UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________
`
`Apotex Inc. and Apotex Corp.,
`Petitioners
`
`v.
`
`ABRAXIS BIOSCIENCE, LLC,
`Patent Owner
`_________________
`
`Case IPR2018-00151
`Patent 8,138,229 B2
`Issued: March 20, 2012
`
`Title: COMPOSITIONS AND METHODS OF
`DELIVERY OF PHARMACOLOGICAL AGENTS
`
`_________________
`
`
`
`
`
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`
`(as of January 10, 2018)
`
` 
`
`Doc. # DC-10809713 v.1  
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 
`
`

`

`IPR2018-00151 (8,138,229 B2) 
`
`LIST OF EXHIBITS
`
`Description
`EX
`1001 Desai et al., U.S. Patent No. 8,138,229 B2, “Compositions and Methods of
`Delivery of Pharmacological Agents” (issued Mar. 20, 2012) (the “ʼ229
`patent”)
`1002 Declaration of Cory J. Berkland, Ph.D.
`in Support of Petition for Inter Partes Review
`1003 Desai et al., U.S. Patent No. 5,439,686, “Methods for In Vivo Delivery of
`Substantially Water Insoluble Pharmacologically Active Agents and
`Compositions Useful therefor” (issued Aug. 8, 1995) (the “ʼ686 patent”)
`1004 Kadima et al., WO 2000/006152, “Pharmaceutically Acceptable
`Composition Comprising an Aqueous Solution of Paclitaxel and Albumin”
`(published Feb. 10, 2000) (“Kadima”)
`1005 Liversidge et al., U.S. Patent No. 5,399,363, “Surface Modified Anticancer
`Nanoparticles” (issued Mar. 21, 1995) (“Liversidge”)
`1006 Desai et al., WO 1999/000113, “Novel Formulations of Pharmacological
`Agents, Methods for the Preparation thereof and Methods for the Use
`thereof” (published Jan. 7, 1999) (“Desai”)
`1007 Li et al., “Fluorescein Binding to Normal Human Serum Proteins
`Demonstrated by Equilibrium Dialysis,” Arch Ophalmol. vol. 100, 484–87
`(March 1982)
`1008 Physicians’ Desk Reference® 309, 881–887 (54th ed. 2000) “Taxol®
`(paclitaxel) Injection” (“Taxol® label”)
`1009 FDA Guideline on Sterile Drug Products Produced by Aseptic Processing
`(June 1987, reprinted June 1991 and Feb. 1997)
`1010 EMEA Guidance on Manufacture of the Finished Dosage Form (April
`1996)
`1011 Elan Pharma Int’l Ltd. v. Abraxis BioScience, Inc., Judgment and Verdict
`Form, No. 06-438-GMS, Dkt. 614 (D. Del. June 16, 2008)
`1012 Elan Pharma Int’l Ltd. v. Abraxis BioScience, Inc., Sixth Day of Trial, No.
`06-438-GMS, Dkt. 624 (D. Del. June 9, 2008)
`1013 Elan Pharma Int’l Ltd. v. Abraxis BioScience, Inc., Seventh Day of Trial,
`No. 06-438-GMS, Dkt. 625 (D. Del. June 10, 2008)
`1014 Grinstaff et al., U.S. Patent No. 5,498,421, “Composition Useful for In Vivo
`Delivery of Biologics and Methods Employing Same (issued Mar. 12,
`1996) (the “ʼ421 patent”)
`
` 
`
`1 
`
` 
`
`Doc. # DC-10809713 v.1  
`
`

`

`IPR2018-00151 (8,138,229 B2) 
`
`1015 Patient Information Leaflet, “ABRAXANE® for Injectable Suspension
`(paclitaxel protein-bound particles for injectable suspension) (albumin-
`bound)” (revised May 2007)
`1016 Administrative Documents, New Drug Application No. 21-660
`1017 Damascelli, B et al. “Intraarterial chemotherapy with polyoxyethylated
`castor oil free paclitaxel, incorporated in albumin nanoparticles (ABI-
`007),” Cancer 2001 Nov; 92(10):2592–2602 (“Damascelli”)
`1018 Ibrahim et al., “Phase I and pharmacokinetic study of ABI-007, a
`Cremophor-free, protein-stabilized, nanoparticle formulation of paclitaxel,”
`Clin Cancer Res. 2002 May; 8:1038–44 (“Ibrahim”)
`1019 U.S. Application No. 11/553,339, Non-Final Office Action (mailed Apr.
`28, 2009)
`1020 U.S. Application No. 11/553,339, Amendment in Response to Non-Final
`Office Action (dated Oct. 27, 2009)
`1021 U.S. Application No. 11/553,339, Final Office Action (mailed Dec. 31,
`2009)
`1022 U.S. Application No. 11/553,339, Amendment After Final Action Under 37
`C.F.R. §1.116 (dated Apr. 14, 2010)
`1023 U.S. Application No. 11/553,339, Declaration of Neil P. Desai Pursuant to
`37 C.F.R. §1.132 (dated Apr. 14, 2010) (the “Inventor Declaration”)
`1024 U.S. Application No. 11/553,339, Notice of Allowance and Fee(s) Due
`(mailed June 1, 2010)
`1025 FDA, Approved Drug Products with Therapeutic Equivalence Evaluations
`(33d ed. 2013) (“Orange Book”)
`1026 Desai et al., “Protein Stabilized Pharmacologically Active Agents, Methods
`for the Preparation Thereof and Methods for the Use
`Thereof,” U.S. Patent No. 5,916,596 (issued Jun. 29, 1999)
`1027 Remington’s Pharmaceutical Sciences (18th ed. 1990), Chapt. 85,
`“Intravenous Admixtures” (“Remington’s”)
`1028 Camden, U.S. Patent No. 6,177,460 B1, “Method of Treatment for Cancer
`or Viral Infections” (issued Jan. 23, 2001)
`1029 E-mail chain between Petitioners’ and Patent Owner’s Counsel re
`additional discovery
`1030 Panacea US Certificate of Dissolution
`1031 Panacea Biotech Annual Report 2016-2017
`
`
`
`
`
`Doc. # DC-10809713 v.1  
`
`  2
`
` 
`
` 
`
` 
`
`

`

`IPR2018-00151 (8,138,229 B2) 
`
`Respectfully submitted,
`
`/John Josef Molenda/
`John Josef Molenda
`Reg. No. 47,804
`
`Lead Counsel for Petitioners
`
`
`
`Vishal Gupta
`(Reg. No. 67,284)
`Siew Yen Chong
`(Reg. No. 62,108)
`Fang Bu
`(to seek pro hac vice admission)
`
`Back-Up Counsel for Petitioners
`
`
`
`
`
`
`Doc. # DC-10809713 v.1  
`
`  3
`
` 
`
` 
`
`
`
`Dated: January 10, 2018
`
`STEPTOE & JOHNSON LLP
`1114 Avenue of the Americas, 35th Floor
`New York, NY 10036
`Phone: 212-506-3900
`Fax: 212-506-3950
`Email: Abraxane@Steptoe.com
`
`
`
`
`
`
`
`
`
` 
`
`

`

`IPR2018-00151 (8,138,229 B2) 
`
`CERTIFICATE OF SERVICE
`
`
`
`I hereby certify that a copy of the foregoing EXHIBIT LIST AND
`
`EXHIBIT NOS. 1029-1031, was served in its entirety on January 10, 2018 by
`
`filing this document through the Patent Trial Appeal Board End to End System as
`
`well as by delivering a copy via electronic mail, with Patent Owner’s consent, to
`
`Date: January 10, 2018
`
`the following attorneys for Petitioner and Patent Owner in the Actavis IPR:
`
`Counsel for Petitioner Actavis Counsel for Patent Owner Abraxis
`Samuel S. Park (lead counsel)
`J. Patrick Elsevier (lead counsel)
`George C. Lombardi
`Anthony M. Insogna
`Charles B. Klein
`Cary Miller
`Kevin E. Warner
`Christopher J. Harnett
`Eimeric Reig-Plessis
`Lisamarie LoGiudice
`WINSTON & STRAWN LLP
`JONES DAY
`AbraxaneIPR@winston.com
`jpelsevier@jonesday.com
`
`aminsogna@jonesday.com
`cmiller@jonesday.com
`llogiudice@jonesday.com
`charnett@jonesday.com
`
`F. Dominic Cerrito
`Andrew S. Chalson
`Daniel C. Wiesner
`Frank C. Calvosa
`QUINN EMANUEL URQUHART & SULLIVAN
`nickcerrito@quinnemanuel.com
`andrewchalson@quinnemanuel.com
`danielwiesner@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`/Siew Yen Chong/
`Siew Yen Chong
`
` Counsel for Apotex Inc. and Apotex Corp
`
`
`
`
`
`
`
`
`
`
`
`
`
` 
`
` 
`
`Doc. # DC-10809713 v.1  
`
`