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`Filed: November 6, 2019
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`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
`____________________________________________
`
`
`REPLY IN SUPPORT OF
`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. Mylan Fails to Support Admissibility of the Post-Priority Date Publications .... 1
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`II. Mylan Fails to Rehabilitate Exhibit 1012 and the Rock Declaration .................. 3
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`III. Mylan Fails to Rehabilitate the Mihail Declaration and Clinical Trials ............. 4
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`IV. Conclusion ........................................................................................................... 5
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`
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`
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`
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`
`
`ii
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`
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`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Allergan, Inc. v. Sandoz Inc.,
`796 F.3d 1293 (Fed. Cir. 2015) ............................................................................ 2
`Endo Pharm. Solutions, Inc. v. Custopharm Inc.,
`894 F.3d 1374 (Fed. Cir. 2018) ............................................................................ 2
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Pat. Litig.,
`676 F.3d 1063 (Fed. Cir. 2012) ............................................................................ 2
`In re EchoStar Commc’n Corp.,
`448 F.3d 1294 (Fed. Cir. 2006) ............................................................................ 5
`In re Lunsford,
`357 F.2d 380 (CCPA 1966) .................................................................................. 2
`Int’l Bus. Machs. Corp. v. Intellectual Ventures II LLC,
`IPR2015-01323, Paper 38 (PTAB Sept. 27, 2016) ............................................... 4
`Palo Alto Networks, Inc. v. Finjan, Inc.,
`IPR2015-01979, Paper 62 (PTAB Mar. 15, 2017) ............................................... 3
`Smart Microwave Sensors GmbH v. Wavetronix LLC,
`IPR2016-00488, Paper 57 (PTAB July 17, 2017) ................................................ 4
`Yeda Research v. Mylan Pharmaceuticals Inc.,
`906 F.3d 1031 (Fed. Cir. 2018) ............................................................................ 1
`Rules
`37 C.F.R. § 1.68 ......................................................................................................... 4
`
`
`
`
`
`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
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`
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`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`I. Mylan Fails to Support Admissibility of the Post-Priority Date Publications
`Mylan contends that it appropriately relies on Fox 2011, EMA 2013, and
`
`Phillips 2013 “to show how skilled artisans would interpret the prior art and to
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`refute Biogen’s claim of unexpected results,” relying on Yeda Research v. Mylan
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`Pharmaceuticals Inc., 906 F.3d 1031 (Fed. Cir. 2018). Opp. 2. However, Yeda
`
`does not support relevance under FRE 401-403 for documents:
`
` created years after the priority date;
`
` written with reliance on non-public data;
`
` providing no information on the activities of POSAs before the
`
`priority date; and
`
` written with hindsight knowledge of the claimed invention.
`
`Yeda addressed an article documenting what had actually been done before
`
`the priority date and published just 3 weeks thereafter. Yeda, 906 F.3d at 1037,
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`1040-42. Here, by contrast, the challenged exhibits were published 4-6 years after
`
`the February 2007 priority date. It is also undisputed that the authors had access to
`
`and relied on unpublished data from the Phase II trial as well as knowledge that
`
`480 mg/day DMF had an unexpectedly high magnitude of clinical efficacy similar
`
`to 720 mg/day in Biogen’s Phase III trials. Mot. 2-3.
`
`Yeda also does not support Mylan’s use of these hindsight references to
`
`contradict what was known at the time of invention (i.e., ineffectiveness of 360
`
`
`
`1
`
`
`
`mg/day DMF). See In re Cyclobenzaprine Hydrochloride Extended-Release
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`
`Capsule Pat. Litig., 676 F.3d 1063, 1079 (Fed. Cir. 2012) (obviousness cannot be
`
`based on “read[ing] into the prior art the teachings of the invention in issue”);
`
`Endo Pharm. Solutions, Inc. v. Custopharm Inc., 894 F.3d 1374, 1380 n.7 (Fed.
`
`Cir. 2018) (rejecting use of undisclosed data to recast prior art conclusion). Using
`
`these hindsight-based publications to support obviousness, as Mylan urges, is
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`clearly erroneous.
`
`Mylan’s argument that the challenged exhibits may be used to dispute
`
`unexpected results is also incorrect. The law requires Mylan to prove obviousness
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`“at the time the invention was made.” 35 U.S.C. § 103; Cyclobenzaprine, 676 F.3d
`
`at 1073. Unexpected results, therefore, must be evaluated “relative to the prior art”
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`as of the priority date, not in light of publications dated 4-6 years too late.
`
`Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1305 (Fed. Cir. 2015); In re
`
`Lunsford, 357 F.2d 380, 385 (CCPA 1966). As Dr. Hay acknowledged,
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`expectations in 2007 were far different than after Biogen’s Phase III results
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`published and Tecfidera® launched. Ex. 2230, 111:3-112:11, 117:15-124:19.
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`Thus, Exhibits 1036, 1037, and 1066 have multiple deficiencies—late
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`publication dates, reliance on non-public information, and hindsight knowledge of
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`the claimed invention—each of which independently renders these exhibits legally
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`irrelevant and prejudicial. They should be excluded under FRE 401-403.
`
`
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`2
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`
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`U.S. Patent No. 8,399,514
`IPR2018-01403
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`II. Mylan Fails to Rehabilitate Exhibit 1012 and the Rock Declaration
`In attempting to support the admissibility of Exhibit 1012 (Butler declaration
`
`and Schimrigk poster), Mylan argues that Mr. Butler has personal knowledge of
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`the Internet Archive’s process for archiving websites. Opp. 5-8. It is undisputed,
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`however, that a different entity—Alexa Internet—purportedly archived the
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`Schimrigk poster. Mot. 5. Mr. Butler thus does not have the requisite personal
`
`knowledge because his declaration is silent about Alexa Internet, as the Board has
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`correctly recognized. Paper 41, 4-5; Ex. 2129, 19:12-16; Ex. 1012. Mylan also
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`does not dispute that Mr. Butler failed to establish any date of alleged public
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`availability of the poster. Mot. 4-6. Thus, Mr. Butler did not have the requisite
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`personal knowledge under FRE 602 and his declaration should be excluded.
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`The Board previously recognized these deficiencies in the Butler
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`declaration, noting that by refusing to cooperate in obtaining Mr. Butler for
`
`deposition, Mylan “runs the risk that the direct testimony will not be considered.”
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`Paper 41, 5; Mot. 6-7. The Board should indeed decline to consider the Butler
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`declaration (Ex. 1012) and exclude it from the record. Palo Alto Networks, Inc. v.
`
`Finjan, Inc., IPR2015-01979, Paper 62, 21 n.11 (PTAB Mar. 15, 2017).
`
`Likewise, Ms. Rock disclaimed the requisite personal knowledge under
`
`FRE 602. Mot. 12-13. Mylan attempts to ameliorate this deficiency by relying on
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`purported timestamps in “West’s internal logging database.” Opp. 10-11. But
`
`
`
`3
`
`
`
`Mylan fails to establish the elements for the business record exception, as Ms.
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
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`Rock’s declaration is silent on those issues. Smart Microwave Sensors GmbH v.
`
`Wavetronix LLC, IPR2016-00488, Paper 57, 27-28 (PTAB July 17, 2017).
`
`Mylan’s reliance on the residual hearsay exception is also misplaced, given the
`
`absence of any supporting testimony as to the reliability of the timestamps or that
`
`they reflect accessibility to a POSA.1 Indeed, Mylan makes no effort to establish
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`that POSAs would have accessed Westlaw, which is targeted to attorneys, not
`
`clinicians or scientists. Nor does Mylan address the absence of searchability and
`
`the special steps required to find a document in Ms. Rock’s database (e.g.,
`
`knowing the title in advance and where to look in a particular database). Mot. 12.
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`Thus, Ms. Rock’s declaration should be excluded and consequently her cited
`
`press releases lack authentication and cannot be prior art.
`
`III. Mylan Fails to Rehabilitate the Mihail Declaration and Clinical Trials
`Mylan fails to establish that the public record hearsay exception of
`
`FRE 803(8) applies to Exhibit 1010, a purported ClinicalTrials.gov webpage,
`
`because Mylan has not shown that it came from that website. Opp. 13. Mylan
`
`
`1 Ms. Rock’s declaration also lacks indicia of trustworthiness because it does not
`
`comply with 37 C.F.R. § 1.68. Ex. 1122 ¶6; Int’l Bus. Machs. Corp. v. Intellectual
`
`Ventures II LLC, IPR2015-01323, Paper 38, 10-11 (PTAB Sept. 27, 2016).
`
`
`
`4
`
`
`
`does not dispute that the URL in Mr. Mihail’s declaration for obtaining Exhibit
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
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`1010 is incorrect, indicating untrustworthiness. Mot. 10; Ex. 2050. Ms. Greb
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`further corroborates this deficiency, testifying that she could only locate a different
`
`version at a different URL. Ex. 1134 ¶4. Moreover, Ms. Greb disclaimed
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`knowledge of any attempt to duplicate Mr. Mihail’s process for allegedly obtaining
`
`Ex. 1010, and questioning about whether she verified the accuracy of Mr. Mihail’s
`
`declaration was blocked on privilege grounds. Ex. 2232, 18:9-21:17. Mylan’s
`
`argument that its evidence has “no lack of untrustworthiness” should be rejected
`
`when it has withheld testimony about trustworthiness and reliability of Exhibit
`
`1010 on the grounds of privilege. In re EchoStar Commc’n Corp., 448 F.3d 1294,
`
`1301 (Fed. Cir. 2006) (a party cannot use privilege as both a shield and a sword).
`
`The different version of Clinical Trials Ms. Greb located is additionally
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`untrustworthy because it cites to publications in 2008 and in 2014, which
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`demonstrates that it was generated after February 2007. Ex. 1057, 12. Ms. Greb
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`also disclaimed any knowledge of whether Exhibit 1010 would have been publicly
`
`available before February 2007. Ex. 2232, 16:13-22, 37:18-38:9. Thus, Clinical
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`Trials (Ex. 1010) lacks authentication and cannot qualify as prior art.
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`IV. Conclusion
`For the reasons previously presented and those set forth above, Biogen
`
`respectfully requests that the Board grant Patent Owner’s Motion to Exclude.
`
`
`
`5
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`
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`Dated: November 6, 2019
`
`
`
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`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`
`
`By: / Barbara C. McCurdy /
`Barbara C. McCurdy, Reg. No. 32,120
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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`6
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`CERTIFICATE OF COMPLIANCE
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`U.S. Patent No. 8,399,514
`IPR2018-01403
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`The undersigned certifies that this brief complies with the page limit
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`
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`limitations of 37 C.F.R. § 42.24(c)(2).
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`
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`Dated: November 6, 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 Reply in Support of
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`
`
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`Patent Owner’s Motion to Exclude Evidence was served electronically via the
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`PTAB electronic filing system and via email on November 6, 2019, in its entirety,
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`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
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`U.S. Patent No. 8,399,514
`IPR2018-01403
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`Email: cprochnow@perkinscoie.com
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`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
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`Petitioner has agreed to electronic service.
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`Dated: November 6, 2019
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`
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`By: /Barbara C. McCurdy/
`Barbara C. McCurdy, Reg. No. 32,120
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