`
`
`
`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,
`Petitioners
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner
`
`
`Case IPR2019-00207
`Patent 9,517,219
`
`
`PATENT OWNER’S REQUEST FOR
`DIRECTOR REVIEW PURSUANT TO ARTHREX
`
`
`
`
`
`
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`IPR2019-00207
`Patent Owner’s Request for Director Review
`
`
`TABLE OF CONTENTS
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`Page
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`B.
`
`I.
`REQUEST FOR DIRECTOR REVIEW ......................................................... 1
`LEGAL STANDARD ..................................................................................... 1
`II.
`III. ARGUMENT ................................................................................................... 1
`A.
`The Board Erred in Finding a Presumption of Obviousness
`Based on Overlapping Ranges in Garrett .............................................. 1
`The Board Failed to Give Weight to Almirall’s Evidence of
`Secondary Considerations ..................................................................... 3
`The Board Erred by Relieving Amneal of Its Burden of
`Proof for a Motivation To Combine References with a
`Reasonable Expectation of Success ...................................................... 5
`D. An Officer Nominated by the President And Confirmed by
`the Senate Must Review the Final Written Decision ............................ 8
`IV. CONCLUSION ................................................................................................ 9
`
`
`C.
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`i
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`IPR2019-00207
`Patent Owner’s Request for Director Review
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`TABLE OF AUTHORITIES
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`Page(s)
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`CASES
`Allergan, Inc. v. Sandoz Inc.,
`796 F.3d 1293 (Fed. Cir. 2015) ............................................................................ 2
`Galderma Laboratories, LP v. Tolmar, Inc.,
`737 F.3d 731 (Fed. Cir. 2013) .............................................................................. 2
`Intendis GMBH v. Glenmark Pharm. Ltd.,
`117 F. Supp. 3d 549 (D. Del. July 15, 2015), aff’d sub nom.
`Intendis GMBH v. Glenmark Pharm. Inc., 822 F.3d 1355 (Fed. Cir.
`2016) ................................................................................................................. 6, 7
`Millennium Pharms., Inc. v. Sandoz Inc.,
`862 F.3d 1356 (Fed. Cir. 2017) ............................................................................ 5
`Orexo AB, et al., v. Actavis Elizabeth LLC,
`903 F.3d 1265 (Fed. Cir. 2018) ............................................................................ 7
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) ............................................................................ 5
`United States v. Arthrex, Inc.,
`141 S. Ct. 1970 (June 21, 2021) ................................................................... 1, 8, 9
`STATUTES AND RULES
`Federal Rules of Evidence 703 .................................................................................. 5
`OTHER AUTHORITIES
`37 C.F.R. § 1.132 ................................................................................................... 4, 5
`37 C.F.R. § 42.62 ....................................................................................................... 5
`37 C.F.R. § 42.71(d) .................................................................................................. 1
`
`
`
`ii
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`IPR2019-00207
`Patent Owner’s Request for Director Review
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`I.
`
`REQUEST FOR DIRECTOR REVIEW
`Pursuant to 37 C.F.R. § 42.71(d), Patent Owner Almirall, LLC (“Patent Owner”
`
`or “Almirall”) respectfully requests review of the Patent Trial and Appeal Board’s
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`(the “Board”) Final Written Decision dated May 29, 2020 (see Paper 58) by a Director
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`of the United States Patent and Trademark Office (“Director”) that was appointed by
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`the President and confirmed by the Senate as required by United States v. Arthrex,
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`Inc., 141 S. Ct. 1970 (June 21, 2021). Almirall requests that the Director finds that
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`Petitioners have not met their burden to show that Claims 1-8 of U.S. Patent No.
`
`9,517,219 (the “’219 Patent”) are unpatentable.
`
`II. LEGAL STANDARD
`The Director reviews Final Written Decisions de novo.1
`
`III. ARGUMENT
`A. The Board Erred in Finding a Presumption of Obviousness Based
`on Overlapping Ranges in Garrett
`Compromising its entire analysis, the Board improperly found a presumption
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`of obviousness based on overlapping ranges despite acknowledging that no reference
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`disclosed a formulation with every element of those claimed in the ’219 patent. The
`
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`1 https://www.uspto.gov/patents/patent-trial-and-appeal-board/procedures/arthrex-
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`qas (A1. Q: “…The Director’s review may address any issue, including issues of
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`fact and issues of law, and will be de novo.”).
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`Patent Owner’s Request for Director Review
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`Board first held that the claims of the ’219 patent were presumptively invalid
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`because Garrett disclosed overlapping or abutting ranges for the values of each
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`component in the claimed formulations, even though Garrett does not disclose an
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`A/SA gelling agent as required by the ’219 patent. But, for the A/SA-based
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`thickener, the Board looked to Nadau-Fourcade or Bonacucina, both of which
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`disclosed “Sepineo” as an A/SA gelling agent. Then, apparently relying on Carbopol
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`and Sepineo’s supposed interchangeability, the Board swapped Sepineo for
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`Carbopol in the Garrett formulation, using Garrett’s Carbopol ranges, creating a
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`fictional prior art formulation that, in the Board’s view, a POSA could routinely
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`optimize to arrive at the compositions recited in the ’219 patent.
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`An overlapping range-based presumption of obviousness applies, if at all,
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`only when a single reference discloses the same process or formulation as claimed,
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`with ranges for certain variables that a POSA would have reason to optimize. With
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`no formulation in the prior art to optimize, there can be no ranges-based presumption
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`of obviousness. See, e.g., Galderma Laboratories, LP v. Tolmar, Inc., 737 F.3d 731,
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`736-38 (Fed. Cir. 2013); Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1304-05 (Fed.
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`Cir. 2015). If the prior art’s formulation differs from the claimed composition – as
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`it does here, significantly – then a POSA cannot possibly optimize it to arrive at the
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`claimed composition: a POSA could not optimize a range of a carbomer-based
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`thickener to arrive at a range or amount of an A/SA-based thickener.
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`IPR2019-00207
`Patent Owner’s Request for Director Review
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`The Board also appears to have ruled that presumption applies limitation-by-
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`limitation rather than to the claim as a whole, repeatedly finding that the amount for
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`a single component in the composition was presumed obvious from a range in the
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`prior art (again, from a reference that discloses a different composition). There is
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`no support in the law for what the Board did: importing a claim element (A/SA-
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`based thickener) from one reference (Nadau-Fourcade or Bonacucina) to “provide
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`the missing claimed subject matter” for purposes of a range-based obviousness
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`presumption based on a different reference (Garrett). The Board’s erroneous
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`presumption infected its entire obviousness analysis because it is impossible to find
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`where the Board’s presumption analysis under DuPont ends and its obviousness
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`analysis under KSR begins.
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`B.
`
`The Board Failed to Give Weight to Almirall’s Evidence of
`Secondary Considerations
`Despite erroneously applying a presumption of obviousness, Almirall offered
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`more than enough evidence of secondary considerations, e.g. unexpected results, to
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`rebut the presumption of obviousness, just as it did to the Examiner’s satisfaction
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`during prosecution. Thus, even if a presumption did apply, Almirall easily met its
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`burden of production. In contrast, Amneal, which retained the burden of persuasion
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`throughout, offered no data, analysis, or other actual evidence in response. Violating
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`the requirement that it consider all evidence of obviousness together before declaring
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`IPR2019-00207
`Patent Owner’s Request for Director Review
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`the claims obvious, moreover, the Board determined that the presumption applied,
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`deemed the claims obvious, and turned to evidence of unexpected results only 20 or
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`so pages later, largely in the context of an evidentiary dispute.
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`Even more the Board erroneously deemed the Warner Declaration, which was
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`evidence of unexpected results, as being waived because Dr. Warner was
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`unavailable for a deposition in which he had a 17-day notice to comply. The Board
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`punished Almirall by dismissing their expert’s, Dr. Osborne, testimony on secondary
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`considerations because Dr. Warner was never cross-examined in the IPR and
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`Dr. Osborne did not consult with Dr. Warner. That determination was made on no
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`legal authority, was arguably unconstitutional, and, as is clear from the Final Written
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`Decision, was highly prejudicial to Almirall.
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`What the Board’s Decision stands for is that, in an IPR of a patent, during the
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`prosecution, of which a 37 C.F.R. § 1.132 Declaration was submitted, that
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`Declaration – existing as part of the public file history since issuance – can have no
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`evidentiary value unless (a) the Declarant is made available for deposition in the IPR
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`proceedings, or (b) opinion testimony that the § 1.132 Declaration is evidence of
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`non-obviousness is proffered by an expert witness who has consulted with the
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`Declarant. Worse, per the Board’s Decision these requirements only operate as
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`against the patent owner, not the challenging Petitioner. Here, the “credited” expert,
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`Dr. Michniak-Kohn – on behalf of the party bearing the burden of proof, no less –
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`IPR2019-00207
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`likewise did not consult the Declarant; nor did she (or Dr. Osborne) consult the
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`authors of Garrett, of Nadau-Fourcade, of Bonacucina, or the Examiner, a co-author
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`of the file history of which the same §1.132 Declaration is a part. Where the Federal
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`Rules of Evidence are to apply in PTAB proceedings (see 37 C.F.R. § 42.62), the
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`Board here selectively treated evidence that is equally admissible under FRE 703, in
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`a manner prejudicial only to the patent owner. That was prohibitively arbitrary and
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`capricious.
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`For at least the reasons above, the Board’s failure to consider all evidence of
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`nonobviousness warrants reversal of the Board’s decision.
`
`C. The Board Erred by Relieving Amneal of Its Burden of Proof for a
`Motivation To Combine References with a Reasonable Expectation
`of Success
`Amneal must prove that the prior art suggested the selection and exact
`
`combination of the claimed formulation as a whole in the ’219 Patent with a
`
`reasonable expectation of success. “[T]he claimed invention is not obvious if a
`
`person of ordinary skill would not select and combine the prior art references to reach
`
`the claimed composition or formulation.” Unigene Labs., Inc. v. Apotex, Inc., 655
`
`F.3d 1352, 1361 (Fed. Cir. 2011); Millennium Pharms., Inc. v. Sandoz Inc., 862 F.3d
`
`1356, 1366 (Fed. Cir. 2017).
`
`The record affirmatively shows that a POSA would not have been motivated
`
`to combine Nadau-Fourcade or Bonacucina with Garrett because, among other
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`IPR2019-00207
`Patent Owner’s Request for Director Review
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`reasons, Nadau-Fourcade and Bonacucina concerned unrelated problems in different
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`fields from that of Garrett; the formulations in Nadau-Fourcade and Bonacucina are
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`antithetical to those in Garrett; neither Nadau-Fourcade nor Bonacucina so much as
`
`mention dapsone; neither Nadau-Fourcade nor Bonacucina teach an A/SA-based
`
`thickener’s compatibility with dapsone, DGME, and methyl paraben, let alone at the
`
`claimed concentrations, all of which are critical to the success of a pharmaceutical
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`composition “treating a dermatological condition.” In the highly unpredictable
`
`pharmaceutical formulation arts, any one of these differences disqualifies Nadau-
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`Fourcade and Bonacucina as references to combine with Garrett.
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`Instead of properly finding a motivation to combine prior art references, the
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`Board found a motivation based on the supposed interchangeability of Carbopol and
`
`Sepineo, stating substitution from one reference into another was “routine and
`
`predictable” because “such thickening agents were known for use in topical
`
`compositions with water insoluble drugs.” See Paper 58 at 39-40; see also Intendis
`
`GMBH v. Glenmark Pharm. Ltd., 117 F. Supp. 3d 549, 590 (D. Del. July 15, 2015),
`
`aff’d sub nom. Intendis GMBH v. Glenmark Pharm. Inc., 822 F.3d 1355 (Fed. Cir.
`
`2016) (“[D]efendants have not carried their burden to demonstrate a reasonable
`
`expectation of success in making the combination. Contrary to defendants’
`
`representation, Dr. Michniak-Kohn never testified as to the ‘routine nature of
`
`optimizing a formulation,’ but instead provided pointed testimony regarding
`
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`IPR2019-00207
`Patent Owner’s Request for Director Review
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`swapping particular excipients in two specific combinations… that excipients and the
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`active ingredient react differently depending on the formulation… leads the court to
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`understand that swapping ingredients in complex chemical formulations is anything
`
`but ‘routine.’); Orexo AB, et al., v. Actavis Elizabeth LLC, 903 F.3d 1265, 1273 (Fed.
`
`Cir. 2018) (“The question is not whether the various references separately taught
`
`components of the [claimed] formulation, but whether the prior art suggested the
`
`selection and combination achieved by [the claimed invention].”). The Intendis case
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`is almost identical to this case in that Glenmark’s expert, Dr. Michniak-Kohn (also
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`Petitioners’ expert here), never testified about a motivation to combine but instead
`
`argued, albeit unsuccessfully, the interchangeability of excipients. There is no
`
`authority supporting that a motivation to combine one prior art reference with another
`
`can be established by reason of alleged “interchangeability” between a claim element
`
`and corresponding unclaimed element in the prior art.
`
`Orexo and Intendis clearly hold that it is not enough for an excipient to be
`
`known, the prior art must teach that the excipient can be combined with the claimed
`
`formulation as-a-whole with a reasonable expectation of success. In this case,
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`Petitioners must prove that the prior art taught a PVB comprising A/SA at the
`
`claimed concentration would be compatible with the claimed invention as-a-whole
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`(e.g., compatible with dapsone, diethylene glycol monoethyl ether [DGME], and
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`methyl paraben at the claimed concentrations). Petitioners’ own expert even affirms
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`7
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`that a person of ordinary skill’s (“POSA”) expectation of success depends on the
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`gelling agent and specific formulation. See Ex. 2063 at 172:19–173:8 (“Again, all
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`of them are classified as gelling agents, but they may not all be interchangeable for
`
`all kinds of reasons, depending on what formulation of dapsone I am using.”). The
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`PVB’s interaction with the claimed formulation as-a-whole could significantly
`
`impact the viscosity, stability (chemical and physical), patient tolerability, adverse
`
`events, permeation rate, excipient compatibility, crystallization, particle size, etc.
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`See Ex. 2057 ¶¶ 63, 67.
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`The Board’s failure to explicitly articulate the affirmative evidence for a
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`motivation to combine the asserted prior art with a reasonable success is legal error,
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`for which alone this Court should reverse the Board’s decision.
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`D. An Officer Nominated by the President And Confirmed by the
`Senate Must Review the Final Written Decision
`The USPTO currently does not have a Director or Acting Director that was
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`nominated by the President and confirmed by the Senate. Arthrex reaffirmed that
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`“the exercise of executive power by inferior officers must at some level be subject
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`to the direction and supervision of an officer nominated by the President and
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`confirmed by the Senate.” Arthrex, 141 S. Ct. at 1988. Currently, Drew Hirshfeld
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`is “performing the functions and duties of the Under Secretary of Commerce for
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`Intellectual Property and Director of the United States Patent and Trademark Office
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`IPR2019-00207
`Patent Owner’s Request for Director Review
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`(USPTO).” See, e.g., IPR2020-00081, Paper 39 (August 2, 2021 P.T.A.B.)
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`(Mr. Hirshfeld denying request for Director review). Like the Administrative Patent
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`Judges (APJs) who issued the Final Written Decision, Mr. Hirshfeld was appointed
`
`by the Secretary of Commerce, not the President. Because Mr. Hirshfeld was not
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`appointed by the President and confirmed by the Senate to perform those duties, his
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`review of a Final Written Decision would be an unlawful exercise of executive
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`authority by an officer not appointed by the President and confirmed by the Senate.
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`That was the exact constitutional defect Arthrex sought to cure. A review by an
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`officer not appointed by the President or confirmed by the Senate would only repeat
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`the unconstitutional decisions made at first instance by the APJs. For at least those
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`reasons, as required by Arthrex, Patent Owner requests a review from a Director that
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`has been appointed by the President and confirmed by the Senate.
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`IV. CONCLUSION
`For the reasons above, Patent Owner respectfully requests that the Director
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`holds that Petitioners did not meet their burden to prove Claims 1-8 of the ’219
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`Patent are unpatentable. Under Arthrex, Mr. Hirshfeld cannot review the Board’s
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`Final Written Decision because “[o]nly an officer properly appointed to a principal
`
`office may issue a final decision binding the Executive Branch…” United States v.
`
`Arthrex, Inc., 141 S. Ct. 1970 (June 21, 2021). Or, in the alternative, Patent Owner
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`requests supplemental briefing on the issues raised above.
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`9
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`IPR2019-00207
`Patent Owner’s Request for Director Review
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`Dated: August 27, 2021
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`
`Respectfully submitted,
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`FENWICK & WEST LLP
`
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`
`Attorney for Patent Owner
`Almirall, LLC
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on August 27, 2021, the
`
`foregoing PATENT OWNER’S REQUEST FOR DIRECTOR REVIEW PURSUANT TO
`
`ARTHREX was served by electronic mail on the following counsel of record for
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`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
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`Additionally, I hereby certify that on August 27, 2021, the foregoing PATENT
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`OWNER’S REQUEST FOR DIRECTOR REVIEW PURSUANT TO ARTHREX was served
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`by electronic mail on the Patent Trial and Appeal Board Director at the following
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`email address: Director_PTABDecision_Review@uspto.gov
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`Dated: August 27, 2021
`
`FENWICK & WEST LLP
`
`
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`Attorney for Patent Owner
`Almirall, LLC
`
`
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`11
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