No, life cannot be patented. But an invention which includes genetic material as an isolated, purified molecule outside the human body can. That means genes. More than 3 000 patents on genetic inventions have been granted since 1980 by the United States Patent and Trademark Office, with the European and Japanese patent offices not far behind.
In the US, according to one study, close to 5 000 DNA-based patents have been issued each year since 1995. The human genome contains some 30 000-70 000 genes and a not insignificant percentage (perhaps 1-5%) of human genes are probably claimed in some way on granted patents.
But how are these patents regulated? Legally, they are subject to the very same restrictions as all other inventions: a patent is only granted if the invention is new, includes an inventive step and is non-obvious, and has an industrial use. Some countries also require that the use of an invention should not contravene public order or morality.
Public concerns are not just ethical ones. Some argue that a proliferation of gene patents inhibits public research, since others are prohibited from using inventions that have a commercial intent, however remote. There is also a sense that the claims patents make are either too obvious or not that inventive. For instance, computer algorithms already make it possible to identify the function of a gene by analogy with known functions of very similar genes in different species. Such questions have made gene patenting a politically sensitive area and only five of the 15 EU countries have ratified the 1998 European Directive on Biotechnology.
A recent OECD workshop* reaffirmed that patents and licenses for genetic inventions are critical for the development of new therapeutics. They also turn inventions into tradable commodities which has helped give rise to thousands of biotechnology firms, making the biopharmaceutical industries more efficient and dynamic. Nor has the growth of patents created the barrier to research and development in the industry that many feared would happen given the number and complexity of biotechnology patents since the start of the 1990s.
Still, licensing practices are sometimes found wanting, OECD experts agreed. Public health services continue to find access to genetic tests far too costly and restrictive. However, most are convinced that patents themselves are not the problem. True, some companies take a predatory approach to patent licensing, and this area could be improved.
That means finding best practice guidelines for licensing and diffusion. The message from the experts in the Berlin workshop was clear: To blame patents would be to throw the baby out with the bath water.
* Genetic Inventions, Intellectual Property Rights, and Licensing Practices, OECD workshop, 24-25 January 2002, Berlin.
For more information, contact Benedicte.Callan@oecd.org
©OECD Observer No 230, January 2002
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