IN THE UNITED STATES 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.: IPR2015-01069
`
`DECLARATION OF THOMAS W. JENKINS IN SUPPORT OF MYLAN
`PHARMACEUTICALS INC.’S RESPONSE REGARDING THE
`IDENTIFICATION OF REAL PARTY-IN-INTEREST
`
`Mylan Exhibit 1045
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`Mylan Pharmaceuticals Inc., Petitioner
`
`v.
`
`Nissan Chemical Industries Ltd.
`Patent Owner
`_____________________
`
`Inter Partes Review No.: IPR2015-01069
`
`DECLARATION OF THOMAS W. JENKINS IN SUPPORT OF MYLAN
`PHARMACEUTICALS INC.’S RESPONSE REGARDING THE
`IDENTIFICATION OF REAL PARTY-IN-INTEREST
`
`Mylan Exhibit 1045
`
`
`
`I, Thomas W. Jenkins, declare as follows:
`
`1.
`
`I am Vice President and Associate Global General Counsel for Patent
`
`Litigation for Mylan Inc. (“MI”). MI pays my salary.
`
`2.
`
`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.
`
`3.
`
`Mylan N.V. (“MNV”) is a publicly-traded, non-operational Dutch
`
`holding company. MNV does not directly engage in the manufacture, distribution,
`
`or sale of drugs.
`
`It also does not generate any revenue itself. MNV has no
`
`independent operations or material assets other than equity ownership in its
`
`subsidiaries.
`
`4.
`
`Mylan Inc.
`
`(“MI”)
`
`is a Pennsylvania non-operational holding
`
`company and an indirect wholly-owned subsidiary of MNV.
`
`5.
`
`Mylan Pharmaceuticals Inc. (“MPI”) is a West Virginia operational
`
`company, which is a wholly-owned subsidiary of MI. MPI is engaged in the
`
`distribution, manufacture, and sale of generic pharmaceuticals. MPI prepares and
`
`files Abbreviated New Drug Applications (“ANDA”) with the U.S. Food and Drug
`
`Administration (“FDA”).
`
`6.
`
`Neither MNV nor MI owns any ANDAs.
`
`1
`
`Mylan Exhibit 1045
`
`
`
`MPI’s ANDA and the Pending Litigation
`
`7.
`
`In 2013, MPI compiled and submitted ANDA No. 206070 directed to
`
`Pitavastatin Tablets (“MPI’s ANDA” or “the ANDA”). MPI was (and continues to
`
`be) the sole named applicant for, and owner of all right and title to, MPI’s ANDA.
`
`8.
`
`MNV was not involved in any part of the development, compilation,
`
`or submission of MPI’s ANDA.
`
`9.
`
`As part of the ANDA, MI submitted a Paragraph IV Certification to
`
`the FDA on MPI’s behalf, indicating that, among others, U.S. Patent No. 5,856,336
`
`(“the ’336 patent”) is invalid and not
`
`infringed.
`
`In connection with that
`
`Certification, MPI, by its outside counsel, served, among others, Nissan Chemical
`
`Industries Ltd. (“Nissan”) with a paragraph IV notice letter, which provided a
`
`detailed legal and factual basis supporting the invalidity of the ’336 patent. MNV
`
`was not involved in any of these actions.
`
`10.
`
`In response to the paragraph IV notice letter, on April 14, 2014,
`
`Nissan sued both MPI and MI in the U.S. District Court for the Southern District of
`
`New York, alleging infringement of, among other patents, the ’336 patent.
`
`11. On July 16, 2014, MPI and MI filed their Answer and Counterclaims
`
`asserting, among other things, that the ’336 patent is invalid and not infringed. The
`
`litigation remains pending solely against MPI and MI.
`
`I am responsible for
`
`managing the litigation. MNV has never exercised any control over the litigation.
`
`2
`
`Mylan Exhibit 1045
`
`
`
`The Pending IPR Proceeding
`
`12. On or about December 2014, MI decided to prepare and file the
`
`petition for inter partes review of the ’336 patent (the “IPR Proceeding”). That
`
`decision was solely made by MI’s in-house counsel, including myself. MNV was
`
`not
`
`involved. I was primarily responsible for selecting and retaining outside
`
`counsel to prepare and file the Petition and prosecute the IPR Proceeding.
`
`13. MI
`
`is, and continues to be, solely responsible for directing,
`
`controlling, and funding the preparation, filing, and prosecution of the IPR
`
`Proceeding. Every decision relating to this IPR Proceeding was, and is, under the
`
`control and direction of only MI and MPI. MI remains the only entity that has paid
`
`and pays all filing fees or legal expenses associated with the IPR Proceeding. As is
`
`the case with the litigation, the day-to-day oversight of the IPR Proceeding is
`
`headed by me.
`
`14. MNV has never exercised any control over the IPR Proceeding.
`
`15.
`
`There are no unified actions between MNV, MI, and MPI with respect
`
`to either the IPR Proceeding or the aforementioned pending litigation.
`
`16. No MNV officer or director, in their capacity as such, has ever acted
`
`on behalf of MI or MPI in connection with the IPR Proceeding. MNV has never
`
`paid any of the legal fees associated with this IPR Proceeding and is not obligated
`
`to provide either MI or MPI any legal support for this matter.
`
`3
`
`Mylan Exhibit 1045
`
`
`
`17.
`
`There is no coordinated interest or strategic relationship between this
`
`IPR Proceeding and any of the other IPR proceedings cited in Nissan’s Preliminary
`
`Response.
`
`18.
`
`I hereby declare that all statements made herein of my own
`
`knowledge are true and that all statements made on information and belief are
`
`believed to be true; and that these statements were made with the knowledge that
`
`willful false statements are punishable under Section 1001 of Title 18 of the U.S.
`
`Code.
`
`4
`
`Mylan Exhibit 1045
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