Patenting life

brca-19241The instruction manual to build a human is a complicated thing. This makes sense – think of the thickness of the technical manual for a car, and figure that our bodies are a lot more complex than our cars. Our instruction manual – our genome – is the end result of a few billion years of evolution. Not only that, but many of our genes are shared with other organisms; some of our genes are shared with the majority of organisms on Earth. In fact, only a small part of our genome – about 5% – is unique to humanity. This makes sense – why throw away something that already works OK? Once a cell finds an efficient way to make energy, why develop another? So most organisms on our planet use the same mechanism – the Krebs Cycle – to power the cells, most organisms share a number of DNA damage repair genes, most complex organisms use hemoglobin to carry oxygen through the blood, and so forth. Cool – but who cares?

Well…the Supreme Court for one, along with a bunch of biotechnology firms, dozens (maybe hundreds) of scientists, thousands of physicians, and potentially millions of patients. Because the Supreme Court recently decided (in a rare unanimous decision) that a company can’t patent a gene because “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” Having said that, the Supreme Court agreed that synthetic genes, and that laboratory methods for identifying a specific gene can be patented – but the genes themselves are no more patentable than is a rock. This seems to make sense, but it’s also contrary to almost a century of precedent in the US.

Part of this controversy goes back to 1906, the first time a patent was granted for a product based on human biochemistry. That’s the year that a patent was granted (and upheld in court) for adrenaline – the rationale for granting the patent was that the laboratory-produced adrenaline was purified, making it more useful than the natural hormone. In the 1970s patents began to be granted for recombinant DNA – stretches of the genome that incorporate genes from foreign organisms. In fact, there’s a huge market for natural compounds made using recombinant DNA – putting the interferon gene into a bacteria made it possible to produce a formerly rare and exceedingly expensive drug for a fraction the cost of laboriously purifying it from human white blood cells. Putting a human interferon gene into a bacterium to produce a valuable drug inexpensively in large quantities was deemed to every bit as patentable as the device that made it possible to produce large quantities of inexpensive cotton.

From there it seemed a small step to patenting the genes themselves regardless of where they were found and in 1981 the Supreme Court permitted General Electric to patent a living organism – a bacterium that was genetically engineered to help clean up oil spills by digesting the spilled petroleum. Other patents followed and, before too long, companies were patenting not only recombinant DNA (and organisms), but also specific genes and methods of identifying them. This led to large-scale patenting of these genes and associated tests, culminating in the legal case of the Association for Molecular Pathology v. Myriad Genetics. Without going into the details of this case, which have been pretty widely reported, the Supreme Court decided that, while the company’s specific testing for the BRCA gene could be patented, but that the company could not own the gene itself – that anybody could develop their own genetic testing methodologies – opening the door for the development of competing tests. This seems to be a good thing – physicians, medical laboratories, and patients all stand to benefit from having not only more possible tests, but cheaper ones as well. So everyone stands to come out ahead…sort of.

Here’s the problem – Myriad Genetics spent a boatload of money to develop their genetic test for the BRCA gene and their test has likely saved a number of lives. It has certainly provided valuable information to all of the physicians and patients who have made use of it. Myriad’s test is medically valuable and Myriad – a for-profit company expected to be compensated for the time and expense they put into developing it. In fact, the whole capitalist system almost demands that Myriad be able to profit from their invention, and Myriad is obligated to do their best to make money for their shareholders. Society benefits from tests such as the one Myriad developed – if Myriad’s shareholders benefit as well then who can complain?

The problem is not Myriad’s profit-seeking motive; rather, the question is what Myriad can do to make their profit. Myriad had patented not only their genetic test, but also the gene that they were testing for and this is where the controversy crept in. By patenting the gene itself Myriad not only secured profits for their own test but they also precluded the development of any competing testing methods – it is this latter point that raised the ire of the medical and research communities, and this is the point that the Supreme Court attacked. Developing a new piece of technology – even biotechnology – is OK and Myriad is welcome to profit from it. But they can’t stake a claim to something that arose in nature and that they only discovered. Natural genes, in other words, are not like mineral deposits and the discoverer is not the owner.

Tags: , ,

No comments yet.

Leave a Reply