Trials@uspto.gov
`571.272.7822
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`
`
`
`
`
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` Paper 11
`
`Entered: November 4, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ROXANE LABORATORIES, INC.,
`Petitioner,
`
`v.
`
`VANDA PHARMACEUTICALS INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00690
`Patent 9,138,432 B2
`____________
`
`
`Before RAMA G. ELLURU, SHERIDAN K. SNEDDEN, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Request for Rehearing
`37 C.F.R. § 42.71(c)
`
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`
`
`
` Paper 11
`
`Entered: November 4, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ROXANE LABORATORIES, INC.,
`Petitioner,
`
`v.
`
`VANDA PHARMACEUTICALS INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00690
`Patent 9,138,432 B2
`____________
`
`
`Before RAMA G. ELLURU, SHERIDAN K. SNEDDEN, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Request for Rehearing
`37 C.F.R. § 42.71(c)
`
`
`
`
`
`
`
`
`
`
`Case IPR2016-00690
`Patent 9,138,432 B2
`
`
`INTRODUCTION
`Roxane Laboratories, Inc. (“Petitioner”) filed a Petition requesting an
`inter partes review of claim 1 of U.S. Patent No. 9,138,432 B2 (Ex. 1001,
`“the ’432 patent”). Paper 2 (“Pet.”). Vanda Pharmaceuticals Inc. (“Patent
`Owner”) filed a Preliminary Response to the Petition. Paper 7 (“Prelim.
`Resp.”). The Board denied the Petition. Paper 8 (“Dec.”). Petitioner filed a
`Request for Rehearing. Paper 9 (“Reh’g Req.”). Patent Owner filed a reply.
`Paper 10 (“Reply”).
`Although we consider Petitioner’s arguments below, the Request for
`Rehearing is denied.
`
`
`STANDARD OF REVIEW
`When considering a request for rehearing on whether to institute trial,
`the Board reviews its decision for an abuse of discretion. 37 C.F.R.
`§ 42.71(c). An abuse of discretion may arise if the decision is based on an
`erroneous interpretation of law, if a factual finding is not supported by
`substantial evidence, or if an unreasonable judgment is made in weighing
`relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281
`(Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir.
`2004); see also PPG Indus., Inc. v. Celanese Polymer Specialties Co., Inc.,
`840 F.2d 1565, 1567 (Fed. Cir. 1988) (stating that an abuse of discretion
`may arise where a decision was based on an erroneous conclusion of law,
`clearly erroneous factual findings, or a clear error of judgment.)
`
`
`ANALYSIS
`The ‘432 patent discloses methods for lowering the risk for QT
`prolongation associated with the administration of iloperidone in patients
`with lower than normal CYP2D6 activity arising from a patient’s genetic
`
`2
`
`
`
`Case IPR2016-00690
`Patent 9,138,432 B2
`background, or by the concomitant administration of a CYP2D6 inhibitor,
`such as fluoxetine. Ex. 1001. The challenged claim relates to a method for
`decreasing the risk of QT prolongation in a patient via a dose reduction in
`patients’ co-administered fluoxetine, in particular, by:
`administering to the patient a dose of iloperidone that is 24
`mg/day if, and because, the patient is not being treated with
`fluoxetine; and
`administering to the patient a dose of iloperidone that is 12
`mg/day if, and because, the patient is being treated with
`fluoxetine.
`Id., claim 1.
` Petitioner contends that the Board erred in overlooking its argument
`that one of ordinary skill in the art would have arrived at the claimed
`reduction by routine experimentation. We do not find Petitioner’s argument
`persuasive.
`We concluded that the record as a whole, including FDA Guidance
`1999, supported a mere invitation to experiment as rejected in In re
`Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent
`Litigation, 676 F.3d 1063, 1073 (Fed. Cir. 2012). Dec. at 19, 22–23; see id.
`at 22 (“Such invitations to experiment do not, in light of the present record,
`predict the dosage reduction of the subject claim.”).
`The Decision, including our citation to Cylobenzaprine, makes clear
`our implicit rejection of Petitioner’s argument that, “to arrive at the claimed
`dosages, a POSA need only have followed FDA Guidance 1999’s
`comprehensive guidelines for the performance of drug interaction and dose
`regimen studies” using only “routine experimentation” and with “predictable
`results.” Pet. 54–55, 58; Reh’g Req. 4–5. Petitioner’s reliance on Merck &
`Co. v. Biocraft Labs., Inc., 874 F.2d 804 (Fed. Cir. 1989) and Genzyme
`
`3
`
`
`
`Case IPR2016-00690
`Patent 9,138,432 B2
`Therapeutic Prods. LP v. Biomarin Pharm. Inc., 825 F.3d 1360 (Fed. Cir.
`2016) underscore our reasoning. See Reh’g Req. 8–9.
`Genzyme involved the question of whether one of ordinary skill in the
`art would have arrived at the claimed dosing parameter for enzyme
`replacement treatment of Pompe’s disease with GAA (human acid alpha
`glucosidase) by routine optimization. Genzyme 825 F.3d at 1365. The
`Genzyme Court noted that dosing schedules for enzyme replacement therapy
`of a similar lysosomal protein deficiency condition were known, as was the
`biological half-life of GAA. Id. at 1364. This factual background “provided
`a sound basis for belief that a dosage interval of one to two weeks would be
`effective. In sum, there was little left to do but to confirm that the strategy
`suggested by the various prior art references would work.” Id. at 1373.
`Merck involved the co-administration of two diuretic compounds,
`whose combined effect “was to be expected from the known natriuretic
`properties of the two diuretics.” Merck, 874 F.2d at 809. Thus, as with
`Genzyme, to determine the appropriate dosing, “routine procedures . . .
`produc[ed] only predictable results.” Id.
`Unlike in Merck and Genzyme, the present case does not involve
`predictable results that may be confirmed or fine-tuned by routine
`experimentation. Rather, upon careful consideration of the asserted prior art
`as a whole, we determined that, “it could not be predicted whether a change
`in iloperidone metabolism would have increased, decreased, or had no effect
`on the risk of QT prolongation” and, thus, the amount of dose reduction (if
`any) was unpredictable and would need to be determined empirically. Dec.
`at 22–23 (quoting Prelim. Resp. 15–16); see also id. at 22 (stating that, “the
`art as a whole taught a careful evaluation of [drugs such as iloperidone] for
`evidence of clinically-relevant drug-drug interactions, which may or may not
`
`4
`
`
`
`Case IPR2016-00690
`Patent 9,138,432 B2
`be addressed with dose reductions”).1 Thus, our determination rejects
`Petitioner’s contention that one of ordinary skill in the art would have
`arrived at the claimed dosage reduction by routine experimentation. See
`Coherus Biosciences, Inc., v. Abbvie Biotechnology LTD., Case IPR2016-
`00189, slip op. at 2 (PTAB July 14, 2016) (Paper 27) (“The Board is not
`obligated to respond in writing to every unpersuasive argument made before
`it.”). Accordingly, we are not persuaded we misapprehended or overlooked
`any of Petitioner’s arguments.
`
`
`CONCLUSION
`For the reasons set forth above, Petitioner has not shown that the
`Board’s determination that Petitioner has failed to demonstrate that at least
`one of the challenged claims is unpatentable is based on an erroneous
`interpretation of law, factual findings not supported by substantial evidence,
`or unreasonable judgment in weighing relevant factors. The Request is
`denied.
`
`
`
`
`
`
`1 Our conclusion is underscored by Patent Owner’s evidence that
`when Novartis conducted the type of study suggested by FDA Guidance
`1999, it reached “exactly the wrong conclusion,” with respect to the need for
`iloperidone dosing adjustments. See Prelim. Resp. at 46–47 (citing Ex. 2001
`¶¶ 88–90); Reply 8–9 (same).
`
`5
`
`
`
`Case IPR2016-00690
`Patent 9,138,432 B2
`
`PETITIONER:
`Daniel Brown
`daniel.brown@lw.com
`Robert Steinberg
`bob.steinberg@lw.com
`Emily Melvin
`emily.melvin@lw.com
`Timothy O’Brien
`timothy.obrien@lw.com
`
`PATENT OWNER:
`David Ball
`dball@paulweiss.com
`Josephine Young
`jyoung@paulweiss.com
`
`6
`
`
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