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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`
`AMNEAL PHARMACEUTICALS LLC,
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, and MYLAN
`PHARMACEUTICALS INC.,
`Petitioners
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner
`
`
`Case IPR2019-002071
`Patent 9,517,219
`
`
`
`PATENT OWNER’S RESPONSE TO
`PETITIONER’S SUPPLEMENTAL BRIEF
`
`
`
`1 Cases IPR2019-00207 and IPR2019-01095 have been joined in this proceeding.
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`I.
`II.
`
`III.
`
`Page
`Introduction ...................................................................................................... 1
`Dr. Warner’s Inventor Testimony Does Not Show
`Prima Facie Obviousness ................................................................................ 2
`Petitioners Have Not Challenged the Reliabilty of
`Dr. Warner’s Declaration ................................................................................ 5
`A.
`Petitioners’ Repeated Argument re Carbopol’s
`Incompatibility Continues to Fail .......................................................... 5
`Petitioners Have Not Shown that A/SA Would
`Be Expected to Be Compatible with 40% DGME ................................ 8
`Dr. Warner’s Declaration Regarding Smaller Particle
`Size Has a Nexus with the Claims ........................................................ 9
`IV. Conclusion ..................................................................................................... 10
`
`
`
`B.
`
`C.
`
`i
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`
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`IPR2019-00207
`Patent Owner’s Response to Petitioner’s Supplemental Brief
`
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`I.
`
`INTRODUCTION
`Petitioners’ supplemental brief does nothing to challenge or in any way
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`undermine the credibility of Dr. Warner’s declaration submitted during prosecution
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`of the ʼ219 patent. Petitioners were granted additional discovery to seek
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`information regarding the reliability of and “explore the factual underpinnings” of
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`the experiments reported in Dr. Warner’s declaration. See Paper 39 at 6. Unable
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`to discredit the reported experiments in his declaration, Petitioners took the
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`10-page opportunity to rehash its arguments already of record, misrepresenting
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`Dr. Warner’s testimony in the process.
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`What matters here is whether Dr. Osborne’s reliance on the Warner
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`Declaration is reasonable, and nothing in Petitioners’ supplemental brief shows
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`that it is not. Dr. Osborne took from the Warner Declaration what POSA reading
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`the file history of the ʼ219 patent would—and what the Examiner did. Petitioners’
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`arguments that Dr. Osborne lacked personal knowledge of the actual experiments
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`performed and described in the Warner Declaration are irrelevant, a fact posturing
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`him no differently than the same POSA, and the same Examiner.
`
`As for the so-called “critical admissions” Dr. Warner allegedly made in his
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`deposition in the Taro action, these fall into two categories. Either they are legally
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`irrelevant to the question of obviousness, prohibitively focused on the path the
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`1
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`IPR2019-00207
`Patent Owner’s Response to Petitioner’s Supplemental Brief
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`inventor himself followed in arriving at the claimed invention, or they are grossly
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`mischaracterized. Read in context, and thus fairly, the prior deposition testimony
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`confirms that Dr. Warner performed (or directed) the experiments just as described
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`in his declaration. And so it remains that the credibility of the parties’ experts in
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`opining as to the import a POSA would ascribe to the Warner Declaration is to be
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`considered and weighed by the Board.
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`II. DR. WARNER’S INVENTOR TESTIMONY DOES NOT SHOW
`PRIMA FACIE OBVIOUSNESS
`Petitioners’ attempts to use Dr. Warner’s testimony as to why and how he
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`came to the inventions claimed in his patent are legally irrelevant. “Patentability
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`shall not be negated by the manner in which the invention was made.” 35 U.S.C.
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`§ 103. And as the Federal Circuit has explained, “[t]he inventor's own path itself
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`never leads to a conclusion of obviousness; that is hindsight. What matters is the
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`path that the person of ordinary skill in the art would have followed, as evidenced
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`by the pertinent prior art.” Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d
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`1280, 1296 (Fed. Cir. 2012). Petitioners are required to show obviousness in
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`respect of the prior art. The inventor’s actions in arriving at the invention are not
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`prior art. Petitioners’ attempts to rely on the inventor’s own steps and reasoning to
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`show prima facie obviousness indeed is hindsight in its purest form. Id.
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`2
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`IPR2019-00207
`Patent Owner’s Response to Petitioner’s Supplemental Brief
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`Proceeding as unaware of this well-settled law, Petitioners nonetheless
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`serially misrepresent Dr. Warner’s deposition testimony in attempting to use his
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`own steps to show obviousness. Rather than testifying, as Petitioners represent,
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`that steps he took were generally “routine,” Dr. Warner took care to testify that
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`increasing solubilized dapsone and increasing DGME was the formulation strategy
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`of his particular team. Ex. 1078 at 51:21–53:7. On its face, the remaining
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`testimony cited by Petitioners on this point—that additional safety studies would
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`need to be done if using more than the maximum amount of DGME listed in the
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`IIG at the time of development of the 7.5% dapsone gel (id. at 58:6–59:20); and
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`that during his experiments in developing the invention he “observed [Carbopol]
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`crashing out at 40 percent and at 35 percent,” so was concerned about “potential
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`incompatibility” at 30% DGME (id. at 185:1–16)—hardly speaks to any
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`“routineness” of increasing DGME concentration.
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`Petitioners’ representations that Dr. Warner testified that Sepineo “was
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`known in the art to have ‘better aesthetics,’ ‘improvements on particle size,’ ‘good
`
`suspension for stability of dapsone,’ as well as ‘ease in manufacturing’” are simply
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`not borne out by the transcript. Paper 49 at 3 (emphasis added). Dr. Warner
`
`testified not to what the prior art disclosed or taught, but instead to what he, the
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`3
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`IPR2019-00207
`Patent Owner’s Response to Petitioner’s Supplemental Brief
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`inventor, observed, regarding the entire formulation, during development of the
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`invention:
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`Q: And that’s one of the advantages the . . .
`manufacturer of Sepineo states that the product has, that
`it doesn’t have to be activated; right?
`
`A: I don’t recall the specifics that Seppic gives. There
`are several advantages that in the development of our 7.5
`that we identified with having Sepineo present.
`
`Q: Okay. What were some of those advantages you
`identified of using Sepineo P600 as opposed to Carbopol
`980?
`
`A: So speaking broadly with the formulation, because
`it’s not just confined to those excipients we’re talking
`about, the advantages we saw with our 7.5 formulations
`during the development were that we had better
`aesthetics, we had improvements on particle size of the
`suspended Dapsone, we had a good suspension for
`stability of Dapsone, and we found, also, ease in
`manufacturing.
`
`Q: Okay. And were each of those advantages a
`consequence of using Sepineo P600 as opposed to
`Carbopol 980?
`
`. . .
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`4
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`IPR2019-00207
`Patent Owner’s Response to Petitioner’s Supplemental Brief
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`A: I’d say, from my experience, it’s not solely related to
`Sepineo, but looking at the whole composition of the
`formulation.
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`Ex. 1078 at 67:11–70:4 (emphases added); see also id. at 70:4–21 (“[T]he whole of
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`the entirety of the formulation, together, that gave us what we felt, during some of
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`our studies, improved aesthetics.”); id. at 76:18–77:16 and 119:22–121:9
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`(discussing what he had seen and concluded from his experiments in developing
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`the invention). And as to Dr. Warner’s testimony regarding knowledge that
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`Sepineo had previously been used in an FDA-approved product, none of the cited
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`testimony (or, indeed, any of the transcript) demonstrates, as Petitioners assert, that
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`this “gave his team confidence in selecting Sepineo.” Paper 49 at 3–4 (citing
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`Ex. 1078 at 122:5–20, 161:12–162:11).
`
`III. PETITIONERS HAVE NOT CHALLENGED THE RELIABILTY OF
`DR. WARNER’S DECLARATION
`A.
`Petitioners’ Repeated Argument re Carbopol’s Incompatibility
`Continues to Fail
`Petitioners’ continued casting as irrelevant Carbopol’s incompatibility with
`
`the overall formulations including higher concentrations of DGME remains
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`unavailing. Paper 49 at 4–6. Despite knowing that Carbopol could clump if added
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`inappropriately, Dr. Warner testified that he was surprised to see aggregates of
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`polymer at high concentrations of DGME. Ex. 1078 at 111:3–113:1. Indeed, he
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`5
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`IPR2019-00207
`Patent Owner’s Response to Petitioner’s Supplemental Brief
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`testified that he and his team were “consistently seeing,” in their experiments, that
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`Carbopol was “crashing out at elevated levels of DGME.” Id.at 116:9–117:7. He
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`concluded, based on those experiments, that “Carbopol is not compatible long-term
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`on stability” with the composition as a whole. Id. at 117:8–15. This consistent
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`tendency of Carbopol to form polymer aggregates—only at increased DGME
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`concentrations—was, as Dr. Warner testified, unexpected. Given his knowledge of
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`the possibility of clumping due to adding Carbopol too quickly,2 the long-term
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`“crashing out” of Carbopol aggregates at higher concentrations of DGME cannot
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`be explained by too rapid an addition of the polymer. It is in any event no matter;
`
`the question is whether, given Carbopol’s unexpected “crashing out” at higher
`
`DGME concentrations, the prior art would lead a POSA to expect that the claimed
`
`PVB comprising A/SA copolymer (Sepineo) would not have the same peculiarity.
`
`Petitioners have presented no evidence suggesting any such expectation.
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`2 Petitioners argue, with no authority, that because Dr. Warner “supervised” rather
`
`than personally carried out each experiment reported in his declaration, the
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`Carbopol aggregation could be due to inexperience. But they present no evidence
`
`that the experiments carried out with sub-par supervision. Moreover, inexperience
`
`does not explain Dr. Warner’s testimony that the aggregation was “consistent” and
`
`only seen at increased concentrations of DGME. Ex. 1078 at 116:9–117:15.
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`6
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`IPR2019-00207
`Patent Owner’s Response to Petitioner’s Supplemental Brief
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`As the Examiner concluded, the data provided in the Warner Declaration are
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`“reasonably representative of, and commensurate in scope with, the [] claimed
`
`7.5% w/w dapsone formulation,” and “the comparative dapsone formulations
`
`employed the same thickening agent used by the closest prior art to Garrett in the
`
`same quantity suggested by this prior art reference (thereby constituting a
`
`reasonable comparison of the instantly claimed formulation with that of the closest
`
`prior art)).” Ex. 1017 at 467–468. As the Examiner noted, for unexpected results,
`
`it is the comparison to the closest prior art that matters. See In re Merchant,
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`575 F.2d 865, 868–69 (CCPA 1978); Bristol-Myers Squibb v. Teva Pharms. USA,
`
`752 F.3d 967, 977 (Fed. Cir. 2014). Here, Dr. Warner describes experiments
`
`comparing a composition—as in the claims—using Sepineo, with one—as in
`
`Garrett—using Carbopol plus a neutralizer. The comparison is directly relevant to
`
`unexpected results because Carbopol plus a neutralizer is the polymeric viscosity
`
`builder (“PVB”) in the closest prior art.
`
`Petitioners’ citation to Fox Factory, Inc. v. SRAM, LLC in inapt. There, the
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`Federal Circuit found that the commercial success of a product lacks nexus when
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`that product’s other properties, claimed as crucial in other patents, caused its
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`commercial success. 944 F.3d 1366, 1375 (Fed. Cir. 2019). Here, the declaration
`
`discusses not commercial success of unclaimed elements, but rather the
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`7
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`IPR2019-00207
`Patent Owner’s Response to Petitioner’s Supplemental Brief
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`functionality of the formulation, as a whole, as compared to the closest prior art.
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`Carbopol’s “crashing out” and forming aggregates at 35% or 40% DGME is
`
`expressly coextensive with the claims in this context. See ʼ219 patent, cl. 1 (“… to
`
`about 40% w/w [DGME]”). It is no surprise the Examiner recognized this.
`
`Ex. 1017 at 466–467 (“In order to increase the dapsone concentration from 5.0%
`
`w/w to 7.5% w/w as desired, the Warner Declaration states that a corresponding
`
`increase in [DGME] from its 25% w/w amount typically found in the 5.0% w/w
`
`ACZONE gel was necessary to solubilize dapsone in the formulation.”).
`
`B.
`
`Petitioners Have Not Shown that A/SA Would Be Expected to Be
`Compatible with 40% DGME
`Petitioners argue that “[n]either Almirall nor Dr. Osborne have identified
`
`any prior art teaching that Sepineo would not be compatible with [DGME].” Paper
`
`49 at 6. But it is not Almirall’s burden to do so. Rather, it is Petitioners’
`
`unshifting burden to show that A/SA, in the context of the claimed concentrations
`
`of dapsone and other excipients, would be expected to be compatible with the
`
`formulation as a whole. Petitioners have not. There is not a single piece of prior
`
`art evidence in the record relating dapsone to Sepineo (or any A/SA copolymer-
`
`based PVB) in terms of compatibility.
`
`Here again Petitioners attempt to use Dr. Warner’s testimony as to the steps
`
`the inventor took to show the invention is obvious. Paper 49 at 7. But here again
`
`8
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`IPR2019-00207
`Patent Owner’s Response to Petitioner’s Supplemental Brief
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`an inventor’s testimony as to his own path cannot prove obviousness. And
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`Dr. Osborne’s testimony that one would “expect success” with Carbopol, until
`
`Dr. Warner’s experiments showed otherwise, is not to the contrary. Ex. 1040 at
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`84:5–23 (“I infer from that that he was expecting 40 percent DGME in Carbopol to
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`work, which is what I stated here. He expected it to work because it worked at
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`25 percent”).
`
`C. Dr. Warner’s Declaration Regarding Smaller Particle Size Has a
`Nexus with the Claims
`Petitioners contend that the manufacturing process, not the claimed
`
`composition, may be responsible for the comparatively smaller particle size over
`
`the prior art described in the Warner Declaration. Paper 49 at 8. Petitioners cite
`
`no authority lending credence to this argument, which is unremarkable, for even if
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`true, the argument assumes that the composition itself has no independent
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`influence on particle size. To the contrary, as Petitioners themselves quote from
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`Morris (not of the Grounds but cited by Petitioners): the physical form of the
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`dapsone particles are governed by all “aspects of the technique used to carry out
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`the precipitation, such as concentration, identity of the solvent, relative amount of
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`water added, the presence of other ingredients, the time period over which the
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`precipitation occurs…” Paper 49 at 8–9 (quoting Morris, Ex. 1008 at [0005]). The
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`questions here is whether it was expected that between the formulations tested, the
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`9
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`IPR2019-00207
`Patent Owner’s Response to Petitioner’s Supplemental Brief
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`two would produce different size particles. Petitioners present no evidence to
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`show that this expectation existed.
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`Petitioners further argue that because, like the prior art compositions, the
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`Carbopol compositions tested by Dr. Warner contained a neutralizer while the
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`Sepineo compositions did not, and the concentrations of thickener differ,3 no
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`comparison can be made. Yet as even Fox Factory points out, perfect
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`correspondence is not required to find a nexus. 944 F.3d at 1374. The appropriate
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`question here is whether the smaller dapsone particle size in the compositions
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`described in the Warner Declaration is attributable to the composition as used in
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`the claims. And as the Examiner noted, it “clear[ly]” is. Ex. 1017 at 467–468.
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`IV. CONCLUSION
`Dr. Warner’s testimony serves only to affirm that experiments presented in
`
`his declaration are reliable. None of Petitioners’ arguments challenge that
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`reliability. Petitioners merely rehash old arguments regarding the import of the
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`Warner Declaration on unexpected results, but to no more avail than before.
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`3 This argument was addressed and appropriately dismissed by the Examiner.
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`Ex. 1017 at 467.
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`10
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`IPR2019-00207
`Patent Owner’s Response to Petitioner’s Supplemental Brief
`
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`Dated: January 31, 2020
`
`
`Respectfully submitted,
`
`
`
`
`
`FENWICK & WEST LLP
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`Attorneys for Patent Owner
`Almirall, LLC
`
`
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`11
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`IPR2019-00207
`Patent Owner’s Response to Petitioner’s Supplemental Brief
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on January 31, 2020, the
`
`foregoing PATENT OWNER’S REPLY IN SUPPORT OF MOTION TO
`
`EXCLUDE EVIDENCE UNDER 37 C.F.R. 42.64 was served by electronic mail
`
`on the following counsel of record for Petitioners:
`
`Dennies Varughese
`Adam C. LaRock
`Tyler C. Liu
`Sterne, Kessler, Goldstein & Fox
`1100 New York Avenue, NW, Suite 600
`Washington, DC 20005
`dvarughe-PTAB@skgf.com
`alarock-PTAB@skgf.com
`tliu-PTAB@skgf.com
`
`
`Jitendra Malik
`Alissa M. Pacchioli
`Heike S. Radeke
`Katten Muchin Rosenman LLP
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`heike.radeke@kattenlaw.com
`Lance Soderstrom
`Katten Muchin Rosenman LLP
`575 Madison Avenue
`New York, NY 10022-2585
`lance.soderstrom@kattenlaw.com
`
`Dated: January 31, 2020
`
`
`Respectfully submitted,
`
`FENWICK & WEST LLP
`|
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`Attorneys for Patent Owner
`Almirall, LLC
`
`
`
`12
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`
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