Patenting God’s Creation?One might think that the controversy over whether we should patent knowledge of DNA sequences would be limited to an argument among scientists, biotechnology companies, and the government. Yet, religious voices have been raised. The loudest of the religious voices have shouted “No!” to patenting intellectual property regarding genes, on the grounds that DNA belongs to God’s creation. Where are we on this? The 1990s chapter in the larger story of the controversy over patenting life forms began with the initial filing, by J. Craig Venter, in June, 1991, for patent property rights on 337 gene fragments, and a second filing in February, 1992, on 2,375 more partial gene sequences. Venter’s method of research, based on a deceptively simple insight, was key. The task of the Human Genome Project has been to sequence the entire 3 billion nucleotides in the DNA and to locate where on the DNA the genes are sited. Relatively speaking, only a small portion of the DNA functions as genes- about 3%. The non-genetic material has been affectionately labeled “junk DNA.” If one wants to find only the genes, thought Venter, then why bother with plodding through all the junk DNA? Noting that only the genes, not the junk DNA, code for proteins by creating messenger RNA (mRNA), Venter set his focus on mRNA. He began making sturdier clone copies of the otherwise fragile mRNA; and these stronger and analyzable copies he called cDNAs. By sequencing only the cDNAs he 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 dramatically. By sequencing a short stretch of cDNA clones—about 300 to 500 bases, and not necessarily the entire gene—Venter created what he called an “expressed sequence tag,” or EST. Venter had begun using automatic sequencing machines to the limit of their capacity and was churning out 50 to 150 such tags per day. In
the fall of 1992, the U.S. Patent and Trademark Office made a
preliminary ruling denying the applications, on the grounds that
gene fragments could not be patented without knowing the function
of the gene. This threw the ball into the court of the private
sector, where similar patent applications have been filed. Some
were filed by Venter
and his colleagues after he left NIH, having garnered $70 million
in venture capital to start a private biotech company, The Institute
for Genomic Research (TIGR). Should knowledge of DNA sequences in the original or natural human genome be patentable? In order to qualify for a patent, an invention must meet three criteria: It must be novel, non-obvious, and useful. At this writing, the U.S. Patent and Trademark Office has issued more than 1,200 patents of the type mentioned above, assuming that these patents meet the three criteria. Do they?
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