Trastuzumab - USA

IPR decision (Oct 03, 2018):

AIA Review	Filing Date	Institution Date	Petitioner	Patent No.	Final Written Decision
IPR2017-00804	01/30/2017	07/27/2017	Hospira, Inc.	6,627,196	Claims 1–3, 5, 7, 9–11, and 17–33 are patentable
IPR2017-01139	03/24/2017	10/04/2017	Celltrion, Inc.		Claims 1–3, 5, 7, 9–11, 13–15, and 17–33 are patentable
IPR2017-00805	01/30/2017	07/27/2017	Hospira, Inc.	7,371,379	Claims 1–3, 5, 7, 9–11, 16–28, and 30–40  are patentable
IPR2017-01140	03/24/2017	10/04/2017	Celltrion, Inc.		Claims 1–3, 5, 7, 9–11, 13–28, and 30–40 are patentable
IPR2017-00737	01/20/2017	07/27/2017	Hospira, Inc.	7,892,549	Claims 1–17 are Unpatentable
IPR2017-01122	03/21/2017	10/04/2017	Celltrion, Inc.		Claims 1–11 and 14–17 are Unpatentable

On US’196 patent, Samsung Bioepis filed IPR (IPR2017-01958) on 08/25/2017 which was terminated.

On US’379 patent, Samsung Bioepis filed IPR (IPR2017-01959) on 08/25/2017 which was terminated.

On US’549 patent, Samsung Bioepis filed IPR (IPR2017-01960) on 08/25/2017 which was terminated & institution was denied on another Hospira’s petition (IPR2017-00739).

US 6,627,196 (Genentech, Inc.; Exp: Aug 25, 2020)

1. A method for the treatment of a human patient diagnosed with cancer characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of an anti-ErbB2 antibody to the human patient, the method comprising: administering to the patient an initial dose of at least approximately 5 mg/kg of the anti-ErbB2 antibody; and administering to the patient a plurality of subsequent doses of the antibody in an amount that is approximately the same or less than the initial dose, wherein the subsequent doses are separated in time from each other by at least two weeks.

16. A method for the treatment of a human patient diagnosed with cancer characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of an anti-ErbB2 antibody to the human patient, the method comprising: administering to the patient an initial dose of the antibody, wherein the initial dose is a plurality of doses, wherein each of the plurality of initial doses is at least approximately 1 mg/kg and is administered on at least 3 consecutive days, and administering to the patient at least 1 subsequent dose of the antibody, wherein at least one subsequent dose is at least approximately 6 mg/kg, and wherein administration of the last initial dose and the first subsequent and additional subsequent doses are separated in time by at least 3 weeks.

24. A method for the treatment of cancer in a human patient comprising administering to the patient a first dose of an anti-ErbB2 antibody followed by two or more subsequent doses of the antibody, wherein the subsequent doses are separated in time from each other by at least two weeks.

US 7,371,379 (Genentech, Inc.; Exp: Feb 16, 2022)

1. A method for the treatment of a human patient diagnosed with cancer characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of an anti-ErbB2 antibody to the human patient, the method comprising: administering to the patient an initial dose of at least approximately 5 mg/kg of the anti-ErbB2 antibody; and administering to the patient a plurality of subsequent doses of the antibody in an amount that is approximately the same or less than the initial dose, wherein the subsequent doses are separated in time from each other by at least two weeks; and further comprising administering an effective amount of a chemotherapeutic agent to the patient.

29. A method for the treatment of a human patient diagnosed with cancer characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of an anti-ErbB2 antibody to the human patient, the method comprising: administering to the patient an initial dose of the antibody, wherein the initial dose is a plurality of doses, wherein each of the plurality of initial doses is at least approximately 1 mg/kg and is administered on at least 3 consecutive days, and administering to the patient at least one subsequent dose of the antibody, wherein at least one subsequent dose is at least approximately 6 mg/kg, and wherein administration of the last initial dose and the first subsequent and additional subsequent doses are separated in time by at least 3 weeks, and further comprising administering an effective amount of a chemotherapeutic agent to the patient.

US 7,892,549 (Genentech, Inc.; Exp: Dec 10, 2018)

1. A method for the treatment of a human patient with breast cancer that overexpresses ErbB2 receptor, comprising administering a combination of an antibody that binds ErbB2, a taxoid, and a further growth inhibitory agent to the human patient in an amount effective to extend the time to disease progression in the human patient, wherein the antibody binds to epitope 4D5 within the ErbB2 extracellular domain sequence.

5. A method for the treatment of a human patient with breast cancer characterized by overexpression of ErbB2 receptor, comprising administering an effective amount of a combination of an anti-ErbB2 antibody which binds epitope 4D5 within the ErbB2 extracellular domain sequence, a taxoid, and a further therapeutic agent, to the human patient.

16. A method for the treatment of a human patient with ErbB2 overexpressing breast cancer, comprising administering a combination of an antibody that binds epitope 4D5 within the ErbB2 extracellular domain sequence, a taxoid and a further growth inhibitory agent, in the absence of an anthracycline derivative, to the human patient in an amount effective to extend the time to disease progression in the human patient.