UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`MSN LABORATORIES PRIVATE LTD.,
`and MSN PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`————————————————
`Case IPR2022-007221
`Patent 7,041,786
`————————————————
`
`PETITIONER MYLAN’S REPLY
`SUPPORTING MYLAN’S MOTION TO EXCLUDE
`37 C.F.R. §42.64(c)
`
`1 IPR2023-00016 has been joined with this proceeding.
`
`
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`MSN LABORATORIES PRIVATE LTD.,
`and MSN PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`————————————————
`Case IPR2022-007221
`Patent 7,041,786
`————————————————
`
`PETITIONER MYLAN’S REPLY
`SUPPORTING MYLAN’S MOTION TO EXCLUDE
`37 C.F.R. §42.64(c)
`
`1 IPR2023-00016 has been joined with this proceeding.
`
`
`
`TABLE OF CONTENTS
`
`Page
`Introduction .......................................................................................................... 1
`I.
`II. Reasons for Relief ................................................................................................ 1
`A.EX2001-EX2007 – Fintiv Exhibits ................................................................. 1
`B.EX2024 and EX2025 – Expert Declarations ................................................... 1
`C.EX2027 and EX2028 – Shailubhai Reports; EX2040 –
`Unauthenticated Hearsay Attributed to Dr. Pennington ................................ 4
`III. Conclusion ........................................................................................................... 5
`
`-i-
`
`
`
`TABLE OF AUTHORITIES
`
`Pages
`
`Cases
`Apator Miitors v. Kamstrup A/S, 887 F.3d 1293 (Fed. Cir. 2018) ............................ 5
`Chen v. Bouchard, 347 F.3d 1299 (Fed. Cir. 2003) .................................................. 4
`Genetics Institute v. Novartis Vaccines & Diagnostics, 655 F.3d 1291
`(Fed. Cir. 2011) ..................................................................................................... 2
`Institute Pasteur v. Focarino, 738 F.3d 1337 (Fed. Cir. 2013) ................................. 2
`Intelligent Bio-Systems v. Illumina Cambridge, 821 F.3d 1359 (Fed. Cir.
`2016) ..................................................................................................................... 2
`Kumho Tire v. Carmichael, 526 U.S. 137 (1999) ...................................................... 4
`U.S. Gypsum v. Lafarge N. Am., 670 F.Supp.2d 737 (N.D. Ill. 2009) ..................1, 2
`Rules
`Federal Rule of Evidence 703 .................................................................................... 4
`
`-ii-
`
`
`
`I.
`
` INTRODUCTION
`
`The Board should exclude Bausch EX2001-EX2007, EX2024, EX2025,
`
`EX2027, EX2028, and EX2040.
`
`II.
`
`REASONS FOR RELIEF
`
`A. EX2001-EX2007 – Fintiv Exhibits
`Mylan moved for exclusion from formal consideration or, alternatively, for
`
`limitation of the exhibits to the forfeited purpose for which they were submitted.
`
`Paper 54 (“MtE”). Bausch does not respond. Paper 59 (“Opp.”) passim.
`
`B. EX2024 and EX2025 – Expert Declarations
`Mylan moved to exclude Bausch’s expert declarations for improper legal
`
`standards and misunderstanding the prior art. MtE 1-8. Bausch argues the motion
`
`improperly discusses the merits and its authority is distinguishable. Opp. 1-9.
`
`Bausch is wrong on both points. Showing how testimony is used improperly
`
`necessarily involves discussing how it was used and why it was improper.
`
`Bausch argues U.S. Gypsum v. Lafarge N. Am., 670 F.Supp.2d 737, 745
`
`(N.D. Ill. 2009), is distinguishable. Opp. 3-4. Yet, as Mylan’s motion showed,
`
`Bausch and its experts persist in pushing a discredited single-lead compound
`
`theory. MtE 2-3, citing EX2024, ¶¶92, 99, 141-41; EX2025, ¶¶64-73. Similarly,
`
`for reasonable expectation of success, Bausch requires “seeking to make a better
`
`anti-constipation drug,” in an attempt to read in unclaimed features; yet claim 1
`
`simply defines a sequence nearly identical to a natural ligand already identified for
`-1-
`
`
`
`treating constipation. The reasonable expectation of success inquiry is defined by
`
`what is claimed. Intelligent Bio-Systems v. Illumina Cambridge, 821 F.3d 1359,
`
`1367 (Fed. Cir. 2016) (if not claimed, it is “of no moment” to REOS); accord
`
`Institute Pasteur v. Focarino, 738 F.3d 1337, 1348-49 (Fed. Cir. 2013) (remanding
`
`claims that did not “require” successful cleavage and break repair for consideration
`
`of other motivations for what was claimed). As U.S. Gypsum shows, expert
`
`testimony based on an improper legal standard should be excluded to create a clear
`
`record and discourage similar testimony in other cases.
`
`Bausch accuses Mylan of “conflat[ing]… reasonable expectation of success
`
`and unexpected results.” Opp. 5, citing MtE 5. Yet, in its reasonable expectation of
`
`success section, Bausch cites a decision on unexpected results. Genetics Institute
`
`v. Novartis Vaccines & Diagnostics, 655 F.3d 1291, 1308 (Fed. Cir. 2011).
`
`Bausch attempts to defend the experts’ technical errors by changing the
`
`subject. Opp. 5-6, discussing MtE 5-6. Mylan’s motion explained how Bausch’s
`
`experts misunderstood Fig. 3 in Li (EX1006, 49), one of the principal grounds
`
`references, regarding relative potency. MtE 5. Bausch first mischaracterizes Li
`
`Fig. 3 as a comparison between different GCC ligands, Opp. 5-6, rather than as
`
`comparisons of pre- and post-incubation pairs of the same ligands. Next, Bausch
`
`changes the focus (Opp. 6) to Li’s prediction that rat, human, and opossum
`
`uroguanylin would have similar affinities—a different point that supports Mylan’s
`
`-2-
`
`
`
`merits argument. Finally, for Hamra 1993, a Bausch exhibit (EX2012) that Bausch
`
`cites for potency (EX2024, ¶95), Bausch never explains why Hamra’s opossum
`
`uroguanylin lacking a residue excuses Bausch’s experts’ misunderstanding of Li.
`
`For the pKA values, Bausch glosses over (Opp. 6-7) Dr. Davies irrelevant
`
`argument about “buried” residues (EX2045) by speculating (without its expert
`
`support) about intrachain reactions because Asp is ionizable. But Glu—the other
`
`acidic residue—is also ionizable. Neither Dr. Davies nor the opposition provide
`
`any reason to believe that Glu3, which follows the uroguanylin consensus
`
`sequence, would fail in [Glu3]-human uroguanylin. The opposition’s baseless
`
`speculations cannot cure Dr. Davies’ irrelevant speculations.
`
`Although Bausch’s experts sought to prove teaching away by relying on
`
`tests bearing no relationship to reasonably expected physiological conditions,
`
`Bausch now urges its experts should not be faulted for failing to anticipate the
`
`obvious response. Opp. 7-8. To support its new argument that “transit times” are
`
`longer in a constipated patient, the opposition cites testimony from Dr. Epstein that
`
`largely rebuts Bausch’s speculation, particularly if you start a page earlier for
`
`context. See EX2070, 44:14-45:14 (“[T]here are conditions where transit time
`
`through the gut can be slow through the small bowel, but that's a very specific
`
`disease called intestinal pseudo-obstruction.”). Bausch similarly makes a new
`
`argument that “any compound…can be toxic if administered at high doses”
`
`-3-
`
`
`
`(Opp. 8.), a strange argument coming from Bausch, which champions enterotoxins
`
`as the only lead compound a POSA would consider.
`
`Finally, Bausch argues (Opp. 8-9) experts may use inadmissible evidence
`
`but concedes its experts did not qualify EX2027, EX2028, and EX2040 as the sort
`
`of evidence on which experts may rely. Yet this question lies at the heart of what
`
`FRE 703 requires. Kumho Tire v. Carmichael, 526 U.S. 137, 148 (1999). Bausch’s
`
`attorney argument in its opposition is no substitute for expert testimony.
`
`C. EX2027 and EX2028 – Shailubhai Reports; EX2040 –
`Unauthenticated Hearsay Attributed to Dr. Pennington
`Mylan’s motion explained why Bausch’s reports belatedly summarizing Dr.
`
`Dheer’s work are baseless, improperly corroborated hearsay. MtE 9. Bausch argues
`
`corroboration does not matter. Opp. 9-10. But it does: reliability determines
`
`whether this evidence is admissible. Kumho, 526 U.S. at 148 (inadmissible for
`
`“failure to satisfy… reasonable reliability criteria”). Bausch also wrongly argues
`
`the reports satisfy the business-records exception. Opp. 10-11. The purported
`
`originator of the information, Dr. Dheer, did not testify, and the reports were
`
`created—and later amended—long after any relevant date. EX2027, 1 (2001);
`
`EX2028, 1 (2001). Documents created long after the fact, without testimony from
`
`the person who conducted the study or corroboration from anyone but an inventor,
`
`and that have later been modified, can hardly be characterized as ordinary business
`
`records. Chen v. Bouchard, 347 F.3d 1299, 1308 & n.2 (Fed. Cir. 2003) (affirming
`
`-4-
`
`
`
`Board’s exclusion of another’s lab notes despite inventor’s testimony). An inventor
`
`merely asserting otherwise does not alter the facially unusual and unreliable nature
`
`of these exhibits.
`
`Bausch finally argues that the reports’ probative value outweighs their
`
`prejudice (Opp. 11-12), but this argument assumes what Bausch has never
`
`shown—that the reports are actually reliable. Self-serving evidence generated after
`
`the fact and corroborated only by an inventor is inherently suspect. Apator Miitors
`
`v. Kamstrup A/S, 887 F.3d 1293, 1296-97 (Fed. Cir. 2018) (“It is no answer that
`
`Apator's evidence is ‘unrebutted,’ as Apator repeatedly points out. This criticism
`
`misunderstands Apator's burden of proof….”).
`
`Similarly, only Dr. Shailubhai vouches for the Pennington letter (EX2040).
`
`Bausch urges this is enough, but for the same reasons as given for the reports, it is
`
`not. Indeed, it is worse because Dr. Shailubhai could not remember anything about
`
`the substance of the letter or how it was received, could not confirm Dr.
`
`Pennington’s signature, testified he was not the custodian of the letter, and could
`
`not remember whether other suppliers of the synthesized peptides had sent him
`
`similar letters much less whether he kept them. MtE 11-12. In short, Dr. Shailubhai
`
`cannot recall enough to make his purported authenticating testimony reliable.
`
`III. CONCLUSION
`
`Mylan’s motion to exclude should be granted.
`
`-5-
`
`
`
`Dated: June 7, 2023
`
` Respectfully submitted,
`
`
`/Richard Torczon/
`Richard Torczon No. 34,448
`Counsel for Mylan Pharmaceuticals Inc.
`
`-6-
`
`
`
`CERTIFICATE OF SERVICE
`I certify that today this paper was served by email on Bausch’s counsel at:
`
`Justin J. Hasford
`
`justin.hasford@finnegan.com
`
`Bryan C. Diner
`
`bryan.diner@finnegan.com
`
`Joshua Goldberg
`
`joshua.goldberg@finnegan.com
`
`Caitlin O’Connell
`
`caitlin.o’connell@finnegan.com
`
`Kyu Yun Kim
`
`kyuyun.kim@finnegan.com
`
`Kassandra Officer
`
`kassandra.officer@finnegan.com
`
`and on MSN’s counsel at:
`
`Andrew Larsen
`
`alarsen@merchantgould.com
`
`Melissa Hayworth
`
`mhayworth@merchantgould.com
`
`Dated: June 7, 2023
`
`Respectfully submitted,
`
`/Robyn Moriarty/
`Robyn Moriarty
`
`
`
`-7-
`
`
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