David Pryor

Mr. PRYOR

Mr. PRYOR. That is absolutely true. The Uruguay Round Agreements Act clearly establishes it is the obligation of the generic competitor to prove a substantial investment before the court. It is the court which determines whether or not a substantial investment has, in fact, been made. This is true for all industries today, except for one.

Mr. PRYOR. Mr. President, I regret I must correct the Senator from Pennsylvania. Both current law and our amendment allows for the sale of generic competitors, contemporaneous to a court determination of substantial investment. In other words, the term substantial investment is defined in the Pryor-Brown-Chafee-Bryan legislation in the present language of the GATT implementing legislation, the Uruguay Round Agreements Act. I thank my colleague for raising a very important point. We are not changing the GATT agreement on substantial investment in any shape, form, or fashion. In fact, by bringing this sole outlier industry into compliance with the rest of the country, one might argue that we are keeping even closer to the spirit and letter of our obligations under that agreement than is the case today.

Mr. PRYOR. No, my friend and colleague is mistaken. The present law says that a generic competitor may come onto the marketplace, even though the court has not resolved the issue of whether they have made substantial investment. If, hypothetically, after the generic competitor has entered the marketplace and competed with the patent holder, it is then determined by the court that a substantial investment has not been made, then the court imposes damages upon the generic competitor to render the patent holder whole.

Mr. PRYOR. That compensation is determined according to the language of the Uruguay Round Agreements Act, the GATT implementing legislation. On that point, let me reference the letter from the Department of Health and Human Services about the Thurmond-Hatch substitute. This is the agency which would have to implement the substitute. The letter states that ``it will be nearly impossible to meet the `substantial investment' requirement'' under the substitute. Elsewhere, it concludes the substitute ``defines substantial investment--a matter that the URAA left to the courts--and does so in a manner that would make it virtually impossible for a generic drug company to meet the requirement.''

Mr. PRYOR. If I might respond to my colleague, in 35 U.S.C. 284, the situation is this. If, in the extremely unlikely event that a false claim of substantial investment is actually made by a generic competitor coming into the marketplace, the court may award damages in full, plus interest. If for some reason the court felt particularly strongly that the claim of substantial investment was false, fraudulent or otherwise inappropriate, it has further discretion to award treble damages to the patent holder.

Mr. PRYOR. Mr. President, let me respond. Then I am going to sit down because I am going to Little Rock in just a few minutes.

Mr. PRYOR. Mr. President, under the circumstances--and the circumstances are these--I have been waiting since January to offer this amendment. I think, as a Member of this body, I am entitled to have a vote on this amendment. Maybe it is a tabling motion. I am not objecting to that. But I think on this particular amendment and on this language, this Senator is entitled to this body deciding, yes, we do want this amendment or, no, we do not. That is all I have asked for all year. It is all I am asking for now. It is apparent I am not going to get that, so I am not going to send up an amendment at this time, and I will wait until next week or I might wait until next July or I might wait until next September, whenever. But I am going to offer this amendment, and I hope to get a vote on it. I hope my colleagues will allow me to get a vote on it. I have never second degreed an amendment here in 18 years--never. In fact, I have never even been tempted to. And I am not going to second degree my own amendment. I am not going to get cute, parliamentarily speaking. I hope my colleague from Utah will understand and the managers will understand, but I just do not think it is protecting of my rights now to offer an amendment. If I may, I would like to ask unanimous consent to add a few cosponsors: Senator Byrd, Senator Dorgan, and Senator Leahy, all to be original cosponsors.

Mr. PRYOR. Mr. President, I thank the Chair.

Mr. PRYOR. We do not have a time agreement. I am more than willing to enter into a time agreement for a vote on our amendment to take place.

Mr. PRYOR. Mr. President, I suggest that we have no more than an hour, or perhaps even a 45-minute time agreement. I would like to inquire of my friend from Utah whether this is agreeable.

Mr. PRYOR. I am just proposing that.

Mr. PRYOR. I would like to make two requests. One, before I agree to such a proposal, I would like to see the amendment in the second degree. I think it would be only fair because the Senator from Utah has had our amendment for many, many months. Second, I would like to ask, should we agree to a time agreement, that I may be immediately recognized should my amendment be tabled or should the second-degree amendment prevail.

Mr. PRYOR. Should the Hatch amendment be agreed to. I should phrase it that way.

Mr. PRYOR. Mr. President, I would like to put in a unanimous consent request, that should the Hatch second-degree amendment prevail--and I not get the vote on my amendment--that I might be immediately recognized for an up-or-down vote on my amendment.

Mr. PRYOR. I would simply reoffer my amendment, and I would like to be recognized for that purpose. And I ask unanimous consent.

Mr. PRYOR. Mr. President, that is precisely what I seek. If I may, I think we can resolve this together if I may respectfully suggest the absence of a quorum.

Mr. PRYOR. I would answer my colleague with reference to the law as it currently affects every industry but one. The court would determine damages on the basis of lost sales or profits, the length of time expired, and the multitude of other facts which leave the court uniquely suited to make such determinations on a case-by-case basis. I believe that was the compelling logic behind adoption of the GATT language in this respect, and I feel it should be equally compelling for this single, rogue industry. I would again emphasize that we are not changing the GATT or URAA language as it relates to substantial investment. We are keeping it. We are applying this language to the drug companies, just as it applies to every other company, every other industry, and every other business entity in our country.

Mr. PRYOR

Mr. PRYOR. I think under the unanimous-consent agreement reached last night, I was to be recognized at this point. Mr. President, if there is no objection, I would like to yield 3 or 4 minutes to the Senator from Nebraska who wants to make a statement, and then also to the Senator from Idaho and the Senator from New Mexico who have an amendment that I understand will be presented and accepted perhaps by a voice vote. Then, if there is no objection, I hope to be recognized. I ask unanimous consent to do so.

Mr. PRYOR

Mr. PRYOR. Mr. President, I thank the distinguished ranking member of the Armed Services Committee for allowing me to make a statement, and I will say to my distinguished chairman of the Armed Services Committee, my statement will be about just one moment, and then we will allow Senator Murray to go forward with her amendment. Mr. President, the amendment that I am going to offer, and it may not be after the disposition of Senator Murray's amendment but it may be after the disposition of a subsequent amendment, is the so-called GATT Glaxo amendment. I have been attempting all of this year, during the entirety of 1996, to bring this amendment to the floor, to have it debated and have it voted on. I have asked for 1 hour of debate, 30 minutes on a side, and then let us vote up or down and dispose of this matter to see if we are willing or not willing to correct a massive abuse that we created by mistake in the GATT treaty. This is allowing one drug firm to prevent other generic firms from coming in and competing fairly in the market. It is also allowing an extra $5 million each day--each day--of profits that we hesitate and fail to correct. It should be a matter of honor that we correct this matter, and I am going on the Department of Defense bill to continue attempting to find a slot where Senator Brown, Senator Chafee, and the Senator from Arkansas, Senator Pryor, may offer this amendment and have the U.S. Senate go on record, once and for all, as to whether we are willing to correct this abusive flaw created by mistake. Mr. President, I yield the floor. Mr. THURMOND addressed the Chair.

Mr. PRYOR. Mr. President, reserving the right to object, I would like to include in the unanimous-consent request, if I might, that I be recognized to offer an amendment immediately upon the disposition of the Murray amendment.

Mr. PRYOR. Mr. President, I object.

Mr. PRYOR. If the distinguished leader will yield for a comment.

Mr. PRYOR. I have consulted two times in an hour and a half with Senator Hatch, the chairman of the Judiciary Committee. He has an intense interest in the issue. He has agreed to a time limit and hopes, like I do, that perhaps tomorrow after the Federal Reserve issues are decided, that we could then possibly go to this amendment.

Mr. PRYOR. I thank the Senator.

Mr. PRYOR

Mr. PRYOR. Mr. President, if the distinguished Senator from Utah will allow me, I would like to make a few comments and maybe engage the Senator in a couple of questions, if that is permissible.