In the last quarter of the 20th century, it became possible for corporations to patent the very stuff of life.
In the 1970s, scientists first patented methods for combining DNA, the techniques that lead to genetically modified organisms, or GMOs. In 1980, the U.S. Supreme Court cleared the way for the Patent Office to grant patents for specific life forms. The case was known as Diamond v. Chakrabarty, and in it the Court voted five to four to allow a genetically modified strain of bacteria to be patented because it did not occur in nature. Ananda Chakrabarty was a genetic engineer working for General Electric who had developed a bacterium that was capable of breaking down crude oil.
Since that case, patents have been issued on whole genes whose functions are not yet known. More recently, inventors began to seek patents on sequences of DNA that were less than a whole gene. Some patents have been granted for fragments of DNA.
In fact, by 2008 there were over 3 million genome-related patent applications that had been filed in the U.S. alone, according to an estimate from the Human Genome Project.
Patents are important because they allow companies that may have invested millions of dollars in researching specific genes or GMOs the exclusive right to profit from those discoveries. Patents give the holder a form of monopoly control for 20 years from the filing of the patent, and create a legal means of limiting competition or getting payments from other companies that want to license the invention.
Agricultural scientists and corporations are applying for patents, as well.
One of the earliest examples of an agricultural genetic patent was the "Flavr Savr" tomato. In the early 80s, a genetic engineer at a company called Calgene figured out that an enzyme in the tomato called polygalacturonase, or PG, caused the tomato to turn soft and spoil. They isolated the specific gene that produced PG, took that gene out of the DNA, flipped it upside down and backward, and put it back into the new tomato variety. By 1988, they had an initial crop of the GMO tomatoes. After harvest, the tomatoes still looked fresh and appetizing four weeks later.
Calgene dubbed the tomato the "Flavr Savr," and got a patent on the technique of flipping a genetic sequence. The patent protected the production of "anti-sense" genes. Then Calgene got FDA approval for the safety of the Flavr Savr tomato.
The problem was that it cost too much to actually produce and ship the Flavr Savrs. Costs were as high as $10 a pound, much more than consumers were willing to pay.
So, in 1996, Monsanto bought out the rights and patents to the Flavr Savr. They had no intention of marketing the tomatoes but saw the value in Calgene's broad patent on anti-sense genes. The patent could apply to any gene-spliced food plant that used the technique, and Monsanto would make money licensing the technique.
That same year, 1996, Monsanto received a patent on the genes that allowed their Bt crop varieties to manufacture their own insecticides. The same day, they filed patent infringement lawsuits against Mycogen and Ciba-Geigy because both seed companies were marketing Bt corn hybrids that incorporated the gene.
The pattern of suit and countersuit has continued to this day. Some companies make millions off of their patents for genetic materials.
In 2008, the Canadian activist organization, the ETC Group (Erosion, Technology and Concentration) estimated that corporations like BASF, Monsanto, Bayer, Syngenta, and Dupont had filed over 530 patent applications for genes in plants that could withstand changes brought on by global warming. If granted, these patents would give the companies monopolies on GMOs that could withstand drought, heat, cold, floods, saline soils, and more, far into the future.
UNL agricultural genetics professor Don Lee (right) says he challenges his students to think about patenting genes in a new way. "The reason there's patenting is not for the benefit of the company but for the benefit of us as consumers," he says. "That seems to catch them off guard. But the reason there are patents is so that a company feels like they can pursue a new idea and create a product from it and that's where we would benefit."
But Don says that we need to find a balance. "The key is to have patenting that happens so that it doesn't suppress creative work because of a certain patent blockades everybody's new ideas. So, patents have to be crafted in such a way that they're specific enough so that they don't suppress other creative avenues that could bring us new products.
Critics are disturbed by allowing patents on genetic material for a number of different reasons
- Some critics say patents could hamper the development of useful plants or drugs by other companies or individuals because of the high cost of getting the right to research patented genes.
- Other critics say that granting patents on partial or uncharacterized DNA sequences will reward those who make routine discoveries but penalize thos who determin the biological functions of the DNA. In effect, the patent office is rewarding those who complete the easiest steps, not the most useful.
- Some are concerned that there will be multiple patents issued on the same gene, first as a short string, then as a longer one, then the full gene and then the gene and its function. Multiple patents increases the cost of any new plant, animal or drug.
- Others note that third world countries often contribute rare and novel genetic material to plant breeders. The breeders largely in the U.S. are now using those genetic materials to develop GMOs. The critics say it's not fair to turn around and charge third world farmers for the new GMO varieties that they may have helped develop but haven't been paid for.
- Finally, many feel uncomfortable about the whole idea of patenting life, especially human life.
By 2009, the National Institutes of Health estimated that at least 20 percent of individual human genes had been patented already or had been filed for patenting. As a result, critics say, research on certain genes was restricted to the corporations holding the patents, and diagnostic genetic tests carried huge price tags.
For example, in 1976 a leukemia patient name John Moor had surgery at the University of California to remove his cancerous spleen. The University later got a patent for a cell line that they had removed from the spleen and could have used to produce valuable proteins. The cell line was called "Mo," but Mr. Moore would not receive any of the money that might come from the cell line. The long term commercial value of the cell line was estimated at over $1 billion. Mr. Moore sued to get his cells returned and to control his body parts. But the California Supreme Court decided he was not entitled to any rights to his own cells after they had been removed from his body.
In March, 2010, a federal judge struck down patents on two genes linked to breast and ovarian cancer. The decision, if upheld, could throw the hundreds of thousands human genetic patents already issued into question. The case was brought by the ACLU (American Civil Liberties Union) and others and involved seven patents that had been issued to Myriad Genetics. The patents were for two genes that could be related to cancer. Myriad had developed a genetic test that could detect the mutations that make breast and ovarian cancer more likely. The test is expensive and, up until now, Myriad had prevented other companies from developing their own versions. The federal judge ruled that the patents were "improperly granted" because they involved a "law of nature." Myriad has indicated that they will appeal the decision to a higher court.
Whether the genes involved come from humans, animals, plants or microbes, the issue will be with us well into the 21st century.
Written by Bill Ganzel, the Ganzel Group. First published in 2009. A partial bibliography of sources is here.