Paper No. ____
`Filed: April 6, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
`LUPIN LTD., and LUPIN PHARMACEUTICALS, INC.,
`Petitioners,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner.
`__________________
`Case IPR2015-00903 (Patent 8,129,431 B2)1
`__________________
`
`
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION TO
`EXCLUDE
`
`
`
`
`
`
`1 IPR2015-01871 has been joined with this proceeding.
`
`
`Filed: April 6, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
`LUPIN LTD., and LUPIN PHARMACEUTICALS, INC.,
`Petitioners,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner.
`__________________
`Case IPR2015-00903 (Patent 8,129,431 B2)1
`__________________
`
`
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION TO
`EXCLUDE
`
`
`
`
`
`
`1 IPR2015-01871 has been joined with this proceeding.
`
`
`
`
`
`
`
`I.
`
`II.
`
`Case IPR2015-00903
`U.S. Patent 8,149,431
`
`TABLE OF CONTENTS
`
`Introduction ...................................................................................................... 1
`
`The Board Should Deny Petitioner’s Request To Exclude Portions of
`Dr. Laskar’s Testimony (EX2272) and Exhibits Discussed Therein
`(EX2266-EX2268) ........................................................................................... 2
`
`A.
`
`B.
`
`C.
`
`D.
`
`Patent Owner’s Actions Are Not Contrary to the Board’s Order
`of March 21, 2016 ................................................................................. 2
`
`Patent Owner’s Properly Used EX2266-EX2268 to Examine
`the Veracity and Credibility of Dr. Laskar’s Opinions ......................... 3
`
`Patent Owner’s Properly Cited EX2267 in Support of Its
`Motion to Exclude Dr. Laskar’s Reply Declaration Under FRE
`702 ......................................................................................................... 4
`
`EX2266-EX2268 Should Not Be Excluded as Inadmissible
`Hearsay .................................................................................................. 5
`
`III. Conclusion ....................................................................................................... 7
`
`ii
`
`
`
`Case IPR2015-00903
`U.S. Patent 8,149,431
`
`Introduction
`
`
`
`
`
`I.
`
`Patent Owner respectfully opposes Petitioner’s motion to exclude certain
`
`exhibits and testimony properly used by Patent Owner to challenge the scope of
`
`Dr. Laskar’s opinion during his reply cross-examination (EX2272 at 119:7-121:12,
`
`127:18-129:1, 141:7-145:21, 134:13-139:19, 177:3-179:15, and 183:5-17; and
`
`EX2266-EX2268). Petitioner’s arguments lack merit, and none of these exhibits
`
`should be excluded.
`
`
`
`The party moving to exclude evidence bears the burden to establish that it is
`
`entitled to the relief requested—namely, that the material sought to be excluded is
`
`inadmissible under the Federal Rules of Evidence. See 37 C.F.R. §§ 42.20(c),
`
`42.62(a). A motion to exclude may not be used to challenge the sufficiency of the
`
`evidence to prove a particular fact. Office Patent Trial Practice Guide, 77 Fed.
`
`Reg. 48765, 48767 (Aug. 14, 2012). It is within the Board’s discretion to assign
`
`the appropriate weight to be accorded the evidence. Id.; see also, e.g., In re Am.
`
`Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004). As discussed
`
`below, Petitioner has failed to establish entitlement to exclusion. Patent Owner
`
`respectfully requests that the Board deny Petitioner’s motion to exclude.
`
`1
`
`
`
`
`II. The Board Should Deny Petitioner’s Request To Exclude Portions of
`Dr. Laskar’s Testimony (EX2272) and Exhibits Discussed Therein
`(EX2266-EX2268)
`
`Case IPR2015-00903
`U.S. Patent 8,149,431
`
`
`
`As discussed in Patent Owner’s Motion to Exclude, during the Reply stage
`
`of these proceedings, Petitioner has gone beyond the scope of the original petition.
`
`Paper 59. A petitioner should not be permitted to go beyond the scope of its
`
`Petition, introduce wholly new arguments, and then protest when the patent owner
`
`cross examines a petitioner’s expert witness to establish that a new argument is
`
`beyond the scope. If such actions were permissible, then petitioners would be
`
`incentivized to add new arguments at the Reply stage, and patent owners would not
`
`have an effective means—cross examination and the related Observations—to
`
`explore the bounds of the new argument and show that the new argument is
`
`impermissible. This would nullify one major purpose of the cross-examination
`
`following a reply declaration. Here, there was nothing improper about Patent
`
`Owner’s use of EX2266-2268 during Dr. Laskar’s cross examination, and nothing
`
`warrants exclusion of Dr. Laskar’s cross examination testimony.
`
`A.
`
`Patent Owner’s Actions Are Not Contrary to the Board’s Order
`of March 21, 2016
`
`
`
`After Petitioner’s March 18, 2016 Reply was filed, Patent Owner emailed
`
`the Board, objecting that Petitioner had included new exhibits, including the
`
`Laskar reply declaration, raising new arguments outside the scope of the Petition
`
`2
`
`
`
`
`and Patent Owner’s Response, and Patent Owner requested a surreply. (EX1154 at
`
`Case IPR2015-00903
`U.S. Patent 8,149,431
`
`2.) The Board denied the request for a surreply, but stated:
`
`The Board will determine whether, under 37 C.F.R. § 42.23(b),
`Petitioner’s Reply briefs, and related evidence, are outside the
`scope of a proper reply and evidence, when the panel reviews
`the record and prepares any final written decision in connection
`with these proceedings. If there are improper arguments or
`evidence, or both, presented with the Reply briefs, the panel
`may exclude such argument and related evidence.
`EX1154 at 1 (emphasis added). Thus, while the Board did not permit a surreply,
`
`the Board did not in any way restrict Patent Owner’s ability to cross-examine Dr.
`
`Laskar or move to exclude Petitioner’s out-of-scope reply and evidence.
`
`B.
`
`Patent Owner’s Properly Used EX2266-EX2268 to Examine the
`Veracity and Credibility of Dr. Laskar’s Opinions
`
`
`
`Accordingly, at Dr. Laskar’s deposition, Patent Owner properly used
`
`EX2266-EX2268 to question the veracity and credibility of Dr. Laskar’s opinions
`
`and to illustrate that Dr. Laskar’s opinions are in fact new. See Fed. R. Evid. 703
`
`(experts can base opinions on facts or data expert has been made aware of even if
`
`not admissible). Indeed, Advisory Committee Notes to Rule 703 makes clear that
`
`one source contemplated by the rule consists of presentation of data to the expert
`
`outside the court and other than by his own perception, e.g., an expert basing his
`
`opinion on statements from other experts, which would only be admissible in
`
`3
`
`
`
`
`evidence with the expenditure of substantial time in producing and examining an
`
`Case IPR2015-00903
`U.S. Patent 8,149,431
`
`authenticating witness. Pub. L. 93-595, §1, Jan. 2, 1975, 88 Stat. 1937; Mar. 2,
`
`1987, eff. Oct. 1, 1987; Apr. 17, 2000, eff. Dec. 1, 2000; Apr. 26, 2011, eff. Dec. 1,
`
`2011. As such, it was not improper of Patent Owner to test the veracity of Dr.
`
`Laskar’s opinions with EX2266-EX2268, regardless of whether EX2266-EX2268
`
`are admissible.2
`
`C.
`
`Patent Owner’s Properly Cited EX2267 in Support of Its Motion
`to Exclude Dr. Laskar’s Reply Declaration Under FRE 702
`
`
`
`Patent Owner properly cited EX2267 to support its motion to exclude. In
`
`objections filed and served March 25, 2016, Patent Owner timely objected to
`
`portions of Dr. Laskar’s reply declaration, EX1104, among others, because Dr.
`
`Laskar showed a complete lack of expertise in organic or medicinal chemistry and
`
`thus was not qualified to form an opinion in this proceeding. Paper No. 56. Patent
`
`Owner then properly moved to exclude Dr. Laskar’s opinions and testimony
`
`regarding any issue of organic or medicinal chemistry. Paper No. 59. In the
`
`Motion to Exclude, Patent Owner cited EX2267 in connection with Patent Owner’s
`
`
`2 For at least these reasons, the Board should not entertain the unprofessional
`
`attacks that Petitioner repeatedly makes in its motion against Patent Owner.
`
`Petitioner’s unprincipled rhetoric, including unwarranted allegations of “egregious
`
`behavior” and “abusive conduct,” has no proper place in these proceedings.
`
`4
`
`
`
`
`position that Dr. Laskar is unqualified to offer opinions regarding organic or
`
`Case IPR2015-00903
`U.S. Patent 8,149,431
`
`medicinal chemistry, specifically highlighting Dr. Laskar’s lack of expertise as
`
`compared to that of Dr. Davies. Paper No. 59 at 5-6.
`
`D. EX2266-EX2268 Should Not Be Excluded as Inadmissible
`Hearsay
`Petitioner cites Google, Inc. v. Meiresonne, IPR2014-01188, Paper No. 38
`
`
`
`(PTAB Jan. 20, 2016)3 in connection with its argument that EX2266-EX2268
`
`should be excluded as hearsay. In Google, two web page exhibits contained
`
`statements made by a Google employee against Google. Id. at 10. The Board in
`
`fact noted those statements are not hearsay under Fed. R. Evid. 801(d)(2). Id.
`
`Similarly, EX2266 and EX2268, deposition transcripts of Petitioner InnoPharma’s
`
`experts Dr. Heathcock and Dr. Cykiert in the parallel district court litigations, are
`
`not hearsay under Fed. R. Evid. 801(d)(2). These statements offered against
`
`InnoPharma (a) were made by in an individual on behalf of InnoPharma in a
`
`representative capacity; (b) are statements that InnoPharma manifested that it
`
`adopted or believed to be true; (c) were made by a person whom InnoPharma
`
`authorized to make a statement on the subject; and (d) were made by InnoPharma’s
`
`agent on a matter within the scope of that relationship and while it existed. Id.
`
`Thus, EX2266 and EX2268 are not inadmissible hearsay.
`
`
`3 Petitioner cites Paper No. 37, not Paper No. 38, but that appears to be an error.
`
`5
`
`
`
`In addition, the sworn declaration of Dr. Davies, dated February 15, 2016
`
`Case IPR2015-00903
`U.S. Patent 8,149,431
`
`
`
`
`(EX2267), should not be excluded under FRE 807, in view of its guarantees of
`
`trustworthiness. See FRE 807(a)(1). Further, Patent Owner offers EX2267 as
`
`evidence of material fact—the inaccuracy of Dr. Laskar’s new opinion that
`
`tyloxapol allegedly is an antioxidant in ophthalmic solutions. Moreover, in light of
`
`the Board’s denial of Patent Owner’s request for a surreply to Petitioner’s new
`
`argument on antioxidant chemistry, EX2267 “is more probative” on the issue of
`
`the veracity of Dr. Laskar’s opinions on antioxidant chemistry than “any other
`
`evidence that the proponent can obtain” at this stage of these proceedings. See
`
`FRE 807(a)(2)-(3). Furthermore, admitting EX2267 is in the interest of justice, as
`
`to ensure that only testimony of qualified experts is admitted. See Sundance, Inc.
`
`v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1362 (Fed. Cir. 2008). Thus,
`
`EX2267 should not be excluded as hearsay. FRE 807.
`
`
`
`In sum, Patent Owner’s reliance on EX2266-EX2268 is not in violation of
`
`the Board’s email of March 21, 2016. None of the exhibits is inadmissible
`
`hearsay. Instead, Patent Owner should be permitted to use these exhibits to test the
`
`veracity and credibility of Dr. Laskar’s opinions (and his underlying expertise in
`
`the subject matter) and to rely on EX2267 in its Motion to Exclude Dr. Laskar’s
`
`testimony under FRE 702. For all of these reasons, the Board should deny
`
`Petitioner’s request to exclude these Exhibits.
`
`6
`
`
`
`
`III. Conclusion
`
`Case IPR2015-00903
`U.S. Patent 8,149,431
`
`For at least the foregoing reasons, Patent Owner respectfully requests that
`
`the Board deny Petitioner’s motion to exclude EX2266-EX2268.
`
`
`By: /Bryan C. Diner/
`Bryan C. Diner, Lead Counsel
`Reg. No. 32,409
`Lead Counsel for Patent Owner
`
`
`
`Date: April 6, 2016
`
`
`
`
`
`
`
`7
`
`
`
`Case IPR2015-00903
`U.S. Patent 8,149,431
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing PATENT
`
`
`
`
`
`OWNER’S OPPOSITION TO PETITIONER’S MOTION TO EXCLUDE,
`
`was served on April 6, 2016 via email to the following counsel of record for the
`
`Petitioner at the following:
`
`Jitendra Malik, Ph.D
`Jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`Bryan.skelton@alston.com
`
`Lance Soderstrom
`Lance.soderstrom@alson.com
`
`Hitetada James Abe
`James.abe@alston.com
`
`Joseph M. Janusz
`Joe.janusz@alston.com
`
`Deborah Yellin
`dyellin@crowell.com
`
`Jonathan Lindsay
`jlindsay@crowell.com
`
`Shannon Lentz
`slentz@crowell.com
`
`
`Dated: April 6, 2016
`
`
`
`
`
`
`
`
`
`/Ashley F. Cheung/
`Ashley F. Cheung
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`8
`
`
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