The recent US Supreme Court decision to put a halt to the patenting of human genes sets limits on how the market can drive discovery.
We hold that a naturally occurring DNA segment is a product of nature and not patent-eligible merely because it has been isolated. - Justice Clarence Thomas
When the US Supreme Court ruled on gene patenting in June, it seemed to answer a 30-year old question: Can you own a piece of another living being? The answer, it seems, is no.
The origins of the case go back to 1994, when Berkeley scientist Mary-Claire King discovered a gene, BRCA1, directly implicated in a particularly severe type of breast cancer. She shared the information with a colleague who found a second gene that plays a similar role, BRCA2, and then developed a blood test to check for mutations in these genes that predisposed women to cancer. Then the colleague formed a company, Myriad Genetics, and patented not only the test, but also the genes themselves, adding a clause to prohibit competitive tests from being created.
The new ruling leaves Myriad’s test protected, but no longer covers the genes. It also allows others to develop new tests for them. This frees the field of synthetic biology from what was becoming an increasingly significant impediment to its ability to research and develop new DNA sequences.
The case has implications for more than just scientists. Nobel Prize-winning economist Joseph Stiglitz wrote: “The case was a battle between those who would privatise good health, making it a privilege to be enjoyed in proportion to wealth, and those who see it as a right for all and a central component of a fair society and well-functioning economy. Even more deeply, it was about the way inequality is shaping our politics, legal institutions and the health of our population.”
These are big claims, with a deeper ethical issue motivating the broader social, legal, political and health issues that Stiglitz mentions. The ethical question revolves around the cost of Myriad’s test and whether it unfairly disadvantages the poor. It favours, for example, patients who can afford the $4,000 Myriad charges for the test.
If you are Angelina Jolie and your mother dies of breast cancer, taking the test and acting on its results is simply sensible. But if you are on welfare, as were the two plaintiffs in the Myriad case, it is impossible to act sensibly, even in the reasonable pursuit of saving your life. In giving the company sole rights to the test, as well as to the means of developing competing tests, patent law allowed Myriad to name its price and create this ethical imbalance. It is bad enough to favour the powerful over the powerless in general, but it is a horrible idea when the stakes rise to the difference between life and death. And, it should be added, although the patent law was American, it had much wider implications as US economic interests shape the policies promoted in international trade.
The case also raised ethical questions about what scientists do and why. The term “scientist” was invented in the 19th century, as sophisticated techniques of seeing the world in greater and greater detail emerged and the capacities of what had been called “natural philosophers” began to wildly increase. It was at that time that modern patent law evolved, not to protect or honour science, but to protect the physical inventions that used science to make new devices and processes.
It is as if Galileo had patented both the telescope and the moons of Jupiter.
Myriad argued that patents create profits, and profits create the incentives that drive discovery. But researchers at Stanford University noted that precisely the opposite is the case. Scientists reported “turning away” from discovery for fear of violating some patent or other. Others noted that many of the best discoveries flourish without patent restriction.
Bioethicist Art Caplan was among those who argued that Myriad had both patented the device for “seeing” a gene and also patented the actual genes that they saw in the natural world. That is as if Galileo had patented both the telescope and the moons of Jupiter.
For many, halting the cascade of patents is a good act, for it set limits on the way the marketplace can drive discovery. Here is the final ethical issue: do we really wish to live in a world where every last being, creature and other living thing is tagged, owned and restricted? The supreme court seemed to say no.
Jonas Salk, it should be remembered, when asked why he had not patented the polio vaccine, turned to the reporter and said solemnly: “Patent it? You might as well patent the sun.”