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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`AMNEAL PHARMACEUTICALS LLC AND AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC, and MYLAN
`PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`_____________________
`
`Case IPR2019-00207
`Patent 9,517,219 B2
`_____________________
`
`
`[REDACTED] PETITIONERS’ SUPPLEMENTAL BRIEF ADDRESSING
`NEW EVIDENCE FROM ADDITIONAL DISCOVERY
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`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
`
`
`Case IPR2019-00207
`Patent 9,517,219 B2
`
`TABLE OF CONTENTS
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`INTRODUCTION ..................................................................................................... 1
`DR. WARNER’S TARO ACTION TESTIMONY FURTHER
`I.
`CONFIRMS THE ’219 PATENT IS PRIMA FACIE OBVIOUS. ................. 2
`II. DR. WARNER’S TARO ADMISSIONS DEFEAT ALMIRALL’S
`ALLEGATIONS OF UNEXPECTED RESULTS. ......................................... 4
`A. Almirall’s evidence of incompatibility between Carbopol
`and 40% ethoxydiglycol was not unexpected and has no
`nexus to the ’219 patent claims. ............................................................ 4
`B. A POSA would have expected Sepineo to be compatible
`with 40% ethoxydiglycol. ..................................................................... 6
`The smaller particle size of undissolved dapsone in the
`dapsone-Sepineo composition does not have a nexus to the
`claims and, in any event, was not unexpected. ..................................... 7
`CONCLUSION ........................................................................................................ 10
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`C.
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`Case IPR2019-00207
`Patent 9,517,219 B2
`
`INTRODUCTION
`Dr. David Osborne is the only Almirall expert has alleging unexpected
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`results in this proceeding. Dr. Osborne’s only evidence and basis for alleging
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`unexpected results is the declaration submitted by co-inventor Dr. Kevin Warner
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`during prosecution (the “Warner Declaration” AMN1017, 289-293). EX2057,
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`¶¶173-194 (citing AMN1017, 289-293). Dr. Osborne has no personal knowledge
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`of the experiments Dr. Warner described. AMN1040, 76:23-82:8, 108:11-15;
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`AMN1043, ¶¶70-71. Nor did Dr. Osborne know who actually conducted the
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`testing or what their level of skill was. See AMN1040, 107:15-108:15. Importantly,
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`Dr. Osborne conceded that he would have liked to have had additional information
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`about the Warner Declaration. See AMN1040, 108:11-15.
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`Accordingly, Petitioner Amneal tried for months to secure Dr. Warner’s
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`deposition in this IPR, which Almirall repeatedly refused, until his deposition was
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`ordered by the Board. Paper 39, 8-9. Even then, Almirall failed to comply with that
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`order. Paper 44, 2-3. Dr. Warner was, however, previously deposed in a related
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`district court litigation, Almirall LLC v. Taro Pharmas. Indus. Ltd., 17-663 (D.
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`Del.), (the “Taro action”) involving the ’219 patent at issue here.
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`After Amneal finally received the Taro action transcript, the reason for
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`Almirall’s steadfast refusal to make Dr. Warner available and to produce his
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`litigation transcript soon became apparent. Dr. Warner made critical admissions in
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`the Taro action that (1) further confirm Petitioner Amneal’s obviousness case and
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`Case IPR2019-00207
`Patent 9,517,219 B2
`(2) entirely disproves any unexpected results alleged by Almirall and Dr. Osborne.
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`These admissions are additional reasons the Board should find that the ’219
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`patent’s claims are unpatentable as obvious.
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`I.
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`DR. WARNER’S TARO ACTION TESTIMONY FURTHER
`CONFIRMS THE ’219 PATENT IS PRIMA FACIE OBVIOUS.
`At his deposition in the Taro action, Dr. Warner provided critical admissions
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`that support Amneal’s obviousness case and undercut Almirall’s defenses.
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`Dr. Warner’s approach is precisely what the prior art taught. As Dr.
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`Michniak-Kohn explained, Garrett taught that an amount between 5% and 10%
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`w/w dapsone could be used once- or twice- daily. AMN1043, ¶19; AMN1004,
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`12:20-30. Further, Dr. Michniak-Kohn explained that because the prior art Aczone
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`Gel 5% product was administered twice-daily, a POSA would have been motivated
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`Case IPR2019-00207
`Patent 9,517,219 B2
`to optimize to once-daily dosing. AMN1043, ¶19.
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` This
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`testimony shows that a POSA would have been motivated to use amounts of
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`ethoxydiglycol greater than 25%, defeating Almirall’s assertion of teaching away.
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` As explained by Dr. Michniak-Kohn, these qualities of Sepineo were all
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`previously known in the art from at least Nadau-Fourcade (AMN1005, 48:5-9),
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`Bonacucina (AMN1015, 2, 7), the Sepineo brochure (AMN1026, 1), and
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`Andersson (AMN 1055, 4). Dr. Michniak-Kohn also explained that these qualities
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`would have motivated a POSA to use Sepineo. AMN1043, ¶¶55-69. Thus, Dr.
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`Warner’s testimony confirms a POSA’s reasons to select Sepineo as a thickener.
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`Case IPR2019-00207
`Patent 9,517,219 B2
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`II. DR. WARNER’S TARO ADMISSIONS DEFEAT ALMIRALL’S
`ALLEGATIONS OF UNEXPECTED RESULTS.
`A. Almirall’s evidence of incompatibility between Carbopol and 40%
`ethoxydiglycol was not unexpected and has no nexus to the ’219
`patent claims.
`Dr. Warner’s Taro action testimony confirms that, at most, the only basis for
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`unexpected results was the purported incompatibility of Carbopol with 40%
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`ethoxydiglycol. First, Almirall has not adequately proven Carbopol’s alleged
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`“incompatibility” because the fact that Carbopol exhibited polymer aggregates
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`would not have been unexpected. Carbopol was known to clump together and form
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`insoluble particles. AMN1043, ¶73; AMN1046, 1. Dr. Osborne even agreed that
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`Carbopol had peculiarities. AMN1040, 42:21-43:4. When improperly added or
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`mixed, Carbopol polymers can clump together, causing the “presence of insoluble
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`particles resembling fish eyes.” AMN1046, 1; AMN1043, ¶73.
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`Second, the Warner Declaration states only that experiments were performed
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`under Dr. Warner’s “supervision,” which means the experience level of the person
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`who performed the experiments or their familiarity with Carbopol’s tendencies and
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`Patent 9,517,219 B2
`peculiarities is unknown. Any observed aggregation in Carbopol-containing
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`compositions is equally attributable to Carbopol’s known tendencies and
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`peculiarities to clump or aggregate as it is to any purported incompatibility. Given
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`that a POSA would have been aware of Carbopol’s tendencies and peculiarities,
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`the fact that Dr. Warner apparently observed undesirable polymer aggregates in his
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`dapsone-Carbopol composition would not have been unexpected.
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`Third, but even if it were true that Carbopol was unexpectedly incompatible,
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`there still is no nexus to the ’219 patent claims. Almirall apparently relies on a
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`presumption of nexus that does not exist here. In Fox Factory, Inc. v. SRAM, LLC,
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`the Federal Circuit held that nexus between objective indicia and patent claims can
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`only be presumed if the claims include limitations related to the secondary
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`consideration. 944 F.3d 1366, 1373 (Fed. Cir. 2019). Because the chainring
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`products at issue in Fox Factory contained multiple unclaimed features that were
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`“critical” to the alleged secondary considerations, no nexus existed. Id. at 1371,
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`1375-76. Similarly, here, Carbopol’s purported incompatibility with
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`ethoxydiglycol is not a claimed feature and, therefore, has no relation to the claims.
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`Dr. Warner’s declaration does nothing to demonstrate that it would have been
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`unexpected that Sepineo would be compatible, as claimed.
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`Finally, even assuming any unexpected incompatibility existed between
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`Carbopol and ethoxydiglycol (and there are none), such results are not
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`Patent 9,517,219 B2
`commensurate with the scope of the claims.
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`Importantly, the Warner Declaration only identifies an alleged “undesired”
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`incompatibility between Carbopol and 40% ethoxydiglycol (AMN1017, 290-291),
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`meaning that the small aggregates observed in the composition containing
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`Carbopol and 35% ethoxydiglycol were not “undesirable.”
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` Dr. Warner’s testimony in the Taro action shows that there
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`is no unexpected incompatibility between Carbopol and ethoxydiglycol.
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`B. A POSA would have expected Sepineo to be compatible with 40%
`ethoxydiglycol.
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`The Warner Declaration fails to explain whether it was unexpected that
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`Sepineo was compatible with ethoxydiglycol. This omission is not surprising
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`because a POSA would have expected Sepineo to be compatible. Neither Almirall
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`nor Dr. Osborne have identified any prior art teaching that Sepineo would not be
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`compatible with ethoxydiglycol. Rather, the art repeatedly describes Sepineo as a
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`Patent 9,517,219 B2
`prime thickener that works well across a wide range of other common excipients,
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`such as ethoxydiglycol, without issue. AMN1043, ¶¶72-73; AMN1055, 4;
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`AMN1013, ¶323; AMN1011, 4:20-41, 5:42-53; AMN1046, 1. Sepineo is also
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`known to tolerate a wide pH range and a wide variety of solvents. AMN1026, 1-2;
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`AMN1055, 4; AMN1043. ¶72.
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` Thus, by the time of
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`the experiments described in the Warner Declaration, Sepineo was expected to be
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`compatible. This further comports with Almirall’s expert declarant Dr. Osborne’s
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`testimony that a POSA would “expect success.” AMN1040, 84:5-19. Therefore,
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`Dr. Warner's testimony confirms that there is no relevant unexpected results here.
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`C. The smaller particle size of undissolved dapsone in the dapsone-
`Sepineo composition does not have a nexus to the claims and, in
`any event, was not unexpected.
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`As an initial matter, Almirall put forward no evidence to establish a nexus
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`for this purported unexpected result. There can be no nexus to the claims here,
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`where the alleged unexpected particle size is “critical” to Almirall’s purported
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`unexpected result, but the claims do not recite any particle size limitation. Fox
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`Factory, 944 F.3d at 1373.
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`Regardless, a POSA would have known that the size of undissolved dapsone
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`particles can be controlled by the preparation process and therefore changes in
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`Case IPR2019-00207
`Patent 9,517,219 B2
`particle size were expected. AMN1008, ¶5; AMN1043, ¶80; AMN1007, 49. A
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`POSA in 2012 would have understood that Sepineo is pre-neutralized and does not
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`require hydration, unlike Carbopol, which requires neutralization with sodium
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`hydroxide and hydration. AMN1002, ¶82, 84; AMN 1043, ¶68; AMN1026, 1;
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`AMN1020, 6, 11, 16, 19, 24, 25; AMN1055, 4.
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` Thus, not only are Dr. Warner’s
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`dapsone-Carbopol and dapsone-Sepineo compositions different, but the process of
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`preparing those compositions would be different. AMN1002, ¶¶101-104;
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`AMN1043, ¶¶80-82.
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`Accordingly, the fact that Dr. Warner observed a dapsone-Sepineo
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`composition with undissolved dapsone particles having a smaller particle size
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`compared to a dapsone-Carbopol composition would not have been unexpected
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`given the differences in the compositions and their preparation processes. Lathrop
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`taught that “[t]he size of the suspended particles of Dapsone may be controlled . . .
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`by the process by which the emulsive composition is compounded.” AMN1007,
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`¶[0049]. Orsoni taught that a gelling agent, like Sepineo, resulted in improved
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`particle size and dispersion. AMN1043, ¶¶81-82; AMN1011, 7:54-64. Similarly,
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`Morris taught that the “physical form [of undissolved dapsone particles] is
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`Case IPR2019-00207
`Patent 9,517,219 B2
`governed by the specifics of the technique used to carry out the precipitation, such
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`as concentration, identity of the solvent, relative amount of water added, the
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`presence of other ingredients, the time period over which precipitation occurs, the
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`temperature, post-precipitation handling, and other variables.” AMN1008, ¶[0005];
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`AMN1043, ¶80. Moreover, the fact that the undissolved dapsone particles in the
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`dapsone-Sepineo composition were less than 100 microns was not unexpected—
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`Lathrop taught that “[t]he size of the suspended particles may range from below 10
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`microns (microparticles or micronized particles) to palpable particles above about
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`100 microns.” AMN1007, ¶[0049].
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`In addition, Dr. Warner did not properly compare the dapsone-Sepineo
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`composition to the dapsone-Carbopol composition to assess whether the smaller
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`dapsone particle size was attributable to Sepineo. AMN1043, ¶84. Dr. Warner’s
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`dapsone-Carbopol compositions contained triethanolamine and sodium hydroxide,
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`while the dapsone-Sepineo compositions did not. Id. And, instead of using the
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`Patent 9,517,219 B2
`same concentration for both thickening agents, Dr. Warner used 4% Sepineo P 600
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`and only 1% Carbopol. AMN1017, 293. Given that Dr. Warner’s dapsone-Sepineo
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`and dapsone-Carbopol compositions were different in multiple respects, any
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`difference in particle size of undissolved dapsone cannot be attributed to Sepineo.
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`Finally, a POSA would have expected the particle size to either increase or
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`decrease, which would have been a difference in degree, not in kind. AMN1043,
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`¶79; Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 739 (Fed. Cir. 2013)
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`(unexpected results must show a difference “in kind and not merely in degree.”).
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`CONCLUSION
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`Almirall attempted to shield Dr. Warner from deposition and to delay
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`producing his Taro action transcript in order to hide his admissions that undermine
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`its case. Although Dr. Warner was not deposed in this proceeding, Dr. Warner’s
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`deposition testimony from the Taro action confirms that the ’219 patent is prima
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`facie obvious and that no unexpected results exist.
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`
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`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C
`
`
`Date: January 24, 2020
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`
`
`
`Dennies Varughese, Pharm.D.
`Registration No. 61,868
`Lead Attorney for Petitioners
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
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`I certify that the above-captioned "Petitioners’ Supplemental Briefing
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`Addressing New Evidence from Additional Discovery” upon the following parties
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`via electronic mail:
`
`
`
`James Trainor
`
`
`RJ Shea
`
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`
`Telephone (212) 430-2600
`Facsimile (650)938-5200
`jtrainor@fenwick.com
`rshea@fenwick.com
`
`Jennifer R. Bush
`FENWICK & WEST LLP
`801 California Street
`Mountain View, CA 94041
`Telephone (650) 988-8500
`Facsimile (650) 938-5200
`jbush@fenwick.com
`
`
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`
`
`Elizabeth B. Hagan
`FENWICK & WEST LLP
`1191 Second Avenue, 10th Floor
`Seattle, WA 98101
`Telephone (206) 389-4510
`Facsimile (206)389-4511
`ehagan@fenwick.com
`
`
`
`
` STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`
`
`
`
`Dennies Varughese, Pharm.D.
`Date: January 24, 2020
`1100 New York Avenue, N.W. Registration No. 61,868
`Washington, D.C. 20005-3934
`Lead Attorney for Petitioners
`(202) 371-2600
`
`
`
`
`
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`
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