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Devil at work: Patenting of life forms.

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January 28, 2007

Re: Framing

Someone (Other Than You) May Own Your Genes By DENISE CARUSO

http://www.nytimes.com/2007/01/28/business/yourmoney/28reframe.html?th= & emc=th & p\

agewanted=print

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.

 

Denise Caruso is executive director of the Hybrid Vigor Institute, which

studies collaborative problem-solving. E-mail: dcaruso.

 

 

Copyright 2007 The New York Times Company

 

 

" When it comes to understanding disease process and the true nature of what a

real healing process is, modern medicine sadly lingers in ignorance. The

pathetic thing is that this ignorance is promoted, fed and maintained by the

profit motive. I realize that modern medicine is a business and not a healing

art. Health and healing is bad for business. " - Comment on a medical forum.

 

 

 

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