`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PAR PHARMACEUTICAL, INC.,
`
`Petitioners
`
`v.
`
`HORIZON THERAPEUTICS, LLC,
`
`Patent Owner
`
`Case IPR 2017-01767
`
`Patent 9,254,278
`
`DECLARATION OF ROBERT F. GREEN IN RESPONSE TO
`PETITIONER’S OBJECTIONS TO EVIDENCE
`
`Horizon Exhibit 2041
`Par v. Horizon
`IPR2017-01767
`
`Page 1 of 4
`
`
`
`I, Robert F. Green, declare as follows:
`
`1.
`
`I am an attorney with Green, Griffith & Borg-Breen LLP, counsel for
`
`Patent Owner. I am a member of the Bar of the State of Illinois. I have personal
`
`knowledge of the matters stated in this declaration and would testify truthfully to
`
`them if called upon to do so.
`
`2.
`
`Exhibit 2002 is a true and correct copy of the Notice of Allowance
`
`dated December 23, 2015 from the Prosecution History of U.S. Patent No.
`
`9,254,278, which is publicly available and was downloaded from the United States
`
`Patent and Trademark Office Public PAIR website at
`
`https://portal.uspto.gov/pair/PublicPair.
`
`3.
`
`Exhibit 2005 is a true and correct copy of pages 16-22 of Par
`
`Pharmaceutical, Inc.’s Initial Invalidity Contentions and Non-Infringement
`
`Contentions for U.S. Patent Nos. 8,404,215 and 8,642,012, as served in Hyperion
`
`Inc. v. Par Pharmaceutical, Inc., C.A. No. 2:14-cv-00384(JRG)(RSP) (E.D. Texas)
`
`on November 13, 2014. Exhibit 2043 is a true and correct copy of the Certificate
`
`of Service which was served with Par’s Contentions in the above-referenced
`
`litigation.
`
`4.
`
`Exhibit 2026 is a true and correct copy of “Specialties of Genetics,” as
`
`it was publicly available on January 17, 2017, and which was downloaded from the
`
`Page 2 of 4
`
`
`
`American Board of Medical Genetics and Genomics website at
`
`http://abmgg.org/pages/training_specialties.shtml on that date.
`
`5.
`
`Exhibit 2027 is a true and correct copy of “About Us,” as it was
`
`publicly available on October 25, 2017, and which was downloaded from the Urea
`
`Cycle Disorders Consortium website at
`
`https://www.rarediseasesnetwork.org/cms/ucdc/About-Us on that date.
`
`6.
`
`Exhibit 2033 is a true and correct copy of Chapter 85: Urea Cycle
`
`Enzymes, which is available online and was downloaded from The Online
`
`Metabolic and Molecular Bases of Inherited Disease website at
`
`http://ommbid.mhmedical.com/book.aspx?bookid=971. Exhibit 2044 is a true and
`
`correct copy of the table of contents for The Online Metabolic and Molecular
`
`Bases of Inherited Disease dated February 27, 2017, showing Chapter 85.
`
`7.
`
`Exhibit 2038 is a true and correct copy of the drugs@FDA: FDA
`
`Approved Drug Products entry for BUPHENYL® which is publicly available on
`
`the FDA’s website: http://www.accessdata.fda.gov/scripts/cder/daf/ by searching
`
`for “BUPHENYL” and selecting the entry for “BUPHENYL (SODIUM
`
`PHENYLBUTYRATE) | NDA #020572 | TABLET;ORAL | Prescription |
`
`HORIZON PHARMA INC.” (Ex. 2045.) Exhibit 2045 is a true and correct copy
`
`of the search results for “BUPHENYL” obtained through the FDA website’s
`
`search function dated February 27, 2017. The full URL for the FDA’s website for
`
`Page 3 of 4
`
`
`
`BUPHENYL® is:
`
`http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process
`
`&ApplNo=020572.
`
`8.
`
`Exhibit 2040 is a true and correct copy of the full prescribing
`
`information PDF for RAVICTI®, as it was publicly available on February 10,
`
`2017, and which was downloaded from
`
`https://hznp.azureedge.net/public/ravicti_1-1g-ml_vial_pi_effective_us.PDF on or
`
`before such date.
`
`9.
`
`I declare that all statements made herein of my 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
`
`and the like so made are punishable by fine or imprisonment, or both, under
`
`Section 1001 of Title 18 of the United States Code.
`
`Dated: February 28, 2018
`
`By: / Robert F. Green /
`Robert F. Green
`
`Page 4 of 4
`
`
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