Genes on Sale! Commercialization and the Ethics of Gene Patenting

Genes on Sale2

Description:  How would you feel knowing that a research company owns your genes? Does owning genes commercialize the human body? Is it right to put a price on the human body? In the last few years, a common practice known as gene patenting has been given prominent attention in the medical world, especially after a company called Myriad Genetics tried to patent or “own” the breast cancer genes. While regular patents do encourage innovation and gives credit to the owner of the patent, we must still evaluate the limits of patenting. Should the Supreme Court allow for companies to patent genes? In terms of fairness and power, is it ethical to patent the human body?

 

 


Introduction

Imagine you are financially challenged and your mother and grandmother have breast cancer. Your doctor then tells you that you could have an 85% chance of developing breast cancer as well. Your doctor would like to conduct research on your DNA but you must pay $4,900 for the test because research institute Myriad Genetics has patented the breast cancer gene in your body. This is the dilemma that quite a few patients with breast cancer mutations face in the medical world. The use of gene patenting to patent a biological invention has gradually become a common process in the United States, such as RiceTec’s genetically modified hybrid rice. Biological patents have also received ethical concern in the medical world. If gene patenting were to be allowed, as in the scenario, then the standards of what is considered natural should be redefined and written more clearly, to appease controversy. Gene patenting and new guidelines should honor the ethical values of equity, freedom, and access. A counterargument that some pharmaceutical companies and research institutes have made is that patenting genes or anything in nature should be considered ethical and legal because patenting genes provides incentive for other companies to conduct research on the gene. Patenting genes gives the actual gene some value.

This paper will explain what gene patenting is and why there is controversy surrounding it. To explain the process of gene patenting and the controversy surrounding it, I will explore the question of “what is considered natural?” and “do biological patents commercialize the human body?” to further support my stance. These ethical questions will be centered around the Myriad Genetics Lawsuit of the BRCA Gene, as an example of gene patenting. This paper will primarily use the Myriad Genetics Lawsuit of the BRCA Gene patenting to support my argument of whether research companies should be able to patent something in nature. Gene patenting should not be considered ethical or legal because it commercializes the the human body, prevents progress for finding cures, and puts too much power in the hands of the company with the patent.

Factual Background

First, we must not forget the importance of a simple patent. According the US Patent and Trademark Office, a patent is an intellectual property right granted by the government of the United States of America to an inventor “to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States” for a limited time (typically ten years). Myriad Genetics’ counter argument or defense in court to receive a patent was based on the definition of a patent. Patents, of course, honor originality and utility of the invention. Patents give your product credibility and gives you credit for your work on the invention. The same way it’s illegal to steal someone’s computer or car, it’s also illegal to steal someone’s original invention. The law refers to it as intellectual property theft. There are several types of patents such as utility patents, design patents, and even plant patents. However, I will be exploring a unique type called the biological patent.

A gene patent or biological patent is “a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time.” The legal practice of patenting a newly discovered gene is controversial because of this topic’s importance in the medical, pharmaceutical, and ethical world. “Gene patenting” is a broad term referring to the patenting of genetic sequences such as DNA and RNA, and to alternative forms of DNA such as cDNA (complementary DNA). Biological patents have been used for many different inventions. The Diamond vs. Chakraburty case won in court for patenting an oil-eating bacteria and the Parke-Davis and Co. vs. H.K. Mulford and Co. Case won for patenting purified human adrenaline. Unlike the Myriad Genetics gene patenting lawsuit, these two cases won in court because they had patented a creation in the field of biology that had actually invented. Myriad Genetics did not invent the BRCA mutations, but rather found them in the body and mapped it out. Think of the map of the California. California had already existed in the world, but someone decided to map the land and sell those maps to the public. They had not invented California, but rather found it and mapped it out. This is similar to what Myriad Genetics has done with the breast cancer gene.

The U.S. Patent and Trademark Office (PTO) issues thousands of patents to research companies and individuals. It must be issued through the government. Different countries and governments set different standards of issuing patents. Different countries have different systems for gene patenting. In Australia, the Federal Court of Australia was involved in the Myriad Genetics lawsuit and voted in favor of the patent. Europe has the European Patent Organization and it allows for patenting of natural biological products. Japan has the Japan Patent Office which also allos for the patent for natural biological products. The standard for issuing a patent is that the discovery must show utility and substantial use, but most of all should not already exist in nature. The PTO even has specific guidelines to what they consider “in nature.” If the discovery is purified, but it has no utility, the invention is not patentable. But if the invention shows how to use the purified gene isolated from its natural state, the patent satisfies the utility requirement. The isolated and purified gene is considered a substantial and credible utility and may be patentable. A patent is only given to a gene that is purified and isolated, not a gene that occurs in nature. It must be isolated from its natural state to patented. The body does not contain the patented, isolated and purified gene because genes in the body are not in the patented, isolated and purified form. The prominent ethical issue of fairness is raised in this section.

Breast cancer develops when a cell changes into an abnormal and sometimes harmful form, dividing and multiplying without dying. The BRCA1 and BRCA2 mutations are human genes that produce tumor suppressor proteins. They are the two mutations most closely associated with breast cancer and increase a woman’s risk for breast cancer by more than 52%. The ethical issue raised in the Myriad Genetics lawsuit is whether the BRCA genes should be considered natural.

Myriad Genetics is an “American molecular diagnostic company that employs a number of technologies to understand the genetic basis for human disease.” In the early 1990’s, human geneticist from Myriad Genetics Mary-Claire King discovered the BRCA1 and BRCA2 genes, the mutations most closely associated with breast cancer. Soon afterward, Myriad Genetics filed for a patent on the BRCA genes with the U.S. Patent Office. This patent case was taken to court and was between the Association for Molecular Pathology and Myriad Genetics. Myriad Genetics, however, did pose an interesting counter argument in court defending their patent on the breast cancer genes. Myriad Genetics argued in court that they merely wanted to “patent the research on the gene” instead of patenting the actual gene itself. By patenting research, Myriad means the process it used to purify and isolate the BRCA mutations from their original, natural states. Also, the BRCA mutations are not easily seen in nature. Even though it exists in nature in its natural state, it was not easily found in nature. Myriad had to “dig” to find the BRCA mutations. Unfortunately, this is not good enough of an argument of make. Even though the BRCA mutation is not easily seen, it still exists in naturally, nonetheless. From 2010 to 2013, the case became a back-and-forth shamble between the Appeals Court and the Supreme Court. While the Appeals Court ruled that companies could patent genes, the Supreme Court invalidated their ruling and decided against the gene patents. But finally, on June 13th, 2013, the recent Federal Circuit court and the Supreme Court came to a final decision to invalidate patents on genes linked to breast cancer. Myriad Genetics lost the case to the Association for Molecular Pathology and as the court noted in its decision, “Myriad’s gene patents were invalid because the company had not invented a unique DNA sequence, the company had only removed DNA that naturally exists in the body.” The ethical issue of power is raised in this section. I believe the Supreme Court is issuing too much power into the hands of a few elite research institutions. Those gene patenting cases are not yet justified based on the guidelines of what is considered in nature.

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There are several stakeholders involved in patent of a biological invention. The medical community, in this case, serves as the most prominent stakeholder. Doctors, breast cancer researchers, and the Myriad Genetics company are all considered part of the medical community and serve as the motivation behind gene patenting. Then, of course, comes government and “money.” A group of gene patenting lawyers, the Supreme Court, United States Patent and Trademark Office, and Myriad Genetics’ lawyers are all within the government boundaries. “Money” stakeholders consist of health insurance companies and private institutions that invest in gene patenting or Myriad Genetics. Breast cancer patients and family members are the last stakeholders that can be viewed in several different ways but do describe the more emotional behavior in the gene patenting case.

Gene patenting opens the door to several questions about fairness of the justice system, commercialization of the body, and the question of what is considered nature. While gene patenting does reward companies and individuals for their work and makes sure there is no intellectual property theft, it also causes several legal and ethical issues.

1st Ethical Issue: Guidelines for What is Considered Natural or Existing in Nature.

The guidelines provided by the Patent Office are the guidelines that most patent lawyers, government firms, private research institutions, and patients have found to agree most on. It follows the values of fairness and power, but also clearly states the boundaries of what is considered nature and what is considered artificial. It sets the proper rules for how the patents will be issued and to whom, but the guidelines of nature are not so restrictive that it discourages research companies from conducting research or filing for patents. The PTO guidelines have struck a balance between encouraging research and filtering out the natural patent applicants. Some philosophers believe that everything is considered natural. Whether it be a plastic bag, a man-made skyscraper or a tree, philosophers believe that even the man-made objects are completely natural because everything we build comes from this earth. Anything that comes from another planet or not from this earth is considered unnatural. However, to avoid any confusion, in this gene patent case the term natural means something that is void of human interference. For example, the oil-eating bacteria case one in court for having genetically modified an organism, making is a product of a lab with human interference rather than naturally existing oil-eating bacteria.

Myriad Genetics did, however, argue that the PTO guidelines have not a struck a balance between encouraging research and filtering out natural patents because its controversial guidelines is what brought Myriad Genetics to court. Myriad’s additional counterargument included that the chemical process used to alter the mutation’s fundamental structure and isolate the mutation from the body (rather than its raw state within the human body) meets the obvious guidelines of the US patent and trademark office. The guidelines for nature are simple but the way in which humans discover biological breakthroughs are slightly more complicated. By following the Patent Office Guidelines for Nature, keeping in mind the ethical values of fairness and power, the future gene patent cases will be easier to identify.

2nd Ethical Issue: Fairness and Power of the Justice System.

Several companies and lawyers have made the argument against patenting of any genetic material, mainly based on the assertion that genes are part of nature and have not been invented by anyone. The PTO rejected this assertion based on the fact that a gene may be removed from a person, then a clone of that gene may be made in a machine, which is then not a part of nature, but a product of the lab. So far, many companies, as well as the government have applied for patents on thousands of human genes. As for the fairness for researchers and companies, it is very easy to make the argument that the legal system could possibly pose a disadvantage to certain companies and individuals with their patent laws. Technically, a person or company that cannot afford to pay for research on these genes but has the knowledge to help advance a cure for the disease, cannot research the BRCA mutations because of the financial disadvantage. This slows down the progress in finding a cure.

In addition, when the federal court weeds out the people who cannot pay for testing, it has created a divide between the people who have the breast cancer mutation and are desperate for treatment and the private equities that monopolize and fund the research sector of breast cancer. It is unfair. Myriad Genetics presented the counterargument that the process of isolating the DNA or breast cancer gene from the body itself turns the mutation into a patentable object because it is not easily seen in the body and is not clearly useful. Myriad continued to argue that the now-useful mutation removed from the body meets the resulting guidelines of the US patent office. As for discrimination against companies and individuals that cannot pay for research, Myriad stated that they set their prices for research very high because a company that can pay the high price is clearly a wealthy company because of its ability to do “good” research. Myriad wants to limit its researchers to good institutes that can pay the high price of Myriad’s research.

As for the fairness for patients, the decision to reject Myriad Genetics a patent for the BRCA mutations prevents this patent from harming patients’ access to care, as stated before. By staking claims on the BRCA1 and BRCA2 genes, Myriad Genetics exclusively controlled the use of these breast cancer genes when isolated from the human body. These BRCA patents would have given Myriad a broad monopoly that hampered scientific discovery and medical care. But as a counter argument we must recognize the usefulness of gene patenting. Gene patenting can create less friction between companies. Biological patenting also creates incentive for other research companies and individuals to do research on genes and foster progress for finding cures. While the gene patenting system does reward those for their work and makes sure it gives credit where it is due, it can slow progress down for a cure. We should have a say in how the Justice system conducts its issuing of patents. Breast cancer patients, especially, should have the more powerful and louder voice in the ethics of gene patenting, especially when this case stands as a life or death situation.

3rd Ethical Issue: Fairness and Power, and its Effect on the Commercialization of the Human Body.

Fairness and power, essentially, inform the commercialization of the human body. The way in which the justice system issues its patents, when it is true to the values of fairness and power, determines whether or not the human body is commercialized in the process of a patent being issued. I believe the breast cancer patient is an overlooked stakeholder in the patent lawsuit. Amongst the heated debates between Myriad Genetics and the government, the values and opinions of the actual breast cancer patient can be diminished and certainly forgotten. The perspective of the breast cancer patient should be weighted equally with that of Myriad Genetics. The patient should be able to waive Myriad Genetics’ right to controlling the BRCA mutations. Most patients, on Myriad’s claim over the BRCA mutations, state that they feel violated because if they want to receive information on a gene that exists in their own bodies, they have to pay for it. Most breast cancer patients also make the argument that they are denied access to information because of the financial disadvantage of being “owned” by a private research institution.

A second complex angle to be analyzed on this issue is putting a price on the human body. Why should the patient have to pay $4,900 to request for research to be conducted on their BRCA mutation? Patients and health insurance companies argue that $4,900 is not reflective of the worth of a breast cancer gene, and claim that is should actually be worth twice or three times as much. There are almost three million women in the United States, alone, who were diagnosed with breast cancer in 2014. The number of women this disease affects should be enough to convince Myriad Genetics to reduce the price of their testing.

Myriad Genetics argues that it can pick the price of their genetic testing at any price because Myriad is one of the few companies that has developed accurate and efficient testing for the BRCA mutations, which is also part of the reason their case lasted longer in the Supreme court. This is not the first instance where putting a price on the body is introduced. Organ donors, for example, are not only given prices but cause corruption; when patients are put on a waitlist for organ donors, the wealthier families pay their way to the top to buy the available organs for their sick family members. Myriad argued that based on its relations with health insurance companies and lawyers, the financial disadvantage of breast cancer patients not being able to get testing done for a cheaper price is a dubious point. Myriad also stated the counterargument that being denied access to information has more to do with the amount of information the breast patients’ doctor is willing to release to them and a dispute that should remain between the patient and the health insurance companies. If the price for testing became lower, then Myriad Genetics would have to give up its patent and therefore the value of the breast cancer gene would go down. Commercializing the human body perhaps devalues cancer patients and putting a price on the human body fuels further debate as to why the price is not reflective of the value of human life.

Conclusion

Having analyzed the Myriad Genetics gene patent lawsuit, I have come to the conclusion that it is not ethically sound to patent genes as it commercializes the human body. Gene patenting has raised the ethical issue of commercialization and in this subject, the values of fairness, power, and theme of nature recur in every debate and discussion. Although gene patents have been much negative attention in the medical world, it is important to remember the importance of the patent in general. The patent awards those and gives credit to those who have created projects, inventions, or businesses that have served truly valuable to society. Patents make sure that ideas are not stolen and honors the originality of the patent holder. And while gene patents create incentive for companies to conduct research as patents give the mutation actual monetary value, gene patents should also not be taken advantage of.

The court’s decision to invalidate Myriad’s patent on the two breast cancer mutations brings into question the validity of other patents based on human DNA and sequencing. The PTO has released a document stating that almost 20% of human DNA has been patented by certain research companies through the US Government and these research institutes have invested billions of dollars in the medical world in hopes of finding cures. Future solutions to the PTO’s guidelines and the ethics of gene patenting would involve discussions with the PTO, the government, research companies like Myriad Genetics, and, most important, the patients themselves. Implications of a continued discussion in patenting genes involves solutions to honoring the ethical values of fairness, power, and trueness to nature.

By Natasha Sharma

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One Response to Genes on Sale! Commercialization and the Ethics of Gene Patenting

  1. Sarah Brigid Konefal says:

    If companies don’t have patons on genes, how will they be regulated? What can we do as a society to make sure science is pursued but also the research is kept “natural”?

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