Seeds of Discord

The farmer rejected the manufacturer’s claims, so the company sued him. The case went all the way to Canada’s Supreme Court, which eventually sided (in a 5–4 decision) with the manufacturer, stating that patent law, as currently written, had indeed been violated. Schmeiser’s main consolation was that the court overturned a lower court’s judgment that had made him liable not only for the company’s original financial demands but also for a significant portion of its legal fees. The farmer is nevertheless out many thousands of dollars for his own defense costs.

Patents and Life

Schmeiser’s case is just one illustration of the way “life patents” are beginning to impact those involved in agriculture. But agriculture is not the only sector that is being affected by DNA-based patents. Serious implications face medical researchers, pharmaceutical companies, doctors, hospitals and society as a whole.

Exactly what is a life patent? The term may refer to a patent on a genetically modified plant or animal, or on a gene that has been taken from a person or other living organism and then scientifically isolated and made to grow in a laboratory. Many patents are filed for abnormal genes associated with disease, such as the BRCA1 and BRCA2 mutations linked to breast and ovarian cancer. A patent might also be filed on a gene that has been identified as beneficial in fighting disease, on drugs and diagnostic tests based on genes, and on gene therapies.

It’s important to note that naturally occurring plants and animals cannot be patented, nor can actual genes in the human body. “You cannot get a patent on any organism found in nature,” says Daniel Kevles, professor of history at Yale University. Kevles is currently working on The Engineering and Ownership of Life, a book about the history of intellectual property pertaining to living organisms. “The gene itself isn’t what’s patented,” he explains, “the complementary DNA version of it is. This complementary version has been scientifically isolated and manipulated in a laboratory. It thus merits a patent, because it has been sufficiently altered by human effort to count as man-made for legal purposes.” He adds, “You could get a patent on corn that has been genetically engineered to be resistant to insect pests, or on salmon that have been genetically modified to grow twice as fast.”

To qualify for a patent, the patentee’s innovation must be something novel rather than an obvious extension of present knowledge; it must have a practical use; the proposed function of the DNA sequence or drug must be credible; and it must be described sufficiently so that other researchers could make and use that invention. If a researcher has merely discovered a particular gene, that will not qualify.

Patents on genes and living things are similar to those for consumer products. “A patent is a kind of license granted by a government to an inventor,” explains Robert Cook-Deegan, director of the Center for Genome Ethics, Law, and Policy at Duke University. “It gives the inventor the right, through the courts, to stop rivals from making, using or selling an invention without his or her permission. However, the patent can be bought, sold, rented or hired.” The holder of a DNA patent does not own the gene sequence; he or she simply has the right, for a limited time, to prevent others from using it. In the United States, patents last for 20 years. During this period, if others want to undertake research relating to the patented gene or organism, or if they want to manufacture it or sell it, they must obtain permission from the patent holder, and usually they must pay a fee.

How does someone obtain a gene patent? “You find a new gene and you figure out what it does or how it can be of use, and then you file a patent,” replies Jon Merz, assistant professor at the Department of Medical Ethics at the University of Pennsylvania School of Medicine in Philadelphia. “If you’re a professor, you license it to a company. The company now has 20 years’ exclusivity in which to use it to find a drug. Once they find a drug, say 10 years later, they get another 20 years, this time on the drug.” At the end of the patent period, anyone is free to use the product or process without asking the permission of the inventor.

There is no worldwide patent system, so inventors must file patent applications in each country in which they plan to do business.

Historic First

While the idea of life patents may seem new, it has been around for a few decades. The first one goes back to 1972, when microbiologist Ananda Chakrabarty filed a patent application for genetically engineered crude oil–eating microbes. He had combined genetic material from four different strains of Pseudomonas bacteria to come up with a super strain of microbes that could be used to clean up bodies of water after tanker spills.

Chakrabarty applied for a patent with the U.S. Patent and Trademark Office (USPTO) to protect his work. The application was quickly rejected on the grounds that the “product” already occurred in nature. Chakrabarty appealed the decision many times until the case finally reached the U.S. Supreme Court, which in 1980 voted that the microbe in question was indeed an invention and thus could be patented.

The USPTO subsequently issued a new policy stating that the accepted definition of patentable subject matter was expanded to include man-made animal life forms. In 1988 it granted a patent for another living organism, the “Harvard Mouse,” a laboratory mouse that was genetically engineered by Harvard University scientists to serve as a model for studying how genes contribute to breast cancer.

Since the Harvard Mouse patent, the USPTO has issued hundreds of patents involving genetically engineered plants and animals, and more than 9,000 patents on genes or their fragments. An estimated 24,000 DNA-based patents are now pending, and new applications are coming in all the time. Patent offices in the United Kingdom, the European Community, Japan and other industrialized countries around the world have been busy granting patents on life as well.

Is that good or bad? Those in the biotech industry generally believe it’s good. But not everyone agrees. A large number of physicians, clerics, bioethicists, humanitarians and even scientists see many potential problems with DNA patents. Their concerns fall into three main categories: ethics, economics and research. That said, these issues shouldn’t be viewed as limited to a few professional groups. The ramifications for society as a whole and for each of us individually are substantial.

The Way Forward

Such concerns notwithstanding, most people in the industry believe patenting is here to stay. The question is, how can we keep it in check? Can we keep it in check?

Most people in the industry believe patenting is here to stay. The question is, how can we keep it in check? Can we keep it in check? 

Wayne Hall, professor and director of the Office of Public Policy and Ethics at the Institute for Molecular Bioscience at the University of Queensland, believes the problems stem not from patenting itself so much as from misuse of the system. In Hall’s view, too many companies have been charging unreasonable licensing fees for accessing DNA sequences, imposing too many restrictions on their genetic products, and charging exorbitant prices for the medicines and tests they’ve developed. He also believes that patenting law has tended to be overgenerous in granting patents on DNA sequences. “Not only are many of the patents broad in scope (meaning they cover the gene itself or all uses for a gene, rather than one specific use for a DNA sequence), but they have been granted when the criteria for inventiveness and utility were weakly applied,” he says.

Still, none of these issues is unsolvable, claims Hall. “It’s really a matter of patent authorities being prepared to use the provisions within most patent law and to overrule companies that engage in wrong practices,” he says. “They can do that by compulsory licensing and by compelling them to license their invention at a reasonable fee so that it can be more widely available. More care also has to be taken so that the very broad, general patents don’t get through.”

In terms of getting needed medications and agricultural products to developing nations, one idea is to create a “market prize system,” suggests Cook-Deegan. Biotech companies would be told that if they make a particular vaccine that is needed for the Third World, wealthy nations would buy a certain number of units for poorer countries. He sees this as a win-win situation in that “you have an incentive to create a vaccine because you have a guaranteed market. That preserves the patent incentive, but it also solves the problem that the people in those countries don’t have money to pay for the medicines they need.”

On a less tangible level, there’s still the larger ethical question of whether any kind of living thing should be patented. “This is probably going to be debated for a long time,” says Grant Sutherland, research fellow at the Women’s and Children’s Hospital in Adelaide, Australia. “Part of the problem is that what one group or individual thinks is ethical is different from what another thinks.”

Yale’s Kevles assesses the situation this way: “Right now the public in general is not really aware of what’s going on. A few bills have been introduced into Congress to regulate patents on human genes, but there aren’t that many yet to be concerned with. Once they get to be more numerous—which I believe they will—and once they start dealing with diseases that are more common than BRCA1 or 2 breast cancer [which accounts for only a small percentage of breast cancers] then you may very well see the public rise up and say, ‘Hey, we deserve better than this!’ Genetic engineering is a growing field. New advances are being made all the time. Along with that, DNA patenting will certainly become a greater issue in the years ahead.”