UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN PHARMACEUTICALS INC. and MYLAN LABORATORIES
`LIMITED,
`Petitioner,
`
`v.
`
`UCB PHARMA GMBH,
`Patent Owner.
`
`_______________
`
`Case IPR2016-00510
`Patent 6,858,650 B1
`_______________
`
`PATENT OWNER’S REQUEST FOR REHEARING OF DECISION TO
`INSTITUTE INTER PARTES REVIEW
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN PHARMACEUTICALS INC. and MYLAN LABORATORIES
`LIMITED,
`Petitioner,
`
`v.
`
`UCB PHARMA GMBH,
`Patent Owner.
`
`_______________
`
`Case IPR2016-00510
`Patent 6,858,650 B1
`_______________
`
`PATENT OWNER’S REQUEST FOR REHEARING OF DECISION TO
`INSTITUTE INTER PARTES REVIEW
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
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`TABLE OF CONTENTS
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`Relief Requested ............................................................................................. 1
`Statement of Facts ........................................................................................... 1
`Procedural Background ........................................................................ 1
`A.
`B.
`Claims 5 and 23 of the ’650 Patent ...................................................... 2
` Legal Standards .............................................................................................. 3 III.
`
` Argument ........................................................................................................ 3
`IV.
`The Board Applied an Erroneous Interpretation of 37 C.F.R.
`A.
`§42.108(c) ............................................................................................. 4
`1)
`Identification of 5-HMT under Ground I ................................... 4
`
`2)
`Identification of 5-HMT under Ground II ................................. 8
`
`The Board’s Factual Findings Regarding Selection of a Mono-
`Ester at the 2 Position of 5-HMT Are Not Supported by
`Substantial Evidence ............................................................................ 8
`1)
`A Mono-Ester at the 2 Position of 5-HMT under Ground I ...... 9
`
`2)
`A Mono-Ester at the 2 Position of 5-HMT under Ground II ... 11
`
`The Board’s Factual Findings Regarding the Method of Treatment
`Claims Are Unreasonable and Unsupported by Substantial
`Evidence ............................................................................................. 12
`1)
`The Method of Treatment Claims under Ground I .................. 12
`
`2)
`The Method of Treatment Claims under Ground II ................. 14
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`Conclusion .................................................................................................... 15
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`V.
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`i
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`I.
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`II.
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`B.
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`C.
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`TABLE OF AUTHORITIES
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`Page(s)
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`FEDERAL CASES
`In re Magnum Oil Tools Int’l, Ltd.,
`2016 WL 3974202 (Fed. Cir. July 25, 2016) ........................................................ 5
`
`REGULATORY CASES
`Atoptech, Inc. v. Synopsys, Inc.,
`Case IPR2014-01160, slip op. (PTAB Jan. 21, 2013) ........................................ 10
`
`Coalition for Affordable Drugs III LLC v. Jazz Pharm., Inc.,
`Case IPR2015-01018, slip op. (PTAB Oct. 15, 2015) ....................................... 10
`
`Endo Pharm. Inc. v. Depomed, Inc.,
`Case IPR2014-00655, slip op. (PTAB Sept. 29, 2014) ...................................... 10
`
`Hopkins Mfg. Corp. v. Cequent Performance Prods., Inc.,
`Case IPR2015-00613, slip op. (PTAB Aug. 7, 2015) .................................. 11, 12
`
`Mylan Pharm., Inc. v. Gilead Sciences, Inc.,
`Case IPR2014-00886, slip op. (PTAB Dec. 17, 2014) ....................................... 10
`
`PNY Techs., Inc. v. Phison Elecs. Corp.,
`Case IPR2013-00472, slip op. (PTAB Apr. 23, 2014) ................... 3, 8, 11, 12, 15
`
`Veeam Software Corp. v. Symantec Corp.,
`Case IPR2013-00142, slip op. (PTAB Sept. 30, 2013) ................................ 14, 15
`
`FEDERAL STATUTES
`
`35 U.S.C. § 103 .......................................................................................................... 2
`
`35 U.S.C. § 316(e) ..................................................................................................... 5
`
`FEDERAL REGULATIONS
`
`37 C.F.R. § 42.65(a) ................................................................................................. 10
`
`37 C.F.R. § 42.71(c) ................................................................................................... 3
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`ii
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`37 C.F.R. § 42.71(d) .............................................................................................. 1, 3
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`37 C.F.R. § 42.104(b)(4) ............................................................................................ 9
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`37 C.F.R. § 42.108(c) ............................................................................... 4, 5, 6, 8, 11
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`81 Fed. Reg. 18750, 18756 (Apr. 1, 2016) (to be codified at 37 CFR
`42) ......................................................................................................................... 5
`
`U.S. Patent No. 6,858,650 .......................................................................... 1, 2, 13, 15
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`PATENTS
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`iii
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`Pursuant to 37 C.F.R. § 42.71(d), Patent Owner UCB Pharma GmbH,
`
`(“UCB”) respectfully submits this request for rehearing of the Decision instituting
`
`inter partes review of claims 5 and 23 of U.S. Patent No. 6,858,650 (“Decision”)
`
`(Paper 12). This filing is timely under 37 C.F.R. § 42.71(d) because it is made
`
`within 14 days of July 20, 2016, the date that inter partes review was instituted.
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`
`I.
`
`Relief Requested
`
`While UCB respectfully disagrees with the Decision in its entirety, this
`
`request is limited to the decision to institute inter partes review of claims 5 and 23
`
`of U.S. Patent No. 6,858,650 (the “’650 patent”). The Board should rehear the
`
`Decision and deny the Petition at least as to claims 5 and 23 of the ’650 patent.
`
`
`II.
`
`Statement of Facts
`A.
`Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited (“Petitioner”
`
`Procedural Background
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`or “Mylan”) filed a Corrected Petition for Inter Partes Review of claims 1-5 and
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`21-24 of the ’650 patent on February 2, 2016 (“Petition”) (Paper 5). In support of
`
`its Petition, Mylan filed the Declaration of Steven E. Patterson, Ph.D. (Ex. 1003).
`
`On May 2, UCB filed its Preliminary Response to Mylan’s Petition (Paper 9)
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`(“Prelim. Resp.”), including the Declaration of William R. Roush, Ph.D. (Ex.
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`2002). On May 20, Mylan requested the opportunity to submit a reply in response
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`to UCB’s Preliminary Response, which the Board denied (Paper 11). On July 20,
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`the Board issued its Decision to institute inter partes review of claims 5 and 23 of
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`the ’650 patent under 35 U.S.C. § 103 on both grounds presented by Mylan.
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`B. Claims 5 and 23 of the ’650 Patent
`The ’650 patent generally claims and “concerns highly pure, crystalline
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`stable compounds of novel derivatives of 3, 3-diphenylpropylamines in the form of
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`their salts,” as well as methods of treatment administering the claimed compounds.
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`Ex. 1001, col.1 ll.10-14. Claim 1, for example, claims various salt forms of a
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`genus of 3,3-diphenlypropylamines. Claims 5 and 23, meanwhile, are much
`
`narrower. Claim 23 is drawn to “a method of treating a patient suffering from
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`urinary incontinence, which method comprises the step of administering to said
`
`patient an effective amount of a compound according to claim 5.” Claim 5 claims
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`two salt forms – the hydrogen fumarate and hydrochloride hydrate salt forms – of a
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`specific compound within the genus claimed in claim 1, the (R) enantiomer of
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`fesoterodine.
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`It is critical to the analysis that fesoterodine is not prior art to the ’650
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`patent. The Board thus recognized the extensive series of showings that Mylan
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`must make to demonstrate a “reasonable likelihood” that claim 23 and thus, claim
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`5, are unpatentable as obvious, which, pertinent to this Motion, include: that it
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`would have been obvious to a skilled artisan, as of November 15, 1999 “to (1)
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`identify 5-HMT as a lead compound for drug development; . . . (3) . . . arrive at a
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`2
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`compound having a short-chain mono-ester derivative at only the [2]-hydroxyl
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`position; … (4) select an acid-addition salt that provides the desired product
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`stability,” specifically the fumarate salt . . . and (6) viably treat a patient suffering
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`from urinary incontinence with the claimed compound. See Decision, 15-16
`
`(emphasis added).
`
` Legal Standards
`III.
`“A party dissatisfied with a decision may file a single request for rehearing,
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`without prior authorization from the Board.” 37 C.F.R. § 42.71(d). “The request
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`must specifically identify all matters the party believes the Board misapprehended
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`or overlooked, and the place where each matter was previously addressed in a
`
`motion, an opposition, or a reply.” Id. When rehearing a decision to institute, the
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`Board applies an abuse of discretion standard, which occurs “if a decision is based
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`on an erroneous interpretation of law, if a factual finding is not supported by
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`substantial evidence, or if the decision represents an unreasonable judgment in
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`weighing relevant factors.” PNY Techs., Inc. v. Phison Elecs. Corp., Case
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`IPR2013-00472, slip op. at 2 (PTAB Apr. 23, 2014) (Paper 16).
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`IV.
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` Argument
`Mylan did not demonstrate a “reasonable likelihood” that claim 5 or 23 is
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`unpatentable under either ground, and the Board’s decision to institute inter partes
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`review of at least those claims was an abuse of discretion for three reasons: (1) the
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`Board applied an erroneous interpretation of 37 C.F.R. § 42.108(c); (2) the Board’s
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`findings with respect to Step 3 in the obviousness analysis (“Selection of a Prodrug
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`. . . at the [2]-hydroxyl Position”) are not supported by substantial evidence; and
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`(3) the Board’s findings with respect to Step 6 in the obviousness analysis (“the
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`Method claims”) are both not supported by substantial evidence, and represent an
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`unreasonable judgment by the Board that UCB did “not directly contest
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`Petitioner’s method claim arguments or evidence...” Decision, 25.
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`A.
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` The Board Applied an Erroneous Interpretation of 37 C.F.R. §42.108(c)
`“The Board’s decision will take into account a patent owner preliminary
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`response where such a response is filed, including any testimonial evidence, but a
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`genuine issue of material fact created by such testimonial evidence will be viewed
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`in the light most favorable to the petitioner solely for purposes of deciding whether
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`to institute an inter partes review.” 37 C.F.R. § 42.108(c) (emphasis added).
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`Identification of 5-HMT under Ground I
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`1)
`At the conclusion of Steps 1 through 5 of Mylan’s obviousness analysis
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`under Ground I, the Board misquoted and misapplied 37 C.F.R. § 42.108(c), by
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`viewing all supporting evidence in the light most favorable to Petitioner, rather
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`than all testimonial evidence. The Board’s decision reads: “Although we find
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`Patent Owner’s arguments reasonable, Patent Owner’s ‘supporting evidence
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`concerning disputed material facts will be viewed in the light most favorable to the
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`petitioner for purposes of deciding whether to institute an inter partes review.’ 37
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`C.F.R. § 42.108(c).” Decision, 17 (emphasis added); see also id., 20, 23, 24, 25,
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`27. The text of 37 C.F.R. § 42.108(c) restricts application of the standard to
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`disputed material facts arising only from testimonial evidence, not any “supporting
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`evidence.” See Amendments to the Rules of Practice for Trials before the Patent
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`Trial and Appeal Board, 81 Fed. Reg. 18750, 18756 (Apr. 1, 2016) (to be codified
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`at 37 CFR 42). The Board’s application of 37 C.F.R. § 42.108(c) runs counter to
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`the law that “[i]n an inter partes review, the burden of persuasion is on the
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`petitioner to prove ‘unpatentability by a preponderance of the evidence,’ 35 U.S.C.
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`§ 316(e), and that burden never shifts to the patentee.” In re Magnum Oil Tools
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`Int’l, Ltd., 2016 WL 3974202, at *6 (Fed. Cir. July 25, 2016) (quotation omitted).
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`This misapplication constitutes clear error at least in connection with Step 1
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`of the obviousness analysis, the “Identification of 5-HMT.” UCB’s decidedly
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`“reasonable” arguments related to Step 1 were based entirely on the face of the
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`prior art, and not on testimonial evidence. Decision, 17. UCB’s declarant, Dr.
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`Roush, offered no testimony on Step 1 and instead began with Step 2: “Reason to
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`modify 5-HMT.” Ex. 2002, 16. In fact, Dr. Roush offered no testimony on any of
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`the prior art references that formed the basis of UCB’s Response concerning Step 1
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`and that were cited in the Decision: the Detrol Label (Ex. 1009), Brynne (Ex.
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`1011), and Nilvebrandt 1997 (Ex. 1015). See Prelim. Resp., 13-17; Ex. 2002.
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`Because UCB offered no testimonial evidence in connection with Step 1, the Board
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`abused its discretion by viewing disputed issues of material fact for Step 1 in the
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`light most favorable to Mylan. Decision, 17-18.
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`The standard for institution is whether Mylan has “demonstrate[d] that there
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`is a reasonable likelihood that [claim 5 or 23] is unpatentable.” 37 C.F.R. §
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`42.108(c). Mylan has not carried that burden. Prelim. Resp., 13-17. To argue that
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`a person of ordinary skill would have avoided tolterodine and thus selected 5-HMT
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`as a lead, Petitioner relied on the general caution of Postlind (Ex. 1010) regarding
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`the possibility of adverse effects related to CYP2D6 metabolism. Petition, 23-24.
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`In its Preliminary Response, UCB identified the unequivocal disclosures of three
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`prior art references that contradicted that exact proposition of Postlind – two of
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`which superseded it – in the Detrol Label (Ex. 1009), Brynne (Ex. 1011), and
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`Nilvebrant 1997 (Ex. 1015). On its face, Brynne discloses its conclusion –
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`affirmatively trumping Postlind by citation to it – that “[d]espite the influence of
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`CYP2D6 polymorphism on the pharmacokinetics of tolterodine, this does not
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`appear to be of great pharmacodynamic importance.” Prelim. Resp., 16 citing
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`Brynne, 537 (fn. 26), 538. The Board itself recognized this conclusion (Decision,
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`10) and, further, summarized the conclusions of the Detrol Label and Nilvebrant
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`1997 (id., 10-11, 17), both of which also negate Mylan’s proffered reason to
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`identify 5-HMT as a lead compound in Step 1 of the analysis. The Board found
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`UCB’s arguments “reasonable,” (id., 17) – but they are much more than that as an
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`evidentiary matter. Without shifting the burden to Patent Owner by viewing the
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`facts in the light most favorable to Mylan (id., 17-18), Mylan cannot demonstrate a
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`reasonable likelihood that Step 1 of the analysis would have been obvious.
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`Even if it was proper to apply the “genuine issue of material fact” standard,
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`which it was not, there can be no genuine issue of material fact as to the teachings
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`of the Detrol Label or Brynne. Mylan was not without opportunity to address the
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`conclusions of the Detrol Label and Brynne – Mylan submitted both as exhibits to
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`its Petition. But the Petition ignored the unhelpful yet clear conclusions of these
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`references, while citing them for other purposes. Mylan requested the opportunity
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`to submit a reply in response to UCB’s Preliminary Response, but the Board
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`denied that request (Order, May 27, 2016 (Paper 11)), which was proper, given that
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`Mylan affirmatively submitted the prior art but did not address the conclusion that
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`there was no therapeutic difference between tolterodine and 5-HMT. See Ex.
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`1009, 2. The teachings of these prior art references, which appear adopted by the
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`Board in its Decision (Decision, 9-11), eviscerate Mylan’s hindsight assertion that
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`a person of ordinary skill would have selected 5-HMT.
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`This supporting, but non-testimonial, evidence should not have been viewed
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`in the light most favorable to Mylan (Decision, 17), particularly where Mylan
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`almost certainly ignored it by design. Mylan’s obviousness argument thus fails at
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`Step 1 of its analysis, and the Board should grant rehearing. See PNY Techs., Inc.,
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`Case IPR2013-00472, slip op. at 3 (modifying decision to institute due to a
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`misapplication of a legal standard).
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`Identification of 5-HMT under Ground II
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`2)
`Mylan’s arguments under Ground II were “substantially the same as for
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`Ground I, except with respect to the citation of Brynne instead of Postlind and [the]
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`Detrol Label…” Decision, 26. In the absence of Postlind, Ground II was even less
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`supported than Ground I, given Brynne’s conclusion. Supra Section IV.A.1. The
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`Board not only seemingly adopted this conclusion, but actually discredited
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`Mylan’s reliance on Brynne’s subsidiary disclosures as a reason to select 5-HMT
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`under Ground II. Decision, 10, 26; see also Prelim. Resp., 40-41.
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`As with Ground I, UCB relied only on prior art, and not on testimonial
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`evidence. As with Ground I, the Board found UCB’s arguments “reasonable,” but
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`nonetheless improperly viewed Mylan’s “supporting evidence concerning disputed
`
`material facts … in the light most favorable” to Mylan. Decision, 27. The Board
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`should grant rehearing based on a misapplication of 37 C.F.R. § 42.108(c).
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`B.
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`The Board’s Factual Findings Regarding Selection of a Mono-
`Ester at the 2 Position of 5-HMT Are Not Supported by
`Substantial Evidence
`
`Step 3 of the Board’s analysis concerned the decision to make a prodrug and
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`arrive at a short-chain mono-ester derivative of the 2 hydroxyl position of 5-HMT,
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`8
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`specifically fesoterodine, the mono-isobutyryl ester of 5-HMT. See, e.g., Petition,
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`27-29; Decision, 21-23. On both Grounds, the Decision was unsupported for lack
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`of any prior art showing on two scores: (1) modification of the 2-position over the
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`5-position, and (2) election of a mono-ester over a di-ester.
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`A Mono-Ester at the 2 Position of 5-HMT under Ground I
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`1)
`The Board devoted only two paragraphs of its Decision to Mylan’s
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`arguments under Ground I in support of the obviousness of both selecting a
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`prodrug and making the specific molecular modifications necessary to arrive at
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`fesoterodine. Decision, 21. The Board cited Dr. Patterson’s testimony that a
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`person of ordinary skill would have “begun experimenting with 2 to 6 carbon
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`mono-ester derivatives of 5-HMT,” and stated that “according to Dr. Patterson,” a
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`person of ordinary skill would have rejected both di-esters and mono-esters at the 5
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`hydroxyl position of 5-HMT. Id., citing Petition, 27-29, Ex. 1003 ¶¶ 16, 122, 126-
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`127. But Dr. Patterson cited to no prior art in support of his declaration that these
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`modifications would have been obvious. See Ex. 1003 at ¶¶ 122-127;1 see also
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`Prelim. Resp., 28-29. This failure of 37 C.F.R. §42.104(b)(4), to “specify where
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`each element of the claim is found in the prior art,” is particularly acute as to the
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`1 Other declaration paragraphs cited by the Board (Ex. 1003 at ¶¶ 116-120; 128-
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`130) neither addressed a preference for mono- over di-esters, nor for the 2- over
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`the 5-position, and art citations therein fail 37 C.F.R. § 42.104(b)(4), in any event.
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`2-over-5-position modification. Only three paragraphs of Patterson testimony are
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`directed to this claim element and, in plain view, none is supported by any prior art
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`citation. Ex. 1003 at ¶¶ 125-27.
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`“Expert testimony that does not disclose the underlying facts or data on
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`which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a).
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`The Board routinely denies institution of inter partes petitions that rely on expert
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`opinion for which there is no objective support. See Mylan Pharm., Inc. v. Gilead
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`Sciences, Inc., Case IPR2014-00886, slip op. at 13 (PTAB Dec. 17, 2014) (Paper
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`15) (“testimony on this matter [is] entitled to little or no weight because it does not
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`disclose the underlying facts or data on which it is based (see 37 C.F.R. §
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`42.65(a))…”); Endo Pharm. Inc. v. Depomed, Inc., Case IPR2014-00655, slip op.
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`at 21 (PTAB Sept. 29, 2014) (Paper 12); Atoptech, Inc. v. Synopsys, Inc., Case
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`IPR2014-01160, slip op. at 15 (PTAB Jan. 21, 2013) (Paper 9). Here, UCB
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`demonstrated Dr. Patterson’s opinions are unsupported in the prior art concerning
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`the mono-over-di-ester, and 2-over-5-position modification. Prelim. Resp., 27-29.
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`Mylan “has the initial burden of production to establish there is prior art that
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`renders the claims unpatentable.” Coalition for Affordable Drugs III LLC v. Jazz
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`Pharm., Inc., Case IPR2015-01018, slip op. at 13 (PTAB Oct. 15, 2015) (Paper 17)
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`(emphasis added). Perhaps because of Mylan’s inability to show the presence of
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`either teaching within the scope and content of the prior art, the Board’s Decision
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`offered more extensive consideration of UCB’s evidence that the prior art “fails to
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`suggest making the specific molecular modifications of the claimed invention.”
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`Decision, 21-23. But it is not a Patent Owner’s burden to prove its invention is
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`nonobvious, particularly when faced with only unsupported assertions of a
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`Petitioner’s declarant. Nor should Petitioner be saved by § 42.108(c) just because
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`there are competing declarations; to do so would excuse Mylan from its burden of
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`showing the claim limitations exist in the prior art and punish UCB for merely
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`proving otherwise. This is not a case of two declarants disputing what the prior art
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`teaches, but rather a case of the requisite art being nonexistent.
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`Mylan has not produced prior art sufficient to establish a “reasonable
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`likelihood” that one of ordinary skill would have “arriv[ed] at a mono-ester
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`derivative within the scope of [claims 5 or 23]” (Decision, 23), i.e., a 5-HMT
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`analog, mono-substituted, with isobutyryl, at the 2-position. See Prelim. Resp., 27-
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`29. Accordingly, the Board’s decision to the contrary is not supported by
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`substantial evidence. See PNY Techs., Inc., Case IPR2013-00472, slip. op. at 2.
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`A Mono-Ester at the 2 Position of 5-HMT under Ground II
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`2)
`Mylan has not attempted to meet its burden of proof with respect to Step 3 of
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`the analysis under Ground II. See Petition, 44-53; Prelim. Resp., 41. Accordingly,
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`its Petition for institution of inter partes review of claims 5 and 23 under Ground II
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`should have been denied. See Hopkins Mfg. Corp. v. Cequent Performance Prods.,
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`Inc., Case IPR2015-00613, slip op. at 16 (PTAB Aug. 7, 2015) (Paper 9) (denying
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`institution; it is “not the Board’s responsibility to search the record and piece
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`together what may support Petitioner’s arguments.” (internal quotations omitted)).
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`The Board was silent on its Step 3 analysis with respect to Ground II, except
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`to cite “reasons similar to those set forth above.” Decision, 27. This was an abuse
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`of discretion because the Board’s finding that a person of ordinary skill in the art
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`would have had reason to “arrive at a mono-ester derivative salt compound that is
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`within the scope of the claims” (id.) was not supported by “substantial evidence.”
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`See PNY Techs., Inc., Case IPR2013-00472, slip. op. at 2. This is unsurprising, as
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`Mylan provided the Board with none. See Petition, 44-53.
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`C. The Board’s Factual Findings Regarding the Method of
`Treatment Claims Are Unreasonable and Unsupported by
`Substantial Evidence
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`1)
`Claim 23 depends from claim 5, and is narrowly limited to a method of
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`The Method of Treatment Claims under Ground I
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`treatment using either the hydrogen fumarate or hydrochloride hydrate salt of
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`fesoterodine. Ex. 1001, claim 23. The Petition, on the “method claims,” did not
`
`address either specific salt compound, but rather only the genus “compound in
`
`claim 1.” Petition, 39 (emphasis added). While the Petition was entirely silent on
`
`the hydrochloride hydrate salt, (Prelim. Resp., 38-39), Mylan cited to Berge (Ex.
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`12
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`IPR2016-00510
`Patent 6,858,650 B1
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`1013) for its disclosure of the fumarate salt in a list of FDA-approved,
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`commercially-marketed salts. See, e.g., Petition, 35-36.
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`The Board was mistaken that UCB did “not directly contest Petitioner’s
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`method claim arguments or evidence at this stage of the proceeding.” Decision,
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`25. In so finding, the Board overlooked UCB’s arguments that Berge, Mylan’s
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`Ground I salt reference, “provides no teaching or direction toward the fumarate
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`salt,” and teaches – on its face – that:
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`“‘there is no reliable way of predicting’ whether a salt would work for
`a compound so that it could be administered as a pharmaceutical
`treatment. Ex. 1013 at 1, 16. A person of ordinary skill in the art
`would have had no reasonable expectation of success that fesoterodine
`fumarate would be effective as a pharmaceutical method of treatment,
`as claim 23 requires.”
`Prelim. Resp., 38-39 (emphases added).
`
`Even if it were routine to select a salt as the Board concluded (see Decision,
`
`23-24), this means only that a salt could be formed. Claim 23 requires more than
`
`that. It requires that the salt be “effective” to treat a patient. The ’650
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`specification makes this distinction clearly: many salts of the disclosed genus
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`might be made, but not all are viable as pharmaceuticals. Ex. 1001, col.1 ll.60-62.
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`On its face, Berge does not teach distinguishing the latter from the former, and
`
`Mylan did not so assert.
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`13
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`IPR2016-00510
`Patent 6,858,650 B1
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`The Board should grant rehearing and deny institution as to claim 23 under
`
`Ground I because it has overlooked UCB’s arguments in response to Mylan’s
`
`method claim arguments. See Veeam Software Corp. v. Symantec Corp., Case
`
`IPR2013-00142, slip op. at 2-3 (PTAB Sept. 30, 2013) (Paper 17) (modifying
`
`institution order having found the Board “overlooked Patent Owner’s argument.”)
`
`The Method of Treatment Claims under Ground II
`
`
`2)
`The Board offered no reason for institution as to claim 23 under Ground II,
`
`except to say generally that it “find[s] Patent Owner’s arguments reasonable,” but
`
`“because Petitioner has not been afforded an opportunity to respond,” UCB’s
`
`“supporting evidence concerning disputed material facts [would] be viewed in the
`
`light most favorable to the petitioner for purposes of deciding whether to institute
`
`an inter partes review.” Decision, 27.
`
`Institution of inter partes review of claim 23 under Ground II was an abuse
`
`of discretion because Mylan’s Petition lacked supporting evidence, and the Board
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`disregarded UCB’s arguments on this point. See Prelim. Resp., 43. The Decision
`
`disregarded UCB’s argument that “for method of treatment claim 23, Petitioner
`
`provides no explanation why the mere mention of a fumarate salt of the
`
`compounds of Johansson suggests that it would have been obvious that the
`
`fumarate salt of fesoterodine could be administered to treat urinary incontinence,”
`
`especially in light of the general teachings of Mylan’s Ground I reference, Berge,
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`14
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`IPR2016-00510
`Patent 6,858,650 B1
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`that there is “‘no reliable way of predicting’ whether a salt would work for a
`
`compound so that it could be administered as a pharmaceutical treatment.” Prelim.
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`Resp. at 43, 35-39. The Board should grant rehearing and deny institution of inter
`
`partes review of claim 23 on Ground II. See PNY Techs., Inc., Case IPR2013-
`
`00472, slip op. at 2; Veeam Software Corp., Case IPR2013-00142, slip op. at 2-3.
`
`V.
`
` Conclusion
`For the above reasons, there is no reasonable likelihood of Petitioner
`
`prevailing as to claims 5 and 23 of the ’650 patent on either instituted ground. The
`
`Board should rehear the Decision and deny the Petition at least as to those claims.
`
`Respectfully submitted,
`
`WHITE & CASE LLP
`
`/Jeffrey J. Oelke/ (Electronically signed)
`Jeffrey J. Oelke, Reg. No. 37,409
`joelke@whitecase.com
`James S. Trainor, Jr., Reg. No. 52,297
`jtrainor@whitecase.com
`Robert E. Counihan, Reg. No. 61,382
`rcounihan@whitecase.com
`White & Case LLP
`1155 Avenue of the Americas
`New York, NY 10036
`(212) 819-8200
`Attorneys for UCB Pharma GmbH
`
`
`15
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`Date: August 3, 2016
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`
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`IPR2016-00510
`Patent 6,858,650 B1
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`CERTIFICATE OF COMPLIANCE WITH 37 C.F.R. § 42.24(a)(1)
`
`1.
`
`This brief complies with the type-volume limitation of 37 C.F.R. §
`
`42.24(a)(1) because:
`
`this brief contains no more than 15 pages, excluding the parts of the
`
`brief exempted by 37 C.F.R. § 42.24(a)(1).
`
`2.
`
`This brief complies with the typeface and type style requirements of 37
`
`C.F.R. § 42.6(a)(2) because:
`
`this brief has been prepared in a proportionally spaced typeface in 14
`
`point Times New Roman font.
`
`
`/Jeffrey J. Oelke/ (Electronically signed)
`Jeffrey J. Oelke
`Reg. No. 37,409
`Phone: (212) 819-8936
`
`
`Date: August 3, 2016
`
`16
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`IPR2016-00510
`Patent 6,858,650 B1
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`CERTIFICATION UNDER 37 C.F.R. § 42.11
`
`The undersigned hereby represents that this paper is being filed in
`
`compliance with the requirements of 37 C.F.R. § 42.11.
`
`More specifically, the undersigned certifies that:
`
`(i)
`
`The paper is not being presented for any improper purpose, such as to
`
`harass someone or to cause unnecessary delay or needless increase in the cost of
`
`any proceeding before the USPTO;
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`(ii) The other legal contentions therein are warranted by existing law or
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`by a nonfrivolous argument for the extension, modification, or reversal of existing
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`law or the establishment of new law;
`
`(iii) The allegations and other factual contentions have evidentiary support
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`or, if specifically so identified, are likely to have evidentiary support after a
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`reasonable opportunity for further investigation or discovery; and
`
`(iv) The denials of factual contentions are warranted on the evidence, or if
`
`specifically so identified, are reasonably based on a lack of information or belief.
`
`
`/Jeffrey J. Oelke/ (Electronically signed)
`Jeffrey J. Oelke
`Reg. No. 37,409
`Phone: (212) 819-8936
`
`17
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`IPR2016-00510
`Patent 6,858,650 B1
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent Owner
`
`Request for Rehearing under 37 C.F.R. § 42.71(d) was served on August 3, 2016,
`
`by filing this document through the Patent Trial and Appeal Board End to End
`
`System as well as delivering a copy via electronic mail upon the following
`
`attorneys of record for the Petitioner:
`
`Mitchell G. Stockwell, Reg. No. 39,389
`mstockwell@kilpatricktownsend.com
`D. Clay Holloway, Reg. No. 58,011
`cholloway@kilpatricktownsend.com
`Alyson L. Wooten, Reg. No. 58,045
`awooten@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE Suite 2800
`Atlanta, Georgia 30309
`(404) 815-6500
`
`
`/Jeffrey J. Oelke/ (Electronically signed)
`Jeffrey J. Oelke
`Reg. No. 37,409
`Phone: (212) 819-8936
`
`18
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`
`
`Date: August 3, 2016
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