September 2000

The Great Gene Grab

Will the frenzy of gene patenting drive innovation-or stifle medical advances?

By Antonio Regalado

Imagine that when Neil Armstrong stepped onto the lunar surface for the first time in July of 1969 to plant the American flag and proclaim "one giant leap for mankind," he found that a number of companies and universities had gotten there first and divvied up the moon for themselves. Not only had they quietly laid claims to the most promising parcels of lunar real estate, but they had done so with the blessings of the U.S. government.

Sound absurd? Well, that's the fate of the 10-year, multibillion-dollar effort to decipher the human genetic code. In June, amid much fanfare, the directors of the publicly funded Human Genome Project and executives at Celera Genomics, a Rockville, Md.-based startup, announced they had separately finished sequencing most of the three billion DNA letters that comprise the human genome-the so-called "Book of Life." This rough draft of the human genome, the leaders of the decade-long public effort proclaimed proudly, represents an invaluable resource free for use by all humanity in its quest to diagnose and cure diseases.

The only problem is that numerous passages (and many of the most interesting sections) in this Book of Life have already been staked out as private property. Even as the Human Genome Project and Celera competed to finish sequencing the genome, a separate race was well under way: a race to patent as many human genes as possible. The frenzied patenting effort, taking advantage of the same automated sequencing technology and high-powered computers that made the Human Genome Project possible, has been spearheaded by a handful of "genomics" companies, high-tech startups whose laboratories are uncovering genes by the fistful-and whose legal departments are filing patent applications almost as fast.

Human Genome Sciences of Rockville, Md., which has been aggressively filing its claims since 1994, holds patents on 103 human genes, including those believed to be responsible for osteoporosis and arthritis; it has patents pending on another 7,500 genes. Incyte Genomics of Palo Alto, Calif., tops the list with some 400 patented genes, while Celera, which only began decoding DNA last year, has already filed patent claims on at least 6,500 gene sequences. Universities and government agencies are also involved: The University of California and the National Institutes of Health are among the most active gene patenters (see table " Gene Patent Fever" on last page).

"The patenting is intense," says Mark Boshar, associate general counsel at Millennium Pharmaceuticals, a genomics firm in Cambridge, Mass. Boshar says the reason for the frenetic pace is simple: "There is one human genome and a finite number of genes." The number of human genes is likely somewhere between 50,000 and 150,000 (geneticists are still debating the actual number). Of those, about 1,000 have already been patented, and applications on thousands of others await approval.