Arlen Specter: “I believe that the problems presented in the pending amendment could be solved if the parties would get together and…”

“I believe that the problems presented in the pending amendment could be solved if the parties would get together and agree to a procedure which would provide for prompt judicial determination as to what is a substantial investment. I agree with my distinguished colleague from Rhode Island that this matter ought to be cured and acted upon, because the more time that passes, the greater the potential damages on one side or another, depending upon whether there has been a substantial investment. That is the issue which is outstanding, and it is my view that the generic manufacturer should be compelled to show that it has complied with the provisions of law and that it has, in fact, made a substantial investment before it can enter the marketplace. With all due respect, I do not believe that this is a matter for editorial comment, or for generalization. Instead, it requires a hard look at the facts and a careful analysis of the law. What we are dealing with here is public policy to encourage pharmaceutical companies to make very substantial investments to produce pharmaceutical products. The other public policy consideration is to make available generic products for the benefit of many parties, once the patent has had a reasonable life term. Those who benefit from generics are many. They are the senior citizens. They are the veterans. They are the Government. Many interested parties ought to have access to generic products.”