This week, the US Supreme Court took on a question considered fundamental to the future of scientific and medical research; can human genes be patented?
This question has spurred a fierce debate, but there may be a solution in the middle ground after all.
At issue in this case are two genes that can indicate a hereditary link to ovarian and breast cancer, called BRCA1 and BRCA2.
Utah-company Myriad Genetics found and isolated these genes in 1994, and then patented the genes and the subsequent diagnostic tests it developed around them.
Myriad is arguing that it should be allowed to retain these patents, a position supported by other biotech and pharmaceutical companies.
On the other side of the debate are doctors, scientists and people like Luba Djurdjinovic, executive director of genetic counseling service, the Ferre Institute in Central New York.
Djurdjinovic says that Myriad’s sole control of these genes has created a monopoly, and limits the ability of other labs to do anything with them. Myriad's control can also be a potential barrier to care.
“I see a problem where you have sole control of doing the testing, and not sharing a license with others who might over time improve the test.”
The diagnostic tests patented by Myriad reportedly cost about $200 to run, but they consistently charge up to $3,000 for the tests. This is slated as a measure to recoup the costs of their investment in developing the tests, according to Myriad president and CEO Peter Meldrum.
A compromise for both parties
Marjorie Hunter, a former patent attorney for biotech companies, says some form of monopoly is necessary as an incentive to initiate original research.
“It took millions of dollars to get this through clinical trials and to get it to the market place in the first place, and would they have been willing to invest that money if there wasn’t some surety that they would be the only ones on the market for a limited period of time,” says Hunter.
But Hunter says a compromise could be reached if congress changed the law so there could be a limited patent on genes. This would mean companies would retain a core patent but would be required to license out procedures like testing to other companies, creating more competitive pricing.
“I think that would be the way to go because then you’re tailoring, you’re still protecting the ability of the companies to go in and recoup their investment, but you’re at the same time still making sure that the other public health needs are met.”
Djurdjinovic agrees. She says it isn’t the patenting of genes that’s the problem, it’s the monopoly that Myriad has created.
“In the genetics community, we have watched the discovery of genes and the patenting of genes for 15 or 20 years. I don’t see any real problem in patenting a gene,” Djurdjinovic says.
Myriad contends that they have the right to keep their exclusive patents on the BRCA genes, because their isolation of the genes is sufficient to make them no longer a product of nature, but a product of man.
Patent law does not allow patenting of laws of nature or other products of nature, no matter how difficult the process of isolation or discovery. That is why gold has never been patented, nor gas, nor Einstein’s E=MC2.
During the oral arguments Monday, the justices of the Supreme Court seemed skeptical about Myriad’s claim that the genes were no longer a product of nature.
“I find it very, very difficult to conceive how you can patent a sequential numbering system by nature, in the same way that I have a problem in thinking that someone could get a patent on the computer binary code merely because they throw a certain number of things on a piece of paper in a certain order. I always thought that to have a patent you had to take something and add to what nature does. So how do you add to nature when all you are doing is copying its sequence?”
She followed up with an analogy, trying to grasp the argument of Myriad’s lawyer, Gregory Castanias.
“I can bake a chocolate chip cookie using natural ingredients -- salt, flour, eggs, butter -- and I create my chocolate chip cookie. And if I combust those in some new way, I can get a patent on that. But I can't imagine getting a patent simply on the basic items of salt, flour and eggs, simply because I've created a new use or a new product from those ingredients.”
Castanias responded with an analogy of his own, arguing that Myriad has done much more than just take a natural substance and place it in a different locale, they created something new.
“A baseball bat doesn't exist until it's isolated from a tree. But that's still the product of human invention to decide where to begin the bat and where to end the bat.”
The deeper issue
But the issue runs deeper than whether or not Myriad created the gene sequence they patented.
Ferre Institute’s Luba Djurdjinovic says that Myriad’s patents prevent other labs and companies from checking their test methods, or improving them.
She says this means that some people are not getting the best available care, and in some cases are getting incomplete results when they get the Myriad test to determine whether the genes BRCA1 and BRCA2 are present in their DNA – indicating they are at a higher risk of developing ovarian and breast cancer.
“More recently we have seen that the original gene test which was called comprehensive was excluding another aspect of testing that would examine the gene from a structural point of view, and this test was not routinely being included.”
“It really took some pressure from the outside, by other researchers, to get this lab to actually provide this additional study of the structure of the genes, but they offered it at an additional cost. So now we had a new era of access issues.”
“To say to someone that you have done a comprehensive analysis of this gene, but they did not have the second part of the test, leaves you with up to a 10-12 percent chance that there’s a problem in that gene. But people are walking away thinking they had a negative test result when they’re really high risk patients.”
Scenarios like this could be avoided, Djurdjinovic says, if other companies were licensed to work on these tests.
The Supreme Court is expected to hand down their decision in June.