Genetic Patenting
Genetic PatentingWe as human beings have brought ourselves into the future, being able to modify our food, our lives and even our own bodies. We have paved the road leading us into the future of being able to take life in our own hands and be able to create it ourselves. Our technological advancements in the last ten years have created an idea of mapping our own DNA and actually use it in our favor to cure disease, and understand the human body. The U.S. Human Genome Project began officially in 1990 as a $3-billion, 15-year program to find the estimated 80,000-100,000 human genes and determine the sequence of the 3 billion DNA building blocks that underlie all of human biology and its diversity. “The early phase of the HGP was characterized by efforts to create the biological, instrumentation, and computing resources necessary for efficient production-scale DNA sequencing. The first 5-year plan was revised in 1993 due to remarkable technological progress, and the second plan projected goals through 1998(ornl.gov)”. On June 26th, 2000, President Clinton, leaders of the Human Genome project (HGP) and representatives of the biotechnology company Celera announced the completion of a “working draft” reference DNA sequence of the human genome. The achievement has provided scientists worldwide with a road map to an estimated 90% of genes on every chromosome. Although the draft contains gaps and errors, it provides a valuable scaffold for generating a high-quality reference genome sequence — the ultimate HGP goal expected to be achieved by 2003 or sooner. We are essentially almost finding out how life had been created and actually becoming the creator.
“A patent is a kind of license granted by the government to an inventor. It gives the inventor the right, through the courts to stop competition or rivals from making, using, or selling and invention without his or her permission. When a patent is granted, the
invention becomes the property of the inventor. However, the patent can be bought, sold, or rented.(www.guardianunlimited.com)” The only way something can be patented is if they meet the four criteria the U.S Patent and Trademark Office has made. The inventor must identify some useful purpose for the invention, it must be a novel invention that was not known or used prior to the filing of a patent. It has to be non-obvious, or not something easily made by someone trained in that area. The invention must also be understandable to one skilled in the field to use it for the stated purpose (or enablement). Patent priority is based on the “first to invent” principle. Whoever made the invention first is awarded property rights for a 20-year period. This means that no one can use the same idea as their own when manufacturing a product, or they can be sued by the patent holder for stealing an idea in the public realm. The main reason why inventors patent is to keep technology going on publicly, without having their ideas taken and used without permission.
When patenting a gene, an inventor must be able to come up with identifying novel gene sequences, specify the gene’s product, how the gene functions in nature, and be able to enable someone knowledgeable enough to use the sequence for its purpose. When a scientist wants to find a gene sequence, he must find expressed sequence tags, which only represent 10 to 30% of the average DNA and the genomic genes are often 10 to 20 times larger than the DNA. A DNA molecule is a laboratory-made version of a gene that contains only its information-rich regions; these molecules provide a way for genome researchers to go through the genome and find biologically important areas. The original chromosome locations and biological functions of the full genes identified by ESTs are unknown in most cases. Single nucleotide polymorphisms, or SNPs, are DNA sequence variations that occur when a single nucleotide (A,T,C,or G) in the genome sequence is changed. For example a SNP might change the DNA sequence AAGGCTAA to ATGGCTAA. SNPs occur every 100 to 1000 bases along the 3-billion-base human genome. SNPs can occur in both coding (gene) and noncoding regions of the genome. Many SNPs have no effect on cell function, but scientists believe others could predispose people to disease or influence their response to a drug.
Research scientists who work in public institutions often are troubled by the concept of intellectual property because their norms tell them that science will advance more rapidly if researchers enjoy free access to knowledge. “By contrast, the law of intellectual property rests on an assumption that, without exclusive rights, no one will be willing to invest in research and development (www.ornl.gov)”. Patenting provides a strategy for protecting inventions without secrecy. A patent grants the right to reject others from making, using, and selling the invention for a limited term, 20 years from application filing date in most of the world. To get a patent, an inventor must reveal the invention fully so as to enable others to make and use it. Within the area of industrial research, the patent system promotes more disclosure than would occur if secrecy were the only means of excluding competitors. This is less clear in the case of public-sector research, which typically is published with or without patent protection. The dispute for patenting public-sector inventions is a variation on the standard validation for patents in commercial settings. The disagreement is that post-invention development costs typically far go beyond pre-invention research outlays, and firms are unwilling to make this significant investment without protection from competition. Patents then help the transfer of technology to the private region by providing limited rights to preserve the profit incentives of innovating firms.
We, as human beings, have dominated this earth by taking what we see as ours. We take land, and say it is our property, while putting a price tag on it. But is taking what is in everybody’s body, and putting a price tag on in acceptable? Making a sickly individual pay thousands of dollars on a test that can only be done by one company. When gene testing occurs, it is open for the public to use, but at a cost. Other companies do not have the chance to make use of this testing, and are opted to go through one singular company: The company holding the patent on the tested gene sequence. Companies can also block research through the outrageous price these people have to go through. These smaller companies have to go through so many restrictions in order to actually help someone. “As soon as a researcher tries to make commercial use of developments based on the original patent - by going into partnership with a drugs firm, for instance, or charging patients at cost for a genetic test - the patent holder can step in to stop them, or oblige them to pay a license fee (pg11, DDD)”. Many biotech companies, big and small, argue that genes must be able to be patented to allow firms to earn their investment in identifying them. But other firms fear allowing genes to be patented before any specific, proven use has been well known for them will hold back medical advances. We are holding a piece of life in our own hands and making it possible for one being to hold another as their own. We are letting companies’ control what is being used out in the world to cure, help, and eliminate diseases. But instead, when a company holds a patent on a human, plant or animal gene gives the holder control over commercial exploitation of that gene. If it’s a human gene, that may involve diagnosis or therapy for a disease; if plant or animal, it may also involve disease, the promotion of a desirable characteristic like a sweet taste, or the transfer of the gene from one organism to another. The patenting of human genes tends to be seen as largely a US-driven trend, fuelled by particular American patent laws, but just as the Cherokee Land Run fades into insignificance compared to European appropriation of colonies, so U.S. firms have become some of the most eager of claims on human DNA. Companies have patented genes which make our brains work, which build our bones, which make our livers grow, which keep our hearts beating, which can give increased chances of getting cancer and which may predict our likelihood of becoming addicted to drugs. They’ve patented genes even before they know what they do: they’ve taken out provisional patents on treatments based on genes even though no such treatments exist. “Our genes are nature’s software - chemical codes honed by millions of years of evolution to fabricate the substances that make us what we are. Scientists’ new knowledge of these codes, and their commonest flaws, promises to make the 21st century an era when some of the deadliest diseases are eradicated (pg156, Copeland). By patenting gene sequences, the claimants argue, they are ensuring they will be able to recover the money they have spent to find them, and gain the financial incentive to work out how to use them to benefit humankind. Not so, argue the critics of gene patenting. For one thing, to claim exclusive rights to commercial exploitation of something everyone is born with is to abuse the patent system, which was set up to reward inventors, not discoverers. One of the troubles with the addition of patenting is that it sets up an arms race. “Biotechnology is today’s dominant cultural instrument for carving out the boundary between nature and culture through intellectual property rights and for defining women’s and farmers’ knowledge and work through nature (pg140, Shiva).”One of the troubles with the extension of patenting is that it sets up an arms race. Companies or universities must feel they must patent their discoveries defensively to stop other companies taking advantage if they don’t. In the US, their shareholders could even sue them if they did so. So it is quite possible that most or all of the patents granted on DNA sequences today will come to nothing. The real problems will come later on, once companies start to patent gene sequences that are nowhere found in nature.
That is when the real dilemmas of gene patenting will emerge in focus, for the problem there is not whether it should be possible to patent a naturally occurring substance like an isolated sequence of naturally occurring DNA. Any conceivable patent law would protect an artificially designed sequence of DNA and the process of inserting it so that it did the job for which it was designed. But if some of the hopes of biotechnology are realized, and such a gene slows down the ageing process, boosts the intelligence of children, or even boosts the production of attractive hormones, the company that patents it could grow well off past the dreams of Bill Gates. “The most basic rule of corporate operation is that it must show a profit over time. Among publicly held companies there is a second basic rule: It must expand and grow to, since growth is the standard by which the stock market judges a company. All other values are secondary: the welfare of the community, the happiness of workers, the health of the planet, and even the general prosperity (pg314,Mander).” We are forced into this corporate behavior each day, letting ourselves pay into these corporations, enabling them to grow bigger and better, resulting in a monopoly. Corporations will stop at nothing to get the big pot of gold at the end of the rainbow, whether it is sacrificing people, money, or the morals and beliefs of this country. We let them set the prices because the government lets them “block” us from getting the information and help. Letting it plague us will let this monster grow even bigger.
The real ethical problems take place from the fact that there is more profit to be made from curing the chronic disease of the rich world than in the simpler and much cheaper work of preventing acute diseases in the third world. We could stop voting for our tax dollars to fund for these court battles. The best we can hope from gene patenting is that it should not further skew this balance
Patenting our own genes open up a door that will not be closed for a while. With the technological advancements taking place, we cannot stop this all together. Corporations will continue to clear everything that is in its path in order for profit incentives. We must realize that there is a certain flow in life, and it must flow without constant pick pocketing from companies. Our lives are at stake, whether God destroys us, or us as god, destroys ourselves.
1. Agree, Ted “Gene Patenting Has it’s Ups and Downs” Drug, Discovery, and Development (Cahner’s Business Information, May 2000).
2. Copeland, Peter and Dean Hamer Living With Our Genes: The Groundbreaking Book about the Science of Personality, Behavior and Genetic Destiny Anchor Books: New York, 1998.
3. Mander, Jerry “The Rules of Corporate Behavior” in Jerry Mander and Edward Goldsmith (Eds.) The Case Against the Global Economy (San Francisco: Sierra Club Books).
4. Meek, James “Beginner’s Guide to Gene Patents” Guardian Unlimited, www.guardianunlimited.com, November, 2000
5. Human Genome Project Information “Genetics and Patenting” www.ornl.gov, August, 2000