ABOUT |
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Shawn Sullivan is an attorney specializing in intellectual property and international law. Mr. Sullivan has represented companies in matters dealing with intellectual property rights in biotechnology. For four years, Mr. Sullivan served as intellectual property counsel for the International Maize and Wheat Improvement Centre (CIMMYT) in Mexico. In this capacity, he dealt with legal matters affecting developing country agriculture and scientific research and development around the world. He has just returned to private practice in Washington, DC, where he works with both private enterprises and public institutions. He is the author of a forthcoming book on intellectual property in agriculture. He is a member of the bars of the District of Columbia, Louisiana and Mississippi.
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Mr. Sullivan obtained his undergraduate and juris doctor degrees from the University of Mississippi and a master of laws degree from the University of Cambridge. He has also conducted postgraduate legal studies at the Universidad Panamericana and the Escuela Libre de Derecho in Mexico City and at Queen Mary College of the University of London.
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I practiced law in Washington D.C., Mississippi, where I'm from, and New Orleans, always as a corporate, commercial lawyer with some intellectual property work.
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Coming to CIMMYT, though, was quite a change. Shortly after arriving, I had a scientist come to me and he asked me to do a search of the patent literature, to determine whether there were patents that might possibly block his ability to do research in an area. The way he introduced it to me caught my attention immediately, because he said, 'I'm working on something to fortify cereal crops in a way that could save thousands of lives.'
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In fifteen years of being a lawyer, I never had a client come to me and say I'd like you to help me with something where I could save thousands of lives. It just doesn't happen for most lawyers, and it's a real privilege to be able to work on that sort of thing.
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"It is such an important issue. The availability of water for agriculture is diminishing and it is predicted that people will just have to get by on less water"
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Most of our scientists have a connection, in one way or another, to developing crops that have resistance to drought, which can get by on less water than normal crops. Some of that research is done using what is called conventional breeding, without the use of genetic engineering. Some of it uses more advanced genetic engineering techniques. In both of these areas, there has been quite a bit of work done around the world because it is such an important issue.
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The availability of water for agriculture is diminishing and it is predicted that people will just have to get by on less water, particularly for agriculture, in the future. There are patents in the field of drought resistance. There are privately owned genomic databases that could be of great use to us in [drought] research, but that require negotiations with the owners of the databases.
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There is tolerance to salinity, tolerance to acidic soils. There is work that is being done at CIMMYT with maize that has very high levels of lysine and tryptophan, two very essential amino acids, that many people think holds the promise for supplementing the diets of those who have very low protein intakes.
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"Everyone who is doing research in this area, in the area of plant genetics for instance, has to be aware of intellectual property, because it is a real issue for everyone now."
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The first developments which allowed the patenting of life, essentially patenting of first microorganisms and then plants, were in the United States. The field of patentable subject matter expanded dramatically in the U.S. in the 1980s. This trend continued in Europe and in some other parts of the world and has been reinforced by the TRIPS Agreement (trade-related aspects of intellectual property rights), which all members of the World Trade Organization are required to sign.
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Because of these developments, there has been a great expansion of patents into areas into research that simply were not protectable in the past, back in the 1970s for instance. So, everyone who is doing research in this area, in the area of plant genetics for instance, has to be aware of intellectual property, because it is a real issue for everyone now.
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TRIPS requires substantive protection for certain intellectual property rights, not just patents, also copyrights and other forms of intellectual property protection. It takes many of the substantive requirements of U.S. law, which also are found in Europe, and requires countries which are signatories to the WTO agreements to implement those over a period of years.
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In the 1990s, Mexico passed a series of laws that substantially changed the way that Mexico protects intellectual property. TRIPS is not like most of the patent intellectual property treaties, it is not primarily a procedural treaty. It's primarily a substantive law treaty that requires actual changes in the substance of the law of the particular country.
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"No one was really that concerned about where one line of germplasm was coming from, because it was all done in a spirit of free exchange."
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I think it's a testament to CIMMYT that for the first thirty-five years of its existence, it didn't have a lawyer and was really able to get by without using one. Things have changed.
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In the past it was possible for public research institutes like CIMMYT to operate with less concern about things like intellectual property and ownership. Claims of ownership in plants, genes, in information and living things have changed pretty dramatically in the last thirty-five years, to the point where we do have to pay attention to them.
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It's interesting to speak to some of the older scientists, who have been here for many years and sort of lament the changes, think back to the old days where everything was essentially freely available. Nobody in the public sector was very concerned about maintaining the confidentiality of the work that they did. No one was really that concerned about where one line of germplasm was coming from, because it was all done in a spirit of free exchange.
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Today, we still try to maintain that system of free exchange, but we have to be more creative about it because of the claims of ownership.
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"In most of those projects we have confidentiality requirements that would keep us from, with complete freedom, publishing, for instance, the results of our research."
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We have research collaborations with private companies. In most of those projects we have confidentiality requirements that would keep us from, with complete freedom, publishing, for instance, the results of our research. Usually we can publish, but it has to go through a vetting process.
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But when it comes to a joint research project that goes on over a period of years, generally the private companies are doing that because they hope to see some financial gain at the end. Some of those research collaborations are a little speculative, and their hopes for financial gain may not be that great, but still, they ultimately are in business to make money for their shareholders.
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Sometimes the materials our people work with--lines of germplasm, seeds of lines of maize or wheat--come to us from private companies or from universities. In these situations, we have to sign an agreement that says we will use the materials only for research purposes, and only under the following circumstances.
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"CIMMYT is a practical research institute whose ultimate aim is not simply to do interesting experiments, but ultimately to provide something that is going to go into the fields of poor farmers and help feed people."
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Part of my job is to ensure that we comply with those agreements. CIMMYT is a practical research institute whose ultimate aim is not simply to do interesting experiments, but ultimately to provide something that is going to go into the fields of poor farmers and help feed people. At some point we have to negotiate a way to get clearance to actually use those materials for practical purposes. These agreements that say that we will only use these materials for research purposes are only good up to a point.
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In the United States it is possible to patent plant varieties. This was a fairly controversial practice but it was upheld by a decision of the U.S. Supreme Court in 2001 and in the U.S. we have to worry about patents more than in some countries. Under the Mexican patent law, plant varieties are not protectable, but there is a plant breeder's rights law, as there are in many countries now, that we have to pay some attention to.
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The plant breeder's rights laws were developed specifically with sexually reproducing plants and so the laws take into account the physiology and the nature of the actual plant. The U.S. utility patent laws were not developed with plants in mind, with self-replicating, living matter in mind. So, there are some significant differences between the plant breeder's rights laws on the one hand and the patent laws on the other.
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"In this environment some people consider intellectual property to be a necessary evil and some people just consider it an evil."
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We are now at a point where scientists have to spend much more time documenting their transactions. CIMMYT's biotech scientists have to keep very meticulous laboratory notebooks. It's not that different from anywhere else in the world, but it is something that they really didn't have to worry about in the public sector fifteen years ago.
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In this environment some people consider intellectual property to be a necessary evil and some people just consider it an evil. It is something that there is some resistance to and some resentment about. I think most of our scientists realize that it is something that we have to deal with. They may not like, but they realize it is something that requires their attention.
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"Companies are concerned about giving up markets that either exist or that have a potential for existing in the future."
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Apart from the patents, sometimes there is even greater difficulty getting clearance to use materials that have been provided to us under a contract. They may have been provided for research purposes only, because companies are concerned about giving up markets that either exist or that have a potential for existing in the future. They are concerned about helping their competitors and they are concerned about technology or a line of germplasm that they developed somehow getting out, and then something going wrong and their being liable for it. So, they are concerned about liability and markets and competition.
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Intellectual property provides its owners a way, in some cases, of ensuring that people don't use materials and inventions in situations where patent owner or the owner of the physical property just doesn't want to take the risk.
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Some of the universities have been more difficult to deal with than private companies, because they didn't have the same level of sophistication and perhaps are not as willing to take risks as some of the private companies.
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"There was a sense on the part of many developing countries that first world companies were coming into their countries and appropriating the benefits of the traditional knowledge of the people."
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There are a couple of recent international treaties that have an impact on this [sharing of germplasm], the Convention on Biological Diversity and the more recent International Treaty on Plant Genetic Resources for Food and Agriculture. Both of these treaties recognize the national sovereignty over genetic resources within their countries.
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There was a sense on the part of many developing countries that first world companies were coming into their countries and appropriating the benefits of the traditional knowledge of the people who have used plants for medicines and for certain types of industrial applications.
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The fear was this: that companies will come in and get that knowledge, take the plants out without paying anyone, refine the active ingredient into a drug or into some kind of industrial application and make a lot of money on it. Then, when the product is imported back into the country where it came from originally, those countries may not share in any of the benefits and may be required to pay a premium price for it. So there was a lot of resentment and suspicion, and I think there still is.
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"Nobody is really happy about the compromises that have been reached in agreements in this area to date."
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Beginning in the 1970s, and into the 80s and 90s and up to now, this was a real concern: that there was a type of "biopiracy" in which developed world companies benefited at the expense of developing countries, who may be poor in terms of technology and material wealth, but have a great wealth of biological diversity.
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The two conventions that I've mentioned [the Convention on Biological Diversity and the International Treaty on Plant Genetic Resources] are an attempt to address some of those concerns, but nobody is really happy about the compromises that have been reached in agreements in this area to date.
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"There are cases in which patents on research tools can provide roadblocks to much needed research."
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When I was a lawyer in private practice, I did work with some clients in biotechnology and the life sciences on intellectual property matters and I made the argument in court, sort of a dogma of intellectual property, which is that patents are good and intellectual property in general is good because it stimulates innovation, doesn't take anything out of the public domain that is already there and it creates things that wouldn't be there without the stimulus that an exclusive right gives.
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I still in general believe in those principles, but now that I am somewhat on the other side - humanitarian, not-for-profit work -- I see that there is another side to this. There are cases in which patents on research tools can provide roadblocks to much needed research. It seems to me that in some instances the incentives to innovate already exist for private companies for instance. They have the incentive to compete and the added incentive of an inclusive right may actually provide an impediment to competition.
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"Intellectual property policy could be made more realistic and more responsive to the needs of societies."
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So, although I generally believe that intellectual property laws accomplish many important purposes, we should reexamine our assumptions from time to time, we should more narrowly tailor intellectual property policies to achieve specific objectives while avoiding unnecessary social costs, and we should not fall prey to the dogma - which is really a substitute for critical thinking - that ever more restrictive intellectual property rights are necessarily better for society in all circumstances.
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In the same way that some stale doctrines of U.S. antitrust law were changed after the infusion of new and critical economic thought in the 1970s, 80's and 90's, I think that intellectual property policy could be made more realistic and more responsive to the needs of societies by challenging some of the established wisdom and by looking critically at the IP proposals of powerful lobbying groups.
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"There is more to human existence than the economic betterment of America."
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I also see a much more human side to the whole intellectual property debate. The whole debate, at least in the United States, seems to be framed in terms of what private, for-profit companies are doing in order to stimulate the U.S. economy. Private enterprise is extraordinarily important in providing what people want and need, but sometimes it doesn't help the poorest of the poor.
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"There is a world out there that desperately needs the help."
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There is more to economics than that. There is more to human existence than the economic betterment of America. There is a world out there that desperately needs the help that our scientists and other scientists doing humanitarian work can provide.
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I should say that it is not my job here to be an advocate for change. My job is to work with the system as it exists. Speaking personally, only in my personal opinion, it seems the laws could be changed in the U.S. and other countries to be more favorable to the type of work that institutions like CIMMYT do.
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Certainly in developing countries where research institution are located, things like broad research exemptions to patent infringement can be a great help to stimulate public sector research. In all cases, we should try to ensure that intellectual property policy doesn't unnecessarily make it harder to help poor people in poor countries.
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"There is a job to be done in agriculture on behalf of the poor to enable people to become self-sufficient."
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CIMMYT is a big institution that has a lot of people working for a lot of different motives, mixed motives, some of us. Most people here could probably make more money doing something else, somewhere else. I think that most of us are here because we believe that there is a job to be done in agriculture on behalf of the poor to enable people to become self-sufficient. And, yes, I think that is one of the reasons for the frustrations that some of our scientists feel when they are told you have to worry, we have to do a patent search to determine if we have freedom to operate in an area. They understand it, they know it is something that has to be done, but it doesn't mean they have to like it.
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Shawn Sullivan can be reached at sullivan@sullivanlaw.net.
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