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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`————————————————
`Case IPR2022-01104
`Patent 9,919,024
`
`————————————————
`
`PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE1
`
`
`
`1 This paper was authorized in the Trials email on November 9, 2022.
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`
`
`TABLE OF AUTHORITIES
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`Page
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`Cases
`Code200, UAB v. Bright Data Ltd., IPR2022-00861, Paper 18 (precedential) ......... 5
`In re Aller, 220 F.2d 454 (CCPA 1955) .................................................................... 5
`In re Morsa, 803 F.3d 1374 (Fed. Cir. 2015) ............................................................ 5
`In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003) ........................................................ 5
`SolarEdge Techs. Ltd v. SMA Solar Tech. AG, IPR2020-00021, Paper 31 ............... 4
`
`Statutes
`35 U.S.C. §314(a) ...................................................................................................... 5
`35 U.S.C. §325(d) ...................................................................................................... 1
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`-ii-
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`
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`Bausch’s POPR (at 23-40) takes the prosecution history out of context and
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`ignores material differences between the present challenge and the prosecution.
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`The petition identified material error resulting from faulty unexpected-
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`results arguments and declarations. Pet., 65, 9-10. The examiner correctly found
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`the unit doses result from routine optimization of prior-art ranges and maintained
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`this finding. E.g., EX1022 (a parent application), 4449, 5104; EX1021, 388-402,
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`726; EX1002, ¶¶57-63, 109-13, 195-98. The examiner also held formulating
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`plecanatide tablets with a low-moisture carrier and a lubricant was prima facie
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`obvious. E.g., EX1022, 4449-51. The examiner only allowed the claims when
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`Bausch amended its claims to exclude excipients other than a low-moisture carrier
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`and lubricant, and argued that the storage stability was unexpectedly improved
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`after 6, 9 and 12 months using low-moisture versus regular-grade carriers without
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`additional stabilizing excipients. EX1022, 0369-86, 5079-94 (“dramatic” stability
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`increase); 4973-77 (adding “consisting of”), 5098-5104 (allowance); EX1021, 698,
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`702-06, 720-27 (similar for later application); EX1002, ¶¶57-67, 72-79, 591-92.
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`Yet the petition and supporting testimony showed the alleged unexpected
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`results failed to overcome the claims’ prima facie obviousness. Pet., 60-65;
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`EX1002, ¶¶593-602. For example, Bausch conflated multiple variables instead of
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`evaluating the low-moisture carrier’s effect in a tablet-to-tablet comparison. Pet.,
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`60-61. Bausch also exaggerated differences between its formulations, alleging a
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`-1-
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`
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`“dramatic” 30-34% degradation reduction after storage showed unexpected
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`stability. Pet., 61-64 & cited exhibits. A more apt tablet-to-tablet comparison
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`“shows essentially identical levels of change in degradants over time.” Id.
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`Moreover, less peptide degradation was the intended result for a low-moisture
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`carrier. Pet., 64. Bausch’s flawed data strongly indicate the claimed storage
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`stability was the expected result when formulating plecanatide in this routine,
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`conventional manner. Pet., 8-9, 28-29, 47-50.
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`The POPR rebuts none of the factual problems with the data and prosecution
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`arguments; instead, it pivots to a new argument that the unexpected result was not
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`storage stability, but the initial purity difference between capsules and tablets
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`before storage. POPR, 2, 18-23. This conclusory attorney argument is unsupported
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`and absurd. The claims recite a “storage” stability limitation, not starting purity.
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`Moreover, prosecution focused on narrowing the claims to correspond better to
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`Bausch’s alleged unexpected results without additional stabilizing excipients.
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`POPR, 21 (“6, 9, and 12 months”). As Dr. Buckton explained, maintaining the
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`same differential over time indicates little or no storage advantage from using low-
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`moisture carrier. EX1002, ¶¶593-601. Also, Bausch assumes without support that
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`initial purity resulted from carrier-moisture difference (rather than, e.g., capsule
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`moisture or starting plecanatide purity in the different dosage forms). Indeed,
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`Bausch’s pivot to a new, baseless “unexpected results” argument confirms trial
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`-2-
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`
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`
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`institution is appropriate, and refutes Bausch’s assertion (POPR, 39) that
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`unexpected results played no role in allowance.
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`Without contrary evidence rebutting expert testimony supporting the
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`petition, Bausch instead asks the Board to ignore this testimony and also attacks
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`Drs. Buckton and Christians individually. POPR, 39-40. But Bausch ignores the
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`POSA is part of a team, Dr. Buckton’s eminent qualifications as a formulator, and
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`Dr. Christians’ eminent qualifications as an M.D. with clinical-pharmacology
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`experience specific to uroguanylin peptides and extensive experience designing
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`and conducting clinical trials. Pet., 11-13; EX1004, ¶¶1-9, 37-40; EX1002, ¶¶1-10,
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`81-84. Dr. Christians testified he knows the level of skill based on his education,
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`experience, and training. EX1004, ¶¶38; EX1002, ¶¶83-84 (Buckton). If relevant,
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`Bausch can test these renowned experts’ qualifications during the trial.
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`The petition also noted the examination failed to apply applicant admissions
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`(e.g., in Shailubhai) that formulating plecanatide in a tablet and determining the
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`amount to administer were routine matters well-within the ordinary skill. See, e.g.,
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`Pet., 18, 32 (plecanatide tablets “may be made using methods well known in the
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`art” and “selection of carrier” is “well within the level of skill in this art” (citing
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`EX1005, 13:18-52)); EX1005, 15:10-17. These admissions prove plecanatide
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`formulation was routine using standard formulation texts (e.g., Remington), which
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`teach a direct-compression tablet consisting of the active ingredient, an inert
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`-3-
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`
`
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`carrier, and a lubricant was among the simplest, most conventional approaches to
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`tablet formulation. Pet., 17-21, 65-67. Bausch’s comparisons (e.g., POPR, 26-28,
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`36-37) fail to prove the examiner ever considered Remington’s and Doelker’s
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`teachings of a routine direct-compression tablet satisfying the “consisting of”
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`limitation.
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`Bausch argues the examiner relied on portions of a different patent
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`document (EX2001) within the same family as Shailubhai during prosecution.
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`POPR, 26-28. But Bausch paints with too broad a brush. For example, where
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`Bausch argues the examiner found EX2001 teaches formulation for oral
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`administration (POPR, 27), the examiner relied only on lines 45-49 of page 17.
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`EX1022, 4449. Bausch fails to show the examiner recognized or asserted Bausch’s
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`admission that Remington teaches well-known methods for formulating
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`plecanatide and that the “selection of carriers” and other suitable components “is
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`well within the level of skill in this art.” Id.; EX1005, 13:18-52; SolarEdge Techs.
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`Ltd v. SMA Solar Tech. AG, IPR2020-00021, Paper 31, at 14-16 (error to ignore
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`applicant admissions regarding skill level); POPR, 8 (Shailubhai “is Patent
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`Owner’s patent”). Bausch fails to account for the differences from this challenge.
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`Nor does the POPR account for petition evidence that routine optimization
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`entailed administering lower dosage amounts to determine the lowest safe and
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`effective plecanatide dose, and that an efficacy plateau was expected based on
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`-4-
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`
`
`
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`plecanatide’s known function as an agonist. Pet., 14. Such routine optimization is
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`obvious. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie
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`case of obviousness typically exists when the ranges of a claimed composition
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`overlap the ranges disclosed in the prior art.”); In re Aller, 220 F.2d 454, 456
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`(CCPA 1955) (“where the general conditions of a claim are disclosed in the prior
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`art, it is not inventive to discover the optimum or workable ranges by routine
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`experimentation”). Bausch compares the petition to the prosecution history but
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`fails to account for this new evidence. When the proper legal standard is applied—
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`with these multiple admissions in mind—obviousness is unavoidable. In re Morsa,
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`803 F.3d 1374, 1377 (Fed. Cir. 2015) (“Here, the Board properly held that the
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`application's specification made numerous admissions as to what one skilled in the
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`art at the time of the invention would have known.”).
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`Bausch urges overlap in art or arguments requires denying institution. Yet
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`the Director must determine if the art and arguments show a reasonable likelihood
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`at least one claim is unpatentable. 35 U.S.C. §314(a). Discretionary denial is no
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`talisman to preserve patents granted in error. E.g., Code200, UAB v. Bright Data
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`Ltd., IPR2022-00861, Paper 18, 4-6 (precedential) (priority for restoring
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`confidence in patent quality where petitioner raises arguments not previously
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`evaluated on the merits). A reasonable likelihood exists that Bausch’s unexpected-
`
`results arguments were wrong and at least one claim is unpatentable; thus,
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`-5-
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`
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`institution is proper despite Bausch’s arguments about the flawed examination.
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` Respectfully submitted,
`
`Dated: November 15, 2022
`
`
`
`
`
`
`
`/Jad A. Mills/
`Jad A. Mills, Reg. No. 63,344
`Counsel for Mylan Pharmaceuticals Inc.
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`-6-
`
`
`
`
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`CERTIFICATE OF SERVICE
`
`I certify this paper was served today electronically on Bausch’s counsel at:
`
`Justin J. Hasford
`
`Bryan C. Diner
`
`Joshua Goldberg
`
`Caitlin O’Connell
`
`Kyu Yun Kim
`
`
`
`
`
`
`
`Dated: November 15, 2022
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`
`
`justin.hasford@finnegan.com
`
`bryan.diner@finnegan.com
`
`joshua.goldberg@finnegan.com
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`caitlin.o’connell@finnegan.com
`
`kyuyun.kim@finnegan.com
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`Respectfully submitted,
`
`/Jad A. Mills/
`Jad A. Mills
`
`-7-
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`
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