Now how

How did Myriad Genetics patent two genes linked to breast cancer and how did the Supreme Court rule these invalid?

What?supreme-court

At its most basic form, a patent is a form of authority granted by the government over some form of property, such as inventions. It is a way for inventors to protect their knowledge and receive acknowledgement for the products of their intellect. Upon their discoveries, Eli Whitney patented the cotton gin; Alexander Graham Bell patented the telephone, and Felix Hoffmann patented aspirin, note that all of these inventions are man-made products.

But what happens if something is patented that wasn’t created but rather, merely discovered? This is the controversy that fueled the landmark Supreme Court case of Association for Molecular Pathology v. Myriad Genetics. The defendant, Myriad Genetics, patented the isolated genetic sequence for two genes linked to an increased risk of breast and ovarian cancer, BRCA1 and BRCA2.  Because of this patent, other researchers and medical companies were prohibited from both experimenting with the genes and administering alternative genetic tests to women at risk for these cancers.

Why?

Scientists may seek to attain gene patents for a number of reasons – acknowledgement in the scientific community, security in one’s own work, protection of intellectual property, and financial benefit. Once Myriad Genetics patented the genetic code for the BRCA1 and BRCA2 genes, no other facilities were able to conduct research on these genes. Furthermore, women who wanted testing for these genes to understand their risk for breast and ovarian cancer could only have such a test done by Myriad Genetics, who has been free to set prices without competition.  This monopoly has resulted in a steep $3,340 for the genetic analysis plus $700 for an additional test to examine a genetic link in 10% of women who test negative the first time (Wolf).

How?

The concept of biological patents has not been consistently treated in court rulings throughout the past century. In 1912, one court ruled that a patent issued for adrenaline was valid because the distilled version produced in a lab was not the same as the kind found naturally. However, a later ruling by the Supreme Court rejected a patent for a mixture of bacteria that could only be made in the lab. The Plant Patent Act of 1930 allowed plant breeders to patent new types of plant life, but this legislation was subsequently followed by 50 years of courts rejecting patents for any other naturally found products. In the 1980s, this pattern of rejecting patents for natural products shifted when the Supreme Court ruled that a life form, such as a strain of bacteria, could receive a patent (Franco).

The first gene patent was issued in 1982, but it was only after the Human Genome Project completed its first working draft in 2000 that scientists began applying for gene patents with greatly increased frequency. Scientists involved with the Human Genome Project had intended from the start for the new DNA sequences discovered to be freely available in the public domain to maximize beneficial results. As a result, all sequence information acquired through the Project was immediately posted onto databases that could be accessed through the Internet (“Intellectual Property”). It may be that, perhaps in a competitive response to this, researchers who discovered genetic sequences independently of the Project were eager to patent their work before it entered the public domain.

The genetic race to identify the BRCA1 and BRCA2 genes began at approximately the same time as the launch of the Human Genome Project. A 5-year competition between several research groups in North America and Europe ended with Myriad Genetic’s announcement of its discovery of BRCA1 in 1994, and the early detection of cancer was revolutionized. With the ability to identify the gene, women could undergo genetic testing for cancer susceptibility (Narod). Those born with a mutation of the BRCA1 gene have their risk of breast cancer raised from 8% to greater than 80%, and with the sequencing of BRCA, women carrying this gene could undergo preventative treatments before the cancer manifested.

Myriad Genetics filed for a patent on the BRCA1 gene in 1994 and the BRCA2 gene in 1995 and bought out or fought off any other company that was performing tests or research on these genes. As a result of Myriad’s patent, the company has exclusive rights to both the genetic sequences and any mutations, methods for locating mutations, and correlations between mutations and breast and ovarian cancer. No other researcher can study, test, or even look at the BRCA1 and BRCA2 genes without Myriad’s permission (“BRCA FAQs”).

So?

Patents are designed both to protect investment and to foster innovation and encourage research. Patents achieve the latter goal by requiring their owners to make information about their designs public, allowing others to learn and build from the initial discovery. However, this principle cannot be applied to gene patents because there is no work-around for naturally occurring genes – a gene patent applies to the information itself, leaving outside researchers nothing to work with.

This is exactly why, almost twenty years after the patent was granted, the Supreme Court has overturned the validity of Myriad’s patents on BRCA1 and BRCA2 and all 5,000 patents on naturally occurring human genes (Wolf). The Court did still allow for patents on edited or artificially created DNA. As a result of this ruling, the cost of breast cancer genetic testing is expected to be slashed by 75%, and researchers will be able to freely study these genes, hopefully leading to faster product development and innovation on genetic testing and treatment.

 Written by Constance Kaita

Works Cited 

Image of the Supreme Court courtesy of abcnews.com – Chip Somodevilla/Getty Images

“BRCA FAQs.” American Civil Liberties Union. n.d. Web. 14 June 2013.

Franco, Michael. “How Gene Patents Work.” HowStuffWorks.com. 03 October 2011. Web. 14 June 2013.

“Intellectual Property and Genomics.” National Human Genome Research Institute. 21 May 2012. Web. 14 June 2013.

Narod, Steven A. “BRCA1 and BRCA2 in 2005.” Discovery Medicine. 16 July 2009. Web. 14 June 2013.

Wolf, Richard. “Justices rule human genes cannot be patented.” USA Today. 13 June 2013. Web. 14 June 2013.

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