To: Cytokine1 who wrote (7844 ) 4/10/2000 10:26:00 PM From: lwd Respond to of 9719
Nature Medicine April 2000 Volume 6 Number 4 pp 362 - 363 medicine.nature.com (needs subscription) Gene patent revisions to remove some controversies Tom Hollon Bethesda, Maryland There is something appealing about 'armchair biology' as a business strategy. Sequence millions of small chunks of DNA, blanket the genome with EST expressed-sequence tag) patents, stake claims to genes you know nothing about, and then kick back and let somebody else figure out what your stuff might be useful for. When they do, demand royalties. But the game could be up for EST patent applicants. On 1 March, the US Patent and Trademark Office (USPTO) released proposed revisions to patent issuance guidelines that will effectively put an end to such practices. ESTs represent cDNA fragments 200-400 bases long. A few years ago, competing genomics companies launched a 'gold rush' into the human genome, racing to file US patent applications for more than a million ESTs. Based on sequence data, and usually little else, many applications claimed broad rights to genes and proteins associated with ESTs. Most of those applications are still pending. However, the USPTO is changing the guidelines for two of the standards used by patent examiners to issue patents: the utility standard, which refers to why an invention might be useful, and the written description standard, which pertains to disclosure of how an invention is made. Utility is a concept mostly important for chemical and genomics patents, for which inventors may not know the function of a chemical or gene at the time of filing. The revised utility standard rejects EST patents claiming broad rights to associated genes and proteins on two grounds: A DNA fragment is not useful as a probe for a gene without specifying what is being probed for; and a DNA fragment cannot be used for protein isolation without stating what the patent office calls the protein's "real world" use. The new written description standard,which, like the utility standard, will apply to all pending applications, also rejects EST patents: Sequences of cDNA fragments are insufficient to describe the genes they are associated with, and therefore are not sufficient to claim rights to them. John Doll, the USPTO director of biotechnology patent examination, says the revisions are unlikely to affect patents for full-length cDNAs or SNPs (single nucleotide polymorphisms), which usually have narrowly based claims. But the chances that EST sequences alone can be used to claim genes and proteins, he says, are "slim and nil." EST applicants whose patents are officially rejected will be free to appeal in federal court, and because potentially billions of dollars are at stake, a court fight over EST patents looks certain. If so, it is possible the patent office's rejection of EST patents by two different standards is a preemptive strike, as it could be harder to overturn two patent standards than one. The guideline revisions, which will probably take effect by September, will not make all gene patent controversies go away, however. There is still the issue of function. A case in point is the recent outcry over the award of the CCR5 patent to Maryland-based Human Genome Sciences (HGS), declared by some as an outrageous decision by the patent office. A few years ago, several groups discovered that a cell surface protein now called CCR5 is an HIV co-receptor essential for viral entry into cells. HGS played no part in the discovery of this function, but had already applied for a patent on the gene. Since receiving the patent, HGS has licensed other companies to use CCR5 for anti-HIV drug discovery programs. William Haseltine, CEO of HGS, expresses sympathy for the researchers who lost out on the patent, but he says that HGS made its application based on its demonstration that CCR5 was a receptor for several inflammatory chemokines, and useful as a tool for discovery of anti-inflammation drugs. If someone else patents use of CCR5 for HIV-related applications, HGS will be ready to consider a licensing arrangement. The CCR5 case is not unique, according to Rebecca Eisenberg, professor of patent law at the University of Michigan. She recalls a similar story a few years back involving the receptor of leptin, an obesity regulation hormone: One group discovered the receptor's function; another owned the gene. With so many cDNA patents still pending,including a staggering 7,500 from HGS alone Eisenberg thinks the CCR5 and leptin receptor cases may be the tip of the gene patent iceberg.