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Staking Claims Talking Gene Patent JOHN J. DOLL, director of biotechnology for the U.S. Patent and Trademark Office, tells SCIENTIFIC AMERICAN about granting exclusive rights to make, sell and use a gene Sci. Am. 2001

The idea of patents on genes is still inherently counterintuitive to some people. Would you explain briefly why genes are patentable?

Genes are complex organic molecules, and when you isolate and purify them from the chromosomes where they reside, they are eligible to be patented as chemical compounds. And that is the extent of the patent protec-tion that is given. We're not giving patents on whole chro-mosomes, and we certainly don't give patents on anything as it exists in nature.

How many genes have been patented in the U.S., and how many applications for patents are still outstanding?

The only number that I have is a guesstimate: since 1980 we have granted more than 20,000 patents on genes or other gene-related molecules [for humans and other organ-isms]. And we also know that we have more than 25,000 applications outstanding that actually claim genes or related molecules.

Can you describe why you recently tightened the rules for gene patent applications?

The four main criteria for getting a patent are that the invention must have a utility; it must have an adequate written description; it must be nonobvious to one of or-dinary skill in that particular field; and it must not have been done exactly before. The biggest hurdle that ge-nomic inventions face is the utility standard. In 1995 we issued guidelines, and we very clearly stated that if you had a secreted protein from a gene and you didn't know what role it played in disease or the di-agnostics of disease, but the protein was secreted in a diseased cell line [breast cancer cells, for instance], you could use that protein as an additive in a shampoo. You could have done that, and we would have allowed you to cross the utility hurdle for getting a patent. So that if anybody else wanted to make, use, sell or import into the United States this protein, your patent rights could be used to stop any of those actions. That is the major change instituted by the new util-ity guidelines. We've gotten rid of proteins being used as shampoo additives or proteins being used as animal food or nutritional supplements. We've gotten rid of transgenic mice being used as snake food. And that is exactly what the utility bar has been raised to do-to exclude throwaway utilities and to make sure that when you have a genomic-type invention that you have a real-world and specific utility that is credible.

One of the major findings of the Human Genome Project was just how common it is for a gene to code for multiple proteins. What if someone applies for a patent for a gene that expresses a particular protein and some-one else applies for a patent for the same gene coding for another protein? Does the owner of a gene patent have rights to all the proteins expressed by a gene?

When you have a patent on a particular gene, it's made up of a series of nucleotide sequences called exons that code for a particular protein. Let's say you have six blocks of exons that came together to express a par-ticular protein. Under a different condition in that cell line, maybe all six of the exons don't function. So now there are maybe four blocks of exons that come to-gether to express a totally different protein. That new set of exon blocks would be a separate patentable in-vention, and the people who had the patent to the first six would not gain exclusive rights to the protein ex-pressed by the four new blocks of exons.