connection with biologicals.

Many products are developed with

human tissues or products. We have noted the products derived

from fractionation of blood plasma.

Heart, and other organ

What is, however, of

transplants are now becoming more routine. greater recent interest has been the use of patient materials for product development in the biotechnology industry, which are enabled by the hybridoma and genetic engineering technologies. In the genetic engineering technology, a piece of body tissue such as skin, or cells from blood or urine can be used by the genetic engineer. Basically, the cells obtained are a source

of information. That is, a cell is a genomic "library" from which the genetic engineers can "probe" for the biological information they are seeking. The cell itself from the patient or volunteer is not used in a product. What is used is typically a protein expressed by a cell line which has had introduced into it the genetic sequence which "codes" for expression of the

particular protein of interest.

The second technology that we discussed which involves the use of patient materials is the so-called hybridoma technology. In this technology, there is a slightly closer link to a patient or volunteer. Here, a piece of diseased tissue provides an "antigenic" source for producing pure monoclonal antibodies against that disease antigen. However, it is again the biological information from the disease that enables the production of monoclonal antibodies (which are also proteins). Indeed, it is possible to "take down the genes" of a particular

monoclonal antibody, reverse engineer that information into a bacteria or other microorganism. This microorganism then becomes

a "biological factory" similar to the hybridoma, and will express that particular protein.

(It should be noted that the protein

from the microorganism is somewhat different from the monoclonal antibody in the nature of certain sugars).

8.

SHOULD UNIVERSITIES INTERACT WITH INDUSTRY?

This paper has discussed the role of universities and university researchers and students in their interactions with industry. The university's primary role in society is one of education and research. Industry's role in society is delivering the fruits of research to the public.

A third role of universities, in addition to education and research, is public service. Taking a positive role in seeing that a university's research results are made available to the public through industry certainly falls into that category of public service. Any net royalty income derived by the universities is applied to educational and research functions which, in a self regenerative fashion, may produce yet other discoveries for public use and benefit.

A university, in carrying out its public service responsibility, cannot undertake downside risk. A university is not a manufacturer and does not factor in product liability risks in the costs of student tuition or research. If a university's direct interaction with industry produces severe financial risks

of loss, a university should properly jettison that activity to protect its primary societal functions of education and research.

There are interesting issues to be considered by society at large in connection with the increased climate of litigiousness and its effect on use of the fruits of biotechnology. Who "owns"

a disease? Is it the patient? Is it the doctor? Is it the hospital or university? Or is it perhaps really those future patients who might either get the disease, and/or who might be saved from ravages of the disease, because of the "information" derived from a patient's disease? If neither the university nor industry can proceed because of the threat of the cost of litigation, the loser is that future patient.

Perhaps we can postulate "disease information" is owned by society at large, in particular those who may be afflicted with the disease.

In the course of developing a therapy for a disease, inventions will be made, patents applied for and issued. The owners of such patents will be those who are the inventors by operation of patent law. The role that patents play in innovation is critical and of particularly great significance in developing medical therapies where enormous expenditures of resources are required before a product can emerge for use by the public at large. The patient from whom the original "disease information" is derived is, in a real sense, a spectator to the

proceedings, his or her body having served as a home for the unwelcome "disease stranger".

10. PATENT PRODUCT LIABILITIES

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. .