Soon after learning that his son had autism, Hollywood producer Jon Shestack (“Air Force One”) tried to get researchers investigating the genetic causes of the disorder to pool their DNA samples, the better to identify genes most likely to cause that disorder. But his approach to scientists at universities across the country in the late 1990s hit a brick wall: They refused to join forces, much less share the DNA.
“Each thought they needed to hold on to it to publish and patent,” Shestack said in an interview. “This seemed criminal to us.”
The U.S. Patent and Trademark Office has granted patents on at least 4,000 human genes to companies, universities and others that have discovered and decoded them. Patents now cover some 40 percent of the human genome, according to a scientific study led by Christopher Mason of Weill Cornell Medical College. But if foes of gene patents have their way, that percentage could be rolled back to zero.
On Monday, the U.S. Supreme Court will hear oral arguments in a case that calls into question whether human DNA can be claimed as intellectual property, and remain off limits to everyone without the permission of the patent holder.
The lawsuit, filed in 2009 by the American Civil Liberties Union and the Public Patent Foundation, challenges seven patents held by Myriad Genetics Inc on two human genes linked to breast and ovarian cancer. A federal judge said the patents were invalid. An appeals court overruled that decision, and the case landed in the Supreme Court.
The legal issues center on whether the genes that Myriad patented, called BRCA1 and BRCA2, are natural phenomena. The ACLU says human DNA is a product of nature, and as such not patentable under the Patent Act. Myriad argues that its patents are for genes that have been “isolated,” which makes them products of human ingenuity and, therefore, patentable.
As scholars debate the legal questions, two parallel issues have emerged: whether patenting genes thwarts scientific research, and whether it harms patients.