proceedings, his or her body having served as a home for the That product liability or attorneys of other legal specialities will seek to involve doctors, scientists and universities in litigation because of the threat, however tenuous, from their research to a therapeutic process or product is clear. The threat of litigation to universities for therapies that emerge from biotechnology apppears to be much higher than therapies that emerged from past medical research. This is because the transfer of technology may involve, in addition to patent rights, genetic information embodied in tangible form such as a plasmid vector or hybridoma. But even a "bare" patent license may not protect a patentee from ligitation. A patent simply gives its owner the right to exclude and nothing more. The rights of a company to manufacture and sell are common law rights and are not given by a patent There have not been as yet liability suits reaching license. back to the patentee, which has simply granted a licensee immunity from suit under the particular patent. However, there recently have been in legal journals hypothetical situations outlined where patentees would be brought into litigation and become potential sources of revenue for the litigant. It may seem improbable that liability may reach back to a licensor involved in the discovery, but not in the end manufacture, marketing, selling and servicing of products enabled by the discovery. But I think few will bet on it. But consider the "deeper pocket" method of who pays for damages won in a liability judgement. If the plaintiff can establish even the slightest connection to the injury by a party with deep pockets, and the party who actually caused the injury has no funds, the deep pockets party pays. And university endowments will be attractive targets. This situation already means a university, if dealing with a small company, must require that the company obtain higher and higher levels of expensive insurance and to name the university as co-insured. And a cynical view of justice is liability litigation against corporate institutions (such as companies and universities) is the institution is presumed guilty unless proven innocent. Those institutions and individuals at the research end of the development spectrum are faceing the considerable threat of the downside risk noted in Section 8. And if that threat is real, not imagined, universities and hospitals engaged in research have the decision to make of whether or not to continue those interactions with industry which have the potential of jeopardizing their primary functions of teaching, education and patient care. What message does society wish to give research institutions, and in the context of this Committee's current investigations, those institutions engaged in biotechnology research? Perhaps this Committee, acting for society at large, can let us know what society's message really is. Mr. VOLKMER. Thank you very much, Mr. Reimers. STATEMENT OF DR. GEORGE RATHMANN, PRESIDENT AND CHIEF EXECUTIVE OFFICER, AMGEN CORP., THOUSAND OAKS, CA Dr. RATHMANN. Well, echoing some of the same comments, reflecting the ideas of the leading biotechnology companies in this country and many of the scientists and many of the people who have studied the field, there is no question that today the United States enjoys a very important lead in this field. That lead has been the result of the Recombinant Advisory Committee, the funding of research by the National Institutes of Health, very strong and effective collaboration between universities and industries, and the risk-capital system that has made the investments possible to further this research and development. I think it's safe to say that today most of these contributions that put the United States in the leadership position have been accomplished by small biotechnology companies, representing dedicated scientists and business people working effectively in that system of collaboration with universities and with risk capital provided, many times, by the public. I think there are certainly possibilities for improving the system, but we should look very carefully at any elements that would adversely affect the momentum that has been created in the last few years that has placed the United States in the position not only for the good of the United States but probably in the position to further this science at a pace that would effectively contribute to worldwide health. So I would be cautious about making major shifts in what's happening, because it's working very effectively, and we are very pleased to be a part of it. Thank you. [The prepared statement of Dr. Rathmann follows:] The Role of Patients, Researchers, Universities and Private Companies in the Development and Marketing of Human Biological Products Statements Submitted by George B. Rathmann Rapid advancements in biotechnology which have been accompanied by rapid acceleration in the development and commercialization of advanced biotechnology have led to the perception that a major change may be occurring in the relationship among patients, researchers, universities and private companies. This statement is intended to provide information which may be helpful for the subcommittee to understand the extent of such changes and their impact. University/Industry Relations--Based on the relationships which Amgen has developed not only with professors at universities, but with investigators at institutions and government laboratories coupled with previous experience in major businesses in this country, it appears that the situation today is more of an evolution than a revolution of typical relationships in the past. In general, academic professionals are open, candid, cooperative and willing to meet and talk freely about their work. Concerning fresh discoveries or those results which indicate new avenues of research and fundamental new ideas, academic investigators, government investigators and scientists at public institutions are highly selective in their communications which seems to have been true for many years. Their willingness to disclose such information is directly related to the confidence which they have that the information will not lead directly to competitive activities which might preempt their ongoing research. These concerns have always been a basis for some delay in communication or formal publication until the scope of the contribution can be established and the obvious extensions of the discovery or observation can be completed by the investigator. More open disclosure undoubtedly occurs when there is a formal relationship between two laboratories or a consultant relationship or other affiliation with an industrial laboratory. Even in such situations complete, real time communication seldom occurs. Selective communication and selective or delayed transfer of materials is determined more by professional issues rather than economic issues. The practice of Amgen and the general practice of most biotechnology companies is to accept the academic system as it stands and to acknowledge the freedom of the investigator to publish or not to publish, to disclose or not to disclose, consistent with the policies of the institution and the practices of the individual investigator. Effective collaboration between |