University-based science and biotechnology products: defining the boundaries of intellectual property

The pharmaceutical and biotechnology industries have long relied on patenting as the primary means of allocating ownership and control over new discoveries. Yet, patent protection is a double-edged sword that has major implications for the future of innovation in biomedical science in the United States. Excessive "upstream" patenting of genes and molecular targets could hinder further research by creating a need for expensive and inefficient cross-licensing. However, limiting such basic science patenting could allow private entities to use the results of years of costly publicly funded research to produce and market lucrative products without compensating university- or public sector-based innovators. Academic and other nonprofit research centers would, therefore, be deprived of revenue for pursuing novel therapeutics or other seminal research work that may not be patentable. Recent court cases illustrate the inherent conflicts in allocating ownership and control of basic biomedical discoveries. Several options exist to avoid the complex problems of overlapping basic science patents while still rewarding pivotal discoveries and encouraging further innovation. These include establishing basic science patent pools and mandating arbitration arrangements that would assign credit and royalties for biotechnology innovations that depend on prior research that was performed, financed, or both in the public sector.