Paper No. 72
`Filed: February 28, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`NEPTUNE GENERICS, LLC,
`APOTEX INC., APOTEX CORP., TEVA PHARMACEUTICALS,
`FRESENIUS KABI USA, LLC, and
`WOCKHARDT BIO AG,
`
`PETITIONERS,
`
`V.
`
`ELI LILLY & COMPANY,
`
`PATENT OWNER.
`
`
`
`___________________
`
`Case IPR2016-002401
`Patent 7,772,209
`___________________
`
`
`
`PETITIONER’S REPLY IN SUPPORT OF ITS
`MOTION TO EXCLUDE PATENT OWNER’S EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(c)
`
`
`1 Cases IPR2016-01191, IPR2016-01337 and IPR2016-01343 have been joined
`with the instant proceeding.
`
`
`Filed: February 28, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`NEPTUNE GENERICS, LLC,
`APOTEX INC., APOTEX CORP., TEVA PHARMACEUTICALS,
`FRESENIUS KABI USA, LLC, and
`WOCKHARDT BIO AG,
`
`PETITIONERS,
`
`V.
`
`ELI LILLY & COMPANY,
`
`PATENT OWNER.
`
`
`
`___________________
`
`Case IPR2016-002401
`Patent 7,772,209
`___________________
`
`
`
`PETITIONER’S REPLY IN SUPPORT OF ITS
`MOTION TO EXCLUDE PATENT OWNER’S EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(c)
`
`
`1 Cases IPR2016-01191, IPR2016-01337 and IPR2016-01343 have been joined
`with the instant proceeding.
`
`
`
`I.
`
`THE BOARD SHOULD EXCLUDE EXHIBIT 2120
`
`Lilly argues that the Board should not exclude Dr. Chabner’s testimony (Ex.
`
`2120) because the District Court credited his testimony in a different proceeding.
`
`(Paper 66 at 1-2.) But the Board has held that “the deference a district court
`
`receives for expert credibility determinations is accorded by the Federal Circuit
`
`reviewing an appeal from the district court, not by the Board in an inter partes trial
`
`proceeding.” (Noven Pharm., Inc. v. Novartis AG, IPR2014-00550, Paper 77 at 4
`
`n.8 (denying rehearing of invalidity decision following District Court and Federal
`
`Circuit findings of validity.)
`
`Lilly tries to force these proceedings into the mold that won at the District
`
`Court, ignoring crucial differences between these proceedings and the District
`
`Court case, especially with respect to Dr. Chabner’s testimony. For example, two
`
`of the primary references here—EP 005 (Ex. 1010) and Rusthoven (Ex. 1011)—
`
`were not mentioned in the District Court decision or related Federal Circuit
`
`decision. See Ex. 1027; Eli Lilly v. Teva, 845 F.3d 1357 (Fed. Cir. 2017). All of the
`
`opposing experts are also different than in the District Court. (Compare Ex. 1027
`
`with Exs. 1077, 1078, 1080.) Thus, Dr. Chabner’s testimony before the District
`
`Court is irrelevant here. Noven, Paper 77 at 4 (“The Federal Circuit’s [] decision
`
`does not control here because [Petitioner] has presented additional prior art and
`
`declaratory evidence that was not before the Court”).
`
`
`
`1
`
`
`
`The declaratory evidence in these proceedings shows that Dr. Chabner
`
`“testified based on his own perspective and that he possesses ‘extraordinary,’ not
`
`ordinary, skill in the art, [such that] his conclusions are improper.” Neutrino Dev.
`
`Corp. v. Sonosite, Inc., 410 F. Supp. 2d 529, 550 (S.D. Tex. 2006) (excluding
`
`expert testimony as unreliable based on use of personal, and not a POSA’s
`
`standard to determine obviousness). Lilly tries to justify Dr. Chabner’s use of the
`
`wrong standard by arguing that an invention that would be obvious to one of
`
`ordinary skill in the art should also be obvious to one of extraordinary skill in the
`
`art. (Paper 66 at 3.) Lilly misses the point. The fatal flaw in Dr. Chabner’s
`
`testimony is not his skill beyond that of a POSA, but is the fact that he brought his
`
`own personal biases to the table when rendering his opinions.
`
`For example, Dr. Chabner testified that his personal “views were formed
`
`about folate pretreatment based on [his] extensive work on methotrexate in the
`
`‘70s and ‘80s”—decades before any of the relevant prior art references were
`
`published. (Ex. 1075 at 208:15-20.) Because of this bias, Dr. Chabner further
`
`testified that he required proof that the “regimen that was patented” “worked in the
`
`clinical setting” in order to “change my mind” because “my frame of mind was
`
`that it wasn’t going to work, and this didn’t [] present any evidence to change that,
`
`and what was really needed was clinical evidence to change that mind – my
`
`mindset about it.” (Ex. 1075 at 214:2-25.)
`
`
`
`2
`
`
`
` Dr. Chabner did not testify as to a POSA’s reasonable expectation of
`
`success, because this “does not necessitate an absolute certainty for success” from
`
`clinical evidence. Par Pharm., Inc.v. TWi Pharms., Inc., 773 F.3d 1186, 1198 (Fed.
`
`Cir. 2014). Instead, a POSA would have a reasonable expectation of success here
`
`where the prior art discloses “initiated human clinical trials for a therapeutic
`
`product or process.” In re Montgomery, 677 F.3d 1375, 1382-83 (Fed. Cir. 2012).
`
`Because Dr. Chabner “failed to analyze the patents from the correct perspective,
`
`his opinions are inadmissible as unreliable.” Weber-Stephen Prods. LLC v. Sears
`
`Holding Corp., 2015 U.S. Dist. LEXIS 170989, *17 (N.D. Ill. Dec. 22, 2015); Am.
`
`Med. Sys. v. Laser Peripherals, LLC, 712 F. Supp. 2d 885, 901 (D. Minn. 2010)
`
`(Expert opinions are “inadmissible [if] they are based on incorrect legal
`
`standards.”) (citing Hebert v. Lisle Corp., 99 F.3d 1109, 1117 (Fed. Cir. 1996)).
`
`II. THE BOARD SHOULD EXCLUDE EXHIBIT 2116
`Lilly does not refute the facts establishing that Dr. Niyikiza’s testimony
`
`(Ex. 2116) is hearsay: Dr. Niyikiza’s prior testimony was not made while testifying
`
`in these IPRs; and his testimony is offered to prove the truth of the matter asserted.
`
`Instead, Lilly suggests Dr. Niyikiza’s cross-examination at the District Court
`
`allows it to rely on his former testimony. This is not so. Fed. R. Evid. 804(b)(1)(B)
`
`provides that former testimony is only exempted from the hearsay rule if “the
`
`declarant is unavailable as a witness.” Lilly states that Dr. Niyikiza is not under
`
`
`
`3
`
`
`
`Lilly’s “control,” but never asserts that he is unavailable. (Paper 66 at 9.)
`
`Moreover, the former testimony exception is limited to prior testimony offered
`
`against the same party who had a chance to cross-examine the witness, an
`
`opportunity Neptune never had. See Fed. R. Evid. 804(b)(1)(B). Nothing suggests
`
`Teva’s cross-examination can serve as a substitute – particularly since Teva did not
`
`examine the context of the particular hearsay testimony on which Lilly now relies.
`
`Lilly’s cases do not hold otherwise. In Petroleum Geo-Services v.
`
`WesternGeco, prior testimony was admissible “because Petitioner had the
`
`opportunity to cross-examine [the witness] in this proceeding[.]” IPR2014-01477,
`
`Paper 71 at 75-76. Arceo and Inadi did not involve hearsay testimony used to avoid
`
`cross-examination. See Arceo v. City of Junction City, 182 F. Supp. 2d 1062, 1080-
`
`81 (D. Kan. 2002); United States v. Inadi, 475 U.S. 387, 394 (1986).
`
`By contrast, the Board’s holding that prior testimony was entitled to no
`
`weight in Organik Kimya AS v. Rohm & Haas Co. is directly on point. IPR2014-
`
`00185, Paper 42 at 2. Lilly argues that the issues were not “the same” in the prior
`
`proceeding in Organik, but this is belied by the fact that prior anticipation-related
`
`testimony was considered relevant to whether the motion to amend in the later
`
`proceeding overcame the anticipatory art. Like Organik, Lilly’s attempted end-run
`
`around the Board’s rules requiring an affidavit and cross-examination should result
`
`in exclusion, or at minimum, the testimony being given no weight. See 37 C.F.R.
`
`
`
`4
`
`
`
`§ 42.53(a), (b)(1)(ii). Further, Lilly cannot hide behind the “prepared for the
`
`proceeding” clause of the affidavit rule here where Dr. Niyikiza’s testimony was
`
`“affirmatively relied upon by a patent owner” and thus interjected into the current
`
`IPR. See Altaire Pharm. v. Paragon Bioteck, PGR2015-00011, Paper 29 at 2.
`
`Finally, corroboration cannot salvage Dr. Niyikiza’s hearsay. (Paper 66 at
`
`10.) Rather than corroborating Dr. Niyikiza’s testimony, Dr. Feigal disagreed that
`
`the FDA believed folic acid would reduce efficacy, testifying that “FDA was no
`
`expressing skepticism as to the benefits of vitamin supplementation, but was
`
`merely performing its statutory duty in requiring that Lilly submit data providing
`
`justification for introducing folate and B12 supplementation”. (Ex. 1080 ¶ 41.)
`
`Moreover, corroboration has no relevance to hearsay.
`
`Lilly’s defends Dr. Niyikiza’s double hearsay about others’ statements of
`
`skepticism by arguing these statements are not offered for their truth because
`
`“what matters to skepticism is that they were said.” (Paper 66 at 14.) This is false.
`
`A third party’s hearsay statement “I am skeptical” can have no bearing on whether
`
`skepticism existed unless offered for the truth. See CaptionCall. v. Ultratec,
`
`IPR2015-00636, Paper 97 (rejecting argument that testimony relating to secondary
`
`considerations was not offered for the truth of the matter asserted). Further, it is
`
`telling that the district court’s stated reasoning for allowing such hearsay was, “I’ll
`
`overrule it. It’s interesting. I would like to hear it.” (Ex. 2116 at 722-23.)
`
`
`
`5
`
`
`
`Respectfully Submitted,
`
`/Sarah E. Spires/
`Sarah E. Spires (Reg. No. 61,501)
`SKIERMONT DERBY LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6601
`Lead Counsel for Petitioner
`
`Dr. Parvathi Kota (Reg. No. 65,122)
`Paul J. Skiermont (pro hac vice)
`SKIERMONT DERBY LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6621
`
`Mieke K. Malmberg (pro hac vice
`requested)
`SKIERMONT DERBY LLP
`800 Wilshire Boulevard
`Los Angeles, CA 90017
`P: 213-788-4500/F: 213-788-4545
`Back-Up Counsel for Petitioner
`
`
`
`February 28, 2017
`
`
`
`
`
`6
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served on the
`
`counsel for Patent Owner a true and correct copy of the foregoing Petitioner’s
`
`Reply in Support of Its Motion to Exclude Patent Owner’s Evidence Pursuant to 37
`
`C.F.R. § 42.64(c), by electronic means on February 28, 2017 at the following
`
`addresses of record:
`
`Dov P. Grossman (Reg. No. 72,525)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`Direct Phone: 202-434-5812
`Facsimile: 202-434-5029
`dgrossman@wc.com
`Lead Counsel for Patent Owner
`
`Adam L. Perlman (pro hac vice)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`Direct Phone: 202-434-5244
`Facsimile: 202-434-5029
`aperlman@wc.com
`Back-Up Counsel for Patent Owner
`
`John C. Demeter (Reg. No. 30,167)
`ELI LILLY AND COMPANY
`Lilly Corporate Center
`Indianapolis, IN 46285
`Direct Phone: 317-276-3785
`Facsimile: 317-276-3861
`demeter_john_c@lilly.com
`Back-Up Counsel for Patent Owner
`
`
`
`
`
`David M. Krinsky (Reg. No. 72,339)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`Direct Phone: 202-434-5338
`Facsimile: 202-480-8302
`dkrinsky@wc.com
`Back-Up Counsel for Patent Owner
`
`James P. Leeds (Reg. No. 35,241)
`ELI LILLY AND COMPANY
`Lilly Corporate Center
`Indianapolis, IN 46285
`Direct Phone: 317-276-1667
`Facsimile: 317-277-6534
`leeds_james@lilly.com
`Back-Up Counsel for Patent Owner
`
`John D. Polivick (Reg. No. 57,926)
`RAKOCZY MOLINO
`MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Tel: 312-527-2157
`Fax: 312-527-4205
`jpolivick@rmmslegal.com
`Lead Counsel for Petitioner Apotex
`
`
`
`
`
`Patrick C. Kilgore (Reg. No. 69,131)
`RAKOCZY MOLINO
`MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Tel: 312-527-2157
`Fax: 312-527-4205
`pkilgore@rmmslegal.com
`Back-Up Counsel for Petitioner Apotex
`
`Mark D. Schuman (Reg. No. 31,197)
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST AND SCHUMAN
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Tel: 612-436-9600
`Fax: 612-436-9605
`mschuman@carlsoncaspers.com
`Back-Up Counsel for Petitioner Teva
`
`Patrick A. Doody
`(Reg. No. 35,002)
`PILLSBURY WINTHROP SHAW
`PITTMAN LLP
`1650 Tysons Boulevard
`McLean, Virginia 22102
`Tel: 703-770-7538
`Fax: 703-770-7901
`patrick.doody@pillsburylaw.com
`Lead Counsel for Wockhardt Bio AG
`
`Deanne M. Mazzochi (Reg. No. 50,158)
`RAKOCZY MOLINO
`MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Tel: 312-527-2157
`Fax: 312-527-4205
`dmazzochi@rmmslegal.com
`Back-Up Counsel for Petitioner Apotex
`
`Gary J. Speier (Reg. No. 45,458)
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST AND SCHUMAN
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Tel: 612-436-9600
`Fax: 612-436-9605
`gspeier@carlsoncaspers.com
`Lead Counsel for Petitioner Teva
`
`Cynthia Lambert Hardman
`(Reg. No. 45,458)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, New York 10018-1405
`Tel: 212-813-8800
`Fax: 212-355-3333
`chardman@goodwinprocter.com
`Back-Up Counsel for Petitioner Teva
`
`
`
`
`
`
`
`
`
`
`
`Respectfully Submitted,
`
`/Sarah E. Spires/
`Sarah E. Spires (Reg. No. 61,501)
`
`Lead Counsel for Petitioner
`
`
`
`Bryan P. Collins
`(Reg. No. 43,560)
`PILLSBURY WINTHROP SHAW
`PITTMAN LLP
`1650 Tysons Boulevard
`McLean, Virginia 22102
`Tel: 703-770-7755
`Fax: 703-770-7901
`bryan.collins@pillsburylaw.com
`Back-Up Counsel for Wockhardt Bio AG
`
`Dated: February 28, 2017
`
`
`
`
`
`
`
`
`
`
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