Patents, Biomedical Research. and Treatments: Examining Concerns, Canvassing Solutions

Article excerpt

On April 12, 1955, after eight years of research and testing, Jonas Salk announced that his polio vaccine was safe, effective, and potent. The 1916 polio outbreak had left six thousand Americans dead and another twenty-seven thousand paralyzed. In the two years following vaccine release, polio cases in the United States dropped by approximately 90 percent. By 1979 no cases of polio from the wild polio virus were reported nationwide. (1) The immediate positive effect of Salk's research on the lives of thousands of Americans is uncontested. Yet despite its enormous success, the vaccine was not patented. When asked who owned the patent, Salk famously responded: "Well, the people, I would say. There is no patent. Could you patent the sun?" (2)

Salk's explanation for not patenting the polio vaccine would probably not convince a court of law--while he is right that no one can patent the sun, he may have been able to obtain a patent on the vaccine (neither he, his employer, nor the funder of the research ever applied for one). But it can still be assessed as an ethical argument--that no one should patent the vaccine because it should belong to everyone, just as the sun does. His argument might have been based on a belief that a patent would have had bad consequences--that it would have impeded access to the vaccine, or that, as a moral principle, certain important, lifesaving discoveries should be placed in the public domain.

Although half a century old, Salk's argument is still very much at play today. The consequences of patenting health-related discoveries for further research and for access to treatments are hotly debated, as is the morality of asserting ownership over certain kinds of discoveries--for example, those deemed lifesaving or essential for ongoing research or those deriving from the human body. The rationale generally provided for the patent system is that it encourages innovation and early stage discoveries. That is, issuing patents eventually results in the availability of knowledge and new products. But this rationale is also contested; some scholars, analysts, and practitioners believe that in some contexts--including sometimes in biomedicine and biomedical research--patents do little to encourage innovation and can even impede access to products and slow research.

One way of thinking about biomedical research and treatment is as an ecology in which a variety of factors and players affect whether, how, and what biomedical research is conducted and whether, how, and which treatments are delivered and to whom. Different forces play niche roles in this ecology, and patents are one such force. Yet the actual and the ideal roles of patents in this ecology are contested. Some commentators argue that patents are inappropriate, ineffective, or even harmful to innovation and access, while others argue that patents are vital to achieving these goals.

In this report we consider these debates and how they play out in the patenting of inventions involving genes and stem cells and the patenting of drugs for HIV/AIDS. We have three purposes--to educate, to analyze, and to make recommendations.

Having explained and assessed these debates, we consider laws, policies, and practices--proposed or put in place at international, national, institutional, and individual levels--that aim to preserve or create incentives for innovation in biomedicine and to improve inputs for further research and access to drugs. Some of these laws, policies, and practices use patents, while others employ quite different mechanisms. What we consider amounts not to an overhaul of the biomedical research and treatment systems, but to "tinkering" with the ecology by affecting when patents are (and are not) used to improve biomedical research and treatment, focusing in particular on stimulating innovation and improving access both to treatments and to knowledge and resources useful for further research. Recognizing that, as in all ecologies, tinkering with one part can have an effect on another, we attempt to offer both an analysis and an ethical justification for laws, policies, and practices within and outside the patent system. …