Trials@uspto.gov
`571-272-7822
`
` Paper 23
` Entered: September 2, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`COALITION FOR AFFORDABLE DRUGS V LLC,
`Petitioner,
`v.
`BIOGEN MA INC.,
`Patent Owner.
`__________
`
`Case IPR2015-01136
`Patent 8,399,514 B2
`__________
`
`Before FRED E. McKELVEY, SALLY GARDNER LANE, and
`DEBORAH KATZ, Administrative Patent Judges.
`
`McKELVEY, Administrative Patent Judge
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`Page 1 of 17
`
`Biogen Exhibit 2027
`Mylan v. Biogen
`IPR2018-01403
`
`
`571-272-7822
`
` Paper 23
` Entered: September 2, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`COALITION FOR AFFORDABLE DRUGS V LLC,
`Petitioner,
`v.
`BIOGEN MA INC.,
`Patent Owner.
`__________
`
`Case IPR2015-01136
`Patent 8,399,514 B2
`__________
`
`Before FRED E. McKELVEY, SALLY GARDNER LANE, and
`DEBORAH KATZ, Administrative Patent Judges.
`
`McKELVEY, Administrative Patent Judge
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`Page 1 of 17
`
`Biogen Exhibit 2027
`Mylan v. Biogen
`IPR2018-01403
`
`
`
`IPR2015-01136
`Patent 8,399,514 B2
`
`
`
`I. Introduction
`Pending before the Board is Petitioner’s First Amended Petition1
`
`(“Pet.”) (Paper 9) seeking entry of an order instituting an inter partes review.
`
`Patent Owner timely filed a Preliminary Response. (“Prelim. Resp.”)
`(Paper 21).
`
`II. Background
`A. Parties
`Petitioner is Coalition for Affordable Drugs V LLC along with ten
`
`other entities.2 Pet. 1–2.
`
`Patent Owner is Biogen MA Inc. Prelim. Resp. 1.
`B. Involved Patent
`The involved patent is U.S. Patent 8,399,514 B2 (“the ʼ514 Patent”)
`
`issued 19 March 2013. Ex. 1001A.
`
`
`1 An earlier version of the Petition appears in the record. See Paper 2
`(1 May 2015). We have considered only the First Amended Petition
`(Paper 9, filed 27 May 2015) in resolving whether to institute an inter partes
`review trial.
`
` 2
`
`
`
`
`
` The ten other entities are identified as:
`
`(1) Hayman Credes Master Fund, L.P. (“Credes”),
`(2) Hayman Orange Fund SPC (“HOF”),
`(3) Hayman Capital Master Fund, L.P. (“HCMF”),
`(4) Hayman Capital Management, L.P. (“HCM”),
`(5) Hayman Offshore Management, Inc. (“HOM”),
`(6) Hayman Investments, L.L.C. (“HI”),
`(7) nXn Partners, LLC (“nXnP”),
`(8)
`IP Navigation Group, LLC (“IPNav”),
`(9)
`J. Kyle Bass, and
`(10) Erich Spangenberg.
`
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`The application which matured into the ʼ514 Patent was filed on
`
`13 February 2012. Ex. 1001A, 1 (22).
`
`The ʼ514 Patent claims priority based on several applications; the
`earliest of which was filed on 8 February 2007. Id. (60).
`
`The ʼ514 Patent contains claims 1–20. Ex. 1001A, cols. 27–30.
`Petitioner challenges all of the claims, viz., claims 1–20. Pet. 1:2–4.
`
`C. Abbreviations
`Dimethyl fumarate3
`Expanded disability status scale—mentioned in Kappos
`Monomethyl fumarate4
`Magnetic resonance imaging—mentioned in Kappos
`Multiple sclerosis
`Per os (by mouth or orally)
`Relapsing-remitting multiple sclerosis—mentioned in
`Kappos
`
`DMF
`EDSS
`MMF
`MRI
`MS
`PO
`RRMS
`
`
`
`
`
`
`
`
`3 The structural formula for DMF is:
`
`
`
`4 The structural formula for MMF is:
`
` 3
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`
`
`ICH Guideline
`
`
`
`
`ClinicalTrials
`NCT00168701
`“ClinicalTrials”
`
`D. Prior art
`The prior art relied upon is:
`J. Neurol. (2005)
`
`252 [Suppl.
`
`2]:A Randomized,
`
`placebo-
`
`controlled phase
`
`II trial of a novel
`Kappos et al.
`oral single-agent
`“Kappos”
`fumarate therapy,
`BG00012, in
`patients with
`relapsing-
`remitting multiple
`sclerosis
`Dose-Response
`Information to
`Support Drug
`Registration E4
`Double-Blind,
`Placebo-
`Controlled, Dose-
`Ranging Study to
`Determine the
`Efficacy and
`Safety of
`BG00012 in
`Subjects with
`Relapsing-
`Remitting
`Multiple Sclerosis
`
`
`
`
`
`
`2005
`
`
`
`
`
`
`Ex. 1003A
`
`
`Ex. 1004A
`
`
`
`
`Ex. 1022A
`
`
`10 Mar. 1994
`
`
`Dated:
`14 Sept. 2005,
`identified as
`downloaded from
`ClinicalTrials.gov
`archive, U.S.
`National
`Institutes of
`Health
`
`
`In addition, Petitioner relies on what it characterizes as an “admission
`
`of prior art” and specifically a statement in the written descriptive portion of
`the Specification of the ʼ514 patent. Ex. 1001A, col. 5:6–7: “Fumaric acid
`
` 4
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`2
`
`3
`
`1–20
`
`1–20
`
`1–20
`
`esters, such as DMF [dimethyl fumarate], have been proposed for treatment
`of MS [multiple sclerosis]” (Pet., page 6:4–5), citing (Ex. 1001A, col. 5:7),
`inter alia, BG 12, 6 Drugs R&D 229–30 (2005) (Ex. 1021A).
`E. Related Proceeding
`The ʼ514 Patent is also involved in Biogen MA Inc. v. Forward
`
`Pharma AS, Interference 106,023 (PTAB Declared 13 Apr. 2015)
`(Interference 106,023, Paper 1).
`In the interference, Forward Pharma was authorized to file, and has
`filed, Forward Pharma Motion 7 seeking entry of a judgment against Biogen
`alleging that the claims of the ʼ514 Patent are unpatentable under 35 U.S.C.
`§ 103(a) over the prior art. Interference 106,023, Paper 167. An Opposition
`to the Motion has not yet been filed.
`In determining whether to institute a trial in this IPR, we have not
`considered any of the evidence offered, or arguments made, by Forward
`Pharma in support of its Motion 7.
`F. Challenges
`While Petitioner mentions only a “Ground 1,” there are in fact three
`challenges—which we identify as Challenges 1–3. Pet. 6.
`35
`Prior art forming basis of
`Challenge
`Claims
`U.S.C.
`No.
`challenge
`1
`§ 103(a)
`Kappos and
`ICH Guideline
`ClinicalTrials and
`ICH Guideline
`Prior art admissions and
`ICH Guideline
`
`§ 103(a)
`
`§ 103(a)
`
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`G. Claims 1, 11, 15, and 20 of the ʼ514 Patent
`The claimed invention is readily understood from the independent
`claims.
`
`
`
`Claim 1
`Claim 1 of the ʼ514 Patent reads [indentation added]:
`A method of treating a subject in need of treatment
`for multiple sclerosis comprising
`orally administering to the subject in need thereof
`a pharmaceutical composition consisting essentially of
`(a) a therapeutically effective amount of dimethyl
`fumarate, monomethyl fumarate, or a combination
`thereof, and
`(b) one or more pharmaceutically acceptable
`excipients,
`wherein the therapeutically effective amount of
`dimethyl
`fumarate, monomethyl
`fumarate, or a
`combination thereof is about 480 mg per day.
`
`
`Claim 11
`Claim 11 of the ʼ514 Patent reads [indentation added]:
`A method of treating a subject in need of treatment
`for multiple sclerosis consisting essentially
`of orally administering to the subject about 480 mg
`per day
`of dimethyl fumarate, monomethyl fumarate, or a
`combination thereof.
`
`
`
`Claim 15
`Claim 15 of the ʼ514 Patent reads [indentation added]:
`A method of treating a subject in need of treatment
`for multiple sclerosis comprising
`orally administering to the subject pharmaceutical
`composition consisting essentially of
`
` 6
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`(a) a therapeutically effective amount of dimethyl
`fumarate and
`(b) one or more pharmaceutically acceptable
`excipients,
`wherein the therapeutically effective amount of
`dimethyl fumarate is about 480 mg per day.
`
`
`Claim 20
`Claim 20 of the ʼ514 Patent reads [indentation added]:
`A method of treating a subject in need of treatment
`for multiple sclerosis comprising
`treating
`the subject
`in need
`therapeutically effective amount of
`dimethyl fumarate, monomethyl fumarate, or a
`combination thereof,
`wherein the therapeutically effective amount of
`dimethyl
`fumarate, monomethyl
`fumarate, or a
`combination thereof is about 480 mg per day.
`
`thereof with a
`
`
`
`
`
`III. Analysis—Challenge 1
`Challenge 1 is limited to Kappos and ICH Guideline.
`
`Kappos describes the following (Ex. 1003A, page ll/148,
`
`cols. 1–2:P574) (italics added):
`Objective: To determine the efficacy and safety of
`a novel single-agent oral fumarate therapy, BG00012,[5]
`in patients with relapsing-remitting multiple sclerosis
`(RRMS).
`
`study
`pilot
`open-label
`Background: An
`demonstrated that a product containing a mixture of
`fumaric acid esters significantly reduced the number and
`
`5 The active ingredient of BG12 or BG00012 is dimethyl fumarate. See
`Exhibit 1 forming part of Ex. 1007A (page 16 of 87; ¶ 5).
`
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`in
`lesions
`volume of gadolinium-enhancing (Gd+)
`patients with RRMS. BG00012 is being investigated for
`the treatment of psoriasis and other autoimmune diseases,
`including MS [multiple sclerosis]. This phase II study
`was designed to evaluate the efficacy of three doses of
`BG00012 on brain lesion activity as measured by
`magnetic resonance imaging (MRI) in patients with
`RRMS.
`
`is a randomized, double-blind,
`Design: This
`placebo-controlled, phase II study being conducted at 45
`clinical centers in Europe. Patients were included in the
`study if they were between 18 and 55 years of age, had a
`definite diagnosis of RRMS, and an Expanded Disability
`Status Scale (EDSS) score between 0.0 and 5.0. In
`addition, patients must have either experienced at least 1
`relapse within 12 months prior to randomization with
`lesions on cranial MRI consistent with MS, or had Gd+
`lesions on a cranial MRI performed within 6 weeks of
`randomization. Eligible patients were randomized to
`receive BG00012 120 mg PO once daily (120 mg/day),
`120 mg PO three times daily (360 mg/day), 240 mg PO
`three times daily (720 mg/day), or placebo. The study
`consists of 2 phases: a 24-week double-blind treatment
`phase followed by a 24-week, blinded, safety-extension
`phase in which all patients will receive some level of
`BG00012. The primary endpoint is the total number of
`Gd+ lesions over four MRI scans at weeks 12, 16, 20,
`and 24 (calculated as the sum of these four MRI scans).
`Secondary MRI endpoints
`include
`the cumulative
`number of new Gd+ lesions and the number of new or
`newly enlarging T2-hyperintense lesions at week 24
`compared with baseline. Additional endpoints include:
`the number of new T1-hypointense lesions at week 24
`compared to baseline, safety and tolerability, disability
`progression as measured by EDSS, relapse rate, and
`proportion of relapse-free patients.
`
` 8
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`Results: This paper will present details of the study
`design, as well as the baseline demographic and clinical
`characteristics of enrolled patients.
`
`study will
`Conclusions: This dose-ranging
`determine the efficacy of BG00012 on brain lesion
`activity in patients with RRMS.
`
`According to Petitioner’s witness Dr. Steven E. Linberg, Kappos
`“discloses a pilot study that orally administered to patients what appears to
`be a therapeutically effective amount of fumaric acid esters, indicated by a
`‘significantly reduced the number of gadolinium-enhancing (Gd+) lesions in
`patients with RRMS.’” Ex. 1005A, 14:1–4.
`From this testimony, Petitioner invites us to find that Kappos
`describes the use of DMF as a compound useful for treating multiple
`sclerosis. We decline the invitation.
`First, a copy of a description of the “pilot study” has not been made of
`record. Hence, we have not been favored with a description of the details of
`the pilot study.
`Second, at best Dr. Linberg said only that it “appears” that
`therapeutically an effective amount of fumaric acid esters was tested. What
`counts is what is described, not what appears to have been tested (a prior use,
`public or otherwise, is not prior art available in an IPR).
`Third, a description of a “fumaric acid ester” may or may not be a
`description of DMF. There are fumaric acid esters other than DMF which
`have been described as potentially useful for treating multiple sclerosis. See,
`e.g., Ex. 1001A, col. 11:11–24:
`
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`In some embodiments, the [fumaric acid ester]
`compound . . . has the structure of Formula IV:
`
`
`or a pharmaceutically acceptable salt thereof, wherein:
`Rl and R3 are independently selected from OH; O–;
`(C1–24)alkoxy . . . .
`
`Formula (IV) is DMF when R1 and R3 are both C1-alkoxy (–OCH3).
`
`Formula (IV) is MMF when R1 is –OH and R3 is C1-alkoxy (–OCH3).
`
`Consistent with In re Hughes, 345 F.2d 184 (CCPA 1965) (if a
`
`reference is subject to two interpretations, then it will not support an
`anticipation rejection), we are unable to find that “a fumaric acid ester” as
`described by Kappos is DMF or MMF.
`Fourth, and perhaps most important, is that Kappos tells one skilled in
`
`the art that there was a pilot study and that a Phase II study will be
`undertaken to evaluate efficacy of BG00012 inter alia for treatment of MS.
`The nature of the pilot study is not apparent. Petitioner has not
`established the precise nature of the study and whether researchers were
`determining a therapeutically effective amount. The Pilot Study is not a
`description that DMF is useful for treating MS; rather, at best it is a “hope”
`that DMF will turn out to be useful for treating MS. A hope may or may not
`come true and does not establish that DMF is useful for treating MS.
`
`Assuming Phase I does not reveal unacceptable toxicity, FDA Phase
`II may determine whether a “drug works in people who have a certain
`disease or condition.” Id. Phase II may or may not establish that DMF is
`
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`useful for treating MS. However, prior to completion and evaluation of
`Phase II, one skilled in the art would not necessarily understand from
`Kappos that DMF is useful for treating MS.
`We wish to make clear that we are not engrafting into the § 103(a)
`obviousness evaluation whether DMF as a drug is effective. In re Anthony,
`414 F.2d 1383 (CCPA 1969) (FDA, not USPTO, is responsible for safety of
`drugs which are sought to be patented); In re Watson, 517 F.2d 465 (CCPA
`1975) (Congress has given responsibility to FDA, not USPTO, to determine
`in the first instance whether drugs are safe); Purdue Pharma L.P. v. Endo
`Pharmaceuticals Inc., 438 F.3d 1123, 1134 (Fed. Cir. 2006) (quantum of
`proof necessary for FDA approval is significantly higher than the proof
`required in the USPTO). Nevertheless, Petitioner has bottomed its case on a
`publication describing potential FDA phase I and II testing and we have
`considered the content of Kappos to determine if it describes DMF as being
`known to be useful in treating MS. We are unable, consistent with the
`“description” requirement of § 102(b), to find a reasonable likelihood that
`Kappos teaches that DMF was known to be useful in treating MS.
`Because Petitioner has failed to establish that Kappos teaches that
`DMF would be useful for treating MS, we need not evaluate whether the
`claimed dosage would or would not have been obvious based on ICH
`Guideline.
`We decline to institute an inter partes review trial on the basis of
`Challenge 1.
`Petitioner has failed to establish that there is a reasonable likelihood
`that it will prevail as to any claim on the basis of Kappos and ICH Guideline.
`
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`IV. Analysis—Challenge 2
`Challenge 2 is based on ClinicalTrials and ICH Guideline.
`ClinicalTrials is a copy of a U.S. National Institutes of Health
`document found by Petitioner on the internet.
`Patent Owner argues that ClinicalTrials “is [not] a prior art printed
`publication.” Prelim. Resp. 22:10.
`Because we decline to institute an inter partes review, we will assume,
`without deciding, that ClinicalTrials is a printed publication.
`A relevant portion of ClinicalTrials reveals the following. Ex. 1022A,
`1–2 of 6 (italics added; citations omitted):
`DMF, the active ingredient in BG00012, is an
`immunomodulator demonstrating definite
`therapeutic
`efficacy in psoriasis . . . and possible therapeutic efficacy
`in MS. . . . However, the target site of action and the
`exact mechanism of action of DMF are unknown.
`
`Like psoriasis, MS has been postulated to be
`driven by a Th1 cytokine reaction and to therapeutically
`respond
`to
`either
`immunosuppression
`or Th2
`suppression . . . . Putative effects of BG00012 include
`suppression of circulating T cell population, down
`regulation of adhesion molecule expression, modulation
`of the Th1/Th2 cytokine expression profile, inhibition of
`neutrophil burst, and TNF-induced CD62E expression
`through suppression of NF-kB nuclear translocation.
`
`Methyl fumaric acid esters (FUMADERMÒ) have
`been shown to reduce peripherally in vivo circulating
`CD4+, CD8+ and CD52+ mononuclear cells . . . . This
`circulatory reduction has been associated with a decrease
`in intradermal mononuclear cell infiltration in psoriasis
`patients (another T cell-mediated disease) . . . . DMF
`
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`induce substantial plasma
`to
`was recently shown
`membrane
`alterations potentially
`linked
`to
`the
`deactivation via apoptosis of lymphocytes . . . .
`
`Methylfumarates have been shown to modulate in
`vitro T cell cytokine profile from Th1 to Th2 . . . . DMF
`and MMF inhibit the proliferation of keratinocytes,
`possibly due to a temporary rise in the intracellular
`calcium concentration . . . . Methylfumarates have been
`shown to prevent acute and chronic rejection in rat
`kidney transplantation models . . . .
`
`
`. . . It is difficult to assess the validity of some in
`vitro data that have been derived using doses that exceed
`serum levels found in human trials . . . .
`
`
`immunomodulatory
`the putative
`In summary,
`effects, the psoriasis efficacy of FUMADERM®, and the
`efficacy data in the pilot MS study of BG00012 support a
`proof of concept study in MS.
`
`ClinicalTrials is deficient as a prior art teaching of DMF being useful
`
`to treat MS for many of the same reasons that Kappos is deficient.
`
`Nowhere does ClinicalTrials state that DMF is useful for treating MS.
`Rather, what is described is a “pilot MS study of BG00012” (not of record)
`and based on that study going forward with “a proof of concept study in MS.”
`Ex. 1022A 1–2. ClinicalTrials, at best, describes a “possible therapeutic
`efficacy in MS,” citing a 2001 article by Schimrigk et al. (not of record).
`
`Petitioner makes an attempt to bolster the effectiveness of DMF for
`treating MS based on Phase II tests described as showing DMF effectiveness
`on psoriasis. However, on the record before us, we find the connection
`between psoriasis and MS too speculative to support a finding that because
`
`
`
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`DMF is effective for treating psoriasis that it also would be effective for
`treating MS. There is insufficient evidence to find that one skilled in the art
`would find that there is a reasonable likelihood of success at the end of DMF
`testing for MS.
`ClinicalTrials might support a finding that one skilled in the art
`“hopes” DMF will be useful in treating MS. However, as noted in our
`discussion of Kappos, a “hope” may or may not come to pass.
`We decline to institute an inter partes review trial on the basis of
`ClinicalTrials and ICH Guideline.
`Petitioner has not established that a reasonable likelihood that it will
`prevail as to any claim attached on the basis of Challenge 2.
`V. Analysis—Challenge 3
`Challenge 3 is based on admissions said to have been in the ʼ514
`Patent and ICH Guideline.
`The admission is believed to be the following:
`Fumaric acid esters, such as DMF, have been proposed
`for treatment of MS (see, e.g., [1] Schimrigk et al., Eur. J.
`Neurol., 2006, 13(6):604-10; [2] Drugs R&D, 2005,
`6(4):229-30).
`
`Ex. 1001A, col 5:6–8.
`Patent Owner attacks use of the admission on the ground that “an
`alleged admission is not a patent or printed publication and therefore cannot
`be a basis to institute an inter partes review. 35 U.S.C. § 311(b).” Prelim.
`Resp. 25.
`
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`The “admission” (or statement in the ʼ514 Patent) is supported by a
`
`citation to Drugs R&D, a document in the record of this IPR (Ex. 1021A).
`Petitioner did not place Schimrigk (2006) in the record.
`
`We do not reach, leaving for another day, any issue of whether an
`“admission” per se can be relevant prior art in an IPR. Given the citation to
`Drugs R&D (of the record), we will consider the “admission” in context
`with Drugs R&D.
`
`When the “admission” in the context of Drugs R&D is considered on
`the merits, it fares no better than Kappos and ClinicalTrials.
`
`Drugs R&D says that Fumapharm AG developed a second-generation
`fumarate (“fumaric acid”—which is not DMF) for oral treatment of psoriasis.
`It goes on to state that Biogen is currently evaluating “the product” in trials
`as an oral treatment for MS and suggests that the trials are FDA Phase II
`trials. See the discussion in the first paragraph of the Abstract, Ex. 1021A.
`
`The remaining portions of Drugs R&D for the most part describe
`treatment of psoriasis, not MS. In Table II there is mention of drug
`development history referring specifically to a Nov 2004 “Phase–II in
`Multiple sclerosis in Europe (PO).” The result of the Phase II European
`trials is not in the record. Nevertheless, nothing in the admission or Drugs
`R&D supports a finding that DMF is useful for treating MS. In other words,
`as of the date of the admission or Drugs R&D, we are back to a “hope” that
`DMF will be useful in treating MS.
`We decline to institute an inter partes review trial on the basis of any
`
`admission or Drugs R&D and ICH Guideline.
`
`
`
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`Petitioner has not established that a reasonable likelihood that it will
`
`prevail as to any claim attached on the basis of Challenge 3.
`VI. Motion for Additional Discovery
`Patent Owner has requested additional discovery. See Paper 15, filed
`
`29 June 2015. The additional discovery is said to be necessary to investigate
`possible sanctions. Id. at 3.
`Granting of additional discovery is discretionary with the Board. See
`
`35 U.S.C. § 316(a)(5)(B) (“discovery shall be limited to — what is
`otherwise necessary in the interest of justice”); see also Cochran v. Kresock,
`530 F.2d 385, 396 (CCPA 1976) (whether a party is entitled to additional
`discovery is discretionary with the board); Keebler Co. v. Murray Bakery
`Products, 866 F.2d 1386, 1388 n.1 (Fed. Cir. 1989) (standard of review of
`discovery order on appeal is abuse of discretion).
`Because we decline to institute an inter partes review based on
`
`Petitioner’s failure to establish a likelihood of success as to any challenged
`claim, we see no need for prolonging this case. This case has ended.
`Authorizing additional discovery in this case at this time would be
`inconsistent with a speedy and inexpensive resolution of the case. 37 C.F.R
`§ 42.1(b).
`
`VII. Order
`We have considered all arguments presented by Petitioner, but find
`
`that none justify instituting an inter partes review.
`Upon consideration of the Petition (Paper 9) and the Preliminary
`Response (Paper 21), and for the reasons given, it is
`ORDERED that the Petition is denied as to all challenged claims, and
`
`
`
`
`16
`
`Page 16 of 17
`
`
`
`IPR2015-01136
`Patent 8,399,514 B2
`
`a trial will not be instituted.
`Upon consideration of Patent Owner’s motion for additional discovery,
`and for the reasons given, the motion is dismissed.
`
`PETITIONER:
`
`Robert W. Hall
`Robert Mihail
`NEIFELD IP LAW, PC
`rhahl@neifeld.com
`rmihail@neifeld.com
`
`PATENT OWNER:
`
`Michael Flibbert
`Maureen Queler
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`michael.flibbert@finnegan.com
`maureen.queler@finnegan.com
`
`17
`
`Page 17 of 17
`
`
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