UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`SANDOZ INC.,
`APOTEX INC., APOTEX CORP.,
`EMCURE PHARMACEUTICALS LTD.,
`HERITAGE PHARMA LABS INC.,
`HERITAGE PHARMACEUTICALS INC.,
`GLENMARK PHARMACEUTICALS, INC., USA,
`GLENMARK HOLDING SA,
`GLENMARK PHARMACEUTICALS, LTD.,
`MYLAN LABORATORIES LIMITED,
`TEVA PHARMACEUTICALS USA, INC.,
`and FRESENIUS KABI USA, LLC,
`Petitioners,
`v.
`ELI LILLY & COMPANY,
`Patent Owner.
`__________________
`
`Case No: IPR2016-003181
`Patent No. 7,772,209
`__________________
`
`PATENT OWNER ELI LILLY’S OPPOSITION TO PETITIONERS’
`MOTION TO CROSS-EXAMINE DR. NIYIKIZA BY DEPOSITION2
`
`1 Cases IPR2016-01340 and IPR2016-01429 have been joined with the instant
`
`proceeding.
`
`2 Except for the cover page, identical copies of this Opposition have been filed in
`
`Sandoz Inc. v. Eli Lilly & Company, IPR2016-00318, and Neptune Generics, LLC
`
`v. Eli Lilly & Company, IPR2016-00237, IPR2016-00240.
`
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`SANDOZ INC.,
`APOTEX INC., APOTEX CORP.,
`EMCURE PHARMACEUTICALS LTD.,
`HERITAGE PHARMA LABS INC.,
`HERITAGE PHARMACEUTICALS INC.,
`GLENMARK PHARMACEUTICALS, INC., USA,
`GLENMARK HOLDING SA,
`GLENMARK PHARMACEUTICALS, LTD.,
`MYLAN LABORATORIES LIMITED,
`TEVA PHARMACEUTICALS USA, INC.,
`and FRESENIUS KABI USA, LLC,
`Petitioners,
`v.
`ELI LILLY & COMPANY,
`Patent Owner.
`__________________
`
`Case No: IPR2016-003181
`Patent No. 7,772,209
`__________________
`
`PATENT OWNER ELI LILLY’S OPPOSITION TO PETITIONERS’
`MOTION TO CROSS-EXAMINE DR. NIYIKIZA BY DEPOSITION2
`
`1 Cases IPR2016-01340 and IPR2016-01429 have been joined with the instant
`
`proceeding.
`
`2 Except for the cover page, identical copies of this Opposition have been filed in
`
`Sandoz Inc. v. Eli Lilly & Company, IPR2016-00318, and Neptune Generics, LLC
`
`v. Eli Lilly & Company, IPR2016-00237, IPR2016-00240.
`
`
`
`
`
`In their Motion, Petitioners make a request for a deposition that is wholly
`
`untethered from the Board’s rules regarding limited discovery. Patent Owner Eli
`
`Lilly and Company (“Lilly”) submitted excerpts of the district court validity trial
`
`testimony of inventor Dr. Clet Niyikiza relating principally to skepticism of the
`
`invention. At Petitioners’ request, Lilly produced the rest of Dr. Niyikiza’s trial
`
`testimony (including his trial cross-examination), his deposition on the same issues
`
`by Joinder-Petitioners Teva and Fresenius (f/k/a APP), and all of the exhibits used
`
`at the validity trial and at his deposition. Unsatisfied, Petitioners seek their own
`
`additional deposition.
`
`Contrary to Petitioners’ arguments, however, the deposition they seek is not
`
`“routine” discovery nor proper “additional” discovery. It is not “routine” discovery
`
`because Dr. Niyikiza has not submitted an affidavit “prepared for the proceeding.”
`
`And because Petitioners have failed to articulate what new information a
`
`deposition would provide, they also cannot show a need for “additional” discovery
`
`under the standards the Board set forth in Garmin. Petitioners’ position amounts to
`
`a per se rule that prior sworn testimony—even where the witness was already
`
`subject to cross-examination—can only be submitted and given consideration if the
`
`witness is deposed. That is not even the law in district courts, never mind in IPR
`
`proceedings where discovery is limited.
`
`
`
`
`
`1
`
`
`
`
`
`I.
`
`A Deposition of Dr. Niyikiza Is Not Routine Discovery
`
`Petitioners first assert that they are entitled to a deposition of Dr. Niyikiza
`
`because “there is no reason to treat sworn trial testimony” from another proceeding
`
`“any differently” from the affidavit testimony for which cross-examination is
`
`authorized under 37 C.F.R. § 42.51(b)(1)(ii). Mot. at 3. But there is a very good
`
`reason: the controlling regulation expressly distinguishes them.
`
`By the plain language of the regulation, “routine discovery” encompasses
`
`only “[c]ross examination of affidavit testimony prepared for the proceeding.” 37
`
`C.F.R. § 42.51(b)(1)(ii) (emphasis added). This language could not be clearer. Dr.
`
`Niyikiza’s trial testimony constitutes sworn testimony from a different adversarial
`
`proceeding—it was not “prepared for” these IPR proceedings. His deposition is
`
`therefore not “routine” discovery and is not authorized under § 42.51(b)(1)(ii).3
`
`
`3 It is also irrelevant, contrary to Petitioners’ arguments, how “extensive” Lilly’s
`
`reliance on Dr. Niyikiza’s testimony is. Mot. at 1, 3. The extent to which Lilly has
`
`relied on the testimony does not affect whether it is an “affidavit prepared for the
`
`proceeding,” which plainly it is not. But Petitioners’ assertions are also grossly
`
`overstated. The relevance of Dr. Niyikiza’s testimony is principally in support of
`
`Lilly’s skepticism arguments, and even as to those arguments the story is well-
`
`supported by documentary evidence that Dr. Niyikiza’s testimony serves to
`
`
`
`
`
`2
`
`
`
`
`
`That should end the matter as to Petitioners’ first argument. But the
`
`conclusion is further supported by the history of the regulation. Until 2015, the
`
`regulation provided that “[c]ross examination of affidavit testimony” was routine
`
`discovery, without a provision specifying the proceeding for which it had to be
`
`prepared. 37 C.F.R. § 42.51(b)(1)(ii) (2012). Panels of the Board were split as to
`
`whether the regulation encompassed testimony from other proceedings. Compare,
`
`e.g., GEA Process Eng’g, Inc. v. Steuben Foods, Inc., IPR2014-00041, Paper 41 at
`
`2–3 (PTAB June 11, 2014) with, e.g., Ikaria, Inc. v. Geno LLC, IPR2013-00253,
`
`Paper 20 (PTAB Apr. 1, 2014). The amended regulation resolved this
`
`disagreement by “clarify[ing] that routine discovery includes only the cross-
`
`examination of affidavit testimony prepared for the proceeding.” 80 Fed. Reg.
`
`28563. Petitioners’ argument thus not only flies in the face of the regulation’s
`
`plain language, but it ignores the history that gave rise to that language.
`
`The cases Petitioners cite to the contrary are inapposite. Petitioners rely
`
`upon Ikaria, Inc. v. Geno LLC, IPR2013-00253, Paper 20 (PTAB Apr. 1, 2014),
`
`
`authenticate and contextualize. Dr. Niyikiza’s additional testimony as to the
`
`background of the invention story further explains the context in which the
`
`skepticism arose. Lilly does not rely on that invention story for the teachings of
`
`the references at issue or the motivations of the person of ordinary skill.
`
`
`
`3
`
`
`
`
`
`but that case was decided before the PTO amended § 42.51(b)(1)(ii) in 2015 to
`
`clarify that cross-examination of testimony from other proceedings as routine
`
`discovery is not authorized. Ikaria also involved a written declaration rather than
`
`oral testimony that was subjected to cross-examination. Id. Similarly, although
`
`the panel in Altaire Pharm., Inc. v. Paragon Bioteck, Inc., PGR2015-00011, Paper
`
`29 (PTAB Apr. 1, 2016), indicated that the Patent Owner must make available for
`
`deposition a witness who had submitted affidavit testimony during patent
`
`prosecution, id. at 1–2, the Patent Owner never raised, and the Altaire panel did not
`
`discuss or analyze, the “prepared for the proceeding” language of
`
`§ 42.51(b)(1)(ii). Where the PTAB has addressed the relevant question here, as in
`
`Maxliner, Inc. v. Cresta Tech. Corp., IPR2015-00594, Paper 32 at 2 (Jan. 15,
`
`2016), it has followed the clear text of § 42.51(b)(1)(ii) and held that cross-
`
`examination of testimony prepared for another proceeding is not authorized.
`
`For these reasons, Petitioners’ assertion that the submission of prior
`
`testimony is somehow a way to “avoid cross-examination” or “circumvent the
`
`Board’s rules,” Mot. at 4, is meritless. Under the rules, witnesses who prepare
`
`affidavits “for the proceeding” are automatically subject to cross-examination.
`
`Witnesses who testified previously—and, as here, were subject to cross-
`
`examination previously—are not.
`
`
`
`4
`
`
`
`
`
`II.
`
`Petitioners Have Not Demonstrated That the Additional Discovery of a
`Deposition of Dr. Niyikiza Is Necessary In the Interest of Justice
`
`Petitioners next resort to the rules on “additional” discovery under 37 C.F.R.
`
`§ 42.51(b)(2)(i). Because discovery in IPR proceedings is “limited” and “less than
`
`what is normally available in district court patent litigation,” Google Inc. v.
`
`Jongerius Panoramic Techs., LLC, IPR2013-00191, Paper 27 at 3 (PTAB Sept. 30,
`
`2013), Petitioners can only obtain such additional discovery if they show that such
`
`additional discovery is “necessary in the interest of justice.” 35 U.S.C. §
`
`316(a)(5). Under the well-known Garmin factors that the Board uses to analyze
`
`this question, Petitioners cannot come close to meeting their burden.
`
`A. Petitioners argue that there is more than a mere possibility that Dr.
`
`Niyikiza’s deposition will uncover information useful to Petitioners regarding
`
`skepticism and the invention story of the claimed invention, Mot. at 5 (Garmin
`
`factor 1), and that there is no other way to obtain this information other than Dr.
`
`Niyikiza’s deposition, Mot. at 6‒9 (Garmin factor 3). Petitioners are mistaken.
`
`To begin with, Dr. Niyikiza was examined extensively in Eli Lilly & Co. v.
`
`Teva Parenteral Meds., Inc., No. 1:10-CV-1376 (S.D. Ind.) (the “Teva Litigation”)
`
`on two separate occasions—once during his day-long deposition, and again at the
`
`trial on validity. The issues to which Petitioners allege Dr. Niyikiza’s testimony
`
`relates were the subject of questioning by Joinder-Petitioners Teva and Fresenius
`
`on both occasions. In response to Petitioners’ requests, Lilly has provided all of
`
`
`
`5
`
`
`
`
`
`this testimony, as well as a wealth of additional discovery from the Teva
`
`Litigation, including all the exhibits from Dr. Niyikiza’s deposition and every
`
`exhibit used at the validity trial.
`
`Yet still Petitioners are not satisfied. However, Petitioners do not even
`
`attempt to identify what information they are missing that could possibly be
`
`gleaned from a deposition of Dr. Niyikiza in this proceeding. Petitioners assert
`
`that “[a]lthough Teva and Fresenius certainly obtained useful admissions from Dr.
`
`Niyikiza on cross-examination, their questioning did not cover all the topics
`
`covered in the 37 pages of testimony cited by Eli Lilly.” Mot. at 6. However,
`
`Petitioners only identify one issue that was allegedly not addressed by Joinder-
`
`Petitioners in Dr. Niyikiza’s prior cross-examinations: a phase III pemetrexed trial
`
`investigator’s praise of Dr. Niyikiza’s invention where he stated that “[i]f you
`
`didn’t do it, the drug would probably be dead.” See Mot. at 6‒7. Petitioners
`
`indicate that Joinder-Petitioners Teva and Fresenius’ cross-examinations did “not
`
`touch on this statement.” Mot. at 7. But Petitioners fail to indicate what additional
`
`information they expect to elicit in a second deposition or why Joinder-Petitioners
`
`could not or did not obtain that information. Petitioners’ cursory identification of
`
`this single topic for questioning falls far short of the first Garmin factor’s
`
`requirement of “evidence tending to show beyond speculation that in fact
`
`something useful will be uncovered” instead of offering “[t]he mere possibility of
`
`
`
`6
`
`
`
`
`
`finding something useful.” Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
`
`IPR2012-00001, Paper 26 at 6 (PTAB Mar. 5, 2013).
`
`Petitioners further argue that the Board should permit Petitioners to take the
`
`deposition testimony of Dr. Niyikiza because the Joinder-Petitioners who
`
`previously examined him are “simply silent understudies” here and “neither
`
`Sandoz nor Neptune had an opportunity to cross-examine Dr. Niyikiza
`
`previously.” Mot. at 6. While that is literally true, it is completely irrelevant. The
`
`Joinder-Petitioners who examined Dr. Niyikiza previously are generic
`
`pharmaceutical companies with exactly the same interests in invalidating the ’209
`
`patent as Petitioners and were represented by competent counsel in the prior
`
`proceeding. There is no basis to believe that Petitioners would glean any new
`
`information if they get their own additional “bite at the apple,” and Petitioners do
`
`not even try to articulate one, much less articulate what that information might be.
`
`Anticipating Lilly’s response, Petitioners further argue that the invalidity
`
`grounds in these IPRs are not the same as the arguments at issue in the Teva
`
`Litigation, and thus, Petitioners should be able to question Dr. Niyikiza “in light of
`
`the particular art and the allegations raised in his testimony.” Mot. at 8‒9. That
`
`misses the point. The issues about which Dr. Niyikiza testified are the same in
`
`both the IPRs and in the Teva Litigation; whether the claimed invention was the
`
`subject of skepticism or praise does not depend on what particular prior art is
`
`
`
`7
`
`
`
`
`
`alleged to render it obvious. Petitioners’ assertion, rather, suggests their true
`
`motivation for seeking to depose Dr. Niyikiza: he is the author of a prior art
`
`reference relied on by Petitioners in these IPRs, and which forms part of the
`
`Grounds in two of the three proceedings. Tellingly, Petitioners have indicated to
`
`counsel for Lilly that they are unwilling to limit the scope of Dr. Niyikiza’s
`
`potential deposition. Petitioners’ desire to fish for admissions that may be relevant
`
`to their prima facie obviousness case has no place in the Garmin framework, and
`
`the Board should not indulge it.
`
`In sum, Petitioners have failed to demonstrate that there is more than a mere
`
`possibility that Dr. Niyikiza’s deposition will uncover useful information (Garmin
`
`factor 1) or that a deposition of Dr. Niyikiza is the only way for Petitioners to
`
`obtain the information sought (Garmin factor 3).
`
`B. The remaining Garmin factors are either inapposite or do nothing to
`
`advance Petitioners’ case. As to the second Garmin factor, the discovery in
`
`question is not a request for litigation positions. As to the fourth, while Petitioners
`
`say there is “nothing complex” about their request, they also have failed to specify
`
`the desired subject of the testimony; this factor thus weighs in Lilly’s favor,
`
`because a deposition of uncertain scope is not a targeted and comprehensible
`
`request for information.
`
`Finally, Petitioners’ request to depose Dr. Niyikiza is overly burdensome
`
`
`
`8
`
`
`
`
`
`and not tailored to a genuine need under the fifth Garmin factor. See Garmin,
`
`IPR2012-00001, Paper 26 at 7. Dr. Niyikiza is not a Lilly employee—he is a third
`
`party. He is the founder and CEO of an unrelated company, L.E.A.F.
`
`Pharmaceuticals. Requiring Dr. Niyikiza to take time away from his work for the
`
`deposition would be a burden both to him and to his company. Petitioners’
`
`arguments concerning whether Dr. Niyikiza has a contractual obligation to help
`
`Lilly or whether a subpoena may be necessary to secure his testimony are not
`
`relevant to the question of the burden to him or his company.
`
`III. Dr. Niyikiza’s Trial Testimony Should Be Accorded Full Weight
`In the event Petitioners’ request for a deposition is denied, they argue that
`
`Dr. Niyikiza’s testimony should be given “no weight.” Mot. at 9. This draconian
`
`suggestion is improper and should also be rejected, as it would turn the rules for
`
`IPR proceedings on their head. As discussed, 37 C.F.R. § 42.51(b)(1)(ii)
`
`authorizes as routine discovery only “[c]ross examination of affidavit testimony
`
`prepared for the proceeding” (emphasis added). See supra p. 2–4. By limiting
`
`routine cross-examination to such affidavits, the rules plainly contemplate that
`
`testimony that is not “prepared for the proceeding” may be at issue. Petitioners’
`
`suggestion would present parties like Lilly with a Hobson’s Choice: either make
`
`any witnesses who offered such testimony available for deposition,
`
`notwithstanding the language of the rule and the limited scope of IPR discovery, or
`
`
`
`9
`
`
`
`
`
`do not bother submitting their testimony because it is not afforded any weight.
`
`Moreover, there is no reason why Dr. Niyikiza’s testimony is rendered any
`
`less reliable just because he is not deposed again. Unlike in the one case
`
`Petitioners cite on this point, Organik Kimya AS v. Rohm & Haas Co., IPR2014-
`
`00185, Paper 42 at 2 (PTAB Dec. 18, 2014), Dr. Niyikiza has already been
`
`examined on the subject matter at issue here. Petitioners do not and cannot
`
`articulate why his prior cross-examinations were inadequate to test Dr. Niyikiza’s
`
`testimony or why Petitioners’ interests were inadequately represented by Joinder-
`
`Petitioners’ capable counsel when they performed those examinations. See supra
`
`p. 6–8. Moreover, there is a wealth of documentary evidence before the Board that
`
`corroborates Dr. Niyikiza’s testimony, but which the testimony will be helpful to
`
`the Board in understanding. Dr. Niyikiza’s testimony should be accorded full
`
`weight.
`
`IV. Conclusion
`For the foregoing reasons, Petitioners’ Motion to Cross-Examine Dr.
`
`Niyikiza By Deposition should be denied. Alternatively, if the Board orders Dr.
`
`Niyikiza’s deposition, the Board should limit the scope of that deposition to Dr.
`
`Niyikiza’s direct testimony regarding skepticism and praise for the invention.
`
`Dated: November 18, 2016
`
`
`
`
`
`
` Respectfully submitted,
`/Dov P. Grossman/
`Dov P. Grossman
`Reg. No. 72,525
`
`
`
`
`
`
`
`10
`
`
`
`
`
`Williams & Connolly, LLP
`725 12th St., NW
`Washington, DC 20005
`Telephone: 202-434-5812
`Facsimile: 202-434-5029
`Email: dgrossman@wc.com
`Lead Counsel for Patent Owner
`
`
`
`11
`
`
`
`CERTIFICATE OF SERVICE
`(37 C.F.R. §§ 42.6(e))
`
`The undersigned hereby certifies that the foregoing document was served on
`
`
`
`November 18, 2016 by delivering a copy via electronic mail on the following
`
`attorneys of record for the Petitioners in IPR2016-00237, IPR2016-00240, and
`
`IPR2016-00318:
`
`Sarah E. Spires
`Reg. No. 61,501
`237Neptune@skiermontderby.com
`240Neptune@skiermontderby.com
`
`Skiermont Derby LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, TX 75201
`P: 214-978-6600/F: 214-978-6601
`
`Attorneys for Neptune Generics, LLC
`
`Ralph J. Gabric
`Reg. No. 34,167
`rgabric@brinksgilson.com
`
`Joshua H. James
`Reg. No. 72,568
`jjames@brinksgilson.com
`
`Brinks Gilson & Lione
`455 Cityfront Plaza Drive
`Suite 3600 NBC Tower
`Chicago, IL 60611-5599
`T: 312-321-4200; F: 312-321-4299
`
`Bryan T. Richardson, Ph.D.
`Reg. No. 70,572
`brichardson@brinksgilson.com
`
`
`
`Dr. Parvathi Kota
`Reg. No. 65,122
`237Neptune@skiermontderby.com
`240Neptune@skiermontderby.com
`
`
`
`Laura Lydigsen
`Pro hac vice
`llydigsen@brinksgilson.com
`
`
`
`
`
`
`
`
`
`
`
`
`Brinks Gilson & Lione
`4721 Emperor Blvd.
`Suite 220
`Durham, NC 27703-8580
`T: 919-998-5700; F: 919-998-5701
`
`Counsel for Sandoz Inc.
`
`John D. Polivick
`Reg. No. 57,926
`jpolivick@rmmslegal.com
`
`William A. Rakoczy
`Pro hac vice to be filed
`wrakoczy@rmmslegal.com
`
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500
`Chicago, IL
`P: 312-527-2157/F: 312-527-4205
`
`Attorneys for Apotex Inc. and Apotex
`Corp.
`
`Thomas J. Parker
`Reg. No. 42,062
`thomas.parker@alston.com
`
`Alston & Bird LLP
`90 Park Avenue, 15th Floor
`New York, NY 10016
`P: 212-210-9529/F: 212-210-9444
`
`Counsel for Mylan Laboratories
`Limited
`
`Gerard A. Haddad
`Reg. No. 41,811
`GHaddad@BlankRome.com
`
`
`
`
`
`
`Deanne M. Mazzochi
`Reg. No. 50,158
`dmazzochi@rmmslegal.com
`
`Patrick C. Kilgore
`Reg. No. 69,131
`pkilgore@rmmslegal.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`Blank Rome LLP
`The Chrysler Building
`405 Lexington Ave.
`New York, NY 10174
`P: 212-885-5135/F: 917-591-6921
`
`Counsel for Glenmark
`Pharmaceuticals Inc., USA, Glenmark
`Holding SA, and Glenmark
`Pharmaceuticals Ltd.
`
`Paul M. Zagar
`Reg. No. 52,392
`PZagar@BlankRome.com
`
`Blank Rome LLP
`The Chrysler Building
`405 Lexington Ave.
`New York, NY 10174
`P: 212-885-5290/F: 917-332-3063
`
`Counsel for Emcure Pharmaceuticals
`Ltd., Heritage Pharma Labs Inc., and
`Heritage Pharmaceuticals Inc.
`
`Gary J. Speier
`Reg. No. 45,458
`gspeier@carlsoncaspers.com
`
`Carlson, Caspers, Vandenburgh,
`Lindquist & Schuman
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`P: 612-436-9600
`F: 612-436-9605
`
`Cynthia Lambert Hardman
`Reg. No. 53,179
`chardman@goodwinprocter.com
`
`
`
`
`
`
`
`
`
`
`Mark D. Schuman
`Reg. No. 31,197
`mschuman@carlsoncaspers.com
`
`
`
`
`
`
`
`
`
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`P: 212-813-8800
`F: 212-355-3333
`
`Attorneys for Teva Pharmaceuticals
`USA, Inc. and Kabi Fresenius USA,
`LLC
`
`Patrick A. Doody
`Reg. No. 35,022
`patrick.doody@pillsburylaw.com
`
`Pillsbury Winthrop Shaw Pittman LLP
`1650 Tysons Boulevard
`McLean, VA 22102
`P: 703-770-7755/F: 703-770-7901
`
`Counsel for Wockhardt Bio AG
`
`
`
`Date: November 18, 2016
`
`
`
`
`Bryan P. Collins
`Reg. No. 43,560
`bryan.collins@pillsburylaw.com
`
`
`
`/Dov P. Grossman/
`Dov P. Grossman
`Reg. No. 72,525
`Lead Counsel for Patent Owner
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