Paper No. 65
`Filed: February 21, 2016
`
`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 RESPONSE TO PATENT OWNER’S MOTION FOR
`OBSERVATIONS ON THE DEPOSITION OF PETITIONER NEPTUNE
`GENERIC’S EXPERT JOEL B. MASON, M.D.
`
`
`
`
`1 Cases IPR2016-01191, IPR2016-01337 and IPR2016-01343 have been joined
`with the instant proceeding.
`
`
`
`
`
`
`Filed: February 21, 2016
`
`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 RESPONSE TO PATENT OWNER’S MOTION FOR
`OBSERVATIONS ON THE DEPOSITION OF PETITIONER NEPTUNE
`GENERIC’S EXPERT JOEL B. MASON, M.D.
`
`
`
`
`1 Cases IPR2016-01191, IPR2016-01337 and IPR2016-01343 have been joined
`with the instant proceeding.
`
`
`
`
`
`
`
`Petitioner respectfully requests that the Board dismiss Patent Owner’s
`
`Motion for Observations on the Deposition of Petitioner Neptune Generic’s Expert
`
`Joel B. Mason, M.D. (“Motion”) and expunge its supporting exhibits because the
`
`purported observations in the Motion are a masked attempt to submit an
`
`argumentative surreply in contravention of the Board’s guidance and prior
`
`decisions. Instead of a short statement of relevance, Patent Owner’s observations
`
`include argument, some of which spans several sentences or is strung together with
`
`a series of semicolons. (E.g., Paper 59, observations 1, 2, 3, 4, 5.) Neptune
`
`discusses particularly egregious examples in further detail below.
`
`As the Office Patent Trial Practice Guide makes clear, “[a]n observation
`
`should be a concise statement of the relevance of identified testimony to an
`
`identified argument or portion of an exhibit…[It] is not an opportunity to raise new
`
`issues, re-argue issues, or pursue objections.” 77 Fed. Reg. 48,755, 48,767-8 (Aug.
`
`14, 2012). The Board has further noted that “each item included as an observation
`
`on cross-examination should be precise, preferably no more than one short
`
`sentence in the explanation of relevance. Observations on cross-examination are
`
`not meant to serve the purpose of an argumentative surreply.” Atrium Medical
`
`Corporation v. Davol Inc., IPR2013-00189, Paper 48 (February 28, 2014) at 2.
`
`“The Board may refuse entry of excessively long or argumentative
`
`observations (or responses)” such as the observations contained in Patent Owner’s
`
`
`
`1
`
`
`
`Motion. See 77 Fed. Reg. 48,755, 48,767-8 (Aug. 14, 2012). In fact, the Board has
`
`previously considered proposed observations similar to the Patent Owner’s
`
`submissions and dismissed them as containing improper argument. In Medtronic
`
`Inc. v. Nuvasive, Inc., the Board reviewed proposed observations that “cite[d]
`
`several pages of [the witness’s] testimony, as opposed to one portion” and
`
`“proceed[ed] to present an argument that the testimony is relevant…” IPR2013-
`
`00506, Paper 37 (October 15, 2014) at 3-4. The Board found the statements
`
`improper, dismissed the Motion, and expunged the relevant exhibits. Id.; see also
`
`LG Elecs., Inc. v. ATI Techs ULC, IPR2015-00325, Paper 52 at 2-5 (January 25,
`
`2016).
`
`While Petitioner maintains that the Board should dismiss the Motion without
`
`considering Patent Owner’s proposed observations due to their inclusion of
`
`argument, Petitioner has responded to the proposed observations below.
`
`Response to Observation # 1
`
`
`
`Patent Owner attempts to set up a contradiction that does not exist and
`
`misleadingly cites to allegedly supporting papers filed in this proceeding, including
`
`Petitioner’s Reply (Paper No. 47), which does not support Patent Owner’s
`
`observation at all. Accordingly, Patent Owner’s observation is nothing more than
`
`an improper attempt to submit an argumentative surreply. First, although Dr.
`
`Mason testified that when administering Vitamin B12 to a Vitamin B12 replete
`
`
`
`2
`
`
`
`patient “you’re probably not going to further lower homocysteine levels,” Patent
`
`Owner ignores testimony wherein Dr. Mason also indicated that none of the tests
`
`are perfect. Ex. 2134 at 146:7-20. Additionally, Dr. Mason did not testify, as
`
`Patent Owner attempts to argue, that it would not have been obvious to administer
`
`Vitamin B12 as a pretreatment to pemetrexed. In fact, Dr. Mason unequivocally
`
`testified, consistent with his expert report, that certain patient populations are more
`
`likely to present with Vitamin B12 deficiencies and “the POSA would have been
`
`treating a lot, many, most of his patients about to embark on pemetrexed with
`
`Vitamin B12.” Ex. 2134 at 182:11-14; Ex. 2134 at 126:22-129:11 (testifying that
`
`“a POSA would likely have been particularly attune to certain patient groups that
`
`might be at a higher risk of B12 depletion” and, therefore, treated them with B12
`
`before those patients received pemetrexed); Ex. 2134 at 129:12-130:17; see also
`
`Ex. 2134 at 140:18-141:7 (testifying that “[s]ince B12 has little or no side effects”
`
`it would not be “inappropriate to co-administer B12 with folic acid.”); Ex. 2134 at
`
`122:7-15 (testifying that “a person of ordinary skill in the art would have pretreated
`
`those who were found to have a low vitamin B12 status . . .”); Ex. 1078 at ¶¶ 58 et.
`
`seq.; Ex. 1078 ¶¶86-87, 91. This is in direct contradiction to Patent Owner’s
`
`misleading statements and attorney argument indicating a POSA would allegedly
`
`be motivated to administer Vitamin B12 “only to patients who are not Vitamin B12
`
`deficient”– an argument that Patent Owner misleadingly sets forth in its
`
`
`
`3
`
`
`
`observation and which does not appear in Petitioner’s Reply. See Paper No. 47 at
`
`27 (stating that the “methyl trap” would only be a concern for B12 deficient
`
`patients, who would be identified and repleted prior to pemetrexed therapy, and
`
`further stating that a POSA would not retrain from using Vitamin B12 in non-B12-
`
`deficient patients.). Furthermore, Dr. Mason testified, contrary to Patent Owner’s
`
`attorney argument appearing in the observation but consistent with his expert
`
`report and Petitioner’s Reply, that the “methyl trap” – wherein administering B12
`
`to a B12 deficient patient can potentially cause usable folate to be released – would
`
`only be a concern for a B12 deficient patient-which patients would be repleted
`
`prior to pemetrexed therapy. Ex. 2134 at 21:10-21; Ex. 1078 at ¶¶53-56.
`
`Response to Observation # 2
`
`
`
`Patent Owner mischaracterizes and misstates Dr. Mason’s testimony; Patent
`
`Owner’s observation that Dr. Mason’s testimony somehow supports Patent
`
`Owner’s argument that the administration of Vitamin B12 may release an
`
`unpredictable amount of reduced folate making it available for cancer cells is
`
`nothing more than wishful thinking. First, consistent with his expert report, Dr.
`
`Mason testified that Patent Owner’s argument was “theoretical” at best. Ex. 2134
`
`at 32:12-14 (“on a theoretical basis, if vitamin B12 was administered to a B12
`
`replete patient, it might make more tetrahydrofolate available.”) (emphasis added);
`
`Ex. 1078 at ¶49. And, consistent with his expert report, Dr. Mason testified that
`
`
`
`4
`
`
`
`the “methyl trap” – wherein administering B12 to a B12 deficient patient can
`
`potentially cause folate to be released – would only be a concern for a B12
`
`deficient patient. Ex. 2134 at 21:10-21; Ex. 1078 at ¶¶53-56. Additionally, Dr.
`
`Mason testified, consistent with his expert report, that such deficient patients
`
`would be repleted before undergoing pemetrexed treatment and therefore the
`
`“methyl trap” would not be an issue at all for those patients – let alone
`
`“worrisome” as Patent Owner misleadingly argues. Ex. 2134 at 126:22-129:11
`
`(testifying that “a POSA would likely have been particularly attune to certain
`
`patient groups that might be at a higher risk of B12 depletion” and, therefore,
`
`treated them with B12 before those patients received pemetrexed); Ex. 2134 at
`
`129:11-130:17; Ex. 1078 at ¶¶52-56.)
`
`Response to Observation # 3
`
`
`
`Patent Owner’s claim that Dr. Mason’s testimony supports Patent Owner’s
`
`argument that folic acid and vitamin B12 pretreatment is non-obvious is
`
`misleading and employs twisted attorney argument, which is highly inappropriate
`
`in a motion for observation. In fact, Dr. Mason unequivocally testified, consistent
`
`with his expert report, that (in 1999) “the common practice was pretreatment with
`
`folic acid and B12.” Ex. 2134 at 186:17-27. Furthermore, Dr. Mason testified that
`
`“the POSA would have been treating a lot, many, most of his patients about to
`
`embark on pemetrexed with Vitamin B12.” Ex. 2134 at 182:11-14; see also Ex.
`
`
`
`5
`
`
`
`2134 at 140:18-141:7 (testifying that “[s]ince B12 has little or no side effects” it
`
`would not be “inappropriate to co-administer B12 with folic acid.”); Ex. 2134 at
`
`122:7-15 (testifying that “a person of ordinary skill in the art would have pretreated
`
`those who were found to have a low vitamin B12 status . . .”); Ex. 1078 at ¶¶ 58 et.
`
`seq.; Ex. 1078 ¶¶86-87, 91. This is in direct contradiction to Patent Owner’s
`
`misleading statements and attorney argument indicating that folic acid and vitamin
`
`B12 pretreatment is non-obvious.
`
`Additionally, Patent Owner misleadingly claims that Dr. Mason’s testimony
`
`somehow supports Patent Owner’s argument that the pretreatment of folic acid and
`
`Vitamin B12 would reduce pemetrexed’s efficacy. However, Patent Owner
`
`outright ignores Dr. Mason’s testimony wherein Dr. Mason testified that “since
`
`pemetrexed inhibits DHFR, it’s not going to make folic acid available in a form
`
`that is going to negate pemetrexed’s efficacy.” Ex. 2134 at 47:24:48:11; see also
`
`2134 at 48:12-49:3 (testifying that “pemetrexed inhibits DHFR to a degree that
`
`makes it impossible for folic acid to be converted into those cellular forms of folate
`
`. . .folic acid should not be capable of interfering with the efficacy of
`
`pemetrexed.”); Ex. 2134 at 65:12-22 (testifying that a POSA would have expected
`
`folic acid not to interfere with efficacy because pemetrexed blocks DHFR).
`
`
`
`6
`
`
`
`Response to Observation # 4
`
`Patent Owner’s claim that Dr. Mason’s testimony somehow supports Patent
`
`Owner’s statement that folic acid pretreatment would serve as “an antidote to
`
`pemetrexed” is misleading, attorney argument, and nothing more than an improper
`
`attempt to submit an argumentative surreply. Rather than focusing on the
`
`testimony actually given by Dr. Mason and a short sentence concerning relevance,
`
`Patent Owner instead opts to cite to multiple snippets of testimony and provide
`
`several sentences of inappropriate attorney argument – both of which are
`
`unacceptable in an observation. In fact, Patent Owner outright ignores Dr.
`
`Mason’s testimony wherein Dr. Mason testified that “since pemetrexed inhibits
`
`DHFR, it’s not going to make folic acid available in a form that is going to negate
`
`pemetrexed’s efficacy.” Ex. 2134 at 47:24:48:11; see also 2134 at 48:12-49:3
`
`(testifying that “pemetrexed inhibits DHFR to a degree that makes it impossible for
`
`folic acid to be converted into those cellular forms of folate . . .folic acid should
`
`not be capable of interfering with the efficacy of pemetrexed.”); Ex. 2134 at 65:12-
`
`22 (testifying that a POSA would have expected folic acid not to interfere with
`
`efficacy because pemetrexed blocks DHFR).
`
`Response to Observation # 5
`
`
`
`Patent Owner’s claim that Dr. Mason’s testimony concerning common
`
`practice to pretreat methotrexate with folic acid and Vitamin B12 somehow
`
`
`
`7
`
`
`
`undermines his expertise and credibility is both misleading and employs
`
`inappropriate attorney argument. First, Dr. Mason, in contrast to Dr. Chabner
`
`(Patent Owner’s expert) and Dr. Bleyer (Petitioner’s expert) is not being offered as
`
`a POSA, defined as a “medical doctor with an M.D. degree who has significant
`
`experience treating cancer patients.” Ex. 1078 at ¶18. Dr. Mason, consistent with
`
`his testimony and his declaration, is offered as an expert in nutrition and the role of
`
`folates and B-vitamins in human nutrition, particularly as it pertains to cancer. Ex.
`
`1078 ¶20. Accordingly, Dr. Mason is more than qualified as an expert to speak on
`
`those topics for which he is offered. Additionally, Dr. Mason qualified his
`
`statement with “I believe the common practice was . . .” (Ex. 2134 at 182:11-14).
`
`Accordingly, issues pertaining to the use of Vitamin B12 pretreatments with
`
`methotrexate in 1999 were outside the scope of Dr. Mason’s report in this matter
`
`and a point on which he did not render an opinion. Furthermore, as Petitioner
`
`explored at length in Petitioner’s Reply (Paper No. 47), Dr. Chabner presented
`
`with a number of credibility issues and even applied the wrong obviousness
`
`standards, so Patent Owner’s reliance on Dr. Chabner’s testimony in this instance
`
`is not only suspect, but also an improper attempt to submit an argumentative
`
`surreply. Additionally, Patent Owner mischaracterizes Dr. Bleyer’s testimony
`
`appearing in the very same paragraph of his declaration cited by Patent Owner
`
`which states, that Vitamin B12 was not used as a pretreatment per se with
`
`
`
`8
`
`
`
`methotrexate, “but as appropriate and needed in selected patients considered to be
`
`at risk of vitamin B12 deficiency.” Ex. 1077 ¶61. Accordingly, Dr. Bleyer’s
`
`testimony does not support the point for which it is offered. In sum, Patent
`
`Owner’s observation is an improper attempt to submit an argumentative surreply.
`
`Response to Observation # 6
`
`
`
`Patent Owner’s observation that Dr. Mason’s testimony somehow supports
`
`Patent Owner’s argument that a POSA would have believed that folic acid
`
`pretreatment would risk accelerating the growth of the tumor is not only
`
`misleading, but the testimony does not at all support Patent Owner’s argument.
`
`Patent Owner leaves out Dr. Mason’s testimony, appearing in the very same
`
`portion of the cited transcript, stating, with respect to his paper, that “if you’re
`
`implying that this might somehow be relevant to the issue at hand with this
`
`petition, I would argue that it’s not analogous or relevant in that the petition is
`
`talking about people that are about to embark on pemetrexed therapy.” Ex. 2134
`
`at 165:20-35 (emphasis added). Patent Owner also leaves out Dr. Mason’s
`
`testimony wherein he states that although “folate can help promote the
`
`proliferation of rapidly dividing cells . . . administering it to the general population,
`
`the vast majority of whom do not harbor any precancer or cancerous lesions, is
`
`different than administering folic acid to a population of people who are about to
`
`embark on antifolate therapy.” 2134 at 165:25-166:7 (emphasis added).
`
`
`
`9
`
`
`
`Response to Observation # 7
`
`
`
`Patent Owner’s observation that Dr. Mason’s testimony somehow
`
`contradicts the testimony of Dr. Bleyer is misleading. Although Patent Owner
`
`argues that Dr. Mason’s testimony somehow supports Patent Owner’s assertion
`
`that Dr. Farber’s work is relevant to other solid tumors, not just leukemia, Patent
`
`Owner ignores the very same portion of Dr. Mason’s testimony where, when
`
`explicitly asked about the differentiations made in the literature between folic
`
`acid’s effect on solid tumors and leukemia, Dr. Mason replied, “I don’t think I’m
`
`going to answer that . . . people didn’t try to – there was little attempt to
`
`distinguish effects of the different types of tumors.” Ex. 2134 at 170:25-171:11
`
`(emphasis added). Dr. Mason also testified, when asked about “a sense in the
`
`field, for example, that folic acid would encourage the growth of leukemia but
`
`would not have a similar effect on solid tumors?” he responded, “there was so little
`
`known about this potential effect that I think it’s fair to say that the scientists
`
`probing this phenomena didn’t know what to expect in terms of which tumors it
`
`might affect, which tumors it might not affect.” Ex. 2134 at 171:12-22.
`
`Additionally, Dr. Mason’s testimony does not contradict the testimony of Dr.
`
`Bleyer, which is also misleadingly cited in Patent Owner’s observation. Dr. Bleyer
`
`did not refer at all to solid tumors in the paragraph cited by Patent Owner, as Patent
`
`Owner suggests. Furthermore, Dr. Bleyer, in the very same paragraph cited by
`
`
`
`10
`
`
`
`Patent Owner, indicated that even leukemia patients who were folate or vitamin
`
`B12 deficient would be pretreated, which is completely consistent with Dr.
`
`Mason’s testimony and report. Ex. 1025 at ¶89; Ex. 2134 at 186:17-27; Ex. 2134
`
`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
`
`at 122:7-15; Ex. 1078 at ¶¶52-56.
`
`
`
`February 21, 2017
`
`
`
`
`
`11
`
`
`
`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
`
`Response to Patent Owner’s Motion for Observations on the Deposition of
`
`Petitioner Neptune Generic’s Expert Joel B. Mason, M.D., by electronic means on
`
`February 21, 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 21, 2017
`
`
`
`
`
`
`
`
`
`
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