Pfizer, Inc. vs Genentech, Inc.

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PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,591,897 UNDER 35 U.S.C. 311 AND 37 C.F.R. 42.100

Power of Attorney

File History of U.S. Patent 8,591,897, Vol. 2

File History of U.S. Patent 8,591,897, Vol. 3

File History of U.S. Patent 8,591,897, Vol. 4

U.S. Patent 8,591,897

File History of U.S. Patent 8,591,897, Vol. 1

Declaration of Dr. Allan Lipton

Van Pelt et al., Neoadjuvant Trastuzumab and Docetaxel in Patients with Breast Cancer: Preliminary Results, 4 CLIN. BREAST CANCER 348 (2003)

File History of U.S. Patent 8,591,897, Vol. 5

File History of U.S. Patent 8,591,897, Vol. 6

File History of U.S. Patent 8,591,897, Vol. 7

File History of U.S. Patent 8,591,897, Vol. 8

File History of U.S. Patent 8,591,897, Vol. 9

Dr. Allan Lipton, Curriculum Vitae and Materials Considered

Sledge et al., Pilot Trial of Paclitaxel-Herceptin Adjuvant Therapy for Early Stage Breast Cancer (E2198), 4 General Sessions 209 (2001)

Herceptin (Trastuzumab) Herceptin Product Label (Sept. 1998)

Gradishar et al., Progress in Systemic Adjuvant Therapy of Early- Stage Breast Cancer, 8 INTL. J.CLIN. ONCOL. 239-247 (May 23, 2003)

Slamon et al., Use of Chemotherapy Plus a Monoclonal Antibody Against HER2 for Metastatic Breast Cancer that Overexpresses HER2, 344 N. ENGL. J. MED. 11, 783-792 (Mar. 15, 2001)

J. Horton, Trastuzumab Use in Breast Cancer: Clinical Issues, 9 CANCER CONTROL 499-507 (2002)

Citron et al., Randomized Trial of Dose-Dense Versus Conventionally Scheduled and Sequential Versus Concurrent Combination Chemotherapy as Postoperative Adjuvant Treatment of Node-Positive Primary Breast Cancer:

Early-stage breast cancer, NCI Dictionary of Cancer Terms, (Feb. 15, 2017)

Devita et al., PRINCIPLES AND PRACTICE OF ONCOLOGY, 289-304 (Principles of Cancer Management: Chemotherapy), 307-333 (Principles of Cancer Management: Biologic Therapy), 1633-1726 (Cancer of the Breast) (Lippincott, Williams & Wilkins 6th ed. 2001), Vol. 1

Devita et al., PRINCIPLES AND PRACTICE OF ONCOLOGY, 289-304 (Principles of Cancer Management: Chemotherapy), 307-333 (Principles of Cancer Management: Biologic Therapy), 1633-1726 (Cancer of the Breast) (Lippincott, Williams & Wilkins 6th ed. 2001), Vol. 2

Devita et al., PRINCIPLES AND PRACTICE OF ONCOLOGY, 289-304 (Principles of Cancer Management: Chemotherapy), 307-333 (Principles of Cancer Management: Biologic Therapy), 1633-1726 (Cancer of the Breast) (Lippincott, Williams & Wilkins 6th ed. 2001), Vol. 3

Piccart-Gebhart et al., Herceptin: The Future in Adjuvant Breast Cancer Therapy, 12 Anti-Cancer Drugs Suppl. 4, S27-S33 (2001)

Romond et al., Trastuzumab plus Adjuvant Chemotherapy for Operable HER2-Positive Breast Cancer, 353 N. ENGL. J. MED. 1673 (Oct. 20, 2005)

Perez et al., Effect of Doxorubicin Plus Cyclophosphamide on Left Ventricular Ejection Fraction in Patients with Breast Cancer in the North Center Cancer Treatment Group N9831 Intergroup Adjuvant Trial, 22 J. CLIN. ONCOL. 3700 (Sept. 15, 2004)

Thomas et al., New Paradigms in Adjuvant Systemic Therapy of Breast Cancer, 10 Endocrine-Related Cancer 75-89 (2003)

Perez et al., Sequential Versus Concurrent Trastuzumab in Adjuvant Chemotherapy for Breast Cancer, 29 J. CLIN. ONCOL. 4491 (2011)

Pegram et al., Inhibitory Effects of Combinations of HER-2/neu Antibody and Chemotherapeutic Agents used for Treatment of Human Breast Cancers, 18 ONCOGENE 2241-2251 (1999)

Buzzoni et al., Adjuvant Chemotherapy with Doxorubicin Plus Cyclophosphamide, Methotrexate, and Fluorouracil in the Treatment of Resectable Breast Cancer with More than Three Positive Axillary Nodes, 9 J. CLIN. ONCOL. 2134-2140 (1991)

Tan-Chiu et al., Moving Forward: Herceptin in the Adjuvant Setting, 63 ONCOLOGY 57-63 (2002)

Devita et al., PRINCIPLES AND PRACTICE OF ONCOLOGY, 289-304 (Principles of Cancer Management: Chemotherapy), 307-333 (Principles of Cancer Management: Biologic Therapy), 1633-1726 (Cancer of the Breast) (Lippincott, Williams & Wilkins 6th ed. 2001), Vol. 4

Herceptin (Trastuzumab) Herceptin Product Label (Revised Dec. 2001),

J. Baselga, Herceptin Alone or in Combination with Chemotherapy in the Treatment of HER2-Positive Metastatic Breast Cancer: Pivotal Trials, 61 ONCOLOGY, 14-21 (2001)

Harries et al., The Development and Clinical Use of Trastuzumab (Herceptin), 9 Endocrine-Related Cancer 75-85 (2002)

Affidavit of Christopher Butler

S. Giordano, Update on Locally Advanced Breast Cancer, 8 ONCOLOGIST 521-530 (2003)

Lasorsa et al., Probing the Interaction Between Cisplatin and the Therapeutic Monoclonal Antibody Trastuzumab, 6 RSC ADVANCE 29229-29232 (2016)

U.S. Provisional Application No. 60/681125

Clark, Do we really need prognostic factors for breast cancer, (1994)

Herceptin (Trastuzumab) Product Label (2016)

Library of Congress Copyright Record for Van Pelt 03

Library of Congress Copyright Record for Romond 05

Declaration of Amanda Hollis

Piccart-Gebhart et al., Trastuzumab After Adjuvant Chemotherapy in HER2-Positive Breast Cancer, 353 N. ENGL. J. MED. 1659 (Oct. 20, 2005)

Library of Congress Copyright Record for Slamon 01

Library of Congress Copyright Record for Citron 03

Library of Congress Copyright Record for Perez 04

Library of Congress Copyright Record for Devita 01

Library of Congress Copyright Record for Buzzoni 91

Library of Congress Copyright Record for Giodano 03

Library of Congress Copyright Record for Piccart-Gebhart 05

Declaration of Christopher Lowden