UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`AMNEAL PHARMACEUTICALS, LLC and
`PAR PHARMACEUTICAL, INC
`Petitioners
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`
`
`_____________________
`
`Case IPR2015-00554
`Patent 7,668,730
`_____________________
`
`DECLARATION OF BARRY GILMAN
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`AMNEAL PHARMACEUTICALS, LLC and
`PAR PHARMACEUTICAL, INC
`Petitioners
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`
`
`_____________________
`
`Case IPR2015-00554
`Patent 7,668,730
`_____________________
`
`DECLARATION OF BARRY GILMAN
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`IPR2015-00554 (Patent 7,668,730)
`Declaration of Barry Gilman (Exhibit 1040)
`
`I, Barry Gilman, declare as follows:
`
`
`
`1.
`
`I am the Deputy General Counsel for Par Pharmaceutical, Inc. (“Par
`
`Inc.”). I am also the Secretary for Par Inc.
`
`2.
`
`Par Inc. is a wholly-owned subsidiary of Par Pharmaceutical
`
`Companies, Inc. (“Par Co.”). Par Co. is the sole wholly-owned subsidiary of Sky
`
`Growth Intermediate Holdings II, Inc. (“SGIH II”), which is the sole wholly-
`
`owned subsidiary of Sky Growth Intermediate Holdings I, Inc. (“SGIH I”). SGIH
`
`I is the sole wholly-owned subsidiary of Par Pharmaceutical Holdings, Inc. (“Par
`
`Holdings”). For ease of reference, I will refer to Par Co., SGIH I, SGIH II, and Par
`
`Holdings collectively as the “Par Parents.”
`
`3.
`
`Par Inc. is a corporation engaged in the business of, inter alia,
`
`manufacturing, distributing, and selling drugs, including generic drugs. As part of
`
`its business, Par Inc. prepares and files Abbreviated New Drug Applications
`
`(“ANDAs”) directed to generic drug products. As Par Inc. is engaged in this
`
`business, Par Inc. holds various Federal and state licenses to engage in the business
`
`of manufacturing, distributing, and selling drugs, including licenses with the
`
`United States Drug Enforcement Agency, the New York State Board of Pharmacy,
`
`and the United States Food and Drug Administration.
`
`4.
`
`The Par Parents, by contrast, do not engage in any operations. The
`
`Par Parents do not manufacture, distribute, or sell generic pharmaceuticals. None
`-2-
`
`
`
`
`
`IPR2015-00554 (Patent 7,668,730)
`Declaration of Barry Gilman (Exhibit 1040)
`of the Par Parents hold any licenses with the United States Drug Enforcement
`
`Agency, any state Pharmacy Board, or the United States Food and Drug
`
`Administration.
`
`5.
`
`Par Inc. solely prepared and filed ANDA No. 205403, which is
`
`directed to a 500 mg/mL sodium oxybate solution that is a generic version of Jazz
`
`Pharmaceuticals, Inc.’s (“Jazz”) XYREM drug product (“the ANDA Product”).
`
`Par Inc. is the owner of all right and title to ANDA No. 205403. Par Inc. paid all
`
`fees associated with filing ANDA No. 205403. The individuals who prepared and
`
`filed ANDA No. 205403 are employed on behalf of Par Inc. Michelle Bonomi-
`
`Huvala, an employee of Par Inc., signed the notice letter to Jazz stating that Par
`
`Inc. had filed an ANDA that included a Paragraph IV certification to Jazz’s
`
`patents.
`
`6.
`
`Jazz has sued Par Inc.—but none of the Par Parents—for infringement
`
`of U.S. Patent Nos. 7,668,730; 7,765,106; 7,765,107; 7,895,059; 8,457,988; and
`
`8,589,182 (“the Petition Patents”) as a result of Par Inc. filing ANDA No. 205403.
`
`Par Inc. is the sole party directing, controlling, and funding that litigation.
`
`7.
`
`Par Inc. was also the sole Par entity responsible for directing,
`
`controlling, and funding the preparation and filing of the petitions for inter partes
`
`review of the Petition Patents (the “instant Petitions”). Par Inc. was the only Par
`
`entity that paid any filing or legal fees associated with the preparation of the instant
`
`
`
`-3-
`
`
`
`IPR2015-00554 (Patent 7,668,730)
`Declaration of Barry Gilman (Exhibit 1040)
`Petitions. None of the Par Parents participated in the decision to file the instant
`
`Petitions, nor did they co-author the instant Petitions, nor exercise any control over
`
`the filing or content of the instant Petitions, nor provide funding or other
`
`compensation for the preparation and filing of the instant Petitions. At no point
`
`was the filing, content, or funding of the instant Petitions discussed at any meeting
`
`of the Board for any of the Par Parents. The individuals primarily responsible for
`
`the decision to file and the content of the instant Petitions, David Silverstein and
`
`Lawrence Brown, are employed on behalf of Par Inc. David Silverstein and
`
`Lawrence Brown are not employed by any of the Par Parents.
`
`8.
`
`None of the Par Parents have any reason for or interest in seeking
`
`review of the Petition Patents. As stated above, each of the Par Parents is a
`
`holding company that merely holds ownership of its subsidiaries, and conducts no
`
`independent operations. Not one of the Par Parents has ever been accused of
`
`infringing the Petition Patents, nor have any of the Par Parents moved to intervene
`
`in the ongoing litigation, or sought a declaratory judgment of invalidity of any of
`
`the Petition Patents in Federal district court.
`
`
`
`-4-
`
`
`
`IPR2015-00554 (Patent 7,668,730)
`Declaration of Barry Gilman (Exhibit 1040)
`I hereby declare that all statements made herein of my own
`
`9.
`
`knowledge are true and that all statements made on information and belief are
`
`believed to be true; and further that these statements were made with the
`
`knowledge that willful false statements and the like so made are punishable by fine
`
`or imprisonment, or both, under Section 1001 of Title 18 of the United States
`
`Code.
`
`
`
`
`
`Respectfully Submitted,
`
`
`
`Barry Gilman
`
`Deputy General Counsel,
`Par Pharmaceutical, Inc.
`
`Secretary,
`Par Pharmaceutical, Inc.
`
`Date: May 26, 2015
`
`
`
`-5-
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