The business of DNA is undergoing a revolution. We can already get our genes scanned for the bargain-basement price of $99. Soon well be able to have entire genomes sequenced for less than the cost of a MacBook Air. Thats 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, theinfamously drawn-out Association for Molecular Pathology v. Myriad Genetics. The casedates back to a 2009 lawsuit filed by the American Civil Liberties Union andcenters 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 Geneticstold the Courtits inventors had created a new, never-before-seen molecule.

Some of the justices dont seem to buy Myriads argument, sparking some hope in the genomics and personalized medicine communities that when the Court finally decides the case probably in late June theyd have reason to celebrate.

What were 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 Myriads 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 dont 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 researcherscease-and-desist ordersand 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.Thats 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.

Read more from the original source:
Health Science | Gene Patents Are Sabotaging the Future of Medicine

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