Where does nature end and human ingenuity start? And what type of "discoveries" are truly deserving of patent protection?
Those two important questions now rest in the lap of the U.S. Supreme Court. On Monday, the court heard arguments on whether private companies should be allowed to claim patents on human genes that they managed to "isolate" as opposed to genes that are modified in some way.
It's hard to imagine a case with more repercussions for patent law, biotechnology and bioethics. For more than 30 years, the U.S. patent office has been granting patents to companies and researchers that isolate living cells and make new uses of them. Bacteria and plant seeds are but two examples.
But researchers, patient advocates and medical groups are pushing back. They note that, for more than 150 years, the high court has held that a product of nature or a law of nature cannot be patented. It all started when Samuel Morse attempted to patent not just the telegraph but the electrical current needed to transmit characters or letters. In 1854, the court invalidated part of Morse's patent because electricity is a product of nature.
In the current case before the court, Myriad Genetics, a Utah biotechnology company, holds a patent for two genes that appear to have strong links to hereditary breast and ovarian cancer. Myriad did not modify these genes, but at significant expense, it spent years successfully isolating them amid the 20,000 genes found in the human body.
In court on Monday, a lawyer from Myriad warned that invalidating the patent would create a chilling effect on other biotechnology investments. "It would be dangerous," he said, for the court to deny patents to innovators who have made scientific advances using natural products.
The justices did not seem convinced. Justice Elena Kagan questioned if, under Myriad's argument, the "first person who found a liver" would be allowed to claim a patent.
Chief Justice John Roberts noted that someone who snipped and commercialized the leaf of a medicinal plant would not be allowed to hold a patent. "I don't see how this is different from snipping," he said.
Well, of course, it is different. Isolating genes is a far more complex undertaking than leaf snipping. Undoubtedly, society benefits when companies have the incentive to isolate genes that could cure or treat cancer or other diseases.
But patents, along with encouraging research, can also discourage it.
Holders of patents effectively have a 20-year monopoly to control how that gene is used for research, diagnostics and treatment. The medical and patient groups challenging Myriad say the company has used the patents to block other laboratories from testing the genes for mutations, hindering possible breakthroughs.
The judges are clearly uncomfortable wading into this intersection of biomedical research and commerce. But given 150 years of case law, it is hard to imagine how it could rule in favor of Myriad. Such companies deserve credit for the hard work involved with isolating genes. But these genes are not true inventions, which is what patent law is designed to protect.
The court should remember what Dr. Jonas Salk said when he was asked if he had a patent on the first effective vaccine to combat polio. He replied, "There is no patent could you patent the sun?"