Arlen Specter: “Well, as the Senator from Arkansas outlines, there is going to be a judicial determination, and the question is whether…”

“Well, as the Senator from Arkansas outlines, there is going to be a judicial determination, and the question is whether the generic drugs may be sold prior to the time the judicial determination is made, or whether the generic drugs may be sold only after the judicial determination is made. Under the expedited procedures that I am proposing, it would be a very, very prompt resolution. If the court determines that the generic had a substantial investment and had been denied access to the market for a period of time, then, for the period of time where the generic had been denied access, there would be damages paid. Really, we are very close together, as the Senator and I discussed this, with the essential difference being, who is going to bear the burden of proof in showing substantial investment? Those facts, really, are within the control of the generic manufacturer--after all, it is the generic manufacturer who knows what the generic manufacturer has sold, and it seems to me that there ought to be that determination made.”