`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’ 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
`
`5112610_1.docx
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`Case IPR2016-01096 (Patent No. 6,667,061)
`Motion to Exclude Evidence
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`TABLE OF CONTENTS
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`Page
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`TABLE OF AUTHORITIES .................................................................................... ii
`PETITIONERS’ EXHIBIT LIST ............................................................................ iii
`INTRODUCTION ........................................................................................... 1
`I.
`
`II.
`
`ARGUMENT ................................................................................................... 2
`
`A. Exhibits 2073, 2075, And 2077-2079 And Portions of
`Exhibit 2081 Should Be Excluded Under 37 C.F.R. § 42.64(a) .............. 2
`
`B. Exhibits 2075 and 2077 Should Be
`Excluded Under 37 C.F.R. § 42.63(b) ...................................................... 3
`
`C. Exhibits 2074 And 2076 Should Be Excluded As Irrelevant ................... 4
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`D. Exhibits 2073, 2078, and 2079
`Should Be Excluded As Irrelevant ........................................................... 5
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`III. CONCLUSION ................................................................................................ 6
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`Case IPR2016-01096 (Patent No. 6,667,061)
`Motion to Exclude Evidence
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`TABLE OF AUTHORITIES
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` Page(s)
`
`Cases
`Blackberry Corp. v. Zipit Wireless,
`IPR2014-01506, Paper 50 (Mar. 29, 2016) .......................................................... 3
`
`Square, Inc. v. REM Holdings 3, LLC,
`IPR2014-00312, Paper 58 (July 7, 2015) ............................................................. 3
`
`Other Authorities
`
`37 C.F.R. § 42.62(a) ................................................................................................... 1
`
`37 C.F.R. § 42.63(b) .............................................................................................. 1, 3
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`37 C.F.R. § 42.64(a) ............................................................................................... 1, 2
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`37 C.F.R. § 42.64(b)(1) .............................................................................................. 1
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`37 C.F.R. § 42.64(c) ................................................................................................... 1
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`FRE 401 ..................................................................................................................... 4
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`FRE 402 ............................................................................................................. 1, 4, 5
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`FRE 403 ..................................................................................................................... 1
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`ii
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`Case IPR2016-01096 (Patent No. 6,667,061)
`Motion to Exclude Evidence
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`PETITIONERS’ EXHIBIT LIST
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`
`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
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`1021
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`1022
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`1023
`1024
`1025
`1026
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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
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`1042
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`1043
`1044
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`iv
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`Case IPR2016-01096 (Patent No. 6,667,061)
`Motion to Exclude Evidence
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`I.
`
`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.64(c), 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 that were filed by Patent Owners on the day of the
`
`deadline for filing Luye’s original motion to exclude on the bases shown in Table 1
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`and argued further below.
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`Evidence
`Ex.2073
`Ex.2074
`
`Ex.2075
`
`Ex.2076
`
`Ex.2077
`Ex.2078
`Ex.2079
`Ex.2081
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`TABLE 1
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`Objections
`FRE 402, 403
`FRE 402, 403
`
`37 C.F.R. § 42.63(b)
`
`FRE 402, 403
`
`37 C.F.R. § 42.63(b)
`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
`
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`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
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`Evidence (“FRE”) pursuant to 37 C.F.R. § 42.62(a). (See Paper 53.) Patent Owners
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`Alkermes Pharma Ireland Ltd and Alkermes Controlled Therapeutics, Inc.
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`(collectively “Alkermes” or “Patent Owners”) raised no subsequent questions
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`regarding Petitioners’ objections and submitted no supplemental evidence or
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`affidavits to address such objections.
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`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.
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`§ 42.64(a) and portions of Dr. DeLuca’s testimony related to such exhibits should
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`also be excluded. “An objection to the admissibility of deposition evidence must be
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`made during the deposition, [and] [e]vidence to cure the objection must be
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`provided during the deposition, unless the parties to the deposition stipulate
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`otherwise on the deposition record.” 37 C.F.R. § 42.64(a). Luye stated its objection
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`to Exhibits 2073, 2075, and 2077-2079 on the record during Dr. DeLuca’s
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`deposition. (Ex.2081, at 132:24-133:11, 163:11-13, 170:11-13; 173:5-8; 177:4-5.)
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`Patent Owners made no attempt to overcome the objection during the deposition
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`nor did the parties stipulate to any other course of action. Thus, Exhibits 2073,
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`2075, and 2077-2079 and the portions of Dr. DeLuca’s testimony related to such
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`exhibits as identified in Table 1 above should be excluded.
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`2
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`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), which provides that “[w]hen a party relies on a document or is required
`
`to produce a document in a language other than English, a translation of the
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`document into English and an affidavit attesting to the accuracy of the translation
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`must be filed with the document.” Alkermes submitted Exhibit 2075, a PCT
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`application in German, and Exhibit 2077, a PCT application in French, on July 24,
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`2017. (Paper 52.) Luye timely objected to the exhibits as failing to provide an
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`English translation and affidavit attesting to the accuracy of the translation
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`pursuant to 37 C.F.R. § 42.63(b) on July 31, 2017. (Paper 53.) Alkermes did not
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`supplement Exhibits 2075 and 2077 with an English translation and affidavit
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`attesting to the accuracy of the same to cure the deficiency. Accordingly,
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`Exhibits 2075 and 2077 should be excluded for failing to comply with 37 C.F.R.
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`§ 42.63(b). See Blackberry Corp. v. Zipit Wireless, IPR2014-01506, Paper 50,
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`at 23-24 (Mar. 29, 2016) (excluding foreign language exhibits where a translation
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`and affidavit was not filed); see also Square, Inc. v. REM Holdings 3, LLC,
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`IPR2014-00312, Paper 58, at 36 (July 7, 2015) (excluding a foreign language
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`document submitted with computer translation and no affidavit).
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`C. Exhibits 2074 And 2076 Should Be Excluded As Irrelevant
`Exhibit 2074 and 2076 should be excluded under FRE 402 as irrelevant.
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`Evidence is irrelevant if it does not make any fact of consequence more or less
`
`probable. FRE 401. Irrelevant evidence is inadmissible. FRE 402. Patent Owners
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`identified to Luye’s declarant, Dr. DeLuca, that Exhibit 2074 is a U.S. patent
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`claiming priority to Exhibit 2075. (Ex.2081, at 160:23-162:4.) Exhibit 2074 has an
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`issue date after the date of invention of November 5, 2002. Similarly, Patent
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`Owners identified to Dr. DeLuca that Exhibit 2076 is a U.S. patent claiming
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`priority to Exhibit 2077. (Ex.2081, at 168:15-25.) Exhibit 2076 has an issue date
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`after the date of invention of May 15, 2001. Exhibits 2074 and 2076 allegedly
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`identify Extralow and Ultralow Blanose CMC, which Patent Owner argues was
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`commercially available in the U.S. prior to the date of invention through the
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`foreign language priority documents, Exhibits 2075 and 2077, respectively. As
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`discussed above, however, Patent Owners have not provided an English translation
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`and affidavit attesting to the accuracy of the English translation for Exhibits 2075
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`and 2077. As such, Exhibits 2074 and 2076 do not make it any more or less
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`probable that the Extralow and Ultralow Blanose CMCs were commercially
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`available in the U.S. prior to the date of invention. Accordingly, Exhibits 2074
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`and 2076 should be excluded pursuant to FRE 402 as they are irrelevant because
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`they are dated after the time of the invention.
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`D. Exhibits 2074-2077 Should Be Excluded As Irrelevant
`Exhibits 2074-2077 should be excluded as irrelevant because they are
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`directed to nonanalogous art. Exhibits 2074 and 2075 are directed to “Dispersions
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`For Producing Paint For Concrete Roof Tiles, Paint For Concrete Roof Tiles And
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`Concrete Roof Tiles Coated With Such Paint,” and Exhibits 2076 and 2077 are
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`directed to the “Supplementation Of Cellulose Nanofibrils With Carboxycellulose
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`With Low Degree Of Substitution.” Exhibit 2078 is directed to “Microneedle And
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`Methods Devices Of Drug Delivering Or Fluid Withdrawal,” whereas Exhibit 2079
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`is directed to “Protein-Based Polymer Tissue Adhesives For Medical Use.” As is
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`clear, none of the references is related to pharmaceutical compositions, and in
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`particular, injectable suspensions of microparticles. Thus, Exhibits 2074-2079
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`should be excluded as irrelevant under FRE 402 as they are nonanalogous art.
`
`E.
`Exhibits 2073, 2078, And 2079 Should Be Excluded As Irrelevant
`Patent Owners rely on Exhibits 2073, 2078, and 2079 to show the
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`knowledge of a POSA with regard to certain CMCs at the time of invention.
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`(Ex.2081, at 132:2-137:6, 170:14-173:8, 174:18-177:9.) In order to be relevant,
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`Exhibits 2073, 2078, and 2079 must make some showing that these products were
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`commercially available and accessible to a POSA at the time of the invention.
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`None of these Exhibits bears a date at or before the time of the invention. Patent
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`Owners allege that Exhibit 2073 has a copyright date of 2000, yet there is no date
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`5
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`on the exhibit. (Id. 132:20-23.) Exhibits 2078 and 2079 have publication dates of
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`July 16, 2009, and June 1, 2010, respectively.
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`Since Patent Owners have failed to show that information relied upon in
`
`Exhibits 2073, 2078, and 2079 would have been within the knowledge of a POSA
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`at or before the time of invention, Exhibits 2073, 2078, and 2079 do not make any
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`fact of consequence more or less probable. As such, Exhibits 2073, 2078, and 2079
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`should be excluded as irrelevant.
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`III. CONCLUSION
`For the reasons stated above, Petitioners submit that Exhibits 2073-2079,
`
`and portions of Exhibit 2081 should be excluded from the record and Patent
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`Owners precluded from using these exhibits (or portions thereof) at any hearing or
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`in any paper in this proceeding.
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`Respectfully submitted,
`
`Dated:
`
`August 22, 2017
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`
`
`By:
`
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`5062864_1.docx
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`/ Paul H. Kochanski /
`Paul H. Kochanski
`Reg. No. 29,660
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a true copy of the foregoing
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`PETITIONERS’ SECOND MOTION TO EXCLUDE EVIDENCE was served
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`on August 22, 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
`
`
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`Dated: August 22, 2017
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`
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`By:
`
`/ Paul H. Kochanski /
`Paul H. Kochanski
`Reg. No. 29,660
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