Paper No. 18
` Entered: August 29, 2016
`
`Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`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
`____________
`
`
`Before KRISTINA M. KALAN, ROBERT A. POLLOCK, and
`MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`
`ANKENBRAND, Administrative Patent Judge.
`
`
`DECISION
`Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
` Entered: August 29, 2016
`
`Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`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
`____________
`
`
`Before KRISTINA M. KALAN, ROBERT A. POLLOCK, and
`MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`
`ANKENBRAND, Administrative Patent Judge.
`
`
`DECISION
`Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
`
`On August 3, 2016, Patent Owner filed a Request for Rehearing
`
`(Paper 15, “Rehearing Request” or “Reh’g Req.”) of our Decision instituting
`an inter partes review (Paper 12, “Decision” or “Dec.”) of U.S. Patent No.
`6,858,650 B1 (Ex. 1001, “the ’650 patent”). The asserted grounds on which
`we instituted an inter partes review are listed in the following table:
`References
`Basis
`Claims Challenged
`Postlind,1 “Bundgaard
`§ 103
`1–5 and 21–24
`publications,”2,3 Detrol Label,4
`and Berge5
`Brynne,6 Bundgaard
`publications, and Johansson7
`
`§ 103
`
`1–5 and 21–24
`
`
`
`Patent Owner requests rehearing on both grounds (Ground I and
`Ground II), but only as to claims 5 and 23. For the reasons discussed below,
`we grant Patent Owner’s Request for Rehearing and reconsider the record
`evidence regarding the identification of the 5-hydroxymethyl derivative of
`tolterodine (“5-HMT”). We modify our analysis in determining that
`
`1 Postlind et al., Tolterodine, A New Muscarinic Receptor Antagonist, is
`Metabolized by Cytochromes P450 2D6 and 3A in Human Liver
`Microsomes, 26(4) DRUG METABOLISM & DISPOSITION 289–293 (1998)
`(Ex. 1010) (“Postlind”).
`2 Bundgaard, Design of Prodrugs, Elsevier (1985) (Ex. 1012)
`(“Bundgaard”).
`3 WO 92/08459, published May 29, 1992 (Ex. 1020) (“Bundgaard PCT”).
`4 Detrol™ (tolterodine tartrate tablets) prescribing information (1998) (Ex.
`1009) (“Detrol Label”).
`5 Berge et al., Pharmaceutical Salts, 66(1) J. PHARM. SCI. 1–19 (1977) (Ex.
`1013) (“Berge”).
`6 Brynne et al., Influence of CYP2D6 polymorphism on the pharmacokinetics
`and pharmacodynamics of tolterodine, 63(5) CLIN. PHARMACOL. &
`THERAPEUTICS 529–539 (1998) (Ex. 1011) (“Brynne”).
`7 Johansson et al., WO 94/11337, published May 26, 1994 (Ex. 1005)
`(“Johansson”).
`
`
`
`2
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
`
`Petitioner has demonstrated a reasonable likelihood that one of ordinary skill
`in the art would have selected 5-HMT over tolterodine for further
`development. We deny the Rehearing Request in all other respects.
`ANALYSIS
`When considering a request for rehearing, the Board reviews its
`
`decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The party
`requesting rehearing bears the burden of showing that the decision should be
`modified, and “[t]he request must specifically identify all matters the party
`believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d).
`
`Patent Owner asserts that our Decision misquotes and misapplies
`37 C.F.R. § 42.108(c) in determining that Petitioner demonstrated a
`reasonable likelihood that one of ordinary skill in the art would have
`selected 5-HMT over tolterodine by viewing all supporting evidence, rather
`than only testimonial evidence, in the light most favorable to Petitioner.
`Reh’g Req. 4–8. Patent Owner also asserts that our factual findings
`regarding the selection of a monoester at the 2 position of 5-HMT and the
`method of treatment claims are unsupported by substantial evidence. Id. at
`8–15. We address each of those assertions below.
`A. Application of 37 C.F.R. § 42.108(c)
`Patent Owner argues that our Decision misquotes and misapplies
`37 C.F.R. § 42.108(c) by viewing all supporting evidence, rather than only
`testimonial evidence, in the light most favorable to Petitioner, at least in
`connection with the “identification of 5-HMT” portion of the obviousness
`analysis. Reh’g Req. 4–8. We acknowledge that 37 C.F.R. § 42.108(c)
`provides that “a genuine issue of material fact created by . . . testimonial
`evidence will be viewed in the light most favorable to the petitioner solely
`
`
`
`3
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
`
`for the purposes of deciding whether to institute an inter partes review.” As
`a result, we have reconsidered the evidence and arguments presented in the
`Petition and Preliminary Response. Upon reconsidering the record, as
`developed at the preliminary stage of this proceeding, we remain of the
`opinion that Patent Owner’s arguments and supporting evidence create
`factual issues that are best resolved at trial, with the benefit of a full record.8
`We, therefore, maintain our determination that Petitioner has demonstrated a
`reasonable likelihood that the ordinarily skilled artisan would have selected
`5-HMT over tolterodine for further development, as well as a reasonable
`likelihood that the ordinarily skilled artisan would have selected the
`remaining steps proposed by the Petitioner, which we analyzed under
`37 C.F.R. § 42.108(c).
`B. The Board’s Factual Findings
`Patent Owner asserts that our factual findings regarding the selection
`of a monoester at the 2 position of 5-HMT and regarding the method of
`treatment claims are unsupported by substantial evidence. Id. at 8–15.
`Patent Owner repeats in the Rehearing Request essentially the same
`arguments raised in the Preliminary Response, e.g., the argument that
`Dr. Patterson’s testimony is not supported by any prior art. Compare
`Prelim. Resp. 28, with Reh’g Req. 9–10. Patent Owner’s disagreement with
`
`
`8 As we explained in the Decision, our determinations at the institution stage
`are preliminary in nature and may be revisited during trial when the record is
`fully developed. Dec. 28. Patent Owner, therefore, may continue to press
`its argument regarding identification of 5-HMT over tolterodine (and its
`arguments regarding the remaining steps) for further development in the
`Patent Owner Response.
`
`
`
`4
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
`
`our assessment of presented arguments and evidence, however, is not a
`proper basis for rehearing.
`Patent Owner also contends that we disregarded an argument
`regarding Petitioner’s showing as to Ground II of method claim 23. Reh’g
`Req. 14–15. As an initial matter, it is not clear from the Rehearing Request
`whether Patent Owner’s argument is directed to using a fumarate salt of
`fesoterodine to treat urinary incontinence, or to making a salt (e.g., a
`fumarate salt) of fesoterodine. To the extent that Patent Owner’s argument
`is directed to the former, we did not disregard that argument. Rather, in the
`Decision, we were persuaded by Petitioner’s argument and evidence that the
`ordinarily skilled artisan “would have expected the use of the compound in
`claim 1 to be quickly metabolized to the active compound, 5-HMT, which
`was well known to be beneficial for the treatment of urinary incontinence.”
`Dec. 25 (quoting Pet. 39).
`To the extent that Patent Owner’s argument is directed to making a
`fesoterodine salt, we also did not disregard that argument. To the contrary,
`we found persuasive Petitioner’s argument, as supported by Dr. Patterson’s
`testimony, that “once the esterified prodrug was made, the selection of [a]
`salt[] would have been a matter of routine experimentation.” Id. at 23–24
`(citing Pet. 20–21; Ex. 1003 ¶ 131); see Ex. 1003 ¶ 131 (citing Ex. 1013
`(Berge) for the proposition that “salt formation is a matter of routine
`experimentation”); Ex. 1013, 1 (“The chemical, biological, physical, and
`economic characteristics of medicinal agents can be manipulated and, hence,
`often optimized by conversion to a salt form.”). In any event, as we
`explained in the Decision, Patent Owner’s arguments and supporting
`
`
`
`5
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
`
`evidence create factual issues that are best resolved at trial, with the benefit
`of a full record. Dec. 28.
`Patent Owner also argues in the request that claim 23:
`requires that the salt be “effective” to treat a patient. The ’650
`specification makes this distinction clearly: many salts of the
`disclosed genus might be made, but not all are viable as
`pharmaceuticals. Ex. 1001, col.1 ll.60-62. On its face, Berge
`does not teach distinguishing the latter from the former, and
`Mylan did not so assert.
`Reh’g Req. 13. Patent Owner, however, does not cite the Preliminary
`Response or direct us to any portion of that document in which it raised such
`an argument. See 37 C.F.R. § 42.71(d) (a request for rehearing “must
`identify . . . the place where each matter was previously addressed”).
`Rather, Patent Owner points to a passage from the ’650 patent specification.
`Reh’g Req. 13 (citing Ex. 1001, 1:60–62). We could not have
`misunderstood or overlooked an argument that was not presented in the
`Preliminary Response. Accordingly, we are not persuaded that we
`misapprehended or overlooked any of Patent Owner’s arguments or abused
`our discretion in instituting an inter partes review.
`We note further that our goal in every proceeding is “the just, speedy,
`and inexpensive resolution” of the validity of the challenged claims.
`37 C.F.R. § 42.1(b). In that regard, we may exercise our discretion under
`37 C.F.R. § 42.108 to have a review proceed on all of the challenged claims
`based on Petitioner’s showing that at least one of the claims challenged in
`the Petition is unpatentable. See FMC Techs., Inc. v. OneSubsea IP UK Ltd.,
`IPR2016-00378, Paper 7, at 6–7 (PTAB June 30, 2016); Intex Recreation
`Corp. v. Bestway Inflatables & Material Corp., IPR2016-00180, Paper 13, at
`8–11 (PTAB June 6, 2016) (“Intex”); see also Synopsys, Inc. v. Mentor
`
`
`
`6
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
`
`Graphics Corp., 814 F.3d 1309, 1316 (Fed. Cir. 2016) (“The validity of
`claims for which the Board did not institute inter partes review can still be
`litigated in district court.”). As the Board explained in Intex:
`Congress, in enacting the Leahy-Smith America Invents Act
`(AIA), contemplated that, “ideally,” inter partes review “will
`completely substitute for at least the patents-and-printed
`publications portion of the civil litigation.” 157 Cong. Rec.
`S1376 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl)
`(emphasis added). . . . In other words, a partial institution could
`very well result in a serial or parallel process where the Board
`reviews some claims of the challenged patent and the district
`court reviews other claims.
`Intex, supra at 8.
`Here, Patent Owner requests rehearing of our Decision to institute an
`inter partes review only as to claims 5 and 23 of the ’650 patent. Should we
`accede to Patent Owner’s request, such partial institution would likely result
`in a parallel process, with the Board reviewing claims 1–4, 21, 22, and 24,
`and the district court reviewing, inter alia, claims 5 and 23 of the ’650
`patent. See Pfizer, Inc. v. Mylan Pharms., Inc., No. 1:15-cv-0079-GMS (D.
`Del.), Docket Item No. 50 at 1 (explaining that plaintiffs have identified the
`asserted claims as “claims 1-5 and 21-24 of the ’650 Patent”). Accordingly,
`efficiency and fairness further dictate that we exercise our discretion to
`maintain a review of all challenged claims on both grounds for which we
`instituted trial.
`
`
`
`
`7
`
`
`
`IPR2016-00510
`Patent 6,858,650 B1
`
`
`ORDER
`
`It is
`
`ORDERED that Patent Owner’s request for rehearing of the Decision
`
`to institute inter partes review is granted-in-part as to reconsideration of the
`record under 37 C.F.R. § 42.108(c); and
`FURTHER ORDERED that the Decision to institute inter partes
`
`review is modified to include the discussion herein regarding our
`determination that Petitioner has demonstrated a reasonable likelihood that it
`would prevail on its assertions of unpatentability as to the challenged claims;
`and
`FURTHER ORDERED that Patent Owner’s request for rehearing is
`
`denied in all other respects.
`
`FOR PETITIONER:
`Mitchell Stockwell
`Clay Holloway
`Alyson L. Wooten
`mstockwell@kilpatricktownsend.com
`cholloway@kilpatricktownsend.com
`awooten@kilpatricktownsend.com
`
`FOR PATENT OWNER:
`Jeffrey Oelke
`Robert Counihan
`James S. Trainor
`joelke@whitecase.com
`rcounihan@whitecase.com
`jtrainor@whitecase.com
`
`
`
`
`
`
`8
`
`
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