Groom 1

Charles J Groom

ENG 1201

Dr. Cassel

19 July 2020

Genetic Patents: Revolutionary, yet Hurtful

The modern world thrives on innovation. Innovation has given the world many things

that were thought to be impossible. The internet, flight, phones, even people on the moon were

all thought to be impossible. Yet, they were all made possible through innovation. It is seen as

the solution to many problems. Innovation helps design new products and new ways of solving

problems such as global warming, hunger, and even discrimination. It can be applied to any

aspect of life, but what fuels innovation? In the scientific world, patents drive innovation. Most

people in the U.S. know about or have heard the word patent, but what is a patent? Put simply, a

patent helps grant legal protection for an inventor’s ideas or inventions. To have a patent

application approved, the application must meet certain criteria based on the type of application.

If it is approved, the inventor is granted a mini monopoly that lasts around 20 years. In those 20

years, anyone who wants to use the patented invention must pay a fee and the patentee can refuse

to let someone use their patented invention. This process helps inventors justify the cost of

innovation. Because patents can justify the cost of research, they were used to kickstart the

biotechnology industry in America. Specifically, gene patenting became very popular from the

1980s until 2013. The biotechnology industry made many major breakthroughs and brought

wonderful inventions into the world. Among some of these inventions are new vaccines, genetic
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testing for a multitude of diseases, and life-saving cures. All of this is thanks to the effort of

researchers. But, genetic patents also have a bad side to them. They have been known to limit

further research, drive up the price of genetic testing, and although their purpose is to share

information, they can contribute to trade secrecy. All of these can end up hurting people more

than they help. Because of how market incentives shaped the biotechnology industry, American

researchers in the early 2000s became more and more interested in patenting human genes,

which had negative effects on the public and led to legal procedures to stop gene patent

monopolies from overcharging for genetic testing.

In 2013, the Supreme Court ruled that human genes are not classified as patentable

material. This seemingly insignificant change was the cause of a tremendous amount of worrying

from the biotechnology industry, who feared that the absence of genetic patenting could spell out

the end of medical research in general (Levy). To understand why this court case is so important,

one must understand the history of genetic patenting in American and how it has shaped one of

the best biotechnology industries in the world. As mentioned in the previous paragraph, patents

are important because they help protect intellectual property and give market incentives such as

mini monopolies which can justify the cost of research and help researchers make money. As

early as 1973, patent law was modified to be more inclusive for chemists by including the

phrase: “[new] composition of matter” into the definition of patentable material (Jackson 40-41).

Another important clarification of patent law is that material must not exist in nature (Levy). So

from the get-go, patentable material has included any new composition of matter not found in

nature. It makes sense that genes could be patentable so long as researchers figured out a way to

manipulate them into a form previously unknown.

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In 1982 the U.S. saw its first genetic patent, marking the first of many gene patents.

Originally, researchers would file patents for DNA that was completely man-made called cDNA

or complementary DNA (Jackson 41). Eventually, researchers found a way to patent genetic

material by isolating DNA, which was technically not found in nature (Ryan). Laws were

eventually updated to restrict patenting isolated DNA unless it served a useful purpose (Jackson

42). This gene patenting was made possible by the 1980 Supreme Court case Diamond v.

Chakrabarty where the Supreme Court ruled that “anything under the sun that is made by man”

would be patentable material (Ryan). This was the precedent that thousands of gene patents were

filed under and is what lead to the rise of the American Biotechnology Industry. As Jackson

notes “By 2002, the U.S. biotechnology industry had purportedly furnished over 437,000 jobs,

generated $47 billion in revenue, and added $10 billion in taxes to the coffers of federal, state,

and local governments in taxes” (Jackson 43). As time progressed, researchers found more

efficient ways to copy and isolate DNA which led to more and more genetic patents (Figure 1).

Clearly, the biotechnology industry, fueled by the promise of patents for genetic research, had an
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enormous impact on the U.S. economy. Not only has gene patenting been beneficial to the

economy but, as Lawrence Horn and Kristin Neuman stress in their article, “Gene Patents

Promote Scientific Progress and Medical Innovation,” “artificial DNA constructs serve as a basis

for new diagnostic tests, particularly in the field of cancer, as well as new vaccines, and have

other important applications in” many other aspects of life. Despite this fact, in the early 2010s,

there were still many who thought that genes should not be considered to be patentable material.

Genetic patenting has been debated again and again but why?

Figure 1. This chart shows the amount of published applications and granted gene patents

over time (Jackson 42).

Despite all of the good that genetic patenting had done, outlined in the previous

paragraphs, some think that gene patenting has actually had a negative effect on genetic research

as “Whoever is first to patent a DNA sequence—for any use—can lock up subsequent uses”

(Then). This can become problematic when a gene is patented before its uses have been
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discovered. Because of this problem, researchers have a hard time conducting research on genes

like the CCR5 receptor which was patented before its connection to AIDS and HIV was

discovered. Other problems can also arise when companies control a monopoly on a certain type

of gene (Then). This can impede genetic research by limiting the amount of data and testing that

can be done which could prove to be life-saving in the right conditions (Levy). Although

“patents are the antithesis of trade secrets, in which an investor decides not to disclose the

invention to the public,” data based on tests that are patented does not have to be shared (Jackson

40). This is where problems can start to occur that limit genetic research (Levy). Because of the

nature of patents, they encourage genetic research by giving market incentives to researchers.

Patents do this by offering mini-monopolies on certain patented material. This mini monopoly

helps to pay for genetic research (Horn and Neuman). Patents also help to share information

within the scientific community given that detailed information must be included in a patent for

the patent to be approved. However, information obtained from the limited, granted use of the

subject of a patent does not have to be shared unless one intends on incorporating that

information into a new patent.

A great example of data hoarding through patents can be seen with Myriad Genetic

INC.’s patents on the BRCA 1 and 2 genes, which are linked to ovarian and breast cancer.

Because of their patents, Myriad was able to control who could and could not test for those

genes. Myriad decided that they should be the only ones who are able to test for BRCA 1 and 2

(Levy). Myriad’s patent monopoly on the BRCA 1 and 2 genes would cause a problem and

would later become the subject of the 2013 Supreme Court case, Association for Molecular

Pathology v. Myriad Genetics, Inc. The result of this court case was a ruling that stated genes

were no longer considered to be patentable material. This means that companies like Myriad
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could not hold patent monopolies in the same ways as before (Levy). Instead, researchers now

have to focus on patenting cDNA. This change means that “[r]aw sequence data will be freely

available [...] but significant changes to the sequence data will be protected” (Levy). Essentially,

anyone is free to make and conduct tests on the BRCA 1 and 2 genes, however, if there was a

specific change to them, such as a drug or a product, those could be patented. While this is a step

in the right direction, it still does not change the fact that Myriad has more data than anyone else

in the U.S. As an added bonus, none of this information is peer-reviewed, so it cannot be

confirmed that their information is completely correct (Levy). Myriad’s decision to withhold

information is proof that gene patents have the potential to impede scientific progress.

What about the effect that gene patents have on the rest of society? As previously

mentioned, until 2013, Myriad had a monopoly on the BRCA 1 and 2 genes which are important

for testing for breast cancer. The problem with this is that “too many women can't access this

expensive test” (Irish). Due to the nature of their patent monopoly, it was impossible for there to

be any competition whatsoever which could have lowered the price of this potentially life-saving

test. Because of this, the price of testing increased by 300% making an already expensive test

even more expensive (Crichton). What’s more, is that while men technically can get breast

cancer, it is very rare so the increase in the cost of testing for breast cancer affects women more

than it does men. The BRCA gene is not the only gene that was patented in the U.S prior to

2013. In fact, many other diseases have had their corresponding gene patented. This means that,

without permission, only the patentee can perform research on these genes and distribute tests

royalty-free. This has made certain researchers hesitant to continue research on life-threatening

diseases because of copyright law (Crichton). Despite having a monopoly on the BRCA genes,

Myriad’s testing still misses around ten percent of mutations that could cause breast cancer.
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Additionally, the BARCAnalysis test has a false negative rate of around twelve percent (Irish).

So, not only are prices for testing around three times higher than they should be but the tests do

not even cover around ten percent of mutations and have a false negative rate of twelve percent.

One could cover for the false-negative rate being so high by getting the test multiple times

however, that is expensive and outrageous. The reason that these tests are so poor is that it is the

only test out there. Because of the patent monopoly, there is no competition so Myriad had no

reason to spend a ton of money trying to make this test better because everyone already had to go

to them for testing.

Although the Myriad gene patent is no longer recognized in the U.S. and Australia,

Myriads gene patent claims are still valid in many countries meaning that they are the only ones

able to perform the BRACAnalysis test (Du). This means that myriad is still able to overcharge

for inaccurate tests because no one else is allowed to develop anything better. Given the pros and

the cons, is genetic patenting worth the risk? The risks being the potential to inhibit genetic

research, trade secrecy, and patent monopolies that drive up prices of genetic testing that could

save lives. Of course, there has also been a lot gained from gene patents. 437,000 jobs, $47

billion in revenue, and $10 billion should all be taken very seriously. All of that, the good and

the bad, happened because of gene patents. The good because of the way that gene patents

incentivized researchers and used the free market to develop a robust biotechnology industry in

America, and the bad because of how patent law allowed companies to misuse patents to make

money. In 2013, the Supreme court said that enough was enough as changed patent law so that

this could not happen anymore (Levy). The Supreme Court had to be very careful about how

they wanted to change genetic patenting. They saw that there was a lot to be gained from

incentivizing genetic research, but also that a lot could be lost. So, they allowed the patenting of
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cDNA but not genes under the assumption that “Any clever researcher or patent agent will be

able to work their way around patents on cDNAs” (Levy). One reason that the court allowed

cDNA to be patentable rather than genes is that the process of making cDNA renders the genes

completely man-made. The process makes use of RNA to get rid of introns, which occur in

nature and does not contribute any useful information. Then the new DNA strand, called mRNA,

is copied making it completely man-made (Jackson 41). This seemed to solve the problem that

many scientists brought up: getting rid of gene patenting will end up destroying the

biotechnology industry.

If many researchers were aware of the problems that could arise with genetic patenting,

why would so many defend the patents? It is evident that researchers were aware that genetic

patenting was, at the very least, somewhat problematic. Researchers, on several occasions, were

reluctant to study diseases that were affecting millions of people due to patent concerns

(Crichton). At the very least, one would think that researchers would be frustrated with the

limited amount of data coming about and the inability to research the BRCA 1 and 2 genes. So,

why were there so many articles published with titles such as: “Gene Patents Promote Scientific

Progress and Medical Innovation.” The reason there was so much resistance to the court’s

decision was probably not that companies like Myriad used their influence to cause a stir, but

rather that scientists looked at the pros and cons and decided that the benefits were great enough

to justify the cost. These pros include but are not limited to human growth hormone, insulin, new

vaccines, diagnostic tests, and food safety. They worried that such breakthroughs would not be

able to happen without some way to justify the cost of researching (Horn and Neuman). In their

minds, genetic patents were the solution. The researchers also feared that the wording of any new

ruling could be used to invalidate other areas of research like chemical. However, the Supreme
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Court was very careful in their wording to make sure that no one could use gene patents to limit

research (Levy). However, this reasoning is simply not enough to incentivize researchers to limit

their own research. This means that researchers should have supported changing the patentable

material from genes to cDNA because it gives them more opportunities to further their life’s

work. Of course, it could be said that researchers were unaware of the possibility of alternatives

and were defensive about gene patents being taken away, however, this is unlikely for educated

professionals not to see the alternative solutions. Therefore, it is only logical to assume that the

reason that scientists and researchers wanted to continue to patent genes was because of the

market incentives that were given and the money they could receive from that. Then, the court

case happened.

Although the court case seemed to solve the major problems with gene patents and

monopolies by allowing cDNA to be patentable but not genes, this decision created its own

problems because it was not specific. In fact, in an article written four years after the court case,

the “impact is still not fully understood” (Du). While things seem to be better than they were

before given that competition can now come in and reduce the price of testing and strive to make

testing my accurate due to the greater freedom that researchers have, it is still unclear if the

court’s decision will have ramifications in other aspects of patent law. The reason this is

concerning is that decision could slow down or potentially stop future research that scientists at

the moment have not even discovered, or it could also destroy other, known, branches of

research. Both of these cases would contradict the purpose of the decision which was to make

research freer while still providing the market incentives that drive the research.

Gene patenting has been affecting the U.S since 1980. In the 33 years that gene patents

were issued, the biotechnology industry in America became one of the best in the world. This led
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to advancements in a plethora of different areas, from pharmaceuticals to agriculture, the

biotechnology industry seemed to help everything. By 2002, a mere 11 years before gene

patenting was made illegal, the biotechnology industry generated $10 billion in tax revenue, $47

billion in profit, and created 437,000 jobs (Jackson 43). It is obvious that the biotechnology

industry made America a better place. The reason that this was allowed to happen is that patents

provided mini monopolies and other incentives to offset the expensive cost of research and

promote growth within the industry. At the same time, advantages that could be taken from the

mini monopolies granted by the patent office were the reason that in 2013 genetic patenting

would cease to exist after the Supreme Court Case, Association for Molecular Pathology v.

Myriad Genetics, Inc. Because the Supreme Court did not want to disincentivize genetic research

as it has redefined modern medicine, they allowed for cDNA to be patented but not genes. This

meant that researchers could still finance their research and other researchers could continue to

research subjects that were previously patented and off-limits. This solved many of the problems

that came with patent monopolies, namely that they could charge whatever they wanted for

testing and the lack of competition meant that they did not have to improve testing. The system

in place now is much better than the previous system. cDNA patents provide more freedom for

research while also providing market incentives. However, this system is not in place globally. In

fact, there are still countries that recognize Myriad’s BRCA patents. There is still much work to

be done, however, cDNA patents seem to be the solution.

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Work Cited

Du, Li. "Patenting human genes: Chinese academic articles' portrayal of gene patents." BMC

Medical Ethics, vol. 19, no. 1, 2018. Gale In Context: Opposing Viewpoints,

https://link-gale-com.sinclair.ohionet.org/apps/doc/A546818402/OVIC?u=dayt30401

&sid=OVIC&xid=13b33f40. Accessed 11 July 2020.

Crichton, Michael. "Genes Should Not Be Patented." Human Genetics, edited by Noël Merino,

Greenhaven Press, 2010. Current Controversies. Gale In Context: Opposing Viewpoints,

https://link-gale-com.sinclair.ohionet.org/apps/doc/EJ3010635223/OVIC?u=dayt30

01&sid=OVIC&xid=e9cbd424. Accessed 11 July 2020. Originally published as

"Patenting Life," New York Times, 13 Feb. 2007.

Horn, Lawrence, and Kristin Neuman. "Gene Patents Promote Scientific Progress and Medical

Innovation." Human Genetics, edited by Louise I. Gerdes, Greenhaven Press, 2014.

Opposing Viewpoints. Gale In Context: Opposing Viewpoints, https://link-gale-com.

sinclair.ohionet.org/apps/doc/EJ3010916214/OVIC?u=dayt30401&sid=OVIC&xid

=d57e7c9d. Accessed 6 July 2020. Originally published as "The Red Herring of Human

Gene Patents," Baltimore Sun, 28 Apr. 2013.

Irish, Kim. "Human Gene Patents Hurt Women." Human Genetics, edited by Louise I. Gerdes,

Greenhaven Press, 2014. Opposing Viewpoints. Gale In Context: Opposing Viewpoints,

https://link-gale-com.sinclair.ohionet.org/apps/doc/EJ3010916216/OVIC?u=

dayt30401&sid=OVIC&xid=24670e6e. Accessed 27 June 2020. Originally published as

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"BCAction Testimony at USPTO Hearing on Genetic Diagnostic Testing,"

www.bcaction.org, 9 Mar. 2012.

Jackson, Myles W. The Genealogy of a Gene : Patents, HIV/AIDS, and Race. The MIT Press,

2015. EBSCOhost, search.ebscohost.com/login.aspx?direct=true&db=e900xww&AN=

961043&site=ehost-live.

Levy, Sharon. "The Supreme Court Gene-Patent Decision Will Inhibit Genetic Research."

Human Genetics, edited by Louise I. Gerdes, Greenhaven Press, 2014. Opposing

Viewpoints. Gale In Context: Opposing Viewpoints, https://link-gale-com.sinclair.ohionet

.org/apps/doc/EJ3010916217/OVIC?u=dayt30401&sid=OVIC&xid=911cf1af. Accessed

6 July 2020. Originally published as "Our Shared Code: The Myriad Decision and the

Future of Genetic Research," Environmental Health Perspectives, vol. 121, no. 8, Aug.

2013.

Ryan, M. Andrea. "Patents on Human Genes Are Ethical and Necessary." Genetic Engineering,

edited by Lisa Yount, Greenhaven Press, 2002. Current Controversies. Gale In Context:

Opposing Viewpoints, https://link-gale-com.sinclair.ohionet.org/apps/doc/EJ3010212228

/OVIC?u=dayt30401&sid=OVIC&xid=ad8cdf3d. Accessed 27 June 2020. Originally

published as "Gene Patents and Other Genomic Inventions," 2000.

Then, Christoph. "Gene Patents Create Social and Economic Problems." Human Genetics, edited

by Noël Merino, Greenhaven Press, 2010. Current Controversies. Gale In Context:

Opposing Viewpoints, https://link-gale-com.sinclair.ohionet.org/apps/doc/EJ3010635222/

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OVIC?u=dayt30401&sid=OVIC&xid=9ad44100. Accessed 11 July 2020. Originally

published as "The True Cost of Gene Patents: The Economic and Social Consequences of

Patenting Genes and Living Organisms," Greenpeace, 15 June 2004.