`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
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`DR. REDDY’S LABORATORIES, INC.
`Petitioner
`v.
`ICOS CORPORATION
`Patent Owner
`______________________
`
`IPR2017-01757
`Patent No. 6,943,166
`______________________
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`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION FOR
`JOINDER
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`IPR2017-01757
`Patent No. 6,943,166
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`TABLE OF CONTENTS
`INTRODUCTION ..................................................................................... 1
`I.
`STATEMENT OF MATERIAL FACTS .................................................. 2
`II.
`III. ARGUMENT ............................................................................................. 3
`A.
`Joinder to the Mylan IPR Is Not Appropriate ..................................... 3
`1.
`No Efficiency When No Overlap in Experts ............................ 4
`2.
`Joinder Will Not Eliminate the Board’s Need to Evaluate
`DRL’s Petition ......................................................................... 7
`Joinder Will Prevent the Speedy Resolution of the Mylan IPR 8
`3.
`Petitioner’s Motion Fails to Meet Burden of Explaining the Impact of
`Joinder on the Trial Schedule, Briefing, or Discovery ........................ 9
`Joinder Will Negatively Impact the Existing Trial and Prejudice
`Patent Owner ....................................................................................11
`The Board’s Decision in the Convergent IPRs Does Not Control .....12
`D.
`IV. CONCLUSION .........................................................................................14
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`B.
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`C.
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`i
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`TABLE OF AUTHORITIES
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`IPR2017-01757
`Patent No. 6,943,166
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` Page(s)
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`Patent Trial and Appeal Board Cases
`Arris Group, Inc. v. Mobile Telecommunications Tech., LLC,
`IPR2016-00765, Paper 15 (PTAB September 21, 2016) ................................ 4, 8
`AT&T Services, Inc. v. Convergent Media Solutions, LLC,
`IPR2017-01237, Paper 10 (PTAB May 10, 2017) ............................................ 13
`Kyocera Corp. v. SoftView LLC,
`Case IPR2013-00004, Paper 15 (PTAB Apr. 24, 2013) ................................. 1, 9
`
`Sierra Wireless America, Inc. v. M2M Solutions LLC,
`IPR2016-00853, Paper 16 (PTAB September 20, 2016) .............................. 9, 13
`Toyota Motor Corp. v. Am. Vehicular Sciences LLC,
`IPR2015-00261, Paper 10 (PTAB Jan. 29, 2015) ............................................... 6
`ZTE Corp. v. Adaptix, Inc.,
`IPR2015-01184, Paper 10 (PTAB July 24, 2015)............................................... 6
`Federal Statutes
`35 U.S.C. § 315(b) ................................................................................................ 11
`35 U.S.C. § 315 (c) ......................................................................................... 1, 4, 7
`35 U.S.C. § 316 (a)(11) ......................................................................................... 11
`Regulations
`37 C.F.R. § 1.7 ........................................................................................................ 3
`37 C.F.R. § 42.1 ...................................................................................................... 8
`
`37 C.F.R. § 42.1(a) ................................................................................................. 3
`37 C.F.R. § 42.1(b) ................................................................................................. 1
`37 C.F.R. § 42.20(c) ............................................................................................... 1
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`ii
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`37 C.F.R. § 42.51(b)(1)(ii) ...................................................................................... 5
`37 C.F.R. § 42.107(b) ............................................................................................. 3
`Other Authorities
`157 Cong. Rec. S1376 (daily ed. Mar. 8, 2011) ...................................................... 6
`Office Trial Practice Guide, 77 Fed. Reg. 48756 (Aug. 14, 2012) ................... 3, 8, 9
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`iii
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`I.
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`INTRODUCTION
`Dr. Reddy’s Laboratories’ (“DRL”) motion for joinder to IPR2017-00323
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`(“the Mylan IPR”) should be denied as it fails to meet the burden of showing that
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`joinder is appropriate. 37 C.F.R. § 42.20(c). To the contrary, joinder of DRL will
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`needlessly complicate and extend the Mylan IPR that Mylan and Patent Owner
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`(ICOS Corp.) have already moved to terminate—contravening the Board’s charge
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`to resolve “every proceeding” in a “just, speedy, and inexpensive” manner. 37
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`C.F.R. §§ 42.1(b) (emphasis added).
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`DRL’s efficiency argument is premised on the false representation that their
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`evidence is “identical” to the Mylan IPR, when in fact DRL uses different experts.
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`DRL’s argument that joinder will avoid “duplicate” efforts by the Board ignores
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`that, even with joinder, the Board still needs to consider the substance of DRL’s
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`petition and Patent Owner’s preliminary response thereto. See 35 U.S.C. 315 (c).
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`DRL’s motion also fails due to its omission of the required specific
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`discussion of the impact that joinder would have on the trial schedule, or how
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`briefing and discovery may be simplified. See Kyocera Corp. v. SoftView LLC,
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`Case IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013) (representative).
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`Indeed, as detailed below, joinder at this stage will have a considerable negative
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`impact on the trial schedule and unduly prejudice Patent Owner.
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`1
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`II.
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`STATEMENT OF MATERIAL FACTS
`DRL’s “Background” section provides a non-chronological overview of
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`IPR2017-01757
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`selected events. In response, Patent Owner presents a more complete chronological
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`timeline of the events relevant to DRL’s motion for joinder:
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`1. November 22, 2016: Petitioner, Mylan Pharmaceuticals, Inc. filed a
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`petition in IPR2017-00323 (“the Mylan IPR”). (IPR2017-00323, Paper 2.) The
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`Petition challenged the patentability of claims 1–12 based on a single ground—
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`obviousness over the combination of Daugan, SNDA, and the FDA Guideline and
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`relied on the expert declarations of Dr. Grass and Dr. Issa. (IPR2017-00323, Paper
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`12 at 4.)
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`2. March 13, 2017: Patent Owner filed a preliminary response in the
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`Mylan IPR. (IPR2017-00323, Paper 9.)
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`3. April 13, 2017: Patent Owner and Eli Lilly and Co. filed a complaint
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`for infringement against DRL. (Paper 6 at 3.)
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`4. June 12, 2017: the Mylan IPR was instituted based on sole proposed
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`ground of unpatentability, and cited the testimony Dr. Grass. (IPR2017-00323,
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`Paper 12 at 14, 17.)
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`5. July 7, 2017: A joint motion to terminate the proceedings was filed by
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`the parties in the Mylan IPR, stating that the parties had settled their disputes
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`regarding the ’166 patent, that the litigation between the parties had been settled,
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`2
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`and requesting termination of the Mylan IPR. (IPR20107-00323, Paper 16.)
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`6. On July 10, 2017: Eight months after Mylan’s petition and almost
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`three months after Patent Owner’s complaint, DRL filed a petition in IPR2017-
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`01757 concurrent with a motion for joinder to the Mylan IPR. (Papers 2 and 3.)
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`7. DRL’s petition contains expert declarations from Dr. Akhlaghi and
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`Dr. Sliwinski. (Exs. 1002, 1004.) These are different experts than in the Mylan
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`IPR. (IPR2017-00323, Ex. 1002 (Dr. Grass Declaration), Ex. 1004 (Dr. Issa
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`Declaration).)
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`8. DRL’s Motion for Joinder states that “no consent was given” to retain
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`Mylan’s experts. (Paper 3 at 7.)
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`9. The scheduling order in the Mylan IPR sets August 28, 2017 as the
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`due date for filing Patent Owner’s response. (IPR2017-00323, Paper 13
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`(Scheduling Order) at 6.)
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`10. A preliminary response to DRL’s petition is due by November 6,
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`2017 (November 5, 2017 falling on a Sunday). (Paper 6); 37 C.F.R. §§ 1.7, 42.1(a),
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`42.107(b).
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`III. ARGUMENT
`Joinder to the Mylan IPR Is Not Appropriate
`A.
`Consistent with the strong public policy considerations that favor settlement
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`between parties to an inter partes review proceeding (see Office Trial Practice
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`3
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`Guide, 77 Fed. Reg. 48756 at 48768 (Aug. 14, 2012)), the parties to the Mylan IPR
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`reached an agreement regarding their dispute over the ’166 patent and jointly
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`moved to terminate the proceeding. IPR2017-00323, Paper 18 at 1-2 (July 7,
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`2017). If the Mylan IPR is terminated as Patent Owner submits is warranted,
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`joinder is moot. See 35 U.S.C. § 315(c); see also Arris Group, Inc. v. Mobile
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`Telecommunications Tech., LLC, IPR2016-00765, Paper 15 at 13 (PTAB
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`September 21, 2016).
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`DRL asserts that terminating the Mylan IPR only with respect to Mylan, and
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`then joining DRL, is appropriate “as a matter of efficiency” and “public policy.”
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`(Mot. at 2.) DRL’s boilerplate efficiency and public policy assertions, however, are
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`disconnected from the facts of this case. Here, DRL’s use of different experts than
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`Mylan adds complexity, not efficiency. Joinder would not preserve Board
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`resources, as the Board would separately need to consider DRL’s Petition in view
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`of Patent Owner’s forthcoming preliminary response. Joinder would also impede
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`the speedy resolution of the Mylan IPR, which is ripe for termination. Public
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`policy favoring settlement, as the parties have reached in the Mylan IPR, also
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`weights against joinder.
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`No Efficiency When No Overlap in Experts
`1.
`As DRL admits, it did not obtain consent to use Mylan’s experts and is
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`instead relying on two entirely different experts. (Mot. at 6-7.) This case is thus
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`4
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`distinct from situations where the party seeking to join an IPR uses the same expert
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`declarant as the existing and active petitioner in the case. And, notably, DRL cites
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`no case where the joining party’s expert was different from the expert in the
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`instituted IPR and the joined case proceeded with only the joining party’s expert.
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`Rather than increase efficiency, joinder with different experts will result in a more
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`complicated proceeding than if the cases remain separate, and DRL itself does not
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`credibly argue otherwise.
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`For example, DRL does not address how it would be possible to proceed on
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`the same schedule of the Mylan IPR when Patent Owner’s response in the Mylan
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`IPR is due on August 28, 2017, Mylan’s experts are not available for a deposition
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`since Mylan is no longer participating in the Mylan IPR, Patent Owner’s
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`Preliminary Response in the DRL IPR is not due before November 6th (see supra
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`II.10), and, of course, the DRL IPR has not been instituted. DRL also fails to
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`address the prejudice to Patent Owner who will be unable to depose experts who
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`submitted declarations in the Mylan IPR, and upon whom the Board relied. 37
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`C.F.R. § 42.51(b)(1)(ii) (routine discovery includes cross examination of affidavit
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`testimony); IPR2017-00323, Paper 12 at 13-14 (June 12, 2017) (citing to the
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`testimony of Mylan’s expert Dr. Grass). Indeed, Patent Owner will be prejudiced
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`by Mylan’s expert statements remaining in the record without being subject to
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`cross-examination.
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`5
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`DRL also argues that it is entitled to joinder as “a matter of right.” (Mot. at
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`6.) Not so. DRL’s reliance on entirely different experts necessarily introduces new
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`issues, including, but not limited to, the experts’ qualifications. See Toyota Motor
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`Corp. v. Am. Vehicular Sciences LLC, IPR2015-00261, Paper 10 at 5 (PTAB Jan.
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`29, 2015) (denying motion for joinder and noting that the reliance on a different
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`expert was a “significant difference”); see also ZTE Corp. v. Adaptix, Inc.,
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`IPR2015-01184, Paper 10 at 4-5 (PTAB July 24, 2015). Moreover, DRL fails to
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`address the substantive differences between the expert declarations, including
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`different language (compare Mylan Ex. 1002 at 12 (“dramatic reduction”) with
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`DRL Ex. 1002 at 12 (“dramatic change”); compare Mylan Ex. 1002 at ¶ 94 with
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`DRL Ex. 1004 at ¶ 94) and deleted opinions (compare Mylan Ex. 1002 at ¶ 26
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`with DRL Ex. 1002 at ¶ 26 (deleting the assertion that “[m]inimal increases to
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`clinical benefit were similarly observed for dosages above 50 mg.”); compare
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`Mylan Ex. 1002 at ¶95 with DRL Ex. 1002 at ¶95 (deleting last sentence regarding
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`“starkly different rates of side effect reporting”)). In view of these substantive
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`differences, DRL’s generic assertion that its declarations are “substantially
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`identical” to the Mylan IPR is without merit.
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`Further, the “matter of right” statement by Senator Kyle that DRL quotes
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`concerned “identical” petitions. 157 Cong. Rec. S1376 (daily ed. Mar. 8, 2011)
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`(statement of Sen. Kyle) (emphasis added). At a minimum, the differences in
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`6
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`expert declarations means that DRL did not submit an identical petition. Senator
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`Kyle, and the resulting statute, 35 U.S.C. §315(c), also recognized that the decision
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`to grant joinder is discretionary. Id. In this case, the inefficiency and prejudice
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`resulting from the lack of expert overlap counsels strongly against joinder.
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`2.
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`Joinder Will Not Eliminate the Board’s Need to Evaluate
`DRL’s Petition
`DRL argues that institution of its Petition as a “novel IPR” would require the
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`Board to “restart the review process, thus duplicating its past efforts.” (Mot. at 2;
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`see also Mot. at 6 (noting that joinder would “avoid de novo review of the same
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`IPR”).) DRL presumes that the Board does not have to consider the merits of
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`DRL’s Petition, Patent Owner’s preliminary response to DRL’s Petition, or write
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`an institution decision on DRL’s Petition. This is incorrect. Under 35 U.S.C.
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`315(c), joinder may only occur after the Director receives a preliminary response
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`(or the time for filing one has expired) and determines that DRL’s petition warrants
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`institution. DRL fails to specifically identify any task of the Board that joinder
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`would remove. Moreover, because the Mylan IPR should be terminated, there is no
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`future duplication of efforts avoided by joinder, only a needless complication of
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`the schedule (see infra at III.C). DRL’s vague assertion that joinder will be a more
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`efficient use of Board time and resources therefore lacks support and should be
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`deemed unpersuasive.
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`7
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`3.
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`Joinder Will Prevent the Speedy Resolution of the Mylan
`IPR
`DRL incorrectly asserts that public policy weighs in favor of joinder by
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`securing the “just, speedy, and inexpensive resolution of the challenge to the ’166
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`patent.” (Mot. at 5-6.) But 37 C.F.R. § 42.1, which DRL cites, requires the just,
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`speedy, and inexpensive resolution of every “proceeding”−not resolution of every
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`patent. As the parties in the Mylan IPR proceeding have submitted a joint motion
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`to terminate, DRL’s proposed joinder can only delay resolution and increase the
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`expense of that proceeding. See Arris Group, IPR2016-00765, Paper 13 at 3.
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`Public policy therefore dictates the opposite of what DRL asserts—termination of
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`the Mylan IPR (“the just, speedy, and inexpensive resolution of [that] proceeding”)
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`and denial of DRL’s motion for joinder. DRL also provides no support for its
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`assertion that joinder would even result in a speedier resolution of the patentability
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`of the ’166 patent claims. (See Mot. at 2, 5-6.) As set forth below, because DRL
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`doesn’t explain the impact joinder would have on the trial proceedings, this claim
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`is unsubstantiated. (See infra III.C.)
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`In addition to being counter to the PTO’s policy promoting the just, speedy,
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`and inexpensive resolution of proceedings, joinder in this case is also counter to
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`the strong public policy favoring settlement between parties in IPR proceedings.
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`See Office Trial Practice Guide, 77 Fed. Reg. 48756 at 48768. As the Trial Practice
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`8
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`Guide states, “the Board expects that a proceeding will terminate after the filing of
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`a settlement agreement, unless the Board has already decided the merits of the
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`proceeding.” Id; (IPR2017-00323, Paper 12 (Mylan IPR is at a stage after
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`institution of trial, but before the patent owner response, with no final decision on
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`the merits having been made). Parties may be less likely to pursue settlement and
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`move to terminate a proceeding if there is considerable uncertainty over whether
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`the Board will indeed terminate the entire proceeding.
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`B.
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`Petitioner’s Motion Fails to Meet Burden of Explaining the
`Impact of Joinder on the Trial Schedule, Briefing, or Discovery
`In the Board’s representative Kyocera Corp. opinion, it stated that a joinder
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`motion must “explain how the impact on the schedule and costs of the current
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`proceedings will be minimized . . . [and] address how briefing and/or discovery
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`may be simplified to minimize schedule impact.” IPR2013-00004, Paper 15 at 4.
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`DRL’s motion fails to meet this burden.
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`With respect to trial impact, DRL states that it agrees to adhere to the Mylan
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`IPR deadlines and that the trial schedule “should not be adversely impacted.” (Mot.
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`at 6-7.) This is insufficient. See Sierra Wireless America, Inc. v. M2M Solutions
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`LLC, IPR2016-00853, Paper 16 at 3 (PTAB September 20, 2016) (finding that
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`petitioner’s general statements regarding the schedule did not sufficiently address
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`the impact joinder would have on the trial schedule). DRL fails to address how the
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`9
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`Mylan IPR schedule could be adhered to when Patent Owner’s response is due on
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`August 28, 2017, but a preliminary response to DRL’s Petition is not due until at
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`least November 6, 2017. (Paper 6; see supra II.10.) Under the current schedule in
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`the Mylan IPR, Petitioner’s reply may be due before DRL could even be joined.
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`DRL’s motion should be denied at a minimum based on its insufficient
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`oversimplification of the impact joinder will have on the trial schedule, as well as
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`on the merits because joinder here would necessary adversely affect the trial
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`schedule.
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`With respect to briefing and discovery, DRL simply states that the
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`depositions should be no more complicated because the expert’s analysis is the
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`same. (Mot. at 7.) But as discussed above, this does not address what experts will
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`be deposed or when they could be deposed as part of routine discovery. It also fails
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`to address any modifications needed to the procedure for exhibit objections:
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`whether Patent Owner’s objections to Mylan’s exhibits (Paper 15 in IPR2017-
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`00323) should apply to DRL’s exhibits; whether DRL is adopting Mylan’s exhibit
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`objections (Paper 14 in IPR2017-00323); the time for filing any new exhibit
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`objections (e.g. to new expert declarations); whether the supplemental evidence
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`served by Patent Owner on Mylan should be served on DRL; or whether DRL will
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`move to serve any supplemental evidence in response to Patent Owner’s exhibit
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`objections. DRL’s motion should therefore be denied for its failure to address any
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`of these briefing and discovery issues.
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`C.
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`Joinder Will Negatively Impact the Existing Trial and Prejudice
`Patent Owner
`DRL’s petition was filed nearly eight months after the petition in the Mylan
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`IPR. Joinder under the same schedule of the Mylan IPR (as DRL asserts), to the
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`extent even theoretically possible, would be incredibly complicated, and either
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`result in extending the pendency of the Mylan IPR or be unduly prejudicial to
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`Patent Owner. In contrast, DRL would not be harmed by allowing the DRL
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`petition to proceed in due course because they are not barred in these current
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`proceedings and do not need to rely on joinder to avoid a bar under 35 U.S.C. §
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`315(b).
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`To conduct the Mylan IPR following joinder of an instituted DRL
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`proceeding, the date for the final determination of the Mylan IPR would need to be
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`extended. The Mylan IPR was instituted on June 12, 2017. A final decision is
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`therefore currently due by June 12, 2018. 35 U.S.C. §316 (a)(11). A preliminary
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`response to the DRL petition is not due, however, until at least November 6, 2017.
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`(Paper 6, see supra II.10.) To allow the Board and the parties the full benefit of the
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`one year timeline of a typical IPR proceeding, the June 12, 2018 date would need
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`to be extended. Id. An extension would be the antithesis of a “speedy resolution”
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`of the Mylan IPR, and especially not appropriate when DRL could have copied
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`11
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`Mylan’s petition against the ’166 patent and filed it at any time in the last eight
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`months.
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`If the timeline is not extended for the Mylan IPR, Patent Owner would be
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`deprived of the necessary time to present a complete defense of its patent. For
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`example, even assuming the Board institutes immediately following a November
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`preliminary response, this leaves only seven months to conduct the entire trial and
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`write a final written decision before June 12, 2018. Either Patent Owner,
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`Petitioner, the Board, or all parties would have to needlessly sacrifice significant
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`portions of its time to meet this deadline.
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`Under either scenario, and in contrast to DRL’s allegations, joinder would
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`have a significant negative impact on the existing Mylan IPR trial schedule. For at
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`least this reason, DRL’s motion should be denied.
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`D. The Board’s Decision in the Convergent IPRs Does Not Control
`DRL incorrectly states that joinder would comport with the Board’s decision
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`in the Convergent IPRs, which it asserts controls1. (Mot. at 1.) To the contrary, the
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`Board looks at issues of joinder on a case-by-case basis, “taking into account the
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`1 The Convergent IPR has not been designated as precedential and therefore is not
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`binding authority. See Patent Trial and Appeal Board Standard Operating
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`Procedure 2 (Revision 9) (https://www.uspto.gov/sites/default/files/documents/
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`sop2-revision-9-dated-9-22-2014.pdf).
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`12
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`particular facts of each case, substantive and procedural issues, and other
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`considerations.” Sierra Wireless America, Inc., IPR2016-00853, Paper 16 at 3.
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`Because the Board’s Convergent IPR decisions concerned entirely distinct facts, it
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`is neither controlling nor comports with the present case.
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`In the Convergent IPRs, the Board granted joinder of a second IPR against
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`Convergent before terminating the petitioner in the first filed IPR. AT&T Services,
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`Inc. v. Convergent Media Solutions, LLC, IPR2017-01237, Paper 10 at 2, 24-27
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`(PTAB May 10, 2017). The Board noted, however, that patent owner waived its
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`right to file a preliminary response, petitioner in the second IPR used the same
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`expert and expert declaration from the first IPR, and that under the “particular
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`circumstances of this case” the Board would act on the motion for joinder before
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`the motion to terminate because the motion for joinder was filed first. Id. Here,
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`Patent Owner has not waived (and is not waiving) its right to file a preliminary
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`response; DRL has not used the same expert as in the Mylan IPR; and the motion
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`for termination in the Mylan IPR was filed before DRL’s motion for joinder (Mot.
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`at 1). Accordingly, none of the “particular circumstances” relied on by the Board in
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`the Convergent IPRs apply to this case. DRL failed to discuss any of these
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`distinctions or explain why the Convergent IPRs should allegedly “control” in light
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`of these differences. Indeed, the lack of overlap in timing and experts between
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`DRL’s Petition and the Mylan IPR counsels against joinder. (See supra III.A,
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`13
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`III.C.)
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`IV. CONCLUSION
`For the foregoing reasons, Patent Owner submits that joinder is not
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`appropriate and therefore the Board should deny Petitioner’s motion.
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`Dated: August 10, 2017
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`Respectfully submitted,
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`By:
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`/ Maureen D. Queler /
`
`
`
`Mark J. Feldstein, Reg. No. 46,693
`Maureen D. Queler, Reg. No. 61,879
`Finnegan, Henderson, Farabow, Garrett
` & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner in
`IPR2017-01757
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing PATENT
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`OWNER’S OPPOSITION TO PETITIONER’S MOTION FOR JOINDER
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`was served on August 10, 2017, via electronic mail directed to counsel of record
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`for the Petitioner at the following:
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`Louis H. Weinstein (Reg. 45,205) lweinstein@buddlarner.com;
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`Alan H. Pollack (Reg. No. 39,802) apollack@buddlarner.com
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`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078
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`Petitioner has consented to electronic service.
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`Date: August 10, 2017
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` By: /John W. Kozikowski/
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`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, LLP
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