Don't Label Me and the Tragedy of the Anticommons.

San Francisco, CA, Feb. 20 - To label or not to label genetically modified food. That was the question at the Monday morning Biotechnology Communications symposium at the annual American Association for the Advancement of Science meeting in San Francisco. The non-labeling side was represented by Susanne Huttner, from the University of California at Berkeley. She's been in charge of agricultural biotech research and education for the UC system. The panel's labeler was Edward Groth, III, who is a senior scientist at Consumers Union.

Both agreed that ag-biotech offers a lot of benefits and that the technology is safe. Where they disagreed was over the issue of whether or not foods produced using biotech crops should be labeled. Huttner pointed out that mandatory labeling would mean the creation of two different food handling systems, one for conventional crops and another for biotech crops. That would add greatly to the expense of foods, while not providing any additional safety to consumers.

Groth agreed that the issue is not food safety--biotech crops are safe--but he framed the issue in terms of consumer choice. Biotech foods should be labeled so that consumers can choose to buy them or not. "Consumers have the right to make the choice to avoid biotech foods," said Groth. Groth was keen on achieving what he called "broad social consensus" on biotech crops, but in his presentation he made it clear what he thinks the "consensus" should be--mandatory labeling of biotech foods. Groth complained "We leave things to the market. What we need is a mechanism where we can decide what's best for society." He suggested, "We can learn from Europe" about how to achieve social consensus.

Huttner responded that regulatory agencies such as the Food and Drug Administration, the U.S. Dept. of Agriculture, and the Environmental Protection Agency are inappropriate arenas for trying to arbitrate between competing values. Regulatory agencies should do what they were created to do and that is concentrate on assuring the safety, quality, and efficacy of the products they regulate. "The marketplace is where people get to exercise their values," Huttner declared. "And the market has worked pretty well in that regard."

When questioned, Groth admitted that the new U.S. Department of Agriculture's organic food labeling regulations now give a choice to consumers who want to avoid biotech foods. "But they have to pay more for organic," Groth lamented. Of course, all of us will have to pay more for our food if mandatory biotech food labeling is imposed. Groth also admitted that he thinks that non-biotech conventional food producers will start labeling their foods as non-biotech if consumers start asking for such information. So, if there's a market solution like that, why does Consumers Union want mandatory labeling? "Institutionally, we just think it's better," said Groth.

In keeping with the day's science policy theme, I attended the afternoon symposium on patenting genes. The day before John Doll, who heads the biotech and pharmaceutical division at the U.S. Patent and Trademark Office, described the new guidelines, issued in January, that define utility for gene patents. In order for the PTO to issue a gene patent, the utility of an applicant's claimed invention must first be credible (e.g., no cold fusion or perpetual motion machines allowed). Second, it must be specific (e.g., can't just say the invention is an antibody that binds to an antigen; it has to specify the structure of both). And third, there is a new test that requires that an applicant show that his claimed invention's utility is substantial (e.g., you can't patent a transgenic mouse and say you developed it for snake food. You have to tell the PTO what substantial purpose the mouse will serve).

Stanford law professor Lawrence Lessig explained the general rationale for patents: If there is no legal protection for invention, he argued, then the incentives for inventors will be less than they would optimally be. "Patents are not about property but they're are not perpetual. Patents are government-backed monopolies," said Lessig.

"The patent system was not designed to promote basic research," clarified patent lawyer Kate Murashige. She pointed out that the Founders included patents in the Constitution "to promote the progress of the useful arts." By bringing the commercial world to the lab bench, it shouldn't be a surprise that it sometimes inhibits scientific research.

Brian Wright, an economist from the University of California at Berkeley, believes that patent "holdups" are becoming a problem, particularly in agricultural biotech. Crop biotech innovations are cumulative--that is one company might develop a nifty new pest-resistant seed, another might have a herbicide-resistant gene; while yet another has found a gene for drought tolerance. Naturally, a company will want to include all these features in their seeds. But this means that there must be a great deal of cross-licensing to achieve this. Holdups occur when holders of patents refuse to allow a commercial license that permits other companies to use their inventions.

The other problem is that the cumulative nature of these patents, combined with a lot of pending competing patent applications, make it commercially hazardous for companies to use these technologies. Wright cited the more than 70 different licenses that need to be obtained in the case of Vitamin A-enriched "golden rice" to illustrate the complexity faced by agriculture biotech companies. One way to address the licensing problem is industry consolidation and in fact, most of America's small seed companies have been purchased or merged with larger life sciences companies.

Citing the work of Rebecca Eisenberg, Wright believes that gene patenting right now is experiencing "The Tragedy of the Anti-commons." The classic tragedy of the commons occurs when nobody owns a resource and it is depleted because no one has an incentive to protect it. The tragedy of the anti-commons occurs when everyone claims to own a resource exclusively and refuses to allow anyone else to use it. In this case, according to Wright, a dysfunctional patent system, rather than encouraging innovation, is instead stifling it.

The new PTO utility guidelines might help sort out some of these problems, according to a none-too-optimistic Murashige, but that the devil is in the details of implementation.

Genomics, Socialized Medicine, and How Long Will You Live?

San Francisco, CA, Feb. 19 - The best part first: Craig Venter, the head of Celera Genomics, the company that beat the publicly funded International Genome Project to the goal of sequencing the human genome, delivered the plenary speech Sunday evening at the American Association for the Advancement of Science's annual meeting in San Francisco. The contrast between Francis Collins, the head of the IGP, and Venter was made vivid by comparing the tones of their two plenary speeches on the human genome. Collins focused primarily on the problems that sequencing the genome might cause, while Venter focused on the opportunities.

Last June, Venter and Collins announced at a White House photo op that draft copies of the human genome had been completed. It appears that Collins' IGP was lagging behind Venter's efforts to complete a draft of the human genome; Collins basically brokered a deal with Venter that he could use the bully pulpit of the White House to announce his success if he would agree to give simultaneous credit to the public project. In a statesmanlike gesture Venter agreed. But Collins, Eric Lander at the Whitehead Institute, and other public project colleagues haven't forgiven Venter for showing them up. The New York Times reported last week that despite the White House agreement that Celera and the public consortium would publish their papers on the human genome simultaneously, the public consortium, behind the scenes, lobbied strongly to block Celera's publication in Science.

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