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The Politics of Patenting Biotechnology

With advances in biotechnology, some economic and ethical considerations arise about patenting such innovation. Who decides whether human genes or genetically engineered animals are patentable?

Who should decide what is patentable? How should these decisions be made? As patent offices across the world decide which parts of biotechnology research and development—including human genes and embryos, genetically engineered animals and plants—are patentable, civil society groups are pressuring these bureaucracies to consider the implications of such actions. In the controversial world of biotechnology, they argue, questions of patentability are not just scientific, legal, and economic, but are also social and ethical.

"These groups worry that biotech patents encourage the commodification of life, stifle research, make health care more expensive, and promote the development of questionable technologies," said Wilson Center Fellow Shobita Parthasarathy, whose Wilson Center project compares the politics of patenting biotechnology in the United States and Europe. Patent lawyers and companies respond that the patent office is an inappropriate place to have these conversations, because it is simply a certification site where inventors are awarded exclusive property rights over their technologies.

Parthasarathy argues the controversy is usually defined in terms of ethics vs. economics, or science vs. politics. "But really, it's a battle over how patent offices should define their roles and responsibilities in democratic contexts," she said. "How should they interpret their commitment to the public interest? Who do they serve, and how do they serve them?"

Patents on biotechnological inventions have been controversial since 1980, when the U.S. Supreme Court decided that living organisms were patentable. Since then, the U.S. Patent and Trademark Office (PTO) has allowed patents on plants, animals, genes, stem cells, and methods of cloning human embryos. PTO has only imposed one vague boundary: it will not allow patents on inventions that "embrace a human being," because they would violate the 13th amendment prohibiting slavery.

"Decisions about what inventions violate this criterion are made by individual patent examiners on an ad-hoc basis," said Parthasarathy. "Is this how we want such decisions to be made?"

While the European Patent Office (EPO) faces the same questions, it tackles them differently. In 1998, when the European Parliament passed a directive that allowed the patenting of biotechnologies, it barred patents on inventions that were "contrary to public policy or morality," including animals whose suffering was not outweighed by potential benefits and the use of human embryos for industrial or commercial purposes.

Since then, critics have become active watchdogs. Using an opposition mechanism that allows third parties to challenge patents, they have forced EPO to confront the ethical and social priorities emphasized by the directive. These skirmishes have led EPO to declare human embryonic stem and germ cells to be not patentable. "EPO is still having trouble, however," said Parthasarathy. "Examiners must defend why each biotech patent is not contrary to public policy or morality, and civil society groups continue to mount challenges."

Through her comparative study of these controversies and the responses of U.S. and European patent offices, Parthasarathy hopes to recommend ways that governments can address biotechnology and patent concerns better so that patent offices can maintain their legitimacy and guarantee public trust.