Owning the Intangible/Patenting the Human Genome

Introduction
In the world of genetics, all organisms have strains of amino acid chains, containing endless amounts of coding information. These molecules provide organisms with their body’s “floor plan”. A relatively new field of study, DNA (deoxyribonucleic acid) is becoming more widely known to scientists and researchers. New discoveries concerning DNA are becoming increasingly crucial in medical practice. Therefore, the race to identify gene sequences and patent them has reached intense levels among research scientists and corporations.

However, this competition is not without controversy, for ethical concerns arise with patenting of human genetic material. The case of Henrietta Lacks (a cancer victim in the early 1950’s) exemplifies this controversy as her cells were “taken without her knowledge” by doctors at Johns Hopkins (Skloot, 2010). Author Rebecca Skloot recounts Henrietta’s story: Eventually I tracked down a few magazine articles about her from the seventies. Ebony quoted Henrietta’s husband saying, “All I remember is that she had this disease, and right after she died they called me in the office wanting to get my permission to take a sample of some kind. I decided not to let them.” Jet said the family was angry --- angry that Henrietta’s cells were being sold for twenty-five dollars a vial, and angry that articles had been published about the cells without their knowledge. It said, “Pounding in the back of their heads was a gnawing feeling that science and the press had taken advantage of them.” (Skloot, 2010)

Even without the consent of Henrietta’s family, doctors decided to continue researching her cells, eventually discovering a plethora of helpful anomalies in them. The scientists profit enormously; Henrietta’s estate receives nothing.

The lack of consent from Henrietta’s family should indicate to the doctors that it is not ethical to continue with experimentation. Soren Holm, Professor of Clinical Bioethics, states “informed consent is seen as a necessary and, in some cases, perhaps even sufficient condition for the ethical acceptability of the enrollment in a biomedical research project.” (Holm, 2002) Although Holm is skeptical about this practice, consenting is what makes the experimentation and patenting of human genes ethical. If Henrietta’s husband had consented to the doctors at Johns Hopkins, the disputes Henrietta’s family makes against the medical school would not be warranted.

Genetic material, being a naturally occurring substance, walks a thin line between qualifying and not qualifying as intellectual property. Most would say that genes do not meet the requirements of intellectual property. Despite their lack of contingencies, there are still many benefits in patenting genes that stretch from capitalistic benefits to health benefits. In this case, with inform consent, genes should be allowed patent rights in order to further our nation scientifically and by doing so, benefiting the population immensely.

Genes in the Sphere of Intellectual Property
In 1901, Japanese chemist Dr. Jokichi Takamine filed for the first patent on a biological substance (Goldstein, 2006). This patent describes the “processes of producing a pure, stable, and concentrated form [of] a substance,” which we call adrenalin (Takamine, 1903). Also known as epinephrine, adrenalin is a naturally occurring molecule within living organisms. According to the United States patent law, “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor.” (Patents, 1952) According to the definition of a patent, one cannot patent a substance that “already exists in nature” (Goldstein & Golod, 2002), which raises the question: If genes occur naturally in nature, then how can scientists across the globe patent their sequences? A gene itself is obviously not patentable, because there is nothing novel about its existence; it was not genetically modified in order to create a new function for that gene nor was a gene sequence isolated and to that a function attached. Although it may seem that there are no valid reasons why genes should be patented, many scientists believe the opposite.

There are two approaches to sequencing DNA: the first starting with the DNA as a whole and working forward to sequence specific genes within that DNA (the genomic approach), and the second being an attempt at using the messenger RNA (mRNA) and working backwards (the cDNA approach). The cDNA approach is most common amongst scientists, because it more rapidly identifies genetic sequences, and since there are about three billion base pairs in the human genome, speed (and of course accuracy) is everything. There was a lot of uncertainty whether or not the cDNA discoveries were going to be allowed patents, but they are capable of applying for patents based on these discoveries if they discover that specific gene’s use (Healy, 1992). With these two methods put into perspective, scientists can better justify why they should be able to patent genes.

All scientists agree that every human gene is a naturally occurring substance. Scientists, including author David Koepsell (2009), use this fact to explain why patenting human DNA is not possible, for it is not patentable. If one cannot patent other naturally occurring objects in nature, such as non-genetically modified plants, other animals, and water, then there would be reason to believe that genes likewise cannot be patented, but somehow scientists are finding a loophole in the system. However, some argue that an isolated gene does not occur in nature, and can be patented (Goldstein & Golod, 2002). This theory, which has held up in court cases (the most notable court case on this plane is Parke-Davis & Co. vs. H.K. Mulford & Co. of 1912), claims because an isolated gene does not exist alone in nature, that it qualifies as intellectual property. Even though the courts favor on the side of allowing the patent of genes, there are others who still believe that genes do not belong in the realm of intellectual property. Opponents of human genetic patenting would counter-argue the supporters’ claims with the court case Diamond vs. Diehr, which stated that “laws of nature, natural phenomenon and abstract ideas” (Diamond v. Diehr, 1981) are excluded from patentability. Clearly, both opposing sides of this matter are supported by one court case or another, making it hard to decipher what the facts are. Therefore, one must look at the issue through multiple media.

In deciding whether or not genes are intellectual property, court cases are a helpful tool. But court cases sometimes provide too much contradiction, keeping people away from the facts by confusing them. A good start is to look at the plain definition of intellectual property: “property (as an idea, invention, or process) that derives from the work of the mind or intellect” (Merriam-Webster, 2010). It is true that this is only Merriam-Webster’s definition of intellectual property, but it gives a very good perspective on with what is being dealt. Genes are not created by the minds of humans, nor does isolating them make them a human creation. In that case, by this definition, there is not way human genes can be considered as intellectual property. The only possible way to get around this fact, is if genes are intentionally modified. In that regard genes would qualify as intellectual property. Unfortunately for most scientists and researchers this is not the case. Disregarding the court’s decisions on this topic, and looking solely at the definition of intellectual property, one can safely say that genes should not be patentable, for they are naturally occurring in nature and are not derived “from the work of the mind or intellect.”

There are many arguments for both sides of the above-stated discussion: are genes intellectual property? Both sides can cite court cases to support their claim, but now the pressure is on for those who support genetic patenting. The new friend-of-the-court brief from the Department of Justice could change this realm of law drastically. Even though many argue that isolation of genes is enough ground to receive a patent, the United States bureaucracy is being persuaded in the other direction towards not allowing gene patents to take place any longer. It is clear that both the supporters and opponents have strong convictions for why they believe whether genes should be patented or not, so then there has to be good reasons why supporters stand behind this practice so defiantly. Regardless of the capability of scientists being able to patent genes, the uses of this scientific process must be further looked into to understand why this controversy even exists.

Advantages and Disadvantages of Patenting Genes
Much like the debate over whether or not genes are patentable, there is a very two-sided debate on the usefulness of gene patents. Many of the arguments for both sides of this dispute can be used across the scope of patents; they are not just limited to the patenting of genes, but are still very relevant in the genetics debate. Many supporters of genetic patenting would use the following explanation of the relationship between patenter and the general public to bolster their arguments: “By granting time-limited market exclusivity, patents create the potential for inventors to generate high returns on successful innovations. In exchange, the inventor provides a complete description of the invention so that others may build on the technology to create improvements or other breakthrough discoveries” (Willison & MacLeod, 2002). On the other side of the dispute, opponents accuse companies for caring only for the monetary benefit of the patent. Although the previous two statements sum up the arguments fairly well, they are not the only that exist; there are many contingencies that are used to argue either side of this discussion.

Since the patent of adrenalin was made in 1901, many other biological patents have come about and their usefulness has been questioned. There have been a lot of myths of the uselessness of genetic patenting which are in need of being cleared up. One of a few popular myths about human genetic patenting is that when a scientist patents someone’s genes that they are patenting that person. Not only does this idea contradict what is said in the 13th amendment of the United States constitution (banning property right on a person) but the law also requires that the genes be isolated or purified if the gene is to be patented (Noonan, 2006). Another common myth is that genetic testing is better in places where patenting is not allowed. People have a misconception that cheaper equals better. In fact, the world’s leading biotechnology companies exist in places where patents can be made on genes (Rosen, 2006). Therefore, the price of genetic testing cannot be the only sign of how well testing is done. Yet another false disadvantage to genetic patenting is someone’s inability to control their genes once they are taken from their body. This is easily told false by consent forms. If the patient does not want their genes to be studied or researched then they have all the power in the world to say “no” to the doctors wanting their consent (Noonan, 2006). This is not true for every case, because there are always exception, but it is highly unethical for a doctor to continue research without consent of a patient. These three “urban myths” of genetic patenting are not the only ones. There are a lot of misconceptions that exist among this field of science, and only when they are cleared up can people truly appreciate the usefulness of what genetic patenting can do for science and research.

Along with the many false impressions made about genetic patenting, there are also many beneficial uses for this practice. By permitting scientists to patent genes, the US gives companies an incentive to create and move research along in a timely fashion. It is even thought that because of allowing these patents the Human Genome Project finished faster with their work (Willison & MacLeod, 2002). Not only does this practice speed up the process by providing incentives for companies to create, but it also provides companies with profit protection. That is to say, because researching some of these genes is very expensive, companies want to make sure their findings will be protected under the law to avoid losing large quantities of money (Willison & Macleod, 2002). Besides the capitalistic benefits to gene patenting, there is also a dire need for patenting for diagnostic purposes. Because scientists, along with deciphering the amino acid chain sequence, determine the function of the gene they are wanting to patent, diagnoses can be more easily made. Patenting a gene puts certain diseases into medical literature, making diagnoses more easily acceptable to doctors around the country (Karny, 2007). Again, these are only a few of the advantages that appertain to genetic patenting. There is a fountain of advantage to genetic patenting that cannot be overlooked.

Both sides of the issue are backed up by many different theories and statements. The difference between the two sides is that when one tries to argue against the usefulness of patenting DNA, they use incorrect preconceived notions that have only been spread by word of mouth that have no factual base. On the other side of the debate, however, there are many well supported statements as to why genetic patenting is a very useful practice in the world of biotechnology.

The Ethics of Human Genetic Patenting
With all medical affairs, ethics comes into play in one way or another. Anytime a sort of risky surgery may take place, consent is required before surgeons can begin surgery. Yet there are times when actions take place without consent, like in the story of Henrietta Lacks, whose cells were taken and researched after her family denied consent. Even though these tragedies do happen, genetic patenting and research are allowable with the proper consent. In order to fully understand both sides of this issue of ethics, it is important to learn about events that have gone wrong in the past so that learning can take place from prior mistakes. The case of Henrietta Lacks proved itself to be one of the lowest moments in genetic research, for even though Henrietta’s husband denied consent, researchers continued to perform experiments on her cells, and as a result, profited from her cells (Skloot, 2010). It is actions like these that give the general public an unfavorable view of the practices of the biotechnology industry. Other experts, like Soren Holm, would argue that even with consent, this practice is still unethical. The issue that Holm raises states that many people are “consenting to an unknown future” (Holm, 2002). He believes that some issues arise due to the lack of knowledge that is received by medical patients. There is a kind of double standard for doctors in this case, however; doctors cannot perform tests if they already know the outcome already. Therefore, there must be some degree of uncertainty in order for there to justify a research experiment. Holm does raise a valid point, but it is not sufficient enough to completely discredit the ethicality of human genetic research and patenting.

Signing the consent form grants all rights to the researcher. One could think of that form as the point of no return, but in reality, one could still back out after the papers have been signed(at least they should be able). Determining whether or not a scientific experiment is ethical is very simple. If a scientist does what she says she will do, after the patient has consented, then her actions are justified. This raises a good question: how does this type of consent relate to genetic patenting? The first step in a genetic patent involves isolating a certain gene and discovering what function it serves the body. In order to perform this experimentation, one must receive consent from the patient. It is not necessarily the act of patenting the gene for which one must receive consent from a certain patient, because as stated before, no one can own any person. If one has to receive consent to patent DNA of a patient, then there is an assumption that a specific human has very unique DNA. This is hardly the case. Unfortunately, it was the case for Henrietta Lacks, and the proper procedures were not taken by doctors at Johns Hopkins. If scientists had obtained the consent of Henrietta’s family, there would be no problem with the actions they took. Simply put, consent is the only requirement to perform research on human cells.

Conclusion
The world of intellectual property is a very nebulous sphere of law, opinion, fact, and is ever-changing, especially when referring to the patenting of human genetic material. It is very difficult to decipher the true state of isolated genes. Many claim that because they are naturally occurring materials that they cannot be considered intellectual property, making them unable to be patented. Others claim that isolated genes do not occur solitary in nature, thereby making them intellectual property, and able to receive a patent. On another note, an amount of overwhelming evidence supports the usefulness of genetic patents on both the industry of biotechnology and the population as a whole. Along with that, one can agree that patenting genes is usually an ethical process, when, of course, consent is given by the patient to due initial testing of the genetic material. With all of these contentions considered, it can be understood how important the patenting of genes are in the lives of humans. It gives us a knowledge of disease, which can help us diagnose people in time to save their lives. It provides the right kind of incentive for biotechnology companies to move biotechnology forward and improve lives globally. A wealth of knowledge has been gained because of the research scientists have been done on our cells and DNA, research they may not have done without the protection they receive from the government in the form of patents. Many more discoveries are still out there waiting for biologists, chemists, and other scientists around the world, making this crucial protection even more important for the future.