Granting a patent on that in 1880 was obvious. The 1980 Diamond v. Chakrabarty case granted the first gene patent — a true game changer so patent claims could include life forms. The patent was granted on the basis that genetically modified bacteria used to clean up oil spills didn’t occur in nature.
But since then, patents on whole genes have been issued. Now there are at least 4,000 sequences that have been patented from human genes.
In theory, patents are supposed to encourage innovation. But as more companies own your genes, the whole business of gene patenting has been put into doubt. The real tragedy occurs when the right of a patent overrides the right of a patient. And this can happen when a company has an exclusive license, the patient can’t get a second-opinion test and is stuck with the one test. That’s exactly what the Myriad patent was doing.
The BRCA1 and BRCA2 genes (linked to breast and ovarian cancer) were licensed exclusively to Myriad Genetics, until the US Southern District Court of New York invalidated them. As Myriad appeals the court’s decision, the biotech community bites its fingernails, worried about what this means for the other thousands of genes that have been patented since the 1980s.
While this might seem like a blow to the biotech industry, some argue this is a major win for human health as it opens up the market for diagnostic tests. The case isn’t completely surprising, as the industry has slowly shifted from focusing on a single gene to include more genes in whole-genome sequence analysis tests. So here’s the dilemma: Unless the patent system adjusts for the recent technological advances in genome sequencing, then the companies will run the risk of infringing gene patents.
The Wall Street Journal reports:
“Patents are fine,” said Robert Cook-Deegan, head of the Center for Genome Ethics, Law & Policy [at Duke University], who led the study. “What is troublesome is gene-by-gene exclusive licensing. If you have hundreds or thousands of patents already issued and exclusively licensed gene by gene, they are being infringed by whole genome sequence analysis,” he said. “How will you offer full gene sequencing without getting sued?”
Exclusive licenses to gene patents hurt competition in genetic testing, rather than encourage it — putting the gene patent practice into question. Cook-Deegan said in a statement:
“That finding suggests that while exclusive licenses have proven valuable for developing drugs and biologics that might not otherwise be developed, in the world of gene testing they are mainly a tool for clearing the field of competition, and that is a sure-fire way to irritate your customers, both doctors and patients,” said Cook-Deegan. “It’s notable that a gene linked to cystic fibrosis is not subject to an exclusive license, yet there is now a vibrant market for tests to identify carriers of the cystic fibrosis gene. This suggests the problem is not patents, per se, but how they are being licensed, particularly by universities.”
The report published in Genetics in Medicine looked at case studies of 10 clinical conditions such as cystic fibrosis and breast cancer. “In seven of the conditions, exclusive licenses have been a source of controversy. But in no case was the holder of exclusive patent rights the first to market with a test,” according to the statement. They concluded that gene patents block competition in the market place, instead of inspiring innovation.
Interestingly enough, despite Myriad’s monopoly on breast and ovarian cancer testing, the researchers found the company’s tests to be reasonably priced compared to the other diagnostic tests. But that wasn’t the main problem with the BRCA1 and BRCA2 gene patents — it was the fact that the broad claims made it impossible for other companies to develop a breast cancer test without running the risk of infringing the company’s patents. In a separate study published in Genomics, the researchers showed how broad the Myriad patents were: The 15 letter code from BRCA1 is so common in the rest of the human genome that it is found in 80 percent of genome sequences in the GenBank database.
Beyond the patent system, there are other ways to reward innovation. For more than a hundred years, the patent system has incentivized discovery, but this winner take all approach might be outdated. Caltech researchers found that the market economy can inspire more innovation than our patent system. Simply put, let investors buy and sell shares off their invention. Even if you do away with the patent system entirely, people would still invent. Creativity and intellectual curiosity are part of human nature.
60 Minutes gave a good overview: