Also, an article by Robin Marantz Henig on genetic research, "The Rush to Claim a Little Slice of Life," did not identify her. She lives in Washington and is the author of "The Monk in the Garden: Mendel's Peas and the Birth of Genetics," to be published in the spring by Houghton Mifflin. (Published 01/11/2000) The correct e-mail address for Robin Marantz Henig ("The Rush to Claim a Little Slice of Life," Outlook, Jan. 9) is firstname.lastname@example.org. She is the author of a forthcoming book on genetics, "The Monk in the Garden" (Houghton Mifflin). The address for Arnold R. Isaacs ("My Measure of the Man: Long Ago, I Learned What I Need to Know About Candidate McCain," Jan. 9), which was inadvertently omitted, is email@example.com. (Published 01/16/2000)
The rush to transcribe the entire genetic message of human chromosomes by the end of 2000 has been in full swing ever since the famously flamboyant scientist who heads Celera Genomics Corp. announced in 1998 that he would beat the federal government's effort with a leaner, meaner technique.
But Celera president J. Craig Venter set off more than a race between his company and the publicly funded Human Genome Project. He also stoked a gold-rush mentality in the world of genome science. In this high-stakes game, players try to outsmart each other by laying claim to particular stretches of DNA--filing for gene patents even before they have any idea what most of those stretches do.
What is ultimately at issue here is patenting the blueprint of the genes' makeup or sequence. That knowledge is what will allow scientists to replicate those genes in the lab (a relatively straightforward chemical process), and use them to create new drugs and specifically targeted therapies. It is in this vast new array of treatments that the potential profit lies--both for private companies and, of course, for patients.
Never before has our 210-year-old patent law been contorted in quite this way, protecting discoveries instead of inventions, biological information instead of machines. At the U.S. Patent and Trademark Office, more than 10,000 provisional patent applications for various segments of the human genome are awaiting action. The applications come from Celera and its two main for-profit competitors, Human Genome Sciences Inc. (which, like Celera, has its headquarters in Rockville) and Incyte Pharmaceuticals Inc., based in Palo Alto, Calif.
In all but a handful of cases, no one at these companies yet understands the function, usefulness or commercial value of the genetic material for which patent applications have been made. The applications serve simply as place holders.
Whoever holds the patent to a sequence that turns out to represent a significant disease gene can eventually sell access to the highest bidder. Pharmaceutical companies will vie for the right to develop more individualized treatments for diseases--or to create handy pills to make folks slimmer or smarter. Not only will straightforward genetic diseases such as cystic fibrosis probably be cured in this way, but so, perhaps, will complex conditions caused by the interactions of several genes: heart disease, cancer, Alzheimer's, maybe even dysfunctional personality traits. Companies will pay millions for the right to develop treatments for such illnesses, knowing the potential profit runs to the tens of millions. That is why genomics companies are hedging their bets with thousands of patent applications.
As Randy Scott, president of Incyte, has said, the winner in this strange endgame will find himself at the helm of "the equivalent of eBay for genes." But is this where we want our astounding new insights into the code of life to lead us--to an auction for the right to manipulate our genes? If not, is it even possible to put the brakes on genetic prospecting? Is there a less wild-eyed way to ensure a fair profit for the investment required to bring gene-based therapies to the marketplace? And is it appropriate to allow anyone to patent a gene's sequence--in effect, patenting life itself?
What gene prospectors hope to patent are arrays of nucleotides, the chemicals that, when strung together in a particular order, constitute the genes. In the most common metaphor for how it all works, nucleotides are said to represent the letters of the genetic alphabet (there are four--A, C, T and G), the genes they form are the sentences, the chromosomes on which genes are arrayed are the chapters, and the genome is the whole gigantic book, made up of long strings of letters arranged in a specific and characteristic sequence. The book, in a sense, is the instruction manual of life.
Individual variations in the genome--the addition or deletion of a few key letters or, occasionally, of entire words or phrases--account for most diseases. Finding the right order for these nucleotides is what sequencing is all about.
But only about 3 percent of the complete sequence represents functional genes. The rest are so-called "junk DNA." Just a fraction of the provisional patents now on file, then, will turn out to be pay dirt that can be exploited for commercial or scientific gain. But, like the gold that lured prospectors westward a century and a half ago in America, that fraction will turn out to be so lucrative that the gene hunters figure that all their mining will be worth it.
In the dark ages of genome research--that is, seven or eight years ago--scientists patented genes one at a time, and then only after they had figured out what the genes did. Today, they are using a more scattershot approach. It is like scouring a beach for beautiful shells by scooping up sand with a backhoe, hoping to sift through it later to see if you collected anything worthwhile.
This isn't the way science is usually done. More typical is how the Human Genome Project has worked since it got underway in 1990: as an international, collaborative effort to decode the basic sentence structure of human biology, one hard-earned letter at a time. It is the team of government scientists from this project that is now mounting a preemptive strike against the upstart biotech companies, trying to beat them at their own game.
In early 1996, all nations involved in the public genome project met in Bermuda to decide how and when the sequence should be released: all at once, or a little at a time. Britain, France, Germany and Japan joined the United States in the so-called Bermuda Accord, which upheld the principle of complete, continuous public disclosure for the sake of science.
The accord said that all public laboratories were to post the sequences discovered each day on the Internet that evening. So every 24 hours, thousands of new bits of data are added to the several billion already collected on GenBank, the international Web site maintained by the National Center for Biotechnology (www.ncbi.nlm.nih.gov/genome/guide).
All those bits of raw data are relatively meaningless. But putting them out there for mass consumption has a felicitous side effect. Every time the public sector puts a gene sequence online, it keeps a private company from obtaining the right to patent it. Once a sequence, however unintelligible, is in the public domain, it is no longer new--and thus no longer patentable.
At the heart of all this is the most basic question of whether anyone has the right to patent life in the first place, even life in so elemental a form as a string of nucleotides. A 1980 Supreme Court decision, which upheld the patenting of a genetically engineered bacterium, set the stage for patent protection for "anything under the sun that is; made by man." It remains to be seen, however, whether the genome sequence can be construed as being made by man. And if so who, if anyone, should be allowed to own it.
In the meantime, gene prospectors are certainly adding to our scientific knowledge by characterizing gene sequences. But they are obstructing further research and understanding of those very sequences by attempting to patent every genetic lump just in case it turns out to be pure gold.
Robin Marantz Henig, who lives in Washington, is the author of "The Monk in the Garden: Mendel's Peas and the Birth of Genetics," to be published in the spring by Houghton Mifflin.