On July the 22nd, 1873, a tall, serious man sat down at his desk. He picked up his fountain pen, plunged it into the ink bowl, and wrote the following words: “Be it known that I, Louis PASTEUR, of Paris, France, have invented Improvements in the Manufacture and Preservation of Beer and in the Treatment of Yeast”.
And thus begins the description of US patent 141072. Flanked by 141071, an improvement in furniture legs, and 141073, an improvement in wheel ploughs, this was no ordinary application. Monsieur Pasteur had invented an ingenious new way to purify brewer’s yeast. However, not content with rights for the process, Pasteur was seeking to copyright the organism itself.
Natural phenomena such as gravity, minerals and wild organisms are strictly off limits for patents. But Pasteur had ‘isolated’ his yeast, detaching it from nature and turning it into a man-made product. As far as this French scientist was concerned, his innovation was no different from inventing a toaster or light bulb.
As it turns out, Pasteur’s philosophy was a hit and scientists, entrepreneurs and patent lawyers have been enthusiastic patrons of biological patents ever since. Across the globe, companies can apply to patent organisms and a cornucopia of molecules, including hormones, enzymes, vitamins, sugars, antibodies, proteins and controversially—genetic material.
Human genetic material is no exception. In fact, babies born in 2015 enter a world in which the rights to a fifth of their genes are owned privately, by universities and commercial enterprises. How did we get to this point?
First: what is a patent?
Patents are documents that protect new inventions in four general categories: a method, a machine, an article of manufacture, and a composition of matter.
The concept of patenting an idea is largely uncontroversial. By providing a competitive edge and helping companies to recoup their costs, patents encourage private investment. Patents on bacterial, viral or non-human animal genes are met with similar indifference.
Human gene patents, on the other hand, are seen differently. Detractors say they lead to an impenetrable legal tangle and high prices for diagnostics, and more crucially stifle important research. Proponents for patents keep to the traditional line, arguing that the commercial security they provide quickens medical innovation, ultimately saving lives.
Dollars from DNA
It began with a group of scientists with an ambitious idea: what if you could chart the genome of the human species, and create a map of all three billion letters of the genetic code? The Human Genome Project, as it was known, soon led to a private sector boom, with investors willing to bet the findings would lead to a deluge of new diagnostics and treatments. Gene patent applications rose from 4,000 to 500,000 in six years.
A year after the publication of the data, Shanghai Joint Gene Technology Co. Ltd applied for more than 3,700 gene patents on genes involved in obesity, cancer, hypertension and dementia. In a healthcare market worth US$357 billion in 2011, the rights to these genes mean big business.
Copyright on cancer
The rules on what you can and cannot patent vary across the globe, but two landmark cases in the US and Australia have recently sharpened up the debate.
Both were filed against Myriad Genetics, a firm which provides genetic testing services. Among others, Myriad looks for BRCA1 and BRCA2 gene variants that are strongly linked to breast and ovarian cancer. It is an extraordinarily useful test; a mutation in the BRCA genes bump one’s lifetime risk up to 45-90 percent.
But at US$3,000 the test wasn’t cheap, and there was only one on the market. This is because, like Pasteur, Myriad Genetics didn’t just patent their technology—they opted to patent the genes themselves. Naturally occurring genes, which had existed long before Myriad Genetics, patent law or the discovery of the structure of DNA, had become property. Was this just land-grabbing, or genuine value-adding?
The ensuing legal battle sought an answer. To argue their case, Myriad Genetics looked to Pasteur again. The genes were isolated from their natural environment, therefore they were an invention, they contended. They were unsuccessful. A judge of the United States Supreme Court ruled that naturally-occurring DNA sequences are not patentable. However, a similar case tried in the Australian Federal Court reached the opposite conclusion.
Cancer Voices Australia, the patient advocacy group which filed the case, told Asian Scientist Magazine, “Cancer Voices is very disappointed in the recent Federal Court Decision. We understand that an appeal to the High Court is underway. [The ruling] will have a negative impact on research (delays, extra costs, less information), especially in the promising field of targeted therapies—something every cancer patient hopes to have good access to.”
Limit patents, don’t abolish them
Understandably, patients perceive gene patenting to be a major hindrance to treatment access. But should we discourage the patenting of genetic material? Intellectual property has a long history of encouraging innovation through investment. In the coming era of personalized medicine, are gene patents simply a pragmatic necessity?
“Overlapping patents on important gene sequences—also known as a patent thicket— tend to stifle downstream research and innovation. So in this case, more patents on a particular gene or technology are not always a good thing for long-term research and innovation, especially from the societal point of view,” Kenneth Huang, professor of innovation and entrepreneurship at Singapore Management University told Asian Scientist Magazine.
“The key thing is to make the patentability bar—such as its novelty, inventive step and industrial applicability—high enough, and the scope of each patent narrow or specific enough, so as not to potentially deter downstream research and innovation.”
The jury is still out on the patenting of genetic material, but perhaps the answer lies somewhere in-between. Until then, we will have to live with the uneasy knowledge that someone may already–or someday–own our genetic material.
To read more, subscribe to Asian Scientist Magazine in print and receive four issues of Asian Scientist Magazine delivered directly to your mailing address for 12 months, inclusive of taxes and postage.