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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`PAR PHARMACEUTICAL, INC.
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`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
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`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
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`PO Box 1450
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`Alexandria, Virginia 22313-1450
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`1
`1
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`PAR PHARMACEUTICAL, INC.
`PAR PHARMACEUTICAL, INC.
`EX. 1028
`
`EX. 1028
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`
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`IPR2015—0l 1 17 (Patent 8,642,012)
`IPR20l5-01127 (Patent 8,404,215)
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`I, Barry Gilman, declare as follows:
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`1.
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`I am the Deputy General Counsel for Par Pharmaceutical, Inc.
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`I am also the
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`Secretary for Par Pharmaceutical, Inc.
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`2.
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`Par Pharmaceutical, Inc. is a wholly—owned subsidiary of Par Pharmaceutical
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`Companies, Inc. (“Par Co.”). Par Co. is the sole wholly—owned subsidiary of Sky
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`Growth Intermediate Holdings II Corporation (“SGIH II”), which is the sole
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`wholly—owned subsidiary of Sky Growth Intermediate Holdings I Corporation
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`(“SGIH I”).
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`SGIH I is the sole wholly—owned subsidiary of Par Pharmaceutical
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`Holdings, Inc. (f/k/a Sky Growth Holdings Corporation) (“Par Holdings”).
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`For
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`ease of reference, I will refer to Par Co., SGIH I, SGIH II, and Par Holdings
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`collectively as the “Par Parents.”
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`3.
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`Par Pharmaceutical, Inc.
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`is a corporation engaged in the business of, inter
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`alia, manufacturing, distributing, and selling drugs, including generic drugs. As
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`part of its business, Par Pharmaceutical, Inc. prepares and files Abbreviated New
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`Drug Applications (“ANDAS”) directed to generic drug products.
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`As Par
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`Pharmaceutical, Inc.
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`is engaged in this business, Par Pharmaceutical, Inc. holds
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`Various Federal and state licenses to engage in the business of manufacturing,
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`2
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`PAR PHARMACEUTICAL, INC.
`PAR PHARMACEUTICAL, INC.
`EX. 1028
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`EX. 1028
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`
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`IPR20l5-0l l 17 (Patent 8,642,012)
`IPR20l5-0l 127 (Patent 8,404,215)
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`distributing, and selling drugs,
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`including licenses with the United States Drug
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`Enforcement Agency, the New York State Board of Pharmacy, and the United
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`States Food and Drug Administration.
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`Par Co. does not conduct any such
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`operations. Par Co. is a non—operational holding company that does not engage in
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`the manufacture, distribution, or sale of drugs.
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`It does not generate any revenues
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`itself (outside revenues are generated by its operating subsidiaries, including Par
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`Pharmaceutical, Inc.). Par Co. has no legal department of its own.
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`4.
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`Par Pharmaceutical,
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`Inc. was solely responsible for preparing and filing
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`ANDA No. 20-5742, which is directed to a glycerol phenylbutyrate product that is a
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`generic version of Horizon Therapeutics, Inc.’s (f/l</a Hyperion Therapeutics, Inc.)
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`(“Horizon’s”) RAVICTI drug product (“the ANDA Product”). Par Pharmaceutical,
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`Inc. is the owner of all right and title to ANDA No. 20-5742. Par Pharmaceutical,
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`Inc. paid all fees associated with filing ANDA No. 20-5742. The individuals who
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`prepared and filed ANDA No. 20-5742 are employed on behalf of Par
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`Pharmaceutical,
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`Inc.
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`Michelle Bonomi-Huvala,
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`an
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`employee of Par
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`Pharmaceutical,
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`Inc.,
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`signed the notice letter
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`to Horizon stating that Par
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`Pharmaceutical, Inc. had filed an ANDA that included a Paragraph IV certification
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`to Horizon’s patents.
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`PAR PHARMACEUTICAL, INC.
`PAR PHARMACEUTICAL, INC.
`EX. 1028
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`EX. 1028
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`
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`IPR2015-01117 (Patent 8,642,012)
`IPR2015-01127 (Patent 8,404,215)
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`5.
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`Horizon has sued Par Pharmaceutical, Inc.—but none of the Par Parents—for
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`infringement of U.S. Patent Nos. 8,642,012 and 8,404,215 (“the Petition Patents”)
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`as a result of Par Pharmaceutical,
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`Inc.
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`filing ANDA No. 20-5742.
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`Par
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`Pharmaceutical,
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`Inc.
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`is the sole party directing, controlling, and funding that
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`litigation.
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`6.
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`Par Pharmaceutical, Inc.
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`is also the sole entity responsible for filing the
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`petitions for inter partes review of the Petition Patents (the “instant Petitions”). Par
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`Pharmaceutical, Inc. directed, controlled, and funded the preparation and filing of
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`the instant Petitions.
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`Par Pharmaceutical, Inc. was the only Par entity that paid
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`any filing or legal fees associated with the preparation of the instant Petitions.
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`None of the Par Parents participated in the decision to file the instant Petitions, nor
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`did any co-author the instant Petitions, nor did any exercise any control over the
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`filing or content of the instant Petitions, nor did any provide funding or other
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`compensation for the preparation and filing of the instant Petitions. At no point
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`was the filing, content, or funding of the instant Petitions discussed at any meeting
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`of the Board for any of the Par Parents. The individuals primarily responsible for
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`the decision to file and the content of the instant Petitions, David Silverstein and
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`PAR PHARMACEUTICAL, INC.
`PAR PHARMACEUTICAL, INC.
`EX. 1028
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`EX. 1028
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`
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`IPR2015—01 117 (Patent 8,642,012)
`IPR2015—01127 (Patent 8,404,215)
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`Lawrence Brown, are employed on behalf of Par Pharmaceutical, Inc.
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`David
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`Silverstein and Lawrence Brown are not employed by any of the Par Parents.
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`7.
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`I have reviewed the March 31, 2015 Form 10-Q for Par Pharmaceutical
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`Companies, Inc. On page 36 of the filing, there is the statement, “On April 23,
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`2014, Hyperion Therapeutics filed a lawsuit against us in the U.S. District Court
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`for
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`the Eastern District of Texas.”
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`In this context, “us” refers
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`to Par
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`Pharmaceutical, Inc., which is the only defendant to that lawsuit.
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`In this same
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`paragraph, there is the statement, “On April 29, 2015, we filed Inter Partes Review
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`petitions seeking institution of a trial on invalidity at
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`the U.S. Patent and
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`Trademark Office for both of the patents asserted in the Texas litigation.” In this
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`context, “we” refers to Par Pharmaceutical, Inc., which is the only entity involved
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`with the “Inter Partes Review.”
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`8.
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`None of the Par Parents have any reason for, or interest in, seeking review of
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`the Petition Patents.
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`As stated above, each of the Par Parents is a holding
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`company that merely holds ownership of its
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`subsidiaries and conducts no
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`independent operations.
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`None of the Par Parents has ever been accused of
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`infringing the Petition Patents, nor have any of the Par Parents moved to intervene
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`PAR PHARMACEUTICAL, INC.
`PAR PHARMACEUTICAL, INC.
`EX. 1028
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`EX. 1028
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`
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`IPR2015-01117 (Patent 8,642,012)
`IPR2015-01127 (Patent 8,404,215)
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`in the ongoing litigation or sought a declaratory judgment of invalidity of any of the
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`Petition Patents in Federal district court.
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`9.
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`I hereby declare that all statements made herein of my own knowledge are
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`true and that all statements made on information and belief are believed to be true;
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`and further that these statements were made with the knowledge that willful false
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`statements and the like so made are punishable by fine or imprisonment, or both,
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`under Section 1001 of Title 18 of the United States Code.
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`Respectfully Submitted,
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`‘fig/l_ Gill’
`
`Barry Gilman
`Deputy General Counsel, Par Pharmaceutical, Inc.
`Secretary, Par Pharmaceutical, Inc.
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`Date: September 2, 2015
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`PAR PHARMACEUTICAL, INC.
`PAR PHARMACEUTICAL, INC.
`EX. 1028
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`EX. 1028