Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`
`
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` Paper No. 99
`
`
`
` Entered: February 5, 2020
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BIOGEN MA INC,
`Patent Owner.
`____________
`
`Case IPR2018-01403
`Patent No. 8,399,514 B2
`____________
`
`
`Before SHERIDAN K. SNEDDEN, JENNIFER MEYER CHAGNON, and
`JAMIE T. WISZ, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`
`ORDER
`Denying In Part and Dismissing In Part Patent Owner’s Motion to Exclude
`37 C.F.R. § 42.64(c)
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`
`
` Paper No. 99
`
`
`
` Entered: February 5, 2020
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BIOGEN MA INC,
`Patent Owner.
`____________
`
`Case IPR2018-01403
`Patent No. 8,399,514 B2
`____________
`
`
`Before SHERIDAN K. SNEDDEN, JENNIFER MEYER CHAGNON, and
`JAMIE T. WISZ, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`
`ORDER
`Denying In Part and Dismissing In Part Patent Owner’s Motion to Exclude
`37 C.F.R. § 42.64(c)
`
`
`
`
`
`
`IPR2018-01403
`Patent No. 8,399,514 B2
`
`
`I.
`INTRODUCTION
`Patent Owner filed a motion to exclude evidence. Paper 75.
`Petitioner opposed (Paper 77) and Patent Owner submitted a reply in support
`of its motion (Paper 82). Patent Owner moves to exclude Exhibits 1010,
`1012, 1036, 1037, 1054, 1055, 1066, and 1122 as inadmissible under the
`Federal Rules of Evidence (“FRE”). We consider each of Patent Owner’s
`contentions below.
`
`A. Exhibits 1036, 1037, and 1066
`Patent Owner moves to exclude Exhibits 1036, 1037, and 1066
`because these documents 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 U.S. Patent No. 8,399,514 B2. Paper 75, 1. Patent
`Owner contends that the exhibits “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.” Id. at 3 (citing FRE 401–403); Paper 82, 1–2.
`Petitioner contends that it does not rely on these documents as
`“obviousness references,” but as evidence “to corroborate Drs. Corboy’s,
`Benet’s, and Greenberg’s testimony on a POSA’s interpretation of prior-art
`clinical trials results, which refutes the basis for Biogen’s claim of
`unexpected results.” Paper 77, 2–3.
`Evidence is relevant if “it has any tendency to make a fact more or
`less probable than it would be without the evidence” and “the fact is of
`consequence in determining the action.” FRE 401 (emphasis added). Given
`that Petitioner relies on the documents to show how skilled artisans would
`2
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`IPR2018-01403
`Patent No. 8,399,514 B2
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`interpret the prior art and to refute Patent Owner’s claim of unexpected
`results, we agree with Petitioner that these exhibits cross the very low
`threshold for relevance. Paper 77, 4.
`As for Patent Owner’s arguments that the evidence should be
`excluded under FRE 403, we do not discern any prejudice to Patent Owner
`under that rule in allowing these exhibits into evidence. Rather, we
`determine that the premise of Patent Owner’s argument goes to the weight
`that should be afforded to the evidence. Such argument is not proper in a
`motion to exclude, which is for challenging the admissibility of evidence,
`not for challenging its sufficiency. See Office Patent Trial Practice Guide
`August 2018 Update, at 16 (available at https://go.usa.gov/xU7GP) (stating
`that a motion to exclude may not be used to challenge the sufficiency of the
`evidence to prove a particular fact); see also November 2019 Consolidated
`Trial Practice Guide, at 79 (available at https://go.usa.gov/xdj8z) (stating the
`same).
`In view of the above, Exhibits 1036, 1037, and 1066 will not be
`excluded.
`
`B. Exhibit 1012
`Patent Owner moves to exclude the Butler Declaration (Ex. 1012, 1),
`which is relied on by Petitioner to establish the public availability date of the
`Schimrigk 2004 Poster (Ex. 1012, 4). Paper 75, 3–4. Patent Owner moves
`to exclude Exhibit 1012 for lack of foundation, personal knowledge, and
`authentication. Id. at 4 (citing FRE 602, 901). In particular, Patent Owner
`contends that “[t]he Butler declaration does not provide any testimony
`
`3
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`IPR2018-01403
`Patent No. 8,399,514 B2
`
`demonstrating personal knowledge of whether the poster was actually
`archived or publicly available before the critical date.” Id.
`We are not persuaded. Rather, we agree with Petitioner that “[Patent
`Owner’s] attacks on the Butler Decl. and Schimrigk 2004 Poster go directly
`to the sufficiency of the evidence to establish the Schimrigk 2004 Poster as
`prior art,” which is improper. Paper 77, 5 (footnote omitted). Mr. Butler’s
`testimony does not aver that he has personal knowledge as to whether the
`printouts attached to his affidavit were actually posted at an accessible
`location on the Internet. Mr. Butler’s testimony instead is directed to the
`general workings of the Internet Archive’s Wayback Machine. See
`Ex. 1012, 1. Exhibit 1012 will not be excluded.
`
`C. Exhibit 1054
`Patent Owner moves to exclude an attorney declaration from Robert
`Mihail Esq. (Ex. 1054) as inadmissible hearsay and as lacking foundation
`and personal knowledge. Paper 75, 7–11. We do not rely on Exhibit 1054
`in our final written decision. Thus, Patent Owner’s motion to exclude
`Exhibit 1054 is dismissed as moot.
`
`D. Exhibit 1010
`Patent Owner moves to exclude Clinical Trials (Ex. 1010) as lacking
`authentication and as inadmissible hearsay. Paper 75, 7–11. Patent Owner
`contends that “the date on the face of Clinical Trials that Mylan relies on to
`prove the date of alleged public availability is inadmissible hearsay.” Id. at
`10. Patent Owner further contends that “[Petitioner] has not proffered any
`
`4
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`IPR2018-01403
`Patent No. 8,399,514 B2
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`testimony or evidence establishing the publication date of Clinical Trials,
`aside from inadmissible testimony from Mr. Mihail.” Id.
`Petitioner contends that it reproduced Clinical Trials (Ex. 1057) and
`provided Patent Owner, as supplemental evidence, this reproduction and an
`attorney declaration explaining how the reproduction was obtained. Paper
`77, 14 (citing Paper 35, 2). Petitioner also contends that Clinical Trials is
`subject to hearsay exceptions under FRE 803(8) because “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.”
`Paper 77, 13.
`We agree with Petitioner that these Exhibits 1010 and 1057 fall within
`the “public records” exception to the hearsay rules under FRE 803(8)
`because they are public records that set out the office’s activities under FRE
`803(8)(A)(i) and because Patent Owner has not shown that the source of
`information or other circumstances indicate a lack of trustworthiness under
`FRE 803(8)(B). Exhibit 1010 will not be excluded.
`
`E. Exhibits 1055 and 1122
`Patent Owner moves to exclude a declaration from Ms. Jennifer Rock
`(Exs. 1055 and 11221), which it contends is relied on by Petitioner to
`establish the prior art date of three press releases available on Westlaw,
`namely Exhibits 1005, 1016, and 1026. Paper 75, 11–13. Patent Owner
`
`
`1 Patent Owner contends that it “objected to Exhibit 1055 and Mylan failed
`to remedy the objections with its supplemental Exhibit 1122.” Paper 75, 11.
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`IPR2018-01403
`Patent No. 8,399,514 B2
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`contends that “[t]he Rock declaration lacks the personal knowledge
`necessary to authenticate the online press releases.” Paper 75, 12.
`We are not persuaded. As noted by Petitioner, Ms. Rock’s testimony
`is based on her knowledge of routine business practices of West and
`Westlaw, which is sufficient evidence of authenticity. Paper 77, 9–10;
`Ex. 1122; see United States v. Bansal, 663 F.3d 634, 668 (3d Cir. 2011)
`(concluding that the screenshot images from the Internet Archive were
`authenticated sufficiently under Federal Rule of Evidence 901(b)(1) by a
`witness with personal knowledge of its contents, verifying that the
`screenshot the party seeks to admit are true and accurate copies of Internet
`Archive’s records). Exhibits 1055 and 1122 will not be excluded.
`
`II. ORDER
`
`Accordingly, it is:
`ORDERED that Patent Owner’s motion to exclude (Paper 75) is
`denied as to Exhibits 1010, 1012, 1036, 1037, 1055, 1066 and 1122; and
`FURTHER ORDERED that Patent Owner’s motion to exclude is
`dismissed as moot as to Exhibit 1054.
`
`
`
`
`
`
`6
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`
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`IPR2018-01403
`Patent No. 8,399,514 B2
`
`
`PETITIONER:
`
`Brandon White
`David Anstaett
`Courtney Prochnow
`Maria Stubbings
`Shannon Bloodworth
`Emily Greb
`PERKINS COIE LLP
`white-ptab@perkinscoie.com
`danstaett@perkinscoie.com
`prochnow-ptab@perkinscoie.com
`mstubbings@perkinscoie.com
`sbloodworth@perkinscoie.com
`greb-ptab@perkinscoie.com
`
`Christopher Ferenc
`KATTEN MUCHIN ROSENMAN LLP
`christopher.ferenc@kattenlaw.com
`
`
`PATENT OWNER:
`
`Barbara McCurdy
`Erin Sommers
`Pier DeRoo
`Mark Feldstein
`Cora R. Holt
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, LLP
`barbara.mccurdy@finnegan.com
`erin.sommers@finnegan.com
`pier.deroo@finnegan.com
`mark.feldstein@finnegan.com
`cora.holt@finnegan.com
`
`7
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`
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