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Will a Smaller Genome Complicate the Patent Chase?

Science  16 Feb 2001:
Vol. 291, Issue 5507, pp. 1194
DOI: 10.1126/science.291.5507.1194

When William Haseltine, president of Human Genome Sciences (HGS), spoke at industry seminars last year, he liked to impress his audiences with a striking statistic: His Rockville, Maryland-based company had applied for patents on a wide array of medical uses for about 7500 newly discovered human genes. Those filings, he noted, give the company an inside track on exploiting 5% of the 140,000 or so genes that he estimated are in the human genome. But it turns out that Haseltine, a man not known for understatement, may unwittingly have downplayed HGS's patent position. Now that researchers have had a chance to survey the entire genome, they believe it contains just 35,000 to 45,000 genes. That means HGS could have claims on up to 20% of the total.

Although that would seem to put HGS in a powerful position, the shrinking gene count could be a mixed blessing for the company and others, from universities to governments, that have rushed to lay claim to gene uses. “A smaller genome may mean more people pursuing claims on the same real estate,” says Mark Edwards of Recombinant Capital, a biotech consulting firm in Walnut Creek, California. As a result, firms may spend millions of dollars over the next decade battling to convince patent examiners and judges that they were the first to invent uses for a particularly valuable swath of DNA.

ILLUSTRATION: TERRY E. SMITH

In the long run, it will be quality—not quantity—that counts. Genes themselves cannot be patented, only the uses to which the information can be put. “The real question is: ‘How many of the genes represent legitimate targets for drug development?'” asks Stephen Bent, a patent attorney with Foley & Lardner in Washington, D.C. “No one yet knows, but finding [commercially valuable genes] is probably not appreciably easier if the total pool is 45,000 instead of 100,000. You are still searching for that needle in a haystack.” Indeed, Randy Scott, chair of Incyte Genomics in Palo Alto, California, which claims ownership of the most patents related to human genes, says that “the actual number of loci is an interesting academic issue, but it is not at all relevant to our business,” which focuses on selling genetic information and helping other companies develop new drugs.

Companies that have tried to lock up rights to huge numbers of genes in the hope of snaring a few with valuable uses could find that to be an expensive strategy. Patent experts estimate it costs $100,000 to $500,000 simply to maintain a single patent over its 10- to 20-year life-span in the United States and other industrialized nations. And actively preventing other companies from infringing is far more costly; in the United States, for instance, legal defenses typically cost $1.6 million per contested patent, according to statistics compiled by the U.S. Patent and Trademark Office (PTO). Gene patent fights, PTO officials say, are likely to be even more expensive because of their biological and legal complexity. To recover such costs, Bent notes, most companies will need to cash in on at least one “blockbuster” patent that leads to a strong-selling product.

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Legal uncertainties over the patentability of uses of gene fragments also cloud the picture. A blockbuster gene may, for example, turn out to be covered by a patchwork of patents, with one firm winning the right to use the complete gene while others lock up related uses for fragments of the same sequence. Evolving patent rules in the United States and Europe are making patenting the uses of small fragments harder. But if the fragment patents came first, their owners could force whole-sequence patenters to cough up royalties, says Stephen Kunin, a PTO expert on gene patenting. The good news, Kunin notes, is that a smaller genome could speed the PTO's process of identifying and rejecting the thousands—if not tens of thousands—of redundant applications that have been filed on gene uses that are already spoken for. If fewer genes are indeed up for grabs, he adds, “a lot of people are going to discover that they lost the race to the patent office.”

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