Selected Papers
Bring Them Back Alive!
Patents on "Products of Nature"
Kathleen R. Terry, Esq., Contributing Editor
Technology Transfer Services
State University of Buffalo
Buffalo, NY, USA
Warren D. Woessner, Esq., Contributing Editor
Schwegman, Lundberg & Woessner, P.A.
Minneapolis, MN, USA
You may have seen the cartoons: lawyers in three-piece suits knock on the door, saying "We've come to take your child. We have patented his genes." An angry God comes down from the sky to try to invalidate a biotech patent.
The public asks, "How can such a thing happen? Don't genes belong to everyone?" The furor over the "Harvard mouse" patent and the patent applications coming out of the human genome project has focused attention on patents on "products of nature."
The latest controversy is over W.R. Grace's patents on aspects of the neem tree of India. Neem is an evergreen native to India, known in Sanskrit as sarva roga nivarini, "the curer of all ailments." Crude preparations of various parts of the tree have been used for centuries to treat leprosy and skin disorders, and as a spermicide, pesticide and fungicide. One or more of the half dozen patents Grace has been granted thus far, or the 40 others owned by 22 different companies, including three Indian companies, cover formulations intended for use as pesticides or fungicides.
According to the self-styled scientific watchdog Jeremy Rifkin, patents on drugs or other chemicals found in plants in the Third World amount to "genetic colonialism," an "[usurpation of] native knowledge" that must be stopped. He posits that such patents remove old methods of extraction and use from the public domain for the benefit of large first world corporations; forcing (in the case of the neem tree) Indian farmers to pay exorbitant royalties for products that were formerly free; taking from them with no return; and contributing to the decrease in genetic diversity. Much of the ensuing public consternation derives from a general misunderstanding of right to patent and the rights granted by patents. Before examining each of the arguments against patenting "God's handiwork", a short digression into the elements of patent law is appropriate, in order to lay a rational foundation for discussion.
Effect of a Patent
Patents are a bargained-for monopoly, granted by national governments to ensure the sharing of scientific progress by allowing the inventor the right to exclude all others from making and using the invention for a limited time. Instead of keeping the knowledge a secret, the inventor must include adequate experimental or clinical details in the patent so the public can reproduce and practice the invention. After expiration of the patent term (twenty years from filing a patent application in most countries), the invention can be used freely by everyone. If the invention is already known to the public or an existing "product of nature," it follows that there is no bargain and should be no patent and, in fact, no country allows patents on known methods or compounds, whether or not they are "products of nature."
Extracts of the neem tree are certainly natural products; are they not then products of nature that should be free to all? The exclusionary limits granted to a patent owner are defined by the claims of the patent. An examination of the claims of Grace's 1992 patent, which is especially under attack, will help to explain this point.
The active pesticidal ingredient of the neem tree is a tetranortriterpenoid, azadirachtin, that disrupts feeding and growth in various orders of insect, acarid and nematode pests. Azadirachtin occurs in variable concentrations in the whole plants, and for many years, interfering substances have been removed, and the concentration of azadirachtin increased by extraction with solvents. However, the resulting fungicidal solutions were low in azadirachtin and not very stable. They also contain other active ingredients, some of which have pharmaceutical uses and some of which possibly interfere with the particular activity sought. Grace could not claim these old extraction methods or the formulations made from them. What Grace has claimed is "[a] storage-stable pesticide composition… containing azadirachtin… [in an aprotic solvent, surfactant, water solution] said solution being non-degrading to azadirachtin." This composition contains the natural product, but it does not occur as such in nature; neither was its exact composition known before it was developed by Grace.
It is possible that pure azadirachtin could be synthesized or obtained by further purification. If so, it would not be something found in nature and would also be proper subject matter for a patent. So would the synthetic route or improved analogs of azadirachtin.
Is This a New Problem?
Historically, most pharmaceuticals have been developed in exactly this manner. Native Americans chewed willow bark or drank willow bark tea to relieve fever and pain. Extracts with more controllable dosages and more useful formulations that could be taken in pill form were made. Analysis eventually showed that the active ingredient was salicylic acid. Syntheses for salicylic acid were developed. Finally, it was found that acetylation improved the properties even more and we now have aspirin. Aspirin itself has been improved by combination with buffers and other compounds. Every step along the way was an advance in the use of crude salicylic acid extracts and could have been the subject of a valid patent. While the public had to pay a royalty or wait for expiration of each patent before using the new knowledge, as each patent expired, the public was free to use the knowledge therein.
Will Stopping Patenting Stop Exploitation?
Patents are only the gateway to commercialization. The patent owner tries to establish a period of exclusivity for a saleable version of the invention in which to recover research and development investment. Controlling or outlawing patents that are considered by special interest groups to be exploitative or even blasphemous may not stop development of a truly valuable product, but rather may drive it underground to be used within a single company as a trade secret. If so, the public will never gain the benefit of the invention, a benefit that could potentially extend far beyond the term of a patent, as in the case of generic drugs such as tetracycline or diazepam. Slamming the patent gateway shut, therefore, is both an overreaction and an ineffective reaction.
There are other, less draconian methods of achieving desired social goals. First, patents are national. Each country can choose to allow or enforce patents as it wishes. In the case of the neem products, Grace's United States patent has no effect in India. Based on its own national policy, India has already disallowed patents on pesticides and fungicides and Indian companies can manufacture azadirachtin for sales in India.
Patent systems are no more perfect than the humans who run them. Patents that should not have issued because the invention is old have been granted and are presumed to be valid when issued. However, mechanisms exist for ridding the public of the burden of truly invalid patents. Rifkin's group, the oddly named Center for the Study of Economic Trends, has already taken an appropriate step to determine whether the Grace patent is invalid by filing a request for reexamination. This is a relatively inexpensive procedure in which the United States Patent and Trademark Office takes a second look at the patentability of the invention, in light of knowledge that the Examiner who approved the patent did not have during the original examination period. If the claimed invention truly was old in the form in which it was patented, the patent will be withdrawn.
Third World Genetic Colonialism?
Colonialism implies that a Third World country is somehow robbed of its resources for the benefit of the developed countries. In the case of the neem tree, Grace built an extraction plant in India which thus far employs sixty Indians. In addition to the employment provided, the factories presumably are taxed, and purchases are made from local suppliers.
The recent neem patents (but only provided that Grace has obtained patents of some sort in India) leave the Indian farmer with two choices: continue to use the crude preparations or the old formulations as always, or pay a premium for the convenience of the new, more active stable formulation. The hypothetical Indian farmer can make that choice, based on his own balance of cost and benefit. Even if he cannot afford the new formulations, he is no worse off than before, since a patent cannot remove the tree or the old formulations from the public domain.
In addition, the farmer may have a new cash crop. Besides harvesting parts of the neem tree for his own use, he may decide to sell to processors. However, the market demand for parts of the neem tree is rising. If the hypothetical farmer did not previously harvest his own neem, but bought the pesticide from his neighbor, depending on the availability of the neem tree, prices for the tree parts and for the old extracts may rise. However, another part of the public—farmers in the remainder of the world—now benefit by the opportunity to use a non-toxic pesticide with a longer shelf life that was unavailable to them before the stable product.
There is a chance that neem tree stock will be exported and the trees grown elsewhere or azadirachtin synthesized in other countries, in which case these economic advantages will disappear. In that case, India will cease to be enriched by the new technology, but unless every neem tree is dug up and exported, India will not be worse off than before. On the other hand, the availability of inexpensive synthetic analogs may both make the benefits of the compound more widely available than before, even in India. It may also ultimately save the native stock of the neem tree from extinction.
Should Countries Solely Own Unique Genetic Resources?
Humans have always shared ideas and resources. From prehistoric times, the uses of domesticated animals and cultivated crops have spread widely from the center of origin. In historical times, rubber trees have been transplanted from Brazil to southeast Asia. Tea reached Japan from India, and Brazil imported the coffee tree from its home in Arabia. Encouraging Third World countries to attempt to monopolize their resources poses a much greater danger to progress than does the patent system. This is particularly true given that many Third World countries lack the resources to carry out more than rudimentary research into their ecological diversity.
Does Patenting Affect Genetic Diversity?
Whenever a valuable cash crop is discovered, the most useful strains gradually become dominant, while the "wild" strains—having wide genetic diversity—cease to be cultivated and may be lost. Overreliance on a single strain puts the consumer in danger should that crop fail. The Irish potato famine remains a chilling example of loss of both intraspecies and interspecies genetic diversity. When a virus destroyed the potato crop, millions of Irish died of starvation, because they had planted nothing else, neither other crops nor a variety of potato strains, some of which might have resisted infection. On the other hand, the availability of wild-type strains for genetic research and manipulation can yield improved strains with high nutritional values and pest and disease resistance.
The global imbalance of resources and loss of genetic diversity are very real problems. Despite the newsworthiness of attacks on patents perceived as monopolizing the "property of the Creator," the global patent system is part of the solution, not part of the problem. We hope that policymakers on both sides of the equator will continue to cooperate to strengthen and expand patents on all the "useful arts."
