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)
