Patentability and higher life forms

Diptych: 'Yin/Yang lilac', by Jacques Deshaies (2002) (detail).

Most of the recent controversy over the patenting of genes has focused on the barriers that patents place in the way of research and medical care¹. But the issue of whether patents should be granted at all on genetic inventions is still pertinent. The Canadian Supreme Court recently denied a patent on a transgenic mouse, and the European Patent Office and several countries would not grant patents on cloning embryos or people.

The Canadian decision that a mouse that had been genetically engineered to express an oncogene was not patentable was surprising for several reasons. Europe, Japan and the United States had all previously granted patents on genetically engineered mice, although they had the power to deny patents on the grounds of “ordre public and morality” — a power which Canadian law does not grant. However, the Canadian court concluded — in a 5–4 decision — that genetically engineered “higher life forms” are not patentable because they cannot be reduced to material objects, and, therefore, are not the new “manufactures” or “compositions of matter” required by Canadian patent law². In addition, the court's distinction between “higher” and “lower” life forms might not be workable, and requires a belief in a vitalistic life-force that has long been absent from contemporary biology.

A more difficult question concerns whether patents should be granted on processes for cloning or modifying the germline of human beings, for human–animal chimaeras and for human stem-cell technologies. Although the European Union specifically prohibits such patents³, the situation in the United States remains unclear. United States anti-patenting activists have applied for a patent on methods of making human–mouse chimaeras to publicize this issue and to block the ability to make such chimaeras if the patent is granted⁴.

Objections to such patents might have more of a symbolic than a substantive basis. A patent on cloning embryos or genetically modifying a human would give a right to exclude someone from making or using that invention, but would give no right to sell or control individuals born as a result. Also, such inventions would not always lead to harm — germline genetic-engineering or stem-cell modification might be essential for some people to have healthy children, just as access to patented drugs is necessary for those suffering from some diseases to survive. Patent holders have an interest in profiting from their inventions, and, therefore, are likely to license their use. Patent uses that harm other individuals can be regulated or prohibited without changing the terms for awarding patents.

Yet, patents are sufficiently commercial that they are easily associated with ideas of human commodification and control. With genetic and biotechnological developments sparking fears of misuse, legal questions about patentability have become the focus of a battle over genetic technology. Whether, and how, new inventions should be used raises complex policy issues that are best considered by legislative or regulatory bodies, not by the patent offices charged with determining whether biotech innovations are patentable.