On January 30th, 2017, Hospira
filed two petitions for inter partes
review of Genentech’s U.S. Patent 7,371,379 (IPR2017-00805) and U.S. Patent
6,627,196 (IPR2017-00804). These patents claim methods of treating cancers characterized by overexpression of ErbB2 receptor with trastuzumab (Herceptin®).
U.S. Patent 7,371,379 claims:
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.
U.S. Patent 6,627,196 Claims
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.
Horpira’s position is that the
claims of these patents are Obvious over the Herceptin Label in View of Baselga
’96[1],
Pegram ’98[2],
and the Knowledge of a Person of Ordinary Skill in the Art:
- The Herceptin Label teaches treatment of a human patient diagnosed with cancer characterized by over expression of ErbB2 by administering an anti-ErbB2 antibody. For example, the Herceptin Label teaches that rhuMAb HER2, which is an anti-ErbB2 antibody, is “administ[ered]” in “dosage[s]” “for the treatment of [human] patients with metastatic breast cancer whose tumors over express the HER2 protein.
- Baselga ʼ96 reports the results of a phase II clinical trial in which patients with ErbB2-over expressing metastatic breast cancer were treated with rhuMAb HER2. The pharmacokinetic goal of the trial “was to achieve rhuMAb HER2 trough serum concentrations greater than 10 µg/mL, a level associated with optimal inhibition of cell grown in the preclinical model.” …Baselga ’96 also teaches that in preclinical studies (both in vitro and in xenografts), rhuMAb HER2 “markedly potentiated the antitumor effects of several chemotherapist agents, including cisplatin, doxorubicin, and paclitaxel, without increasing their toxicity.”
- Pegram ʼ98 reports that a rhuMAb HER2 “target trough serum concentration of 10 to 20 µg/mL” was used. Pegram ’98 also reports a toxicity profile of the combination that paralleled the toxicity of cisplatin alone. This led to the conclusion that rhuMAb HER2 did not increase toxicity.
Hospira’s previously filed Herceptin related
IPR petitions can be accessed here: <http://biopharmapatent.blogspot.com/2016/12/hospira-has-filed-petition-for-inter.html>
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