IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In the Inter Partes Review of:
`
`Trial Number: To Be Assigned
`
`
`
`U.S. Patent No. 7,892,549
`
`Filed: February 3, 2003
`
`Issued: February 22, 2011
`
`Inventor(s): Virginia E. Paton, Steven Shak,
`Susan D. Hellmann
`
`Assignee: Genentech, Inc.
`
`
`
`
`
`
`
`
`
`
`
`Title: Treatment with Anti-ErbB2 Antibodies
`
`Panel: To Be Assigned
`
`Mail Stop Inter Partes Review
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`DECLARATION OF AMANDA HOLLIS
`
`
`
`1
`
`HOSPIRA EX. 1110
`Page 1
`
`
`
`In the Inter Partes Review of:
`
`Trial Number: To Be Assigned
`
`
`
`U.S. Patent No. 7,892,549
`
`Filed: February 3, 2003
`
`Issued: February 22, 2011
`
`Inventor(s): Virginia E. Paton, Steven Shak,
`Susan D. Hellmann
`
`Assignee: Genentech, Inc.
`
`
`
`
`
`
`
`
`
`
`
`Title: Treatment with Anti-ErbB2 Antibodies
`
`Panel: To Be Assigned
`
`Mail Stop Inter Partes Review
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`DECLARATION OF AMANDA HOLLIS
`
`
`
`1
`
`HOSPIRA EX. 1110
`Page 1
`
`
`
`I, Amanda Hollis, declare under penalty of perjury as follows:
`
`1.
`
`2.
`
`I am an attorney and Partner of the law firm Kirkland & Ellis, LLP.
`
`I make this Declaration in support of the petition for inter partes
`
`review of U.S. Patent No. 7,892,549 before the United States Patent and
`
`Trademark Office. I make this Declaration of my own personal knowledge.
`
`3.
`
`4.
`
`Exhibit 1101 is a true and correct copy of U.S. Patent No. 7,892,549.
`
`Exhibit 1102 is a true and correct copy of Assignment to Genentech,
`
`Inc. filed in U.S. Patent No. 7,846,441.
`
`5.
`
`Exhibit 1103 is a true and correct copy of Eur. Patent Specification
`
`No. 1,037,926 B1.
`
`6.
`
`Exhibit 1105 is a true and correct copy of Baselga et al., Phase II
`
`Study of Weekly Intravenous Recombinant Humanized Anti-p185HER2 Monoclonal
`
`Antibody in Patients with HER2/neu-Overexpressing Metastatic Breast Cancer,
`
`14(3) J. CLIN. ONCOL. 737–44 (1996).
`
`7.
`
`Exhibit 1106 is a true and correct copy of Baselga et al., Anti-HER2
`
`Humanized Monoclonal Antibody (MAb) Alone and in Combination with
`
`Chemotherapy Against Human Breast Carcinoma Xenografts, 13 PROC. AM. SOC.
`
`CLIN. ONCOL. 63 (Abstract 53) (1994).
`
`
`
`2
`
`HOSPIRA EX. 1110
`Page 2
`
`
`
`8.
`
`Exhibit 1107 is a true and correct copy of Baselga et al., HER2
`
`Overexpression and Paclitaxel Sensitivity
`
`in Breast Cancer: Therapeutic
`
`Implications, 11(3)(Suppl. 2) ONCOLOGY 43–48 (1997).
`
`9.
`
`Exhibit 1108 is a true and correct copy of U.S. Patent No. 5,677,171.
`
`10. Exhibit 1109 is a true and correct copy of Baselga et al., The
`
`Epidermal Growth Factor Receptor as a Target for Therapy in Breast Carcinoma,
`
`29(1) BREAST CANCER RESEARCH AND TREATMENT 127–38 (1994).
`
`11. Exhibit 1113 is a true and correct copy of Pegram et al., Phase II
`
`Study of Intravenous Recombinant Humanized Anti-p185 HER-2 Monoclonal
`
`Antibody
`
`(rhuMAb HER-2) Plus Cisplatin
`
`in Patients with HER-2/neu
`
`Overexpressing Metastatic Breast Cancer, 14 PROC. AM. SOC. CLIN. ONCOL 106
`
`(Abstract No. 124) (1995).
`
`12. Exhibit 1114 is a true and correct copy of Nabholtz et al., Results of
`
`Two Open-Label Multicentre Pilot Phase II Trials with Herceptin®
`
`in
`
`Combination with Docetaxel and Platinum Salts (Cis- or Carboplatin) (TCH) as
`
`Therapy for Advanced Breast Cancer In Women with Tumors Over-Expressing
`
`HER2, 64(1) Breast Cancer Research and Treatment 82 (Abstract 327) (2000).
`
`13. Exhibit 1115 is a true and correct copy of Hudziak et al., p185HER2
`
`Monoclonal Antibody has Antiproliferative Effects in Vitro and Sensitizes Human
`
`
`
`3
`
`HOSPIRA EX. 1110
`Page 3
`
`
`
`Breast Tumor Cells to Tumor Necrosis Factor, 9(3) Molecular and Cellular
`
`Biology 1165–72 (1989).
`
`14. Exhibit 1116 is a true and correct copy of Carter et al., Humanization
`
`of an anti-p185HER2 antibody for human cancer therapy, 89(10) PROC. NATL.
`
`ACAD. SCI. USA 4285–89 (1992).
`
`15.
`
` Exhibit 1118 is a true and correct copy of Pegram et al., Phase II
`
`Study of Receptor-Enhanced Chemosensitivity Using Recombinant Humanized
`
`Anti-p185HER2/neu Monoclonal Antibody Plus Cisplatin in Patients with HER2/neu-
`
`Overexpressing Metastatic Breast Cancer Refractory to Chemotherapy Treatment,
`
`16(8) J. CLIN. ONCOL. 2659–71 (1998).
`
`16. Exhibit 1119 is a true and correct copy of Certified File History of
`
`U.S. Patent No. 7,892,549 (7 Volumes).
`
`17. Exhibit 1120 is a true and correct copy of U.S. Provisional Patent
`
`Application No. 60/069,346.
`
`18. Exhibit 1121 is a true and correct copy of U.S. Patent Application No.
`
`09/208,649.
`
`19. Exhibit 1123 is a true and correct copy of Pietras et al., Antibody to
`
`HER-2/neu Receptor Blocks DNA Repair After Cisplatin in Human Breast and
`
`Ovarian Cancer Cells, 9(7) ONCOGENE 1829–38 (1994).
`
`
`
`4
`
`HOSPIRA EX. 1110
`Page 4
`
`
`
`20. Exhibit 1125 is a true and correct copy of Gelmon et al., Phase I/II
`
`Trial of Biweekly Paclitaxel and Cisplatin in the Treatment of Metastatic Breast
`
`Cancer, 14(4) J. CLIN. ONCOL. 1185–91 (1996).
`
`21. Exhibit 1133 is a true and correct copy of Slamon et al., Human
`
`Breast Cancer: Correlation of Relapse and Survival with Amplification of the
`
`HER-2/neu Oncogene, 235(4785) SCIENCE 177–82 (1987).
`
`22. Exhibit 1134 is a true and correct copy of Slamon et al., Studies of the
`
`HER-2/neu Proto-Oncogene in Human Breast and Ovarian Cancer, 244(4905)
`
`SCIENCE 707–12 (1989).
`
`23. Exhibit 1136 is a true and correct copy of Nicolaou et al., Taxoids:
`
`New Weapons against Cancer, 274(6) SCIENTIFIC AMERICAN 94–98 (1996).
`
`24. Exhibit 1137 is a true and correct copy of DeVita et al., A History of
`
`Cancer Chemotherapy, 68(21) CANCER RES. 8643–53 (2008).
`
`25. Exhibit 1140 is a true and correct copy of Pegram et al., Monoclonal
`
`Antibody to HER-2/neu Gene Product Potentiates Cytotoxicity of Carboplatin and
`
`Doxorubicin in Human Breast Tumor Cells, 33 PROCEEDINGS OF THE AMERICAN
`
`ASSOCIATION FOR CANCER RESEARCH, 442 (Abstract 2639) (1992).
`
`26. Exhibit 1141 is a true and correct copy of Pegram et al., The Effect of
`
`HER-2/neu Overexpression on Chemotherapeutic Drug Sensitivity in Human
`
`Breast and Ovarian Cancer Cells, 15(5) ONCOGENE 537–47 (1997).
`
`
`
`5
`
`HOSPIRA EX. 1110
`Page 5
`
`
`
`27. Exhibit 1142 is a true and correct copy of Shan et al., Anthracycline-
`
`Induced Cardiotoxicity, 125(1) ANN. INTERN. MED. 47–58 (1996).
`
`28. Exhibit 1143 is a true and correct copy of Mendelsohn et al.,
`
`Epidermal Growth Factor Receptor Family and Chemosensitization, 89(5) J.
`
`NATL. CANCER INSTITUTE 341–43 (1997).
`
`29. Exhibit 1145 is a true and correct copy of Jones et al., Replacing the
`
`Complementarity-Determining Regions in a Human Antibody With Those From a
`
`Mouse, 321(6069) NATURE 522–25 (1986).
`
`30. Exhibit 1148 is a true and correct copy of Burris et al., Phase II Trial
`
`of Herceptin Induction Followed by Combination Therapy with Paclitaxel and
`
`Carboplatin: A Minnie Pearl Research Network Trial, 64(1) BREAST CANCER
`
`RESEARCH AND TREATMENT 31 (Abstract 24) (2000).
`
`31. Exhibit 1150 is a true and correct copy of Leyland-Jones et al., Phase
`
`III Comparative Study of Trastuzumab and Paclitaxel With and Without
`
`Carboplatin in Patients with HER-2/neu Positive Advanced Breast Cancer,
`
`76(Suppl. 1) BREAST CANCER RESEARCH AND TREATMENT S37 (Abstract 35)
`
`(2002).
`
`32. Exhibit 1151 is a true and correct copy of Pienkowski et al., Taxotere,
`
`Cisplatin and Herceptin (TCH) in First-Line HER2 Positive Metastatic Breast
`
`Cancer (MBC) Patients, a Phase II Pilot Study by the Breast Cancer International
`
`
`
`6
`
`HOSPIRA EX. 1110
`Page 6
`
`
`
`Research Group (BCIRG 101), 20 PROC. AM. SOC. CLIN. ONCOL. 70b (Abstract
`
`2030) (2001).
`
`33. Exhibit 1152 is a true and correct copy of Slamon et al., Phase II Pilot
`
`Study of Herceptin Combined with Taxotere and Carboplatin (TCH) in Metastatic
`
`Breast Cancer (MBC) Patients Overexpressing the HER2-Neu Proto-Oncogene a
`
`Pilot Study of the UCLA Network, 20 PROC. AM. SOC. CLIN. ONCOL. 49a (Abstract
`
`193) (2001).
`
`34. Exhibit 1153 is a true and correct copy of Yardley et al., Final Results
`
`of the Minnie Pearl Cancer Research Network First-Line Trial of Weekly
`
`Paclitaxel/Carboplatin/Trastuzumab in Metastatic Breast Cancer, 76(Suppl. 1)
`
`BREAST CANCER RESEARCH AND TREATMENT S113 (Abstract 439) (2002).
`
`35. Exhibit 1154 is a true and correct copy of Pegram et al., Results of
`
`Two Open-Label, Multicenter Phase II Studies of Docetaxel, Platinum Salts, and
`
`Trastuzumab in HER2-Positive Advanced Breast Cancer, 96(10) J. NATL. CANCER
`
`INST. 759–69 (2004).
`
`36.
`
` Exhibit 1155 is a true and correct copy of Library of Congress
`
`Copyright Record for Baselga ʼ96.
`
`37. Exhibit 1156 is a true and correct copy of Library of Congress
`
`Copyright Record for Baselga ʼ97.
`
`
`
`7
`
`HOSPIRA EX. 1110
`Page 7
`
`
`
`38. Exhibit 1157 is a true and correct copy of Library of Congress
`
`Copyright Record for Hudziak ʼ89.
`
`39. Exhibit 1158 is a true and correct copy of Library of Congress
`
`Copyright Record for Carter ʼ92.
`
`40. Exhibit 1159 is a true and correct copy of Library of Congress
`
`Copyright Record for Gelmon ʼ96.
`
`41. Exhibit 1160 is a true and correct copy of Library of Congress
`
`Copyright Record for Slamon ʼ87.
`
`42. Exhibit 1161 is a true and correct copy of Library of Congress
`
`Copyright Record for Slamon ʼ89.
`
`43. Exhibit 1162 is a true and correct copy of Library of Congress
`
`Copyright Record for Nicolaou ’96.
`
`44. Exhibit 1163 is a true and correct copy of Library of Congress
`
`Copyright Record for Pegram ʼ92.
`
`45. Exhibit 1164 is a true and correct copy of Library of Congress
`
`Copyright Record for Shan ’96.
`
`46. Exhibit 1165 is a true and correct copy of Library of Congress
`
`Copyright Record for Mendelsohn ʼ97.
`
`47. Exhibit 1166 is a true and correct copy of Library of Congress
`
`Copyright Record for Jones ’86.
`
`
`
`8
`
`HOSPIRA EX. 1110
`Page 8
`
`
`
`48. Exhibit 1167 is a true and correct copy of Library of Congress
`
`Copyright Record for Pegram ’04.
`
`49. Exhibit 1168 is a true and correct copy of Library of Congress
`
`Copyright Record for Pegram ’98.
`
`50.
`
`I declare under penalty of perjury under the laws of the United States
`
`of America that all statements made herein of my own knowledge are true and that
`
`all statements made on information and belief are believed to be true; 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 the Title 18 of the United States Code.
`
`Executed on January 20, 2017 in Chicago, Illinois.
`
` /Amanda Hollis/
`Amanda Hollis
`
`
`
`9
`
`HOSPIRA EX. 1110
`Page 9
`
`
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
