If it's natural, it can't be patented, U.S. Supreme Court says. / PB Post
Now that the U.S. Supreme Court has decided that human genes cannot be patented, but a man-made molecule can, leading scientists, cancer patients and patent lawyers are debating what the decision will mean both for people and for the biotechnology industry.
Women have used the BRCA 1 and 2 tests by Myriad Genetics to decide whether to have healthy breasts and ovaries removed as a precaution, because of the test’s ability to predict cancer. But Myriad’s U.S. monopoly has raised the test’s price and made it difficult for consumers to obtain second opinions, many say.
The reaction to the decision was swift and strong:
Democratic National Committee Chairwoman Rep. Debbie Wasserman Schultz, on Twitter:
Debbie Wasserman Schultz, D-Florida
With #breastcancer I made life-altering choices based on 1 test b/c gene patent allowed no 2nd opinion. #SCOTUS lifted burden today. #BRCA
— D Wasserman Schultz (@DWStweets) June 13, 2013
Dr. Eric Topol, genomics professor at The Scripps Research Institute, writing in the San Diego Union-Tribune:
“Each test that Myriad runs costs $4,000; last year they brought in over $400 million of revenue for the two gene tests…
The massive database that Myriad assembled should ideally be released to the public, as it will take years to reassemble such information…
In Europe…there are about 70 laboratories that currently perform BRCA gene testing. In the United States there is one.”
Peter D. Meldrum, president and CEO, Myriad Genetics
“Following today’s decision, Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis® test…While we are confident that Myriad offers the highest quality genetic tests in the world, we also support patients’ rights to seek second opinion tests…”
Wendy H. Bost, Quest Diagnostics media relations director:
“…We expect it will open opportunities for Quest Diagnostics to develop new testing services, including in the area of hereditary breast cancer…We now intend to validate and offer a BRCA1 and BRCA2 test service to physicians and patients later this year.”
Genes are made from DNA./NIH
“That the Patent Office approved patents on our genes is a profoundly disturbing idea…The patents on normal DNA sequences have led to limits on research to develop diagnostic tests and treatments, and thus have also greatly increased the cost for tests…”
Pharmacology professor John B. Hogenesch, University of Pennsylvania School of Medicine, former founding Scripps Florida scientist
“For the most part, I don’t think this will have a significant impact on biotech or the speed of scientific progress. However, the ruling is important: It means that other companies can develop methods to read naturally occurring genotypes…This will bring the price down and make these tests more available to patients. So patient care will be improved.”
Thomas Fitting, chief patent counsel for The Scripps Research Institute
“Most relevant genes have already been identified, and most of the patents that were filed are already expired… I think over all, people are breathing a sigh of relief because it’s over. We have clarity.”
J. Craig Venter, CEO of Synthetic Genomics Inc. and the J. Craig Venter Institute
“This ruling is good news for the biotech industry as it clarifies the rules and reduces uncertainty…The field of genomics and specifically synthetic genomics holds great promise…These man-made genetic constructs are already being used to create new vaccines, biofuels and nutritional products. And the ability to protect this intellectual property is a necessary component of a vital and robust science and biotechnology industry.”
