US Supreme Court Denies Human Gene Patent

On the 13th of June 2013, the Supreme Court of the United States unanimously ruled that patents were not eligible for natural human DNA (deoxyribonucleic acid) as they are a “product of nature”. Myriad Genetics Inc., a Utah based firm, attempted to patent two well known genes that are linked to ovarian and breast cancer. This company currently performs tests to see if people carry the genes, with a widely known example being Angelina Jolie, who recently revealed that she carried one of the genes and underwent a double mastectomy in order to reduce her chances of developing breast cancer; she also plans to undergo a hysterectomy and an oophorectomy (uterus and ovary removal, respectively).

What Genes Did They Try To Patent?

BRCA1 and BRCA2 – these two genes are known as tumour suppressors or antioncogenes, but mutations within these genes increase the chance of cancer. Cancer can generally be defined as uncontrolled cell replication – so without healthy suppressor genes, replication and tumour growth becomes a higher possibility. More information about these two genes can be found here.

File:DNA Double Helix.png

In May, Angelina Jolie wrote a piece in The New York Times called “My Medical Choice“. Within the work she revealed that she carries the faulty BRCA1 gene and that she had an estimated 87% chance of developing breast cancer, as well as a 50% chance of developing ovarian cancer, which her mother died of aged 56. By having the double mastectomy, she has now reduced the odds of breast cancer developing to 5%.

Why Was The Patent Rejected? What Was Approved?

Both of these genes are found within every person, thus meaning that it hasn’t been invented by anyone and therefore can’t be classed as intellectual property – though Myriad did try to argue that as they developed the technology to isolate the genes, they should be able to patent them.

What the Supreme Court did allow however, was the patenting of cDNA (complementary DNA). cDNA is often used in research and diagnostic tests and was approved as it is synthetically produced and requires innovation to produce it.

A very interesting piece in Bloomberg, written by Noah Feldman, explains that this cDNA can be considered natural due to its source being natural RNA, which is then manipulated within the laboratory to produce a slightly different, but still working, molecule. Feldman therefore argues that this patent is still going against the rules that the Supreme Court used to deny the patent for the genes themselves and that this decision was taken as a compromise between big pharmaceutical companies and ethical considerations.

What Do You Think Of The Ruling?

Personally, I think it’s a good idea that the patent of specific genes was rejected. It naturally occurs within everyone, and I don’t think that companies should hold intellectual property over genes, even though in a BBC report about this case, they did state that patents now cover over 40% of the human genome…

What I found interesting was that for a short while, Myriad did hold the patent to the genes until it was challenged and taken to the Supreme Court, meaning that they were the only company that could provide testing for the genes in women and men who were at risk of carrying mutations. At the end of the day, it all comes down to making money, and whilst it’s true that the money procured by patents can provide funding/refunding of important research, being able to ‘own’ the rights to parts of peoples DNA is very risky in terms of ethics. After all, everybody has their own DNA (apart from identical siblings, they share), so having a company owning the rights to something within you, something that is essentially you, is not a nice idea for me and many others.

Another positive that I read about this is that without the patent on the genes, other companies can set out to do their own research, without having to pay for the patent or risk legal action. Also, as Myriad has been the only choice for BRCA1 and BRCA2 testing, therefore giving them dominance in a sector of the healthcare market, other companies could offer a similar service in the near future, which would also increase patient choice. There are mentions of a downside to this case though, as seen here in the Guardian, where it is explained that a lack of patent on a sequence of DNA might get rid of the commercial incentive for a company to continue it’s research.

What I can also understand is the want to protect the technology and techniques that were developed by Myriad. Many years, a lot of money and a lot of man power goes into developing research, and I don’t think that many people realise the monumental effort involved (or maybe scientists make things look easy), so patents can not only financially aid a company, but can also lead to recognition of an original piece of work. So kudos to Myriad for being able to isolate the specific genes and provide testing that can help so many women and men make decisions about their healthcare future.

I will finally say this though, healthcare these days isn’t driven by the simple desire to cure diseases, not by the higher up executives at least. Healthcare is all about profit margins, which is where patents then become involved to try to protect and earn as much money as possible, and that’s a shame. In an ideal world, big pharmaceutical companies wouldn’t focus on making as much money as they can, sometimes to the detriment of new research, but we don’t live in a ideal world, and the presence of faulty BRCA1 and BRCA2 genes proves this.

What do you think of the Supreme Court decision? I’m interested in hearing other opinions on this matter, so comment below!

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1 Comment

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