Gene Patents Create Social and Economic Problems

By Christoph Then, a Greenpeace patent expert. Greenpeace is an independent organization that uses peaceful, direct action and creative communication to draw attention to global environmental problems.

One example of the situations the patenting of genes may lead to was given in Science in 1997, under the title "HIV Experts vs. Sequencers in Patent Race." The article describes the discovery of the CCR5 receptor, which caused a great stir in the international scientific community because it plays a major role in the penetration of the AIDS virus into the cell. After many scientists had already looked into the CCR5 receptor and its possible therapeutic implications, they found that a company, Human Genome Sciences, had already filed a patent application for the corresponding gene sequence in 1995. Although the patent specification does not even mention a connection with the HIV infection, Human Genome Sciences also claims the rights to this gene in the framework of AIDS research. Jorge Goldstein, the company's attorney, declares: "Whoever is first to patent a DNA sequence—for any use—can lock up subsequent uses."

The Patent Model

A major part of the problem stems from the transfer of patent law from the sphere of chemistry and physics to the living world. In connection with chemistry, so-called product patents can be granted. These cover all properties of the patented substances, independently of whether they are described in the patent specification or not. Only one single commercial application needs to be stated in order to receive exclusive control of the substance and all its properties. This model was transferred to the genetic code. If one commercial application is described, the patent protects all biological functions of the gene inasmuch as they can be commercially exploited.

Now that the human genome has been decoded and it has become evident that genes usually perform several and often very different functions, this type of patent appears completely inappropriate. Genes now appear to be much more like encoded information than like active chemical substances. The genes that govern the laying of eggs in the threadworm may be responsible for Alzheimer's [disease] in human beings. Genes that cause breast cancer may also play an important role in diseases of the colon or prostate gland. Moreover, under this kind of patent protection, a company that receives a patent connected with a diagnostic procedure also has the rights to the gene if it is used to develop a much more complex therapy or medicine. This monopoly makes no sense either in scientific or in economic terms, since it does far more to hamper research and development than to promote it.

Genes Are Not Chemicals

The Nuffield Council on Bioethics therefore states quite clearly: "We note, further, that the fact that DNA sequences are essentially just genetic information distinguishes them from other chemical compounds, with regard to the patent system."

In the modern view, a gene is therefore not a precisely defined unit of DNA, but a set of DNA sequences that may recombine continually in a new way and interact in a complex manner with other gene sequences or their environment. It is still not known exactly how the synthesis of several proteins may be induced by one gene. Initial knowledge exists of some mechanisms that lead to this variety of proteins, but it now appears impossible to transform the dynamic and constantly changing set of gene sequences into a patentable object with a precisely defined structure and function. All that is patented is an intellectual construct that has little to do with reality.

An additional factor is that, unlike with chemical substances, it is rarely possible to circumvent a patent on genetic information by inventing a new chemical substance, particularly because the number of human genes is finite. Once these have been analyzed and patented, the blockade effect is much more extensive than in the case of chemical substances, whose number can be constantly increased by means of variations and experimental modifications.

As soon as different patent owners are involved and there is a risk of royalty stacking, research and development are considerably impeded.

The Negative Consequences

The negative consequences also become apparent for small companies that not only sequence genes, but also handle scientifically more complex problems such as gene therapy. Thus, an employee of Mologen [AG] in Berlin has repeatedly voiced public criticism of gene patenting. The company itself has filed numerous patent applications, but fears dependence via patents on genes that are upstream of gene therapy. "Sequencing, the technology by which a gene can be recognized, 'read,' and then patented, has meanwhile become an automated process. Robots, one would think, cannot make inventions, and it should therefore not be possible to patent genes," says Claas Junghans of Mologen AG. In the newspaper "transcript," Junghans also expresses grave reservations about too extensive gene patents: "If we are being asked in 30 years, why the development of a drug against AIDS took so long, then patent law should not be the answer."

Finally, the hasty patenting of human genes really does affect the entire development of drugs and vaccines, which are mainly based on protein technologies. When both are concentrated in one company, as is the case with the large pharma corporations, difficulties can be skimmed over. But as soon as different patent owners are involved and there is a risk of royalty stacking, research and development are considerably impeded. "This could lead to a situation where there will be a need to obtain multiple licenses in order to complete diagnosis. In addition, where a company acquires a bundle of patent rights over different, yet related, aspects of any given invention, the resulting thicket of patents could make further research work difficult as the morass of patents to work around could be perceived to be impenetrable."

Adapted from: Christoph Then, "The True Cost of Gene Patents: The Economic and Social Consequences of Patenting Genes and Living Organisms," Greenpeace, June 15, 2004. Retrieved from <www.greenpeace.org>.

 Copyright 2010 Greenhaven Press, a part of Gale, Cengage Learning.