You can’t patent a gene. It’s that simple. That point was confirmed last week in a unanimous decision of the United States Supreme Court. That decision, announced last week, held that the human genetic code cannot be patented by a corporation, individual or institution. That’s a good thing because I can’t really imagine a couple paying royalty payments upon the birth of a child – a bit of a stretch, but not much.
Intellectual property is a complicated area of the law. However, the basis of the law is pretty simple. You have to invent it. You have to create it. You cannot just think of it (i.e. it cannot be an idea). You cannot just discovery it (e.g. If I discover a new star in the galaxies does it belong to me).
The Court has confirmed something that I think is basic, common sense. Last week’s decision affects the future of genetic testing, but it can really be applied to any field.
The test case revolves around a gene, which has been implicated directly in causing breast and ovarian cancers. In fact, it’s the genetic information encoded in the BRCA1 and BRCA2 genes, involved in Angelina Jolie’s decision to undergo a preventative double mastectomy.
Until the legal challenge, the patent holder of the gene, Myriad Genetics, charged as much as $3,000 for a genetic test to detect the cancer-linked BRCA mutations. Because of the patent it was the only company producing the test. The price tag put it beyond the reach of many people who may have needed it. That’s likely to change. Lower cost tests are great, but an unfortunate by product may be that commercial firms will have fewer financial incentives to pursue genetic research if they can’t own the genes.
The whole issue raises some fascinating and disturbing questions about out nation’s patent system. How can a company patent a gene (or anything else) that occurs naturally in our bodies? You can’t, according to the Supreme Court.
Justice Clarence Thomas wrote:
“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” he said. “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.”
You can patent the process by which you isolate the gene (although here Myriad was using widely known techniques), you can patent “synthetic DNA” produced in the laboratory and you can patent new applications. You just can’t patent the gene. Again, you can’t patent the discovery.
The patent system, originally, was devised by the nation’s Founding Fathers (who even gave it a place in the Constitution) to provide an incentive for innovation. The theory was and is that to innovate and to continue to innovate you need to be able to reap some of the rewards. That needs to be balanced by the need for other innovators to take cutting edge science and to run with it.
The balance is that you can reap the rewards of a patent – but only for a limited time. The patent also cannot be overly broad. If its scope is to0 all-encompassing the incentive to create and innovate will disappear.
Has that balance been upset? It’s a relevant and extremely important question in this digital age, and the answer seems almost unequivocal: Yes. The Myriad case seems an example of what can go wrong. Companies are incentivized to create important, potentially life saving tests only if the result is akin to winning the lottery. Patents are now so broadly drawn that a class of patent owners no longer innovates but spends their time searching for patent violators to sue.
It is time to revisit the nation’s patent process. The digital age has not only driven the pace of change to breakneck speeds, but has mired or perhaps co-mingled innovation and litigation. It’s time to reboot the system to once again achieve a balance between innovation and incentive.