Whistling in the Wind

By Caulfield, Timothy A.; Gold, E. Richard | Forum for Applied Research and Public Policy, Spring 2000 | Go to article overview

Whistling in the Wind


Caulfield, Timothy A., Gold, E. Richard, Forum for Applied Research and Public Policy


Patents on genetic research are a reality. It's time to reframe the debate.

Newspapers and popular magazines alike seem to fall over themselves labeling the 21st century as the biotech century. Media pundits point to the great benefits in health care and agriculture that await us. But they also point to major concerns, such as the private ownership of life. In this, they are aided by commentators such as the futurist Jeremy Rifkin, who argues that the

debate over life patents is one of the most important issues ever to face the human family. Life patents strike at the core of our beliefs about the very nature of life and whether it is to be conceived of as having intrinsic or mere utility value. [1]

A casual observer could not be blamed for thinking that patenting human genetic material is still an open question. But that casual observer would be wrong. Patent offices in the United States, Europe, Japan, and Canada routinely grant patents on this material--and they have done so for quite a few years. But the mere existence of human genetic patents does not mean that the debate is over; it has simply shifted focus.

The reality is that patent law has overtaken and reframed the debate over patenting human genetic material. Despite strong national and international policy initiatives addressing the patenting of human DNA, the economic drive of the biotechnology industry has made these initiatives obsolete almost as soon as they were taken.

$64 Question

The old, big question that continues to be debated is whether any-one should be allowed to patent human genes. But the question is largely irrelevant, considering the widespread granting of such patents.

The commercialization of human genetics has become closely linked to intellectual property protection. Biotechnology and pharmaceutical companies, venture capitalists, and even universities view the grant of a patent as an important first step in the commercialization process. An executive with the pharmaceutical giant Merck and Co., for example, believes that

the availability of intellectual property protection for genomic inventions will promote the advancement of biomedical research and the development of new gene-based or gene-derived therapeutics and diagnostics. [2]

While there is strong industry support for patent protection, many others, including researchers and some ethicists, have expressed concern over the commercialization of human genetic material. Critics believe that allowing patents on human genetic material amounts to an affront to human dignity that will further commodify the human experience. Groups such as the Council for Responsible Genetics, for example, have suggested that the "commercialization and expropriation of these life materials is a violation of the sanctity of human, animal, and plant life." [3]

Many national and international bodies have likewise expressed concern over the commodification of life. For example, in 1997, UNESCO, in its Universal Declaration on the Human Genome and Human Rights, declared that the "human genome in its natural state shall not give rise to financial gains." Similarly, a Working Group for the European Commission on the Ethical, Social and Legal Aspects of Human Genome Analysis suggested in 1991 that "the Human Genome or any part of it as such, should not be patentable.[ldots]" French legislation explicitly provides that the "human body and its elements and products, as well as knowledge of the total or partial structure of a human gene, may not, as such, be subject to a patent." [4]

Despite these policy statements, patent law has continued to evolve unabated. In fact, researchers and biotechnology companies can patent human genes in the United States, Europe, Japan, Canada, and elsewhere around the world. This is because many courts and patent offices consider that isolated human genes--that is, genetic material extracted and modified or concentrated in the laboratory--meet the requirements of novelty, inventiveness, and utility required by patent law and international treaties. …

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