Cancer cells. Credit: Getty
Across each human’s 46 chromosomes lie some 25,000 genes. But are these bits of nature — or removed variants of them — patentable or suitable to claim ownership of?
Such a question has divided the biotechnology industry after federal judges sided with Myriad Genetics, a diagnostic company wishing to patent two genes after it discovered mutations in them that appear to increase the risk of breast and ovarian cancer in women. Following the finding in the 1990s, it began charging women for gene analyses.
Last year a district court initially ruled against Myriad, but the decision was overturned last week. Critics of Myriad’s gene patenting argue that natural products such as genes cannot be patented and that claiming ownership over basic scientific findings slows down other researchers from developing treatments.
Though some are shocked by the second ruling, the truth is it’s more in line with previous gene patents. It depends on how one defines “isolated” DNA.
When scientists extract DNA from cells to study it, they often remove the genetic material from surrounding cellular matter such as proteins and other organelles. What you end up with is an isolated strand or segment of DNA, which can be further picked through to isolate areas with a specific set of genes on it.
If you could hypothetically reinsert an isolated gene into the area from which it originated, it may not even function the same. Along these lines, some scientists argue that isolated genes are different from natural genes and should continue to be patented.
But not everyone agrees that isolating genes is enough to deny others the right to study them.
Techdirt’s Mike Masnick draws an analogy that the DNA is still much like a severed finger (Ew, but bear with me). Even though a finger is removed from its source — a hand, it’s still fundamentally a finger.
In addition, critics of gene patenting express concerns about how the actions will affect patients who need treatment and might have to pay more because companies own the rights for particular diagnostic techniques (Myriad charges for its services, but states most insurance plans will help). Others think patents spur scientific innovation through garnering the funding needed to make the technology available to others, according to one industry blog post.
So what does it take to be able to patent a gene?
With between 3,000 and 5,000 genes already patented, it’s likely scientists have to prove that the isolated DNA is something that cannot be found in nature. There are also patents on the diagnostic methods parties develop to use the gene in helping patients.
The debate will continue, especially if the Myriad case is taken to the Supreme Court. Until then, what it means to claim ownership over genetic material remains as controversial as ever.