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.
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`
`Case IPR2015-00902 (Patent 8,669,290 B2)
`
`Filed: April 11, 2016
`
`PETITIONER’S REPLY TO PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`
`Case IPR2015-00902 (Patent 8,669,290 B2)
`
`Filed: April 11, 2016
`
`PETITIONER’S REPLY TO PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`II.
`
`Patent Owner Cannot Justify the Lateness of Exhibits 2247-2263 ............... 1
`Patent Owner Fails to Show that Dr. Paulson’s Methods Were
`Reliable........................................................................................................ 1
`Patent Owner Fails to Justify its Improper Conduct ..................................... 3
`III.
`EX2267 Is Not Being Offered Under Fed. R. Evid. 702............................... 4
`IV.
`EX2266-2268 Are Inadmissible Hearsay ..................................................... 4
`V.
`VI. Conclusion................................................................................................... 5
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`CASES
`Pozen Inc. v. Par Pharm., Inc.,
`696 F.3d 1151 (Fed. Cir. 2012)..........................................................................5
`
`Page(s)
`
`Rembrandt Vision Techs., L.P. v. Johnson & Johnson Vision Care,
`Inc.,
`282 F.R.D. 655 (M.D. Fla. 2012) aff'd, 725 F.3d 1377 (Fed. Cir.
`2013) .............................................................................................................2, 3
`SanDisk Corp. v. Kingston Tech. Co.,
`863 F. Supp. 2d 815 (W.D. Wis. 2012)..............................................................4
`Standard Innovation Corp. v. Lelo, Inc.,
`IPR2014-00148, Paper 42 (PTAB April 23, 2015).............................................5
`
`RULES
`Fed. R. Evid. 703 ....................................................................................................3
`Fed. R. Evid. 801(d)(2)...........................................................................................4
`Rule 702 .............................................................................................................2, 4
`OTHER AUTHORITIES
`37 CFR 42.53(c) .....................................................................................................5
`37 CFR 42.53(d)(3).................................................................................................5
`
`ii
`
`
`
`I.
`
`Patent Owner Cannot Justify the Lateness of Exhibits 2247-2263
`Patent Owner cannot justify any delay in providing Exhibits 2247-2263.
`
`Patent Owner’s only explanation is to insist that the untimely exhibits were
`
`Petitioner’s fault for not objecting sooner, thus notifying Patent Owner of its own
`
`deficiencies. Presumably, Patent Owner was aware that the preservation efficacy
`
`testing was incomplete because Dr. Paulson’s declaration admits that it would not
`
`be complete until “12/26/15,” i.e., after Patent Owner’s filing. See, e.g., EX2128 at
`
`11. Given Patent Owner has had access to its product for years, it simply should
`
`not have waited so late to run its tests. Patent Owner’s “explanation” that it only
`
`became aware of the incompleteness of its reports “because of the parallel district
`
`court litigations” (Opp’n, Paper 70 at 9) strains credulity because Patent Owner is
`
`stating that it is not aware of its own testing and the express content of its reports.
`
`Patent Owner does not dispute that Petitioner timely objected. Further, Petitioner’s
`
`use of the served exhibits at the cross-examinations were subject to Petitioner’s
`
`objections in the event Patent Owner later filed the exhibits, which it has. See, e.g.,
`
`EX1082 at 60:15-61:4; Opp’n, Paper 70 at 4 (relying on EX2247-2263 to support
`
`Dr. Paulson’s testing). The Board should exclude these untimely exhibits.
`
`II.
`
`Patent Owner Fails to Show that Dr. Paulson’s Methods Were Reliable
`Patent Owner’s only response to the Rule 702 challenge is that Dr. Paulson
`
`didn’t think the numerous deviations from the European Pharmacopeia procedures
`
`1
`
`
`
`were a problem. See Opp’n, Paper 70 at 4-5 (regarding the excessively high
`
`concentration of initial inoculum, Patent Owner insists that “Petitioner ignores Dr.
`
`Paulson’s testimony, however, that he does not agree that this number is too high
`
`because ‘it’s not calculated that way,’ as explained in EX2257.”). All other
`
`deviations are brushed off in the same causal manner. See Opp’n, Paper 70 at 5-6
`
`(Dr. Paulson insisted that deviations “never caused a problem” and they weren’t
`
`“anything major”). These conclusory statements are not enough to establish that
`
`the deviations did not affect the reliability of the tests and justify exclusion.
`
`Rembrandt Vision Techs. v. Johnson & Johnson Vision Care, Inc., 282 F.R.D. 655,
`
`667 (M.D. Fla. 2012) aff'd, 725 F.3d 1377 (Fed. Cir. 2013).
`
`Patent Owner brushes off Rembrandt by insisting the deviations in
`
`Rembrandt were “serious” but according to the ipse dixit of Dr. Paulson, his were
`
`not. (EX1082 at 138:12-139:19.) Rembrandt didn’t focus on the seriousness of
`
`the deviations, but rather whether the methodology complied with generally
`
`accepted scientific standards that made it sufficiently reliable. Id. at 666. EP
`
`standards are governed by well-established criteria and Dr. Paulson’s deviated
`
`from them. For example, Dr. Paulson’s numerous deviations included using
`
`incorrect: (1) initial concentrations of inoculum; (2) concentrations of inoculum
`
`for the neutralization validation testing; (3) media for neutralization validation
`
`procedures; (4) temperature for the molten agar; (5) and the wrong incubation time.
`
`2
`
`
`
`Mot. to Exclude, Paper 62 at 14. Dr. Paulson’s admitted deviations are even more
`
`serious than those of Rembrandt, and just as in Rembrandt, the Board should not
`
`accept Dr. Paulson’s ipse dixit assertions. Rembrandt, 282 F.R.D. at 666.
`
`III. Patent Owner Fails to Justify its Improper Conduct
`Patent Owner really does not dispute that it violated the Board’s Order
`
`barring a surreply, but instead asserts that back-dooring in its surreply declaration
`
`of its expert during Dr. Laskar’s cross-examination is proper because Dr. Laskar
`
`was being cross-examined. Opp’n, Paper 70 at 10-11. Patent Owner’s right to
`
`cross-examine Dr. Laskar does not give counsel for Patent Owner the right to
`
`violate this Board’s Order and read pages upon pages of surreply evidence into the
`
`record under the guise that counsel was properly ‘cross-examining’ Dr. Laskar.
`
`Patent Owner argues that under Fed. R. Evid. 703 “experts can base opinions
`
`on facts or data expert (sic) has been made aware of even if not admissible.”
`
`Opp’n, Paper 70 at 11. There is no evidence that Dr. Laskar was even aware of
`
`these hearsay statements—let alone relied on them. EX2272 at 139:14-19. Rule
`
`703, moreover, does not excuse violating a Board Order, or Patent Owner’s
`
`counsel’s reading pages and pages of sur-reply evidence into the record. Indeed,
`
`Patent Owner does not dispute that the purpose of its use of Exhibits 2266 – 2268
`
`was to introduce evidence that would have been incorporated into a sur-reply.
`
`Patent Owner concedes as much in its Opposition. Opp’n, Paper 70 at 14
`
`3
`
`
`
`(“Moreover, in light of the Board’s denial of Patent Owner’s request for a sur-reply
`
`. . . EX2267 is more probative . . . than any other evidence that the proponent can
`
`obtain at this stage of these proceedings.”) (internal quotations omitted).
`
`IV. EX2267 Is Not Being Offered Under Fed. R. Evid. 702
`Continuing its effort to justify defying the Board’s Order, Patent Owner then
`
`asserts that EX2267 should not be excluded because it is cited to support its motion
`
`to exclude Dr. Laskar under Fed. R. Evid. 702. Opp’n, Paper 70 at 4-5. Patent
`
`Owner does not explain the relevance of the sur-reply evidence to Dr. Laskar’s
`
`qualifications, and does not even provide any analysis of the applicability of Rule
`
`702. To the extent Patent Owner now asserts that EX2267 is relied upon for
`
`impeachment only, that is simply not true because, as Patent Owner states in its
`
`Opposition, it “offers EX2267 as evidence of material fact.” Opp’n, Paper 70 at 6.
`
`V.
`
`EX2266-2268 Are Inadmissible Hearsay
`Patent Owner’s argument that Exhibits 2266 and 2268 are admissible under
`
`Fed. R. Evid. 801(d)(2) is unavailing. An expert’s deposition testimony from a
`
`related proceeding is inadmissible under the rule. SanDisk Corp. v. Kingston Tech.
`
`Co., 863 F. Supp. 2d 815, 818 (W.D. Wis. 2012) (“The mere fact that SanDisk
`
`used Reed as an expert witness in a prior case does not mean that SanDisk believed
`
`all of Reed’s deposition statements were true, that Reed was within SanDisk’s
`
`control or that SanDisk authorized him to speak on its behalf in all matters.”).
`
`4
`
`
`
`Neither Dr. Heathcock nor Dr. Cykiert submitted a declaration in this proceeding.
`
`Patent Owner’s underhanded actions have prevented Petitioner from it right of
`
`redirect examination of Dr. Heathcock and Dr. Cykiert. 37 CFR 42.53(c).
`
`Moreover, if Patent Owner wanted the testimony of third party witnesses Dr.
`
`Heathcock and Dr. Cykiert, the Board’s rules provide a proper mechanism for
`
`obtaining such direct testimony. 37 CFR 42.53(d)(3).
`
`Patent Owner’s remaining argument that the prohibited sur-reply evidence
`
`(Exhibit 2267) is admissible under the residual hearsay exception is unavailing.
`
`The residual exception transforms hearsay evidence into admissible evidence only
`
`in “exceptional” cases and even a substantial guarantee of trustworthiness is not
`
`enough to trigger the residual exception. Pozen Inc. v. Par Pharm., Inc., 696 F.3d
`
`1151, 1161 n.6 (Fed. Cir. 2012); Standard Innovation Corp. v. Lelo, Inc., IPR2014-
`
`00148, Paper 42, 15 (PTAB April 23, 2015) (“The residual exception to the
`
`hearsay rule is to be reserved for exceptional cases, and is not a broad license on
`
`trial judges to admit hearsay statements . . . .”). This does not exclude the violation.
`
`VI. Conclusion
`Exhibits 2266–2268, 2247-2263, 2126, 2128, and any testimony elicited
`
`should be excluded.
`
`Date: April 11, 2016
`
`Respectfully submitted,
`Alston & Bird LLP
`By: /Jitendra Malik/
`Lead Counsel for Petitioners
`
`5
`
`
`
`CERTIFICATION OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4) and 42.105, the undersigned
`
`certifies that on the 11th day of April, 2016, a complete copy of the foregoing
`
`Petitioner’s Reply to Patent Owner’s Opposition to Petitioner’s Motion to Exclude
`
`Under 37 C.F.R. § 42.64(c) was served on counsel of record for the Patent Owner:
`
`Bryan C. Diner
`bryan.diner@finnegan.com
`
`Justin J. Hasford
`justin.hasford@finnegan.com
`
`Joshua L. Goldberg
`Joshua.goldberg@finnegan.com
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`Reg. No. 50893
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`bryan.skelton@alston.com
`
`6
`
`
`
`Lance Soderstrom
`Reg. No. 65405
`Alston & Bird LLP
`90 Park Avenue
`15th Floor
`New York, NY 10016-1387
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`Reg. No. 61,182
`Alston & Bird LLP
`333 South Hope Street
`16th Floor
`Los Angeles, CA 90071
`james.abe@alston.com
`
`Joseph M. Janusz
`Reg. No. 70396
`ALSTON & BIRD LLP
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28205
`Telephone: 704-444-1000
`Fax: 704-444-1111
`joe.janusz@alston.com
`
`Attorneys for Petitioners InnoPharma
`Licensing, Inc., InnoPharma Licensing
`LLC, InnoPharma Inc., InnoPharma
`LLC, Mylan Pharmaceuticals Inc., and
`Mylan Inc.
`
`7
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