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.