`
`
`
`
`Paper No. ___
`Filed: April 17, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`APOTEX INC., APOTEX CORP., ARGENTUM PHARMACEUTICALS
`LLC, ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA,
`INC., SUN PHARMACEUTICAL INDUSTIRES, LTD., SUN
`PHARMACEUTICAL INDUSTRIES, INC., AND SUN PHARMA GLOBAL
`FZE,
`Petitioners,
`
`v.
`
`NOVARTIS A.G.,
`Patent Owner.
`_____________________________
`
`IPR2017-008541
`Patent No. 9,187,405
`_____________________________
`
`PETITIONERS’ MOTION TO EXCLUDE
`37 C.F.R. §42.64
`
`
`1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been joined
`
`with this proceeding.
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`TABLE OF CONTENTS
`
`INTRODUCTION ........................................................................................ 1
`I.
`ARGUMENT................................................................................................ 1
`II.
`A.
`Exhibits 2057& 2070 and any reliance thereon. .................................. 1
`B.
`Exhibit 2063-2066 and any reliance thereon. ...................................... 5
`C.
`mouse data purportedly underlying the Webb reference. ................... 11
`III. CONCLUSION .......................................................................................... 15
`
`Testimony based on unpublished and unproduced granular
`
`
`
`
`
`
`
`
`
`
`-i-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`I.
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. §§ 42.62 and 42.64(c), Petitioners respectfully move
`
`to exclude Exhibits 2057, 2063-2066, 2070, and portions of Exhibits 2022, 2024,
`
`2025, 2096-2098. The Federal Rules of Evidence apply. 37 C.F.R. § 42.62; LKQ
`
`Corp. v. Clearlamp, LLC, IPR2013-00020, Paper 17, at 3 (Mar. 5, 2013). This
`
`Motion addresses issues listed in Petitioner’s Objections to Evidence (Paper
`
`Nos.14, 31, 71) and information subsequently obtained through the depositions of
`
`Novartis’s witnesses. See, e.g., EX1042, EX1050, EX1061-EX1064.
`
`II. ARGUMENT
`
`A. Exhibits 2057& 2070 and any reliance thereon.
`
`Novartis served Exhibits 2057 and 2070 with its Patent Owner Response
`
`(“POR”) (Paper 27). Novartis’s exhibit list describes EX2057 as a May 12, 2009
`
`Novartis report and EX2070 as a “signature sheet.” Dr. Jusko discusses EX2057 in
`
`¶¶101-07 of his second declaration (EX2024) but never cites EX2070. Dr.
`
`Steinman discusses EX2057 in his First Declaration (EX2022, ¶¶101-08) and
`
`incorporates his prior testimony into his Third Declaration (EX2096, ¶53). but
`
`never cites EX2070. Novartis relies on EX2057 and EX2070 and the cited
`
`paragraphs of Exhibits 2022 and 2024 in Paper 27 at 22-25. Petitioners timely
`
`objected to Exhibits 2057 and 2070 and reliance thereon. Paper 31 at 8-10.
`
`Exhibits 2057 and 2070 and the above-referenced paragraphs of EX2022, EX2024,
`
`-1-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`and EX2096 should be excluded under F.R.E. 602, 801-803, 805, and 901.
`
`
`
`Novartis relies on statements in the report for the truth of the matters
`
`asserted, namely that Peter Hiestand did, in fact, perform the EAE experiments and
`
`observed the results recited in EX2057. POR at 22-25. Novartis relies on these
`
`statements to prove that administering 0.3 mg/kg of fingolimod once per week to
`
`Lewis rats with EAE did, in fact “suppress the progression of subsequent relapses,
`
`and also reduced the relapse’s symptoms,” to support the claims of the ’405 patent.
`
`Id. Because Novartis relies on the underlying assertions in the report, Novartis
`
`must establish admissibility of the underlying assertions. F.R.E. 801, 802, 805,
`
`901; Neste Oil OYJ v. REG Synthetic Fuels, LLC, IPR2013-00578, Paper 52 at 6-8
`
`(excluding meeting minutes authenticated by author because each hearsay-within-
`
`hearsay required its own exception to the hearsay rule); US Endodontics, LLC v.
`
`Gold Standard Instr., LLC., PGR2015-00019, Paper 54 at 40-41-42 (excluding
`
`sworn declaration from another proceeding as hearsay).
`
`Novartis submitted a declaration from an in-house attorney, Peter Waibel, to
`
`identify Exhibit 2057 as having been produced from a collection of documents
`
`previously submitted to FDA. EX2078, ¶10. But Mr. Waibel does not address or
`
`purport to have personal knowledge of how the report itself came to be created or
`
`how the experiments discussed therein were conducted. In short, Mr. Waibel’s
`
`testimony merely establishes that Novartis placed a document into its records
`
`-2-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`system at some undisclosed point in time and thereafter maintained that copy in its
`
`records. This is insufficient to satisfy F.R.E. 602, 801-803, 805, or 901.
`
`
`
`Christian Schnell’s declaration (EX2026) fails to remedy these deficiencies.
`
`Mr. Schnell purports to authenticate Exhibit 2057 as a Novartis report “we
`
`prepared in 2009.” EX2022, ¶¶1-4. He states that Exhibit 2070 was filed in the
`
`same system as EX2057, that it is common for the final signature pages to be filed
`
`separately from the main report, and that “this is the signature page that I
`
`remember going with this report.” Id. However, Mr. Schnell admitted during his
`
`deposition that he did not see Peter Hiestand sign the final report, that “I have not
`
`seen the signed page by Peter Hiestand and the TR head,” that he did not
`
`personally enter the final report or signature page into the Novartis computer
`
`system, that he never looked at the final report in the Novartis system until he was
`
`preparing his declaration, and that he “had no role” in filing either Exhibit 2057 or
`
`2070 in the Novartis system. EX1050 at 32:12-36:6, 42:11-15. Mr. Schnell’s fails
`
`to establish admissibility of EX2057 or EX2070.
`
`Peter Hiestand, not Christian Schnell, is the purported, unsworn and
`
`unauthenticated declarant of the hearsay assertions in EX2057. Mr. Schnell
`
`testified that Peter Hiestand was in charge of designing the protocol for the EAE
`
`experiments, that Mr. Schnell prepared only the “neoangiogenesis casing part of
`
`the document, not the EAE-related part,” and that Mr. Schnell did not review the
`
`-3-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`EAE-related part of the document prior to its finalization. EX1050 at 56:8-57:17.
`
`Mr. Schnell testified that his contribution was assessing whether there was a
`
`pattern of increased neoangiogenesis as a result of EAE in Lewis rats, but he
`
`agreed that his November 2005 experiments with Peter Hiestand did not invent
`
`using FTY720 to inhibit S1P and VEGF-induced neoangiogenesis. Id., 24:14-21,
`
`55:21-56:4. Mr. Schnell also testified that he had only ever reviewed a handful of
`
`pages of EX2057 prior to his deposition. Id., 57:18-60:4. Mr. Schnell was unable
`
`to answer basic questions about the EAE experiments because everything other
`
`than neoangiogenesis was purportedly written by Peter Hiestand. Id., 60:5-62:24.
`
`In summary, Mr. Schnell lacks personal knowledge of the creation or signing of
`
`the report, the EAE experiments described in the report, and whether the signature
`
`page in Exhibit 2070 “goes” with the report. He is not competent to authenticate or
`
`provide foundation for the report or the statements made therein, or their
`
`admissibility. F.R.E. 602, 801-803, 805, 901.
`
`In addition to the report being inadmissible, the assertions contained therein
`
`are inadmissible hearsay. F.R.E. 801-802, 805. Novartis purports to make the
`
`report admissible hearsay as a record of regularly conducted activity, but F.R.E.
`
`803(6) applies only to a record of an act, event, condition, opinion, or diagnosis,
`
`and only if (1) the record was made at or near the time of the act or event by or
`
`from information transmitted by someone with knowledge; (2) the record was kept
`
`-4-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`in the course of regularly conducted activity; (3) making the record was a regular
`
`practice of that activity; (4) all of these conditions are shown by testimony of the
`
`custodian or another qualified witness; and, (5) the opponent does not show that
`
`the source of information or method of circumstances of preparation indicate a lack
`
`of trustworthiness. Id. These conditions are not satisfied here.
`
`For example, no witness establishes that the report itself and the assertions
`
`made therein qualify for admission under F.R.E. 803(6). The acts or events at issue
`
`are the experiments themselves and the data that allegedly resulted from them. No
`
`witness, qualified or otherwise, testifies that the report was made at or near the
`
`time of the act or events described (the experiments). Indeed, Mr. Schnell admits
`
`that the report was not prepared until 2009, but that the experiments described
`
`therein were conducted in November 2005. EX2026, ¶2. Novartis cannot use
`
`F.R.E. 803(6) to launder the assertions in EX2057 regarding the underlying
`
`experiments from 2005 into admissible evidence by purporting to describe them
`
`four years later and preserving a copy of that belated description in its files.
`
`For each of the reasons discussed above, Exhibits 2057 and 2070 and
`
`Novartis’s experts’ reliance upon them should be excluded under F.R.E. 602, 801-
`
`803, 805 and 901.
`
`B.
`
`Exhibit 2063-2066 and any reliance thereon.
`
`Novartis served EX2063-EX2066 in connection with its POR. Novartis’s
`
`-5-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`exhibit list describes EX2063 as a redacted email chain copying Fred Lublin,
`
`EX2064 as a letter written by Novartis, EX2065 as an email chain, and Exhibit
`
`2066 as another letter written by Novartis. Dr. Lublin discusses Exhibits 2063-
`
`2066 in ¶¶46-47 (EX2064) and 50-58 (EX2063, EX2065, EX2066) of his Second
`
`Declaration (EX2025) and refers to information he derives from them in ¶¶4-7, 39,
`
`and 44 of the same. Dr. Lublin relies on and repeats this testimony in ¶¶2-3, 6-7,
`
`14-15, 19 of his Fourth Declaration (EX2097). Novartis relies on EX2063-EX2066
`
`and portions of EX2025 and EX2097 at least in Paper 27 at 20, 25-27, Paper 63 at
`
`9-10, and Paper 64 at 8-9. Petitioners timely objected to Exhibits 2063-2066 and
`
`any reliance thereon. Paper 31 at 9-10. Petitioners ask that Exhibits 2063-2066 and
`
`the above-referenced paragraphs of EX2025 and EX2097 be excluded under F.R.E.
`
`106, 602, 801-803, 805, and 901.
`
`As a threshold matter, Novartis has failed to demonstrate that a record of the
`
`correspondence in EX2063, EX2065, and EX2066 was maintained in the course of
`
`regularly conducted business activities. Mr. Waibel’s own declarations have
`
`demonstrated that Novartis does not keep all of its employees’ emails in the regular
`
`course of business. Mr. Waibel originally testified that “Novartis personnel draft
`
`and maintain records of all communications with third parties regarding clinical
`
`trials in the ordinary course of business and as a regularly conducted business
`
`activity” and Novartis “continuously maintains copies of communications with
`
`-6-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`third parties regarding clinical trials in the ordinary course of business.” EX2078,
`
`¶6 (emphasis added). In his Second Declaration, however, Mr. Waibel testified that
`
`Novartis only retains “some correspondence with centers that participate in a given
`
`clinical trial” and that Novartis “has no central collection of correspondence with
`
`Mount Sinai for this study.” EX2088, ¶8 (emphasis added).2 Although Mr. Waibel
`
`admits that one of the Novartis employees involved in the correspondence in
`
`Exhibit 2063 and 2065 was still at Novartis at least as recently as January 29, 2018,
`
`Novartis had not maintained her emails with Mt. Sinai hospital in the regular
`
`course of business. EX2088, ¶9. Indeed, Mr. Waibel admitted that the
`
`correspondence produced in Exhibit 2063 and 2065-2066 was available “only due
`
`to the happenstance” of a litigation hold for Mr. Watson in another case. EX2088,
`
`¶¶9-10. In other words, Novartis has failed to establish even that the
`
`correspondence itself “was kept in the course of a regularly conducted activity,” as
`
`opposed to being kept for the purposes of litigation. Novartis’s narrow and
`
`selective production of documents does not support admissibility of Exhibits 2063-
`
`2066.
`
`
`2 Mr. Waibel’s Second Declaration contains attorney characterization of
`
`EX2065 and Mt. Sinai. Novartis declined to produce Mr. Waibel for deposition
`
`and agreed not to rely upon Mr. Waibel’s testimony substantively for patentability.
`
`-7-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`Moreover, Novartis and Dr. Lublin rely on specific assertions within each
`
`document, not just the existence of the document in Novartis’s files, and must
`
`therefore prove admissibility of the underlying statements. For example, Dr. Lublin
`
`relies on Mr. Watson’s statements in EX2066 to establish that two sentences in Mr.
`
`Watson’s email actually came from minutes of a meeting between Novartis and
`
`FDA, that the minutes reflect an assertion made by FDA, and that the assertions
`
`are true. EX2025 at ¶55. Dr. Lublin repeatedly testified that the FDA selected the
`
`0.5 mg dose for inclusion in the “phase III studies as the minimum effective dose.”
`
`EX1042 at 165:16-24; EX2025 at ¶¶4-6, 39, 44, 53-58, 64); EX2097, ¶¶19-21;
`
`POR at 25-27; Paper 63 at 10. Dr. Lublin stated that he was relying on assertions in
`
`the documents that those two sentences came from minutes of a meeting with the
`
`FDA, and that the assertions were made by FDA, and that he was relying on the
`
`sentences to establish the content of FDA’s alleged request. EX1042 at 158:24-
`
`161:4, 162:25-164:16, 193:8-195:10.
`
`As another example, Dr. Lublin relies on EX2064 to provide a March 3,
`
`2008 description of a “futility analysis” plan allegedly submitted to FDA in a
`
`“briefing book.” EX2025, ¶¶46, 53-54. During his deposition, Dr. Lublin admitted
`
`he was “relying on counsel’s representation” that Exhibit 2064 contains “the final
`
`plan that was actually submitted to the FDA.” EX1042 at 169:5-170:25. As another
`
`example, Dr. Lublin relies on the truth of Colleen Farrell’s statements that the
`
`-8-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`comments attributed to the IRB were actually said by the IRB, as well as the truth
`
`of the statements attributed to the IRB (e.g., about being unable to approve the
`
`project; it being the IRB’s opinion that the inclusion of 0.5 mg dose the Phase III
`
`trial was questionable). EX2063 at 2; EX2065 at 5. Thus, Novartis relies upon the
`
`document not merely to establish that the documents existed in Novartis’s files, but
`
`also to establish the truth of the statements asserted in the documents.
`
`The purported excerpts of minutes from a meeting with FDA in Exhibit
`
`2066 and from the briefing book in EX2064 should be excluded under F.R.E. 106.
`
`Under this rule, Petitioners are entitled to “require” the introduction of “any other
`
`part” of a recorded statement “that in fairness ought to be considered at the same
`
`time.” Novartis and its witnesses have relied on the excerpts as proving the content
`
`of statements made by FDA in the minutes and as proof of the final study plan
`
`employed in the study. Novartis and its witnesses have incorrectly characterized
`
`those statements as meaning that FDA selected the 0.5 mg dose for inclusion in the
`
`phase 3 trials because it believed the dose would lack any efficacy and that
`
`including the 0.5 mg dose in the phase 3 trial without first performing a separate
`
`phase 2 trial reflected skepticism that the dose would have any efficacy. Fairness
`
`requires that Petitioners be permitted to introduce the remainder of the minutes and
`
`briefing book to demonstrate that Novartis’s characterizations are incorrect and
`
`that the 0.5 mg dose was included in the phase 3 study because it was reasonably
`
`-9-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`believed that it would work. Petitioners requested production of the minutes and
`
`briefing book, Novartis refused, and the Board denied Petitioners motion for
`
`discovery. Papers 35, 47. Novartis’s refusal to permit Petitioners access to the full
`
`document renders Novartis’s reliance on the excerpts a violation of F.R.E. 106.
`
`Exhibits 2063-2066 are also inadmissible because they contain multiple
`
`levels of hearsay. F.R.E. 801-803, 805. For example, Exhibit 2065 contains
`
`hearsay assertions from Tom Watson, Valentina Curovic-Perisic, Jim Prodafikas,
`
`and Colleen Farrell, including Ms. Farrell’s assertions that “the IRB” made still
`
`further hearsay assertions and Mr. Watson’s assertions that “FDA” made other
`
`hearsay assertions. As discussed above, Novartis relies on these documents to
`
`establish more than simply delivery of the correspondence without respect to the
`
`truth.
`
`Novartis has submitted no testimony that would render the underlying
`
`statements admissible. For example, Mr. Waibel’s First Declaration (EX2078)
`
`merely asserts that copies of the documents were preserved in Novartis’s records.
`
`As discussed above in Section II.A, however, this is insufficient to render each
`
`level of hearsay within the e-mail chain admissible. Indeed, Novartis never
`
`submitted in this case a record made “at or near the time” of the alleged
`
`conversation with FDA, has not established who made the minutes, whose
`
`assertion was allegedly being quoted by Mr. Watson as a statement by FDA, or
`
`-10-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`whether the anonymous individual who allegedly wrote the minutes had personal
`
`knowledge of the conversation. The fact that a company’s email system
`
`automatically puts time-stamps on employees’ emails does not render the
`
`statements made by or to its employees admissible evidence. Novartis’s theory
`
`amounts to trial built on unsworn statements in emails, in violation of Board and
`
`evidentiary rules. 37 C.F.R. § 42.53(a).
`
`Dr. Lublin’s testimony similarly does not render the underlying assertions
`
`admissible. Dr. Lublin testified that he was never even copied on Exhibits 2065-
`
`2066, did not discuss this case with Colleen Farrell or anyone other than Novartis’s
`
`attorneys, that he received Exhibits 2065-66 from Novartis’ counsel, and that he
`
`was relying on counsel for Exhibits 2064, 2065, & 2066. EX1042 at 176:5-179:10.
`
`For each of the reasons discussed above, Exhibits 2063-2066 and Novartis’s
`
`experts’ reliance upon them should be excluded under F.R.E. 106, 602, 801-803,
`
`805, and 901.
`
`C. Testimony based on unpublished and unproduced granular
`mouse data purportedly underlying the Webb reference.
`
`Novartis served Exhibits 2096 and 2098 on March 23, 2018 in connection
`
`with its Sur-Reply (Paper 63) and its Reply in support of its Motion to Amend
`
`(Paper 64). Novartis’s exhibit list describes EX2096 as the Third Declaration of
`
`Lawrence Steinman, M.D. and EX2098 as the Declaration of Jerold Chun, M.D.,
`
`Ph.D. Each of these exhibits provides testimony based on data that was not
`
`-11-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`published in the Webb reference and that was not produced in this case. See, e.g.,
`
`EX2096, ¶¶28, 31-40; EX2098, ¶¶6-8, 17, 26-43.Novartis relies upon Dr.
`
`Steinman’s and Dr. Chun’s theories based on this unpublished and unproduced
`
`data in its Sur-Reply (Paper 63), at least at 6-7.
`
` Petitioners objected to Exhibits 2096 and 2098 and any reliance thereon.
`
`Paper 71 at 2-4. Petitioners requested production prior to Dr. Chun’s deposition of
`
`the data underlying the Webb reference and any descriptions or summaries of the
`
`data Dr. Chun relied upon, but Novartis informed Petitioners that neither Novartis
`
`nor Dr. Chun had the underlying data in its possession. EX1063 at 103:13-25,
`
`106:2-107:14. Novartis’s failure to produce the underlying data renders the
`
`testimony cited above both unreliable and entitled to no weight, justifying
`
`exclusion of the testimony from consideration. F.R.E. 702-703; Mylan
`
`Pharmaceutical Inc. v. Allergan, Inc., IPR2016-01127, Paper 33, at 3
`
`(“Accordingly, because Patent Owner will not produce the clinical trial data
`
`underlying Schiffman Exhibits B, D, E, F and Attar Exhibits C and D, those
`
`exhibits and related testimony are entitled to no weight and will not be considered
`
`in determining patentability of the challenged claims. 37 C.F.R. § 42.65.”).
`
`To the extent Novartis intends to argue that it may evade evidentiary and
`
`Board rules requiring disclosure of data underlying an expert’s opinion by having
`
`the expert rely upon his or her “memory” of that data, the fallacy of this argument
`
`-12-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`is demonstrated by the breadth of the exception. Indeed, a memory exception to the
`
`rule requiring disclosure of underlying data would swallow the rule requiring the
`
`disclosure of underlying data.
`
`Furthermore, Dr. Chun’s memory cannot be relied upon to support the
`
`testimony. In his deposition, Dr. Chun testified that he has not had access to the
`
`data underlying the Webb reference since he left Merck in June 2003, has not
`
`reviewed the data since approximately 16 years ago in 2002, that he left any Webb-
`
`related materials describing the data at Merck when he left, and that he did not
`
`review the data or any summaries or descriptions of the data in preparing his
`
`declaration. EX1063 at 101:14-20, 103:13-107:18, 125:17-25.
`
`Dr. Chun’s deposition testimony also confirms that Novartis’s
`
`unsubstantiated claims about the unpublished and unproduced data should not be
`
`credited. Dr. Chun’s deposition revealed that his involvement in the preparation of
`
`the Webb publication was extremely limited. He confirmed that he was not the
`
`lead author of the Webb paper. EX1063 at 150:14-151:16. He did not know the
`
`role of the various co-authors in the experiments because it was Drs. Webb and
`
`Rao, not Dr. Chun that were involved in running the experiments. Id. at 90:5-
`
`94:13. He testified that he did not personally submit the Webb manuscript for
`
`publication and did not know who did, and that he did not know when any of the
`
`co-authors gave final approval for the manuscript to be submitted for publication.
`
`-13-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`EX1063 at 126:2-127:8, 181:7-13, EX1063 at 181:14-182:15. He also testified that
`
`he did not know how many peer reviewers provided comments on the Webb
`
`reference manuscript and did not know what revisions were made to the original
`
`manuscript. EX1063 at 271:23-272:13.
`
`An example illustrates the danger in relying on Novartis’s new arguments
`
`about the granular mouse data purportedly underlying the Webb paper. Novartis’s
`
`experts drafted almost identically-worded assertions in the Chun and Steinman
`
`declaration that all nine authors of the Webb paper had agreed that the
`
`unpublished, unproduced granular mouse data supported Novartis’s “at least” 70%
`
`lymphopenia argument. EX2096,¶40 (“That finding was the product of the nine
`
`authors’ collective judgment.”); EX2098, ¶¶7-8 (“Our conclusion…was the
`
`product of our collective judgment….it was the result of collective judgment”)
`
`(emphases added). In his deposition, however, Dr. Chun confirmed that, prior to
`
`the submission of the Webb manuscript for publication, he never discussed with
`
`any of co-authors Hale, Tham, Lin, Lariosa-Willingham, Yu, or Mandala any
`
`correlation between lymphopenia and cumulative clinical score. EX1063 at
`
`182:16-183:15. He testified that co-author Hale was not even on his team. Id. at
`
`92:5-18. Dr. Chun’s testimony confirms that the speculative and unsubstantiated
`
`discussion of granular mouse data in the declarations of Novartis’s declarants was
`
`merely aspirational on the part of Novartis’s attorneys and is untethered from the
`
`-14-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`facts in evidence. Novartis should not be permitted to rely upon imputed,
`
`unpublished, and unproduced granular data in support of its teaching away
`
`arguments. The paragraphs identified above should be excluded from consideration
`
`as unreliable and for failure to disclose the underlying data. F.R.E. 702-703; 37
`
`C.F.R. §42.65(a).
`
`III. CONCLUSION
`
`For the foregoing reasons, Petitioners request that this Motion to Exclude be
`
`granted.
`
`Dated: April 17, 2018
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
`
`
`
`
`
`
`
`
`
`
`-15-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`This is to certify that I caused to be served true and correct copies of the
`
`foregoing Petitioners’ Motion To Exclude on this 17th day of April, 2018, on the
`
`Patent Owner at the correspondence address of the Patent Owner as follows:
`
`Jane M. Love, Ph.D.
`Robert W. Trenchard
`GIBSON, DUNN & CRUTCHER LLP
`200 Park Avenue, 47th Floor
`New York, NY 10166
`Email: jlove@gibsondunn.com
`Email: rtrenchard@gibsondunn.com
`
`
`
`
`Dated: 17 April 2018
`
`
`
`
`
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
`
`
`
`-16-
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
