UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`NISSAN CHEMICAL INDUSTRIES, LTD.,
`PATENT OWNER
`
`_________________________
`
`U.S. Patent No. 5,856,336
`
`Issue Date: January 5, 1999
`
`Title: Quinoline Type Mevalonolactones
`
`Inter Partes Review No. IPR2015-01069
`
`PATENT OWNER’S REPLY REGARDING
`PETITIONER’S FAILURE TO NAME A
`REAL PARTY-IN-INTEREST
`
`
`_________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`NISSAN CHEMICAL INDUSTRIES, LTD.,
`PATENT OWNER
`
`_________________________
`
`U.S. Patent No. 5,856,336
`
`Issue Date: January 5, 1999
`
`Title: Quinoline Type Mevalonolactones
`
`Inter Partes Review No. IPR2015-01069
`
`PATENT OWNER’S REPLY REGARDING
`PETITIONER’S FAILURE TO NAME A
`REAL PARTY-IN-INTEREST
`
`
`
`The Jenkins Declaration
`
`Petitioner Mylan’s Response relies exclusively on the 3+ page unsupported
`
`declaration of Thomas W. Jenkins (“Decl.”).
`
`Jenkins’s declaration is unreliable. He claims: “I either have personal
`
`knowledge of the facts stated in this Declaration or believe them to be true based
`
`on my experience, review of business records, or information I have otherwise
`
`received in the course of my duties.” Decl. ¶2 (emphasis added). At his
`
`deposition, however, Jenkins testified that he did not look at a single document for
`
`purposes of preparing his declaration. Jenkins Transcript (“Tr.”) 18:24-20:17,
`
`44:5-21, 109:6-111:7. Jenkins did not even bother to sign the declaration himself.
`
`Tr. 12:18-17:22.
`
`Jenkins could not explain how he came to know that MNV was “a non-
`
`operational holding company” (Decl. ¶3). The circumstances suggest that he
`
`copied the term from the Par opinion, and he does not even know what it
`
`means. Tr. 56:14-17 (“I’m not a incorporate [sic] lawyer, so I can’t tell you what
`
`constitutes exactly non-operational versus operational.”); see also id. 39:19-40:9;
`
`40:24-41:1. He refused to explain why it was that MNV’s non-operational status
`
`was relevant to whether it should have been named as a real party-in-interest
`
`(“RPI”), claiming it was privileged. Id. 41:2-43:4. He claimed that MNV lacked
`
`the authority to act on IPRs, but could not say why, relying only on what he had
`
`
`
`been told by others – i.e., hearsay. Id. 118:16-120:3. When asked how MNV
`
`came to be identified as an RPI in other IPR proceedings, he refused to answer. Id.
`
`at 66:16-69:8, 120:4-21.1
`
`Not only was Jenkins’ knowledge limited, it appears that he kept
`
`deliberately uniformed (cf. 37 C.F.R. § 42.51(b)(1)(iii)). Jenkins did not even look
`
`at any of the information or documents available on MNV’s website regarding its
`
`corporate structure and corporate activities. Tr. 108:20-109:5; 44:5-21. Jenkins did
`
`not review MNV’s Articles of Association (id. 50:4-20), its Corporate Governance
`
`principles (id. 113:9-114:23), or Leadership pages (id. 45:1-17), which speak
`
`directly to MNV’s business purpose, corporate structure, activities, and personnel.
`
`See Exs. 2034, 2035, 2045.
`
`MNV
`
`Jenkins claimed that MNV could not control this IPR because MNV has no
`
`employees. Tr. 32:25, 83:4-8, 117:7-118:15. In fact, MNV does have employees,
`
`not to mention a very highly compensated Board of Directors and Executive
`
`1 Jenkins and his counsel continually obstructed the deposition process with
`
`improper speaking objections and refusals to answer non-privileged questions.
`
`Such resistance to discovery relating to the RPI issue is inappropriate. Cf.
`
`Reflectix, Inc. v. Promethean Insulation Techn. LLC, IPR2015-00044, Paper 18 at
`
`16-17 (PTAB Apr. 24, 2015) (duty of candor and good faith in discovery).
`
`2
`
`
`
`Officers. Exs. 2036 p.6; 2049, 2050. One of MNV’s officers, Mark Nance (who
`
`also works for Mylan Inc.), is the direct boss of Jenkins’ boss, Jill Ondos. Tr.
`
`33:1-18.
`
`Moreover, Mylan’s corporate lines are blurred. Tr. 83:18-88:25; 94:6-22.
`
`This blurring is demonstrated by both internal confusion and by multiple MNV
`
`documents that show sharing of many of the same executives. Id.; see Reflectix,
`
`IPR2015-00044, Paper 18 at 6-7, 11; Galderma S.A., et al. v. Allergan Industrie,
`
`SAS, et al., IPR2014-01422, Paper 14, at 8-12 (PTAB Mar. 5, 2015).
`
`Mylan argues: “MNV was not involved nor could it have been involved in
`
`this proceeding because MNV was nothing more than a non-operational, holding
`
`company having no capability to control it.” Br. at 10 (emphasis added). Mylan’s
`
`own factual allegations and public filings undermine this argument. First, Mylan’s
`
`assertion that a “non-operational holding company” cannot control this proceeding
`
`is belied by Mylan’s assertion that MI (which Mylan also says is a non-operational
`
`holding company, Decl. ¶ 4) allegedly controls this proceeding. Br. at 4. Second,
`
`it is undisputed fact that Mylan identified MNV as an RPI in 15 IPRs since March
`
`2015. Mylan argues that the Board should ignore all of those other IPRs.
`
`However, Mylan failed and refused to explain how MNV can be an RPI in those
`
`15 IPRs, but not in this IPR. See Tr. 62:15-81:3; see generally Ex. 2009. Third,
`
`MNV’s Articles of Association specifically authorize it “(a) to participate in,
`
`3
`
`
`
`finance, collaborate and conduct the management of companies, businesses and
`
`other enterprises … and (e) to take any and all actions relating to, in connection
`
`with or in furtherance of the foregoing to the fullest extent permitted by applicable
`
`law.” Ex. 2035 at § 1.03. Mylan’s position is also directly contrary to MNV’s
`
`public statements, which show it to be intricately involved in IPR proceedings (of
`
`which Jenkins said he was not aware). See Ex.2036, at 19 (especially MNV’s
`
`President and Executive Director’s comments regarding one of its IPRs); Ex. 2040,
`
`at 4 (MNV’s CEO’s explanation of why it files IPRs).
`
`MNV also has issued numerous press releases announcing its launch of new
`
`drug products, and touting its many ANDAs (over 260). See, e.g., Exs. 2042,
`
`2043, 2051. MNV’s investor call discussions tell an even more comprehensive
`
`story of MNV’s active business activities. See, e.g., Ex. 2036, at 8-11, 18-19. A
`
`more proactive and involved leadership than the MNV officers would be hard to
`
`find. In addition, in an effort to avoid being acquired by Teva, MNV argued to the
`
`FTC that MNV should be afforded the protections of U.S. law because MNV’s
`
`operations are based in Canonsburg, Pennsylvania. See Ex. 2052. MNV is thus far
`
`more than the empty shell company Mylan claims.
`
`Mylan Cannot Shift Its Burden to Patent Owner
`
`Mylan devotes § III(B) of its brief to arguing that Patent Owner has failed to
`
`prove that MNV is an RPI. Br. at 6-9. Mylan misstates the law. The burden of
`
`4
`
`
`
`proof with respect to the RPI issue is squarely on the petitioner, who is “more
`
`likely to be in possession of, or have access to, evidence relevant to the issue than
`
`is a patent owner.” Zerto, Inc. v. EMC Corp., Case IPR2014-01254, Paper 35 at 7.
`
`The instant petition exemplifies the reason for this burden allocation, as Mylan,
`
`which has access to the evidence, has chosen to try to assume unsupported “facts”
`
`into existence through unsupported hearsay, and provide no documentary support.
`
`This IPR Is Unlike Par Pharm. v. Jazz Pharms.
`
`Mylan is wrong that the facts at issue here are “very similar” to those in Par
`
`Pharm. et al. v. Jazz Pharms Inc., IPR2015-00546, Paper 25 at 13 (PTAB July 28,
`
`2015). In Par, the unnamed RPIs were not proactive regarding sales of drugs or
`
`patent matters, e.g., they did not routinely issue press releases touting their new
`
`product launches and the number of ANDAs they own, or comment on pending
`
`IPRs in which they had an interest. Exs. 2042, 2043, 2051, 2036 at 19, 2040 at 4.
`
`Perusal of any of Mylan’s pertinent business records conclusively establishes that
`
`MNV is anything but an inactive non-operating company. In Par, the unnamed
`
`RPIs were not identified as such in any other IPRs. In Par, multiple corporate
`
`entities were alleged to be unnamed RPIs while here there is only one—the one
`
`that holds itself out to the public as being in control. MNV has the power to “call
`
`the shots.”
`
`5
`
`
`
`Dated: September 17, 2015
`
`Respectfully submitted,
`
`NISSAN CHEMICAL INDUSTRIES,
`LTD.,
`
`By its attorneys,
`
`/David G. Conlin/
`David G. Conlin, Reg. No. 27,026
`Kathleen B. Carr, Reg. No. 41,658
`MINTZ, LEVIN, COHN, FERRIS,
`GLOVSKY AND POPEO P.C.
`One Financial Center
`Boston, MA 02111
`(617) 542-6000
`(617) 542-2241 fax
`DGConlin@mintz.com
`KBCarr@mintz.com
`
`6
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent
`
`Owner’s Reply Regarding Petitioner’s Failure to Name a Real Party-in-Interest
`
`was served on September 17, 2015 by sending a copy by overnight courier and by
`
`email to:
`
`Jitendra Malik
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, North Carolina 27703
`Jitty.Malik@alston.com
`
`Deepro R. Mukerjee
`Thomas J. Parker
`Alston & Bird LLP
`90 Park Avenue
`New York, NY 10016
`Deepro.Mukerjee@alston.com
`Thomas.Parker@alston.com
`
`and
`
`Deanne M. Mazzochi
`Amy D. Brody
`Thomas R. Burns
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard St., Suite 500
`Chicago, Illinois 60654
`dmazzochi@rmmslegal.com
`abrody@rmmslegal.com
`tburns@rmmslegal.com
`
`/David G. Conlin/
`David G. Conlin
`Reg. No. 27,026
`
`7
`
`
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