Gene Patents Are Sabotaging the Future of Medicine
The business of DNA is undergoing a revolution. We can already get our genes scanned for the bargain-basement price of $99. Soon we’ll be able to have entire genomes sequenced for less than the cost of a MacBook Air. That’s huge considering that not so long ago it cost billions of dollars to map a single genome.
But the ability of scientists, doctors and companies to tell us how our genes might impact our health now hinges on a case being debated by the U.S. Supreme Court, the infamously drawn-out Association for Molecular Pathology v. Myriad Genetics. The case dates back to a 2009 lawsuit filed by the American Civil Liberties Union and centers on the question of whether genes — those snippets of DNA that encode the proteins inside cells — can be patented. The ACLU and the scientists, advocacy organizations and patients it represents say no because a gene is something that exists in nature, just like a leaf, an oxygen molecule or gold. Myriad Genetics told the Court its inventors had created a new, never-before-seen molecule.
Some of the justices don’t seem to buy Myriad’s argument, sparking some hope in the genomics and personalized medicine communities that when the Court finally decides the case — probably in late June — they’d have reason to celebrate.
“What we’re arguing about is really the future of medicine and either accelerating it or slowing it down,” says Dietrich Stephan, the CEO of SV Bio and founder of Navigenics. “[Gene patenting] turned into this quagmire that was holding the field back.
“We need to be able to instantaneously deliver that information to [patients] and their doctors and not go through all these crazy hoops of paying the license holder.”
The real value and potential for innovation, experts say, comes after genes or gene mutations are identified, and that genetic insight is then applied to a new process, method or algorithm. In most cases, those new processes, methods or algorithms would still be patentable, but not the underlying genetic code.
Diagnostic and therapeutic companies would compete on the quality and price of their tests instead of having a monopoly on the entire pipeline, as Myriad does now with its patents on BRCA1 and BRCA2, two genes associated with early-onset breast and ovarian cancers. Women who want to be tested for these genes have to take Myriad’s test, which can cost several thousand dollars.
As it stands now, the patent-happy U.S. Patent and Trademark Office has doled out thousands of gene patents since the early 1980s, many of which cover human genes. Myriad Genetics is not the only organization that holds these kinds of patents. 23andMe, Incyte Genomics, Genentech, Harvard, MIT and the University of California are but a few of the institutions that have held or continue to hold gene patents. Some of the patents don’t require licensing fees and are pretty open. Others are locked up tight. Run afoul of the wrong gene patent, and you can expect a lawyer to get involved.
Myriad has sent researchers cease-and-desist orders and Harvard and MIT have filed lawsuits. All of which hampers the progress of scientific research, says Rochelle Dreyfuss, a professor at the New York University School of Law who specializes in intellectual property law and science. “In order to do a full sequence for a person, you might have to get permission from all of them,” says Dreyfuss.”That’s a lot of different people, and any one person could just say no.”
That defeats the purpose — and potential — of whole-genome sequencing, and in a way, robs patients of their right to know their own genetics, a point the Association for Molecular Pathology has made in the past, says Dreyfuss. Their argument is that people have a First Amendment right to know the information inside their own bodies, but “the courts have never ruled on that issue,” she said.
Like the pharmaceutical industry, Myriad and others argue that without the ability to patent genes, patients might be worse off. Lacking financial incentives, companies might not be willing to put in the years and millions of dollars it can take to make these kinds of advances, a point some of the Justices seemed to recognize this week. Whether that’s true or not is debatable.
“In the drug space, people have very clearly figured out that the most airtight patents are around the molecules themselves,” says SV Bio’s Stephan. “Even if that molecule targets a gene, no one would argue that you’d need to have the gene patented in order for that patent to stand on its own.” We should take that model and apply it to diagnostics, he says, where the patentable discoveries are not genes, but new test kits that probe for genetic conditions or predispositions to certain diseases better and faster than previous technologies. That’s how you foster innovation and how you assuage the field that the market is going to be okay, Stephan argues.
Whatever the Court decides this summer, one thing is clear: this case is only the beginning of the debate around who owns what genetic information, says Stanford’s Drew Endy, a bioengineer and an advocate of open-source biotechnology. In the future, scientists, doctors, companies and lawyers will have to grapple not only with gene sequences, but “what you can use the sequence to do.” That, he says, takes us into the brave new world of genetic copyright law, and if the music and software industries have taught us anything, it’s going to be a very long, uncomfortable ride.