Case IPR2016-01096
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`Mail Stop: Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`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
`__________________________________________________________________
`
`REPLY TO PATENT OWNERS’
`OPPOSITION TO MOTION TO EXCLUDE
`
`
`
`
`
`Patent No. 6,667,061
`Opposition to Patent Owners’ Motion to Exclude
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`Mail Stop: Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`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
`__________________________________________________________________
`
`REPLY TO PATENT OWNERS’
`OPPOSITION TO MOTION TO EXCLUDE
`
`
`
`
`
`
`Case IPR2016-01096 (Patent No. 6,667,061)
`Reply to POs’ Opposition to Motion to Exclude
`
`
`
`TABLE OF CONTENTS
`
`
`Page
`TABLE OF AUTHORITIES .................................................................................... ii
`
`I.
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`ARGUMENT ................................................................................................... 1
`
`A. CMC Exhibits And 2049 Do Not Fall
`Within The Exception Under FRE 803(17) .............................................. 1
`
`B. The CMC Exhibits Have Not Been Authenticated
`As Documents Available Before The Priority Date ................................. 2
`
`C. The CMC Exhibits, Dr. Berkland’s
`Declaration (Ex.2014), And Dr. Gehrke’s
`Declaration (Ex.2059) Should Be Excluded As Irrelevant ...................... 4
`
`D. Exhibits 2020-2022-2030, 2035, 2037, 2042, 2044,
`2047, And 2056-2058 Should Be Excluded As Irrelevant ....................... 5
`
`II.
`
`CONCLUSION ................................................................................................ 5
`
`
`
`
`
`
`
`
`i
`
`
`
`Case IPR2016-01096 (Patent No. 6,667,061)
`Reply to POs’ Opposition to Motion to Exclude
`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`CASES
`Google, Inc. v. Michael Meiresonne,
`IPR2014-01188, Paper 38 (P.T.A.B. Jan. 20, 2016.) ........................................... 2
`
`Johns Manville Corp. v. Knauf Insulation, Inc.,
`IPR2016-00130, Paper 35 (P.T.A.B. May 8, 2017) ......................................... 1, 3
`
`TRW Auto. U.S. LLC v. Magna Elecs. Inc.,
`IPR2014-01348, Paper 25 (P.T.A.B. Jan. 15, 2016) ........................................ 2, 3
`
`STATUTES, RULES & OTHER AUTHORITIES
`
`FRE 401 ................................................................................................................. 4, 5
`
`FRE 402 ..................................................................................................................... 5
`
`FRE 802 ..................................................................................................................... 2
`
`FRE 803(17) ........................................................................................................... 1, 2
`
`FRE 901 ..................................................................................................................... 3
`
`
`
`
`
`
`
`
`ii
`
`
`
`Case IPR2016-01096 (Patent No. 6,667,061)
`Reply to POs’ Opposition to Motion to Exclude
`I.
`
`INTRODUCTION
`
`Petitioners (“Luye”) respectfully submit this reply to Patent Owners’
`
`(“Alkermes”) Opposition to Petitioners’ motion to exclude certain evidence.
`
`I.
`
`ARGUMENT
`A.
`
`CMC Exhibits And 2049 Do Not Fall
`Within The Exception Under FRE 803(17)
`Alkermes alleges that certain CMC Exhibits fall within the hearsay
`
`exception set forth in 803(17), which includes “[m]arket quotations, lists,
`
`directories, or other compilations that are generally relied on by the public or by
`
`persons in particular occupations.” In support, Alkermes relies on Johns Manville
`
`Corp. v. Knauf Insulation, Inc., IPR2016-00130, Paper 35 (P.T.A.B. May 8, 2017),
`
`wherein the Patent Owner sought to exclude the dates on advertising brochures as
`
`hearsay. Id. at 16. Petitioners in that case submitted corroborating testimony from
`
`two of its employees who testified that the dates on the brochures were print dates
`
`and it was standard practice to disseminate the brochures to customers shortly
`
`thereafter. Id. at 18. The Board found the brochures admissible under FRE 803(17)
`
`based on the witnesses’ sworn testimony. Id. at 19.
`
`Here, Alkermes seeks to rely on the brochures as showing that the products
`
`were available before the priority date. Id. at 17. Unlike in Johns Manville,
`
`Alkermes, however, has failed to provide any corroborating testimony or evidence
`
`that the dates on the CMC Exhibits are the publication dates, and thus, available
`
`
`
`
`
`Case IPR2016-01096 (Patent No. 6,667,061)
`Reply to POs’ Opposition to Motion to Exclude
`
`before the priority date. Exhibits 2034, 2036, 2038, 2039, and 2040 all have
`
`multiple dates and at least one of the dates on each document is after the priority
`
`date. See TRW Auto. U.S. LLC v. Magna Elecs. Inc., IPR2014-01348, Paper 25,
`
`at 8 (P.T.A.B. Jan. 15, 2016) (a copyright is not probative that an article was
`
`published). Moreover, Alkermes failed to provide any evidence that CMC Exhibits
`
`are “generally relied on by the public or by persons in particular occupations” as
`
`required by FRE 803(17). Exhibits 2036, 2039, and 2052 are web pages, not
`
`product brochures. See Google, Inc. v. Michael Meiresonne, IPR2014-01188,
`
`Paper 38, at 9-10 (P.T.A.B. Jan. 20, 2016.) Thus, these exhibits are inadmissible
`
`hearsay under FRE 802 and do not fall with the exception under FRE 803(17).
`
`Exhibit 2049 is similarly inadmissible. Exhibit 2049 is a press release posted
`
`on Johnson & Johnson’s own web page. Alkermes has offered no evidence that a
`
`press release would be relied on by the public or persons in particular occupations
`
`or that Johnson & Johnson had “incentive to compile this information accurately.”
`
`(Opp’n 12.) As such, Exhibit 2049 is inadmissible hearsay under FRE 802 and
`
`does not fall within the exception under FRE 803(17).
`
`B.
`
`The CMC Exhibits Have Not Been Authenticated
`As Documents Available Before The Priority Date
`Alkermes alleges that it is not relying on the CMC Exhibits “solely as
`
`evidence of commercial availability” prior to the date of invention. (Opp’n 4.) To
`
`the extent Alkermes does rely on them for that purpose, such as in Dr. Berkland’s
`
`2
`
`
`
`Case IPR2016-01096 (Patent No. 6,667,061)
`Reply to POs’ Opposition to Motion to Exclude
`
`and Dr. Gehrke’s Declarations, it has not provided any evidence “to support a
`
`finding that the item is what [Alkermes] says it is[,]” FRE 901, a document that
`
`was available before the priority date. In its response, Alkermes alleges that it is
`
`has provided “sufficient evidence” to show that the CMC Exhibits were all
`
`available before the critical date. (Opp’n 4-8.) Yet, the only evidence it relies on is
`
`information found in the very exhibits that Luye alleges has not been authenticated.
`
`In Johns Mansville, the Board found the printed date information
`
`“intertwined with admissibility” because the Petitioner relied on the date evidence
`
`to support public availability and authenticity. Johns Manville, IPR2016-00130,
`
`Paper 35, at 17. There, the Board found the product brochures authentic, based on
`
`the corroborating testimony from Petitioner’s employees. Id. at 18. Alkermes has
`
`offered no such evidence.
`
`The CMC Exhibits are unreliable as being available prior to the priority date
`
`because on their face, each of the CMC Exhibits contains multiple dates that are
`
`before and after the critical date or are dated after the priority date. Alkermes
`
`argues that the URL found on the face of some of the exhibits is corroborative
`
`evidence. Even if the URL is immediately accessible, “it would merely prove that
`
`the article is published as of today, not as of any particular past date.” TRW,
`
`IPR2014-01348, Paper 25, at 10. Also, Dr. Deluca’s
`
`testimony does not
`
`corroborate the date on the Aqualon brochure as the cited testimony is unrelated to
`
`3
`
`
`
`Case IPR2016-01096 (Patent No. 6,667,061)
`Reply to POs’ Opposition to Motion to Exclude
`
`Exhibit 2034. Thus, the CMC Exhibits have not been authenticated.
`
`C. The CMC Exhibits, Dr. Berkland’s
`Declaration (Ex.2014), And Dr. Gehrke’s
`Declaration (Ex.2059) Should Be Excluded As Irrelevant
`Alkermes alleges that Luye is “mistaken about the Federal Rules of
`
`Evidence” because it seeks to exclude portions of Dr. Berkland’s Declaration and
`
`Dr. Gehrke’s Declaration as irrelevant. (Opp’n 9.) As discussed above, Alkermes
`
`has not established that the CMCs discussed in the CMC Exhibits relied upon by
`
`their experts were available prior to the critical date. In order to be relevant,
`
`evidence must make a material fact more or less probable. FRE 401. Here,
`
`Alkermes’ experts provide testimony related to CMCs, which Alkermes has not
`
`proven were available prior to the critical date, in an attempt to disprove Luye’s
`
`argument that the viscosity of the Johnson and Gustafsson vehicles is within the
`
`claimed range of the ’061 Patent. If none of the CMCs in the CMC Exhibits were
`
`available prior to the critical date, then they would not have been available to a
`
`POSA in preparing the Johnson and Gustafsson vehicles and thus, are irrelevant as
`
`to whether those vehicles have an inherent viscosity within the claimed range.
`
`Although Alkermes’ experts may rely on inadmissible evidence, however, it does
`
`not make their testimony relevant as their testimony does not make any material
`
`fact more or less probable. Therefore, Dr. Berkland’s and Dr. Gehrkes’ cited
`
`testimony should be excluded.
`
`4
`
`
`
`Case IPR2016-01096 (Patent No. 6,667,061)
`Reply to POs’ Opposition to Motion to Exclude
`D.
`
`Exhibits 2020-2022-2030, 2035, 2037, 2042, 2044,
`2047, And 2056-2058 Should Be Excluded As Irrelevant
`Alkermes alleges that Luye’s objection under FRE 401 is improper.
`
`FRE 401 is the test for relevancy. Evidence is excludable under FRE 402, which
`
`Luye bases its objection. Thus, Luye’s objections are proper. Exhibits 2020,
`
`2022-20301, 2035, 2037, 2042, 2044, 2047, and 2056-2058 are irrelevant as they
`
`do not make any fact more or less probable. Thus, these exhibits should be
`
`excluded.
`
`II. CONCLUSION
`Accordingly, Exhibits 2020-2030, 2034-2037, 2038-2040, 2042, 2044, 2049,
`
`2052, 2056-2059, and portions of Exhibit 2014 should be excluded from the
`
`record.
`
`Respectfully submitted,
`
`Dated:
`
`August 14, 2017
`
`
`
`By:
`
`5101994_1.docx
`
`
`
`
`s/ Paul H. Kochanski /
`Paul H. Kochanski
`Reg. No. 29,660
`
`
`
`
`
`
`1 Alkermes states that Exhibits 2022-2030 show the “routine use of low
`concentrations of CMC in formulations comprising risperidone.” None of these
`references discloses the use of risperidone in low concentration CMC injection
`vehicle.
`
`5
`
`
`
`Case IPR2016-01096 (Patent No. 6,667,061)
`Reply to POs’ Opposition to Motion to Exclude
`
`
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a copy of the foregoing REPLY TO
`
`PATENT OWNERS’ OPPOSITION TO MOTION TO EXCLUDE, was
`
`served on August 14, 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:
`
`5101994_1.docx
`
`August 14, 2017
`
`
`
`By:
`
`
`
`
`
`s/ Paul H. Kochanski /
`Paul H. Kochanski
`Reg. No. 29,660
`
`
`6
`
`
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