Since 1980 the U.S. Patent and Trademark Office has granted patents on more than 20,000 genes or gene-related molecules. This thicket of intellectual property can make it difficult to develop biotechnologies without bumping up against patents held by others. In response, a number of companies have devised ingenious technological means of getting around such IP hurdles.

To obtain a patent, one of the things an inventor must prove is that a creation is truly novel. Genes, proteins, kidneys and all endogenous living tissue in its natural form do not meet that criterion. "A basic tenet of patent law is that you can't patent something as it is found in nature," says Kathleen Madden Williams, an attorney with the Boston law firm of Palmer and Dodge. "It has to encompass something new." The genomics gold rush revolves around genes that have been isolated and purified outside an animal, plant or microorganism. But turning on a gene to make a protein while the DNA is still lodged inside the body--or in the nucleus of a cell in a laboratory dish--would allow someone to avoid infringing a patent.

This article was originally published with the title Legal Circumvention.

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