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IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PAR PHARMACEUTICAL, INC.
`
`Petitioner
`
`v
`HORIZON THERAPEUTICS, INC.
`Patent Owner
`
`Case IPR2015—01l17 (Patent 8,642,012)
`Case IPR2015—01127 (Patent 8,404,215)
`
`DECLARATION OF BARRY GILMAN
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`
`PO Box 1450
`
`Alexandria, Virginia 22313-1450
`
`1
`1
`
`PAR PHARMACEUTICAL, INC.
`PAR PHARMACEUTICAL, INC.
`EX. 1028
`
`EX. 1028
`
`

`
`IPR2015—0l 1 17 (Patent 8,642,012)
`IPR20l5-01127 (Patent 8,404,215)
`
`I, Barry Gilman, declare as follows:
`
`1.
`
`I am the Deputy General Counsel for Par Pharmaceutical, Inc.
`
`I am also the
`
`Secretary for Par Pharmaceutical, Inc.
`
`2.
`
`Par Pharmaceutical, 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 Corporation (“SGIH II”), which is the sole
`
`wholly—owned subsidiary of Sky Growth Intermediate Holdings I Corporation
`
`(“SGIH I”).
`
`SGIH I is the sole wholly—owned subsidiary of Par Pharmaceutical
`
`Holdings, Inc. (f/k/a Sky Growth Holdings Corporation) (“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 Pharmaceutical, 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 Pharmaceutical, Inc. prepares and files Abbreviated New
`
`Drug Applications (“ANDAS”) directed to generic drug products.
`
`As Par
`
`Pharmaceutical, Inc.
`
`is engaged in this business, Par Pharmaceutical, Inc. holds
`
`Various Federal and state licenses to engage in the business of manufacturing,
`
`2
`
`PAR PHARMACEUTICAL, INC.
`PAR PHARMACEUTICAL, INC.
`EX. 1028
`
`EX. 1028
`
`

`
`IPR20l5-0l l 17 (Patent 8,642,012)
`IPR20l5-0l 127 (Patent 8,404,215)
`
`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.
`
`Par Co. does not conduct any such
`
`operations. Par Co. is a non—operational holding company that does not engage in
`
`the manufacture, distribution, or sale of drugs.
`
`It does not generate any revenues
`
`itself (outside revenues are generated by its operating subsidiaries, including Par
`
`Pharmaceutical, Inc.). Par Co. has no legal department of its own.
`
`4.
`
`Par Pharmaceutical,
`
`Inc. was solely responsible for preparing and filing
`
`ANDA No. 20-5742, which is directed to a glycerol phenylbutyrate product that is a
`
`generic version of Horizon Therapeutics, Inc.’s (f/l</a Hyperion Therapeutics, Inc.)
`
`(“Horizon’s”) RAVICTI drug product (“the ANDA Product”). Par Pharmaceutical,
`
`Inc. is the owner of all right and title to ANDA No. 20-5742. Par Pharmaceutical,
`
`Inc. paid all fees associated with filing ANDA No. 20-5742. The individuals who
`
`prepared and filed ANDA No. 20-5742 are employed on behalf of Par
`
`Pharmaceutical,
`
`Inc.
`
`Michelle Bonomi-Huvala,
`
`an
`
`employee of Par
`
`Pharmaceutical,
`
`Inc.,
`
`signed the notice letter
`
`to Horizon stating that Par
`
`Pharmaceutical, Inc. had filed an ANDA that included a Paragraph IV certification
`
`to Horizon’s patents.
`
`PAR PHARMACEUTICAL, INC.
`PAR PHARMACEUTICAL, INC.
`EX. 1028
`
`EX. 1028
`
`

`
`IPR2015-01117 (Patent 8,642,012)
`IPR2015-01127 (Patent 8,404,215)
`
`5.
`
`Horizon has sued Par Pharmaceutical, Inc.—but none of the Par Parents—for
`
`infringement of U.S. Patent Nos. 8,642,012 and 8,404,215 (“the Petition Patents”)
`
`as a result of Par Pharmaceutical,
`
`Inc.
`
`filing ANDA No. 20-5742.
`
`Par
`
`Pharmaceutical,
`
`Inc.
`
`is the sole party directing, controlling, and funding that
`
`litigation.
`
`6.
`
`Par Pharmaceutical, Inc.
`
`is also the sole entity responsible for filing the
`
`petitions for inter partes review of the Petition Patents (the “instant Petitions”). Par
`
`Pharmaceutical, Inc. directed, controlled, and funded the preparation and filing of
`
`the instant Petitions.
`
`Par Pharmaceutical, Inc. was the only Par entity that paid
`
`any filing or legal fees associated with the preparation of the instant Petitions.
`
`None of the Par Parents participated in the decision to file the instant Petitions, nor
`
`did any co-author the instant Petitions, nor did any exercise any control over the
`
`filing or content of the instant Petitions, nor did any 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
`
`PAR PHARMACEUTICAL, INC.
`PAR PHARMACEUTICAL, INC.
`EX. 1028
`
`EX. 1028
`
`

`
`IPR2015—01 117 (Patent 8,642,012)
`IPR2015—01127 (Patent 8,404,215)
`
`Lawrence Brown, are employed on behalf of Par Pharmaceutical, Inc.
`
`David
`
`Silverstein and Lawrence Brown are not employed by any of the Par Parents.
`
`7.
`
`I have reviewed the March 31, 2015 Form 10-Q for Par Pharmaceutical
`
`Companies, Inc. On page 36 of the filing, there is the statement, “On April 23,
`
`2014, Hyperion Therapeutics filed a lawsuit against us in the U.S. District Court
`
`for
`
`the Eastern District of Texas.”
`
`In this context, “us” refers
`
`to Par
`
`Pharmaceutical, Inc., which is the only defendant to that lawsuit.
`
`In this same
`
`paragraph, there is the statement, “On April 29, 2015, we filed Inter Partes Review
`
`petitions seeking institution of a trial on invalidity at
`
`the U.S. Patent and
`
`Trademark Office for both of the patents asserted in the Texas litigation.” In this
`
`context, “we” refers to Par Pharmaceutical, Inc., which is the only entity involved
`
`with the “Inter Partes Review.”
`
`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.
`
`None of the Par Parents has ever been accused of
`
`infringing the Petition Patents, nor have any of the Par Parents moved to intervene
`
`PAR PHARMACEUTICAL, INC.
`PAR PHARMACEUTICAL, INC.
`EX. 1028
`
`EX. 1028
`
`

`
`IPR2015-01117 (Patent 8,642,012)
`IPR2015-01127 (Patent 8,404,215)
`
`in the ongoing litigation or sought a declaratory judgment of invalidity of any of the
`
`Petition Patents in Federal district court.
`
`9.
`
`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 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,
`
`‘fig/l_ Gill’
`
`Barry Gilman
`Deputy General Counsel, Par Pharmaceutical, Inc.
`Secretary, Par Pharmaceutical, Inc.
`
`Date: September 2, 2015
`
`PAR PHARMACEUTICAL, INC.
`PAR PHARMACEUTICAL, INC.
`EX. 1028
`
`EX. 1028

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