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There is increasing scrutiny of relationships among academic health centers, their faculty, and commercial for-profit entities. In response, congressional inquiries and actions may result in changes in our practices. This essay highlights some of these concerns and offers suggestions about remediation.
HISTORICAL DEVELOPMENTS
The notion that universities should contribute to the development of technology and, in the case of the biomedical sciences, to new treatments for disease has gone through decades of revision. The postwar period saw development of an entire computer-based industry framed around relationships with universities, notably at Massachusetts Institute of Technology, Carnegie Mellon, and Stanford. These institutions had long histories of engineering applications critical for development of new products and devices. These relationships were regarded by most in both the academic and for-profit sectors as mutually advantageous.
By 1970, universities and the private sector were deploying intellectual property agreements in the biologic sciences that allowed filing and licensing of patents owned by the university; income sharing with inventors occurred with restrictions. While patents could be filed in the inventors' names, those inventors did not retain ownership of the patents; rather, rights were assigned to the university in exchange for a share of income. These arrangements allowed successful technology development and revenue streams to support the academic mission.
The revolution in biotechnology influenced greatly the implementation of intellectual property agreements, since the potential of new therapies evoked 3 fundamental differences from prior experience with engineering and computer technologies.
First, the issues involved life and death. Patients had serious illnesses, and their lives depended on the success of new therapies. The development of safety and efficacy standards for testing potential drugs in human subjects demanded formulation of new ethical contracts, requiring the informed consent of patients facing real or potential dangers.
Second, the promise of new drugs based on rapid advances …
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