`from using these exhibits (or portions thereof) at any hearing or in any paper in this
`
`proceeding.
`
`Respectfully submitted,
`
`Dated:
`
`July 24, 2017
`
`
`
`By:
`
`/ Tedd Van Buskirk /
`Tedd W. Van Buskirk
`Reg. No. 46,282
`
`
`
`
`
`
`5062864_1.docx
`
`
`
`15
`
`

`

`Case IPR2016-01096
`Motion to Exclude Evidence
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a true copy of the foregoing
`
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE was served on July 24,
`
`2017 as follows.
`
`VIA E-MAIL
`
`Scott K. Reed, Esq.
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: 212.218.2100
`E-mail:
`sreed@fchs.com
`
`
`July 24, 2017
`
`
`
`By:
`
`/ Tedd Van Buskirk /
`Tedd W. Van Buskirk
`Reg. No. 46,282
`
`
`
`
`
`
`
`
`
`
`Dated:
`
`
`
`
`
`

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