UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Sandoz Inc.
`
`Petitioner
`
`V.
`
`EKR Therapeutics, LLC (f/k/a EKR Therapeutics, Inc.)
`Patent Owner
`
`US. Patent No. 8,455,524
`
`Case No. IPR2015—00005
`
`DECLARATION OF JOSEPHINE LIU, J.D., PH.D
`
`
`
`IPR2015-00005
`
`Sandoz Exhibit 1026 Page 1
`
`

`

`I, Josephine Liu, am Senior IP Litigation Counsel at Sandoz Inc.
`1.
`have responsibility for litigation pending in the District of New Jersey, Chiesz'
`USA, Inc, at al., v. Sandoz Inc, et 61]., CiV. A. No. 13-05723 (D.N.J.), relating
`to a nicardipine injectable product (the “‘Litigation”).
`I also have responsibility
`for this inter partes review proceeding. I make this Declaration to the best of
`my knowledge, information, and belief as to the matters set forth herein.
`
`I
`
`After the commencement of the litigation against Sandoz Inc., the
`2.
`Plaintiffs in that Litigation amended their complaint to add two new defendants,
`Sandoz AG and ACS Dobfar Info S.A. (“Dobfar”).
`
`I am informed and believe that Sandoz AG and Dobfar responded
`3.
`to the Amended Complaint on October 13, 2014, and did not assert
`counterclaims.
`
`On October 1, 2014, Sandoz Inc. commenced the interpartes
`4.
`review proceedings before the Patent and Trademark Appeals Board
`challenging the validity of US. Patent Nos. 7,612,102, 7,659,290, 7,659,291
`and 8,455,524 (“nicardipine IPRS”).
`
`Sandoz Inc. is a member of the Novartis Group of companies. It is
`5.
`not a parent or subsidiary of Sandoz AG. Sandoz AG and Sandoz Inc. are
`legally separate, and Sandoz Inc. manages its business independently from
`Sandoz AG. Its business is not operated by Sandoz AG. Sandoz Inc. has no
`corporate affiliation with Dobfar.
`
`Upon approval of the ANDA at issue in the Litigation, Sandoz Inc.
`6.
`(and not Sandoz AG) will be approved to sell the product that is the subject of
`the ANDA in the United States. Sandoz AG is not authorized to and does not
`
`operate in the United States.
`
`Sandoz Inc. maintains its own legal budget for legal challenges
`7.
`relating to patents that may be asserted against it with respect to its nicardipine
`injectable product. If Sandoz Inc. decides to bring any challenge to such
`patents before the US. Patent Office, it funds the cost of those challenges.
`
`In this case, Sandoz Inc. has been and will continue to be invoiced
`8.
`for and will pay all costs and expenses connected with the nicardipine IPRs.
`
`
`
`IPR2015-00005
`
`Sandoz Exhibit 1026 Page 2
`
`

`

`Sandoz Inc. does not expect to be reimbursed and is not entitled to
`9.
`reimbursement or indemnification of the nicardipine IPR fees or expenses from
`any other entity.
`
`10. Neither Sandoz AG nor Dobfar directed, funded or controlled
`Sandoz Inc.’s filing of the nicardipine IPRs.
`
`11.
`
`Sandoz AG and Dobfar had no input into the content of the
`
`nicardipine IPRS.
`
`Executed this {1th day of February 2015, at Princeton, NJ.
`
`.
`/ ,
`
`‘\
`
`v"
`
`/
`
`~
`
`
`
`IPR2015-00005
`
`Sandoz Exhibit 1026 Page 3
`
`