Experts Say Court's Decision on Human Gene Patents Is a Win-Win
Georgina Gustin; Blythe Bernhard, St Louis Post-Dispatch (MO)
The Supreme Court ruling Thursday that naturally occurring human genes cannot be patented effectively ended the monopoly that Utah- based Myriad Genetics had on breast and ovarian cancer tests.
The news was hailed as a victory by health advocates and medical researchers, who can now not only access the genes at issue the BRCA1 and BRCA2 but all other patented human genes without infringement. In the wake of the decision, several other testing companies, including Quest Diagnostics, announced it would perform the tests and at far cheaper prices than Myriad's.
The court's unanimous ruling, however, was mixed. It said that naturally occurring DNA could not be patented, but synthetic DNA can still be, giving patent protection advocates and Myriad a victory, too. The decision also means that methods of isolating genes still qualify for patent protection.
The Post-Dispatch interviewed experts from a broad range of fields, from medicine to law, about the court's ruling.
Here's what they had to say about what was at stake and what the decision could mean.
Professor of physiology, biophysics and computational biomedicine, and author of a study showing that 41 percent of the human genome is covered by patents, Cornell University
I'd say this represents a great win for genetic liberty, both for patients and for doctors. The American Medical Association said it was a big win for patients, and I couldn't agree more especially for breast and ovarian cancer, but for all types of cancer. This is an important cancer gene and now it's open for study to everyone.
(Myriad) didn't just own a test or a method, they owned anyone's DNA as soon as it was isolated. They didn't say we patented a series of letters, they said we patent anything that remotely looks like that, which the court correctly said is not patentable.
It would have been great to have both the patents (on natural and synthetic DNA), but of the two this is the most restrictive one 99.9 percent of testing is done on DNA not cDNA.
Plenty of companies aren't scared anymore. This is going to open the floodgates on new research and ideas.
Dr. Julie Margenthaler
Associate professor of surgery and breast cancer specialist, Siteman Cancer Center
This ruling has important implications for physician scientists actively engaged in genetic research. We are on the brink of significant strides in our understanding of the genetic links to many diseases.
For those of us who care for cancer patients, personalized cancer care hinges on the ability to genetically examine the pathways that result in a normal cell becoming a malignant cell. Because some companies held patents to pieces of the genome involved when whole genome sequencing is performed, there was at least some concern over patent infringement. With this ruling, we can continue to move our research forward and benefit the lives of our current and future patients.
Executive director, American College of Medical Genetics and Genomics (plaintiffs in the case), and former professor of pediatrics at Washington University
It has enormous implications for labs and the public, certainly for breast cancer and for many other cancers. Since the case was settled (Thursday), at least four labs have put the test online. Prices are about half of Myriad's $3,500 down to $2,000 overnight.
It's a win-win for everybody. It used to be when you had the tests done by Myriad, you couldn't get that test confirmed by anyone else. Now the public can confirm the test and get second opinions, and that has a lot of value for patients. And I think it'll open up the research.
There are two aspects of this that still remain open. Because 4,000 to 5,000 genes have patents on them, many people signed licensing agreements to use the gene. One of the questions is about the contract they signed. They will probably be able to challenge their contract now. …