IPR2015-01069
`
`IN THE UNI I ED STA 1 ES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Mylan Pharmaceuticals Inc., Petitioner
`
`v.
`
`Nissan Chemical Industries Ltd.
`Patent Owner
`
`Inter Partes Review No.: IPR20 15-01069
`
`PETITIONER'S RESPONSE TO THE
`REAL PARTY -IN- INTEREST ALLEGATIONS
`RAISED IN PATENT OWNER'S PRELIMINARY RESPONSE
`
`EXHIBIT
`
`ricti.0
`
`NCI Exhibit 2033
`
`
`
`IN THE UNI I ED STA 1 ES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Mylan Pharmaceuticals Inc., Petitioner
`
`v.
`
`Nissan Chemical Industries Ltd.
`Patent Owner
`
`Inter Partes Review No.: IPR20 15-01069
`
`PETITIONER'S RESPONSE TO THE
`REAL PARTY -IN- INTEREST ALLEGATIONS
`RAISED IN PATENT OWNER'S PRELIMINARY RESPONSE
`
`EXHIBIT
`
`ricti.0
`
`NCI Exhibit 2033
`
`
`
`1PR2015 -01069
`
`Pursuant to the Board's August 14, 2015 Order (Paper 9), Petitioner, Mylan
`
`Pharmaceuticals Inc. ( "MPI "), responds to Nissan Chemical Industries, Ltd.'s
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`( "Nissan") Preliminary Response (Paper 7, "Prelim. Resp. "). Nissan seeks
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`dismissal of MPI's petition ( "the Petition) for inter partes review of U.S. Patent
`
`No. 5,856,336 ( "the '336 patent ")
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`( "the Proceeding ") for allegedly failing to
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`identify a real party-in- interest ( "RPI "). Id. at 4 -11. Nissan alleges that the
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`corporate lines between Mylan N.V. ( "MNV "), Mylan Inc. ( "MI "), and MPI are
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`blurred such that MNV should have been identified as an RPI. Not so. While MI is
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`an appropriate RPI, MNV is not. MNV is a non -operational holding company that
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`has no interest, involvement, or ability to control this IPR Proceeding. Simply put,
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`MNV was not required to be identified as an RPI.
`
`I.
`
`FACTUAL BACKGROUND
`
`MNV is a publicly- traded, non- operational Dutch holding company. Ex.
`
`1045, Decl. of Thomas W. Jenkins ( "Jenkins Decl. ") at ¶ 3. It was formed as part
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`of a transaction that was completed on February 27, 2015. NCI Ex. 2012 at 9. Prior
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`to the transaction, MNV's predecessor existed as "New Mylan," a private limited
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`liability company, which did not conduct any activity other than that incidental to
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`MNV's formation. NCI Ex. 2007 at 4.
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`MI is a Pennsylvania non -operational holding company and an indirect
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`wholly -owned subsidiary of MNV. Jenkins Decl. at ¶ 4. MPI is a West Virginia
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`
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`IPR2015 -01069
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`operational company, which is a wholly -owned subsidiary of ML Id. at 115. MPI is
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`engaged in the manufacture and sale of generic pharmaceuticals. Id. MPI prepares
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`and files Abbreviated New Drug Applications ( "ANDA ") with the U.S. Food and
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`Drug Administration ( "FDA "). Id.
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`In 2013, MPI compiled and submitted ANDA No. 206070 seeking approval
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`of generic Pitavastatin Tablets ( "MPI's ANDA" or "the ANDA "). Id. at IT 7. MPI
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`was (and continues to be) the sole named applicant for, and owner of all right and
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`title to, MPI's ANDA. Id.
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`MNV was not involved in any part of the development, compilation, or
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`submission of MPI's ANDA. Id. at it 8. As part of this ANDA, MI submitted a
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`Paragraph IV Certification to the FDA on MPI's behalf, indicating that the '336
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`patent is invalid and not infringed. Id. at ¶ 9. In connection with that Certification,
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`MPI, by its outside counsel, served, among others, Nissan with a Paragraph IV
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`notice letter. The letter sets forth the legal and factual basis supporting the
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`invalidity of the '336 patent. Id.
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`In response, on April 14, 2014, Nissan sued both MPI and MI in the U.S.
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`District Court for the Southern District of New York, alleging infringement of the
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`'336 patent, among others. Id. at ¶ 10. On July 16, 2014, MPI and MI filed their
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`Answer and Counterclaims asserting, among other things, that the '336 patent is
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`invalid and not infringed. Id. at ¶ 11. On or about December 2014, MI decided to
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`2
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`IPR2015 -01069
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`prepare and file the Petition. Id. at ¶ 12. The decision was made solely by MI's in-
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`house counsel, which included Thomas W. Jenkins, MI's Vice -President and
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`Associate Global General Counsel for Patent Litigation. Id.
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`MNV was not involved in any of the preceding actions or decisions. Id. at
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`¶¶ 8, 9, 11, and 12. Notably, the decision to prepare and file the Petition predates
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`ÌvINV's formation.
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`On April 18, 2015, MPI filed the Proceeding. MI is, and continues to be, the
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`only entity that has paid, and pays, any filing fees or legal expenses associated with
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`this Proceeding. Id. at If 13. MNV has never exercised any control over the
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`Proceeding or the pending litigation. Id. at ¶ 14.
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`II.
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`LEGAL STANDARD
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`While the petitioner bears the ultimate burden, "[a] patent owner challenging
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`a petitioner's RPI disclosure must provide sufficient evidence to show the
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`disclosure is inadequate." Par Pharm. et al. v. Jazz Pharms Inc., IPR2015- 00546,
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`Paper 25 at 13 (P.T.A.B. July 28, 2015). The RPI analysis is a specific inquiry into
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`the "`relationship between a party and a proceeding;' not `the relationship between
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`parties. ' Id. at 14 (emphasis in original). "[The] focus `is on the degree of control
`the nonparty could exert over the [IPR], not the petitioner. ' Id.
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`Whether a non -party is an RPI "is a highly fact dependent question." Ici
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`There is no bright line test. Nonetheless, "the evidence as a whole must show that
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`3
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`
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`IPR2015 -01069
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`the non -party possessed effective control over the [IPR] proceeding as measured
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`from a practical, as opposed to a purely theoretical standpoint." Jiawei Tech, (HK)
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`Ltd., et at v. Richmond, IPR2014- 00935, Paper 52 at 8. (P.T.A.B. Aug. 21, 2015).
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`But "rarely will one fact, standing alone, be determinative of the RPI issue." Id. at
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`6; see also Corning Optical Commc 'ns RF, LLC v. PPC Broadband, Inc.,
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`IPR2014- 00440, Paper 68 at 14 -15 (P.T.A.B. Aug. 18, 2015) (setting forth factors
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`to be considered in an RPI analysis).
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`III.
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`ARGUMENT
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`A. MNV Never Had Control of This Proceeding
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`MNV has no role in this IPR Proceeding. MI is, and continues to be, solely
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`responsible for directing, controlling, and funding the preparation, filing, and
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`prosecution of the Proceeding. Jenkins Decl. at 111 MI remains the only entity
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`that has paid and pays all filing fees or legal expenses associated with the
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`Proceeding. Id. In fact, the day -to -day oversight of the Proceeding is headed by
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`Mr. Jenkins of MI. Id.
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`Further, as previously noted, MNV is a non -operational holding company.
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`Id. at ¶ 3. ìvINV does not engage in the manufacture, distribution, or sale of drugs.
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`Id. It also does not generate any revenue. Id. MNV has no independent operations
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`or material assets other than equity ownership in its subsidiaries. Id. Under very
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`similar facts, the Board has found that the relationship between the petitioner and
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`4
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`IPR2015 -01069
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`its corporate parents was not blurred and, therefore, did not require that the parents
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`be listed as RPIs. Par Pharm., IPR2015- 00546, Paper 25 at 15 -16. The same is true
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`here.
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`The present case is unlike others where the Board found that the petitioner's
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`actions blurred the lines of corporate separation. For example, in Zoll Lifecor Corp.
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`v. Philips Elec. N. Am. Corp., the Board found that the parent company should
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`have been listed as an RPI because the evidence established that the parent exerted
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`some degree of control over the IPR proceeding and that there were unified actions
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`between the petitioner and the parent in a related litigation involving the same
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`patents at issue in the IPRs. IPR2013- 00609, Paper 13 at 10 (P.T.A.B. Mar. 20,
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`2014). Here, MNV does not exert any control over the Proceeding and there are no
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`unified actions between MNV and MI, or MNV and M.PI with respect to either the
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`Proceeding or the pending litigation. Jenkins Decl. at ¶¶ 14-15,
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`Similarly, in Atlanta Gas Light Co. v. Bennett Regulator Guards, Inc., the
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`Board found a non -party parent was an RPI based on an officer of the parent acting
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`on the petitioner's behalf in an indemnity dispute related to a litigation involving
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`the patent at issue in the IPR. IPR2013- 00453, Paper 88 at 9 -I1 ( P.T.A.B. Jan. 6,
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`2015). It was also unclear whether the parent or petitioner paid the filing fee and
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`legal expenses for the IPR. Id.; see also Zerto, Inc. v. EMC Corp., IPR2014- 01254,
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`Paper 35 at 13 (P.T.A.B. Mar. 3, 2015) (requiring that the parent needed to be an
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`
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`IPR2015 -01069
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`RPI because, in part, it was not clear whether the parent funded the IPR). In this
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`matter, no MNV officer or director, in their capacity as such, has ever acted on
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`behalf of either MI or MPI for any reason. Jenkins Decl. at ¶ 16. Moreover, Mi-
`not MNV -is responsible for Petitioner's filing fees and legal expenses. Id. at 1113.
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`Finally, in Reflectix, Inc. v. Promethean Insulation Tech. LLC, which Nissan
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`relies upon, the Board found a non -party to be an RPI because, in part, it paid the
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`petitioner's legal fees and was obligated to provide legal support for preparation of
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`the IPR petition at issue. IPR2015- 00044, Paper 18 at 10 -11 (P.T.A.B. Apr. 24,
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`2015). Once again, MNV did not pay any of IVIPI's legal fees associated with this
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`IPR Proceeding and is not obligated to provide either MI or MPI any legal support
`
`for this matter. Jenkins Decl. at ¶ 16.
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`B. Nissan's Evidence Is Insufficient
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`Nissan mischaracterizes MNV as the parent company of MPI, erroneously
`
`asserting that MPI and MI have "acknowledged that each is an indirect wholly -
`
`owned subsidiary of [MNV]" in corporate disclosure statements filed in federal
`
`district court. Prelim. Resp. at 5 -6, 11. First, MNV is the indirect parent of MI, not
`
`MPI. Jenkins Decl. at ¶¶ 4 -5. This fact is also made clear in the same corporate
`
`disclosure statements to which Nissan cites. Ex. 2014 at 1, 3. Regardless, in an RPI
`
`inquiry, corporate disclosure statements filed in court proceedings are generally not
`
`6
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`
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`IPR2015 -01069
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`given any weight, Intellectual Ventures Mgmt. v. Xilinx, Inc., 1PR2012- 00018,
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`Paper 12 at 3 -4 (P.T.A.B. Jan. 24, 2013).
`
`Nissan also alleges that the corporate lines are blurred because MNV and MI
`
`share the same executive officers/directors. There, Nissan makes a reference to a
`
`broad statement that MNV's "executive officers will carry out the day -to -day
`
`activities of Mylan NV's worldwide business." Prelim. Resp. at 6.
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`Mere overlap of executive officers and directors between MNV and MI does
`
`not establish the requisite control necessary for MNV to be a required RPI in this
`
`Proceeding.' See, e.g., Jiawei, IPR2014- 00935, Paper 52 at 9 (adhering to Supreme
`
`Court precedent that corporate lines were not blurred because "directors and
`
`officers holding positions with a parent and its subsidiary can and do `change hats'
`
`to represent the two corporations separately "); First Quality Baby Prod., LLC v.
`
`Kimberly -Clark Worldwide, Inc., 1PR2014- 01023, Paper 41 at 9 -10 (P.T.A.B. July
`
`16, 2015). And Nissan's quote provides no basis to conclude that MNV's corporate
`
`The instant case is distinguishable from the recent Corning decision. IPR2014-
`
`00440, Paper 68. There, the Board conferred RPI status,
`
`in part, because
`
`overlapping corporate officers were acting "at the same time, interchangeably," on
`
`behalf of both the petitioner and its sister company on the subject IPR. Id at 19.
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`Here, none of these facts exist. See Jenkins Decl. at ill 14 -16.
`
`7
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`
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`1PR2015 -01069
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`officers and directors, in their capacities as such, play any role in or exert any
`
`control over the Proceeding. They do not. Jenkins Decl. at IT 16.
`
`Misconstruing multiple press releases, Nissan also alleges that "MNV...
`
`identifies ANDA applications previously filed by MI as its own." Prelim. Resp. at
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`9. Nissan goes so far as to allege that MNV owns MPI's ANDA based on
`
`"common sense." Id. at 10. Nissan is wrong. First, none of the press releases state
`
`that either MNV or MI owns any ANDAs. In fact, they do not. Jenkins Decl, at ¶ 6.
`
`Second, the Board has rejected attempts
`
`to base RPI status on generalized
`
`references in publicly -available documents. See, e.g., TRW Auto. US LLC v.
`
`Magna Elec. Inc., IPR2014- 01499, Paper 7 at 7 11 (P.T.A.B. Mar. 19, 2015)
`
`(giving no weight to multiple press releases containing general references to both
`
`the parent and its subsidiaries).
`
`Nissan's attempt to confer required -RPI status on MNV based on SEC
`
`filings is equally misplaced. Specifically, Nissan cites to IVJNV's and MI's SEC
`
`filings, alleging that "MNV has access to MPI's accounts receivable" and that "MI
`
`which is also owned by MNV, has represented that its U.S. sales are derived
`
`principally through the activities of MPI." Prelim. Resp. at 9. However, the
`
`portions of the SEC filings on which Nissan relies do not mention MNV, but
`
`consistently use the descriptors "Our" or "the Company," both of which are
`
`common parlance in SEC filings showing nothing more than the existence of a
`
`8
`
`
`
`IPR2015 -01069
`
`parent/subsidiary relationship. See Sony Computer Entrn't Am. LLC v. Game
`
`Controller Tech. LLC, IPR2013- 00634, Paper 31 at 7 -8 (P.T.A.B. April 2, 2015);
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`TRW Auto., IPR2014 -01499, Paper 7 at 8.
`
`None of Nissan's purported evidence, when taken as a whole, links MNV
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`with this Proceeding. Nor does it indicate any activity by MNV, MI, or MPI that
`
`blurs the lines of corporate separation such that MNV could have controlled the
`
`filing and prosecution of this Proceeding. See Par, IPR2015- 00546, Paper 25 at 15.
`
`While MI's or MPI's activities may inure, ultimately, to the benefit of MNV, such
`
`benefit does not per se confer RPI status. Id. at 17.
`
`C. MNV's Identification in Unrelated IPR Proceedings Does Not
`Mean that MNV Is an RPI in this Proceeding
`
`Nissan has alleged that MPI, MI and MNV have acknowledged their
`
`"intertwined interests" simply because MNV was listed as an RPI in 15 other IPRs.
`
`Prelim. Resp. at 6. Nissan's analysis misses the mark. "The RPI analysis [] is an
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`inquiry into the relationship between [MNV] and the [instant Proceeding], not the
`
`relationship between [MPI, Ml, and MNV]" in other non -related IPR proceedings.
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`See Par, 1PR2015 -00546 at 14. ( "A party [is] not ... a[n] [RPI] merely through
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`association with another party
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`in
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`an endeavor unrelated
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`to
`
`the
`
`[IPR
`
`petition /proceeding at issue]. ").
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`Here, there is no coordinated interest or strategic relationship between this
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`Proceeding and any of the other proceedings cited by Nissan. Jenkins Decl. at IT 17.
`
`
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`IPR2015-01069
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`Also, the identification of MNV in other proceedings does not confer any special
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`authority or obligation on MNV to be involved in, or exercise any control over,
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`every Mylan IPR petition now and in the future. Under Nissan's rationale, no
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`analysis would ever be needed to determine whether MNV should be listed. All
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`that would matter is that MNV was previously and /or subsequently identified in
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`unrelated IPR proceedings. That is not the law. Each RN analysis for a given
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`proceeding is separate and distinct. Jiawei, IPR2014- 00935, Paper 52 at 13 (RPI
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`inquiry is a "highly fact -dependent question ").
`
`The corporate lines between MNV and MI, here, were not blurred. Every
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`decision relating to this IPR Proceeding was under the control and direction of only
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`MI and MPI. Jenkins Decl. at ¶ 13. MNV was not involved nor could it have been
`
`involved
`
`in this proceeding because MNV was nothing more than a non-
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`operational, holding corporation having no capability to control it.
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`IV.
`
`CONCLUSION
`
`MP1 has fully satisfied the requirements of § 312(a) and the Board should
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`maintain the current Petition filing dates and institute review of the '336 Patent.
`
`Respectfully submitted,
`
`Date: August 28, 2015
`
`/ Jitendra Malik /
`
`Jitendra Malik
`
`10
`
`
`
`IPR2015-01069
`
`Reg. No. 55823
`4721 Emperor Blvd., Suite 400
`Durham, North Carolina 27703
`Telephone: 919- 862 -2200
`Fax: 919- 862 -2260
`Jitty.Malik @alston. corn
`
`Deanne M Mazzochi
`Reg. No. 50158
`Back -Up Counsel for Petitioner
`
`Rakoczy Molino Mazzochi Siwik
`LLP
`6 West Hubbard St., Suite 500
`Chicago, Illinois 60654
`Telephone: 312-222-6305
`Fax: 312- 222 -6325
`dazzochi@rmmslegal. corn
`
`
`
`CERTIFICATION OF SERVICE ON PATENT OWNER
`
`The undersigned hereby certifies that the foregoing document entitled
`
`Petitioner's Response to the Real Party -In- Interest Allegations Raised in
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`Patent Owner's Preliminary Response was served electronically via e -mail
`
`on August 28, 2015 to Patent Owner's counsel of record upon the following:
`
`David G. Conlin
`Reg. No. 27,026
`Lead Counsel for Patent Owner
`Mintz Levin Cohn Ferris Glovsky
`and Popeo, P.C.
`One Financial Center,
`Boston, Massachusetts 02111
`Tel.: 617 -348 -1856
`Fax: 617 -542 -2241
`DGConlin @mintz.com
`
`Kathleen B. Carr
`Reg. No. 41,658
`Back -up Counsel for Patent Owner
`Mintz Levin Cohn Ferris Glovsky and
`Popeo, P.C.
`One Financial Center,
`Boston, Massachusetts 02111
`Tel.: 617- 348 -1857
`Fax: 617 -542 -2241
`KBCarr @mintz.com
`
`Respectfully submitted,
`
`ALSTON & BIRD LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik
`Reg. No. 55823
`Lead Counsel for Petitioner
`4721 Emperor Blvd., Suite 400
`Durham, North Carolina 27703
`Telephone: 919- 862 -2200
`Fax: 919 -862 -2260
`Jitty.Malik @alston, corn
`
`L6GAL02l35454033v1
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