Case IPR2016-01096
`Patent No. 6,667,061
`Authorized Second 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’ AUTHORIZED
`SECOND 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
`
`
`Patent No. 6,667,061
`Authorized Second 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’ AUTHORIZED
`SECOND 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
`
`
`
`Case IPR2016-01096 (Patent No. 6,667,061)
`Authorized Second Motion to Exclude Evidence
`
`
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES .................................................................................... ii
`PETITIONERS’ EXHIBIT LIST ............................................................................ iii
`INTRODUCTION ........................................................................................... 1
`I.
`
`II.
`
`ARGUMENT ................................................................................................... 1
`
`A. Exhibits 2073, 2075, And 2077-2079 And Portions Of
`Exhibit 2081 Should Be Excluded Under 37 C.F.R. § 42.64(a) .............. 1
`
`B. Exhibits 2075 And 2077 Should Be
`Excluded Under 37 C.F.R. § 42.63(b) ...................................................... 2
`
`C. Exhibits 2074 And 2076 Should Be Excluded As Irrelevant ................... 3
`
`D. Exhibits 2074-2079 Should Be Excluded As Irrelevant ........................... 3
`
`E. Exhibits 2073, 2078, And 2079
`Should Be Excluded As Irrelevant ........................................................... 4
`
`III. CONCLUSION ................................................................................................ 4
`
`
`
`
`
`
`
`
`i
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`
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`Case IPR2016-01096 (Patent No. 6,667,061)
`Authorized Second Motion to Exclude Evidence
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`CASES
`Blackberry Corp. v. Zipit Wireless,
`IPR2014-01506, Paper 50 (Mar. 29, 2016) .......................................................... 2
`
`Square, Inc. v. Rem Holdings 3, LLC,
`IPR2014-00312, Paper 58 (July 7, 2015) ............................................................. 2
`
`STATUTES, RULES, & OTHER AUTHORITIES
`
`37 C.F.R. § 42.62(a) ................................................................................................... 1
`
`37 C.F.R. § 42.63(b) .............................................................................................. 1, 2
`
`37 C.F.R. § 42.64(a) ............................................................................................... 1, 2
`
`37 C.F.R. § 42.64(b)(1) .............................................................................................. 1
`
`37 C.F.R. § 42.64(c) ................................................................................................... 1
`
`FRE 401 ..................................................................................................................... 3
`
`FRE 402 ............................................................................................................. 1, 3, 4
`
`FRE 403 ..................................................................................................................... 1
`
`
`
`ii
`
`
`
`Case IPR2016-01096 (Patent No. 6,667,061)
`Authorized Second Motion to Exclude Evidence
`
`
`PETITIONERS’ EXHIBIT LIST
`
`
`Exhibit # Reference
`1001
`U.S. Patent No. 6,667,061 (“the Patent”)
`1002
`Declaration of Dr. Patrick P. DeLuca
`1003
`Curriculum Vitae of Dr. Patrick P. DeLuca
`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
`Stedman’s Medical Dictionary (26th ed. 1995)
`
`1009
`1010
`1011
`1012
`1013
`1014
`
`1015
`1016
`1017
`1018
`1019
`1020
`
`1021
`
`1022
`
`1023
`1024
`1025
`1026
`
`
`
`iii
`
`
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`Case IPR2016-01096 (Patent No. 6,667,061)
`Authorized Second Motion to Exclude Evidence
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`
`1033
`1034
`
`1035
`1036
`1037
`1038
`1039
`
`1040
`
`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
`
`1041
`
`1042
`
`1043
`1044
`
`
`
`iv
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`
`
`Case IPR2016-01096 (Patent No. 6,667,061)
`Authorized Second Motion to Exclude Evidence
`
`I.
`
`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.64(c), Petitioners move to exclude the following
`
`exhibits from the record on the bases shown below.
`
`Evidence
`Ex.2073
`Ex.2074
`
`Ex.2075
`
`Ex.2076
`
`Ex.2077
`
`Ex.2078
`Ex.2079
`Ex.2081
`
`Objections
`FRE 402, 403
`FRE 402, 403
`
`37 C.F.R. § 42.63(b)
`FRE 402, 403
`FRE 402, 403
`
`37 C.F.R. § 42.63(b)
`FRE 402, 403
`FRE 402, 403
`FRE 402, 403
`37 C.F.R. § 42.64(a)
`
`Cited In
`Ex.2081, at 132:2- 137:6
`Ex.2081, at 158:19-161:8,
`242:19-243:14
`Ex.2081, at 161:9-163:4,
`164:11-16
`Ex.2081, at 163:6-168:7;
`242:19-244:5
`Ex.2081, at 168:8-170:13
`
`Ex.2081, at 170:14-173:8
`Ex.2081, at 174:18-177:9
`
`
`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 53.) Patent Owners
`
`submitted no supplemental evidence or affidavits to address such objections. The
`
`Board authorized this motion during the oral argument on August 28, 2017.
`
`II. ARGUMENT
`A. Exhibits 2073, 2075, And 2077-2079 And Portions Of
`Exhibit 2081 Should Be Excluded Under 37 C.F.R. § 42.64(a)
`Exhibits 2073, 2075, and 2077-2079 should be excluded under 37 C.F.R.
`
`§ 42.64(a) and portions of Dr. DeLuca’s testimony related to such exhibits should
`
`
`
`
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`Case IPR2016-01096 (Patent No. 6,667,061)
`Authorized Second Motion to Exclude Evidence
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`also be excluded. “An objection to the admissibility of deposition evidence must be
`
`made during the deposition, [and] [e]vidence to cure the objection must be
`
`provided during the deposition, unless the parties to the deposition stipulate
`
`otherwise on the deposition record.” 37 C.F.R. § 42.64(a). Petitioners stated their
`
`objections
`
`to Exhibits 2073, 2075, and 2077-2079 on
`
`the record during
`
`Dr. DeLuca’s deposition. (Ex.2081, at 132:24-133:11, 163:11-13, 170:11-13,
`
`173:5-8, 177:4-5.) Patent Owners made no attempt to overcome the objection
`
`during the deposition. Thus, Exhibits 2073, 2075, and 2077-2079 and the portions
`
`of Dr. DeLuca’s testimony related to such exhibits above should be excluded.
`
`B. Exhibits 2075 And 2077 Should Be
`Excluded Under 37 C.F.R. § 42.63(b)
`Exhibits 2075 and 2077 should be excluded pursuant to 37 C.F.R.
`
`§ 42.63(b). Exhibit 2075 is a PCT application in German, and Exhibit 2077 is a
`
`PCT application in French. (Paper 52.) Petitioners timely objected to the exhibits
`
`as failing to comply with 37 C.F.R. § 42.63(b). (Paper 53.) Patent Owners did not
`
`supplement Exhibits 2075 and 2077 with English translations and affidavits to cure
`
`the deficiencies. Accordingly, Exhibits 2075 and 2077 should be excluded. See
`
`Blackberry Corp. v. Zipit Wireless, IPR2014-01506, Paper 50, at 23-24 (Mar. 29,
`
`2016) (excluding foreign language exhibits where a translation and affidavit was
`
`not filed); see also Square, Inc. v. REM Holdings 3, LLC, IPR2014-00312,
`
`2
`
`
`
`Case IPR2016-01096 (Patent No. 6,667,061)
`Authorized Second Motion to Exclude Evidence
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`Paper 58, at 36 (July 7, 2015) (excluding a foreign language document submitted
`
`with computer translation and no affidavit).
`
`C. Exhibits 2074 And 2076 Should Be Excluded As Irrelevant
`Exhibits 2074 and 2076 should be excluded under FRE 402 as irrelevant.
`
`Evidence is irrelevant if it does not make any fact of consequence more or less
`
`probable. FRE 401. Exhibit 2074 has an issue date of November 5, 2002, and
`
`Exhibit 2076 has an issue date of May 15, 2001, both after the date of invention.
`
`Exhibits 2074 and 2076 allegedly identify Extralow and Ultralow Blanose CMC,
`
`which Patent Owners argue were commercially available in the U.S. prior to the
`
`date of invention through the respective foreign language priority documents,
`
`Exhibits 2075 and 2077. But, as discussed above, Patent Owners have not provided
`
`translations and affidavits for Exhibits 2075 and 2077. As such, Exhibits 2074
`
`and 2076 do not make it any more or less probable that the Extralow and Ultralow
`
`Blanose CMCs were commercially available in the U.S. prior to the date of
`
`invention. Exhibits 2074 and 2076 should be excluded pursuant to FRE 402.
`
`D. Exhibits 2074-2079 Should Be Excluded As Irrelevant
`Exhibits 2074-2079 should be excluded as irrelevant because they are
`
`directed to nonanalogous art. Exhibits 2074 and 2075 are directed to “Dispersions
`
`For Producing Paint For Concrete Roof Tiles, Paint For Concrete Roof Tiles And
`
`Concrete Roof Tiles Coated With Such Paint,” and Exhibits 2076 and 2077 are
`
`3
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`
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`Case IPR2016-01096 (Patent No. 6,667,061)
`Authorized Second Motion to Exclude Evidence
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`directed to the “Supplementation Of Cellulose Nanofibrils With Carboxycellulose
`
`With Low Degree Of Substitution.” Exhibit 2078 is directed to “Microneedle
`
`Devices And Methods Of Drug Delivering Or Fluid Withdrawal,” whereas
`
`Exhibit 2079 is directed to “Protein-Based Polymer Tissue Adhesives For Medical
`
`Use.” None are directed to injectable suspensions. Thus, Exhibits 2074-2079
`
`should be excluded as irrelevant under FRE 402.
`
`E.
`Exhibits 2073, 2078, And 2079 Should Be Excluded As Irrelevant
`Patent Owners rely on Exhibits 2073, 2078, and 2079 to show the
`
`knowledge of a POSA with regard to certain CMCs at the time of invention.
`
`(Ex.2081, at 132:2-137:6, 170:14-173:8, 174:18-177:9.) In order to be relevant, the
`
`exhibits must make some showing that these products were commercially available
`
`and accessible to a POSA at the time of the invention. None of these Exhibits bears
`
`a date before the time of the invention. Patent Owners allege that Exhibit 2073 has
`
`a copyright date of 2000, but the exhibit is not dated. (Id. 132:20-23.)
`
`Exhibits 2078 and 2079 have publication dates of July 16, 2009, and June 1, 2010,
`
`respectively. Since Patent Owners failed to show that these exhibits were available
`
`at the time of the invention, they are irrelevant and should be excluded.
`
`III. CONCLUSION
`For the reasons stated above, Petitioners submit that Exhibits 2073-2079,
`
`and portions of Exhibit 2081 should be excluded from the record.
`
`4
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`
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`Case IPR2016-01096 (Patent No. 6,667,061)
`Authorized Second Motion to Exclude Evidence
`
`
`Respectfully submitted,
`
`Dated:
`
`August 30, 2017
`
`
`
`By:
`
`
`5120123_1.docx
`
`/ Paul H. Kochanski /
`Paul H. Kochanski
`Reg. No. 29,660
`
`
`
`5
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`Case IPR2016-01096 (Patent No. 6,667,061)
`Authorized Second Motion to Exclude Evidence
`
`
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a true copy of the foregoing
`
`PETITIONERS’ AUTHORIZED SECOND MOTION TO EXCLUDE
`
`EVIDENCE was served on August 30, 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
`
`
`
`Dated: August 30, 2017
`
`5120123_1.docx
`
`
`
`By:
`
`/ Paul H. Kochanski /
`Paul H. Kochanski
`Reg. No. 29,660
`
`
`
`
`
`
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`
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