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Private investment in biotechnology, a growth industry over the last 20 years, has depended on the combination of large, risky investments in research and development with monopoly profits secured through patent protection of the successful products. This business model, which has made pharmaceuticals first in profits on the list of Fortune 500 global companies, is everywhere under assault. The article begins by explaining the relationship of the importance of the business model to the success of the biotech industry. The changing nature of innovation in the biological sciences and the growing importance of incremental discoveries are then examined. The challenges posed by the escalating costs of pharmaceutical expenditures, the crumbling health care infrastructure in the USA, and the global unavailability of lifesaving medications are also considered. These changes are linked to the legal infrastructure, explaining the role of patent protection in encouraging and potentially deterring further innovation. The ethical obligations of the industry to address the needs of a global citizenry are considered, and the question is raised of whether the relationship between public and private partnerships in the development of biotechnology needs to be reconsidered.