To patent, or not to patent?

Patenting human genetic sequences has been going on for decades, and has allowed biotech companies all over the world to monopolise the market for genetic testing. But, for better or worse, a the recent ruling of the US Supreme Court has changed the way such genetic material can be patented.

On May 14th 2013, Angelina Jolie made an announcement in the New York Times that she had had a preventative double mastectomy because she had an “87 per cent risk of developing breast cancer and a 50 per cent risk of developing ovarian cancer.” Jolie had paid the hefty $3000 sum to be tested for defaults within BRCA1 and BRCA2 genes to identify her likelihood of getting breast and ovarian cancer in the future. By telling her story in the New York Times, she was hoping to inspire other women to get tested, but she acknowledged the price tag for a test was “an obstacle for many women.” But what Jolie didn’t allude to was why the testing is so expensive.

In 1998 Myriad Genetics, a biotech company based in Utah, USA, discovered, and patented BRCA1 and BRCA2 genes. This doesn’t mean that they literally own a piece of your genetics; instead they own the BRCA1 and BRCA2 genetic sequences once they have been isolated from their natural environment. But as they had exclusive rights to these genes, Myriad was then able to develop tests for the mutations of the genes which they trademarked “BRCAnalysis”. As a result, no one else was able to develop, let alone provide a testing service for them: Myriad had the monopoly on BRCA1 and BRCA2.

In 2009, the ACLU (American Civil Liberties Union) filed a case against Myriad Genetics on behalf of researchers, patients, medical organisations and many others. They argued that naturally occurring human genetic sequences shouldn’t be patented as they are products of nature and hence should not be monopolised and exploited.

On June 13th 2013 the US Supreme Court announced its decision on the Association for Molecular Pathology vs Myriad case: naturally occurring human genetic sequences were no longer patentable. Four years after filing it, the ACLU had won their case.

But there is far more to this than is evident from the media coverage, and far more consequences to consider before we all start celebrating the decision as a victory.

The headlines covered the fact that naturally occurring genes can now not be patented, but in fact the courts ruled that only some genes were no longer eligible for patents.  Since the Human Genome project was born, biotechnology has been able to fiddle with the chemistry of naturally occurring DNA to create artificial DNA. What the courts actually decided is that patenting genes all depends on how much fiddling is involved.

The decision made a distinction between two types of genetic material: gDNA, or genomic DNA, the molecule as it is extracted from human cells by isolation and purification processes (very little fiddling) is no longer patentable. Complimentary or cDNA, which is created in a laboratory by editing pieces of RNA (a lot of fiddling), is still patentable.

The ruling means that Myriad no longer holds a patent on the isolated BRCA1 and BRCA2 genetic sequences as found in nature. But it does hold patents for the cDNA sequences of the BRCA1 and BRCA2 genes that it created, and hence it still holds the patents for the BRCAnalysis tests. What Myriad is no longer able to do is monopolise the industry: many other biotech companies will now also be able to develop alternative, and most probably cheaper tests for the breast cancer genes.

But the murky world of patent law is a double-edged sword. Patents, according to Rob Carlson, founder of Seattle based biotech company Biodesic, offer an incentive to keep producing inventions. “It is the root of all intellectual property law in some sense: to keep people inventing,” he said. But at the same time, it is increasingly important, especially in modern society, to be open and transparent about your work: patents also allow inventors to share their inventions without them needing to be afraid of their ideas being stolen.

What might receive more attention now is the inventiveness criteria: how routine is it to convert DNA to cDNA? cDNA patents are not too difficult to work around. Someone could invent a new piece of cDNA, and get a patent for it. This wouldn’t prevent someone else developing exactly the same chemically structured molecule, just in a different way.

If particularly clever, one could still work around the patent system to get gDNA patented. According to Dr Siva Thambisetti from the London School of Economics, the decision was “a matter of genetics trumping chemistry.” If you try and look at the gDNA from a chemical standpoint rather than a genetic one, you might be able to get a patent.

The US has broken away from the global status quo in which naturally occurring human genetic sequences, once isolated, can be patented. Here in the UK, patents these sequences can still be applied for. Whether this change is for better or worse remains to be seen, and will depend on other countries following suit. But in the US, the decision has changed how the industry can use genetic material for profit and will hopefully put an end to the previous monopolisation of the market.

Julie Gould is currently studying for an MSc in Science Communication at Imperial College.

Image Credit: JohnGoode (via Flickr)
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