Roche/Genentech now argues that AMGN cannot partially opt out of the BCPIA Patent Dance, and that once AMGN voluntarily handed its 351(k) application to Roche for inspection (as dictated by the Patent Dance) it forfeited its right to discontinue the remainder of the Patent Dance procedures.
AMGN disagrees, and asserts that Roche’s only legal remedy is to sue AMGN for patent infringement.
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