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Synthesis/Regeneration 17   (Fall 1998)

Patenting Products of Nature

by Henry Robertson, Gateway Green Alliance

In 1980 the U.S. Supreme Court by a 5-4 vote held that a bacterium genetically engineered to break down crude oil could be patented. Despite a longstanding rule that "products of nature" cannot be patented, the majority, adopting a phrase from a Congressional report, said "anything under the sun that is made by man" is patentable subject matter. Splicing in a gene or two transforms nature into the creation of man.

This case, Diamond v. Chakrabarty effectively ended a debate that should have been just beginning. Soon patents were granted on multicellular plants and on a new strain of oysters (not genetically engineered). In 1987 the Patent and Trademark Office (PTO) announced a new policy: "The Patent and Trademark Office now considers non-naturally occurring non-human multicellular living organisms, including animals, to be patentable subject matter." The next year a patent was issued for a mouse genetically engineered to be especially susceptible to cancer-the Harvard Mouse, marketed by DuPont chemical company under the trade name Oncomouse.

In 1991 and 1992 the National Institutes of Health (NIH) filed patent applications on over 2,000 short, cloned human gene segments sequenced by one of its scientists, Craig Venter, while working on the Human Genome Project. (Venter was about to go private and start his own institute.) The PTO balked-not because the gene segments couldn't be patented but because Venter didn't even know what their function was. The NIH withdrew the applications.

A naturally occurring DNA sequence is still considered a product of nature, but federal courts have upheld patent claims like this: "A purified and isolated DNA sequence consisting essentially of a DNA sequence encoding human erythropoietin" (a protein useful in treating anemia). In other words, a patent will issue for a cloned gene which has been stripped-"purified"- of the natural DNA segments of unknown function called introns, even though the protein it codes for is identical to the one produced in our bodies.

...a patent will issue for a cloned gene...even though the protein it codes for is identical to the one produced in our bodies.

The Supreme Court's decision is more understandable when you consider how patentable subject matter is defined: "any new and usefulůmachine, manufacture, or composition of matter, or any new or useful improvement" thereof. This language has been in the law since Thomas Jefferson wrote it in 1793. The court believed that recombinant DNA technology involves such human ingenuity that the resulting life forms can be considered either "manufactures" or "compositions of matter."

Patents are lumped with copyrights and trade-marks in the category of intellectual property (IP), but if patents can be considered property it is only in a limited sense. A patent is a temporary monopoly. In theory it is an incentive to would-be inventors and a reward to those who succeed. An inventor can use it exclusively, license it to others, or sit on it. In exchange for this benefit, he is forbidden to keep his invention a secret; he must disclose how it can be made. When the patent expires the invention enters the public domain.

It is disconcerting to think of researchers with their micromanipulators and fully degenerate probes slicing and dicing the world's genome. Presently our ability to alter a species' identity is limited to adding small amounts of foreign DNA. That may or may not change.

As long as some way can be found to make it pay, the manipulation will continue. This is not altogether a bad thing; biotech does promise benefits to society, at least in the medical field. Several reforms are possible. We could revise our antiquated patent laws, not necessarily ruling out some form of patent protection for bioengineered life forms that would not otherwise exist. Or we could let scientists have process patents on the technology they invent but not product patents on the organisms they modify. Public pressure could be brought to bear on the PTO to tighten up its policies, which have been extraordinarily generous to the industry.

Indigenous plants and their properties which peoples have freely used for thousands of years can suddenly be expropriated and patented by multinational corporations.

By itself, patent policy cannot address the greater problems of whether there is to be any democratic control of the uses of biotechnology and what regulation is necessary to protect us from its dangers. But the industry clearly wants patents badly as a way to control agriculture and pharmaceuticals and grasp the profits they create. The larger debate is over the issue of corporate power.

The International Scene

In the developing countries of the south more is involved than exotic new variations on life. Indigenous plants and their properties which peoples have freely used for thousands of years can suddenly be expropriated and patented by multinational corporations.

The Human Genome Diversity Project begun by northern scientists in 1990 collects DNA samples form unique and "endangered" human groups. If valuable genetic material is found it can be patented and used commercially. The assumption is that these cultures will soon be extinct and the people, if they survive, will blend into the general population.

In 1983 the UN Food and Agriculture Organi-zation founded the Global System for the Conservation and Utilization of Plant Genetic Resources, which issued an International Undertaking on Plant Genetic Resources based on the common heritage principle: "plant genetic resources are a heritage of mankind and consequently should be available without restriction." The US does not adhere to this non-binding undertaking.

NAFTA allows for patenting products of nature.

Until recently the primary patent treaty was the 1883 Paris Convention for the Protection of Industrial Property, which now falls under the jurisdiction of the World Intellectual Property Organization of the UN. The Paris Convention embodies "national treatment" -- foreign patentees must file separate applications in each member country, and they are to be treated the same as the nationals within each country. But today's trend is globalization-like goods and money, patents, wherever issued, must be free to move about the world.

Out of the 1992 Rio Conference on Environ-ment and Development came the Convention on Biological Diversity (CBD). The CBD protects patent rights but also calls for technology transfer and "fair and equitable" access to the results of biotechnology, especially to the developing countries which provided the genetic resources being utilized. President Bush refused to sign, and when the Clinton administration did sign, it issued an "interpretive statement" demanding more stringent property rights. Instead of common heritage the CBD emphasizes the "sovereign rights of States over their natural resources," which is consistent with a regime of IP rights.

NAFTA allows for patenting products of nature. A member country can make exceptions "to protect human, animal or plant life or health or to avoid serious prejudice to nature or the environment." It can bar patenting multicellular plants and animals; but it must allow patenting of microorgan-isms and microbiological processes. Canada, Mexico, and the US must extend reciprocal patent rights on "pharmaceutical or agricultural chemicals" including natural microbiological products and processes. Reciprocity goes beyond national treatment in demanding uniform, least common denominator enforcement of IP rights.

NAFTA also requires patent protection for new breeds of plants. Farmers are allowed only a limited exemption for planting "saved seed" from last year's crop on their own land; the old custom of selling "brown bag" seed to other farmers is banned. NAFTA did this by incorporating another treaty, the International Convention for the Protection of New Varieties of Plants (UPOV). Congress brought US law into conformity in 1994 by amending the Plant Variety Protection Act, tightening the grip of IP rights on agriculture.

But the biggest step toward global "harmonization" is the Trade Related Intellectual Property Rights (TRIPs) agreement of the 1994 revisions to GATT, the General Agreement on Tariffs and Trade. It prohibits discrimination against foreign patents based on "place of invention" or "field of technology." It defines patentable subject matter as any product or process that involves an "inventive step" and is "capable of industrial application." Developing countries have a 10-year grace period in which they may continue any existing policies against patenting life forms or inventions in the medical and agricultural fields.

Transnational corporations (TNCs) complain of counterfeiting and IP piracy. In their favor TRIPs would stop practices like reverse engineering (taking a product apart and figuring out how it works so it can be copied). Compulsory licensing, by which countries like India force foreign patentees to make their processes available so as to foster domestic industries, is now banned.

The TRIPs accord cements the monopoly position of the TNCs.

The TRIPs accord cements the monopoly position of the TNCs. They may refuse to set up factories in countries which grant them patents or, if they do, require them to import raw materials but prohibit them from exporting the product or performing their own research and development. All the benefits of the new technologies accrue to the TNCs, except for high-priced medicines and synthetic substitutes which destroy the markets for indigenous commodities.

Indonesia is rich in biological resources, but its drug makers pay heavily for patent royalties and raw materials 80% of which are imported. Now, with its currency collapsing, the country can no longer afford the $900 million a year price. Without subsidies, Indonesia will run out of medicine.

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