Paper No. 53
`Filed: May 24, 2023
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`MYLAN PHARMACEUTICALS INC.,
`MSN LABORATORIES PRIVATE LTD.,
`and MSN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-007221
`U.S. Patent No. 7,041,786
`__________________
`
`PATENT OWNER’S MOTION TO EXCLUDE
`
`
`
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`
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`1 IPR2023-00016 has been joined with this proceeding.
`
`
`Filed: May 24, 2023
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`
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`MYLAN PHARMACEUTICALS INC.,
`MSN LABORATORIES PRIVATE LTD.,
`and MSN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-007221
`U.S. Patent No. 7,041,786
`__________________
`
`PATENT OWNER’S MOTION TO EXCLUDE
`
`
`
`
`
`
`
`
`1 IPR2023-00016 has been joined with this proceeding.
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`Case IPR2022-00722
`Patent No. 7,041,786
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`I.
`II.
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`B.
`C.
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`B.
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`TABLE OF CONTENTS
`PRELIMINARY STATEMENT ..................................................................... 1
`EXHIBIT 1067 SHOULD BE EXCLUDED .................................................. 1
`Exhibit 1067 Is Hearsay Without Exception Under Federal Rule
`A.
`of Evidence 802 ..................................................................................... 1
`Exhibit 1067 Is Not in Accordance with 37 C.F.R. § 42.65(b) ............ 3
`Exhibit 1067 Is Incomplete Under Federal Rule of Evidence
`106 ......................................................................................................... 5
`III. EXHIBIT 1063 SHOULD BE EXCLUDED .................................................. 5
`Portions of Exhibit 1063 Are Irrelevant, Prejudicial, Confusing,
`A.
`and/or a Waste of Time Under Federal Rules of Evidence 402
`and 403 .................................................................................................. 6
`Portions of Exhibit 1063 Present Opinion Testimony, Including
`on an Ultimate Issue, from Witnesses Without Qualification or
`Proper Basis Under Federal Rules of Evidence 701-705 ...................... 6
`Portions of Exhibit 1063 Are Hearsay Without Exception
`Under Federal Rule of Evidence 802 .................................................... 7
`Portions of Exhibit 1063 Are Not in Accordance with 37 C.F.R.
`§ 42.65(a) ............................................................................................... 8
`IV. CONCLUSION ................................................................................................ 9
`
`
`
`C.
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`D.
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`i
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`TABLE OF AUTHORITIES
`
`Case IPR2022-00722
`Patent No. 7,041,786
`
` Page(s)
`
`Cases
`Abbott Vascular, Inc. v. FlexStent,
`IPR2019-00882, Paper 48 (PTAB Oct. 2, 2020) .................................................. 3
`Altair Pharm., Inc. v. Paragon Bioteck, Inc.,
`PGR2015-00011, Paper 48 (PTAB Nov. 14, 2016) ............................................. 4
`Emerson Elec. Co. v. IPCO, LLC,
`IPR2017-00213, Paper 42 (PTAB May 11, 2018) ............................................... 4
`Rohm & Haas Co. v. Brotech Corp.,
`127 F.3d 1089 (Fed. Cir. 1997) ............................................................................ 8
`Rules
`FRE 106 ................................................................................................................. 5, 6
`FRE 402 ................................................................................................................. 5, 6
`FRE 403 ................................................................................................................. 5, 6
`FRE 701 ................................................................................................................. 6, 7
`FRE 702 ................................................................................................................. 6, 7
`FRE 703 ................................................................................................................. 6, 7
`FRE 704 ................................................................................................................. 6, 7
`FRE 705 ................................................................................................................. 6, 7
`FRE 802 ............................................................................................................passim
`Regulations
`37 C.F.R. § 42.64 ....................................................................................................... 1
`37 C.F.R. § 42.65 ..............................................................................................passim
`
`ii
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`Case IPR2022-00722
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`Patent No. 7,041,786
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`77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012) (updated Nov. 2019) ......................... 8
`
`
`iii
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`
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`I.
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`
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`Case IPR2022-00722
`Patent No. 7,041,786
`
`PRELIMINARY STATEMENT
`Pursuant to 37 C.F.R. § 42.64, Patent Owner Bausch Health Ireland Limited
`
`moves to exclude the entirety of Exhibit 1067 and paragraphs 34, 149, 152-57, 160,
`
`162-64, and 166-67 of Exhibit 1063.
`
`II. EXHIBIT 1067 SHOULD BE EXCLUDED
`Patent Owner timely objected to Exhibit 1067, an excerpt from the file history
`
`of European Patent No. 1 379 224, as incomplete under Federal Rule of Evidence
`
`(“FRE”) 106, hearsay without exception under FRE 802, and not in accordance with
`
`37 C.F.R. § 42.65(b). Paper 40 at 1-2. Petitioner relies on Exhibit 1067 for its
`
`arguments related to Patent Owner’s objective evidence of nonobviousness,
`
`specifically unexpected results. Reply at 22-28.
`
`A. Exhibit 1067 Is Hearsay Without Exception Under Federal
`Rule of Evidence 802
`Exhibit 1067 should be excluded under FRE 802 because it is hearsay without
`
`exception. The file history of European Patent No. 1 379 224 contains statements,
`
`including data, made by the opponent in Europe and its witness, Mark Currie, and
`
`Petitioner relies on these statements to prove the truth of the matter Petitioner asserts,
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`without identifying any exception to support such use. In particular, Petitioner relies
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`on Currie’s data to assert that plecanatide—the claimed compound at issue here—
`
`and human uroguanylin do not differ “in activity, heat stability, or topoisomeric
`
`interconversion.” Reply at 23. Petitioner further asserts that “[b]ased on scientific
`1
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`Case IPR2022-00722
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`Patent No. 7,041,786
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`indicia included in each data set,” Currie’s data are “more reliable” than Patent
`
`Owner’s data. Id. Currie’s data are only relevant to unexpected results if they are
`
`true. Thus, Petitioner seeks to rely on inadmissible hearsay. FRE 802.
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`Currie’s data are particularly unreliable and prejudicial due to their lack of
`
`internal and external consistency. Although the same T84 cell bioassay was used to
`
`produce the data in Figures 1 and 2, for example, the cGMP levels in Figure 2 are
`
`roughly half of those in Figure 1. Ex. 1067 at 121-22. Further, the data in Figure 1
`
`indicate that the potencies of plecanatide’s and human uroguanylin’s active
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`topoisomers are roughly the same, whereas Figure 2 indicates that the potency of
`
`plecanatide’s active topoisomer is ~82% of the potency of human uroguanylin’s
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`active topoisomer. Id. Additionally, the cGMP levels for human uroguanylin’s
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`active topoisomer presented in Figures 1 and 2 are considerably lower than those
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`reported in the literature. Compare Ex. 1067 at 121-22 (showing cGMP levels of
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`~25 and ~70 pmol/well at 0.1 μM and 1.0 μM, respectively), with Ex. 2012 at Fig. 5
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`(wild-type human uroguanylin produces ~100 and ~500 pmol/well of cGMP at 0.1
`
`and 1.0 μM, respectively) and Exhibit 2065 at Fig. 4A. This is particularly
`
`problematic because the data reported in the literature use wild-type uroguanylin—
`
`a mixture of inactive and active topoisomers—and Currie’s data are purportedly
`
`obtained using the active topoisomer of human uroguanylin. Exhibit 1067 at 120.
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`Indeed, Currie’s data would have shown higher cGMP levels consistent with the
`
`2
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`Case IPR2022-00722
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`Patent No. 7,041,786
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`literature if Currie’s data were scientifically reliable, which they plainly are not in
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`light of the foregoing. In addition to these significant inconsistencies, Currie’s data
`
`are particularly prejudicial because Patent Owner had no opportunity to cross-
`
`examine Currie regarding how the tests were performed and the data were generated.
`
`As a result, Exhibit 1067 should be excluded under FRE 802.
`
`Exhibit 1067 Is Not in Accordance with 37 C.F.R. § 42.65(b)
`B.
`Exhibit 1067 should be excluded because Petitioner failed to provide the
`
`requisite affidavit, rendering Exhibit 1067 not in accordance with 37 C.F.R.
`
`§ 42.65(b). Under 37 C.F.R. § 42.65(b), if a party relies on a technical test or data
`
`from such a test, the party must provide an affidavit explaining:
`
`(1) Why the test or data is being used;
`(2) How the test was performed and the data was
`generated;
`(3) How the data is used to determine a value;
`(4) How the test is regarded in the relevant art; and
`(5) Any other information necessary for the Board to
`evaluate the test and data.
`
`37 C.F.R. § 42.65(b). The Board has excluded or afforded technical tests or data no
`
`weight where a party fails to provide the affidavit required under 37 C.F.R.
`
`§ 42.65(b). Abbott Vascular, Inc. v. FlexStent, IPR2019-00882, Paper 48 at 35-36
`
`(PTAB Oct. 2, 2020) (excluding untrustworthy expert testimony based in part on
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`3
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`failure to comply with 37 C.F.R. §42.65(b)); Emerson Elec. Co. v. IPCO, LLC,
`
`IPR2017-00213, Paper 42 at 25-26 (PTAB May 11, 2018) (affording expert
`
`testimony no weight for failure to comply with 37 C.F.R. § 42.65(b)); Altair Pharm.,
`
`Inc. v. Paragon Bioteck, Inc., PGR2015-00011, Paper 48 at 16-17 (PTAB Nov. 14,
`
`2016) (“Without the necessary information prescribed in § 42.65(b), we cannot
`
`determine whether the evidence . . . is credible.”). Without this affidavit, the Board
`
`cannot assess the credibility of the tests.
`
`Here, Petitioner relies on the Currie data included in Exhibit 1067 without
`
`providing the affidavit required by 37 C.F.R. § 42.65(b). Without such an affidavit,
`
`Petitioner cannot adequately explain, for example, how the Currie tests were
`
`performed and how the Currie data were generated as required by 37 C.F.R.
`
`§ 42.65(b)(2). For example, it is unclear whether the T84 cell bioassay used to
`
`generate the data in Figures 1 and 2 involved pre-incubation, as it is not included in
`
`the method steps specified by Currie but is included in the referenced patent’s
`
`method, which Currie purports to follow. Ex. 1067 at 120. Nor can Petitioner
`
`adequately explain how the Currie data were used to determine a value or regarded
`
`in the relevant art as required by 37 C.F.R. § 42.65(b)(3) and (4), respectively. For
`
`example, it is unclear how a person of ordinary skill in the art would regard Currie’s
`
`chromatographs purporting to show the formation of plecanatide’s inactive
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`topoisomer absent the inclusion of human uroguanylin as a comparator. Id. at 91.
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`4
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`The unreliability of the Currie data is further underscored by the fact that the EPO
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`did not credit Currie’s data and declined to invalidate the plecanatide patent at issue.
`
`Id. at 66 (“The OD does not see itself in a position to judge with certainty which of
`
`the contradictory data provided by O1 and by the P during the written procedure is
`
`scientifically more accurate. Therefore, the OD has based its decision solely on the
`
`data disclosed in the patent.”); Ex. 2069 at 104:15-19.
`
`C. Exhibit 1067 Is Incomplete Under Federal Rule of Evidence
`106
`Exhibit 1067 should be excluded under FRE 106 because it is an incomplete
`
`excerpt of the file history of European Patent No. 1 379 224. Exhibit 1067 is a
`
`mere 311 pages whereas the full file history is nearly 1,500 pages. Further to the
`
`incomplete nature of Exhibit 1067, the pages in Exhibit 1067 are not even in order.
`
`For example, the patentee’s letter and data appearing on pages 128-30 of Exhibit
`
`1067 should be included after the patentee’s submission on pages 138-40; instead,
`
`they are included after the opponent’s submission on pages 124-127. As a result,
`
`Exhibit 1067 is highly prejudicial and should be excluded under FRE 106.
`
`III. EXHIBIT 1063 SHOULD BE EXCLUDED
`Patent Owner timely objected to paragraphs 34, 149, 152-57, 160, 162-64, and
`
`166-67 of Exhibit 1063, the Second Declaration of Blake R. Peterson, Ph.D., as
`
`irrelevant, prejudicial, confusing, and/or a waste of time under FRE 402 and 403;
`
`presenting opinion testimony, including on an ultimate issue, from witnesses without
`5
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`Patent No. 7,041,786
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`qualification or proper basis under FRE 701-705; hearsay without exception under
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`FRE 802; and not in accordance with 37 C.F.R. § 42.65(a). Paper 40 at 2. Petitioner
`
`relies on Exhibit 1063 for its arguments related to Patent Owner’s objective evidence
`
`of nonobviousness, specifically unexpected results. Reply at 22-28.
`
`A.
`
`Portions of Exhibit 1063 Are Irrelevant, Prejudicial,
`Confusing, and/or a Waste of Time Under Federal Rules of
`Evidence 402 and 403
`Paragraphs 34, 149, 152-57, 160, 162-64, and 166-67 of Exhibit 1063 should
`
`be excluded under FRE 402 and 403 because they are irrelevant, prejudicial,
`
`confusing, and a waste of time. These paragraphs cite to and rely on Exhibit 1067,
`
`which should be excluded for the reasons explained above. Because Petitioner offers
`
`no admissible evidence on which Dr. Peterson could base his opinions, they should
`
`be excluded under FRE 402 and 403.
`
`B.
`
`Portions of Exhibit 1063 Present Opinion Testimony,
`Including on an Ultimate Issue, from Witnesses Without
`Qualification or Proper Basis Under Federal Rules of
`Evidence 701-705
`Paragraphs 34, 149, 152-57, 160, 162-64, and 166-67 of Exhibit 1063 should
`
`be excluded under FRE 701-705 because they present opinion testimony, including
`
`on an ultimate issue, from witnesses without qualification or proper basis. These
`
`paragraphs concern technical opinion testimony regarding how Currie’s data were
`
`generated and how it should be interpreted. Dr. Peterson, however, admitted that he
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`is not an expert in GCC receptors or receptor agonists and that he has never
`6
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`Case IPR2022-00722
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`conducted a T84 cell bioassay. Ex. 2069 at 10:6-9, 15:22-16:2, 10:15-20. Dr.
`
`Peterson further admitted he is not an expert in statistics or biostatistics. Ex. 2069
`
`at 114:13-19. As a result, Dr. Peterson is not qualified to assess the Currie data, let
`
`alone its reliability. As one example, Dr. Peterson acknowledged that the Currie
`
`data deviated from T84 assay results in the literature, but nonetheless jumped to the
`
`conclusion that these deviations within the Currie data “provided no justification for
`
`questioning the validity of his experiments.” Ex. 1063 at ¶160. Thus, because Dr.
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`Peterson’s opinions are not based upon established expertise or first-hand
`
`experience, they are inadmissible under FRE 701-705 and should be excluded.
`
`C.
`
`Portions of Exhibit 1063 Are Hearsay Without Exception
`Under Federal Rule of Evidence 802
`Paragraphs 34, 149, 152-57, 160, 162-64, and 166-67 of Exhibit 1063 should
`
`be excluded under FRE 802 because they rely on inadmissible hearsay without
`
`exception. Dr. Peterson relies on Exhibit 1067 for the truth of the matters asserted
`
`therein, rendering his testimony inadmissible under FRE 802. As explained above,
`
`Dr. Peterson is not an expert in GCC receptors or receptor agonists, has never
`
`conducted a T84 cell bioassay, and is not an expert in statistics or biostatistics. Ex.
`
`2069 at 10:6-9, 15:22-16:2, 10:15-20, 114:13-19. As a result, the Currie data are not
`
`data upon which he would reasonably rely. See FRE 703. Dr. Peterson’s opinions
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`should thus be excluded under FRE 802.
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`7
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`Case IPR2022-00722
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`Patent No. 7,041,786
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`Portions of Exhibit 1063 Are Not in Accordance with 37
`C.F.R. § 42.65(a)
`Paragraphs 34, 149, 152-57, 160, 162-64, and 166-67 of Exhibit 1063 should
`
`D.
`
`be excluded because they do not disclose the underlying facts or data on which the
`
`opinions are based, rendering them not in accordance with 37 C.F.R. § 42.65(a).
`
`Under 37 C.F.R. §42.65(a), expert testimony that does not disclose the underlying
`
`facts or data on which the opinion is based is entitled to little or no weight. 37 C.F.R.
`
`§ 42.65(a); see also Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed.
`
`Cir. 1997) (holding that nothing in the Federal Rules of Evidence or Federal Circuit
`
`jurisprudence requires the fact finder to credit unsupported assertions of an expert
`
`witness); Patent Trial and Appeal Board Consolidated Trial Practice Guide, 40-41
`
`(“Affidavits expressing an opinion of an expert must disclose the underlying facts
`
`or data upon which the opinion is based.”); 77 Fed. Reg. 48,756, 48,767 (Aug. 14,
`
`2012) (updated Nov. 2019).
`
`Here, Dr. Peterson failed to sufficiently disclose any underlying facts or data,
`
`thus failing to comply with 37 C.F.R. § 42.65(a). At least paragraphs 34, 149, 152-
`
`57, 160, 162-64, and 166-67 of Exhibit 1063 should be excluded because they rely
`
`on Exhibit 1067, which fails to comply with 37 C.F.R. § 42.65(b) as a reliable
`
`underlying source of data. See supra Section II. For instance, in paragraphs 153-
`
`154 of Exhibit 1063, Dr. Peterson speculated that the Currie data results are “more
`
`8
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`Case IPR2022-00722
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`Patent No. 7,041,786
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`reliable” than reports provided by Dr. Shailubhai despite also acknowledging that
`
`Dr. Currie, the author of the Currie data, “performed binding, potency, thermal
`
`stability, and topoisomerism studies like those relied upon by Bausch.” Ex. 1063 at
`
`¶¶ 153-54 (emphasis added). Dr. Peterson also practically acknowledged that the
`
`Currie data were generated solely to respond to Bausch’s data, further calling into
`
`question the reliability of the Currie data and Dr. Peterson’s reliance on these data.
`
`Id.; see also Ex. 1067 at 90 (“[I]n order to examine the reliability of Patentee’s data,
`
`Opponent 1 has asked [the company affiliated with Dr. Currie] to perform
`
`experiments similar to the experiments that were conducted by Patentee.”).
`
`Additionally, Dr. Peterson acknowledged that he has never communicated with Dr.
`
`Currie in connection with or outside of his work for this case. Ex. 2069 at 15:22-
`
`16:2.
`
`IV. CONCLUSION
`For the foregoing reasons, Patent Owner respectfully requests that the Board
`
`exclude the entirety of Exhibit 1067 and paragraphs 34, 149, 152-57, 160, 162-64,
`
`166-67 of Exhibit 1063.
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`Respectfully submitted,
`
`Date: May 24, 2023
`
`
`
`By: /Justin J. Hasford/
`Justin J. Hasford, Reg. No. 62,180
`Lead Counsel
`Bryan C. Diner, Reg. No. 32,409
`Back-up Counsel
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`9
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`Case IPR2022-00722
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`Patent No. 7,041,786
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`Joshua L. Goldberg, Reg. No. 59,369
`Back-up Counsel
`Kassandra M. Officer Reg. No. 74,083
`Back-up Counsel
`Lauren J. Robinson Reg. No. 74,100
`Back-up Counsel
`Caitlin E. O’Connell, Reg. No. 73,934
`Back-up Counsel
`Kyu Yun Kim, Reg. No. 72,783
`Back-up Counsel
`
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for the Patent Owner
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`10
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`CERTIFICATE OF SERVICE
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`Case IPR2022-00722
`Patent No. 7,041,786
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`The undersigned certifies that a copy of the foregoing Patent Owner’s
`
`Motion to Exclude was served electronically via email on May 24, 2023, to counsel
`
`of record for the Petitioner at the following:
`
`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati PC
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`jmills@wsgr.com
`
`Richard Torczon
`Tasha M. Thomas
`Wilson Sonsini Goodrich & Rosati PC
`1700 K Street N.W., 5th Floor
`Washington, DC 20006
`rtorczon@wsgr.com
`tthomas@wsgr.com
`
`
`Dennis D. Gregory
`Wilson Sonsini Goodrich & Rosati PC
`900 South Capital of Texas Highway, Las Cimas IV, Fifth Floor
`Austin, TX 78746-5546
`dgregory@wsgr.com
`
`4863-5899-2145@mail.vault.netdocuments.com
`
`Andrew O. Larsen
`Merchant & Gould, P.C.
`500 Fifth Avenue, Suite 4100
`New York, NY 10110
`alarsen@merchantgould.com
`
`Melissa Hayworth
`Merchant & Gould, P.C.
`1900 Duke, Street, Suite 600
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`Case IPR2022-00722
`Patent No. 7,041,786
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`Alexandria, VA 22314
`mhayworth@merchantgould.com
`
`Christopher J. Sorenson
`Merchant & Gould, P.C.
`150 South Fifth Street, Suite 2200
`Minneapolis, MN 55402
`csorenson@merchantgould.com
`
`plecanatidemerchant@merchantgould.com
`
`
`
`By: /Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`Date: May 24, 2023
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