By Harold C. Wegner, former Professor of Law and Director
of the Intellectual Property Law Program at
the George Washington University Law School, and currently
a member of Foley & Lardner, a Washington law firm
The rapid advances in biotechnology have generated questions about the protection of intellectual property rights and the potential conflict that may result over those seeking to make broad use of the new developments. "The challenge facing society is advancing agricultural science without jeopardizing intellectual property rights and thereby guaranteeing greater food security for emerging economies," says Harold C. Wegner. In this article, he examines some of the critical legal issues involving intellectual property protection and the modern advances in biotechnology.
The persistence of hunger and the accompanying extreme poverty found in many developing economies are indefensible during a period of rapid advances in food production using agricultural biotechnology. The genetically engineered wheat gene, Norin 10, for example, has helped such countries as India and Pakistan increase their wheat harvests by 60 percent. Similarly, Costa Rican scientists have created a new genetically modified rice, one that will help not only Costa Ricans but should be suitable for India, Vietnam, Japan, and other rice-growing countries as well. Biotechnology offers the promise of crops that not only generate their own pesticides to create disease-free products, but also plants with genes that provide improved nutritional content and allow the products to stay on the market shelf longer without rotting.
At the same time, developments in genetically engineered foods are occurring in a proprietary environment, where biotechnology products and the processes are being patented and their release to the public restricted because of the enormous investments by the private sector. Should Costa Rica have exclusive rights to its newly created rice, or should it be shared freely with other countries? Who owns the rights to nature and that which nature produces?
There are no easy answers. The challenge facing society is how to agricultural science without jeopardizing intellectual property rights and thereby guarantee greater food security for emerging economies. This article seeks to raise some of the key questions that policymakers and courts must address and whose outcome will have a profound influence on the development and trade of biotechnology products.
ENCOURAGING INVESTMENT IN BIOTECHNOLOGY
Incentive is vitally important for any innovation that requires a large expenditure of funds and intellectual innovation. To take a bioengineered product out of the laboratory and onto the fields as a commercial crop, the greatest possible care must be exercised to test for the safety of the environment. Large numbers of clinical and field trials are hugely expensive and lengthy, but necessary. The international patent regime is thrust squarely in the middle of the debate because, without an effective international patent regime, there is no realistic possibility that the private sector will invest the significant resources required to advance state-of-the-art genetic engineering.
Without patent protection that would exclude others for a limited period of time, once a product hit the market it could easily be duplicated by everyone. This is particularly true when dealing with "living" inventions. If there is a new strain of rice, all that would be needed to copy the invention and enter into competition with the originator would be a small investment in a modest amount of seed and then the collection of the seed from the resulting crop. Clearly, if the originator of a genetically engineered crop can have no competitive advantage, then what incentive is there to spend the millions of dollars necessary to develop and market a new genetically engineered product? The reality is that without a patent regime, there would be far fewer new products that have the potential to better the human condition.
At the same time, patent law must be structured in a way that not only encourages the original inventor but also provides access to others so that the new product can be improved upon. And it must protect against commercial concerns that obtain patents in the area of biotechnology without carrying through with a concrete product, thus depriving society of a direct benefit.
WHO OWNS AN INVENTION?
Should, however, a patent be granted to something found in nature? One could very well imagine the outcry that would be created if someone enters a rain forest, pulls out a leaf with special medicinal qualities, and then seeks a patent on that leaf. What "invention" was made on the part of man? If the leaf is already known as a native medicinal, then there may not be anything patentable. To be patentable, something must be "new." If someone discovers that a purified extract from that leaf has medicinal qualities, the extract may be patentable. Indeed, Nobel Laureate Sune Bergstrom's isolation of prostaglandin, a class of molecules that help in the control of blood pressure, did not make him the "inventor" of prostaglandin; rather, he was the inventor of a "purified" prostaglandin that had not previously existed in nature.
While someone clearly may be determined to be the "inventor" of a form of the leaf, who owns that invention? A country is free to legislate ownership rights as it sees fit to meet its national policy goals. If the inventor works for a company, in most cases the patent right will go to the company rather than to the inventor.
But merely to discover the active principle involved in the medicinal qualities of the purified form of our leaf does not end the matter of patent ownership. Take, for example, the case of steroids. Decades ago, scientists discovered a basic steroid molecule with its characteristic arrangement of carbon rings. Scientists created synthetic steroids by manipulating chemicals to introduce various atoms onto the steroid's molecular structure. Each of these synthetic modifications, whether made in California or Kyoto, is considered a separate invention and not part of the original invention of the synthetic steroid.
Just as the discovery of the basic steroid molecule has limited benefit to the patent owner, the discovery of a purified leaf extract has limited benefit to the inventor. The real value of the discovery is bestowed on those who produce modifications that lead to needed and valuable products. Since the knowledge of the structure of that purified leaf extract will be in the public domain as part of the scientific literature (and since anyone is also free to use that structure for research even if it is patented), patent law provides little benefit to the "leaf" patent owner unless the structure of the leaf is kept secret. Then the owner of the invention, whether an individual or a company, will have the lead time to first identify the key structure of the purified leaf extract and be able to obtain patents on that structure.
TECHNOLOGY TRANSFER
Obviously, inventions cannot be developed everywhere. Does a company that has the patent on the leaf structure give away the rights to other countries? As I previously stated, that would reduce, and in most cases probably eliminate, the incentive for developing the new product. Consider, for example, a Latin American development of a new crop line that would be suitable in Latin America, Japan, and elsewhere. If the Latin American inventor has not exploited his invention in foreign markets, other countries may be able to take advantage of the technology by providing certain compensations to the investor. Such compensations might include royalty income or an agreement to expend additional resources to improve the initial technology -- the possibilities are limitless.
Not all countries have the resources to buy into the new technology. Here there is a role for international development and research organizations such as the Consultative Group on International Agricultural Research and the World Bank. These groups need to consider whether they should allocate additional resources toward the development of genetically engineered products that would be freely shared with the poorest countries.
THE IMPORTANCE OF PATENT PROTECTION
A direct result of the Uruguay Round global trade accord concluded several years ago was the establishment of minimum standards for patent and related intellectual property protection, including those for products resulting from genetic engineering. Such standards are vital not only for protecting products from industrial countries but also for encouraging the creation of and protecting developing country inventions. Countries such as India, with its large number of highly trained scientists and engineers, are well placed for taking advantage of patent protections. Brazil and China are examples of countries that have made great strides in both the creation and implementation of modern patent laws.
Those countries that follow the lead of China and Brazil will have the incentives of the patent system to fuel innovation. Those that fail to move forward with strong patent laws will remain on the sideline, trapped by the lack of an effective patent law, unable to provide the legal setting to foster and encourage innovations in the local economy.
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Note: The opinions expressed in this article do not necessarily reflect the views or polices
of the U.S. government.