Paper No. 69
`Filed: February 22, 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 IPR2016-002371
`Patent 7,772,209
`___________________
`
`
`
`PETITIONER’S RESPONSE TO PATENT OWNER’S MOTION FOR
`OBSERVATIONS ON THE DEPOSITION OF PETITIONER NEPTUNE
`GENERIC’S EXPERT DAVID W. FEIGAL, JR., M.D.
`
`
`
`
`1 Cases IPR2016-01190, IPR2016-01335 and IPR2016-01341 have been joined
`with the instant proceeding.
`
`
`
`
`
`
`Filed: February 22, 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 IPR2016-002371
`Patent 7,772,209
`___________________
`
`
`
`PETITIONER’S RESPONSE TO PATENT OWNER’S MOTION FOR
`OBSERVATIONS ON THE DEPOSITION OF PETITIONER NEPTUNE
`GENERIC’S EXPERT DAVID W. FEIGAL, JR., M.D.
`
`
`
`
`1 Cases IPR2016-01190, IPR2016-01335 and IPR2016-01341 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
`
`David W. Feigal, Jr., 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.
`
`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
`
`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
`
`
`
`1
`
`
`
`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’s claim that Dr. Feigal is not “rendering an opinion on that
`
`subject [of obviousness]” is misleading. Dr. Feigal clearly testified that although
`
`he was not opining about obviousness “in the patent sense,” he was opining that
`
`“in the everyday meaning of that language there has been a role in vitamins in the
`
`evaluation of most of the antifolate drugs so in that sense of a developing a new
`
`one, it is an obvious aspect of developing this class of drugs.” Ex. 2133 at 16:13-
`
`20. He further testified that the FDA documents at issue “reflect [] the fact the
`
`FDA recognized that with antifolate drugs that folate is sometimes part of the
`
`regimen in order to have drugs that are safer and more effective. So most of the
`
`
`
`2
`
`
`
`discussions where not about whether this made sense, but how exactly to study it
`
`and meet the statutory requirements for approval.” Ex. 2133 at 18:3-14; see also
`
`Ex. 2133 at 21:23-22:20. Consistent with these statements and his report, Dr.
`
`Feigal testified that: (1) the FDA “insisting on having a statistical plan before
`
`agreeing to make a change to include vitamins in the clinical trials and having a
`
`statistical plan does not bear on the issue of whether – whether vitamins were
`
`obvious or not” (Ex. 2133 at 18:22-19:4; Ex. 1080 ¶39(a) (emphasis added)); (2)
`
`modifying clinical protocol in the midst of trial “is a very generic issue that has to
`
`do with what happens with trials that are split and trials that are modified in the
`
`course that may become difficult to interpret so it doesn’t directly relate to the
`
`issue of obviousness” (Ex. 2133 at 19:6-16 (emphasis added); Ex. 1080 ¶39(b));
`
`(3) changing a treatment midstream becomes an issue “because the first half of the
`
`study and the second half, that’s not a randomized comparison that – that such
`
`studies are difficult to interpret no matter what the topic of the study is so, again,
`
`that’s why I felt in my opinion the FDA was raising these issues as issues that
`
`would undermine the quality of the evidence necessary for approval of the product
`
`and didn’t relate to the obviousness issue with respect to the vitamins” (Ex. 2133 at
`
`19:17-20:5 (emphasis added); Ex. 1080 ¶39(c)); and (4) that FDA policies on
`
`combination drug regulations have nothing to do with obviousness, instead they
`
`demonstrate “specifics what combination products need to do for approval . . . and
`
`
`
`3
`
`
`
`how the trials would – would, could or might not accomplish that,” (Ex. 2103 at
`
`20:6-13; Ex. 1080 ¶39(d)).
`
`Response to Observation # 2
`
`
`
`Patent Owner’s observation that Dr. Feigal’s testimony concerning the
`
`FDA’s statements regarding efficacy purportedly supports Patent Owner’s
`
`argument that “the FDA expressed skepticism about pretreatment with folic acid
`
`and vitamin B12,” which testimony supports a finding of nonobviousness, is both
`
`misleading and false. Dr. Feigal clearly testified that the “FDA was not expressing
`
`skepticism as to the benefits of vitamin supplementation.” Ex. 2133 at 93:14-18
`
`(emphasis added). Dr. Feigal further testified that safety and effectiveness must
`
`always be evaluated in accordance with “statutory requirements that evidence of
`
`effectiveness comes from adequate and well-controlled trials . . . So every product
`
`that is approved has to, you know, has to meet that standard and FDA has the
`
`responsibility to decide how to apply that standard . . .” Ex. 2133 at 94:10-95:4.
`
`Additionally, Dr. Feigal testified that “the FDA’s concerns about successful
`
`clinical trials would almost always – almost always involve that the trials are
`
`adequate to establish efficacy . . . efficacy is almost always involved.” Ex. 2133 at
`
`96:3-20 (emphasis added). Accordingly, Dr. Feigal’s testimony does not and
`
`cannot support Patent Owner’s argument of nonobviousness, where Dr. Feigal
`
`testified: (1) that the “FDA recognized that with antifolate drugs that folate is
`
`
`
`4
`
`
`
`sometimes part of the regimen in order to have drugs that are safer and more
`
`effective” (Ex. 2133 at 18:3-14); (2) “that [the] FDA was very used to seeing these
`
`kinds of – these kinds of additions for this, this kind of drug, and there were
`
`different study designs that could be used to tease out exactly what the contribution
`
`of vitamins would be but it wasn’t whether vitamins wouldn’t have a role in the
`
`safety and effectiveness of this type of a product, it is just a question of how to
`
`study it” (Ex. 2133 at 21:23-22:20); and (3) that “in the everyday meaning of that
`
`language there has been a role in vitamins in the evaluation of most of the
`
`antifolate drugs so in that sense of a developing a new one, it is an obvious aspect
`
`of developing this class of drugs.” Ex. 2133 at 16:13-20.
`
`Response to Observation # 3
`
`
`
`Patent Owner’s observation that Dr. Feigal’s testimony concerning the End
`
`of Phase 2 meeting somehow supports Patent Owner’s argument that the FDA
`
`expressed skepticism about vitamin supplementation and therefore supports a
`
`finding of nonobviousness is both misleading and false. Dr. Feigal clearly testified
`
`that “the option of including vitamins was discussed as you know before this trial
`
`even began and some options for different – different trial designs . . . there were
`
`different study designs that could be used to tease out exactly what the contribution
`
`of vitamins would be but it wasn’t whether vitamins wouldn’t have a role in the
`
`safety and effectiveness of this type of product, it is just a question of how to study
`
`
`
`5
`
`
`
`it.” Ex. 2133 at 22:4-20; see also Ex. 2133 at 26:7-27:21 (testifying that the FDA
`
`suggested a comparison of vitamins plus pemetrexed versus pemetrexed alone as a
`
`standard way in which the FDA would have suggested proceeding with trials on
`
`combination products). Dr. Feigal further testified that safety and effectiveness
`
`must always be evaluated in accordance with “statutory requirements that evidence
`
`of effectiveness comes from adequate and well-controlled trials . . . So every
`
`product that is approved has to, you know, has to meet that standard and FDA has
`
`the responsibility to decide how to apply that standard . . .” Ex. 2133 at 94:10-
`
`95:4. Accordingly, Dr. Feigal also testified that even before a trial begins, “the
`
`FDA’s concerns about successful clinical trials would almost always – almost
`
`always involve that the trials are adequate to establish efficacy . . . efficacy is
`
`almost always involved.” Ex. 2133 at 96:3-20 (emphasis added); Ex. 2100.
`
`Additionally, Dr. Feigal testified that at the End of Phase 2 meeting “the addition
`
`of vitamins was discussed, the fact that might reduce efficacy was raised as a
`
`possibility, and that the FDA left it up to Lilly to decide whether to use the – use
`
`the vitamins in the study or not.” Ex. 2133 at 69:10-20. In the end, “the study did,
`
`you know, did proceed, FDA allowed it to proceed and FDA felt that was Lilly’s
`
`risk to actually do a study that might not actually work out because the change
`
`might have adversely impacted the interpretability of the trial.” Ex. 2133 at 91:
`
`17-92:5.
`
`
`
`6
`
`
`
`Accordingly, the FDA did not express skepticism about vitamin
`
`supplementation and his testimony cannot support Patent Owner’s argument of
`
`nonobviousness, where Dr. Feigal testified: (1) that the “FDA recognized that with
`
`antifolate drugs that folate is sometimes part of the regimen in order to have drugs
`
`that are safer and more effective” (Ex. 2133 at 18:3-14); (2) “that [the] FDA was
`
`very used to seeing these kinds of – these kinds of additions for this, this kind of
`
`drug, and there were different study designs that could be used to tease out exactly
`
`what the contribution of vitamins would be but it wasn’t whether vitamins
`
`wouldn’t have a role in the safety and effectiveness of this type of a product, it is
`
`just a question of how to study it” (Ex. 2133 at 21:23-22:20); and (3) that “in the
`
`everyday meaning of that language there has been a role in vitamins in the
`
`evaluation of most of the antifolate drugs so in that sense of a developing a new
`
`one, it is an obvious aspect of developing this class of drugs.” Ex. 2133 at 16:13-
`
`20.
`
`Response to Observation # 4
`
`
`
`Patent Owner’s claim that Dr. Feigal’s lack of experience as an oncologist,
`
`his role in prescribing antifolates for treating cancer and his involvement with
`
`cytotoxic chemotherapy drugs is relevant to his expertise and ability to opine on
`
`the FDA’s review of pemetrexed is misleading and baseless. First, although Dr.
`
`Feigal is not an oncologist he testified that he treated patients with cancer,
`
`
`
`7
`
`
`
`managed the care of oncology patients, and did in fact prescribe antifolates. Ex.
`
`2133 at 9:13-24; 11:10-12:2. Additionally, Dr. Feigal testified extensively
`
`concerning his experience at the FDA and familiarity and experience with
`
`regulatory and industry matters pertinent to evaluating the safety and efficacy of all
`
`new drugs, including antifolates, and the approval process to which all new drugs,
`
`including antifolates, are subject. See, e.g., Ex. 2133 at 26:7-27:21 (testifying
`
`concerning formulating trials for combination drugs); 41:19-46:12 (testifying
`
`concerning the phases of drug trials); Ex. 2133 at 52:21-53:10 (testifying
`
`concerning experience signing approvals as division director of the FDA); 57:16-
`
`58:21 (testifying concerning End of Phase 2 Meetings); Ex. 2133 at 78:22-85:9
`
`(testifying concerning roles in the FDA); Ex. 1080 at ¶¶5-16. Dr. Feigal’s
`
`testimony is consistent with his report and establishes him as an expert qualified to
`
`provide opinions and testimony concerning the communications issued by the FDA
`
`in its review of pemetrexed, irrespective of his experience treating cancer patients
`
`with antifolates.
`
`Response to Observation # 5
`
`
`
`Patent Owner’s claim that Dr. Feigal’s testimony only refers to the FDA
`
`documents discussed in his declaration and does not include “the asserted prior art
`
`or other information” is somewhat inaccurate. Dr. Feigal testified extensively
`
`concerning his experience at the FDA and familiarity and experience with
`
`
`
`8
`
`
`
`regulatory and industry matters pertinent to evaluating the safety and efficacy of all
`
`new drugs, including antifolates, and the approval process to which all new drugs,
`
`including antifolates, are subject. See, e.g., Ex. 2133 at 26:7-27:21 (testifying
`
`concerning formulating trials for combination drugs); 41:19-46:12 (testifying
`
`concerning the phases of drug trials); Ex. 2133 at 52:21-53:10 (testifying
`
`concerning experience signing approvals as division director of the FDA); 57:16-
`
`58:21 (testifying concerning End of Phase 2 Meetings); Ex. 2133 at 78:22-85:9
`
`(testifying concerning roles in the FDA); Ex. 1080 at ¶¶5-16. Accordingly,
`
`although Dr. Feigal only reviewed selective documents comprising the “record” to
`
`which he testified, his opinions and testimony utilized years of expertise
`
`concerning FDA regulatory and drug approval practice.
`
`9
`
`
`
`
`
`
`
`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 22, 2017
`
`
`
`
`
`10
`
`
`
`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 David W. Feigal, Jr., M.D., by electronic
`
`means on February 22, 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 22, 2017
`
`
`
`
`
`
`
`
`
`
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