Something important happened a few months back. Something which you probably don’t know anything about, because it wasn’t given the prominence it deserved. But you should know about it, because it could, potentially, impact every single one of us.
An Australian grandmother won a landmark legal case, which has major ramifications for scientific research. And what did she win?
Say……….WHAT???? What the hell does THAT mean?? Of course Australians own their own bodies! They’re not slaves!
Ah……but that’s the thing. Up until she won that case, there were people in Australia who didn’t own their own body….at least, not all of it. There were teeny weeny bits of every Australian that actually, legally, belonged to someone else. And it’s not just Australians….there are literally billions of people in the same situation. Even YOU, sitting there, reading this may not legally own all of yourself. Maybe even ME, as I write this, may not own all of myself…..
Let me explain. In my last post, I spoke about the way that scientists are starting to identify and characterise tumour-specific genes and gene mutations, which they will use to develop new therapies and improve treatment planning. Which is all very well and good, obviously, but it raises an interesting question. One which has probably never occurred to most people before.
Who owns these genes?
“Huh?” I here you ask, “What do you mean, who OWNS them? How can anyone “own” a gene?” Well, that’s a good question. And it takes us into a very tricky, and VERY controversial area: Gene Patenting.
In one sense, it sounds like madness. How can you patent a human gene? After all, these tumour-specific genes are present in cancer patients, aren’t they? They aren’t artificial or synthetic. They are part of the patients’ genetic makeup. They are entirely natural. So, how could it be possible for another person or business to OWN them? It would mean that a cancer patient’s genome didn’t belong to them. Part of their genome would actually belong to some other person or persons. How the hell could that be possible?
Well, as mad as it sounds, this is EXACTLY what happens. Many of the genes which have been identified – genes which are an entirely natural part of the human genome – are currently under patent. They are owned by Biotech companies who are able to profit from their commercial exploitation.
But….how can this be?? How can you patent a naturally occurring gene? And how can you make money from it?
Well……technically you can’t. A patent only covers a new, novel concept or invention. Therefore, any organism which is found in nature cannot be patented. And this is why you cannot patent a plant or animal which is found in the wild.
So, surely this means that anyone who tried to patent a human gene would be laughed out of the building, right? Nope. This is because, in order to identify a gene in the first place, you have to use some sophisticated scientific techniques, which require specialised Hi-tech equipment. Both of which had to be thought of. Both of which had to be created. And both of which can be PATENTED. This is the loophole in the patenting laws which Biotech companies can exploit. While the GENE cannot be patented because it’s natural, the METHOD used to identify it can. And therefore, anything found by using that method comes under the terms of the patent and can be exploited commercially. And has been. Oh boy…..has it ever! The numbers are a little unclear, but one recent study suggested that as much as 41% of the genes in the human genome have been patented in this fashion!
Now, to say that this had been controversial is a bit of an understatement. Research scientists object because it stifles their work. If their research identifies new genes then their work – their effort – will become the property of someone else, so why bother? Other biotech companies object because it eats into any potential profits from their own products. Clinicians object because it increases the costs of new diagnostic tests & treatments. And lots of people across the board (scientists, doctors, patients, politicians, lawyers), they object for ethical reasons and question the legality of a gene – a naturally occurring object – being under patent.
The legal wrangles have been rumbling on for years. The U.S. Supreme Court ruled against the gene patenting in 2013. Which is great, obviously, but if the company holds patents in different countries, then the rules need changing in every one. So the U.S. decision is not enforceable anywhere else.
Which brings us to the Australian case. In a nutshell, a breast cancer patient called Yvonne D’Arcy brought a case against a Biotech company called Myriad Genetics which holds a patent for the BRCA1 gene. BRCA1 is involved in DNA repair processes, and BRCA1 mutation has long been known to be associated with an increased risk of hereditary breast and ovarian cancers. Now, an important point here is that Mrs D’Arcy didn’t have a BRCA1 mutation herself, so her decision wasn’t based on self-interest. Instead, Mrs D’Arcy objected to this patent on the basis that it increased the costs of genetic screening and could, therefore, mean lower identification rates for women with a predisposition for breast and ovarian cancers.
Initially, the Australian Federal Court ruled in the company’s favour, but Mrs D’Arcy appealed and, at the end of 2015, the Appeal Court ruled that the BRCA1 protein, both the normal active form and the mutant which indicates of susceptibility to breast and ovarian cancer, was not a “patentable invention”.
Success!…and it seems as if the tide is turning. Already, there are cases being brought in Canada against the patenting of genes and it looks as if the number of patents being filed for genetic sequences is falling worldwide. So hopefully, one day, private businesses will no longer be able to claim ownership of naturally occurring genes and genetic material.
But until then, the fight goes on….
Rosenfeld, J., & Mason, C. (2013). Pervasive sequence patents cover the entire human genome Genome Medicine, 5 (3) DOI: 10.1186/gm431
Liddicoat J, Whitton T, & Nicol D (2015). Are the gene-patent storm clouds dissipating? A global snapshot. Nature biotechnology, 33 (4), 347-52 PMID: 25850055