Rebirth of Reason


The Controversy over Gene Patenting, Part One
by Anthony Teets

The Human Genome Project (HGP) came about as a result of a longing among geneticists for a systematic approach to the study of the human genome. According to The New Fontana Dictionary of Human Thought, he human genome refers to "the chromosomal make-up characteristic of human beings and to the sum total of the genetic information which it embodies and imparts." In the 1980s, the mapping of the Huntington disease gene to chromosome 4 increased confidence in the human power to uncover the secrets of the code locked up within us. The HGP was a federally funded project begun in 1990. It created the tools that would allow for an easier exploration of the human chromosome and promised to compile a very detailed map showing the location of specific genes. Bioethicists, notwithstanding, have presented many arguments pro and con as to the potentialities open to the human community to further our knowledge in this area.

One controversy that erupted in the scientific community was over the question of patenting the genes for human diseases. When Craig Venter, former researcher of the National Institutes of Health (NIH), founded Celera Genomics Corporation, a private, for-profit company, he began withholding the information it had compiled and registered over 6,000 genes for patenting. Bioethicists soon began questioning the basis of ownership, commonly referred to as intellectual property.

The subject of patents and copyrights is intellectual property, by which is meant the legal implementation of the base of all property rights: a man's right to the product of his mind. Inventors should have the right to the enjoyment of the fruits of their labor. The Patent and Trademark Office (USPTO) of the Department of Commerce determines the patentibility of inventions under U.S. law. Four criteria are used in order to determine eligibility: "usefulness" of the invention (practicality), "novelty (it must be an invention that is new and not previously used)," "nonobvious (not something that could be readily innovated by specially trained persons)," and "enablement (meaning that the invention must be made understandable so that those who might use it would know how to do so)." By far the most familiar argument used against those who patent genes is that they are attempting to patent a part of nature and thus allowing one organism to own all or a piece of another organism.

In 1987, the Department of Commerce published a final rule implementing the Bayh-Dole Act of 1980. The Bayh-Dole Act encourages researchers to patent and market their inventions by guaranteeing patent rights to all. Bayh-Dole grants first rights to a patent for an invention or innovation fully or partially funded by a federal agency. Widely regarded as a landmark in intellectual property law, Bayh-Dole has stimulated entrepreneurial behavior in academic science. An unintended favorable consequence is that it resulted in the launch of new biotechnology companies, and brought new products to market at a greater speed. But in objection to the PTO's laissez-faire approach to patenting genes and gene fragments, some scientists feel it may have pushed the pendulum too far in the direction of private ownership of the genetic code. They feel that this will eventually hamper scientific research that is unbiased and truly benevolent. They seem to operate by the rule of thumb: "If it isn't free then it's not right."

When one considers gene patenting it is important to distinguish what it is that is to be patented. What are the claims of the inventors? The several categories of DNA-related patents that warrant applications include: gene fragments (EST's and cDNA), SNPS (single nucleotide polymorphisms), gene tests, and proteins. In this case, patentibility is determined by the same criteria explained above. Accoring to The Human Genome Proejct itself, "The 300- to 500-base gene fragments, called expressed sequence tags (EST's), represent only 10 to 30% of the average cDNA, and the genomic genes are often ten to 20 times larger than the cDNA." What is it that expressly warrants patentibility? This is the new center of controversy. Some now hold that only cDNA ("c" stands for complementary) merits patent rights. The argument is based on the claim that cDNA is the active part of a gene's coding for amino acids, which in turn are the elements that make up proteins. Those who support patenting,however, state that it is not the patenting of disease genes per se that is being sought, but the process of making use of the DNA in a specific diagnosis.

Noting that only the genes, not the junk DNA, provide code for proteins by creating messenger RNA (mRNA), Venter set his focus. He began making sturdier clone copies of the mRNA; and these stronger and analyzable copies he called cDNAs. By sequencing only the cDNAs Venter could be assured that he was gaining knowledge of actual genes; and by focusing the research this way he brought the price of sequencing down. By sequencing a short stretch of cDNA clones Venter created ESTs, and thus narrowed the center of the controversy. Venter had begun using automatic sequencing machines to the limit of their capacity and was churning out 50 to 150 such tags per day.

Craig Venter, a self-described "adrenaline junkie," gave an overview of his method of operation and compared it to the one used by the publicly funded Human Genome Project. "Assembling genomes is very much like doing a jigsaw puzzle," he said. "The trouble is, there were no corner pieces." And with 27 million of these pieces-each of them consisting of a string of 500 to 600 proteins-comparing each piece to each other piece individually would have taken decades. "Some of my colleagues in England proposed doing this in monasteries over the next several centuries."

(to be continued...

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