throbber
Filed: October 24, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`
`MYLAN PHARMACEUTICALS INC.,
`SAWAI USA, INC., AND
`SAWAI PHARMACEUTICAL CO., LTD.,
`Petitioner,
`
`
`v.
`
`
`BIOGEN MA INC.,
`Patent Owner.
`____________________________________________
`
`IPR2018-01403*
`Patent No. 8,399,514
`____________________________________________
`
`
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`

`* Case IPR2019-00789 has been joined with this proceeding. 
`
`

`

`TABLE OF CONTENTS
`
`U.S. Patent No. 8,399,514
`IPR2018-01403

`
`Page(s)
`
`I.  STATEMENT OF RELIEF REQUESTED ........................................................ 1 
`
`II.  ARGUMENT ....................................................................................................... 1 
`
`A.  Post-Priority Date Publications (Exs. 1036, 1037, and 1066) .......................... 1 
`
`B.  The Internet Archive Declaration & Schimrigk Poster (Ex. 1012) .................. 3 
`
`C.  The Mihail Declaration (Ex. 1054) and Clinical Trials (Ex. 1010) ................. 7 
`
`D.  The Rock Declaration (Ex. 1055 and Ex. 1122) ............................................ 11 
`
`III.  CONCLUSION .................................................................................................. 14 
`
`
`
`
`

`
`
`
`ii 
`
`

`

`U.S. Patent No. 8,399,514
`IPR2018-01403

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`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`CaptionCall, L.L.C. v. Ultratec, Inc.,
`IPR2015-00637, Paper 98 (PTAB Sept. 7, 2016) ................................................. 9
`Hospira, Inc. v. Genentech, Inc.,
`IPR2017-00805, Paper 83 (PTAB Oct. 3, 2018) .................................................. 1
`HTC Corp. v. NFC Tech., LLC,
`IPR2014-01198, Paper 41 (PTAB Nov. 6, 2015) ....................................... 7, 9, 11
`In re Cronyn,
`890 F.2d 1158 (Fed. Cir. 1989) .......................................................................... 13
`KVK-Tech, Inc. v. Shire PLC,
`IPR2018-00290, Paper 58 (PTAB July 3, 2019) .................................................. 2
`Neptune Generics, LLC v. Eli Lilly & Co.,
`921 F.3d 1372 (Fed. Cir. 2019) ............................................................................ 2
`Neste Oil Oyj v. REG Synthetic Fuels, LLC,
`IPR2013-00578, Paper 53 (PTAB Mar. 12, 2015) ............................. 9, 10, 12, 13
`Stride Rite Children’s Grp., LLC v. Shoes By Firebug LLC,
`IPR2017-01809, Paper 64 (PTAB Jan. 16, 2019) ................................................ 7
`US Endodontics, LLC v. Gold Standard Instruments, LLC,
`PGR2015-00019, Paper 54 (PTAB Dec. 28, 2016) .............................................. 8
`Rules
`37 C.F.R. § 42.12 ......................................................................................... 4, 6, 7, 11
`37 C.F.R. § 42.51 ....................................................................................................... 7
`37 C.F.R. § 42.52 ....................................................................................................... 7
`37 C.F.R. § 42.53 ....................................................................................................... 7
`37 C.F.R. § 42.64 ....................................................................................................... 1
`

`
`iii 
`
`

`

`U.S. Patent No. 8,399,514
`IPR2018-01403

`
`TABLE OF ABBREVIATIONS
`DESCRIPTION
`ABBREVIATION
`U.S. Patent No. 8,399,514
`’514 patent
`Biogen or Patent Owner Biogen MA Inc.
`Bolded Italics
`Emphasis added unless otherwise noted
`Clinical Trials
`Ex. 1010
`DMF
`Dimethyl fumarate
`EMA 2013
`Ex. 1037
`Fox 2011
`Ex. 1036
`MS
`Multiple sclerosis
`Mylan or Petitioner
`Mylan Pharmaceuticals Inc.
`Phillips 2013
`Ex. 1066
`POSA
`Person of Ordinary Skill in the Art
`
`
`
`
`
`

`
`iv 
`
`

`

`I. STATEMENT OF RELIEF REQUESTED
`Pursuant to 37 C.F.R. § 42.64(c), the amended Scheduling Order (Paper 31),
`
`U.S. Patent No. 8,399,514
`IPR2018-01403

`
`and Patent Owner’s timely filed objections (Papers 14, 72), Patent Owner Biogen
`
`hereby moves to exclude Exhibits 1010, 1012, 1036, 1037, 1054, 1055, 1066, and
`
`1122 filed by Petitioner Mylan as inadmissible under the Federal Rules of
`
`Evidence (“FRE”).
`
`II. ARGUMENT
`A.
`Post-Priority Date Publications (Exs. 1036, 1037, and 1066)
`Mylan relies on Fox 2011 (Ex. 1036), EMA 2013 (Ex. 1037), and Phillips
`
`2013 (Ex. 1066) in support of its obviousness allegations. These exhibits were
`
`published after Biogen’s Phase III results with the claimed 480 mg/day dose were
`
`known and long after the February 2007 priority date of the ’514 patent. Paper 38,
`
`28-31; Ex. 1036, 2; Ex. 1037, 1; Ex. 1066, 1. They are necessarily tainted by the
`
`knowledge that the 480 mg/day dose was effective in Phase III trials—information
`
`not known to a POSA as of Biogen’s February 2007 priority date. The law,
`
`however, requires assessment of information available in the prior art “at the time
`
`the invention was made.” 35 U.S.C. § 103. Exhibits 1036, 1037 and 1066 should
`
`therefore be excluded as irrelevant and unfairly prejudicial under FRE 401-403.
`
`Hospira, Inc. v. Genentech, Inc., IPR2017-00805, Paper 83 at 34-35 (PTAB Oct. 3,
`
`2018) (rejecting petitioner’s reliance on post-priority date references).
`

`
`1 
`
`

`

`Fox 2011, EMA 2013, and Phillips 2013 are particularly irrelevant and
`
`U.S. Patent No. 8,399,514
`IPR2018-01403

`
`prejudicial because they were motivated by the unexpected results demonstrated by
`
`the claimed 480 mg/day dose of DMF in Biogen’s post-filing date Phase III trials.1
`
`Researchers involved in the Phase III trials were so surprised by the unexpected
`
`magnitude of efficacy of 480 mg/day that they retroactively searched for reasons
`
`why it happened, relying on data that was not available in the prior art. Ex. 1125,
`
`138:16-139:7. Reinterpretations of data in view of later-discovered surprising
`
`results have no place in a § 103 analysis. See Neptune Generics, LLC v. Eli Lilly &
`
`Co., 921 F.3d 1372, 1377 (Fed. Cir. 2019) (declining to read prior art references in
`
`view of post-priority date analyses); KVK-Tech, Inc. v. Shire PLC, IPR2018-
`
`00290, Paper 58 at 42-43 (PTAB July 3, 2019) (rejecting petitioner expert’s
`
`“current reinterpretation” of prior art data). Accordingly, Exhibits 1036, 1037 and
`
`1066 should be excluded.
`

`1 Fox 2011 states that in Biogen’s Phase III trials, “MS patients treated with 240
`
`mg twice daily (480 mg/d) had a 49% reduction in the proportion with relapses.”
`
`Ex. 1036, 7. Phillips 2013 similarly states that 480 and 720 mg/day “reduced the
`
`annualized relapse rate . . . by 44 to 53%.” Ex. 1066, 5. EMA 2013 also states that
`
`480 and 720 mg/day had “statistically significant effects . . . of similar direction
`
`and magnitude” in Biogen’s Phase III trials. Ex. 1037, 75. 
`

`
`2 
`
`

`

`Additionally, the authors of Fox 2011, EMA 2013, and Phillips 2013 had
`
`U.S. Patent No. 8,399,514
`IPR2018-01403

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`access to unpublished data from Biogen’s clinical studies. This further taints these
`
`documents because they draw post-priority date conclusions based on information
`
`that was never available to a POSA. Mylan’s expert, Dr. McKeague,
`
`acknowledged that the individual patient data upon which conclusions in EMA
`
`2013 were based were not publicly available. Ex. 2064, 116:19-24; Ex. 2060 ¶83.
`
`Dr. Thisted testified that the post hoc calculations in Fox 2011 also cannot be
`
`derived from the information in Phase II publications, but instead rely on different,
`
`non-public data. Ex. 2060 ¶¶69-70. Dr. Thisted’s testimony is uncontradicted.
`
`Dr. McKeague acknowledged a discrepancy between figures in Fox 2011 and
`
`figures in the Phase II publications and was unwilling and unable to replicate post
`
`hoc calculations in Fox 2011 using publicly available information. Ex. 2064,
`
`92:10-94:11.
`
`For at least the reasons above, Exhibits 1036, 1037, and 1066 should be
`
`excluded because they have no relevance to Mylan’s obviousness challenge and
`
`any probative value is substantially outweighed by the danger of unfair prejudice
`
`from hindsight bias. FRE 401-403.
`
`B.
`The Internet Archive Declaration & Schimrigk Poster (Ex. 1012)
`Mr. Christopher Butler, an Office Manager of the Internet Archive, provided
`
`a declaration for Mylan purporting to establish public availability of a Schimrigk
`

`
`3 
`
`

`

`Poster (Ex. 1012) prior to the priority date of the ’514 patent. Biogen moves to
`
`U.S. Patent No. 8,399,514
`IPR2018-01403

`
`exclude Exhibit 1012 on three bases, any one of which is sufficient: lack of
`
`foundation, personal knowledge, and authentication. FRE 602, 901.
`
`Independently, Biogen further requests that the Board exercise its authority under
`
`37 C.F.R. § 42.12 to exclude Exhibit 1012 because Mr. Butler’s routine cross-
`
`examination was thwarted by Mylan, the proponent of his testimony. Paper 41, 5.
`
`The Butler declaration is inadmissible because it is not based on personal
`
`knowledge and fails to provide any foundation for alleged public availability of the
`
`attached poster. He testified that the documents attached to his declaration are
`
`merely “true and accurate copies of printouts of the Internet Archive’s records of
`
`the HTML files or PDF files for the URLs and the dates specified in the footer of
`
`the printout.” Ex. 1012, 1. The Butler declaration does not provide any testimony
`
`demonstrating personal knowledge of whether the poster was actually archived or
`
`publicly available before the critical date.
`
`Mr. Butler’s cross-examination in another PTAB proceeding (DocsCorp
`
`LLC v. Litéra Technologies, LLC, IPR2016-00541) confirms the deficiencies in
`
`Mr. Butler’s declaration here. Ex. 2129. Mr. Butler only began working for the
`
`Internet Archive in 2009, after the purported archival date of the poster attached to
`
`his declaration. Paper 41, 4; Ex. 2129, 6:11-16. Throughout his employment
`
`history, including at the Internet Archive, Mr. Butler has possessed no experience
`

`
`4 
`
`

`

`programming web crawlers or archiving web pages. Ex. 2129, 7:5-8:25.
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`U.S. Patent No. 8,399,514
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`Therefore, he does not and cannot have any personal knowledge of whether the
`
`poster in Exhibit 1012 was allegedly archived from a public source in 2004.
`
`In addition to his own lack of personal knowledge, Mr. Butler failed to
`
`establish that his employer (the Internet Archive) operated the web-crawlers that
`
`purportedly archived the poster in Exhibit 1012. Ex. 1012, 1. Biogen made a
`
`showing that the webpage Mr. Butler seeks to authenticate was “crawled” by a
`
`third party—Alexa Internet—not by the Internet Archive. Ex. 2128. Alexa
`
`Internet was a separate entity from the Internet Archive in 2004, the year the
`
`webpage archival addressed in Exhibit 1012 allegedly occurred. Ex. 2129, 18:6-
`
`19:16. Mr. Butler admits to having no knowledge of the operations of Alexa
`
`Internet. Ex. 2129, 19:12-16. Mr. Butler therefore has no personal knowledge to
`
`support any authenticating testimony, much less to establish when it was allegedly
`
`crawled and archived.
`
`Mr. Butler also admitted that the standard affidavit he supplies to parties in
`
`litigation—like Mylan—is prepared by receiving a “specific” URL on the public
`
`Internet Archive website from a requesting party, and then Mr. Butler “visit[s]” the
`
`same URL to print out the requested webpage. Ex. 2129, 13:12-15:4. Mr. Butler’s
`
`declaration thus evinces no more knowledge than any member of the public would
`
`have from accessing the Internet Archive website. Mr. Butler’s mere use of the
`

`
`5 
`
`

`

`same publicly available Internet Archive website fails to provide any foundation
`
`U.S. Patent No. 8,399,514
`IPR2018-01403

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`based on personal knowledge for establishing that the pages attached to his
`
`declarations are what they purport to be, or that those pages were ever publicly
`
`available at the relevant times. Id.; FRE 901.
`
`Mr. Butler’s declaration is also silent as to the alleged public availability of
`
`the poster. Ex. 1012, 1. In fact, the Internet Archive’s legal policy regarding its
`
`standard affidavits completed by Mr. Butler disclaims making any representations
`
`as to public availability, stating: “It remains your burden to convince the finder of
`
`fact what pages were up when.” Ex. 2129, 24:14-25. Dr. Corboy, the Mylan
`
`witness who cites the poster in Exhibit 1012, also does not establish any personal
`
`knowledge about its public availability. Instead, he relies solely on the deficient
`
`declaration of Mr. Butler. Ex. 1002 ¶53. Accordingly, the Board should exclude
`
`Exhibit 1012 as inadmissible under FRE 602 and 901.
`
`Finally, the Board should exercise its authority under 37 C.F.R. § 42.12 to
`
`exclude Exhibit 1012 because Biogen was deprived of the opportunity to cross-
`
`examine Mr. Butler. As recognized by the Board and conceded by Mylan, the
`
`Butler declaration is subject to routine discovery (Paper 30, 2), which imposes on
`
`Mylan an affirmative obligation to make Mr. Butler available for cross-
`

`
`6 
`
`

`

`examination.2 See 37 C.F.R. §§ 42.51-42.53. But Mylan thwarted all of Biogen’s
`
`U.S. Patent No. 8,399,514
`IPR2018-01403

`
`efforts to cross-examine Mr. Butler. Paper 33, 1. Mylan opposed Biogen’s motion
`
`seeking Mr. Butler’s testimony under routine discovery and refused to join
`
`Biogen’s request for a subpoena. Id.; Paper 41, 5. Flouting discovery obligations,
`
`as Mylan has done, alone justifies excluding Exhibit 1012. Paper 41, 5; HTC
`
`Corp. v. NFC Tech., LLC, IPR2014-01198, Paper 41 at 4 (PTAB Nov. 6, 2015).
`
`Accordingly, Exhibit 1012 should be excluded for lack of foundation,
`
`personal knowledge, and authentication. FRE 602, 901. The Board should also
`
`exercise its authority to exclude Exhibit 1012 under 37 C.F.R. § 42.12.
`
`C. The Mihail Declaration (Ex. 1054) and Clinical Trials (Ex. 1010)
`Mylan relies on Exhibit 1054, an attorney declaration from Robert Mihail,
`
`Esq. (“the Mihail declaration”) originally filed in a different IPR, to establish
`
`public availability and authenticity of Exhibit 1010 (“Clinical Trials”). Exhibit
`
`1010 is asserted as a reference in Ground 4 of the Petition. Biogen moves to
`
`exclude Exhibit 1054 as inadmissible hearsay and as lacking foundation and
`

`2 “The right to cross-examine an adversarial witness is a long-standing and vital
`
`feature of the law in all cases including administrative actions.” Stride Rite
`
`Children’s Grp., LLC v. Shoes By Firebug LLC, IPR2017-01809, Paper 64 at 21
`
`(PTAB Jan. 16, 2019).
`

`
`7 
`
`

`

`personal knowledge, and Exhibit 1010 as lacking authentication and as
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`U.S. Patent No. 8,399,514
`IPR2018-01403

`
`inadmissible hearsay.
`
`Exhibit 1054 should be excluded as inadmissible hearsay. Exhibit 1054 is
`
`out-of-court testimony under the hearsay rules because it was filed in a different
`
`IPR by a different petitioner. US Endodontics, LLC v. Gold Standard Instruments,
`
`LLC, PGR2015-00019, Paper 54 at 38-42 (PTAB Dec. 28, 2016) (excluding a
`
`declaration submitted in another proceeding as hearsay). Mylan offered this out-
`
`of-court testimony to prove the alleged truth of the matter asserted, i.e., that
`
`“[Clinical Trials] is a document publicly available from ClinicalTrials.gov as of
`
`September 14, 2005.” Pet. 23 (citing Ex. 1054). The Mihail declaration is
`
`therefore inadmissible hearsay pursuant to FRE 801-802.
`
`The former testimony exception does not apply. Former testimony from
`
`another proceeding may be admitted as an exception to hearsay under FRE 804
`
`only if the declarant is “unavailable.” Rule 804 imposes five specific criteria for
`
`determining when a declarant is “unavailable.” FRE 804(a). Mylan has not
`
`asserted or shown that any of the five criteria are met, but instead refused to make
`
`Mr. Mihail available3 and represented that Mylan “does not control Mr. Mihail.”
`

`3 Nothing in the record suggests that Mylan tried to secure Mr. Mihail’s availability
`
`for cross-examination or that Mr. Mihail is even aware that Mylan has submitted
`

`
`8 
`
`

`

`Paper 28, 6. Mylan’s excuse is irrelevant: Mylan “is responsible for the
`
`U.S. Patent No. 8,399,514
`IPR2018-01403

`
`availability of its chosen declarants, regardless whether or not they are employed
`
`by” Mylan. HTC, IPR2014-01198, Paper 41 at 4 (expunging declaration when
`
`cross-examination was unavailable).
`
`The Mihail declaration also lacks foundation for authenticating Clinical
`
`Trials based on personal knowledge. FRE 602. To authenticate a website, the
`
`proponent of the evidence must present testimony from a witness “with knowledge
`
`of the website . . . for example, a web master or someone else with personal
`
`knowledge.” Neste Oil Oyj v. REG Synthetic Fuels, LLC, IPR2013-00578, Paper
`
`53 at 3-4 (PTAB Mar. 12, 2015). Mr. Mihail does not meet this standard. Rather
`
`than having personal knowledge of ClinicalTrials.gov from 2005, Mr. Mihail is an
`
`attorney who merely participated in a different IPR on behalf of a different
`
`petitioner. Ex. 1054, 1-2. The Mihail declaration is therefore also inadmissible
`
`pursuant to FRE 602.
`
`Accordingly, because the Mihail declaration fails to provide authenticating
`

`his testimony in this proceeding. CaptionCall, L.L.C. v. Ultratec, Inc., IPR2015-
`
`00637, Paper 98 at 16 (PTAB Sept. 7, 2016) (denying application of Rule 804
`
`exception where “no attempt to bring [the declarant] forward as a witness in this
`
`proceeding” was made by the proponent of the testimony).
`

`
`9 
`
`

`

`U.S. Patent No. 8,399,514
`IPR2018-01403

`testimony, Exhibit 1010 (Clinical Trials) is inadmissible as lacking authentication.
`
`FRE 901. In addition, the date on the face of Clinical Trials that Mylan relies on to
`
`prove the date of alleged public availability is inadmissible hearsay. Neste,
`
`IPR2013-00578, Paper 53 at 5-6. Mylan has not proffered any testimony or
`
`evidence establishing the publication date of Clinical Trials, aside from
`
`inadmissible testimony from Mr. Mihail. The date on Exhibit 1010, as well as the
`
`entire content, is therefore inadmissible hearsay under FRE 802.
`
`The residual exception to hearsay, reserved for “exceptional cases,” does not
`
`apply to the Mihail declaration and Clinical Trials. Neste, IPR2013-00578, Paper
`
`53 at 10. To fall under this exception, a hearsay statement must: (1) have
`
`circumstantial guarantees of trustworthiness; (2) be offered as evidence of a
`
`material fact; (3) be more probative on the point for which it is offered than any
`
`other evidence the proponent can obtain through reasonable efforts; and (4) be in
`
`the interests of justice to admit. FRE 807.
`
`Here, three of the four considerations strongly weigh against admission.
`
`First, these exhibits lack circumstantial guarantees of trustworthiness. Biogen
`
`already proffered evidence that the Mihail declaration’s accuracy is suspect. Paper
`
`24, 2, 4; Ex. 2050 (showing error message resulting from entering the URL Mr.
`
`Mihail purportedly used to obtain the Clinical Trials webpage). Second, cross-
`
`examination testimony of Mr. Mihail would have been more probative evidence.
`

`
`10 
`
`

`

`But Mr. Mihail’s unavailability is of Mylan’s own making—Mylan refused to
`
`U.S. Patent No. 8,399,514
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`make Mr. Mihail available and never represented that it made even a “reasonable
`
`effort” under FRE 807 to secure his availability. Paper 24, 1-3. Third, for the
`
`same reasons, it is not in the interest of justice to admit these exhibits. The Board
`
`should require the proponent of the evidence to do more than print a website and
`
`offer testimony from a different proceeding. Otherwise, the opponent would be
`
`deprived of any meaningful ability to cross-examine the declarant or otherwise test
`
`the veracity of the proffered hearsay statements. The residual exception therefore
`
`should not rescue Exhibits 1010 and 1054.
`
`Additionally, the Board should exercise its authority under 37 C.F.R. §42.12
`
`to exclude Ex. 1054 because Biogen was deprived of the opportunity to cross-
`
`examine Mr. Mihail. Having chosen to submit and rely upon Mr. Mihail’s
`
`declaration in this IPR, Mylan cannot escape its obligation to produce the witness
`
`for cross-examination. HTC, IPR2014-01198, Paper 41 at 4.
`
`D. The Rock Declaration (Ex. 1055 and Ex. 1122)
`Mylan relies upon Exhibit 1055, a declaration from Ms. Jennifer Rock, to
`
`establish authenticity of “Business Wire” press releases printed from a Westlaw
`
`website, as well as their alleged dates of public availability. Biogen timely
`
`objected to Exhibit 1055 and Mylan failed to remedy the objections with its
`
`supplemental Exhibit 1122. Biogen moves to exclude Exhibits 1055 and 1122
`

`
`11 
`
`

`

`(collectively, “the Rock declaration”) as lacking foundation and personal
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`U.S. Patent No. 8,399,514
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`knowledge, as irrelevant, and as inadmissible hearsay. FRE 401-403, 602, 802,
`
`805.
`
`The Rock declaration lacks the personal knowledge necessary to
`
`authenticate the online press releases. To authenticate a website, the proponent of
`
`the evidence must present testimony from a witness “with knowledge of the
`
`website . . . for example, a web master or someone else with personal knowledge.”
`
`Neste, IPR2013-00578, Paper 53 at 3-4. Ms. Rock’s testimony does not meet this
`
`standard because it is admittedly not based on personal knowledge. Ex. 2065,
`
`33:1-34:12. The Rock declaration is therefore inadmissible pursuant to FRE 602.
`
`The Rock declaration is also irrelevant. Far from demonstrating public
`
`availability of the press releases before the February 2007 priority date, Ms. Rock
`
`testified that the press releases are “accurate copies of the articles as they appear on
`
`Westlaw as of today’s date.” Ex. 1122 ¶5. She admitted that she did not pull any
`
`archived versions of the press releases at the relevant time period. Ex. 2065, 31:1-
`
`6. Nor did she testify that the press releases were available to a POSA. Ex. 1122
`
`¶6. Instead, she admitted that access was limited to attorneys—not POSAs under
`
`either party’s definition—and that special steps would have been required to find
`
`the press releases. Ex. 2065, 14:20-15:6, 16:24-17:19, 19:2-16, 23:5-27:7.
`
`Finally, Ms. Rock’s testimony as to the alleged dates of public availability of
`

`
`12 
`
`

`

`the press releases is inadmissible hearsay-within-hearsay. FRE 802, 805. The
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`dates and times identified in paragraph 6 of Ms. Rock’s declaration repeat out-of-
`
`court statements (for which she has no personal knowledge of their accuracy) and
`
`are offered to prove the truth of the matter asserted—that the documents were
`
`available as of those dates and times.4 Ex. 2065, 33:10-36:4; Neste, IPR2013-
`
`00578, Paper 53 at 7-8. The dates/times alleged in the Rock declaration to be the
`
`publication dates of the press releases are therefore inadmissible hearsay under
`
`FRE 802 and 805.
`
`Mylan has not proffered any further testimony or evidence adequately
`
`establishing the publication dates of the press releases, aside from inadmissible
`
`testimony from Ms. Rock. The inadmissibility of the Rock declaration further
`
`confirms that Mylan failed to meet its burden of establishing that the press releases
`
`were “sufficiently accessible to the public interested in the art” before the critical
`
`date. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989).
`

`4 Ms. Rock admitted that the times identified in her declaration differ from the
`
`information on the face of the underlying press releases themselves. Ex. 2065,
`
`34:14-36:4. With the Rock declaration’s accuracy in doubt, the residual exception
`
`to hearsay should not apply.
`

`
`13 
`
`

`

`III. CONCLUSION
`For the foregoing reasons, the Board should exclude Exhibits 1010, 1012,
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`U.S. Patent No. 8,399,514
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`
`1036, 1037, 1054, 1055, 1066, and 1122 from the record.
`
`
`
`
`Dated: October 24, 2019
`
`
`
`
`
`By: /Barbara C. McCurdy/
`Barbara C. McCurdy, Reg. No. 32,120
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`

`
`14 
`
`

`

`CERTIFICATE OF COMPLIANCE
`
`U.S. Patent No. 8,399,514
`IPR2018-01403

`
`The undersigned certifies that this brief complies with the page limit
`
`
`
`
`limitations of 37 C.F.R. § 42.24(a)(1)(v), as measured by the word-processing
`
`system used to prepare this paper.
`
`
`
`Dated: October 24, 2019
`
`
`By: /Barbara C. McCurdy/
`Barbara C. McCurdy, Reg. No. 32,120
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`U.S. Patent No. 8,399,514
`IPR2018-01403

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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing Patent Owner’s
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`Motion to Exclude Evidence was served electronically via the PTAB electronic
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`filing system and via email on October 24, 2019, in its entirety, on the following:
`
`Brandon M. White
`Shannon M. Bloodworth
`Michael A. Chajon
`Maria A. Stubbings
`Nathan Kelley
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`Email: bmwhite@perkinscoie.com
`Email: sbloodworth@perkinscoie.com
`Email: mchajon@perkinscoie.com
`Email: mstubbings@perkinscoie.com
`Email: nkelley@perkinscoie.com
`
`David L. Anstaett
`Emily J. Greb
`Perkins Coie LLP
`One East Main St., Suite 201
`Madison, WI 53703
`Telephone: (608) 663-7494
`Email: danstaett@perkinscoie.com
`Email: egreb@perkinscoie.com
`
`Courtney M. Prochnow
`Perkins Coie LLP
`633 W. 5th St., Suite 5850
`Los Angeles, CA 90071
`Telephone: (310) 788-3284
`Email: cprochnow@perkinscoie.com
`
`

`

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`

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`U.S. Patent No. 8,399,514
`IPR2018-01403

`
`Brian Sodikoff
`Martin S. Masar III, Ph.D.
`Katten Muchin Rosenman LLP
`525 West Monroe Street
`Chicago, IL 60661-3693
`Telephone: (312) 902-5462
`Email: brian.sodikoff@kattenlaw.com
`Email: martin.masar@kattenlaw.com
`
`Christopher B. Ferenc
`Katten Muchin Rosenman LLP
`2900 K Street NW,
`North Tower - Suite 200
`Washington, DC 20007
`Telephone: (202) 625-3647
`Email: Christopher.ferenc@kattenlaw.com
`
`Petitioner has agreed to electronic service.
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`Dated: October 24, 2019
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`
`
`By: /Barbara C. McCurdy/
`Barbara C. McCurdy, Reg. No. 32,120
`
`
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