PATENTS ON CELLS, GENES, AND ORGANISMS UNDERMINE THE EXCHANGE OF SCIENTIFIC IDEAS

by Jonathan King and Doreen Stabinsky

The Chronicle of Higher Education
February 5, 1999

The biotechnology revolution offers extraordinary new possibilities for preventing and treating diseases, and for a deeper understanding of how organisms interact with each other and their environment. Many of the recent breakthroughs in molecular genetics, biochemistry, and cell biology also promise valuable commercial applications, such as new methods of manufacturing vaccines, enzymes, and new organic compounds.

An unforeseen and deeply troubling aspect of this commercialization, however, is the transformation of biological entities -- the products of hundreds of millions of years of evolution -- into private property. This is taking place through a radical extension of patent law to encompass gene sequences, isolated cells and tissues, genetically engineered animals, and even natural species. These profound changes in patent policy -- first allowed through a narrow Supreme Court ruling in 1980 -- are being carried out through the administrative procedures of the U.S. Patent and Trademark Office, with virtually no public debate or Congressional oversight.

Furthermore, in spite of widespread opposition to such "life patents" in many other countries, the U.S. government, in response to pressures from corporations in the United States, is seeking to force all countries to accept U.S.-style patent laws. For example, the government threatened to end science and technology agreements with India, unless the Indian patent laws were extended to cover pharmaceutical and agricultural products. The public is only just realizing the speed and scope of this privatization of biological material. For instance, Monsanto owns a patent covering all genetically engineered cotton, and Duke University has patented genes involved in Alzheimer's disease. Human Genome Sciences has patented the entire genomes of certain bacteria that can cause serious diseases in humans, to gain a monopoly on the development of new antibacterial agents. Myriad Genetics owns patents on the human genes that, when damaged, lead to breast cancer. And Axys Pharmaceuticals has applied for patents on the cells and genes of New Guinea tribes, for their presumed value in the development of certain treatments against viruses to which the tribes may have developed immunities.

Lawyers often argue that life patents protect intellectual property rights. It is important, though, to distinguish between the intellectual property involved when someone writes a book or song, or creates a painting, and the information contained in human genes or cotton plants. Life patents do not protect inventors' rights to their creations; instead, they award monopolies on organisms or their components. This distortion of the patent system hamstrings scientific and medical research by restricting access to information and materials, and by preventing competition.

Such patents also represent a sharp departure from traditional views of the rights of individuals and societies with respect to animals and plants. Farmers have always owned the crops they grew, but in the past, they had no legal rights to keep others from growing the same crops. The Monsanto patent on transgenic cotton extends to all the progeny of those plants and allows Monsanto to prevent farmers from saving the seed of crops they have grown, for planting the next season.

RiceTec has even obtained a patent on basmati rice, grown in India for thousands of years; the patent means that RiceTec can require farmers in the United States, and any other country in which the company has patented the rice, to purchase a license from the company if they want to grow the rice. Such private expropriation of biological resources reflects qualitative changes in access to basic biological knowledge and in the relations between humans and the natural world.

This social transformation has been the subject of several recent books, including Sheldon Krimsky and Roger P. Wrubel's Agricultural Biotechnology and the Environment: Science, Policy, and Social Issues (University of Illinois Press, 1996); Vandana Shiva's Biopiracy: The Plunder of Nature and Knowledge (South End Press, 1997); Jeremy Rifkin's The Biotech Century: Harnessing the Gene and Remaking the World (Tarcher/Putnam, 1998), and Seth Shulman's forthcoming Owning the Future (Houghton Mifflin, 1999).

U.S. law permits the owner of a patent to prevent others from using or benefiting from the subject of the patent, without the owner's permission, for 20 years. After that time, the patented material enters the public domain. However, it is common for patent holders to modify their inventions and apply for additional patents.

Thomas Jefferson, who was active in collecting and breeding plants at his Monticello plantation, supervised the drafting of the first U.S. patent laws when he was Secretary of State. The laws excluded animals, plants, and other "products of nature." Jefferson believed that the role of patents was not to establish monopolies, but to insure that inventors were able to make a living, and thus continue to contribute to society. He wrote that whenever the monopoly granted by a patent was contrary to the public interest, the public interest should take precedence.

With the commercialization of plant breeding and seed production in the 1920s, breeders attempted to restrict competition by expanding the patent laws to include plants. Resistance from consumer groups and farmers prevented that expansion, but Congress granted breeders some protection by passing the Plant Patent Act of 1930 and later the Plant Variety Protection Act of 1970. These laws gave breeders of new plant varieties limited rights, such as the right to prevent competitors from marketing the same varieties. It remained impossible to patent organisms in general, or their component parts, such as genes, proteins, and cells.

This 200-year-old legacy was breached in 1980 when the Supreme Court ruled, in Diamond v. Chakrabarty, that an applicant could patent a genetically engineered bacterium. The court's decision was very close (four of the nine justices dissented from the majority's opinion), and it was narrowly written to apply only to genetically modified microorganisms. However, since the decision, under pressure from pharmaceutical, biotechnology, and agrotechnology companies, the patent office has issued patents on plants, animals, genes, and human cell lines.

Before the Diamond decision, the U.S. Patent and Trademark Office granted patents only for inventions that were novel, useful, and not obvious. Thus, only machines, novel processes, synthetic materials, and other "compositions of matter," as the patent legislation puts it, could be patented. "Products of nature" such as animals, plants, elements, and minerals could not be patented, because they are found or discovered, not invented. As biologists, we are appalled that now, however, patents are being granted for discoveries such as the determination of the nucleotide sequence of a gene -- hardly something that somebody invented.

The fundamental issues here are questions of social policy and not legal interpretation. The U.S. Constitution gives Congress the power "to promote the progress of science and useful arts by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries." Patent laws are passed, modified, and superseded by Congress just as other laws are. They are means to social progress, not an end in themselves. Congress should amend the existing patent laws to explicitly exclude life patents.

Scientists and scientific societies must be willing -- even at the risk of losing important corporate support -- to work harder to show legislators and other policy makers the dangers of considering human genes or rice plants the same as original creations such as machines, books, drawings, and other true products of the human intellect. The coalition of 25 organizations concerned with environmental protection, indigenous peoples, and human rights was on the right path back in June 1995, when its members met in Blue Mountain, N.Y., and issued a statement that read, in part: "The plants, animals, and microorganisms comprising life on earth are part of the natural world into which we were all born. The conversion of these species, their molecules, or parts into corporate property through patent monopolies is counter to the interests of the peoples of this country and of the world. No individual, institution, or corporation should be able to claim ownership over species or varieties of living organisms. Nor should they be able to hold patents on organs, cells, genes, or proteins." The full text of the statement and related information can be found on the World-Wide Web (at http://www.essential.org/crg/petition.html).

The life patents already granted threaten to obstruct scientific and technological research. The biotechnology revolution in the United States was the product of research -- most of it sponsored by the federal government since World War II -- at colleges, universities, and medical schools throughout the nation. The free communication and exchange of materials and ideas were essential to that research. Scientists readily communicated major advances, such as the determination of the amino-acid sequences that make up protein chains -- information that any scientist could use in future research. The enormous inventiveness of that period flourished without patent protections granted to individuals or companies.
Now that life patents are being awarded, however, patent attorneys regularly advise researchers to limit what they tell their colleagues about their work before they apply for a patent. This is because patent law requires that the content of the patent not be revealed in "prior art." Oral reports, abstracts, grant proposals, and published papers all are considered to be prior art. Thus, the Roslin Institute in Scotland did not announce the cloning of Dolly until it had applied for patents on cloned sheep. The resulting undermining and reversal of the biomedical culture of open communication and exchange are among the most destructive impacts of life patents.

Life patents may also interfere with the delivery of health care. Patent monopolies lead to higher costs for drugs and treatments, which price them out of many patients' reach. And they retard the development of products that are more efficient and cost less. For example, Genentech has repeatedly charged other companies with patent infringement when they have produced more-sophisticated forms of a clot-dissolving protein patented by Genentech.

Healthy competition is particularly at risk in the seed industry. Patents on plants deprive farmers of free access to an essential public resource -- crop seed. Farmers for millennia have saved the seed of their harvests for replanting the following year, and they continue to do so even in the industrialized agricultural systems of the United States. Patents on seeds are a legal means to make sure farmers buy seed every year. Since the Monsanto Corporation began marketing genetically engineered cotton and soybeans, it has investigated 475 farmers suspected of saving seed from the patented plants. Some of the farmers who were found to have violated patents have had to pay Monsanto tens of thousands of dollars each.

Together, Monsanto and DuPont now produce half of the soybean and more than half of the corn seed sold in the United States. The dominance by a few companies, permitted by their life patents, is a sure recipe for higher seed costs -- and, ultimately, higher food prices for consumers.

In Europe, Southeast Asia, and South America, public opposition to life patents is strong. Dramatic public demonstrations occurred in India in response to W.R. Grace's obtaining U.S. patents on components of the neem tree that can be used to kill fungi and insects. Other large demonstrations against life patents occurred last year in Europe. The European Parliament recently voted to allow such patents, but two member states -- Italy and the Netherlands -- have attempted to block the move by challenging it in the European Court of Justice.

Within the United States, we need to make every effort to maintain the open flow of information that gave birth to the revolution in biotechnology. Concerned citizens, educators, researchers, and policy makers need to press for widespread discussion and debate -- on campuses, in professional societies, and in Congress -- of the consequences of life patents.

The U.S. government and the United Nations have recognized the necessity of protecting essential common resources -- such as the oceans, the atmosphere, and the moon -- from national sovereignty or private ownership. Surely the earth's life forms should be in the same category.

Jonathan King is a professor of molecular biology at the Massachusetts Institute of Technology. Doreen Stabinsky is an assistant professor of environmental studies at California State University at Sacramento. Both serve on the Board of Directors of the Council for Responsible Genetics in Cambridge, Mass.