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Friday, June 21, 2002

Welcome and Opening Remarks

CHAIRMAN KASS: Would the Council Members please join the table and take their seats. Good morning. This morning will be devoted to two sessions on the patentability of human organisms; the first session on history and current law; and the second session on ethics and public policy.

The topic of the patenting of life, with special attention to the patenting of human organisms, is a topic that we selected here for a number of reasons. First of all, as part of a larger interest in the interaction between biotechnology and society, the question of patenting policy is relevant.

Second, a number of the members of the council, going back to the very first meeting, expressed an interest in the significance of the commercial aspects of the new biomedical technology, and wondered about those special ethical and policy questions that arise from commercialization.

Third, patent protection, though not primarily an instrument for regulation, is nevertheless one area where this question of commercialization can be explored. And though it does not serve as a regulator, it does work as an accelerator, and therefore does have some considerable impact on what happens.

Fourth, as the staff has looked at documents and read case law, it seems as if patenting of human organisms and their parts may at least, and following the existing statute as the Supreme Court cases have interpreted them, be at least silent on, and perhaps even allow for the patenting of human life and human parts.

And one wonders whether there is an existing either ambiguity or lacuna in the current law as interpreted on this question that would allow the patenting of human organisms from embryos on up or the parts.

And we thought that we would investigate the question as to first of all is there such a lacuna, and we are not experts in this matter. And second is that lacuna a problem, and if so, why.

And if it does would that difficulty be sufficient to warrant a legislative remedy, and I think those are the larger questions that we would to at least think about with the help of our invited guests.

This morning, in considering the history and current law, we are very fortunate to have two guests seated to my right. First, Daniel Kevles, who is the Woodward Professor of History at Yale University; and a scholar of the history of science and its interactions with society.

And second, Karen Hauda, who is a patent attorney in the Office of Legislative and International Affairs at the United States Patent and Trademark Office, and was for a while the patent examiner, or one of the patent examiners, in gene therapy and transgenic animal art.

And we have asked Professor Kevles to talk about the history of patenting life as it leads up to the question of human organisms. And Ms. Hauda will speak about the existing state of the patent law, and try to educate us about what goes on over there, and how it affects these questions.

The larger biographies of our guests are in the briefing book, and I won't say any more about it. Professor Kevles has provided a wonderfully rich and long paper, which I hope everybody has had a chance to read, and he, I think, is going to begin here by summarizing, embellishing, or adding to that, and let me without further ado please turn it over to Professor Kevles..

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