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`IPR2017-00412
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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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`_______________
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`MONOSOL RX, LLC
`Petitioner
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`v.
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`ICOS CORPORATION,
`Patent Owner
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`_______________
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`Case: IPR2017-00412
`Patent 6,943,166 B1
`_______________
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`PETITIONER MONOSOL RX, LLC’S REQUEST FOR REHEARING
`37 C.F.R. § 42.71
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`IPR2017-00412
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`TABLE OF CONTENTS
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`Table of Contents ....................................................................................................... i
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`Introduction ................................................................................................................ 1
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`Standard Of Review ................................................................................................... 2
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`Argument.................................................................................................................... 3
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`I. The Board Overlooked the Expert Declaration of Dr. Roger Williams in
`Analyzing the Prior Art. ...................................................................................... 3
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`II. The Board Misapprehended the Prior Art’s Teachings Including the FDA
`Petition and Admitted Prior Art ........................................................................ 10
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`III. Institution Would Be Consistent with the Board’s Prior Decision ................... 12
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`Conclusion ............................................................................................................... 13
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`i
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`IPR2017-00412
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`TABLE OF AUTHORITIES
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`CASES
`Blue Coat Systems, Inc. v. Finjan Inc.,
`IPR2016-01444, Paper 11 (P.T.A.B. July 18, 2017) ............................................ 2
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`Page(s)
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`Hoffmann-La Roche Inc. v. Apotex Inc.,
`No. 2013-1128 (April 11, 2014) ........................................................................... 8
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`Merial Ltd. v. Virbac,
`IPR2014-01279, Paper 18 (P.T.A.B. Apr. 15, 2015) ....................................... 2, 7
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`CODE OF FEDERAL REGULATIONS
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`37 C.F.R. § 42.71(c) ............................................................................................... 2, 7
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`37 C.F.R. § 42.71(d) .............................................................................................. 1, 2
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`37 C.F.R. § 42.108 ..................................................................................................... 1
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`ii
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`IPR2017-00412
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`INTRODUCTION
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`MonoSol Rx, LLC (“Petitioner”), by this motion under 37 C.F.R. § 42.71(d),
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`respectfully requests rehearing of the Board’s Decision Denying Institution of Inter
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`Partes Review 37 C.F.R. § 42.108 (Paper No. 11, Entered July 3, 2017)
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`(hereinafter “Decision”). Claims 1-12 of the patent at issue, U.S. Patent No.
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`6,943,166 (“the ‘166 patent”), relate to methods of administering a known
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`compound, tadalafil, in a dose range that was taught in the prior art. Claim 1, the
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`only independent claim, includes the dose limitations of “about 1 to about 20 mg,
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`up to a maximum total dose of 20 mg per day.”
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`In denying institution of the IPR, the Board stated that even though in the
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`pharmaceutical field an ordinary artisan would strive to optimize a drug dose to
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`minimize adverse side effects while maintaining efficacy, “a claimed invention is
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`not shown to be unpatentable where ‘the prior art gave only general guidance as to
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`the particular form of the claimed invention or how to achieve it.’” Decision, p. 9
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`(internal citations omitted). However, as explained below, the Decision not to
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`institute this IPR should be modified because: (I) the Board overlooked the Expert
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`Declaration of Dr. Roger Williams (Ex. 1010), which provides clear guidance as to
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`the form of the claimed invention and how a person of ordinary skill would
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`achieve the claimed dose; (II) the Board’s factual findings with respect to the FDA
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`petition and admitted prior art were not supported by substantial evidence; and (III)
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`institution would be consistent with the Board’s prior decision in IPR2017-00323,
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`which relied on the same evidence that Dr. Williams analyzed and that Petitioner
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`had submitted in this Request. For these reasons, as explained below, Petitioner
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`asks that the Board revisit its decision not to institute trial.
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`STANDARD OF REVIEW
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`Requests for rehearing are governed by 37 C.F.R. § 42.71(d), which
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`provides in pertinent part:
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`A party dissatisfied with a decision may file a single request for re-
`hearing without prior authorization from the Board. The burden of
`showing a decision should be modified lies with the party challenging
`the decision. The request must specifically identify all matters the
`party believes the Board misapprehended or overlooked, and the place
`where each matter was previously addressed in a motion, an
`opposition, or a reply.
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`Id. When rehearing a decision on petition, a panel reviews the decision for an
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`abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when the
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`Board has misapprehended or overlooked a significant fact. See Merial Ltd. v.
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`Virbac, IPR2014-01279, Paper 18 at 8 (P.T.A.B. Apr. 15, 2015) (“[W]hen we
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`recognize that we have misapprehended or overlooked a significant fact, the
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`necessary abuse of discretion required by Rule 42.71(c) has been established.”) A
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`request for rehearing is granted when a Petitioner demonstrates a reasonable
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`likelihood of prevailing on its challenge. See Blue Coat Systems, Inc. v. Finjan
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`Inc., IPR2016-01444, Paper 11 (P.T.A.B. July 18, 2017) (granting request for
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`IPR2017-00412
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`rehearing when Board found that insufficient consideration was given to
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`Petitioner’s previous assertions).
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`ARGUMENT
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`I.
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`The Board Overlooked the Expert Declaration of Dr. Roger Williams in
`Analyzing the Prior Art.
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`The Board overlooked the Expert Declaration of Dr. Roger Williams (Ex.
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`1010), and failed to address this declaration entirely in its analysis. This 75-page
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`declaration, which contained a thorough analysis of the ‘166 patent, its prosecution
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`history, the prior art, and design need and market pressure, was a critical piece of
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`evidence in Petitioner’s patentability challenge.
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`Petitioner’s first ground of unpatentability was obviousness over Daugan1
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`and The Guideline for Industry2. Petitioner argued in view of Post-KSR law,
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`Daugan in view of the Guideline for Industry would have taught a person of
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`ordinary skill (such as Dr. Williams) that it would have been obvious to orally
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`administer tadalafil (a known compound) in one or more unit doses containing
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`about 1 to about 20 mg, up to a maximum total dose of 20 mg per day. Petition, pp.
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`7-13. Petitioner specifically cited the “market pressure to compete with Viagra®
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`and the design need to avoid side effects of the claimed drug” citing the ‘166
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`patent and Dr. Williams’s Declaration. Petition at 10. Dr. Williams opined,
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`1 WO 97/03675, published Feb. 6, 1997 (Ex. 1005) (“Daugan”).
`2 The Guideline for Industry, Dose Response Information to Support Drug
`Registration, published November 9, 1994 (Ex. 1014) (“Guideline for Industry”).
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`3
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`“Based on the prior art, a POSA could readily identify a reasonable starting dose at
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`50 mg, for example, and design ‘reasonable, response guided titration steps’ to
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`titrate the dose down to a maximum of maximum total dose of 20 mg per day.” Ex.
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`1010, ¶¶ 166. He reasoned that given the need for fewer side effects and a “finite
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`number of identified, predictable solutions (a beginning range of 0.2-400 mg, or 50
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`mg), it would have been obvious to try about 1 to about 20 mg unit dosage forms
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`as needed, up to a maximum total dose of 20 mg per day”. Ex. 1010, ¶ 167.
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`Despite noting that Petitioner was relying on the Declaration of Dr. Williams
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`(Decision at p. 4), the Board never addressed this Declaration in its analysis.
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`Instead, the Board mistakenly concluded that:
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`The Guideline for Industry teaches developing dose-response information to
`support drug registration … [but] teachings of the asserted prior art, at best,
`provide “general guidance” to identify a maximum daily dosage of tadalafil.
`Petitioner does not point to any other persuasive evidence to account for the
`claimed limitation. Instead, Petitioner relies on “common sense.”
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`Decision at p. 9.
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`This is not accurate. The teachings of the prior art, as laid out in detail in
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`Dr. Williams’s Declaration, provided much more than “general guidance,” and
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`there was ample “other persuasive evidence” to account for the claimed limitation.
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`Dr. Williams provided a thorough discussion of the Guideline for Industry along
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`with the ‘166 patent claims, the ‘166 patent’s prosecution history, a discussion of
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`known phosphodiesterase (PDE)-5 inhibitors including sildenafil (Viagra®), the
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`IPR2017-00412
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`known problems of Viagra®, and other prior art teachings including Daugan, and
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`Cutler3. See Ex. 1010, ¶¶ 122-202.
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`A. Dr. Williams Explained that Tadalafil is Similar to Sildenafil, but
`More Potent.
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`Dr. Williams explained that before the critical date of April 30, 1999,
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`tadalafil, like sildenafil, was a PDE5(phosphodiesterase-5) inhibitor known to be
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`effective at treating erectile dysfunction, and both were known to be administered
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`orally. See Ex. 1010, ¶¶ 22-23. He explained that both sildenafil and tadalafil
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`share a common mechanism of action and are only pharmacologically active when
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`cGMP synthesis is activated. Ex. 1010, ¶¶ 20-21. He further explained that PDE
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`potency is commonly expressed as IC50, the concentration required to reduce the
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`activity of the tested PDE by 50%. Ex. 1010, ¶ 22. Typically, a lower IC50 value
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`means a higher potency of the inhibitory agent. Sildenafil was known to have an
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`IC50 between 3.5–3.9 nM. Ex. 1010, ¶ 22. Tadalafil, was known to have an IC50
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`of 2 nM. See Ex. 1010, ¶¶ 22-23; see also Petition at 33-34.
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`Dr. Williams explained that a POSA would recognize that if Cialis 5 mg to
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`10 mg was comparable to Viagra® 50 -100mg®, then it is common sense and/or
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`mere optimization for a POSA to arrive at the conclusion that Cialis® could be
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`provided in 5, 10 and 20 mg doses to compete with Viagra’s 25, 50 and 100 mg per
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`3 Cutler, et al., Defining the Maximum Tolerated Dose: Investigator, Academic,
`Industry and Regulatory Perspectives, J. Clin. Pharmacol. 1997; 37:767-783
`(“Defining the Maximum Tolerated Dose”).
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`day dosing. See Ex. 1010, ¶¶ 185. Specifically, Dr. Williams opined that a POSA
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`would know that the adverse event profiles generated by early clinical studies can
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`be used to construct the pharmacodynamic models of the dose-response curve for
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`PDE5 inhibitors including tadalafil. Ex. 1010, ¶ 134. Given tadalafil’s known
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`potency and the finite dose range taught in the prior art of 0.2-400 mg (with a 50
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`mg example), the design need to maintain efficacy, minimize side effects, and the
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`market pressure to compete with sildenafil and obtain FDA approval, a POSA
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`would be motivated to use the “lower” doses up to a maximum total dose of 20 mg
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`per day. Ex. 1010, ¶¶ 134-146, 185-186.
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`B. Dr. Williams Established that Known Adverse Effects of PDE5
`Inhibitors Provide Guidance to Lower Dose of Tadalafil
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`Dr. Williams also explained that, as acknowledged in the ‘166 patent, prior
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`to the critical date of April 30, 1999, it was widely known that the use of sildenafil
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`in patients taking organic nitrates caused “a clinically significant drop in blood
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`pressure which could place the patient in danger.” Ex. 1001 (‘166 patent), col. 1,
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`line 66- col. 2, line 1; Ex. 1010, ¶¶ 25, 117-120. Dr. Williams opined that since
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`tadalafil is chemically similar to sildenafil, and also known to be used for treating
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`sexual dysfunction, a POSA would recognize that similar side effects would be
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`expected. Ex. 1010, ¶ 120. He also opined that there was a recognized market
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`need for drug similar to Viagra® that would safer, and effective at lower doses,
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`specifically below 50 mg. Ex. 1010, ¶ 121.
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`Dr. Williams explained that given tadalafil’s known potency as shown in its
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`IC50 value, the finite dose range taught in the prior art of 0.2-400 mg, a 50 mg
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`example, the design need to maintain efficacy and minimize side effects, the
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`market pressure to compete with sildenafil (Viagra®), and the desire to obtain
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`FDA approval, a POSA would therefore be motivated to use a therapeutic dose
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`range that would minimize side effects, and hence, lower the dose up to a
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`maximum total dose of 20 mg per day. Ex. 1010, ¶ 167, 187-202.
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`The prior art, and particularly Daugan in view of the Guideline for Industry,
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`establish that the dose range claimed by Patent Owner would have been obvious as
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`explained in the Expert Declaration of Dr. Williams. Petition, pp. 7-23. Petitioner
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`submits that the Board did not fully apprehend the Daugan in view of the Guideline
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`for Industry proposed combination, leading to a Decision not supported by
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`substantial evidence. See Merial Ltd., IPR2014-01279, Paper 18 at 8 (P.T.A.B.
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`Apr. 15, 2015) (“[W]hen we recognize that we have misapprehended or
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`overlooked a significant fact, the necessary abuse of discretion required by Rule
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`42.71(c) has been established.”) Therefore, the Decision not to institute inter
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`partes review should be modified.
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`C. Dr. Williams Opined on the Purported Unexpected Results of the
`‘166 Patent
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`The patent examiner’s reasons for allowing the ‘166 patent depended on the
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`claimed dose range achieving purported “unexpected results.” See Ex. 1009, Pros.
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`History, Examiner’s Reasons for Allowance. However, the Board overlooked Dr.
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`Williams’ opinions and Petitioner’s argument on this critical point.
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`Dr. Williams opined that given tadalafil’s known potency, and the finite
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`range to optimize, as taught in Daugan ‘675, the claimed dose range is not
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`“unexpected” but an obvious result of routine testing or optimization for tadalafil’s
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`lowest effective dose. Ex. 1010, ¶ 194. In view of this, Petitioner argued that in
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`granting the ‘166 patent, the Examiner was necessarily applying the obviousness
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`standards at that time (before the 2007 seminal KSR case), which required an
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`express teaching, suggestion, or motivation to arrive at the claimed dose range.
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`While that reasoning was applicable at that time, it is no longer applicable under
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`the post-KSR legal standards. Petition at 44. Under the current legal standards for
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`obviousness, the claimed daily dose range (maximum total dose of 20 mg) is part
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`of a finite range already disclosed in the art (0.2-400 mg, and a 50 mg example),
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`and it would be obvious to optimize, specifically given the knowledge of the
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`POSA and the industry guidance discussed herein.
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`As Petitioners argued, the Federal Circuit has in recent years, established
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`that evidence supporting superior efficacy at a specific claimed dose “does
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`nothing to undercut the showing that there was a reasonable expectation of success
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`even if the level of success may have turned out to be somewhat greater than
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`would have been expected.” Hoffmann-La Roche Inc. v. Apotex Inc., No. 2013-
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`1128 (April 11, 2014). In that case, the Federal Circuit held that a 150 mg monthly
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`dose, as compared to a 2.5 mg daily dose, with improved efficacy, does not rebut
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`the strong showing that the prior art disclosed monthly dosing and that there was a
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`reason to set that dose at 150 mg. This case is particularly applicable here. The
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`prosecution history of the ‘166 patent shows that the patent was allowed only due
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`to perceived “unexpected results” in the claimed dose range. Ex. 1009, Pros.
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`History, Reasons for Allowance. Under post-KSR law, the specific dose range need
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`not be expressly found in the prior art. Rather, (as explained by Dr. Williams) a
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`POSA can optimize a dose range to minimize adverse side effects while
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`maintaining pharmaceutical efficacy. Ex. 1010, ¶¶ 158-188.
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`However, the Board did not address this argument, and indeed, did not
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`address the prosecution history at all and the admitted prior art in the ‘166 patent.
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`The ’166 patent sought to address the known problems of sildenafil including side
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`effects, including vision abnormalities, hypotension, and, most significantly,
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`hypotension in individuals who also use organic nitrates. Ex. 1001, col. 2, lines 61-
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`64. To solve these well-known problems, the applicants for the ’166 patent
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`provided a well-known solution: tadalafil, a known compound, known to be orally
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`administered in doses from 0.2-400 mg in a daily dose (with a 50 mg example),
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`without “significant adverse side effects.” Id. at col. 2, lines 12-21. Ex. 1010, ¶¶
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`50-51.
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`IPR2017-00412
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`II. The Board Misapprehended the Prior Art’s Teachings Including the
`FDA Petition and Admitted Prior Art
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`In addition to overlooking the Declaration of Dr. Williams, the Board also
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`overlooked the FDA petition in view of admitted prior art under currently
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`applicable law.4 The Board completely failed to account for the admitted
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`similarities between sildenafil and tadalafil, the adverse effects of this class of
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`drugs and consequently, why a lower dose would be obvious to try.
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`A. Admitted Similarities of Sildenafil and Tadalafil
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`The ‘166 patent acknowledges that it was already known that tadalafil was
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`pharmacologically similar to sildenafil, and both were PDE5 inhibitors that were
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`known to treat sexual dysfunction. Ex. 1001, col. 1, lines 58- col. 2, line 21. The
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`‘166 patent also admits that it was known that certain side effects limited
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`sildenafil’s use in certain individuals. Ex. 1001, col. 1, lines 58- 65. The ‘166
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`patent also admits that tadalafil did not have apparent “significant side effects”
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`when orally administered in doses of 0.2-400 mg. Id.
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`Petitioner had previously submitted (in Ground 2) that in view of the FDA
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`4 The Board discounted Exs. 1018 and 1019 as not shown to be publicly accessible
`before April 1999. Decision at 11. While Petitioner respectfully disagrees, these
`documents were not the only documents relied upon. Moreover, Dr. Williams
`opined that a POSA could have requested and obtained the documents. Ex. 1010,
`¶175-176.
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`Petition5, an ordinary artisan “would have known that based on the market pressure
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`to compete with sildenafil, a drug manufacturer would have to market a drug that
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`had the same or better efficacy, and in a dose that maintained efficacy but that also
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`minimized adverse effects.” Petition at 23-24. However, in its analysis, the Board
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`failed to consider the FDA Petition in the context of the prior art. Indeed, the only
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`reference to the FDA Petition was when the Board stated that the “FDA Petition
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`merely addresses the side effects of sildenafil.” Decision at 9.
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`In analyzing the maximum daily dosage of tadalafil, the Board failed to
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`consider the prior art’s specific examples of 50 mg doses of tadalafil (Daugan) and
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`the known adverse effects of PDE5 inhibitors discussed above, as viewed through
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`the lens of a POSA under currently applicable law.
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`B. Finite Dose Range to Optimize
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`Petitioner submitted and Dr. Williams opined that at the very least, given the
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`finite size of the dose range disclosed in the prior art (0.2-400 mg of orally
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`administered tadalafil, including a specific 50 mg example), the claimed range of
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`“about 1 to about 20 mg, up to a maximum total dose of 20 mg per day” would
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`have been obvious to try. Ex. 1010, ¶¶ 158-167; Petition at 22.
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`In sum, even if the Board contends that the FDA Petition “merely addresses
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`5 Public letter from Sidney M. Wolfe, M.D., Larry Sasich, Pharm. D., M.P.H., and
`Elizabeth Barbehenn, Ph.D. to Lead Deputy Commissioner for the FDA to petition
`FDA to change the labeling to warn regarding dangers of sildenafil. Ex. 1015.
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`the side effects of sildenafil” (Decision at 9), a POSA would have been motivated
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`to optimize the dose of tadalafil to achieve an effective but safe range based on the
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`similar nature of sildenafil and tadalafil, and the need for a minimally effective
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`dose. Given the finite dose range (with a 50 mg example for tadalafil), and the
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`knowledge that tadalafil was more potent than sildenafil (based on the IC50 as
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`discussed above), the specific claimed dose range would have been obvious to try.
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`The Decision misapprehends the FDA Petition by not considering it in view of the
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`totality of the prior art, and does not address the obvious to try argument at all.
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`III.
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`Institution Would Be Consistent with the Board’s Prior Related
`Decision
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`The Board recently decided to institute Inter Partes Review in IPR2017-
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`00323 (“Mylan Petition”) which involves the same ‘166 patent (Paper 12, June 12,
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`2017). In that Decision, the Board found that:
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`• Daugan teaches that tadalafil is useful for treating male or female
`sexual dysfunction, and that it may be administered orally to treat
`erectile dysfunction in individual tablets or capsules contain from 0.2-
`400mg of active compound, and also “teaches preparing tablets with
`50 mg active compound.” Daugan at 12:15-14:16.
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`
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`• The Approval Package for VIAGRA® (“SDNA”) teaches that
`sildenafil is therapeutically effective for treating ED at doses of 25,
`50, and 100 mg and in some patients, doses as low as 5 and 10 mg are
`therapeutically effective over placebo.6
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`6 The Board found that there was no direct evidence that SDNA was publicly
`available on March 27, 1998, but found an ordinary artisan could have requested
`and obtained the documents. The same logic applies here based on the Expert
`Declaration of Dr. Roger Williams (Ex. 1010) (see Fn 4, infra).
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`12
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`• The FDA Guideline “describes why dose-response information is
`useful and how it should be obtained in the course of drug
`development.”
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`Paper 12 at 6-7.
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`The Petitioner in that case (Mylan) argued that based on the unit doses of
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`sildenafil and the ratio of IC50 values, it was a routine matter for a person of
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`ordinary skill in the art to identify a safe and effective dose range of tadalafil for
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`the treatment of sexual dysfunction. Id. at 12. The Board agreed that there was
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`sufficient evidence to institute inter partes review.
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`In the instant case, Petitioner MonoSol also submitted and relied upon the
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`exact same evidence: (1) Daugan (submitted as Petitioner’s Ex. 1005): (2) the
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`SNDA (submitted as Petitioner’s Ex. 1011); (3) the FDA Guideline (submitted as
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`Petitioner’s “Guideline for Industry,” Ex. 1009) - and Dr. Williams relied upon
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`these references, among other prior art teachings for his technical analysis and
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`obviousness conclusions. Ex. 1010, ¶¶117-202. It would be inconsistent to find
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`that there was sufficient evidence in IPR2017-00323, but not in this case,
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`particularly when the expert testimony of Dr. Williams contains the same analysis.
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`For at least the reasons set forth herein, the Decision not to institute inter
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`partes review should be modified.
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`CONCLUSION
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`For the reasons stated above, Petitioner respectfully requests rehearing and
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`reconsideration of the decision not to institute the IPR and institution of the IPR as
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`requested.
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`Date: July 21, 2017
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`Customer Number: 27890
`Steptoe & Johnson LLP
`1330 Connecticut Avenue, N.W.
`Washington, DC 20036-1795
`Telephone: (202) 429-3000
`Facsimile: (202) 429-3902
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`Respectfully Submitted,
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`
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`By: /Harold H. Fox/
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`Harold H. Fox
`Reg. No. 41,498
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`14
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing PETITIONER
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`MONOSOL RX, LLC’S REQUEST FOR REHEARING was served on July 21,
`2017 by filing this document through the Patent Trial and Appeal Board End to
`End system as well as by delivering a copy via electronic email to the attorneys of
`record for the Patent Owner’s as follows:
`Mark J. Feldstein
`mark.feldstein@finnegan.com
`
`Joshua L. Goldberg
`joshua.goldberg@finnegan.com
`
`Yieyie Yang
`yieyie.yang@finnegan.com
`
`Maureen D. Queler
`maureen.queler@finnegan.com
`
`Mark J. Stewart
`stewart_mark@lilly.com
`
`Dan L. Wood
`wood_dan_l@lilly.com
`
`Gerald P. Keleher
`keleher_gerald@lilly.com
`
`
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`
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`
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`By: /Harold H. Fox/
`
`Harold H. Fox
`
`Reg. No. 41,498
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`Counsel for MonoSol Rx, LLC
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`Date: July 21, 2017
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