WASHINGTON (AP) — The Supreme Court seemed worried Monday about the idea of companies patenting genes that can be found inside the human body, as it heard arguments in a case that could profoundly reshape U.S. medical research and the fight against diseases such as breast and ovarian cancer.
The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years, but opponents of Salt Lake City-based Myriad Genetics Inc.’s patents on two genes linked to an increased risk of breast and ovarian cancer say patent protection should not be given to something that can be found inside the human body.
“Finding a new use for a product of nature, if you don’t change the product of nature, is not patentable. If I find a new way of taking gold and making earrings out of it, that doesn’t entitle me to a patent on gold. If I find a new way of using lead, it doesn’t entitle me to a patent on lead,” lawyer Christopher Hansen said.
Allowing companies such as Myriad to patent human genes or parts of human genes will slow down or cripple lifesaving medical research such as that in the battle against breast cancer, he said.
But companies have billions of dollars of investment and years of research on the line, with Myriad arguing that without the ability to recoup their investment through the profits that patents bring, breakthrough scientific discoveries needed to combat all kind of medical maladies wouldn’t happen.
That concerned several justices.
“Why shouldn’t we worry that Myriad or companies like it will just say, ‘Well, you know, we’re not going to do this work anymore?’” Justice Elena Kagan said.
Mr. Hansen said that a company could get recognition for its work and that money for research would always be available, a statement that Justice Anthony M. Kennedy said wasn’t sufficient.
“I don’t think we can decide the case on: ‘Don’t worry about investment. It’ll come,’” Justice Kennedy said.
The Supreme Court already has said that abstract ideas, natural phenomena and laws of nature cannot be given a patent, which gives an inventor the right to prevent others from making, using or selling a novel device, process or application.
Myriad has used its patents to develop its BRACAnalysis test, which looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer.
Women with a faulty gene have a three to seven times greater risk of developing breast cancer and a higher risk of ovarian cancer. Men also can carry a BRCA mutation, raising their risk of prostate, pancreatic and other types of cancer. The mutations are most common in people of Eastern European Jewish descent.
Myriad sells the only BRCA gene test.
The American Civil Liberties Union and other groups challenged Myriad’s patents, arguing that genes couldn’t be patented, and in March 2010 a U.S. District Court in New York agreed. But the U.S. Court of Appeals for the Federal Circuit has now ruled twice that genes can be patented. In Myriad’s case, it’s because the isolated DNA has a “markedly different chemical structure” from DNA within the body.
But the ACLU is arguing that isolating the DNA molecules doesn’t stop them from being DNA molecules, which they say aren’t patentable.