Patent protection—that holy designation of intellectual property rights for inventors of novel and non-obvious gadgets, doo-hickeys, and thingamabobs—now extends in Australia to any genetic material extracted from the human body, according to a federal court ruling earlier this month. The decision, which upholds a controversial ruling from last February, officially ushers in an era of genetic privatization that many Australians worry affords companies a dangerous level of exclusive control over natural gene sequences. Awarding sole ownership of these sequences threatens the general public’s ability to take advantage of any medical innovations the patents may produce.
The case revolves around a gene mutation known as BRCA1, which, when detected in individuals, is used to diagnose hereditary breast and ovarian cancers. Only one company in Australia, the one that owns the rights to the gene, may conduct these tests, which take weeks to generate results, have a sizable margin for error, and cost upwards of $4,000 dollars. Advocates say this right to exclusive use is a necessary incentive to fund the research required to extract and isolate such genetic material, but many critics believe this restricts the development of cures for genetically associated diseases, and fundamentally disagree that any naturally occurring gene should even classify as an invention. “This is a bit like patenting oxygen,” a patent lawyer told Guardian Australia.
Australia isn’t the only country struggling with this ethical and scientific dilemma. Last year the U.S. Supreme Court ruled the opposite, claiming that isolated DNA is a “product of nature and not patent eligible.” This language harkens back to 1889, to when the U.S. Commissioner of Patents’ first rejected a biological patent application, for a fiber found in pine tree needles, which the commissioner called an “unreasonable and impossible” proposal, as ludicrous as attempting to patent “any new gem or jewel in the earth.” Meanwhile, the European Patent Organisation still allows the patenting of natural biological products if they are “isolated from [their] natural environment or produced by means of a technical process,” and Japan, in an utterly reasonable compromise, allows biotechnological patents as long as they are “industrially applicable,” but not for medical activity like diagnosis, therapy, or surgery.
But the question extends far beyond breast cancer. Until the U.S. ruling last June, America’s particularly aggressive patent office had issued between 3,000 and 5,000 patents on human genes and 47,000 more on inventions involving genetic material. Scientists have isolated genes associated with increased risk of cystic fibrosis, heart arrhythmias, hemochromatosis, and more. Patents have also been issued for hormones, vitamins, and even, since 1980, genetically modified organisms, the first of which was controversially granted to a General Electric engineer for a genetically modified bacterium that could break down crude oil to help clean up oil spills.
And yet, the idea of owning real human DNA still doesn’t sit quite right with the public. In Australia, the company exclusively licensed to conduct breast and ovarian cancer tests stopped enforcing its patent rights against pathology and cancer centers years ago after intense public backlash, blunting the blow of this month’s court decision. Even Myriad Genetics, the company that owns the BRCA1 patent, after the U.S. Supreme Court decision last year, admitted (however cynically) to understanding the vital crux of this debate: medical progress. “The battle that really matters isn’t in court,” they said. “It’s the one against cancer.”
We agree.
