`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`ACTAVIS LLC,
`Petitioner
`
`v.
`
`ABRAXIS BIOSCIENCE, LLC,
`Patent Owner
`
`
` Case IPR2017-01104
`Patent 8,138,229 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. 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)
`
`
`
`
`
`IPR2017-01104 (8,138,229 B2)
`
`1018
`
`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”)
`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)
`
`2
`
`
`
`IPR2017-01104 (8,138,229 B2)
`
`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 Declaration of George C. Lombardi In support of Motion for Pro Hac Vice
`Admission
`1030 Declaration of Charles B. Klein. In support of Motion for Pro Hac Vice
`Admission
`1031 Declaration of Kevin E. Warner In support of Motion for Pro Hac Vice
`Admission
`1032 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
`
`
`
`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. 1029-1032” 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
`
`
`
`
`
`
`IPR2017-01104 (8,138,229 B2)
`
`
`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
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
