Intellectual Property Considerations

The appropriateness of patenting life forms has been a source of considerable controversy in this country. Until 1980, life forms were considered to be “products of nature” and ineligible for patent protection. In the twenty years since the first biotechnology patents were granted, various critics have claimed that the patenting of living things promotes a reductionist conception of life that removes any distinction between living and non-living things. Some scientists and lawyers have questioned whether these patents promote the advancement of science. Several ethicists have argued that genes and genetically modified organisms should be considered part of the common heritage of all people. Other thinkers and advocates have raised equity issues about the role of patents in impeding development and access to beneficial technologies.

In response, the biotechnology industry has emphasized the need for patent protection to warrant the very large investments and long time periods usually required for the development of biotechnology. Proponents of life patents typically emphasize that the products being patented do not occur in nature, but are isolated and purified forms representing important technological advances. It is also claimed that strong biotechnological patent protection in the U.S. has been a major factor facilitating U.S. leadership in this field.

The U.S. Patent and Trademark Office (PTO) has already stated that purified and isolated stem cells are patentable subject matter. According to the PTO, stem cell products and research tools meet the three criteria for patentability: novelty, utility, and non-obviousness.

When research is funded entirely by the private sector, as is currently the case with stem cell research, it is a private matter whether, and under what terms, new intellectual property is obtainable for commercial or research purposes. Corporations can, for example, make the stem cell products over which they hold patents available only under a very restrictive material transfer agreement. They can also set the terms, including limitations that reduce access to these cells.

Given the promise of stem cell research, it is important to encourage the development of broadly beneficial therapeutic products with widespread access. Government investment in promising areas of research would enable federal agencies and laboratories to hold patents and to exercise them in ways that enhance development and dissemination of stem cell technology. To maximize this public benefit, Congress or the PTO could take steps to ensure that research tools are obtained in ways that protect basic and future product development. One way of doing this is to define a strong research exemption that would give third parties access to stem cell products and research tools for research purposes without having to obtain permission from the patent holder. Another would be to negotiate non-exclusive licenses whenever possible. Still another possibility is to require compulsory licensing under limited and clearly defined circumstances.

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