Research-Use Exemption Is Practiced as Rational Forbearance

Bristol-Myers Squibb often licenses to the research community basic research tools that we develop that would not otherwise be available to investigators at academic or other research institutions. I am sure that our practice and that of others in the pharmaceutical industry is similar to that of many academic and other research institutions conducting federally funded research. In that context, the National Institutes of Health (NIH) maintains a policy of facilitating the availability of unique or novel biologic materials and resources developed with NIH funds. In all those circumstances, the competing interests must be balanced.

To some extent, intellectual property law helps to provide some rationality for the use of patented research tools. Damages generally cannot be collected from an infringer who is merely engaging in research. Typically, in fact, an inhouse research program is not sufficiently far along to know whether a lawsuit would actually protect valuable property or technology or even whether that property will ultimately prove to be of no value. Frankly, we all know that it is not good form to sue researchers in academic institutions and stifle their progress. Consequently, much potential litigation has been held in check, and we have not often had to confront the vexing issues that would arise in the litigation context. I hope that this rational forbearance will continue.

Why Intellectual Property Is Important in Molecular Biology

Clearly, there are likely to be a variety of important issues on the horizon. In fact, in the slightly more than 30 years that I have been a member of the human genetics community, our field has been responsible for a successive list of the issues that seem to vex the public in ethical, legal, and commercial ways. Early on, it was a prenatal diagnosis, then it was gene therapy, then it was genetic counseling, then it became DNA sequencing, and today it is genomics. Tomorrow, it will surely be something else. That is part of why it has been so exciting to be a member of this community for all these years.

Those issues and others are indicative of the fact that intellectual property rights will be an increasingly important component of future research developments. However, they also demonstrate that neither intellectual property rights nor science can or should try to trump the other. We must continue to engage in reasonable discourse, acknowledge and deal with our differences constructively, and strive to find the compromises that provide maximal support for a biomedical research enterprise that has enormous potential for the alleviation of human suffering. This remains, despite all the problems, a remarkably exciting time for the conduct of biomedical science. Judging by what we heard in this workshop, I have no doubt that it will remain as exciting a time for the commercialization of science as well.



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