Patents, profits and genes

04/03/2000

When Cesar Milstein discovered monoclonal antibodies in Cambridge in 1975, he disdained to patent this new knowledge. The Americans, however, did so ? and made millions of dollars. Today such patenting looks like becoming the rule. The director of the Science and Human Dimension project at Cambridge comments. A NATIONAL newspaper recently reported that Professor Susan Greenfield, a high-profile neuroscientist well known for her contributions to public understanding of science, was seeking a patent on a brain molecule. Claims to property rights over natural phenomena such as molecules, genes, or even whole organisms, raise profound questions about the commercialising of the biological sciences. Should scientists be allowed to claim ownership of knowledge about life forms? Should they be allowed to restrict access to that knowledge? Should they be allowed to profit from such ownership? The case is particularly interesting since Greenfield is not only professor of pharmacology at Oxford University but also director of the Royal Institution and director of the Science Education Programme. In these capacities she is a respected and highly opinionative communicator.

Greenfield and her colleagues have applied for a patent not, it seems, on an actual molecule but on information about a section of a molecule ? a natural substance in the brain known as acetylcholinesterase (AChE). She aims to take the findings of their subsequent research to a pharmaceutical company in the hope that a successful treatment will be developed for Alzheimer?s disease and Parkinson?s. Greenfield is convinced that AChE promotes the growth of brain cells; but sometimes a fault in the molecule leads to the process going hay-wire, causing cell death which leads to Alzheimer?s. Greenfield has set up a company called Synaptica to protect the property rights of her research and to ensure that if their work leads to a cure for Alzheimer?s, the company will profit. She wants, in effect, to patent the strategy by which she hopes to prevent one of the most widespread and devastating diseases of old age.

Greenfield responds that she is not patenting a real molecule but an item of information. It is as if she is attempting to avoid the accusation of patenting a natural phenomenon, by translating her real molecule into a state of virtual reality. It?s more accurate, she told me in a recent interview, to call this the patenting of an idea rather than the patenting of part of nature.

But is there not also an objection to be made to the notion of exclusive ownership of an idea relating to nature? And could this not prevent other researchers from working on the molecule? And by what principle do researchers lay claim to knowledge of this kind? Greenfield has no reservations. It is identical in the commercial sphere to peer- review publishing in academia, she tells me. Scientists get to know speedily and accurately about your idea or discovery, since it is now in the public domain and research can prosper in all kinds of ways as a result. Although, she might have added, at a cost.

Next, she moves to a familiar consequentialist argument: that the potential medical benefits of what she is doing far outweigh any scruples over the commercial exploitation of biological information. The problem, she says, is that there is always a shortage of funding with any kind of research that involves risk of eventual failure. By seeking a patent and setting up a company, we are attracting long-term risk funding through commercial investment; and the commercial backers will want a dividend if it works.

Finally she talks about academia versus commerce, and accusations that universities do not profit from such patenting. When we set up the company, we gave Oxford University a 30 per cent stake, she states. In this way the university under whose auspices the research is being conducted would get a just reward for its own contribution over the years. If a treatment results from our research, the university will profit.

The patenting of biotechnological information has been a major ethical issue ever since the discipline took off in earnest in the 1970s. An explosion of knowledge about living organisms at the molecular level was naturally linked to potentially profitable therapies and diagnosis.

Should the scientists, institutions, governments, that employed so much ingenuity and funding to achieve valuable therapies go unrewarded? Scientists ? and certain politicians ? in Britain still remember ruefully an episode in Cambridge in 1975, when the molecular biologist Cesar Milstein discovered the monoclonal antibodies process that led to the development of universally used diagnostic testing procedures for immunological diseases. The Medical Research Council (MRC), under which Milstein was working, disdained to copyright the discovery. Then a patent was taken out by the Americans. Huge sums of money accrued to the patent holders which helped fund America?s burgeoning biotech industry. It has been claimed that hundreds of millions of dollars were lost to British biotech research funding as a result. The patenting issue next came to prominence after the Human Genome Project was established in the late 1980s. The plan is to identify all 100,000 human genes in the hope that the knowledge gained will transform our understanding of what makes us tick biologically and that cures will be discovered for a vast array of genetically linked diseases. No sooner had the project got under way than the National Institutes of Health (NIH) in Washington DC made a bid in 1992 to patent some of the genes (or genetic information) they had discovered in relation to brain function, threatening international collaboration and the notion of free access to the genome database.

The argument advanced by the NIH at the time, as it is by Greenfield in the case of her molecule today, was that research would be starved of much-needed funding unless there was a return on the investment. The NIH, like Greenfield, also insisted that what was being patented was not so much genes themselves, but gene information ? known as cDNA. The process of discovering genes and storing the information in databases, moreover, was from the outset associated with the progress of information technology, as was the patenting bid. A research team in Washington DC had discovered a speedy and very expensive method of identifying genes, involving advanced information technology, which enabled the Americans to surge ahead of the rest of the world. Should they not be rewarded for the investment that had enabled them to crack sections of the genome code several years ahead of schedule?

There was vehement opposition from the international scientific community to the patenting of information derived from the human genome project (in the end, the bid failed for technical and legal reasons). Professor James Watson (of the Watson and Crick partnership, pioneers of work on DNA) resigned as director of the project over the issue. He never came up with a clear statement of his position on patenting, but his stand was associated with his insistence that such decisions should be left to the scientists and not to politicians and bureaucrats. The patenting bid had been led by the head of NIH, Bernadine Healey (formerly Ronald Reagan?s health-policy adviser), a medical bureaucrat, rather than by a card-carrying research scientist.

A life-long colleague of Watson?s, the Cambridge biologist Sidney Brenner, a distinguished Fellow of the Royal Society, vociferously defended Watson?s conviction on the primacy of the scientists in such disputes. The project, he commented at the time, was in excellent hands while Watson continued to steer it through all its shoals of ethical, commercial and scientific hazard. His departure is a watershed indicating the need for the dominant role of the scientist.

A curious current row in Iceland, however, reveals that people of all kinds (not only scientists, bureaucrats, and politicians) believe, and indeed insist, that we all of us have an important stake in information about our own nature. Last year the Icelandic Government sold its population?s medical database in the expectation of linking the nation?s medical histories with human genome information. Reykjavik transferred ownership of the database to a company called deCODE genetics, which in turn signed a $200-million deal with the Swiss pharmaceutical giant Hoffmann-La Roche. Iceland is promised free of charge any drugs developed as a result of the database: no mean return on the investment. But the project has not had a smooth ride. A number of doctors and their patients are threatening to withdraw their records from the database, arguing that there is no protection of confidentiality and no plan to compensate individuals for use of their personal information.

Taking careful note of the Icelandic experience, Britain?s Medical Research Council is currently, and more cautiously, preparing its own medical record database of 500,000 volunteers in order to create a useful interface with the human genome database ? which is nearing completion. The initial plan is to operate the database through the MRC and the Wellcome Trust and to funnel profits back into biomedical research. But there is nothing so far to stop these groups from selling on the information to private companies.

It is abundantly clear that these storm clouds gathering around bids to own and control information about molecules, genes, and our own medical life histories are associated not only with the advance of molecular biology but with developments in information technology. A useful analysis in this regard is Jean-Fran?ois Lyotard?s prophetic essay, The Postmodern Condition (1984). Lyotard locates the new information technologies at the centre of an emerging social reality in which the only kinds of knowledge to survive will be those that are amenable to information processing.

HE concludes that in time scientific research will depend on investment made possible by demonstrations of improved performance, in terms of efficiency (the development of drugs and diagnostic tools, for example) and hence commercial viability. In consequence science, in his view, will continue to drift away from its original modern narrative ? freedom of all branches of knowledge for its own sake and for all ? towards the reality of knowledge as intellectual property, translated, via information technology, into forms fit for storage, dissemination and exploitation for profit.

With the human genome project fast approaching completion, and medical histories rapidly being translated into info-tech databases for commercial exploitation, claims for patenting and intellectual property rights are on the increase, with inevitable and far-reaching consequences. The issues deserve detailed, open, and informed debate, with the full participation of Christian and other religious and philosophical viewpoints.

There is surely nothing un-Christian as such in the quest to master and transform nature for the benefit of human kind; in fact one might argue the very reverse: that nature transformed for the good ? made by human hands ? is a truly Christian, sacramental pursuit. In this sense, the biotechnologists could be said to be emphatically on the side of the angels. And if it is true that commercial exploitation of knowledge via patenting could mean the difference between finding a cure for Alzheimer?s disease or not, who is to say that the patent-seekers, with their strong consequentialist arguments, should be thwarted? While Christians accept that it is good to transform nature to the individual and collective benefit of humanity, they also have a view about what kind of creatures we think we are, and on whence we came and whither we are destined. The Christian view of natural phenomena ? molecules, genes, and whole organisms ? is not inimical to biological explanations, but it offers deeper and wider meanings which are at variance with the concept of ownership, commercialisation, and control.