OFFICE MEMORANDUA

URANDUM • STANFORD UNIVERSITY OFFICE MEMORANDUM. STANFORD UNIVERSITY OFFICE MEMORANDUM

The proposal to seek patent protection for discoveries arising from research on recombining DNA has aroused at Stanford a range of emotions that includes enthusiasm, dismay, and most of the stops in between. That this is so is not surprising, for Stanford scientists have been centrally involved in the research that produced the ability to recombine DNA elements, in the public policy debate over the kinds of research that might safely be allowed to proceed and the safeguards for any such research, and in the "invention" for which patent protection is being sought. In a situation in which different points of view exist among individuals, and in which some individuals are ambivalent or conflicted, it is especially important to define the issues clearly. Dispute, if there is to be any, should be over real differences about real issues. The purpose of this memorandum is to state the issues as clearly as I am able to do it. I hope that reader of it will help, by their comments, to add still greater clarity to the discussion.

I

The Effect of Patents on the Conduct of Science

It is probably the case that most scholars have had a good
deal more experience with the use of copyrights than with
the use of patents. However, both devices are expressions
of a single purpose and are in fact authorized in a single
section of the Constitution:

[The Congress shall have power]...

To promote the progress of science and useful arts,
by securing for limited times to authors and inventors
the exclusive right to their respective writings and
discoveries;... (Article I, Section 8)

An elaborate structure of copyrights, patents, licenses,
litigation, special courts, and so forth, has grown from
that spare statement. I cite it because it seems to me
useful to recall that the purpose of the Founders (and the
English law on which they built) in providing for patents,
was indistinguishable from one of the central purposes of
the university, "to promote the progress of science and the
useful arts."

It is, perhaps, ironic that a major theme in the present
debate is the fear that if scientists are forced to think
about the patentability of their work, there will be an
unhealthy increase in secrecy and that the progress of science

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• STANFORD UNIVERSITY OFFICE MEMORANDUM

STANFORD UNIVERSITY •

OFFILE

EMUKANDUM

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which depends on prompt, free, and open communication will be
compromised. While the academic world is not without
experience in the use of patents, it is characteristically
without good evidence of the effects of their use. To state
the matter in the negative, though, I have seen no evidence
that the fairly common expectation of patentable inventions
that characterizes some areas of engineering or chemistry
has inhibited the progress of science in those areas or has
damaged openness and collegiality.

It could, of course, happen, and it is impossible to prove
that it will not happen in the biomedical sciences. It is
fair to observe, however, that other developments in recent
years have posed what might have been thought in prospect
to be serious threats to the openness of science more
serious in fact than the patent system. For example, the
adoption of research funding based almost exclusively on
competitive applications to government agencies might have
led to the kind of secrecy that characterizes competition
for government contracts in business in industry. That it
has not. is encouraging evidence of the strength of the
values that prevail in science and in academic institutions,
and it suggests that it is those values, rather than the
addition or subtraction of particular incentives, that will
determine the way science is conducted in the future

Commercial Development and Basic Research

The report of the University of Michigan committee that
recommended that recombinant DNA research be permitted
under appropriate controls started by rejecting the notion.
"that any and all such research should be permitted because
freedom of inquiry is an absolute freedom that must never
be abridged." Indeed, few people today would argue in
support of so extreme a statement of scientific freedom.

Perhaps the chief limiting factor, the one that is most
likely to generate a demand for controls, is the element
of risk. Some hazards are so great and so imminent as to
render the research that produces them unacceptable
atmospheric nuclear explosions are such a case. In other
instances judgments must be made that balance the magnitude
and likeliness of risk against the size and probability of
benefit. Nowhere in recent years has that balancing been
argued so publicly among scientists as in the debate over
the future of recombinant DNA research. To an outsider,
reading the literature of that debate, one fact stands out:
there would be no debate were it not for the enormous pro-
spective benefits that are predicted to accrue from continu-
ation of the research. Were it not for those benefits it
is highly unlikely that funding agencies would find it
politically possible to accept the degree of risk that is

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inherent in the method.

Indeed, public concern aside,
it seems likely that the balance of scientific judgment
would be quite different were not the prospect of benefit
both great and imminent.

If that assessment is correct, or even nearly so, then it
is essential to address squarely the nature of the links
among research, development, and commercial exploitation.
It is not acceptable to justify taking the risks of pursu-
ing a line of research by pointing to its benefits unless
one is also willing to aid--or at least not inhibit--the
process of bringing those benefits to fruition. The ability
of a company to hold exclusive license for a long enough
period of time to justify the risk of investment in the
development of a product is an important part of that process.
The value of a patent is precisely to make such a license
possible. Those who argue that the patent-license process
has adverse consequences so severe as to bar its use, must
accept the responsibility of proposing feasible alternatives
to assure useful development, or face the prospect of inhib-
iting the very benefits that serve to justify the basic
research. The obligation seems to me inescapable.

The University's Financial Condition

While I do not believe that personal profit is a base or
ignoble motive, it happens that no member of the Stanford
faculty stands to be enriched personally as a result of
this patent. The departments involved, the Medical School,
and the University would be the beneficiaries of success.
It is a fact that the financing of private universities is
more difficult now than at any time in recent memory and
that the most likely prediction for the future is that a
hard struggle will be required to maintain their quality.
I do not want to overstate the weight of this fact on the
matter at hand, but neither should it be ignored. Clearly,
there are things that we would not want Stanford to do,
even though doing them might be profitable. To put the
point as precisely as I can, we cannot lightly discard the
possibility of significant income that is derived from
activity that is legal, ethical, and not destructive of
the values of the institution.

Conflict of Interest and Public Policy

As I indicated at the outset, the special force of the
patent question for Stanford comes from the fact that
Stanford scientists have been leaders both in the science
of recombinant DNA and the public policy of the subject.
A question of special moment, therefore, is whether their
future impact on public policy would be diminished by the

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fact (or inferences from the fact) that Stanford stands
to gain from the commercial exploitation of the science.
Some of the individuals involved believe that that will
happen. Here, too, it is impossible to prove the negative.
In any event, their concerns must be taken seriously because
their ability to affect policy is a valuable asset to them
and to the University. Let me suggest some ways in which
the appearance of conflict of interest might be mitigated.
1. It is essential that the University be open about
entire process. We should not try to hide our actions
or disguise our motives.

2.

3.

the

Before the decision is finally taken to press for
patent protection, the leaders of the most relevant
public agencies, e.g., NIH, the President's Science
Advisory Council, should be consulted. We should seek
their agreement that the decision is a proper one and
their willingness to say so publicly..

If the conduct of basic research carries safety hazards,
the conduct of commercial development programs will be
many-fold more dangerous. The restraints of government
regulation will be largely absent and the restraints
of peer pressure may well be overwhelmed by the pressure
to produce results. So far as I can tell, no serious
thought has yet been given to the development end of
the safety issue. Here, Stanford could make a genuine
contribution. We might consider, for example, the
establishment of a committee (not unlike the existing
Human Subjects Review Committees) consisting of
scientists and non-scientists and perhaps including
persons from outside the University. This committee
would review licensing proposals to evaluate the hazards
of the proposed line of development compared to the
likely benefits; it might also advise on laboratory
and testing precautions required in the conduct of the
work.

It is within our power, in short, to act to protect our
faculty's important role in public policy deliberations.
Guarantees are not possible, but reasonable assurances are.
We should see if those are obtainable.

This is an incomplete catalog of issues and arguments, but it includes what seem to me the central ones. If I have missed some important ones, they should be added; if my analysis of the issues is defective, it should be corrected. It will be clear to readers by now that my strong preference is to press for patent protection and a responsible licensing program. However, if the reaction to our inquiries suggests that a serious and damaging perception of conflict of interest would result from that course of action, then I would strongly urge caution until safer (although undoubtedly less rewarding and effective) mechanisms can be devised. I solicit the views of all who read this.