Filed: October 31, 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.
`____________________________
`Case No. IPR2018-01431
`U.S. Patent No. 8,399,514
`____________________________
`
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE
`
`
`1 Case IPR2019-00789 has been joined with this proceeding.
`
`
`
`
`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.
`____________________________
`Case No. IPR2018-01431
`U.S. Patent No. 8,399,514
`____________________________
`
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE
`
`
`1 Case IPR2019-00789 has been joined with this proceeding.
`
`
`
`INTRODUCTION ................................................................................. 1
`ARGUMENT ........................................................................................ 2
`A.
`Biogen Failed to Establish That Fox 2011, EMA 2013,
`and Phillips 2013 Are Inadmissible ............................................ 2
`Biogen Failed to Establish That the Butler Decl. and
`Schimrigk 2004 Poster Are Inadmissible ................................... 5
`Biogen Failed to Establish That the Rock Decl. Is
`Inadmissible ................................................................................ 9
`Biogen Failed to Establish That the Mihail Decl. and
`Clinical Trials Are Inadmissible ............................................... 12
`III. CONCLUSION ................................................................................... 15
`
`B.
`
`C.
`
`D.
`
`I.
`II.
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`
`
`i
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`3BTech, Inc. v. Jingle Master Int’l Ltd.,
`IPR2018-00663, 2019 WL 3992794 (PTAB Aug. 23, 2019) ............................... 4
`Afton Chem. Corp. v. Infineum Int’l Ltd.,
`IPR2017-01321, 2018 WL 5099771 (PTAB Oct. 18, 2018) ................................ 6
`Apple, Inc. v. VirnetX, Inc.,
`IPR2017-00337, 2018 WL 2459607 (PTAB May 30, 2018) ............................. 13
`Chesapeake & Del. Canal Co. v. United States,
`250 U.S. 123 (1919) ............................................................................................ 13
`Chi. Mercantile Exch., Inc. v. 5th Mkt., Inc.,
`CBM2014-00114, 2015 WL 4976739 (PTAB Aug. 18, 2015) .................... 12, 13
`Comcast Cable Commc’ns, LLC v. Rovi Guides, Inc.,
`IPR2017-00941, 2018 WL4278984 (PTAB Sept. 7, 2018) ............................... 14
`Coriant (USA) Inc. v. Oyster Optics, LLC,
`IPR2018-00258, 2018 WL 2761411 (PTAB June 6, 2018) ............................... 11
`Crestron Elecs., Inc. v. Intuitive Bldg. Controls, Inc.,
`IPR2015-01379, 2015 WL 13631028 (PTAB Dec. 15, 2015) ................... 6, 7, 10
`Ericsson Inc. v. Intellectual Ventures I LLC,
`IPR2014-00527, Paper 41 (PTAB May 18, 2015) ............................................. 11
`Ex Parte ePlus, Inc.,
`2010-00784, 2011 WL 1918594 (BPAI May 18, 2011) .................................... 10
`Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.,
`IPR2017-00062, 2018 WL 1605264 (PTAB Mar. 29, 2018) ............................... 9
`FLIR Sys., Inc. v. Leak Surveys, Inc.,
`IPR2014-00411, Paper 113 (PTAB Sept. 3, 2015)............................................... 5
`Fox Factory, Inc. v. Sram, LLC,
`IPR2017-00118, 2018 WL 1633537 (PTAB Apr. 2, 2018) ................................. 4
`
`ii
`
`
`
`
`Google Inc. v. Performance Price Holdings, LLC,
`CBM2016-00049, 2017 WL 4082446 (PTAB Sept. 13, 2017) ............................ 4
`HTC Corp. v. NFC Tech., LLC,
`IPR2014-01198, Paper 41 (PTAB Nov. 6, 2015) ................................................. 9
`Int’l Bus. Machines Corp. v. Intellectual Ventures II LLC,
`IPR2015-00092, 2016 WL 3598530 (PTAB Apr. 25, 2016) ............................... 1
`Intel Corp. v. Alacritech, Inc.,
`IPR2017-01392, 2018 WL 6190430 (PTAB Nov. 26, 2018) ............................... 9
`Johns Manville Corp. v. Knauf Insulation, Inc.,
`IPR2015-01453, 2017 WL 378547 (PTAB Jan. 11, 2017) .............................. 7, 9
`Mylan Pharm. Inc. v. Janssen Oncology, Inc.,
`IPR2016-01332, 2018 WL 456305 (PTAB Jan. 17, 2018) .................................. 1
`Smart Microwave Sensors GmbH v. Wavetronix LLC,
`IPR2016-00488, 2017 WL 3034507 (PTAB July 17, 2017) .............................. 13
`Stored Value Solutions, Inc. v. Card Activation Techs., Inc.,
`499 F. App’x 5 (Fed. Cir. 2012) ......................................................................... 11
`United States v. Quezada,
`754 F.2d 1190 (5th Cir. 1985) ............................................................................ 13
`Valeo N. Am., Inc. v. Magna Elecs., Inc.,
`IPR2014-01204, 2016 WL 762567 (PTAB Jan. 25, 2016) .............................. 8, 9
`Xactware Sols., Inc. v. Pictometry Int’l Corp.,
`IPR2016-00594, 2017 WL 3671031 (PTAB Aug. 24, 2017) ............................... 5
`Xilinx, Inc. v. Godo Kaisha IP Bridge 1,
`IPR2017-00842, 2018 WL 2933511 (PTAB June 7, 2018) ................................. 6
`Yeda Research v. Mylan Pharm. Inc.,
`906 F.3d 1031 (Fed. Cir. 2018) .................................................................... 1, 2, 3
`OTHER AUTHORITIES
`Fed. R. Evid. 401 ....................................................................................................... 4
`Fed. R. Evid. 803(6) ................................................................................................. 11
`
`iii
`
`
`
`
`Fed. R. Evid. 803(8) ............................................................................................. 2, 13
`Fed. R. Evid. 807 ............................................................................................... 11, 14
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756 .......................................... 6
`
`
`
`
`
`
`iv
`
`
`
`
`
`TABLE OF ABBREVIATIONS
`Abbreviation Description
`Biogen
`Patent Owner Biogen MA Inc.
`Butler Decl.
`Ex. 1012, Affidavit of Christopher Butler, July 2, 2018
`Clinical Trials Ex. 1010, NCT00168701, CLINICALTRIALS.GOV,
`https://clinicaltrials.gov/ archive/NCT00168701/2005_09_14
`Coalition for Affordable Drugs V LLC v. Biogen MA Inc., IPR2015-
`IPR2015-
`01993 (PTAB)
`01993
`Federal Rules of Evidence
`FRE
`Kappos 2006 Ex. 1007, L. Kappos et al., Efficacy of a Novel Oral Single-Agent
`Fumarate, BG00012, in Patients with Relapsing-Remitting Multiple
`Sclerosis: Results of a Phase 2 Study, 253 (Suppl. 2) J. NEUROL.
`II27, O108 (2006)
`Ex. 1046, L. Kappos et al., Efficacy of a Novel Oral Single-Agent
`Fumarate, BG00012, in Patients with Relapsing-Remitting Multiple
`Sclerosis: Results of a Phase II Study (16th Meeting of the European
`Neurological Society, May 30, 2006) attached as Exhibit C to the
`Declaration of Katherine T. Dawson in Biogen U.S. Patent App. No.
`12/526,296 and marked as Ex. 1018 in Biogen MA Inc. v. Forward
`Pharma A/S, Interference No. 106,023
`Ex. 1054, Declaration of Robert Mihail, Sept. 27, 2015, filed in
`Coalition for Affordable Drugs V LLC v. Biogen MA Inc., IPR2015-
`01993 (PTAB)
`Paper 75, Patent Owner’s Motion to Exclude Evidence
`Petitioner Mylan Pharmaceuticals Inc.
`U.S. National Institute of Health
`Ex. 1055, Declaration Regarding Thomas Reuters/West Publishing
`Corporation, (“West”) Business Wire Articles on WestLawNext,
`July 3, 2018; and
`Ex. 1022, Declaration Regarding Thomas Reuters/West Publishing
`Corporation, (“West”) Business Wire Articles on WestLawNext,
`Feb. 27, 2019
`
`Motion
`Mylan
`NIH
`Rock Decl.
`
`Kappos 2006
`Presentation
`
`Mihail Decl.
`
`v
`
`
`
`
`
`Abbreviation Description
`Schimrigk
`Ex. 1006, S. Schimrigk et al., A Prospective, Open-Label, Phase II
`2004
`Study of Oral Fumarate Therapy for the Treatment of Relapsing-
`Remitting Multiple Sclerosis, 10 (Suppl. 2) MULTIPLE
`SCLEROSIS CLIN. & LAB. RES. S258, Abstract P642 (2004)
`Ex. 1012, S. Schimrigk et al., A Prospective, Open-Label, Phase II
`Study of Oral Fumarate Therapy for the Treatment of Relapsing-
`Remitting Multiple Sclerosis (2004), available at
`http://web.archive.org/web/
`20041021033354/http://www.fumapharm.ch:80/pdf/BG-12_
`Schimrigk_Poster_Final.pdf
`
`Schimrigk
`2004 Poster
`
`vi
`
`
`
`
`
`I.
`
`INTRODUCTION
`Biogen moves to excludes two sets of documents: (1) publications that
`
`confirm the testimony of Mylan’s experts explaining how skilled artisans would
`
`have understood prior art disclosures about a 360 mg/day DMF dose to treat MS
`
`(i.e., they would immediately have questioned the conclusions), and also refute
`
`Biogen’s assertion of unexpected results for the 480 mg/day dose; and (2) witness
`
`declarations authenticating certain prior art publications and establishing their public
`
`availability date (and, for some, the authenticated documents themselves). Motion 1.
`
`But Biogen fails to meet its burden of showing the challenged evidence should be
`
`excluded. See Mylan Pharm. Inc. v. Janssen Oncology, Inc., IPR2016-01332, 2018
`
`WL 456305, at *19 (PTAB Jan. 17, 2018).
`
`Although Biogen argues the first set of documents is irrelevant based on the
`
`post-priority publication date, post-priority documents are relevant when properly
`
`considered. See Yeda Research v. Mylan Pharm. Inc., 906 F.3d 1031, 1041 (Fed.
`
`Cir. 2018). Regarding the witness declarations, Biogen’s challenges are directed to
`
`the sufficiency of the evidence, not its admissibly, and are therefore improper to
`
`justify exclusion. In any event, the motion fails on the merits. To authenticate a
`
`website and establish a public availability date, the proponent must adduce testimony
`
`from “someone with knowledge of the website.” Int’l Bus. Machines Corp. v.
`
`Intellectual Ventures II LLC, IPR2015-00092, 2016 WL 3598530, at *27 (PTAB
`
`1
`
`
`
`
`
`Apr. 25, 2016) (citations omitted). Two of the declarants, as employees of the
`
`websites in question, have the requisite personal knowledge. The third website is
`
`authentic and establishes its public availability date under FRE 803(8) as a public
`
`record of NIH.
`
`II. ARGUMENT
`A. Biogen Failed to Establish That Fox 2011, EMA 2013, and Phillips
`2013 Are Inadmissible
`Biogen’s arguments to exclude Fox 2011, EMA 2013, and Phillips 2013 fail
`
`because post-priority publications can be relied on for obviousness. As the Federal
`
`Circuit recently explained, under “the statutory scheme, the PTO’s own regulations,
`
`and prior Board decisions,” the Board may “consider non-prior art evidence . . . in
`
`considering the knowledge, motivations, and expectations of a POSITA regarding
`
`the prior art.” Yeda, 906 F.3d at 1041. This evidence can, for example, show “how
`
`one with ordinary skill in the art would have under-stood [sic] a prior art disclosure.”
`
`Id. (citation omitted). Here, Mylan cites the evidence to show how skilled artisans
`
`would interpret the prior art and to refute Biogen’s claim of unexpected results.
`
`To sidestep the law, Biogen glosses over how Mylan uses the exhibits. Biogen
`
`vaguely asserts (at 1) that Mylan “relies on” the challenged exhibits “in support of
`
`its obviousness allegations.” But Mylan does not use them as obviousness
`
`references. Instead, Mylan cites them to corroborate Drs. Corboy’s, Benet’s, and
`
`Greenberg’s testimony on a POSA’s interpretation of prior-art clinical trials results,
`
`2
`
`
`
`
`
`which refutes the basis for Biogen’s claim of unexpected results. See Paper 2, 54–
`
`59; Paper 68, 10; Ex. 1121 ¶¶ 158, 168; Ex. 1002 ¶¶ 205–11; Ex. 1003 ¶¶ 215–22.
`
`Specifically, Mylan explains that Schimrigk 2004 taught an effective DMF
`
`dose range of 360 mg/day to 720 mg/day for treating MS. See, e.g., Paper 2, 36–37;
`
`Paper 68, 4; Ex. 1002 ¶ 145; Ex. 1003 ¶¶ 133–34, 145, 161, 165; Ex. 1121 ¶¶ 205–
`
`13. Mylan also states that Kappos 2006 and the Kappos 2006 Presentation reinforced
`
`this teaching by disclosing that 720 mg/day DMF significantly reduced brain lesions
`
`and DMF reduced disease activity in a dose-dependent manner. See, e.g., Paper 2,
`
`34, 45; Paper 68, 7–8; Ex. 1002 ¶¶ 167–69, 173–81; Ex. 1121 ¶¶ 184–87. Further,
`
`Mylan argues a POSA would immediately have noticed that the 360 mg/day group
`
`had much higher baseline disease activity than the placebo group, suspected this
`
`imbalance obscured the 360 mg/day dose’s treatment effect, and corrected the data.
`
`See, e.g., Paper 2, 46; Paper 68, 8; Ex. 1002 ¶¶ 179–80, 203–04; Ex. 1003 ¶¶ 169–
`
`78; Ex. 1121 ¶¶ 141, 149–50, 153–57. Mylan references the challenged exhibits to
`
`note that other skilled artisans likewise noticed and corrected for this imbalance.
`
`See, e.g., Paper 2, 54–59; Paper 68, 10; Ex. 1002 ¶ 145; Ex. 1003 ¶¶ 204–11; Ex.
`
`1121 ¶¶ 158–70. Notably, Mylan does not argue the references render the claims
`
`obvious. See Paper 2, 34–53; Paper 68, 10. Mylan thus relies on the challenged
`
`exhibits for a use the Federal Circuit approved in Yeda.
`
`While Biogen claims the evidence is irrelevant, it confirms that a POSA would
`
`3
`
`
`
`
`
`question Biogen’s Phase II results for the 360 mg/day dose. But the standard for
`
`relevance is low, requiring only that evidence have “any tendency to make a fact [of
`
`consequence] more or less probable than it would be without the evidence.” FRE
`
`401. The Board has noted the low standard on several occasions. See, e.g., Google
`
`Inc. v. Performance Price Holdings, LLC, CBM2016-00049, 2017 WL 4082446, at
`
`*15 (PTAB Sept. 13, 2017) (noting “the very low threshold for relevance”), aff’d
`
`sub nom. Performance Price Holdings, LLC v. Google LLC, 757 F. App’x 1013
`
`(Fed. Cir. 2019); Fox Factory, Inc. v. Sram, LLC, IPR2017-00118, 2018 WL
`
`1633537, at *21 (PTAB Apr. 2, 2018) (noting “the low standard of Rule 401”);
`
`3BTech, Inc. v. Jingle Master Int’l Ltd., IPR2018-00663, 2019 WL 3992794, at *14
`
`(PTAB Aug. 23, 2019). Biogen next argues (at 2) that the challenged exhibits “are
`
`particularly irrelevant and 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.” But the results of the 480 mg/day dose
`
`were simply not unexpected. See, Paper 2, 54–60; Paper 68, 12–13. Biogen’s
`
`premise for “particular irrelevance” falls flat.
`
`Finally, Biogen asserts (at 3) the authors of the challenged exhibits had access
`
`to non-public Phase II data, which supposedly “taints these documents.” But Mylan
`
`does not cite the exhibits for the non-public data or the results of the authors’
`
`corrections to those data. It cites them for more general facts—that the authors, like
`
`4
`
`
`
`
`
`all other POSAs would have, questioned the Phase II data in Kappos 2006 and the
`
`Kappos 2006 Presentation for the 360 mg/day dose, knew the data needed to be
`
`adjusted for baseline imbalances, and could perform simple corrections to confirm
`
`the dubious nature of Kappos 2006 and the Kappos 2006 Presentation’s conclusions.
`
`See, e.g., Paper 2, 54–59; Paper 68, 10; Ex. 1002 ¶¶ 204–11; Ex. 1003 ¶¶ 204–11;
`
`Ex. 1121 ¶¶ 158–70. As Dr. Greenberg explained, “based solely on the data provided
`
`in the Kappos 2006 Presentation, skilled artisans would have the motivation and
`
`ability to normalize the data and adjust for the baseline Gd+ lesions in a variety of
`
`ways as described above.” Ex. 1121 ¶ 183.
`
`B.
`
`Biogen Failed to Establish That the Butler Decl. and Schimrigk
`2004 Poster Are Inadmissible
`Biogen moves to exclude the Butler Decl., which authenticates and establishes
`
`the public availability date of the Schimrigk 2004 Poster. Biogen’s attacks on the
`
`Butler Decl. and Schimrigk 2004 Poster2 go directly to the sufficiency of the
`
`evidence to establish the Schimrigk 2004 Poster as prior art. “A motion to exclude
`
`is the wrong vehicle to challenge public availability, which is a substantive issue that
`
`goes to the sufficiency of the evidence, not to admissibility.” FLIR Sys., Inc. v. Leak
`
`Surveys, Inc., IPR2014-00411, Paper 113 at 4 (PTAB Sept. 3, 2015); Xactware Sols.,
`
`
`2 Biogen’s attempts to exclude the Rock Decl., the Mihail Decl., and Clinical Trials
`
`are similarly improper attempts to argue the sufficiency of the evidence.
`
`5
`
`
`
`
`
`Inc. v. Pictometry Int’l Corp., IPR2016-00594, 2017 WL 3671031, at *3 (PTAB
`
`Aug. 24, 2017), aff’d, 742 F. App’x 509 (Fed. Cir. 2018); Afton Chem. Corp. v.
`
`Infineum Int’l Ltd., IPR2017-01321, 2018 WL 5099771, at *18–19 (PTAB Oct. 18,
`
`2018); Xilinx, Inc. v. Godo Kaisha IP Bridge 1, IPR2017-00842, 2018 WL 2933511,
`
`at *2 (PTAB June 7, 2018); Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756,
`
`48,767 (Aug. 14, 2012) (“A motion to exclude must explain why the evidence is not
`
`admissible (e.g., relevance or hearsay) but may not be used to challenge the
`
`sufficiency of the evidence to prove a particular fact.”).
`
`Nonetheless, even if Biogen’s motion to exclude is provided any
`
`consideration, it should be denied. To authenticate a webpage and establish its public
`
`availability date, the proponent of the webpage may present declaration testimony
`
`demonstrating a clear reliable process for capturing, preserving, and presenting the
`
`web page. For example, in Crestron Electronics, Inc. v. Intuitive Building Controls,
`
`Inc., the petitioner relied on a collection of printouts of archived web pages from the
`
`Wayback Machine (referred to as “SavoySoft”), and the Board was “persuaded that
`
`SavoySoft [wa]s a printed publication.” IPR2015-01379, 2015 WL 13631028, at *6
`
`(PTAB Dec. 15, 2015). The Board credited a declaration from Mr. Butler that
`
`explained the process used to capture, preserve, and present web pages on the
`
`Wayback Machine: “The Butler Affidavit explains the processes used to archive web
`
`pages from the Internet and how the archived copies of web pages can be associated
`
`6
`
`
`
`
`
`with a date of archiving.” Id. at *5. The declaration also “indicate[d] the Wayback
`
`Machine uses ‘crawler’ programs to locate web pages on the Internet.” Id. at *6. The
`
`Board was “persuaded, on th[at] record, that it [wa]s reasonably likely that web
`
`pages locatable by crawlers of the Wayback Machine would be locatable to
`
`interested persons using typical search engines available at least one year before the
`
`critical date.” Id.
`
`The Butler Decl. here does the same. It is admissible as relevant evidence to
`
`establish the Schimrigk 2004 Poster’s authenticity and public availability date. As
`
`noted above, moreover, the issue on this motion is only admissibility, not whether
`
`Mylan has established the public availability date (Mylan has). The merits must not
`
`be conflated on an evidentiary issue, and the declaration surely meets the lower
`
`threshold for admissibility (also the higher one for public availability).
`
`Biogen nevertheless lobs a series of hollow arguments, first urging that Mr.
`
`Butler lacks personal knowledge of whether the Schimrigk 2004 Poster was archived
`
`or publicly available before the critical date. But Mr. Butler has extensive personal
`
`knowledge of the Internet Archive’s process for archiving websites and making them
`
`publicly available, the pertinent issues here. Ex. 1012 ¶¶ 2–5. Personal knowledge
`
`to the level Biogen pleads for is not required to render a declaration like this
`
`admissible. Johns Manville Corp. v. Knauf Insulation, Inc., IPR2015-01453, 2017
`
`WL 378547, at *6 (PTAB Jan. 11, 2017) (accepting Mr. Butler’s testimony on
`
`7
`
`
`
`
`
`reference published before his employment began), aff’d, 730 F. App’x 934 (Fed.
`
`Cir. 2018); Valeo N. Am., Inc. v. Magna Elecs., Inc., IPR2014-01204, 2016 WL
`
`762567, at *8 (PTAB Jan. 25, 2016) (“Personal knowledge is not a necessary
`
`condition of relevance.”). Biogen’s reliance (at 4–5) on Mr. Butler’s employment
`
`date, experience programing web crawlers, or knowledge of third-party Alexa
`
`Internet’s operations is thus beside the point. In fact, the Board already recognized
`
`the irrelevance of Mr. Butler’s start date and Alexa Internet’s operations: “We are
`
`not persuaded, however, that compelled testimony related to the start date of Mr.
`
`Butler’s employment would yield any additional useful information. . . .
`
`Accordingly, that the Internet Archive uses Alexa Crawls is not disputed and Patent
`
`Owner does not explain how cross-examination testimony on the matter would yield
`
`useful information.” Paper 41, 4–5.
`
`In a last-ditch effort, Biogen accuses Mylan of supposedly “thwart[ing] all of
`
`Biogen’s efforts to cross examine Mr. Butler” by opposing the motion to compel
`
`cross examination. Motion 7. But Biogen ignores the Board’s well-reasoned Order
`
`agreeing that cross examination is unwarranted. Id. Mr. Butler is a third-party
`
`unwilling to be voluntarily deposed, and the Board explained that “Patent Owner has
`
`not met its burden of showing that it should be authorized to compel testimony from
`
`Mr. Butler on any issue identified in its Motion.” Paper 41, 5. And Mr. Butler’s
`
`declarations have repeatedly been accepted without deposition to establish
`
`8
`
`
`
`
`
`Archive.org document availability. Intel Corp. v. Alacritech, Inc., IPR2017-01392,
`
`2018 WL 6190430, at *5–6 (PTAB Nov. 26, 2018); Fisher & Paykel Healthcare
`
`Ltd. v. ResMed Ltd., IPR2017-00062, 2018 WL 1605264, at *1 n.3 & n.6 (PTAB
`
`Mar. 29, 2018). Biogen ignores these cases and instead cites one involving a
`
`declaration to establish an earlier invention date and extensive delay from efforts by
`
`the parties and Board to coordinate the deposition. See HTC Corp. v. NFC Tech.,
`
`LLC, IPR2014-01198, Paper 41 at 1,5 (PTAB Nov. 6, 2015).
`
`C. Biogen Failed to Establish That the Rock Decl. Is Inadmissible
`Biogen next moves to exclude the Rock Decl. Ms. Rock is an employee of
`
`West Publishing Corporation in the area that acquires new articles for Westlaw.
`
`Exs. 1055, 1122. She provided testimony that authenticates and establishes the prior-
`
`art date of three Biogen press releases available on Westlaw. Id.; see also Exs. 1005,
`
`1016, and 1026. Although Ms. Rock been at Westlaw for 14 years and has personal
`
`knowledge of its customary and routine business practices for obtaining articles and
`
`making them publicly available, Ex. 1055, 1122, Biogen moves to exclude her
`
`declaration for lack of foundation and personal knowledge, as irrelevant, and as
`
`inadmissible hearsay. Motion 12. Biogen asserts she lacks the personal knowledge
`
`needed to authenticate and date the press releases. Id. But as explained above,
`
`intricate personal knowledge is not required for admissibility. See Johns Manville,
`
`2017 WL 378547, at *6; Valeo, 2016 WL 762567, at *8. Ms. Rock nevertheless has
`
`9
`
`
`
`
`
`the pertinent knowledge. To authenticate an internet document and establish its
`
`public availability date, testimony is required that demonstrates a clear reliable
`
`process for capturing, preserving, and presenting the web page. Crestron, 2015 WL
`
`13631028, at *5. Ms. Rock’s declaration does that.
`
`Biogen attempts (at 12) to obscure the declaration’s admissibility by noting
`
`that, to access the press releases on Westlaw, a subscription is needed and certain
`
`steps must be taken. These requirements are not prohibitive and are irrelevant to
`
`accessibility. See Ex Parte ePlus, Inc., 2010-00784, 2011 WL 1918594, at *8 (BPAI
`
`May 18, 2011) (“[W]e do not find the cost [of the license] to necessarily be material
`
`[to accessibility]. An expensive peer-reviewed journal would be no less a printed
`
`publication just because a poorer researcher could be denied access.”), aff’d per
`
`curiam, In re ePlus, Inc., 540 F. App’x 998 (Fed. Cir. 2013). Biogen also argues Ms.
`
`Rock’s testimony is hearsay-within-hearsay. That too is wrong. Ms. Rock’s
`
`declaration testimony is not hearsay—because there is usually no live testimony in
`
`IPR proceedings, Ms. Rock’s declaration is her trial testimony (not an out of court
`
`statement) and Biogen had full opportunity to cross examined her in deposition. Ms.
`
`Rock provided the dates and times that the press releases were made publicly
`
`available. Ex. 1055 ¶ 6; Ex. 1122 ¶ 6. She obtained those timestamps from West’s
`
`internal logging database for tracking documents it receives, which includes fields
`
`on the document that indicate when it was created and originated. Ex. 2065, 37:17–
`
`10
`
`
`
`
`
`38:5. The timestamps are not hearsay because they come from documents created in
`
`the regular course of West’s business. FRE 803(6). Accordingly, neither the Rock
`
`Decl. nor the timestamps are hearsay.
`
`Ms. Rock’s testimony, moreover, is corroborated by the press releases’
`
`copyright dates and Biogen’s SEC filings. Stored Value Solutions, Inc. v. Card
`
`Activation Techs., Inc., 499 F. App’x 5, 14 (Fed. Cir. 2012); Coriant (USA) Inc. v.
`
`Oyster Optics, LLC, IPR2018-00258, 2018 WL 2761411, at *4 (PTAB June 6, 2018)
`
`(“For established publishers, demonstrating a date of publication is alone sufficient
`
`for showing accessibility to the public.”); Ex. 1078, 12. In fact, because of the
`
`copyright dates, even if the timestamps were hearsay, they are admissible under the
`
`residual exception of FRE 807. That rule allows documents to be admitted even if
`
`they have “equivalent circumstantial guarantees of trustworthiness.” FRE 807. In
`
`Ericsson Inc. v. Intellectual Ventures I LLC, for example, the Board admitted
`
`evidence of an IEEE publication’s copyright date under FRE 807 because “IEEE is
`
`a well-known, reputable compiler and publisher of scientific and technical
`
`publications” and “the publication date on the copyright line [was] more probative
`
`on the point for which it is offered than any other evidence that [Petitioner] could
`
`have obtained through reasonable efforts.” IPR2014-00527, Paper 41 at 10–11
`
`(PTAB May 18, 2015). Westlaw likewise is a reputable compiler and publisher of
`
`public press releases and the copyright dates are probative.
`
`11
`
`
`
`
`
`D. Biogen Failed to Establish That the Mihail Decl. and Clinical
`Trials Are Inadmissible
`Finally, Biogen moves to exclude the Mihail Decl., which authenticates an
`
`entry from NIH’s online clinical trial registry (ClinicalTrials.gov) for Biogen’s
`
`Phase II DMF clinical trial, Clinical Trials. The declaration was filed in IPR2015-
`
`01993 (another challenge to Biogen’s ’514 Patent) and attached a copy of Clinical
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`Trials. Biogen claims the declaration is hearsay and lacks foundation and personal
`
`knowledge, and Clinical Trials lacks authentication and is hearsay. Motion 7–8.
`
`As an initial matter, Biogen should not be allowed to raise these challenges
`
`because it did not dispute the Mihail Decl.’s or Clinical Trials’ admissibility in
`
`IPR2015-01993, nor Clinical Trials’ prior-art status. See Chi. Mercantile Exch., Inc.
`
`v. 5th Mkt., Inc., CBM2014-00114, 2015 WL 4976739, at *11 (PTAB Aug. 18,
`
`2015). The Board in that proceeding applied Clinical Trials as prior art and
`
`concluded the petitioner had established a prima facie obviousness case with a
`
`combination that included Clinical Trials. IPR2015-01993, Paper 63 at 11–12, 25–
`
`26. In fact, Biogen filed no objection to the Mihail Decl. or Clinical Trials, did not
`
`seek to depose Mr. Mihail, and filed no motion to exclude. IPR2015-01993 Paper
`
`51. The Board questioned similar conduct in Chicago Mercantile. 2015 WL
`
`4976739, at *11. The patent owner there challenged the prior-art status of a reference
`
`(CFTC), which had been applied as prior art in two prior reexams and one CBM
`
`proceeding. Id. In those prior proceedings, the patent owner “did not dispute that
`
`12
`
`
`
`
`
`CFTC qualifies as a prior art printed publication.” Id. According to the Board, “it is
`
`unclear to us why such arguments were not brought in the prior proceedings before
`
`the Office, especially given their potential to be dispositive.” Id.
`
`Even if the Board permits the challenges, they fail. While Biogen alleges the
`
`date on Clinical Trials is hearsay, it is subject to several hearsay exceptions. For one,
`
`FRE 803(8) applies: Clinical Trials is a public record of NIH, a federal agency,
`
`setting out its legally-mandated duty to maintain a clinical trial registry, and there is
`
`no lack of trustworthiness. See Smart Microwave Sensors GmbH v. Wavetronix LLC,
`
`IPR2016-00488, 2017 WL 3034507, at *24 (PTAB July 17, 2017), aff’d sub nom.
`
`Wavetronix LLC v. Smart Microwave Sensors GmbH, 746 F. App’x 984 (Fed. Cir.
`
`2018); Apple, Inc. v. VirnetX, Inc., IPR2017-00337, 2018 WL 2459607, at *25
`
`(PTAB May 30, 2018). NIH is required by statute to maintain a registry of clinical
`
`trials and, to meet that mandate, NIH developed the online registry, “which was
`
`made available to the public in February 2000.” Background, CLINICALTRIALS.GOV,
`
`https://clinicaltrials.gov/ct2/about-site/background (last visited Oct. 31, 2019).
`
`FRE 803(8) is based on the notion that public records are reliable because there is a
`
`“lack of . . . motivation on the part of the recording official to do other than
`
`mechanically register an unambiguous factual matter.” United States v. Quezada,
`
`754 F.2d 1190, 1194 (5th Cir. 1985); see also Chesapeake & Del. Canal Co. v.
`
`United States, 250 U.S. 123, 128–29 (1919). This is precisely what NIH does for
`
`13
`
`
`
`
`
`clinical trial. There are also several other indications of trustworthiness (the NIH and
`
`ClinicalTrials.gov headers, the clinical trial identifier number, the URL, the
`
`timestamp). Moreover, Mylan’s counsel recently reproduced Clinical Trials
`
`(Ex. 1057) and provided Biogen a copy and a declaration explaining how it was
`
`obtained. Paper 35, 2. With its indications of trustworthiness, Clinical Trials is also
`
`admissible under FRE 807. It has “equivalent circumstantial guarantees of
`
`trustworthiness,” is offered for a material fact (invalidity), and, because of its
`
`invalidating disclosures, it is more probative than other evidence. FRE 807.
`
`FRE 807 also applied to the Mihail Decl. It has indications of trustworthiness,
`
`most notably, that Biogen did not challenge it in IPR2015-01993. It also includes
`
`the URL Mr. Mihail used and his admonition. It is offered for a material fact
`
`(invalidity), the cross-exam Biogen posits (at 10) would not be more probative (the
`
`declaration already contains all needed facts), and the interest of justice would be
`
`served by admission (a full record on invalidity would be made). Biogen again
`
`argues that the deponent lacked the requisite personal knowledge. But Mylan relies
`
`on the Mihail Decl. only to establish Clinical Trials as an accurate website printout
`
`(not its prior art date). All that is needed for that is testimony from the person who
`
`captured the web page, which Mr. Mihail provided. See Comcast Cable Commc’ns,
`
`LLC v. Rovi Guides, Inc., IPR2017-00941, 2018 WL4278984 at *23 (PTAB Sept. 7,
`
`2018) (attorney declaration established web “documents as true and accurate”). The
`
`14
`
`
`
`
`
`prior art date is established by the “September 9, 2005” date indicated on Clinical
`
`Trials (at 16), which is subject to the public record exception as explained above.
`
`Even if these exhibits are excluded, Ground IV would proceed because Mylan
`
`reproduced Clinical Trials (Ex. 1057) on February 26, 2019, served it with an
`
`attorney declaration on March 6, 2019, and Biogen deposed Mylan’s counsel on
`
`September 20, 2019. As the Board suggested, Mylan submits that declaration with
`
`this opposition. Paper 35, 4 (“Petitioner may file the previously served supplemental
`
`evidence with any opposition to the motion to exclude . . . .”); Ex. 1134.
`
`Finally, Biogen’s argument (at 11) that it was “deprived of the opportunity to
`
`cross-examine Mr. Mihail” is of no moment. As the Board explained, Mr. Mihail’s
`
`declaration was “not prepared for the purposes of this inter partes review, and thus,
`
`that the routine-discovery provisions of § 42.51(b)(1) do not apply,” and “cross-
`
`examination of the declarants is not provided as routine discovery.” Paper 22, 2. The
`
`Board also was “not persuaded that Patent Owner has shown that the cross-
`
`examination of Mr. Mihail, whose testimony was not prepared for this proceeding,
`
`is in the interests of justice based on the facts and circumstances present here.” Paper
`
`35, 4. And Biogen did have a chance to depose Mylan’s counsel regarding the
`
`reproduced version of Clinical Trials. Biogen’s claims of “deprivation” fall flat.
`
`III. CONCLUSION
`For the reasons above, Biogen’s motion to exclude should be denied.
`
`15
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`
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`October 31, 2019
`
`
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`
`
`Respectfully submitted,
`
`
`
`/s/ Emily J. Greb
`Emily J. Greb
`Reg. No. 68,244
`Perkins Coie LLP
`33 East Main Street, Suite 201
`Madison, WI 53703
`
`Telephone: (608) 663-7494
`E-mail: EGreb@perkinscoie.com
`Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
`
`16
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`CERTIFICATE OF SERVICE
`
`Pursuant to
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