THE Food and Drug Administration’s recent declaration that food from cloned animals is safe was a fresh reminder of how poorly the biotech industry and its regulators have managed the field’s portfolio of innovation over the years.
A recent survey found that Americans overwhelmingly distrust government and industry to provide truthful information about biotech’s risks and safety. Yet equally important as risk — and more often overlooked — are the public’s equally real and unaddressed concerns about who is looking out for its interests as the genes of plants, animals and microbes, as well as entire organisms, become privatized through the patenting system.
Stephen Hilgartner of Cornell University said he believed that the economic and political challenges surrounding these so-called life patents would come to rival those of biotech risk, and he has come up with a sensible framework for starting a new conversation about them.
From the moment the first biotech patents were granted in 1980, the industry was hailed as a new frontier — uncharted territory where a new generation of scientist-inventors could reap the traditional rewards of innovation.
But even as the gold rush began, critics as varied as scientists and human rights advocates declared that biotech’s new intellectual property frontier was already occupied. Claims of novelty and innovation as the basis for life patents, they said, disregarded the realities of not only nature, but also of research practices, democratic decision-making and global governance.
These realities led Mr. Hilgartner, an associate professor in Cornell’s science and technology studies department, to think about how society might deal with biotech discoveries outside the strict economic imperatives of intellectual property law.
The title of an intriguing paper he wrote on the subject, “Acceptable Intellectual Property,” is a wordplay on the well-known concept of “acceptable risk” — that is, the level of risk a society considers acceptable, given existing social, economic and cultural conditions.
In other words, what level of intellectual-property protection is society — not the biotech industry or its phalanx of patent lawyers — willing to accept in exchange for the benefits of biotechnology?
With this question in mind, Professor Hilgartner began to investigate whether legal theories of real property, rather than innovation, might be a more useful way to think about who owns biotech inventions and what can be done with them.
He notes that the law frames the ownership of property as a bundle of rights. People who “own” real estate actually own a set of expectations, relationships and obligations to various communities and regions.
Depending on the communities’ rules, property owners may not be able to drill for oil, cut down trees or build new structures without permission, for example. They are obliged to prevent dangerous conditions, to pay for damages if they don’t, and so forth. Communities are accountable in various ways to property owners as well.
In contrast, there is no analog to this network of obligations for a patent holder. As Tim Hubbard, a Human Genome Project researcher, noted at a 2001 conference: “If you have a patent on a mousetrap, rivals can still make a better mousetrap. This isn’t true in the case of genomics. If someone patents a gene, they have a real monopoly.”
This monopoly gives patent holders total control over patented genetic materials for any use whatsoever — whether for basic research, a diagnostic test, as a test for the efficacy of a drug or the production of therapies.
Professor Hilgartner said patents don’t just determine who will own new technologies and who has access to them. They also influence what technologies cost, whose cultural and ethical values they represent, and what aspects of the research and development process will be transparent — and to whom.
The degree of control that life patents grant their owners is of growing concern to scientists, human rights and patient advocates and ethicists. More than 20 percent of human genes have already been patented, and most of those patents are owned by corporations.
Professor Hilgartner noted how this kind of control can play out in the real world. In the case of the Canavan disease patent, for example, a family afflicted by this rare genetic disorder initiated an effort to find the gene mutation responsible for the disease. They raised money, collected DNA samples and attracted researchers to the cause.
After a researcher found the gene in the late 1990s, he and his employer, Miami Children’s Hospital, patented it and began charging royalties on a genetic test to screen for the disease — despite the fact that they would never have found the gene without the efforts and the DNA samples of the afflicted.
Patient groups filed suit in 2000, contending misappropriation of trade secrets by using their children’s DNA without consent to obtain a patent. It took until 2003 for the parties to reach a confidential settlement; it allows certain laboratories to continue collecting royalties but lets institutions, doctors and scientists use the patented gene sequences without paying.
There are many other examples of life patents causing public concern. One of the most important examples involves patents on food crops and cloned animals. These patents have a growing potential to cede control of the world’s food supply to biotech patent holders.
Important questions must also be answered about who can legitimately “own” or control our personal genetic information. And no one has yet been able to address economic, social and legal questions raised by the patenting of genetic resources taken from developing countries.
This month, for example, Peruvian farmers protested against the biotech giant Syngenta, which genetically modified a common potato variety so that the potatoes are sterile unless a chemical is applied.
Risk concerns aside, farmers say they want to know why the company can charge a premium for adding a few new genes to a potato variety — yet they cannot, in turn, demand a royalty from Syngenta for using the “property” that they and their ancestors have been “genetically modifying,” by traditional means, for centuries.
Biotech companies are also amassing huge patent portfolios by tapping the genetic diversity found in volcanoes, rain forests and deep sea hydrothermal vents. They collect DNA from micro-organisms they find, patent it, and sell access to the gene sequences to pharmaceutical, agricultural, chemical and industrial companies.
Only rarely do such companies voluntarily work with indigenous communities to come to mutually agreeable terms for these kinds of activities. There has been much international protest as a result, but very little concrete action to change the situation.
These concerns may sound like the nattering of nabobs to those who believe the present system of protecting intellectual property is acceptable. But like it or not, a large and powerful infrastructure has declared that patents are crucial for getting discoveries out of the lab and into the market, and it will not change on its own.
NEVERTHELESS, that does not change the larger reality that Professor Hilgartner describes: that decisions about intellectual property are about much more than simply finding ways to stimulate and reward innovation.
They directly affect what technologies make it to the marketplace. They determine who is accountable for biotech products and processes, under what circumstances, and how they affect everyone.
Shifting the terms of the debate from patents and innovation to the rights-based framework that Professor Hilgartner has proposed may not be an immediate solution. But it is certainly the most direct route to a more democratic and inclusive conversation about intellectual property concerns as biotech marches on.