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Who owns the human genome? A profound confusion reigns today over the issue of proprietary rights to human genes, and it is setting the stage for a long-term intellectual-property disaster. The U.S. Patent and Trademark Office, backlogged with tens of thousands of private claims to genetic information, cannot seem to decide where to draw the line on ownership rights; animosity between government-funded genome researchers and their industry counterparts continues to mount; and an ominous tangle of lawsuits already looms on the horizon.

And this, as everyone in the field will tell you, is only the beginning of many decades of fast-paced genomic research.

The controversy was simmering just behind the happy faade presented during the White House ceremony in June when President Clinton announced the completion of two working drafts of a human genome map. Despite the grand announcement, there is a startling uncertainty about how to apportion the lucrative information the map contains. For an economic indication of this uncertainty, look no further than the joint statement Clinton and British Prime Minister Tony Blair issued last March. In the statement, Clinton and Blair did nothing more than affirm the widely agreed-upon need to maintain open access to the human genome’s raw genetic sequences. Then they watched dumbfounded as a stunning flight of capital bled billions of dollars from the biotech companies involved in the genome field. Some firms, such as Palo Alto, Calif.-based Incyte Genomics, lost nearly one-third of their stock market value in one day.

The irony in Wall Street’s jittery response is that firms like Incyte, Millennium Pharmaceuticals, Celera Genomics and Human Genome Sciences-the most vociferous proponents of proprietary rights over human genes-all clamored to explain that they welcomed the Clinton-Blair announcement. Why? Because these companies recognize that some level of open access to the human genome is essential to building a robust industry in the future.

These genomics firms see the tremendous potential of the decoded human genome to medical science. They know, in more detail than most of us, that the diagnostic screening tests and drugs now coming to market offer only a glimmer of the promise ahead. They also understand something else: They have the most to lose if they are shut out from developing these treatments by their competitors’ capricious and overly broad intellectual-property claims.

The race to discover and patent human genes is frequently likened to a gold rush, an analogy that captures much of the current frontier flavor. But the savviest players recognize a fundamental difference. Prospectors forever removed the gold when they panned it from rivers and mined it from the earth. But the information in the human genome is not depleted upon its discovery. The genome is a resource to which biomedical researchers will return again and again to solve the puzzles of human disease; it is a wellspring that will nurture a myriad of overlapping discoveries and inventions for many decades to come. In this sense, the human genome can-and must-support what economists call nonrival consumption: a situation where multiple parties profitably share the same resource.

The problem with the gold rush analogy, then, is that the land claims that helped tame the prospectors’ free-for-all were a crude but necessary framework to divide rights to a tangible and decidedly finite resource. By carving up the genome into parcels of exclusive, private real estate, the Patent Office is needlessly replaying this history. Instead, what is called for is an enlightened policy designed to govern the multiple and overlapping uses of the “genome commons”: a policy that insures unfettered access to the data and materials that will serve as the building blocks for countless drugs and treatments in the future.

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Tagged: Biomedicine

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