Man-Made Genes

During a decade and a half of lecturing on biotechnology law, University of Michigan legal scholar Rebecca Eisenberg says she’s been asked the same question countless times: How can anyone “invent” and patent the genes that each of us have carried since birth? Although patent law allows inventors to claim new and useful machines, processes and compositions of matter (say, the chemical recipe for a novel plastic) as proprietary creations, that privilege traditionally has not extended to “products of nature,” such as the elements in the periodic table. However, when it comes to human genes, says Eisenberg, legal precedent offers a way around that prohibition, namely that genes captured and identified in the lab aren’t in their natural form. In order to be studied, genes are copied, abbreviated, spliced into bacteria or otherwise altered. From the point of view of patent law, a gene is just another man-made chemical.

Using that logic, the U.S. Patent Office began issuing the first patents on human genes in the 1970s. Since then, gene patents have become the bedrock of the burgeoning biotech industry. Human growth hormone, insulin and erythropoietin-protein drugs with billions of dollars in combined annual sales-are all manufactured using patented DNA sequences. Given the incentive of 20-year patent protection, several dozen new drugs have been brought to market (with hundreds more in the pipeline) by a U.S. biotech industry that now numbers 1,200 companies and counts $13 billion in sales, according to the Biotechnology Industry Organization (BIO), a Washington, D.C., trade group. ” No one would develop a drug if you didn’t have a patent,” says Human Genome Sciences CEO William Haseltine (see article: “The Case for Gene Patents,” this issue).