IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`COALITION FOR AFFORDABLE DRUGS VIII LLC, Petitioner
`
`v.
`
`TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA,
`Patent Owner, based on Electronic Records of PTO
`U.S. Patent 7,932,268 to Rader
`Filing Date: June 21, 2007
`Issue Date: April 26, 2011
`TITLE: METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED
`WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING
`SIDE EFFECTS
`_____________________
`
`Inter Partes Review No.: IPR2015-01836
`
`
`
`Declaration of Christopher Casieri in Support of
`Coalition for Affordable Drugs’ Petition for Inter Partes Review of U.S.
`Patent No. 7,932,268 and Opposition To Motion To Amend
`
`
`
`Exhibit 1057
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`COALITION FOR AFFORDABLE DRUGS VIII LLC, Petitioner
`
`v.
`
`TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA,
`Patent Owner, based on Electronic Records of PTO
`U.S. Patent 7,932,268 to Rader
`Filing Date: June 21, 2007
`Issue Date: April 26, 2011
`TITLE: METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED
`WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING
`SIDE EFFECTS
`_____________________
`
`Inter Partes Review No.: IPR2015-01836
`
`
`
`Declaration of Christopher Casieri in Support of
`Coalition for Affordable Drugs’ Petition for Inter Partes Review of U.S.
`Patent No. 7,932,268 and Opposition To Motion To Amend
`
`
`
`Exhibit 1057
`
`
`
`
`
`Petitioner’s Responses To Patent Owner’s Objections Dated September 14, 2016
`Petition for Inter Partes Review 2015-01836
`
`I, Christopher Casieri, declare as follows:
`
`1.
`
` I am a partner with the law firm of McNeely Hare & War LLP,
`
`counsel for Petitioner Coalition for Affordable Drugs VIII (“Coalition”) in this
`
`matter.
`
`2.
`
`I am a practicing attorney and am a member in good standing of the
`
`Bars of the State of New Jersey (2000) and the District of Columbia (2000), as
`
`well as the United States District Court for the District of New Jersey (2000). I am
`
`also admitted to practice before USPTO (Registration No. 50,919).
`
`3.
`
`I submit this Declaration in support of Coalition for Affordable
`
`Drugs’ Petition for Inter Partes Review of U.S. Patent No. 7,932,268 and
`
`Opposition To Motion To Amend Petition for Inter Partes Review of U.S. Patent
`
`No. 7,932,268 B2, and, in particular, to authenticate certain exhibits cited and
`
`referenced in Coalition’s Petition . I understand that my declaration will be
`
`included in Petitioner’s Exhibit List as CFAD Ex. 1057.
`
`4.
`
`I have personal knowledge of the facts stated in this Declaration. All
`
`of the exhibits cited herein are publically available.
`
`5.
`
`Exhibit 1058 is a true and correct copy of a document entitled
`
`“Guidance for Industry 2002, Estimating the Safe Starting Dose in Clinical Trials
`
`for Therapeutics in Adult Healthy Volunteers” (2002). It is publically available
`
`from the Food and Drug Administration’s (FDA) website at
`
`1
`
`
`
`Petitioner’s Responses To Patent Owner’s Objections Dated September 14, 2016
`Petition for Inter Partes Review 2015-01836
`
`http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0492-gdl0001-vol1.pdf. This
`
`exhibit is included in Petitioner’s Exhibit List as CFAD Ex. 1042. The yellow
`
`highlighting in Ex. 1042 does not appear in the original and is removed from
`
`Exhibit 1058.
`
`6.
`
`Exhibit 1059 is a true and correct copy of ICH-E4, Dose-Response
`
`Information to Support Drug Registration (1994). It is publically available from
`
`the FDA’s website at
`
`http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/g
`
`uidances/ucm073115.pdf. This exhibit is included in Petitioner’s Exhibit List as
`
`CFAD Ex. 1043. The yellow highlighting in Ex. 1043 does not appear in the
`
`original and is removed from Exhibit 1059.
`
`7.
`
`Exhibit 1060 is a true and correct copy of the FDA Label for
`
`Crestor®. It is publically available from the FDA’s website at
`
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21366_crestor_lbl.pdf.
`
`This exhibit is included in Petitioner’s Exhibit List as CFAD Ex. 1046. The
`
`yellow highlighting in Ex. 1046 does not appear in the original and is removed
`
`from Exhibit 1060.
`
`8.
`
`Exhibit 1061 is a true and correct copy of the FDA Label for
`
`VytorinTM. It is publically available from the FDA’s website at
`
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21687lbl.pdf . This
`
`2
`
`
`
`Petitioner’s Responses To Patent Owner’s Objections Dated September 14, 2016
`Petition for Inter Partes Review 2015-01836
`
`exhibit is included in Petitioner’s Exhibit List as CFAD Ex. 1047. The yellow
`
`highlighting in Ex. 1047 does not appear in the original and is removed from
`
`Exhibit 1061.
`
`9.
`
`Exhibit 1062 is a true and correct copy of the FDA Label for Zocor®.
`
`It is publically available from FDA’s website at
`
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19766s45s53lbl.pdf.
`
`This exhibit is included in Petitioner’s Exhibit List as CFAD Ex. 1048. The
`
`yellow highlighting in Ex. 1048 does not appear in the original and is removed
`
`from Exhibit 1062.
`
`10. Exhibit 1063 is a true and correct copy of the FDA Label for
`
`Caduet®. It is publically available from the FDA’s website at
`
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21540_caduet_lbl.pdf.
`
`This exhibit is included in Petitioner’s Exhibit List as CFAD Ex. 1049. The
`
`yellow highlighting in Ex. 1049 does not appear in the original and is removed
`
`from Exhibit 1063.
`
`11. Exhibit 1064 is a true and correct copy of the FDA Label for
`
`Lipitor®. It is publically available from the FDA’s website at
`
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20702s25lbl.pdf. This
`
`exhibit is included in Petitioner’s Exhibit List as CFAD Ex. 1050. The yellow
`
`3
`
`
`
`Petitioner’s Responses To Patent Owner’s Objections Dated September 14, 2016
`Petition for Inter Partes Review 2015-01836
`
`highlighting in Ex. 1050 does not appear in the original and is removed from
`
`Exhibit 1067.
`
`12. Exhibit 1065 is a true and correct copy of the FDA Label for ZetiaTM.
`
`It is publically available from the FDA’s website at
`
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21445lbl.pdf. This
`
`exhibit is included in Petitioner’s Exhibit List as CFAD Ex. 1051. The yellow
`
`highlighting in Ex. 1051 does not appear in the original and is removed from
`
`Exhibit 1065.
`
`13.
`
` I hereby declare that all statements made herein are true and correct;
`
`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.
`
`
`
`Date: September 28, 2016
`
`
`
`
`
`
`
`
`
`
`
`Respectfully Submitted,
`
`Christopher Casieri
`
`
`
`
`
`
`
`4
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