The Issue of patenting Human Genes.

The U.S Supreme Court on Thursday 13, 2013, ruled that naturally occurring genes cannot be patented. From my twitter timeline, many people were surprised that genes could even be patented and some wondered what exactly a gene is and why/how it is patented. I will attempt to explain these questions then discuss why I am of two minds on this issue.

Let’s start from the basics…

What is a gene?          

 A gene is basically a sequence (or stretch) of DNA (or RNA) molecules that encode or can be “read” to produce a product which function in the organism. By products, I’m talking about enzymes, hormones, etc. So generally speaking, we can say a gene is a template in the body’s factory to make products.

We all have genes that are supposed to code for the same products, but whether it will code for a product or not, or produce a different form of it is determined by the slight genetic variations within our genome (whole set of genes) as a result of evolution.

It is this template in every human that biotechnology companies and universities have patented making millions of dollars out of it. A 1980 Supreme Court ruling paved the way for gene patenting by allowing genetically modified organisms to be patented. So why decide against patenting now?

Patenting a gene can have different meanings or give the holder different rights depending on how it is drafted of course. I am no lawyer so I’ll just stick to the science aspect here. Usually, a patent provides the holder with rights to exclude others from using, making selling, conducting research, testing etc for that gene for a particular period of time.

This after all is what patents are meant to do right? But why genes? Something shared by all humanity. Why does a company want the sole rights to control it? Doesn't it in a way give them ownership over humans?

On the other hand, you don’t really need your genes outside your body in your day to day activities except to stay in there, function properly and keep you alive and healthy, and it’s not like they came to extract it from your body, so what’s the big deal?

Let’s examine a few arguments from both sides…..

Opponents of gene patenting identify its potential to hinder research as one of their reasons. When one company holds the rights to exclude other scientists from researching on a gene it impedes the collective effort research is all about.  And I am sure many people care more about finding better treatments for diseases than which company came up with the findings.

A second reason, one that affects many directly, scientist or not is the issue of high costs. See, holding patents over a gene can also give you the right to dictate what tests can be done and for how much. Not everyone can afford the usually high price when they need to make diagnostic tests in order to take life saving medical decisions. (Eg. Angelina Jolie undergoing mastectomy to reduce her risk of breast cancer after diagnostic tests showed she had a very high chance because of her genes.)

These are the main reasons that led the American Civil Liberties Union (ACLU) to combine forces with some scientists and health professionals and present a case against Myriad Genetics; a biotechnology company that held patents for many genes including two breast cancer genes BRCA1 and BRCA2.

Myriad Genetics argued that the genes are their invention once it is outside the body (I’m guessing this is because it is through their research that located the genes in the genome and devised ways to extract and carry out tests on it).

Well, the Supreme Court concluded that a naturally occurring gene is not an invention; there is no invention in the discovery or isolation of it. This ruling goes beyond just the two breast cancer genes and affects 1000’s of patented human genes. ACLU hails it as great news, it definitely sets precedence and will discourage monopoly and the negative effects of capitalism in research.

So why am I of two minds on this issue?

First of all let me just say that I do agree with the ruling, monopoly can impede research. Then is the issue of costs, screening for the breast cancer gene is said to cost about $3000. Not many people have that kind of money or medical insurance to cover it, meanwhile time sensitive life saving medical decisions need to be made. The high price usually discourage such tests and results in cancer that is bound to kill the patient without much you can do about it. So some regulations to avoid this is fine by me.

On the other hand, as a scientist working in a Biotechnology company, I am well aware of the laboring and demanding job that is research. Only a small percentage of ideas work and you have to sink in millions of dollars into that idea with no guarantees. Let’s take the drug discovery process for example; it costs between $500 million-$1.2 billion dollars. And the chances of it failing are enormous. Only about 20 drugs are approved every year and they are usually just modifications of old ones.

So basically, research is very expensive, you need money, and you need investors. Investors, well... want a return on their investment. Let us also not forget that money is a strong motivation for innovation and a very effective way to attract the “best and brightest” as they say to a particular field. Patenting is just a way to make some profit off their product and get much deserved reward for innovation and hard work.

But whiles innovation is involved in identifying and isolating a gene, because it is still “as is” generally speaking from the body, I agree naturally occurring genes should be left out of patenting. But anything done with that gene, any further processing or utilization, should be patented because it is at least a “method” patent and it is innovation.

This is probably why the Supreme Court compromised and said cDNA (which they classified as artificial genes) can be patented. The ACLU objects and claim cDNA is not really different from a naturally occurring gene, it’s a “mirror copy”, so that makes the ruling a placebo; not changing much. Well, yes and no. The cDNA is a mirror copy of “processed” mRNA which is a copy of the gene. But the processing step is what specifies what product will be made. So if a scientist designs a cDNA from a gene, there is tremendous innovation in that they have a specific product in mind and have succeeded in figuring out the template to make it. The cDNA gene is not “as is”, so in my opinion that justifies patenting.

I think the patent argument will go beyond human gene patents to plants (hint; Monsanto) and microbes. And at the end of the day, I hope a balance can be made between creating the right environment for research and innovation and being “fair” to people, the latter believe it or not, is a gray area, something we never seemed to be able to agree on in bioethics class. But that, including the issue of Monsanto and their plant gene patents is another post. Thanks for reading and stay tuned.

Image:(www.american.com)