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If a drug has three approved indications and only one is covered by a listed method-of-use patent, a generic applicant can seek approval only for the two non-patented indications by filing a section viii statement, carving out the patented use from the proposed labeling

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Thus, hemolysis reflects just the mechanically induced injury to erythrocytes and does not allow for determining specific signal transduction modules involved in cell death induction and execution

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