A federal district court judge effectively voided the monopoly on breast cancer gene testing and leaves the rest of the human genome up for a squabble.
The ruling by New York District Court Judge Robert Sweet has stripped Utah-based Myriad Genetics of the patent on the BRCA 1 and BRCA2 genes, opening the door for rivals to offer testing. Myriad plans to appeal the ruling. All breast cancer gene testing in the country has been performed by Myriad up until now.
More than 20 percent of the human genome is already patented and is potentially impacted by the judge's ruling. This translates into about 4,300 genes that have already been patented by various companies, scientists, and academics. The consensus in the biomedical field is that Sweet’s ruling could have wide-ranging consequences.
Despite the patents already granted for these genes - patents now in question - scientists and researchers could begin to withhold their information, for fear of not being compensated, experts said.
“You won't have disclosure to move onto the next step in biology,” said Kevin Noonan, a Ph.D.with more than 10 years of experience in the biotechnology field and who is also a practicing patent attorney at Chicago-based McDonnel Boehnen Hulbert & Berghoff.
“It's like someone provided all the parts to my car, and right now I have all of these parts on the garage floor and I know what a car looks like and what the parts look like, but I don't have a blueprint to put it together. The problem here is that if you say you can't have a patent for genes than you will have companies that won't disclose their information and then you won't have a blueprint to move forward with.”
Dr. Deborah Lindner, a physician with The Women’s Group of Northwestern Obstetrics and Gynecology, said she believes that Sweet’s ruling will have another impact. “There could be an increase in the amount of research done to attempt to find cures for disease.”
If this ruling sticks, Myriad Genetics could find other labs rivaling it and might be forced to lower the cost for the BRCA test.It costs about $3,000 for Myriad to perform the analysis and insurance companies don’t always foot the bill. According to Sweet, the same test in Canada, where there is no patent, can be performed for less than $1,000.
While Noonan and Lindner may not agree on the patenting of genes they do agree that Myriad must protect its investment
“When it comes to patenting a test, though, there should be no controversy,” Linder says. “The company spent significant time and money figuring out the structure of the gene and how to test for it, and thus are able to charge what they want to for the test. This ‘monopoly’ is the same thing that occurs anytime a drug is developed or a medical device is developed. The company spends time and money researching and developing the test, drug or device, and then is able to charge a high price while it is under patent to recoup the money they put into the research and development and make a profit that justifies doing the R&D in the first place.”
Since Sweet’s ruling, a big question has become why anyone would want to patent genes in the first place?
“A gene should not [be] patented because the patent then restricts anyone else from studying that gene, looking for new ways to develop therapies for the genetic condition or figuring out what other genes interact with that gene to affect the condition,” she says. “Patenting a gene limits other scientists from making progress in discovering new things about the gene or the disease process it causes.”
Noonan says that the opposite is true, "People miss that the patent system requires, demands disclosure, because you don't get a patent without disclosure,” he says.
Examination of the actual patents for the BRCA1 and BRCA2 genes make it clear that everything is divulged. There is information pertaining to the background of the invention, a summary of it, and there is also a detailed description of the invention. Everything is provided, right down to the last nucleotide.
In May 2009, the American Civil Liberties Union along with several breast cancer awareness groups and scientific associations that represent about 150,000 researchers filed the lawsuit against Myriad in federal court, seeking to invalidate the patenting of the BRCA1 and BRCA2 genes. The lawsuit stated that "products of nature" cannot be patented.
Sweet agreed. According to the judge, the patents were “improperly granted” because they involved a “law of nature.”
Lindner said that there is no reason for Myriad not to appeal that ruling, “They are trying to protect their source of income," she said.
According to Noonan, Myriad has a chance to win. “In the correct reading of the law they would win hands down. The problem is that there is a possibility that the court would decide, in what I would characterize, as the wrong way, but there is no way to predict the outcome."