Co-Authored By Kevin W. McCabe
Originally published in Legal Times, October 16, 2000
This past spring, an amazing press conference was held. An international public consortium called the Human Genome Project and a private American firm named Celera Genomics announced that they would soon publish a "working draft" of the approximately 3.5 billion bits of DNA that make up the human genome. It's not an exaggeration to say that the keys to human life have been found.
Immediately, commentators started talking about the biotechnological wonders that were sure to follow from the companies that patented genes. And other commentators started worrying about the patenting of human genes. Do our laws allow that?
THE SIMPLE ANSWER IS YES, as all patent lawyers know. The more complicated answer is yes, but genomic patents are subject to all the usual rules and regulations that guide the awarding of intellectual property rights by the Patent and Trademark Office. The upcoming publication of the decoded human genome will also restrict the patentability of such genetic discoveries, and perhaps even the downstream inventions. And it is the very fact that genes can be patented that makes possible these stunning scientific advances.
To understand the impending revolution in biotechnology, perhaps it's best to begin with what we know about the human genome, and then consider how the promise of genomic patents is being shaped by our patent laws.
A FLOOD OF INFORMATION
What the Human Genome Project and Celera announced in June was that, by the end of the year, they would each publish a nearly complete map of the human genetic code. That map will identify and set forth the sequence of the 3.5 billion bits of DNA, known as bases, that make up a complete set of human DNA.
The Human Genome Project's draft will reveal approximately 85 percent of the code. Celera's draft should be more complete because it pools its own information with that provided by the public consortium. But both versions are viewed as rough drafts because some of the information is still missing, some is out of order, and some needs to be rechecked. A final, more polished draft is not expected until about 2003.
Even then, we will have only begun to realize the full potential of this new knowledge of our genetic code. The genome's sequence is merely of preliminary importance. It is the information locked within the sequence that researchers seek.
To unlock this information, researchers must next annotate the sequence of the genome. It is predicted that scientists will spend the next decade discovering where exactly each of the estimated 30,000 to 100,000 genes are found within the human genome and what those genes do. They will use a wide array of sophisticated "bioinformatic" tools and techniques coupled with traditional bench science. Many of these tools and techniques are only now being developed. For example, bioinformatic programs are being written to create phylogenetic trees, to perform "Rosetta Stone" Analysis, and to correlate the function of genes based on their proximity in a chromosome.
In addition to the efforts of Celera and the Human Genome Project, another somewhat less heralded but extremely vital project will provide crucial genomic information. The international SNP Consortium and others are working to discover the location and sequence of hundreds of thousands of single...