Trials@uspto.gov
`Tel. 571-272-7822
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`Paper 18
`Entered: March 5, 2018
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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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`MONOSOL RX, LLC,
`Petitioner,
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`v.
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`ICOS CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2017-00412
`Patent 6,943,166 B1
`_______________
`
`
`Before SHERIDAN K. SNEDDEN, SUSAN L. C. MITCHELL, and
`ZHENYU YANG, Administrative Patent Judges.
`
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`YANG, Administrative Patent Judge.
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`
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`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
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`

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`IPR2017-00412
`Patent 6,943,166 B1
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`INTRODUCTION
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`I.
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`MonoSol Rx, LLC (“Petitioner”) filed a Petition for an inter partes
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`review of claims 112 of U.S. Patent No. 6,943,166 B1 (Ex. 1001, “the
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`’166 patent”). Paper 4 (“Pet.”). We denied the Petition. Paper 11 (“Dec.”).
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`Petitioner filed a request for rehearing of the Decision. Paper 12 (“Reh’g
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`Req.”). With our authorization, ICOS Corporation (“Patent Owner”) filed
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`an opposition to the request for rehearing (Paper 14), and Petitioner filed a
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`reply (Paper 15 (“Reply”)).
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`For the following reasons, we deny Petitioner’s request.
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`II.
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`STANDARD OF REVIEW
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`When rehearing a decision on institution, the Board reviews the
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`decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of
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`discretion occurs when a “decision was based on an erroneous conclusion of
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`law or clearly erroneous factual findings, or . . . a clear error of judgment.”
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`PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567
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`(Fed. Cir. 1988) (citations omitted). The request must identify, specifically,
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`all matters the party believes the Board misapprehended or overlooked.
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`37 C.F.R. § 42.71(d).
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`III. DISCUSSION
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`Claim 1 of the ’166 patent is directed to a method of treating sexual
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`dysfunction comprising “orally administering one or more unit dose
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`containing about 1 to about 20 mg, up to a maximum total dose of 20 mg per
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`day,” of tadalafil. In our Decision denying the Petition, we declined to
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`institute inter partes review of the challenged claims as obvious over the
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`teachings of Daugan, (1) alone, (2) in combination with the Guideline for
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`Industry, or (3) in combination with the FDA Petition. Dec. 7–11.
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`2
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`IPR2017-00412
`Patent 6,943,166 B1
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`In its rehearing request, Petitioner argues that (1) we overlooked the
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`Declaration of Dr. Roger Williams (Ex. 1010), “which provides clear
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`guidance as to the form of the claimed invention and how a person of
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`ordinary skill would achieve the claimed dose;” (2) our “factual findings
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`with respect to the FDA petition and admitted prior art were not supported
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`by substantial evidence;” and (3) “institution would be consistent with the
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`Board’s prior decision in IPR2017-00323, which relied on the same
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`evidence that Dr. Williams analyzed and that Petitioner had submitted in this
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`Request.” Reh’g Req. 1–2. We are not persuaded.
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`As a preliminary matter, we note the Petition improperly incorporates
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`by reference a large amount of the Williams Declaration. For example,
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`Petitioner argues that “a POSA would only need routine optimization to find
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`that 1 to about 20 mg, up to a maximum total dose of 20 mg per day would
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`be obvious even in view of Daugan ‘675 alone.” Pet. 9. As support, the
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`Petition cites to 26 paragraphs and over 20 pages of the Williams
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`Declaration. Id. (citing Ex. 1010, ¶¶ 105, 131–155). Merely a paragraph
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`later, still on page 9 of the Petition, Petitioner contends that “[t]o the extent
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`it was not obvious based on Daugan ‘675 alone, it would have been obvious
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`to a POSA to optimize the dose range to minimize adverse side effects while
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`maintaining pharmaceutical efficacy, as was typical for the pharmaceutical
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`industry.” Id. As support, the Petition cites to another over 30 paragraphs of
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`the Williams Declaration. Id. (citing Ex. 1010, ¶¶ 158–188). By
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`incorporating nearly 60 paragraphs of the Williams Declaration into one
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`page of the Petition, Petitioner circumvents the page/word number limits.
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`Our Rules do not permit this practice. See 37 C.F.R. § 42. 6(3) (“Arguments
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`3
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`IPR2017-00412
`Patent 6,943,166 B1
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`must not be incorporated by reference from one document into another
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`document.”); § 42.24 (providing page/word number limits for the papers).
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`Nevertheless, we did not, as Petitioner asserts, overlook the Williams
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`Declaration. After all, Petitioner presents the Williams Declaration to
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`support its arguments, which we addressed. See Dec. 8 (discussing the
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`“routine optimization” argument), 9 (discussing the argument regarding
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`optimizing the dose range to minimize adverse side effects while
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`maintaining pharmaceutical efficacy). If we had not considered nearly 60
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`paragraphs of the Williams Declaration as supporting evidence, we would
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`have dismissed those contentions as unsupported attorney arguments. In
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`other words, not explicitly citing the Williams Declaration at every turn in
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`the Decision does not suggest we overlooked it.1
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`Petitioner, in its rehearing request, also alleges that we overlooked the
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`FDA Petition in view of admitted prior art. Reh’g Req. 10–11. According
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`to Petitioner, we failed to account for the similarities between tadalafil and
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`sildenafil, and tadalafil’s higher potency than sildenafil. Id. at 10–12. We
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`disagree. In the Decision, we cited, in length, the disclosures of the FDA
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`Petition (Dec. 7), and summarized it as addressing the side effects of
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`1 In our Decision, we stated that “a claimed invention is not shown to be
`unpatentable where ‘the prior art gave only general guidance as to the particular
`form of the claimed invention or how to achieve it.’” Dec. 9 (citing In re
`O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988)). Petitioner appears to contend that
`it is erroneous, or at least improper, that we cited In re O’Farrell because that case
`was from “1988, when [obvious to try] was still ‘improper grounds for a § 103
`rejection.’” See Reply 1. We disagree. As discussed in a 2009, a post-KSR
`decision, In re O’Farrell clarifies the meaning of obvious to try and differentiates
`between proper and improper applications of obvious to try. In re Kubin, 561 F.3d
`1351, 1359 (Fed. Cir. 2009) (stating KSR “actually resurrects [the Federal
`Circuit]’s own wisdom in In re O’Farrell”).
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`4
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`IPR2017-00412
`Patent 6,943,166 B1
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`sildenafil (id. at 9). We addressed Petitioner’s argument that “in view of the
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`FDA Petition, an ordinary artisan ‘would have known that based on the
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`market pressure to compete with sildenafil, a drug manufacturer would have
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`to market a drug that had the same or better efficacy, and in a dose that
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`maintained efficacy but that also minimized adverse effects.’” Id. (citing
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`Pet. 25) (emphasis added). We, however, found Petitioner’s argument
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`unpersuasive because the FDA Petition only provided “general guidance” to
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`identify a maximum daily dosage of tadalafil. Id. Petitioner may disagree
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`with our analysis; that, however, does not mean we overlooked the evidence.
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`Petitioner is correct that we previously instituted trial in
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`IPR2017-00323. Mylan Pharmaceuticals Inc. v. ICOS Corp., IPR2017-
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`00323 (“Mylan IPR”) (PTAB June 12, 2017) (Paper 12). Petitioner is also
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`correct that Dr. Williams analyzed the prior art asserted in Mylan IPR.2
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`Reh’g Req. 12–13. Evidence of the record in the two cases, however, is not
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`the same. As we explained in Mylan IPR,
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`Petitioner points to SNDA for teaching that sildenafil is
`therapeutically effective in treating ED at doses as low as 5 mg
`and as high as 100 mg. Id. at 36 (citing Ex. 1008, 126–28).
`Citing the testimony of Dr. Grass, Petitioner argues that “these
`doses, adjusted for the increased potency of tadalafil, are
`expected to be approximately equivalent to tadalafil doses of
`2.8 mg and 57 mg, respectively.” Id. (citing Ex. 1002 ¶ 79); see
`also Ex. 1002 ¶ 77 (calculating the predicted doses of tadalafil
`based on the doses of sildenafil and the ratio of IC50 values).
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`Petitioner emphasizes the teaching of SNDA that a dose of 25 mg
`sildenafil “is already fairly high on the dose-response curve.”
`Pet. 37 (citing Ex. 1008, 70). According to Petitioner, 25 mg of
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`2 Petitioner in this case, however, challenges claims 1–12 of the ’166 based on
`grounds different from the one asserted in the Mylan IPR. Compare Pet. 6–7 with
`Mylan IPR, Paper 2, 27.
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`5
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`IPR2017-00412
`Patent 6,943,166 B1
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`sildenafil is approximately equivalent to 15 mg of tadalafil. Id.
`(citing Ex. 1002 ¶¶ 77–78). Relying on the testimony of
`Dr. Grass, Petitioner contends that an ordinary artisan “would
`have reasonably expected a 15 mg dose of tadalafil to be near the
`top of the tadalafil dose-response curve based on the PDE5
`inhibition results disclosed” in the SNDA. Id. (citing Ex. 1002
`¶ 78).
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`Mylan IPR, Paper 12, 13.
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`In Mylan IPR, the expert testimony provided detailed analysis of the
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`tadalafil dosage. Petitioner in this case does not refer us to such evidence.
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`Thus, we see no inconsistency in our disposition of the two cases.
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`In sum, in the Petition, Petitioner did not establish a reasonable
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`likelihood that it would prevail in showing the unpatentability of the
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`challenged claims. On rehearing, we see no error in our findings of fact or
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`conclusions of law. Thus, we conclude that Petitioner has not demonstrated
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`that we abused our discretion in denying institution of the challenged claims.
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`IV. ORDER
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`Accordingly, it is
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`ORDERED that Petitioner’s request for rehearing is denied.
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`6
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`IPR2017-00412
`Patent 6,943,166 B1
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`PETITIONER:
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`Harold Fox
`hfox@steptoe.com
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`Gretchen Miller
`gmiller@steptoe.com
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`PATENT OWNER:
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`Mark Feldstein
`mark.feldstein@finnegan.com
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`Joshua Goldberg
`joshua.goldberg@finnegan.com
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`Yieyie Yang
`yieyie.yang@finnegan.com
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`Maureen Queler
`maureen.queler@finnegan.com
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`Mark Stewart
`stewart_mark@lilly.com
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`Dan Wood
`wood_dan_l@lilly.com
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`7
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