Someone (Other Than You) May Own Your Genes

By Denise Caruso
New York Times
January 28, 2007

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.

Bush Directive Increases Sway on Regulation

By Robert Pear
New York Times
January 30, 2007

WASHINGTON, Jan. 29 - President Bush has signed a directive that gives the White House much greater control over the rules and policy statements that the government develops to protect public health, safety, the environment, civil rights and privacy.

In an executive order published last week in the Federal Register, Mr. Bush said that each agency must have a regulatory policy office run by a political appointee, to supervise the development of rules and documents providing guidance to regulated industries. The White House will thus have a gatekeeper in each agency to analyze the costs and the benefits of new rules and to make sure the agencies carry out the president's priorities.

This strengthens the hand of the White House in shaping rules that have, in the past, often been generated by civil servants and scientific experts. It suggests that the administration still has ways to exert its power after the takeover of Congress by the Democrats.

The White House said the executive order was not meant to rein in any one agency. But business executives and consumer advocates said the administration was particularly concerned about rules and guidance issued by the Environmental Protection Agency and the Occupational Safety and Health Administration.

In an interview on Monday, Jeffrey A. Rosen, general counsel at the White House Office of Management and Budget, said, "This is a classic good-government measure that will make federal agencies more open and accountable."

Business groups welcomed the executive order, saying it had the potential to reduce what they saw as the burden of federal regulations. This burden is of great concern to many groups, including small businesses, that have given strong political and financial backing to Mr. Bush.

Consumer, labor and environmental groups denounced the executive order, saying it gave too much control to the White House and would hinder agencies' efforts to protect the public.

Typically, agencies issue regulations under authority granted to them in laws enacted by Congress. In many cases, the statute does not say precisely what agencies should do, giving them considerable latitude in interpreting the law and developing regulations. The directive issued by Mr. Bush says that, in deciding whether to issue regulations, federal agencies must identify "the specific market failure" or problem that justifies government intervention.

Besides placing political appointees in charge of rule making, Mr. Bush said agencies must give the White House an opportunity to review "any significant guidance documents" before they are issued.

The Office of Management and Budget already has an elaborate process for the review of proposed rules. But in recent years, many agencies have circumvented this process by issuing guidance documents, which explain how they will enforce federal laws and contractual requirements.

Peter L. Strauss, a professor at Columbia Law School, said the executive order "achieves a major increase in White House control over domestic government."

"Having lost control of Congress," Mr. Strauss said, "the president is doing what he can to increase his control of the executive branch."

Representative Henry A. Waxman, Democrat of California and chairman of the Committee on Oversight and Government Reform, said: "The executive order allows the political staff at the White House to dictate decisions on health and safety issues, even if the government's own impartial experts disagree. This is a terrible way to govern, but great news for special interests."

Business groups hailed the initiative.

"This is the most serious attempt by any chief executive to get control over the regulatory process, which spews out thousands of regulations a year," said William L. Kovacs, a vice president of the United States Chamber of Commerce. "Because of the executive order, regulations will be less onerous and more reasonable. Federal officials will have to pay more attention to the costs imposed on business, state and local governments, and society."

Under the executive order, each federal agency must estimate "the combined aggregate costs and benefits of all its regulations" each year. Until now, agencies often tallied the costs and the benefits of major rules one by one, without measuring the cumulative effects.

Gary D. Bass, executive director of O.M.B. Watch, a liberal-leaning consumer group that monitors the Office of Management and Budget, criticized Mr. Bush's order, saying, "It will result in more delay and more White House control over the day-to-day work of federal agencies."

"By requiring agencies to show a 'market failure,' " Dr. Bass said, "President Bush has created another hurdle for agencies to clear before they can issue rules protecting public health and safety."

Wesley P. Warren, program director at the Natural Resources Defense Council, who worked at the White House for seven years under President Bill Clinton, said, "The executive order is a backdoor attempt to prevent E.P.A. from being able to enforce environmental safeguards that keep cancer-causing chemicals and other pollutants out of the air and water."

Business groups have complained about the proliferation of guidance documents. David W. Beier, a senior vice president of Amgen, the biotechnology company, said Medicare officials had issued such documents "with little or no public input."

Hugh M. O'Neill, a vice president of the pharmaceutical company Sanofi-Aventis, said guidance documents sometimes undermined or negated the effects of formal regulations.

In theory, guidance documents do not have the force of law. But the White House said the documents needed closer scrutiny because they "can have coercive effects" and "can impose significant costs" on the public. Many guidance documents are made available to regulated industries but not to the public.

Paul R. Noe, who worked on regulatory policy at the White House from 2001 to 2006, said such aberrations would soon end. "In the past, guidance documents were often issued in the dark," Mr. Noe said. "The executive order will ensure they are issued in the sunshine, with more opportunity for public comment."

Under the new White House policy, any guidance document expected to have an economic effect of $100 million a year or more must be posted on the Internet, and agencies must invite public comment, except in emergencies in which the White House grants an exemption.

The White House told agencies that in writing guidance documents, they could not impose new legal obligations on anyone and could not use "mandatory language such as 'shall,' 'must,' 'required' or 'requirement.' "

The executive order was issued as White House aides were preparing for a battle over the nomination of Susan E. Dudley to be administrator of the Office of Information and Regulatory Affairs at the Office of Management and Budget.

President Bush first nominated Ms. Dudley last August. The nomination died in the Senate, under a barrage of criticism from environmental and consumer groups, which said she had been hostile to government regulation. Mr. Bush nominated her again on Jan. 9.

With Democrats in control, the Senate appears unlikely to confirm Ms. Dudley. But under the Constitution, the president could appoint her while the Senate is in recess, allowing her to serve through next year.

Some of Ms. Dudley's views are reflected in the executive order. In a primer on regulation written in 2005, while she was at the Mercatus Center of George Mason University in Northern Virginia, Ms. Dudley said that government regulation was generally not warranted "in the absence of a significant market failure."

She did not return calls seeking comment on Monday.

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