On October 2000, I argued in “Who Owns Your Genes?” that naturally occurring genes should not be patented because they are not inventions, but discoveries of what already exists in nature. On January 2001, the U.S. Patent and Trademark Office (PTO) issued its guidelines for patents on genes and proved me wrong.
The PTO argued that “an isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent because that DNA molecule does not occur in that isolated form in nature.”
The PTO’s argument is that in discovering and isolating a gene, a scientist creates something that has never existed before: the isolated gene. A patent is therefore given as recognition that a gene, once identified, isolated, and shown to have a specific utility, acquires commercial value, value that it did not have before. Only then can it be manipulated and used for commercial purposes. And the same line of reasoning goes for any other material or substance that is discovered in nature and isolated from its source. In fact, the PTO observes that “patenting compositions or compounds isolated from nature follows well-established principles, and is not a new practice.”
Consider some historical precedents that support the PTO’s argument.
In 1873, for example, Louis Pasteur received a patent for “yeast, free from organic germs of disease, as an article of manufacture.” Yeast had existed for thousands, if not millions of years before Pasteur developed an interest in it. But before Pasteur’s investigations, yeast had never been processed to be free of germs. Pasteur created disease-free yeast, and properly received a patent for it.
Another precedent is a patent given for adrenaline. The patent was challenged in court in 1911 on the grounds that adrenaline was not invented but discovered. The court’s decision affirmed the patent’s validity and explained why it did so: “Takamine was the first to make [adrenaline] available for any use by removing it from the other gland-tissue in which it was found, and, while it is of course possible logically to call this a purification of the principle, it became for every practical purpose a new thing commercially and therapeutically. That was a good ground for a patent.” The court’s point was that adrenaline, as well as any other substance, should be patentable “even if it were merely an extracted product without change.”
The PTO reiterates the court’s point in defense of its own guidelines: “Like other chemical compounds, DNA molecules are eligible for patents when isolated from their natural state and purified or when synthesized in a laboratory from chemical starting materials.”
But if isolated genes identical to genes in our own bodies can be patented, wouldn’t we be violating their patents just by being alive and making use of our genes in our metabolic processes?
No, argued the PTO. “A patent on a gene covers the isolated and purified gene but does not cover the gene as it occurs in nature. Thus, the concern that a person whose body includes a patented gene could infringe the patent is misfounded. The body does not contain the patented, isolated and purified gene because genes in the body are not in the patented, isolated and purified form. When the patent [was] issued for purified adrenaline about one hundred years ago, people did not infringe the patent merely because their bodies naturally included unpurified adrenaline.”
In light of the PTO’s clear case for the propriety of patenting genes, I am glad that my arguments did not prevail. It would indeed be utterly unjust not to grant a patent to a scientist for a gene he worked to discover, isolate, and find a use for.
Historically, patents have been a huge incentive to inventors, researchers, and businessmen who, in the absence of patents, would not have invested so much of their time, effort and capital in their endeavors. If we want progress in medical research and treatment to continue we must keep in mind that granting patents for genes is not only practical, but moral as well.
