Supreme Court Says Human Genes Cannot Be Patented, But Synthetic Genes Can

In its first ever ruling on human genes, the U.S. Supreme Court unanimously decided Thursday that individual human genes may not be patented, but ruled to allow the patenting of synthetically produced genetic material, a decision which may lead to lower costs for some genetic tests.

Recent research led by Dr. Christopher E. Mason of New York's Weill Cornell College of Medicine determined that a handful of for-profit companies held the patents to more than 40,000 DNA molecules, essentially claiming the entire human genome for profit.

One of the companies, Myriad Genetics, was named in the court case Association for Molecular Pathology v. Myriad Genetics, No. 12-398. Central to the legal arguments was the question of whether isolated genes are a product of nature or if their isolation is a human-made construction eligible for patent protection.

Myriad Genetics, a Salt Lake City, Utah-based biotechnology company, holds the patents in question by the court. Myriad owned or licensed the patents for two genes linked to breast and ovarian cancer: BRCA1 and BRCA2. The genes made their way into headlines recently when actress Angelina Jolie revealed she carried "faulty" BRCA1 genes and underwent a preventative double mastectomy.

The high price of the genetic test used to diagnose Jolie and others like her is associated with the patents held by Myriad. The company reportedly filed patent infringement suits against others who conducted testing based on the gene. As a result of the Supreme Court decision, the price is expected to fall.

The court ruled that isolated genes are part of nature and cannot be patented, even if the nature of their isolation is the work of man. On the other hand, synthetically produced genetic material, known as cDNA, may be patented, the court determined.

Speaking for the court, Justice Clarence Thomas wrote "A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes."

"Groundbreaking, innovative or even brilliant discovery does not by itself satisfy the criteria" for patent eligibility, Justice Thomas said, according to The New York Times.

Dr. Mason, of the Weill Cornell College of Medicine, said in March before the Supreme Court hearing began, "If these patents are enforced, our genomic liberty is lost."

"I am extremely pro-patent, but I simply believe that people should not be able to patent a product of nature," Dr. Mason said in a statement. "Moreover, I believe that individuals have an innate right to their own genome, or to allow their doctor to look at that genome, just like the lungs or kidneys. Failure to resolve these ambiguities perpetuates a direct threat to genomic liberty, or the right to one's own DNA."