News Article

Supreme Court says natural human genes can't be patented
Date: Jun 13, 2013
Author: Pete Williams
Source: NBC News ( click here to go to the source)

Featured firm in this article: Myriad Genetics Inc of Salt Lake City, UT



The Supreme Court ruled unanimously Thursday that natural human genes cannot be patented by companies, but it said that synthetically produced genetic material can.

A naturally occurring piece of DNA is "a product of nature and not patent eligible merely because it has been isolated," the court said.

The case centered on a Salt Lake City company called Myriad Genetics that was granted patents for isolating two human genes, known as BRCA1 and BRCA2, that indicate a higher risk of breast and ovarian cancer. The company now markets tests for those genes.

Myriad said before the ruling that it never wanted to patent genes in people's bodies — only the molecules of DNA that it creates in the lab to test patients and determine their cancer risks.
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Those molecules appear to be patent-eligible under the Supreme Court ruling, and Myriad stock soared after it was handed down. In late morning trading, the stock was up 11 percent.

BRCA1 is the gene carried by actress Angelina Jolie, who determined after a test that she was at higher risk of developing breast cancer and chose to have a double mastectomy.

Mladen Antonov / AFP - Getty Images, file

A woman holds a banner demanding a ban on human-gene patents during a protest outside the Supreme Court in April.

The court said that Myriad had found something important and useful, but it ruled that "groundbreaking, innovative, or even brilliant discovery" does not by itself guarantee a patent.

The opinion was written by Justice Clarence Thomas.

The justices had wrestled with whether Myriad's work was a product of invention or nature. The biotechnology industry warned that a ruling against the company would threaten billions of dollars in investment.

The government has already granted patents on 4,000 human genes, mostly to companies and universities.

An oral argument in April was so deeply technical — introns, exons and messenger RNA were all discussed in detail — that justices and lawyers alike had to grope for everyday analogies.

Gregory Castanias, a lawyer for Myriad, likened the isolation of genes to the creation of a baseball bat, which "doesn't exist until it's isolated from a tree."

"But that's still the product of human invention," he said, "to decide where to begin the bat and where to end the bat."

Doctors and scientists who challenged the patents said that their research had been hindered. The lawyer arguing for them said that Myriad deserved credit for unlocking the secrets of genes — just not a patent.

"One way to address the question presented by this case is: What exactly did Myriad invent?" asked the lawyer, Christopher Hansen of the American Civil Liberties Union. "And the answer is nothing."

Justices on both sides of the ideological spectrum seemed concerned about whether companies like Myriad would scale back investment in research if they were not rewarded with patents.

"What does Myriad get out of this deal?" Justice Elena Kagan wondered. "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?

Solicitor General Donald Verrilli, representing the Obama administration, argued that manipulating a gene into something new might qualify for patent protection, but that isolating what's already there should not.

The administration has supported the compromise position — allowing patents for synthetically produced genetic material but not natural genes themselves.

The case challenged seven Myriad patents that are set to expire in 2015.