By George Dvorsky
The idea of patenting a gene seems strange, and it’s a practice that’s made weirder by virtue of the fact that the genes of living humans can also be patented. How is this possible? And what are the potential pitfalls? Here’s what you need to know about the current state of human gene patents — and why the current laws need to be reconsidered.
The Human Gene Patent
Patents are typically granted for something that’s tangible, like a mechanical device. It’s done to protect inventors and companies from being ripped-off by their competitors; they’re the ones who put the time and work into developing the technology, so they should be protected from those looking to copy their ideas. It’s a process that works, and it makes sense.
Recently, the system has been expanded to keep pace with developments in technology, including advances that have been brought about by the biotech revolution. Subsequently, patents have been granted for less tangible things — including “inventions” that are connected to fragments of genetic code.
Specifically, a gene patent can be granted for a claim on a nucleic acid, or for a method of diagnosing a genetic condition. Claims can be made over a DNA or RNA sequence, or a method of identifying the existence of a DNA or RNA sequence in an individual. This can include both coding and non-coding DNA. So, for example, a patent can be taken out on the gene sequence responsible for a predisposition to Alzheimer’s.
Product and process claims tend to fall within four broad categories, namely isolated DNA or RNA molecules, diagnostic kit tests, methods of diagnosis through genetic testing, and gene chips and microarrays. Consequently, by patenting human genes that can be associated with these potential products, companies stand to make a lot of money — hence the intense demand for human gene patent claims.
The Mad Rush to Patent
And indeed, once the practice of gene sequencing began in the late 1990s, there was a mad rush to patent human genes. As far back as 2005, a study showed that over 4,000 genes — about 10-20% of the human genome — were claimed in some way by U.S. patents (it’s worth noting that a more recent study has taken exception to this claim). A similar number of patent claims appeared in both Canada and Europe. The wild west era of human gene patenting had begun.
The flurry of human gene patenting sparked a furious debate in legal, political, health, and philosophical circles. Since the practice began, a flurry of questions have been raised in regards to the sensibility of human gene patenting, and whether or not it’s in the public’s best interest.
A common argument was that the human genome — and all its inner workings — was part of the commons, and that no one should be able to own or patent it.
But of all the issues, the one that clearly stood out was the logic behind declaring a gene patent as an invention or a discovery — which to this very day qualifies it for patentability. According to the key statutory provision (Section 101 of Title 35) of the U.S. Code:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
This complex and open-ended wording is what has allowed companies to patent human genes — a practice that came under scrutiny in an important case that began back in 2009.
The Myriad Genetics Case
Several years ago, a U.S. company called Myriad Genetics was granted a patent for two human genes: BRCA1 and BRCA2. Both of these genes are linked to an increased risk of breast and ovarian cancer — which would be of great interest to women wanting to know if their DNA carried this mutation.
Not surprisingly, Myriad Genetics was criticized for charging costly fees for its diagnostic services. Many people condemned the practice, arguing that women have the right to look at their own DNA without having to pay a license fee.
Even the ACLU chimed in, saying that the patents stifled diagnostic testing and research that could lead to cures, and that it limited women’s options regarding their medical care. The ACLU also declared patents on these two human genes as being unconstitutional and invalid.
The case went to court. In 2010, a federal judge overturned Myriad’s patents, arguing that genes are a “product of nature,” and that they should not be patentable. The U.S. Justice Department noted that, “genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible” and added that “the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a “human-made invention.”