On Monday, the justices will grapple with a big, seemingly straightforward question: Can a company patent a human gene? Two genes: BRCA1 and BRCA2 are linked to women who are at higher risk for breast cancer. In the mid 1990s, the geneticist who won the race to find the precise locations of the genes (on chromosomes 17 and 13), and isolate them, founded Myriad Genetics and took out 20-year patents on the genes themselves. Myriad then developed the test women take to discover whether they are BRCA carriers.
The problem is that Myriad’s test was the only one. Doctors and scientists who wanted to develop alternatives were blocked. Patients had no choices. The company’s handling of its monopoly generated outrage “Why were physicians and scientists so upset? It was the breadth of Myriad’s claims,” Robert Cook-Deegan, a policy researcher at Duke, explained to me. “And it really bothers women when they can’t get a second opinion, and there’s only one way to get the test, which is the way Myriad has chosen. This case is about who gets to make decisions—whether the company with the patent gets to say, ‘this is how we’re going to do testing for these genes in the United States.’ ”
The point of patents is to protect the investment it took to create or invent something new. It’s a way we reward and encourage invention. In 1793, as Yale history of science professor Daniel Kevles points out in his extremely helpful article for the New York Review of Books, Congress borrowed the words of Thomas Jefferson and declared patents available “for any new and useful art.” In 1952, the scope of potential patents expanded to “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement.”
Does “composition of matter” include the BRCA genes—and should it?
According to Kelves, the company blocked several biomedical scientists from conducting clinical research on the BRCA DNA, except under severe restrictions. It could, if it wished, prevent scientists from exploring the meaning of mutations of unknown significance that the tests might reveal. Myriad also kept for itself the right to incorporate the discovery of the new alterations in the BRCA genes, even those made by others, into the diagnostic tests. It thus retarded the development of the most comprehensive tests possible for women at risk. Except as the company allowed, no other laboratory could assess the reliability of its tests or improve upon their speed or cost.
Kelves goes on to say, "By empowering Myriad to control all research and uses of a unique part of nature, the patents impeded the progress of science and the useful arts. By restricting access to and use of the genetic information that the DNA embodied, they gave Myriad control over all 'thought, knowledge, and ideas' concerning the genes, a monopoly that the First Amendment, in accord with judicial holdings, prohibited the PTO [Patent Trade Office] from granting." Thus, with Myriad, the Court stands on the verge of endorsing a venerable principle in biotechnology patent law: human beings are improper subject matter for patenting.
Read the original link in Slate.
I especially encourage a better understanding by reading the article by Daniel Kelves' in the NYTimes Review of Books, "Can They Patent Your Genes?"
The problem is that Myriad’s test was the only one. Doctors and scientists who wanted to develop alternatives were blocked. Patients had no choices. The company’s handling of its monopoly generated outrage “Why were physicians and scientists so upset? It was the breadth of Myriad’s claims,” Robert Cook-Deegan, a policy researcher at Duke, explained to me. “And it really bothers women when they can’t get a second opinion, and there’s only one way to get the test, which is the way Myriad has chosen. This case is about who gets to make decisions—whether the company with the patent gets to say, ‘this is how we’re going to do testing for these genes in the United States.’ ”
The point of patents is to protect the investment it took to create or invent something new. It’s a way we reward and encourage invention. In 1793, as Yale history of science professor Daniel Kevles points out in his extremely helpful article for the New York Review of Books, Congress borrowed the words of Thomas Jefferson and declared patents available “for any new and useful art.” In 1952, the scope of potential patents expanded to “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement.”
Does “composition of matter” include the BRCA genes—and should it?
According to Kelves, the company blocked several biomedical scientists from conducting clinical research on the BRCA DNA, except under severe restrictions. It could, if it wished, prevent scientists from exploring the meaning of mutations of unknown significance that the tests might reveal. Myriad also kept for itself the right to incorporate the discovery of the new alterations in the BRCA genes, even those made by others, into the diagnostic tests. It thus retarded the development of the most comprehensive tests possible for women at risk. Except as the company allowed, no other laboratory could assess the reliability of its tests or improve upon their speed or cost.
Kelves goes on to say, "By empowering Myriad to control all research and uses of a unique part of nature, the patents impeded the progress of science and the useful arts. By restricting access to and use of the genetic information that the DNA embodied, they gave Myriad control over all 'thought, knowledge, and ideas' concerning the genes, a monopoly that the First Amendment, in accord with judicial holdings, prohibited the PTO [Patent Trade Office] from granting." Thus, with Myriad, the Court stands on the verge of endorsing a venerable principle in biotechnology patent law: human beings are improper subject matter for patenting.
Read the original link in Slate.
I especially encourage a better understanding by reading the article by Daniel Kelves' in the NYTimes Review of Books, "Can They Patent Your Genes?"
3 comments:
This is a tricky topic because Myriad did not create these genes, they merely discovered their existence and relation to Breast Cancer. Many of the arguments made in favor of allowing these patents, if applied to other fields and industries, could be crippling. For example, if someone at Google or Cisco discovered a new medium of transferring information electronically that could revolutionize the way people communicate, would it be fair for them to patent that knowledge - not necessarily the technology, but the knowledge and the theory!?
What makes the plaintiff claims so significant are the friend of the court briefs from so many supporters and researchers in science who feel their ability to find cures for people and better science is being hindered by a single organization's claim to the idea.
I strongly disagree with their stance that these genes be protected by patent. Scientific findings are the one area that I really don't believe there is any place for greed. Scientists work round the clock to find cures and make life better for people, and companies like Myriad are making this process a lot harder by trying to limit the useful research on the topic of these genes to only their own scientists.
Definitely seems to me that Myriad's patents are a gross extension of patent law. At the same time, I think Myriad should be financially rewarded for their discovery and research.
Economically speaking, patent law is one topic that invokes a lot of "grey" areas. There are fine lines, such as in this case, in which you want to protect the invention/creation/discovery/research of the acting party while not limiting innovation and competition. This is a key to the free market. Property rights need to be protected but not at the expense of new innovations. In this case, it seems Myriad's patents are causing an inefficient and noncompetitive market.
This story was also featured on NPR on Monday morning (4/15). I have attached the link.
Justices Appear Skeptical of Patenting Human Genes
I think one of the great takeaways from the show was when someone once asked Dr. Jonas Salk, inventor of the Polio vaccine, on who owns the patent. Salk’s response, “Well, the people, I would say. There is no patent. Could you patent the sun?”
Gene-patenting is dangerous territory. It would be easy to imagine an Orwellian future where some future disease can only be cured by some costly method from patent-holding medical company. The cure would be limited only to those that can afford it or are willing to indenture themselves for it. Hollywood has covered this topic ad nauseam.
On the other hand, patent laws should probably be reworked in its entirety to reduce the stranglehold on the competitive free-markets. I could probably live with an extremely low short shelve life on gene patents to help a medical company reduce costs and get a leg-up on the competition. If a five year patent method was put in place for gene-related cures, with no hope of renewal, then t could encourage more medical companies to find cures.
But in the end, it is about doing what is right. Saving lives and reducing suffering will always have its supporters. Like Dr. Jonas Salk, who has secured his place in history.
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