`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`ACTAVIS LLC,
`Petitioner
`
`v.
`
`ABRAXIS BIOSCIENCE, LLC,
`Patent Owner
`
`
`
`Case IPR2017-01103
`Patent 7,923,536 B2
`
`
`
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`(as of November 3, 2017)
`
`
`
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313–1450
`Submitted Electronically via the Patent Review Processing System
`
`
`
`
`
`
`
`LIST OF EXHIBITS
`
`
`EX. Description
`1001 Desai et al., U.S. Patent No. 7,923,536 B2, “Compositions and Methods of
`Delivery of Pharmacological Agents” (issued Apr. 12, 2011) (the “ʼ536
`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)
`
`1
`
`
`
`
`
`
`
`1018
`
`EX. Description
`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”)
`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”)
`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”)
`
`2
`
`
`
`
`
`
`
`EX. Description
`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 Declaration of George C. Lombardi In support of Motion for Pro Hac Vice
`Admission
`1028 Declaration of Charles B. Klein. In support of Motion for Pro Hac Vice
`Admission
`1029 Declaration of Kevin E. Warner In support of Motion for Pro Hac Vice
`Admission
`1030 Declaration of Eimeric Reig-Plessis In support of Motion for Pro Hac Vice
`Admission
`
`
`Dated: November 3, 2017
`
`
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`Telephone: 312-558-7931
`Fax: 312-558-5700
`Email: AbraxaneIPR@winston.com
`
`
`Respectfully submitted,
`
` /Samuel S. Park/
`Samuel S. Park
`Reg. No. 59,656
`
`Lead Counsel for Petitioner
`
`George C. Lombardi
`(to seek pro hac vice admission)
`Charles B. Klein
`(to seek pro hac vice admission)
`Kevin E. Warner
`(to seek pro hac vice admission)
`Eimeric Reig-Plessis
`(to seek pro hac vice admission)
`
`Back-Up Counsel for Petitioner
`
`3
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), this is to certify that on
`
`November 3, 2017, I caused to be served a true and correct copy of the foregoing
`
`“PETITIONERS’ UPDATED EXHIBIT LIST As Of November 3, 2017 and
`
`Exs. 1027-1030” was served by electronic mail upon the following counsel for
`
`Patent Owner:
`
`Lead Counsel:
`J. Patrick Elsevier, Ph.D. (Reg. No. 44,668)
`Jones Day
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121-3134
`Tel: (858) 314-1200
`Fax: (844) 345-3178
`jpelsevier@jonesday.com
`
`Backup Counsel:
`Anthony M. Insogna (Reg. No. 35,203)
`aminsogna@jonesday.com
`
`Cary Miller, Ph.D. (Reg. No. 54,708)
`cmiller@jonesday.com
`
`Lisamarie LoGiudice, Ph.D. (Reg. No. 71,047)
`llogiudice@jonesday.com
`
`F. Dominic Cerrito (Reg. No. 38,100)
`nickcerrito@quinnemanuel.com
`
`Frank C. Calvosa (Reg. No. 69,064)
`frankcalvosa@quinnemanuel.com
`
`Andrew S. Chalson (pro hac vice)
`Andrewchalson@quinnemanuel.com
`
`
`1
`
`
`
`
`
`
`
`
`Dated: November 3, 2017
`
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`Telephone: 312-558-7931
`Fax: 312-558-5700
`Email: AbraxaneIPR@winston.com
`
`Respectfully submitted,
`
`
` /Samuel S. Park/
`Samuel S. Park
`Reg. No. 59,656
`
`Lead Counsel for Petitioner
`
`
`
`
`2
`
`
`