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., MYLAN INC., LUPIN LTD., and LUPIN
`PHARMACEUTICALS, INC.
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`
`Case IPR2015-00903 (Patent 8,129,431 B2)1
`
`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)
`
`1 IPR2015-01871 has been joined with IPR2015-00903.
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., MYLAN INC., LUPIN LTD., and LUPIN
`PHARMACEUTICALS, INC.
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`
`Case IPR2015-00903 (Patent 8,129,431 B2)1
`
`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)
`
`1 IPR2015-01871 has been joined with IPR2015-00903.
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`PATENT OWNER FAILS TO JUSTIFY ITS IMPROPER CONDUCT......... 1
`
`II. EX2267 IS NOT BEING OFFERED UNDER FED. R. EVID. 702 ................ 2
`
`III.
`
`EX2266 –2268 ARE INADMISSIBLE HEARSAY .................................... 3
`
`IV. CONCLUSION ........................................................................................... 5
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`Pozen Inc. v. Par Pharm., Inc.,
`696 F.3d 1151 (Fed. Cir. 2012)..........................................................................4
`SanDisk Corp. v. Kingston Tech. Co.,
`863 F. Supp. 2d 815 (W.D. Wis. 2012)..........................................................3, 4
`RULES
`Fed. R. Evid. 702 ................................................................................................2, 3
`Fed. R. Evid. 703 ................................................................................................1, 2
`Fed. R. Evid. 801(d)(2).......................................................................................3, 4
`Fed. R. Evid. 807 ....................................................................................................4
`OTHER AUTHORITIES
`37 C.F.R. § 42.53(c) ...............................................................................................4
`37 CFR § 42.53(d)(3)..............................................................................................4
`
`ii
`
`
`
`I.
`
`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 64 at 2-3. 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.”
`
`Patent Owner's Opp’n, Paper 64 at 3. However, Patent Owner fails to show how
`
`Dr. Laskar relied upon the Reply Expert Report of Dr. Davies (EX2267) or the
`
`deposition transcripts of Dr. Heathcock and Dr. Cykiert that Patent Owner’s
`
`counsel read into testimony. For example, there is no evidence that Dr. Laskar was
`
`even aware of Dr. Davies’ Reply Expert Report or the testimony provided Dr.
`
`Heathcock and Dr. Cykiert—let alone relied on it. See, e.g., EX2272 at 139:14-19.
`
`Moreover, Patent Owner’s questioning does not even test the veracity of Dr.
`
`Laskar’s opinions as Dr. Laskar’s deposition transcript shows that Patent Owner’s
`
`counsel merely reads portions of the exhibits into the record and fails to
`
`substantively engage Dr. Laskar in any substantive line of questioning. EX2272 at
`
`1
`
`
`
`119:7–121:12 (reading portions of Exhibit 2266), at 134:15-139:19 (reading
`
`portions of Exhibit 2267), at 141:7–144:20 (reading portions of Exhibit 2268).
`
`Accordingly, it is clear that Patent Owner was uninterested in using the exhibits to
`
`question Dr. Laskar and was focused on attempting to ensure that the substantive
`
`portions of the exhibits were received, albeit improperly, into evidence.
`
`Lastly, Rule 703 does not excuse Patent Owner’s conduct by which it
`
`violated a Board Order. 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 surreply. Patent Owner concedes as much in its Opposition.
`
`Opp’n, Paper 64 at 6 (“Moreover, in light of the Board’s denial of Patent Owner’s
`
`request for a surreply . . . EX2267 is more probative . . . than any other evidence
`
`that the proponent can obtain at this stage of these proceedings.”) (internal
`
`quotations omitted). The Board should put a stop to Patent Owner’s egregious
`
`conduct, which stands in derogation of the Board’s Order, by excluding Exhibits
`
`2266 – 2268.
`
`II.
`
`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 of its
`
`motion to exclude Dr. Laskar under Fed. R. Evid. 702. Opp’n, Paper 64 at 4-5.
`
`Patent Owner does not explain the relevance of surreply evidence to Dr. Laskar’s
`
`2
`
`
`
`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 purposes only (Opp’n, Paper 64 at 4-5), that is simply not true
`
`because, as Patent Owner states in its Opposition, it “offers EX2267 as evidence of
`
`material fact.” Opp’n, Paper 64 at 6. Patent Owner has no valid reason for
`
`offering EX2267, and, thus, it should be excluded.
`
`III. 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. Patent Owner merely repeats the text of the
`
`rule with the conclusory claim that Exhibits 2266 and 2268 fit within the exception
`
`and has failed to prove that any of the exceptions apply. Contrary to Patent
`
`Owner’s assertion, an expert’s deposition testimony from a different proceeding is
`
`inadmissible under the rule. See 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.”). Notably, in
`
`SanDisk, the court held that all of the subsections of the rule were inapplicable; in
`
`other words, the rule did not save the expert’s testimony from being inadmissible
`
`3
`
`
`
`hearsay. Id. (“None of the categories of statements deemed party admissions by
`
`Rule 801(d)(2) apply to [the expert’s] testimony.”).
`
`Neither Dr. Heathcock nor Dr. Cykiert submitted a declaration in this
`
`proceeding. Patent Owner’s underhanded actions have prevented Petitioner from
`
`its right of redirect examination of Dr. Heathcock and Dr. Cykiert. 37 C.F.R. §
`
`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. See 37 CFR 42.53(d)(3).
`
`Patent Owner’s remaining argument that the prohibited surreply evidence
`
`(EX2267) is admissible under the residual hearsay exception is unavailing. The
`
`Federal Circuit has held that 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) (refusing to
`
`admit a sworn declaration under Fed. R. Evid. 807); see, e.g. Standard Innovation
`
`Corp. v. Lelo, Inc., IPR2014-00148, Paper 42, 15 (PTAB April 23, 2015)
`
`(excluding evidence as hearsay and holding that “[t]he 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 that do not fall within one of the other
`
`4
`
`
`
`exceptions.”) (internal quotations and citations omitted). Rule 807 also does not
`
`excuse violating the Board’s Order.
`
`IV.
`
`CONCLUSION
`Exhibits 2266–2268 and any testimony elicited should be excluded.
`
`Date: April 11, 2016
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`Lead Attorney 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.
`
`Deborah H. Yellin (Reg. No. 45,904)
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Avenue, N.W.
`Washington, DC 20004-2595
`Telephone No.: (202) 624-2947
`Facsimile No.: (202) 628-5116
`
`7
`
`
`
`DYellin@Crowell.com
`
`Jonathan Lindsay (Reg. No. 45,810)
`Crowell & Moring LLP
`Intellectual Property Group
`3 Park Plaza, 20th Floor
`Irvine, CA 92614-8505
`Telephone No.: (949) 798-1325
`Facsimile No.: (949) 263-8414
`JLindsay@Crowell.com
`
`Shannon Lentz (Reg. No. 65,382)
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave., N.W.
`Washington, DC 20004-2595
`Telephone No.: (202)624-2897
`Facsimile No.: (202)628-5116
`SLentz@Crowell.com
`
`Attorneys for Petitioners Lupin Ltd. and
`Lupin Pharmaceuticals, Inc.
`
`8
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