Trials@uspto.gov
`571-272-7822
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`
` Paper 16
`Entered: March 22, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`
`Petitioner,
`v.
`MONOSOL RX, LLC,
`Patent Owner.
`____________
`
`Case IPR2016-01111
`Patent 8,603,514 B2
`____________
`Before ERICA A. FRANKLIN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`

`

`IPR2016-01111
`Patent 8,603,514 B2
`
`INTRODUCTION
`I.
`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
`(collectively, “Petitioner”) request a rehearing of the Decision Denying
`Institution, entered on December 5, 2016 (Paper 14, “Dec.”). Paper 15
`(“Reh’g Req.”). As background, Petitioner filed a Petition to institute an
`inter partes review of 1–3, 9, 15, 62–65, 69–73, and 75 of U.S. Patent No.
`8,603,514 B21 (Ex. 1001, “the ’514 patent”). Paper 1 (“Pet.”). In the
`Petition, Petitioner raised the following challenges to the claims:
`
`Claims Challenged
`1–3, 9, 15, 62–65, 69–73, and 75
`
`Basis
`§ 103
`
`References
`Bess2 and Chen3
`
`1–3, 9, 15, 62–65, 69–73, and 75
`
`§ 103
`
`Chen and Cremer4
`
`Petitioner also relied upon the Declaration of Metin Çelik, Ph.D. (Ex.
`
`1003). MonoSol RX, LLC (“Patent Owner”) filed a Preliminary Response
`to the Petition. Paper 10 (“Prelim. Resp.”).
`Upon considering the Petition, Preliminary Response, and evidence of
`record, we determined that Petitioner failed to demonstrate a reasonable
`likelihood of prevailing in showing the unpatentability of the challenged
`claims. Dec. 1. In the Rehearing Request, Petitioner seeks reconsideration
`of that determination. Reh’g Req. 1.
`
`
`
` 1
`
` Issued to Robert K. Yang et al., Dec. 10, 2013.
`2 US Patent No. 7,067,116, issued Jun. 27, 2006 (Ex. 1004) (“Bess”).
`3 Patent Application Publication No. WO 00/42992, published Jul. 27, 2000
`(Ex. 1005) (“Chen”).
`4 Patent Application Publication No. CA 2,274,910 A1, issued Jun 25, 1998
`(Ex. 1006) (“Cremer”).
`
`
`
`
`2
`
`

`

`IPR2016-01111
`Patent 8,603,514 B2
`
`II. ANALYSIS
`“When rehearing a decision on petition, a panel will review the
`decision for an abuse of discretion.” 37 C.F.R. § 42.71(c). “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.” Id.
`§ 42.71(d). Because Petitioner has not met its burden, as discussed below,
`the Rehearing Request is denied.
`At issue in the Rehearing Request is a decision rendered in Appeal
`2014-000547, an inter partes reexamination of U.S. Patent 7,824,588 B2
`(“the ’588 patent”), referred to as “the ’588 patent decision” (Ex. 1038).
`Petitioner asserts that the “Board overlooked very specific evidence
`provided in the ’588 patent decision, which resulted in misapprehending the
`applicability of the collateral estoppel issue.” Reh’g Req. 3. According to
`Petitioner, the dispositive claim limitation identified in the Decision was
`previously decided in the ’588 patent decision, i.e., that the individual unit
`dose does “not vary by more than 10” of said desired amount of said at least
`one active. Id. (citing Dec. 4). Petitioner asserts also that the Board
`overlooked the “previous finding of inherency as it relates to Chen for the
`very same issue” in the ’588 patent decision. Id. at 11.
`We disagree with Petitioner’s assertion that the Decision overlooks
`Petitioner’s arguments relying upon the ’588 patent decision. The Decision
`specifically addresses those arguments. Dec. 16–17. In that discussion, we
`explain the following:
`
`
`
`
`3
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`

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`IPR2016-01111
`Patent 8,603,514 B2
` In the ’588 patent decision, because Patent Owner did not
`argue any claims separately, the Board resolved the issue of
`whether Chen met the uniformity requirement based on
`independent claim 1 of the ’588 patent. Ex. 1038, 12. Unlike
`independent claims 1 and 62 of the challenged patent, claim 1
`of the ’588 patent, as amended, required only “substantially
`uniform content of therapeutic active composition per unit of
`film.” Ex. 1038, 4. Thus, the ’588 patent decision did not
`resolve the issue of whether Chen met the 10% variation limit
`required by the challenged patents. Consequently, Petitioner
`has not shown that the instant situation meets the requirements
`for applying collateral estoppel, i.e., issue preclusion, because
`the issue presented in the ’588 patent decision is not identical to
`the issue presented here, and resolution of the issue presented in
`this case was not essential to the final judgment in the ’588
`patent decision. See In re Freeman, 30 F.3d 1459, 1465 (Fed.
`Cir. 1994) (setting forth the four requirements for issue
`preclusion).
`Id.5 Thus, we were not persuaded by Petitioner’s argument because
`Petitioner failed to establish, at least, that the issue addressed in the Decision
`is identical to one decided in the first action and that the issue was actually
`litigated in the first action. See Freeman, 30 F.3d at 1465. Because that
`matter was addressed in the Decision, Petitioner has not established that we
`overlooked it.
`
`
`
` 5
`
` Petitioner inappropriately uses its Rehearing Request to take issue with a
`footnote here in the Decision noting that a “district court has issued a
`decision addressing the disclosures of Chen and Bess with respect to the
`’514 patent” and that “our findings are consistent with those set forth in that
`decision.” Reh’g Req. 11 (quoting Dec. 17 n.3.), 13. To the extent that
`Petitioner suggests that note means that the Decision relies, in any way,
`upon the district court findings, that contention is unfounded. The basis for
`the Decision is set forth expressly in the body of the “Analysis” section. See
`Dec. 5–19.
`
`
`
`4
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`

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`IPR2016-01111
`Patent 8,603,514 B2
`Also at issue in the Rehearing Request is the Patent Owner’s reference
`to “findings provided in IPR2015-00165, IPR2015-00167, IPR2015-00168,
`and IPR2015-00169.” Reh’g Request 12. According to Petitioner, because
`those decisions were not “formally entered as exhibits . . . all arguments in
`reliance on these prior IPR proceedings should have carried no evidentiary
`weight in deciding this Petition.” Id. We note that Petitioner did not request
`authorization from the Board to file a reply to the Preliminary Response to
`raise that argument. Presenting that issue for the first time in a Rehearing
`Request is inappropriate. A rehearing request provides a party with an
`opportunity to identify a previously raised matter that the party believes the
`Board misapprehended or overlooked. See 37 C.F.R. § 42.71(d). Here,
`Petitioner has not done so.
`For the foregoing reasons, we conclude that Petitioner has not shown
`that the Board abused its discretion in denying institution of the challenged
`claim. See 37 C.F.R. § 42.71(d).
`
`
` ORDER
`III.
`In consideration of the foregoing, it is hereby ordered that the
`Petitioner’s Rehearing Request is denied.
`
`
`
`
`
`5
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`

`

`IPR2016-01111
`Patent 8,603,514 B2
`
`
`
`
`FOR PETITIONER:
`
`Jeffrey Arnold
`Peter Hagerty
`Leslie-Anne Maxwell
`Andrew Ryan
`CANTOR COLBURN LLP
`jarnold@cantorcolburn.com
`phagerty@cantorcolburn.com
`amaxwell@cantorcolburn.com
`ryan@cantorcolburn.com
`
`
`FOR PATENT OWNER:
`
`Harold Fox
`John Abramic
`STEPTOE & JOHNSON LLP
`hfox@steptoe.com
`jabramic@steptoe.com
`
`
`
`
`
`6
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