Nick's Final Paper

Nick Wilcox C&C: Bioethics
April 18, 2008 Final Paper
Patenting Genes: Who Owns What is in Our Body?
Over the past thirty years incredible advances in the field of genetics have allowed geneticists to learn more than once thought possible. For example today scientists have almost completely mapped the human genome as well as many other species. (NIGMS) Some companies though have turned this extraordinary discovery into a major ethical dilemma. The company Celera Genomics, for example, has filed for 5,600 patents on human genes. (BBC 1999) The fact that the companies have the ability to patent genes can lead to many different problems, including economical, ethical, and legal. Therefore, patenting genes needs to be stopped as soon as possible; that’s why Representative Xavier Becerra has proposed a bill that would put an end to the patenting of genes.
Genes are the expression of each person’s individual heredity, and for heredity you need to have one set of genes from each parent. Genes exist as segments of DNA which are found on each of our forty-six chromosomes. Genes are composed of different combinations of nucleotides, which include Adenine (A), Cytosine (C), Thymine (T), and Guanine (G). (Moss 1970) Genes become expressed through these two different processes: Transcription and Translation. Transcription is the first of the two processes which begins with the split of the segment of DNA for the corresponding gene. The segment is then known as the messenger RNA (mRNA). Translation is the second stage which starts with the mRNA leaving the nucleus and entering the cytoplasm. Once there the mRNA attaches to a ribosome, where mRNA gets converted into amino acids. Proteins are the resulting product of the amino acids and carry out the expression of the designated gene. Our genome is the sum of all of these genes. It is estimated that humans have between 20 and 25 thousand coding genes, which means that the gene has a specific function whether it is displayed physically or is part of our prevalence for contracting a certain disease. There has been an extensive amount of research done on connecting some of these genes to familiar diseases. Our genome also consists of an estimated 10,000 psuedogenes which have no understood purpose as of now. (Russell 2006) This is an amazing accomplishment considering thirty years ago scientists were just beginning to understand the composition of genes.
There were two main organizations that contributed to the sequencing of the human genome. The first of the two founded was the Human Genome Project a publicly funded project. The second is an organization that was founded later in order to compete with the Human Genome Project. This organization was started with only private donations. Without the help of these two organizations the field of genetics would not be what we think of it as today.
The organization that started first was the Human Genome Project which was initiated by the National Institute of Health and the U.S. Department of Energy in 1990. This project needed three-billion public dollars to get this project completed. Designers of this project wanted to keep the public satisfied so they designated about five percent of this budget to social, ethical, and legal issues. They did this more as a deterrent so they could avoid any possible negative attacks from the media. (Ojha &Thertulien) The project hoped to accomplish two main things. The first of course was to sequence the human genome and be able to do it more efficiently so effort could be spent elsewhere. The samples that they used to help sequence the genome were sperm and blood samples. The HGP also released their findings publicly as they became known. (Russell 2006) The second goal was to develop resources and technology that could help find out which genes led to what expression. (Barnhart 2003) Ten years into this project though the view shifted it became more of a race to finish the genome so patents for genes could be filed. In fact to make sure that this happened private funding surpassed the already massive three-million dollar budget. The project was officially called complete by the U.S. Department of Energy in 2003. (Ojha & Thertulien 2005)
The second of the two organizations was Celera Genomics which started 1998 with same long term goal as the HGP, to completely sequence the human genome. (Celera 2007) The founder Craig Venter, formerly of The Institute of Genomic Research, said however he has trying to create a company that could rival what was being done at the HGP. (Caplan 2008) Celera’s budget was far less than that of the Human Genome Project with only $300 million to start the project. Most of the company’s money was spent toward sophisticated computers with the ability to breakdown and decode the sequences. The technique Celera used was the called the whole genome shotgun (WGS) approach, which considered to be risky since it had only be used on animals as complex as rats. The WGS approach worked by breaking down the genome into many segments of overlapping sequences to make sure no part was overlooked. (Russell 2006) Because of their approach however their findings were considered to be superior to the HGP when released to the public in 2001. Celera, however, used some of HGP findings in their results. (Kling 2005) Celera had planned on filing for about 6,500 patents by the time they completed the genome.
It usually takes well over a year to get one of these patents approved. There are three criteria the item pending the patent must have. Those three are, it cannot exist in nature, the item must have a new, non-obvious use, and it must be a new way of doing something. When an item receives a patent the data regarding the item must disclosed to the public. A patent also gives the owner exclusive rights to the product. A patent is essential in being able to keep the item from being used illegally. (USPTO 2004)
People have many different reasons for wanting to obtain a patent for a gene. In the cases like Celera the main draw for a patent is the monopoly it creates on the decoded sequences. There are other reasons for patenting the genes like the companies feel they are following all the rules, so why shouldn’t they be able to. The ability to patent also is able to create more research opportunities and more information can become available. Again, for the companies money incentives are always the biggest drive.
Being able to patent a product allows the patent holder to create all sorts of money possibilities. First, the person who finds this information is almost immediately able to find a company or corporation who wants this information so they can develop drugs or tests. For this companies pay the patent holder some type of royalty to use and continue using the gene for development of products. Basically with this patent on the gene the holder determines how much money they could potentially get. This patent eliminates all other competitors from the market, so if you need something pertaining to a certain gene there is only one person to see about it.
As I said the companies are following all the rules, so they feel they aren’t doing anything wrong. In the case of Diamond v. Chakrabarty U.S. Supreme Court ruled that Chakrabarty’s modified bacteria was okay to patent. Currently the courts rule that a patent for living things can be obtained, so the US Patent and Trademark Office have changed their criteria for getting a patent for the gene. The first of the criteria is the person must have found a new genetic sequence no one else has tried to patent. Next, the person must be able to say that the sequence makes a certain gene. After that the person has to try and find how the gene is expressed in the body. The last requirement is the person must allow a professional to use the sequence to try and create some new medical use from it. By these rules the companies are able to obtain a patent on their genes.
The last big reason that the companies are trying to patent the genes is for research opportunities and new information. Supporters of gene patenting feel that the incentive of a patent will create a rush to find new information. While this new information is being found it will allow science in general to advance at a much quicker rate. With the new criteria for getting gene patents duplicate information won’t waste time, because people will be looking harder for something new to capitalize off of. Supporters also feel that the faster the genome is finished the faster scientist can start researching other areas. Despite these positives there is an even more negative side of gene patenting. (HGPI 2006)
Almost all of the sources out there are strongly against the patenting of genes. One of the huge reasons is the fact that the monopoly creates problems with researching and developing on top of other problems. Also, the ownership of other living beings gets into an ethical dilemma. Luckily there is a lot of support for the banning of gene patents including HR 977. It will become apparent to most to people that the risks of gene patenting are far worse than the possible gains from it.
Already about 47% of geneticists have reported being denied access to information, data, and materials, because of the patent a certain gene may have. Without the ability to access this information it severely interferes with the training of the next generation of doctors. Some research has been stopped on diagnoses and cures for fear that they may infringe on a gene patent, which can result in a fine for the researcher or institution. So, even if a research came up with a treatment for a disease it couldn’t be released to the public without first convincing the patent holder to let you use properties rendered from the gene. Not to mention a patent stops a person from donating the certain types of genes, so even if you wanted more research done on medications for heart disease it can’t happen. While a patent hinders the research of medicines they seem to reward someone for making a, relatively speaking, mundane discovery. (Becerra 2007) Other problems stem from the monopoly created by a patent. For example the patent holder can charge whatever they see fit for the use of their property. One specific example that I found is a breast cancer test that once cost $1,000 can now run upwards of $3,000. (Crichton 2007) There is a possibility that one day someone could have found a new treatment for Alzheimer’s disease. If the gene that codes for the Alzheimer’s is patented the holder could essentially make the patient pick between life being broke or dying with your money. While supports of gene patenting list monopoly as a benefit, but the monopoly only helps the patent holder and hurts everyone else.
Another controversial issue that arises from this situation is the ability to patent and essentially own another being. Humans are almost exactly alike in genetic makeup yet already one-fifth of every human’s genes are owned by somebody. For the people that have the patent it may give them an undeserved sense of superiority. Some bacteria and diseases are being patented. We start out this small but with the sense of greed that our society has it won’t be long before other things and animals are owned. By allowing one bacteria to be patented it has opened a flood gate for the patenting of animals, and from there where does it stop?
The support for the ban comes from a bill introduced by House Rep. Xavier Becerra. The bill is HR 977 known as The Genomic Research Accessibility Act. The act would prohibit any patents from being obtained for a nucleotide sequence, its functions, or its naturally occurring product. The bill is currently being looked over by the House Subcommittee on Courts, Internet, and Intellectual Property. This bill has the support of many different medical institutes, Rep. Xavier Becerra has the backing from six other representatives, and the author of Jurassic Park, Michael Crichton is a big supporter as well. There is no lack of support for getting rid of gene patents. (Becerra 2007)
It is hard for people to be informed on the possibilities that could happen to the medical care without their consent. Gene patenting is only good for the patent holder; everyone else is only going to wind up getting hurt. If people could be more informed on what is happening there is a good possibility that people will try to be more involved with this issue. That is why so many people are on board with HR 977. It going to stop the problems that current gene patenting has brought.

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